diff --git "a/data/2100/s2106.html.txt" "b/data/2100/s2106.html.txt" new file mode 100644--- /dev/null +++ "b/data/2100/s2106.html.txt" @@ -0,0 +1,20505 @@ +[ +# 2106 Patent Subject Matter Eligibility [R-10.2019] + +**I.** **TWO CRITERIA FOR SUBJECT MATTER ELIGIBILITY**First, the claimed invention must be to one of the four + statutory categories. **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** defines the four categories of invention that + Congress deemed to be the appropriate subject matter of a patent: processes, machines, + manufactures and compositions of matter. The latter three categories define "things" or + "products" while the first category defines "actions" (i.e., inventions that consist of + a series of steps or acts to be performed). See **[35 U.S.C. 100(b)](mpep-9015-appx-l.html#d0e302350)** ("The term + ‘process’ means process, art, or method, and includes a new use of a known process, + machine, manufacture, composition of matter, or material."). See **[MPEP § + 2106.03](s2106.html#ch2100_d29a1b_139b2_397)** for detailed information on the four categories. + + + +Second, the claimed invention also must qualify as + patent-eligible subject matter, i.e., the claim must not be directed to a judicial + exception unless the claim as a whole includes additional limitations amounting to + significantly more than the exception. The judicial exceptions (also called "judicially + recognized exceptions" or simply "exceptions") are subject matter that the courts have + found to be outside of, or exceptions to, the four statutory categories of invention, + and are limited to abstract ideas, laws of nature and natural phenomena (including + products of nature). *Alice Corp. Pty. Ltd. v. CLS Bank Int'l,* 573 + U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing *Ass'n for Molecular + Pathology v. Myriad Genetics, Inc.,* 569 U.S. 576, 589, 106 USPQ2d 1972, + 1979 (2013). See **[MPEP § 2106.04](s2106.html#ch2100_d29a1b_139db_e0)** for detailed information + on the judicial exceptions. + + + +Because abstract ideas, laws of nature, and natural + phenomenon "are the basic tools of scientific and technological work", the Supreme Court + has expressed concern that monopolizing these tools by granting patent rights may impede + innovation rather than promote it. See *Alice Corp.,* 573 U.S. at 216, + 110 USPQ2d at 1980; *Mayo Collaborative Servs. v. Prometheus Labs., + Inc.,* 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012). However, the Court has + also emphasized that an invention is not considered to be ineligible for patenting + simply because it involves a judicial exception. *Alice Corp.,* 573 + U.S. at 217, 110 USPQ2d at 1980-81 (citing *Diamond v. Diehr,* 450 U.S. + 175, 187, 209 USPQ 1, 8 (1981)). See also *Thales Visionix Inc. v. United + States,* 850 F.3d. 1343, 1349, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017) ("That + a mathematical equation is required to complete the claimed method and system does not + doom the claims to abstraction."). Accordingly, the Court has said that integration of + an abstract idea, law of nature or natural phenomenon into a practical application may + be eligible for patent protection. See, *e.g., Alice,* 573 U.S. at 217, + 110 USPQ2d at 1981 (explaining that "in applying the **[§101](mpep-9015-appx-l.html#d0e302376)** exception, we must distinguish + between patents that claim the ‘buildin[g] block[s]’ of human ingenuity and those that + integrate the building blocks into something more" (quoting *Mayo,* 566 + U.S. at 89, 110 USPQ2d at 1971) and stating that *Mayo* "set forth a + framework for distinguishing patents that claim laws of nature, natural phenomena, and + abstract ideas from those that claim patent-eligible applications of those concepts"); + *Mayo,* 566 U.S. at 80, 84, 101 USPQ2d at 1969, 1971 (noting that + the Court in *Diamond v. Diehr* found "the overall process patent + eligible because of the way the additional steps of the process integrated the equation + into the process as a whole," but the Court in *Gottschalk v. Benson* + "held that simply implementing a mathematical principle on a physical machine, namely a + computer, was not a patentable application of that principle"); *Bilski v. + Kappos,* 561 U.S. 593, 611, 95 USPQ2d 1001, 1010 (2010) + ("*Diehr* explained that while an abstract idea, law of nature, or + mathematical formula could not be patented, ‘an application of a law of nature or + mathematical formula to a known structure or process may well be deserving of patent + protection.’" (quoting *Diamond v. Diehr,* 450 U.S. 175, 187, 209 USPQ + 1, 8 (1981)) (emphasis in original)); *Diehr,* 450 U.S. at 187, 192 + n.14, 209 USPQ at 10 n.14 (explaining that the process in *Parker v. + Flook* was ineligible not because it contained a mathematical formula, but + because it did not provide an application of the formula). See *Diamond v. + Diehr,* 450 U.S. 175, 209 USPQ 1 (1981); *Gottschalk v. + Benson,* 409 U.S. 63, 175 USPQ 673 (1972); *Parker v. + Flook,* 437 U.S. 584, 198 USPQ 193 (1978). + + + + The Supreme Court in *Mayo* laid out a + framework for determining whether an applicant is seeking to patent a judicial exception + itself, or a patent-eligible application of the judicial exception. See *Alice + Corp.,* 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing + *Mayo*, 566 U.S. 66, 101 USPQ2d 1961). This framework, which is + referred to as the *Mayo* test or the *Alice/Mayo* + test, is discussed in further detail in subsection III, below. The first part of the + *Mayo* test is to determine whether the claims are directed to an + abstract idea, a law of nature or a natural phenomenon (i.e., a judicial exception). + *Id.* If the claims are directed to a judicial exception, the second + part of the *Mayo* test is to determine whether the claim recites + additional elements that amount to significantly more than the judicial exception. + *Id.* citing *Mayo,* 566 U.S. at 72-73, 101 USPQ2d + at 1966). The Supreme Court has described the second part of the test as the "search for + an 'inventive concept'". *Alice Corp.,* 573 U.S. at 217-18, 110 USPQ2d + at 1981 (citing *Mayo*, 566 U.S. at 72-73, 101 USPQ2d at 1966). + + + +The *Alice/Mayo* two-part test is the + only test that should be used to evaluate the eligibility of claims under examination. + While the machine-or-transformation test is an important clue to eligibility, it should + not be used as a separate test for eligibility. Instead it should be considered as part + of the "integration" determination or "significantly more" determination articulated in + the *Alice/Mayo* test. *Bilski v. Kappos,* 561 U.S. + 593, 605, 95 USPQ2d 1001, 1007 (2010). See **[MPEP § + 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)** for more information about evaluating whether a + claim reciting a judicial exception is integrated into a practical application and + **[MPEP § + 2106.05(b)](s2106.html#ch2100_d29a1b_13ccf_18c)** and **[MPEP § + 2106.05(c)](s2106.html#ch2100_d29a1b_13cfb_2e)** for more information about how the + machine-or-transformation test fits into the *Alice/Mayo* two-part + framework. Likewise, eligibility should not be evaluated based on whether the claim + recites a "useful, concrete, and tangible result," *State Street Bank*, + 149 F.3d 1368, 1374, 47 USPQ2d 1596, 1602 (Fed. Cir. 1998) (quoting *In re + Alappat,* 33 F.3d 1526, 1544, 31 USPQ2d 1545, 1557 (Fed. Cir. 1994)), as + this test has been superseded. *In re Bilski,* 545 F.3d 943, 959-60, 88 + USPQ2d 1385, 1394-95 (Fed. Cir. 2008) (*en banc*), aff'd by + *Bilski v. Kappos,* 561 U.S. 593, 95 USPQ2d 1001 (2010). See also + *TLI Communications LLC v. AV Automotive LLC,* 823 F.3d 607, 613, + 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) ("It is well-settled that mere recitation of + concrete, tangible components is insufficient to confer patent eligibility to an + otherwise abstract idea"). The programmed computer or "special purpose computer" test of + *In re Alappat*, 33 F.3d 1526, 31 USPQ2d 1545 (Fed. Cir. 1994) + (*i.e.*, the rationale that an otherwise ineligible algorithm or + software could be made patent-eligible by merely adding a generic computer to the claim + for the "special purpose" of executing the algorithm or software) was also superseded by + the Supreme Court’s *Bilski* and *Alice Corp.* + decisions. *Eon Corp. IP Holdings LLC v. AT&T Mobility LLC,* 785 + F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) ("[W]e note that + *Alappat* has been superseded by *Bilski,* 561 U.S. + at 605–06, and *Alice Corp. v. CLS Bank Int’l,* 573 U.S. 208, 110 + USPQ2d 1976 (2014)"); *Intellectual Ventures I LLC v. Capital One Bank (USA), + N.A.,* 792 F.3d 1363, 1366, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015) ("An + abstract idea does not become nonabstract by limiting the invention to a particular + field of use or technological environment, such as the Internet [or] a computer"). + Lastly, eligibility should not be evaluated based on whether the claimed invention has + utility, because "[u]tility is not the test for patent-eligible subject matter." + *Genetic Techs. Ltd. v. Merial LLC,* 818 F.3d 1369, 1380, 118 USPQ2d + 1541, 1548 (Fed. Cir. 2016). + + + +Examiners are reminded that **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** is + not the sole tool for determining patentability; **[35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)** , **[35 U.S.C. 102](mpep-9015-appx-l.html#d0e302383)**, and + **[35 U.S.C. + 103](mpep-9015-appx-l.html#d0e302450)** will provide additional tools for ensuring that the claim + meets the conditions for patentability. As the Supreme Court made clear in + *Bilski,* 561 U.S. at 602, 95 USPQ2d at 1006: + + + + +> +> The **[§ 101](mpep-9015-appx-l.html#d0e302376)** patent-eligibility inquiry +> is only a threshold test. Even if an invention qualifies as a process, machine, +> manufacture, or composition of matter, in order to receive the Patent Act’s +> protection the claimed invention must also satisfy ‘‘the conditions and requirements +> of this title.’’ **[§ +> 101](mpep-9015-appx-l.html#d0e302376)**. Those requirements include that the invention be novel, +> see **[§ +> 102](mpep-9015-appx-l.html#d0e302383)**, nonobvious, see **[§ 103](mpep-9015-appx-l.html#d0e302450)**, and fully and particularly +> described, see **[§ +> 112](mpep-9015-appx-l.html#d0e302824)**. +> +> +> +> + +**II.** **ESTABLISH BROADEST REASONABLE INTERPRETATION OF CLAIM AS A WHOLE**It is essential that the broadest reasonable interpretation + (BRI) of the claim be established prior to examining a claim for eligibility. The BRI + sets the boundaries of the coverage sought by the claim and will influence whether the + claim seeks to cover subject matter that is beyond the four statutory categories or + encompasses subject matter that falls within the exceptions. See *MyMail, Ltd. + v. ooVoo, LLC,* 934 F.3d 1373, 1379, 2019 USPQ2d 305789 (Fed. Cir. 2019) + ("Determining patent eligibility requires a full understanding of the basic character of + the claimed subject matter"), citing *Bancorp Servs., LLC v. Sun Life Assurance + Co. of Can. (U.S.),* 687 F.3d 1266, 1273-74, 103 USPQ2d 1425, 1430 (Fed. + Cir. 2012); *In re Bilski,* 545 F.3d 943, 951, 88 USPQ2d 1385, 1388 + (Fed. Cir. 2008) (*en banc* ), aff'd by *Bilski v. + Kappos,* 561 U.S. 593, 95 USPQ2d 1001 (2010) ("claim construction … is an + important first step in a **[§ 101](mpep-9015-appx-l.html#d0e302376)** analysis"). Evaluating + eligibility based on the BRI also ensures that patent eligibility under + **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)** does not depend simply on the draftsman’s art. + *Alice,* 573 U.S. 208, 224, 110 USPQ2d at 1984, 1985 (citing + *Parker v. Flook,* 437 U.S. 584, 593, 198 USPQ 193, 198 (1978) and + *Mayo,* 566 U.S. at 72, 101 USPQ2d at 1966). See + **[MPEP § + 2111](s2111.html#d0e200352)** for more information about determining the BRI. + + + +Claim interpretation affects the evaluation of both + criteria for eligibility. For example, in *Mentor Graphics v. EVE-USA, + Inc.,* 851 F.3d 1275, 112 USPQ2d 1120 (Fed. Cir. 2017), claim interpretation + was crucial to the court’s determination that claims to a "machine-readable medium" were + not to a statutory category. In *Mentor Graphics,* the court + interpreted the claims in light of the specification, which expressly defined the medium + as encompassing "any data storage device" including random-access memory and carrier + waves. Although random-access memory and magnetic tape are statutory media, carrier + waves are not because they are signals similar to the transitory, propagating signals + held to be non-statutory in *Nuijten*. 851 F.3d at 1294, 112 USPQ2d at + 1133 (citing *In re Nuijten,* 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. + 2007)). Accordingly, because the BRI of the claims covered both subject matter that + falls within a statutory category (the random-access memory), as well as subject matter + that does not (the carrier waves), the claims as a whole were not to a statutory + category and thus failed the first criterion for eligibility. + + + +With regard to the second criterion for eligibility, the + *Alice/Mayo* test, claim interpretation can affect the first part of + the test (whether the claims are directed to a judicial exception). For example, the + patentee in *Synopsys* argued that the claimed methods of logic circuit + design were intended to be used in conjunction with computer-based design tools, and + were thus not mental processes. *Synopsys, Inc. v. Mentor Graphics + Corp.,* 839 F.3d 1138, 1147-49, 120 USPQ2d 1473, 1480-81 (Fed. Cir. 2016). + The court disagreed, because it interpreted the claims as encompassing nothing other + than pure mental steps (and thus falling within an abstract idea grouping) because the + claims did not include any limitations requiring computer implementation. In contrast, + the patentee in *Enfish* argued that its claimed self-referential table + for a computer database was an improvement in an existing technology and thus not + directed to an abstract idea. *Enfish, LLC v. Microsoft Corp.,* 822 + F.3d 1327, 1336-37, 118 USPQ2d 1684, 1689-90 (Fed. Cir. 2016). The court agreed with the + patentee, based on its interpretation of the claimed "means for configuring" under + **[35 U.S.C. + 112(f)](mpep-9015-appx-l.html#al_d1d85b_2ae7b_ec)** as requiring a four-step algorithm that achieved the + improvements, as opposed to merely any form of storing tabular data. See also + *McRO, Inc. v. Bandai Namco Games America, Inc.* 837 F.3d 1299, + 1314, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) (the claim’s construction incorporated + rules of a particular type that improved an existing technological process). Claim + interpretation can also affect the second part of the *Alice/Mayo* test + (whether the claim recites additional elements that amount to significantly more than + the judicial exception). For example, in *Amdocs (Israel) Ltd. v. Openet + Telecom, Inc.,* where the court relied on the construction of the term + "enhance" (to require application of a number of field enhancements in a distributed + fashion) to determine that the claim entails an unconventional technical solution to a + technological problem. 841 F.3d 1288, 1300-01, 120 USPQ2d 1527, 1537 (Fed. Cir. 2016). + + + +**III.** **SUMMARY OF ANALYSIS AND FLOWCHART**Examiners should determine whether a claim satisfies the + criteria for subject matter eligibility by evaluating the claim in accordance with the + following flowchart. The flowchart illustrates the steps of the subject matter + eligibility analysis for products and processes that are to be used during examination + for evaluating whether a claim is drawn to patent-eligible subject matter. It is + recognized that under the controlling legal precedent there may be variations in the + precise contours of the analysis for subject matter eligibility that will still achieve + the same end result. The analysis set forth herein promotes examination efficiency and + consistency across all technologies. + + + + As shown in the flowchart, Step 1 relates to the + statutory categories and ensures that the first criterion is met by confirming that the + claim falls within one of the four statutory categories of invention. See + **[MPEP § + 2106.03](s2106.html#ch2100_d29a1b_139b2_397)** for more information on Step 1. Step 2, which is the + Supreme Court’s *Alice/Mayo* test, is a two-part test to identify + claims that are directed to a judicial exception (Step 2A) and to then evaluate if + additional elements of the claim provide an inventive concept (Step 2B) (also called + "significantly more" than the recited judicial exception). See **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)** for more information on Step 2A and + **[MPEP § + 2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)** for more information on Step 2B. + + + +The flowchart also shows three pathways (A, B, and C) to + eligibility: + + + +* Pathway A: Claims taken as a whole that fall within + a statutory category (Step 1: YES) and, which may or may not recite a judicial + exception, but whose eligibility is self-evident can be found eligible at Pathway + A using a streamlined analysis. See **[MPEP § + 2106.06](s2106.html#ch2100_d29a1b_13e6a_88)** for more information on this pathway and on + self-evident eligibility. +* Pathway B: Claims taken as a whole that fall within + a statutory category (Step 1: YES) and are not directed to a judicial exception + (Step 2A: NO) are eligible at Pathway B. These claims do not need to go to Step + 2B. See **[MPEP § 2106.04](s2106.html#ch2100_d29a1b_139db_e0)** for more + information about this pathway and Step 2A. +* Pathway C: Claims taken as a whole that fall + within a statutory category (Step 1: YES), are directed to a judicial exception + (Step 2A: YES), and recite additional elements either individually or in an + ordered combination that amount to significantly more than the judicial exception + (Step 2B: YES) are eligible at Pathway C. See **[MPEP § + 2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)** for more information about this pathway and Step + 2B. + + +Claims that could have been found eligible at Pathway A + (streamlined analysis), but are subjected to further analysis at Steps 2A or Step 2B, + will ultimately be found eligible at Pathways B or C. Thus, if the examiner is uncertain + about whether a streamlined analysis is appropriate, the examiner is encouraged to + conduct a full eligibility analysis. However, if the claim is not found eligible at any + of Pathways A, B or C, the claim is patent ineligible and should be rejected under + **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)**. + + + +Regardless of whether a rejection under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** is + made, a complete examination should be made for every claim under each of the other + patentability requirements: **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)**, **[103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)**, + **[112](mpep-9015-appx-l.html#d0e302824912)**, and **[101](mpep-9015-appx-l.html#d0e302376)** (utility, inventorship and + double patenting) and non-statutory double patenting. **[MPEP § + 2103](s2103.html#ch2100_d1b13f_18960_3c9)**. + + + +![Subject Matter Eligibility Flowchart](graphics/2106-1.png) + +# 2106.01 [Reserved] + + + + +# 2106.02 [Reserved] + + + + +# 2106.03 Eligibility Step 1: The Four Categories of + Statutory Subject Matter [R-10.2019] + +**I.** **THE FOUR + CATEGORIES****[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** enumerates four + categories of subject matter that Congress deemed to be appropriate subject matter + for a patent: processes, machines, manufactures and compositions of matter. As + explained by the courts, these "four categories together describe the exclusive reach + of patentable subject matter. If a claim covers material not found in any of the four + statutory categories, that claim falls outside the plainly expressed scope of + **[§ + 101](mpep-9015-appx-l.html#d0e302376)** even if the subject matter is otherwise new and useful." + *In re Nuijten,* 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. + Cir. 2007). + + + +A process defines "actions", *i.e.,* + an invention that is claimed as an act or step, or a series of acts or steps. As + explained by the Supreme Court, a "process" is "a mode of treatment of certain + materials to produce a given result. It is an *act, or a series of + acts,* performed upon the subject-matter to be transformed and reduced to + a different state or thing." *Gottschalk v. Benson,* 409 U.S. 63, + 70, 175 USPQ 673, 676 (1972) (italics added) (quoting *Cochrane v. + Deener,* 94 U.S. 780, 788, 24 L. Ed. 139, 141 (1876)). See also + *Nuijten,* 500 F.3d at 1355, 84 USPQ2d at 1501 ("The Supreme + Court and this court have consistently interpreted the statutory term ‘process’ to + require action"); *NTP, Inc. v. Research in Motion, Ltd.,* 418 F.3d + 1282, 1316, 75 USPQ2d 1763, 1791 (Fed. Cir. 2005) ("[A] process is a series of + acts.") (quoting *Minton v. Natl. Ass’n. of Securities Dealers,* 336 + F.3d 1373, 1378, 67 USPQ2d 1614, 1681 (Fed. Cir. 2003)). As defined in + **[35 U.S.C. + 100(b)](mpep-9015-appx-l.html#d0e302350)**, the term "process" is synonymous with "method." + + + +The other three categories (machines, manufactures + and compositions of matter) define the types of physical or tangible "things" or + "products" that Congress deemed appropriate to patent. *Digitech Image Techs. + v. Electronics for Imaging,* 758 F.3d 1344, 1348, 111 USPQ2d 1717, 1719 + (Fed. Cir. 2014) ("For all categories except process claims, the eligible subject + matter must exist in some physical or tangible form."). Thus, when determining + whether a claimed invention falls within one of these three categories, examiners + should verify that the invention is to at least one of the following categories + **and** is claimed in a physical or tangible form. + + + +* • A machine is a "concrete thing, consisting of + parts, or of certain devices and combination of devices." + *Digitech,* 758 F.3d at 1348-49, 111 USPQ2d at 1719 + (quoting *Burr v. Duryee,* 68 U.S. 531, 570, 17 L. Ed. 650, + 657 (1863)). This category "includes every mechanical device or combination of + mechanical powers and devices to perform some function and produce a certain + effect or result." *Nuijten,* 500 F.3d at 1355, 84 USPQ2d at + 1501 (quoting *Corning v. Burden,* 56 U.S. 252, 267, 14 L. Ed. + 683, 690 (1854)). +* • A manufacture is "a tangible article that is + given a new form, quality, property, or combination through man-made or + artificial means." *Digitech,* 758 F.3d at 1349, 111 USPQ2d at + 1719-20 (citing *Diamond v. Chakrabarty,* 447 U.S. 303, 308, + 206 USPQ 193, 197 (1980)). As the courts have explained, manufactures are + articles that result from the process of manufacturing, + *i.e.,* they were produced "from raw or prepared materials + by giving to these materials new forms, qualities, properties, or combinations, + whether by hand-labor or by machinery." *Samsung Electronics Co. v. + Apple Inc.,* 580 U.S. \_\_, 120 USPQ2d 1749, 1752-3 (2016) (quoting + *Diamond v. Chakrabarty,* 447 U. S. 303, 308, 206 USPQ 193, + 196-97 (1980)); *Nuijten,* 500 F.3d at 1356-57, 84 USPQ2d at + 1502. Manufactures also include "the parts of a machine considered separately + from the machine itself." *Samsung Electronics,* 137 S. Ct. at + 435, 120 USPQ2d at 1753 (quoting 1 W. Robinson, The Law of Patents for Useful + Inventions §183, p. 270 (1890)). +* • A composition of matter is a "combination of + two or more substances and includes all composite articles." + *Digitech,* 758 F.3d at 1348-49, 111 USPQ2d at 1719 + (citation omitted). This category includes all compositions of two or more + substances and all composite articles, "'whether they be the results of + chemical union or of mechanical mixture, or whether they be gases, fluids, + powders or solids.'" *Chakrabarty,* 447 U.S. at 308, 206 USPQ + at 197 (quoting *Shell Dev. Co. v. Watson,* 149 F. Supp. 279, + 280 (D.D.C. 1957); *id.* at 310 holding genetically modified + microorganism to be a manufacture or composition of matter). + + +It is not necessary to identify a single category into + which a claim falls, so long as it is clear that the claim falls into at least one + category. For example, because a microprocessor is generally understood to be a + manufacture, a product claim to the microprocessor or a system comprising the + microprocessor satisfies Step 1 regardless of whether the claim falls within any + other statutory category (such as a machine). It is also not necessary to identify a + "correct" category into which the claim falls, because although in many instances it + is clear within which category a claimed invention falls, a claim may satisfy the + requirements of more than one category. For example, a bicycle satisfies both the + machine and manufacture categories, because it is a tangible product that is concrete + and consists of parts such as a frame and wheels (thus satisfying the machine + category), and it is an article that was produced from raw materials such as aluminum + ore and liquid rubber by giving them a new form (thus satisfying the manufacture + category). Similarly, a genetically modified bacterium satisfies both the composition + of matter and manufacture categories, because it is a tangible product that is a + combination of two or more substances such as proteins, carbohydrates and other + chemicals (thus satisfying the composition of matter category), and it is an article + that was genetically modified by humans to have new properties such as the ability to + digest multiple types of hydrocarbons (thus satisfying the manufacture category). + + + +Non-limiting examples of claims that are not directed + to any of the statutory categories include: + + + +* • Products that do not have a physical or + tangible form, such as information (often referred to as "data per se") or a + computer program per se (often referred to as "software per se") when claimed + as a product without any structural recitations; +* • Transitory forms of signal transmission + (often referred to as "signals per se"), such as a propagating electrical or + electromagnetic signal or carrier wave; and +* • Subject matter that the statute expressly + prohibits from being patented, such as humans per se, which are excluded under + The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33, 125 + Stat. 284 (September 16, 2011). + + +As the courts' definitions of machines, manufactures + and compositions of matter indicate, a product must have a physical or tangible form + in order to fall within one of these statutory categories. + *Digitech,* 758 F.3d at 1348, 111 USPQ2d at 1719. Thus, the + Federal Circuit has held that a product claim to an intangible collection of + information, even if created by human effort, does not fall within any statutory + category. *Digitech,* 758 F.3d at 1350, 111 USPQ2d at 1720 (claimed + "device profile" comprising two sets of data did not meet any of the categories + because it was neither a process nor a tangible product). Similarly, software + expressed as code or a set of instructions detached from any medium is an idea + without physical embodiment. See *Microsoft Corp. v. AT&T + Corp.,* 550 U.S. 437, 449, 82 USPQ2d 1400, 1407 (2007); see also + *Benson,* 409 U.S. 67, 175 USPQ2d 675 (An "idea" is not patent + eligible). Thus, a product claim to a software program that does not also contain at + least one structural limitation (such as a "means plus function" limitation) has no + physical or tangible form, and thus does not fall within any statutory category. + Another example of an intangible product that does not fall within a statutory + category is a paradigm or business model for a marketing company. *In re + Ferguson,* 558 F.3d 1359, 1364, 90 USPQ2d 1035, 1039-40 (Fed. Cir. 2009). + + + +Even when a product has a physical or tangible form, + it may not fall within a statutory category. For instance, a transitory signal, while + physical and real, does not possess concrete structure that would qualify as a device + or part under the definition of a machine, is not a tangible article or commodity + under the definition of a manufacture (even though it is man-made and physical in + that it exists in the real world and has tangible causes and effects), and is not + composed of matter such that it would qualify as a composition of matter. + *Nuijten,* 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03. As such, + a transitory, propagating signal does not fall within any statutory category. + *Mentor Graphics Corp. v. EVE-USA, Inc.,* 851 F.3d 1275, 1294, + 112 USPQ2d 1120, 1133 (Fed. Cir. 2017); *Nuijten,* 500 F.3d at + 1356-1357, 84 USPQ2d at 1501-03. + + +**II.** **ELIGIBILITY STEP 1: WHETHER A CLAIM + IS TO A STATUTORY CATEGORY**As described in **[MPEP § 2106](s2106.html#d0e197244)**, + subsection III, Step 1 of the eligibility analysis asks: Is the claim to a process, + machine, manufacture or composition of matter? Like the other steps in the + eligibility analysis, evaluation of this step should be made after determining what + applicant has invented by reviewing the entire application disclosure and construing + the claims in accordance with their broadest reasonable interpretation (BRI). See + **[MPEP § + 2106](s2106.html#d0e197244)**, subsection II, for more information about the + importance of understanding what the applicant has invented, and + **[MPEP § + 2111](s2111.html#d0e200352)** for more information about the BRI. + + + +In the context of the flowchart in + **[MPEP § + 2106](s2106.html#d0e197244)**, subsection III, Step 1 determines whether: + + + +* • The claim as a whole does not fall within any + statutory category (Step 1: NO) and thus is non-statutory, warranting a + rejection for failure to claim statutory subject matter; or +* • The claim as a whole falls within one or + more statutory categories (Step 1: YES), and thus must be further analyzed to + determine whether it qualifies as eligible at Pathway A or requires further + analysis at Step 2A to determine if the claim is directed to a judicial + exception. + + +A claim whose BRI covers both statutory and + non-statutory embodiments embraces subject matter that is not eligible for patent + protection and therefore is directed to non-statutory subject matter. Such claims + fail the first step (Step 1: NO) and should be rejected under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**, + for at least this reason. In such a case, it is a best practice for the examiner to + point out the BRI and recommend an amendment, if possible, that would narrow the + claim to those embodiments that fall within a statutory category. + + + +For example, the BRI of machine readable media can + encompass non-statutory transitory forms of signal transmission, such as a + propagating electrical or electromagnetic signal per se. See *In re + Nuijten,* 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the BRI + encompasses transitory forms of signal transmission, a rejection under + **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)** as failing to claim statutory subject matter would be + appropriate. Thus, a claim to a computer readable medium that can be a compact disc + or a carrier wave covers a non-statutory embodiment and therefore should be rejected + under **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)** as being directed to non-statutory subject matter. See, + *e.g., Mentor Graphics v. EVE-USA, Inc.,* 851 F.3d at 1294-95, + 112 USPQ2d at 1134 (claims to a "machine-readable medium" were non-statutory, because + their scope encompassed both statutory random-access memory and non-statutory carrier + waves). + + + +If a claim is clearly not within one of the four + categories (Step 1: NO), then a rejection under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** must be made + indicating that the claim is directed to non-statutory subject matter. Form + paragraphs **[7.05](#fp7.05)** and **[7.05.01](#fp7.05.01)** should be used; see + **[MPEP + § 2106.07(a)(1)](s2106.html#ch2100_d2c183_20b8d_1b9)**. However, as shown in the flowchart in + **[MPEP § + 2106](s2106.html#d0e197244)** subsection III, when a claim fails under Step 1 (Step + 1: NO), but it appears from applicant’s disclosure that the claim could be amended to + fall within a statutory category (Step 1: YES), the analysis should proceed to + determine whether such an amended claim would qualify as eligible at Pathway A, B or + C. In such a case, it is a best practice for the examiner to recommend an amendment, + if possible, that would resolve eligibility of the claim. + + + + + +# 2106.04 Eligibility Step 2A: Whether a Claim is Directed + to a Judicial Exception [R-10.2019] + +**I.** **JUDICIAL EXCEPTIONS**Determining that a claim falls within one of the four + enumerated categories of patentable subject matter recited in **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** + (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not + end the eligibility analysis, because claims directed to nothing more than abstract + ideas (such as a mathematical formula or equation), natural phenomena, and laws of + nature are not eligible for patent protection. *Diamond v. Diehr,* + 450 U.S. 175, 185, 209 USPQ 1, 7 (1981). *Alice Corp. Pty. Ltd. v. CLS Bank + Int'l,* 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing + *Association for Molecular Pathology v. Myriad Genetics, Inc.,* + 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013)); *Diamond v. + Chakrabarty,* 447 U.S. 303, 309, 206 USPQ 193, 197 (1980); + *Parker v. Flook,* 437 U.S. 584, 589, 198 USPQ 193, 197 (1978); + *Gottschalk v. Benson,* 409 U.S. 63, 67-68, 175 USPQ 673, 675 + (1972). See also *Bilski v. Kappos,* 561 U.S. 593, 601, 95 USPQ2d + 1001, 1005-06 (2010) ("The Court’s precedents provide three specific exceptions to + **[§ + 101's](mpep-9015-appx-l.html#d0e302376)** broad patent-eligibility principles: ‘laws of nature, + physical phenomena, and abstract ideas’") (quoting *Chakrabarty,* + 447 U.S. at 309, 206 USPQ at 197 (1980)). + + + +In addition to the terms "laws of nature," "natural + phenomena," and "abstract ideas," judicially recognized exceptions have been + described using various other terms, including "physical phenomena," "products of + nature," "scientific principles," "systems that depend on human intelligence alone," + "disembodied concepts," "mental processes," and "disembodied mathematical algorithms + and formulas." It should be noted that there are no bright lines between the types of + exceptions, and that many of the concepts identified by the courts as exceptions can + fall under several exceptions. For example, mathematical formulas are considered to + be a judicial exception as they express a scientific truth, but have been labelled by + the courts as both abstract ideas and laws of nature. Likewise, "products of nature" + are considered to be an exception because they tie up the use of naturally occurring + things, but have been labelled as both laws of nature and natural phenomena. Thus, it + is sufficient for this analysis for the examiner to identify that the claimed concept + (the specific claim limitation(s) that the examiner believes may recite an exception) + aligns with at least one judicial exception. + + + +The Supreme Court has explained that the judicial + exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural + phenomena are "the basic tools of scientific and technological work", and are thus + excluded from patentability because "monopolization of those tools through the grant + of a patent might tend to impede innovation more than it would tend to promote it." + *Alice Corp.,* 573 U.S. at 216, 110 USPQ2d at 1980 (quoting + *Myriad,* 569 U.S. at 589, 106 USPQ2d at 1978 and *Mayo + Collaborative Servs. v. Prometheus Labs. Inc.,* 566 U.S. 66, 71, 101 + USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary + principle" is pre-emption. *Alice Corp.,* 573 U.S. at 216, 110 + USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws + of nature, or natural phenomena, even if the judicial exception is narrow (e.g., a + particular mathematical formula such as the Arrhenius equation). See, *e.g., + Mayo,* 566 U.S. at 79-80, 86-87, 101 USPQ2d at 1968-69, 1971 (claims + directed to "narrow laws that may have limited applications" held ineligible); + *Flook,* 437 U.S. at 589-90, 198 USPQ at 197 (claims that did not + "wholly preempt the mathematical formula" held ineligible). This is because such a + patent would "in practical effect [] be a patent on the [abstract idea, law of nature + or natural phenomenon] itself." *Benson,* 409 U.S. at 71- 72, 175 + USPQ at 676. The concern over preemption was expressed as early as 1852. See + *Le Roy v. Tatham,* 55 U.S. (14 How.) 156, 175 (1852) ("A + principle, in the abstract, is a fundamental truth; an original cause; a motive; + these cannot be patented, as no one can claim in either of them an exclusive + right."). + + + +While preemption is the concern underlying the + judicial exceptions, it is not a standalone test for determining eligibility. + *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d 1042, 1052, + 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent + in and resolved by the two-part framework from *Alice Corp. and + Mayo* (the *Alice/Mayo* test referred to by the Office + as Steps 2A and 2B). *Synopsys, Inc. v. Mentor Graphics Corp.,* 839 + F.3d 1138, 1150, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016); *Ariosa Diagnostics, + Inc. v. Sequenom, Inc.,* 788 F.3d 1371, 1379, 115 USPQ2d 1152, 1158 (Fed. + Cir. 2015). It is necessary to evaluate eligibility using the + *Alice/Mayo* test, because while a preemptive claim may be + ineligible, the absence of complete preemption does not demonstrate that a claim is + eligible. *Diamond v. Diehr,* 450 U.S. 175, 191-92 n.14, 209 USPQ 1, + 10-11 n.14 (1981) ("We rejected in *Flook* the argument that because + all possible uses of the mathematical formula were not pre-empted, the claim should + be eligible for patent protection"). See also *Synopsys v. Mentor + Graphics,* 839 F.3d at 1150, 120 USPQ2d at 1483; *FairWarning IP, + LLC v. Iatric Sys., Inc.,* 839 F.3d 1089, 1098, 120 USPQ2d 1293, 1299 + (Fed. Cir. 2016); *Intellectual Ventures I LLC v. Symantec Corp.,* + 838 F.3d 1307, 1320-21, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); + *Sequenom,* 788 F.3d at 1379, 115 USPQ2d at 1158. Several Federal + Circuit decisions, however, have noted the absence of preemption when finding claims + eligible under the *Alice/Mayo* test. *McRO, Inc. v. Bandai + Namco Games Am. Inc.,* 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-03 + (Fed. Cir. 2016); *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 + F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016); *BASCOM Global + Internet v. AT&T Mobility, LLC,* 827 F.3d 1341, 1350-52, 119 USPQ2d + 1236, 1243-44 (Fed. Cir. 2016). + + + +The Supreme Court’s decisions make it clear that + judicial exceptions need not be old or long-prevalent, and that even newly discovered + or novel judicial exceptions are still exceptions. For example, the mathematical + formula in *Flook,* the laws of nature in *Mayo,* + and the isolated DNA in *Myriad* were all novel or newly discovered, + but nonetheless were considered by the Supreme Court to be judicial exceptions + because they were "‘basic tools of scientific and technological work’ that lie beyond + the domain of patent protection." *Myriad,* 569 U.S. 576, 589, 106 + USPQ2d at 1976, 1978 (noting that *Myriad* discovered the BRCA1 and + BRCA1 genes and quoting *Mayo,* 566 U.S. 71, 101 USPQ2d at 1965); + *Flook,* 437 U.S. at 591-92, 198 USPQ2d at 198 ("the novelty of + the mathematical algorithm is not a determining factor at all"); + *Mayo,* 566 U.S. 73-74, 78, 101 USPQ2d 1966, 1968 (noting that + the claims embody the researcher's discoveries of laws of nature). The Supreme + Court’s cited rationale for considering even "just discovered" judicial exceptions as + exceptions stems from the concern that "without this exception, there would be + considerable danger that the grant of patents would ‘tie up’ the use of such tools + and thereby ‘inhibit future innovation premised upon them.’" + *Myriad,* 569 U.S. at 589, 106 USPQ2d at 1978-79 (quoting + *Mayo,* 566 U.S. at 86, 101 USPQ2d at 1971). See also + *Myriad,* 569 U.S. at 591, 106 USPQ2d at 1979 ("Groundbreaking, + innovative, or even brilliant discovery does not by itself satisfy the + **[§101](mpep-9015-appx-l.html#d0e302376)** inquiry."). The Federal Circuit has also applied this + principle, for example, when holding a concept of using advertising as an exchange or + currency to be an abstract idea, despite the patentee’s arguments that the concept + was "new". *Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, 714-15, + 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). *Cf. Synopsys, Inc. v. Mentor + Graphics Corp.,* 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. + 2016) ("a ***new*** abstract idea is still an abstract + idea") (emphasis in original). + + + + For a detailed discussion of abstract ideas, see + **[MPEP + § 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**; for a detailed discussion of laws of nature, + natural phenomena and products of nature, see **[MPEP § + 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)**. + + +**II.** **ELIGIBILITY STEP 2A: WHETHER A CLAIM + IS DIRECTED TO A JUDICIAL EXCEPTION**As described in **[MPEP § 2106](s2106.html#d0e197244)**, + subsection III, Step 2A of the Office’s eligibility analysis is the first part of the + *Alice/Mayo* test, *i.e.,* the Supreme Court’s + "framework for distinguishing patents that claim laws of nature, natural phenomena, + and abstract ideas from those that claim patent-eligible applications of those + concepts." *Alice Corp. Pty. Ltd. v. CLS Bank Int'l,* 573 U.S. 208, + 217-18, 110 USPQ2d 1976, 1981 (2014) (citing *Mayo,* 566 U.S. at + 77-78, 101 USPQ2d at 1967-68). Like the other steps in the eligibility analysis, + evaluation of this step should be made after determining what applicant has invented + by reviewing the entire application disclosure and construing the claims in + accordance with their broadest reasonable interpretation. See **[MPEP § 2106](s2106.html#d0e197244)**, + subsection II for more information about the importance of understanding what the + applicant has invented, and **[MPEP § 2111](s2111.html#d0e200352)** for more information + about the broadest reasonable interpretation. + + + +Step 2A asks: Is the claim directed to a law of + nature, a natural phenomenon (product of nature) or an abstract idea? In the context + of the flowchart in **[MPEP § 2106](s2106.html#d0e197244)**, subsection III, Step 2A determines whether: + + + +* • The claim as a whole is not directed to a + judicial exception (Step 2A: NO) and thus is eligible at Pathway B, thereby + concluding the eligibility analysis; or +* • The claim as a whole is directed to a + judicial exception (Step 2A: YES) and thus requires further analysis at Step 2B + to determine if the claim as a whole amounts to significantly more than the + exception itself. + +**A.*****Step 2A Is a Two Prong Inquiry***Step 2A is a two-prong inquiry, in which examiners + determine in Prong One whether a claim recites a judicial exception, and if so, then + determine in Prong Two if the recited judicial exception is integrated into a + practical application of that exception. Together, these prongs represent the first + part of the *Alice/Mayo* test, which determines whether a claim is + directed to a judicial exception. + + + +The flowchart below depicts the two-prong analysis + that is performed in order to answer the Step 2A inquiry. + + + +![Subject Matter Eligibility Flowchart](graphics/210604_step_2a.png)**1.** **Prong One**Prong One asks does the claim recite an abstract + idea, law of nature, or natural phenomenon? In Prong One examiners evaluate + whether the claim recites a judicial exception, i.e. whether a law of nature, + natural phenomenon, or abstract idea is **set forth** or + **described** in the claim. While the terms "set forth" and + "described" are thus both equated with "recite", their different language is + intended to indicate that there are two ways in which an exception can be recited + in a claim. For instance, the claims in *Diehr,* 450 U.S. at 178 + n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical + equation in the repetitively calculating step, and the claims in + *Mayo,* 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), + clearly stated laws of nature in the wherein clause, such that the claims "set + forth" an identifiable judicial exception. Alternatively, the claims in + *Alice Corp.,* 573 U.S. at 218, 110 USPQ2d at 1982, described + the concept of intermediated settlement without ever explicitly using the words + "intermediated" or "settlement." + + + +The Supreme Court has held that Section 101 + contains an implicit exception for ‘‘[l]aws of nature, natural phenomena, and + abstract ideas,’’ which are ‘‘the basic tools of scientific and technological + work.’’ *Alice Corp.,* 573 U.S. at 216, 110 USPQ2d at 1980 + (citing *Mayo,* 566 US at 71, 101 USPQ2d at 1965). Yet, the Court + has explained that ‘‘[a]t some level, all inventions embody, use, reflect, rest + upon, or apply laws of nature, natural phenomena, or abstract ideas,’’ and has + cautioned ‘‘to tread carefully in construing this exclusionary principle lest it + swallow all of patent law.’’ *Id.* See also *Enfish, LLC + v. Microsoft Corp.,* 822 F.3d 1327, 1335, 118 USPQ2d 1684, 1688 (Fed. + Cir. 2016) ("The ‘directed to’ inquiry, therefore, cannot simply ask whether the + claims involve a patent-ineligible concept, because essentially every routinely + patent-eligible claim involving physical products and actions involves a law of + nature and/or natural phenomenon"). Examiners should accordingly be careful to + distinguish claims that **recite** an exception (which require further + eligibility analysis) and claims that merely **involve** an exception + (which are eligible and do not require further eligibility analysis). + + + +An example of a claim that recites a judicial + exception is "A machine comprising elements that operate in accordance with F=ma." + This claim sets forth the principle that force equals mass times acceleration + (F=ma) and therefore recites a law of nature exception. Because F=ma represents a + mathematical formula, the claim could alternatively be considered as reciting an + abstract idea. Because this claim recites a judicial exception, it requires + further analysis in Prong Two in order to answer the Step 2A inquiry. An example + of a claim that merely involves, or is based on, an exception is a claim to "A + teeter-totter comprising an elongated member pivotably attached to a base member, + having seats and handles attached at opposing sides of the elongated member." This + claim is based on the concept of a lever pivoting on a fulcrum, which involves the + natural principles of mechanical advantage and the law of the lever. However, this + claim does not recite these natural principles and therefore is not directed to a + judicial exception (Step 2A: NO). Thus, the claim is eligible at Pathway B without + further analysis. + + + +If the claim recites a judicial exception + (*i.e.,* an abstract idea enumerated in **[MPEP § + 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**, a law of nature, or a natural phenomenon), + the claim requires further analysis in Prong Two. If the claim does not recite a + judicial exception (a law of nature, natural phenomenon, or abstract idea), then + the claim cannot be directed to a judicial exception (Step 2A: NO), and thus the + claim is eligible at Pathway B without further analysis. + + + +For more information how to determine if a claim + recites an abstract idea, see **[MPEP § + 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**. For more information on how to determine if + a claim recites a law of nature or natural phenomenon, see **[MPEP § + 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)**. For more information on how to determine if + a claim recites a product of nature, see **[MPEP § + 2106.04(c)](s2106.html#ch2100_d29a1b_13bc1_b1)**. + + +**2.** **Prong Two**Prong Two asks does the claim recite additional + elements that integrate the judicial exception into a practical application? In + Prong Two, examiners evaluate whether the claim as a whole integrates the + exception into a practical application of that exception. If the additional + elements in the claim integrate the recited exception into a practical application + of the exception, then the claim is not directed to the judicial exception (Step + 2A: NO) and thus is eligible at Pathway B. This concludes the eligibility + analysis. If, however, the additional elements do not integrate the exception into + a practical application, then the claim is directed to the recited judicial + exception (Step 2A: YES), and requires further analysis under Step 2B (where it + may still be eligible if it amounts to an ‘‘inventive concept’’). For more + information on how to evaluate whether a judicial exception is integrated into a + practical application, see **[MPEP § 2106.04(d)(2)](s2106.html#ch2100_d2e827_17196_6c)**. + + + +The mere inclusion of a judicial exception such as + a mathematical formula (which is one of the mathematical concepts identified as an + abstract idea in **[MPEP § 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**) in a claim + means that the claim "recites" a judicial exception under Step 2A Prong One. + However, mere recitation of a judicial exception does not mean that the claim is + "directed to" that judicial exception under Step 2A Prong Two. Instead, under + Prong Two, a claim that recites a judicial exception is not directed to that + judicial exception, if the claim as a whole integrates the recited judicial + exception into a practical application of that exception. Prong Two thus + distinguishes claims that are "directed to" the recited judicial exception from + claims that are not "directed to" the recited judicial exception. + + + +Because a judicial exception is not eligible + subject matter, *Bilski,* 561 U.S. at 601, 95 USPQ2d at 1005-06 + (quoting *Chakrabarty,* 447 U.S. at 309, 206 USPQ at 197 (1980)), + if there are no additional claim elements besides the judicial exception, or if + the additional claim elements merely recite another judicial exception, that is + insufficient to integrate the judicial exception into a practical application. + See, *e.g., RecogniCorp, LLC v. Nintendo Co.,* 855 F.3d 1322, + 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to + another abstract idea (encoding and decoding) does not render the claim + non-abstract"); *Genetic Techs. v. Merial LLC,* 818 F.3d 1369, + 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by + the unpatentable law of nature (or natural phenomenon or abstract idea) itself."). + For a claim reciting a judicial exception to be eligible, the additional elements + (if any) in the claim must "transform the nature of the claim" into a + patent-eligible application of the judicial exception, *Alice + Corp.,* 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in + Step 2B. If there are no additional elements in the claim, then it cannot be + eligible. In such a case, after making the appropriate rejection (see + **[MPEP § 2106.07](s2106.html#ch2100_d29a1b_13fb7_330)** for more information on formulating a + rejection for lack of eligibility), it is a best practice for the examiner to + recommend an amendment, if possible, that would resolve eligibility of the claim. + + + +**B.*****Evaluating Claims Reciting Multiple Judicial + Exceptions***A claim may recite multiple judicial exceptions. + For example, claim 4 at issue in *Bilski v. Kappos,* 561 U.S. + 593, 95 USPQ2d 1001 (2010) recited two abstract ideas, and the claims at issue in + *Mayo Collaborative Servs. v. Prometheus Labs. Inc.,* 566 U.S. + 66, 101 USPQ2d 1961 (2012) recited two laws of nature. However, these claims were + analyzed by the Supreme Court in the same manner as claims reciting a single + judicial exception, such as those in *Alice Corp.,* 573 U.S. 208, + 110 USPQ2d 1976. + + + +During examination, examiners should apply the + same eligibility analysis to all claims regardless of the number of exceptions + recited therein. Unless it is clear that a claim recites distinct exceptions, such + as a law of nature and an abstract idea, care should be taken not to parse the + claim into multiple exceptions, particularly in claims involving abstract ideas. + Accordingly, if possible examiners should treat the claim for Prong Two and Step + 2B purposes as containing a single judicial exception. + + + +In some claims, the multiple exceptions are + distinct from each other, *e.g.,* a first limitation describes a + law of nature, and a second limitation elsewhere in the claim recites an abstract + idea. In these cases, for purposes of examination efficiency, examiners should + select one of the exceptions and conduct the eligibility analysis for that + selected exception. If the analysis indicates that the claim recites an additional + element or combination of elements that integrate the selected exception into a + practical application or that amount to significantly more than the selected + exception, then the claim should be considered patent eligible. On the other hand, + if the claim does not recite any additional element or combination of elements + that integrate the selected exception into a practical application, and also does + not recite any additional element or combination of elements that amounts to + significantly more than the selected exception, then the claim should be + considered ineligible. *University of Utah Research Foundation v. Ambry + Genetics,* 774 F.3d 755, 762, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014) + (because claims did not amount to significantly more than the recited abstract + idea, court "need not decide" if claims also recited a law of nature). + + + +In other claims, multiple abstract ideas, which + may fall in the same or different groupings, or multiple laws of nature may be + recited. In these cases, examiners should not parse the claim. For example, in a + claim that includes a series of steps that recite mental steps as well as a + mathematical calculation, an examiner should identify the claim as reciting both a + mental process and a mathematical concept for Step 2A Prong One to make the + analysis clear on the record. However, if possible, the examiner should consider + the limitations together as a single abstract idea for Step 2A Prong Two and Step + 2B (if necessary) rather than as a plurality of separate abstract ideas to be + analyzed individually. + + + + +# 2106.04(a) Abstract Ideas [R-10.2019] + + +The abstract idea exception has deep roots in the + Supreme Court’s jurisprudence. See *Bilski v. Kappos,* 561 U.S. 593, + 601-602, 95 USPQ2d 1001, 1006 (2010) (citing *Le Roy v. Tatham,* 55 + U.S. (14 How.) 156, 174–175 (1853)). Despite this long history, the courts have + declined to define abstract ideas. However, it is clear from the body of judicial + precedent that software and business methods are not excluded categories of subject + matter. For example, the Supreme Court concluded that business methods are not + "categorically outside of **[§ 101's](mpep-9015-appx-l.html#d0e302376)** scope," stating that "a + business method is simply one kind of ‘method’ that is, at least in some + circumstances, eligible for patenting under **[§ 101](mpep-9015-appx-l.html#d0e302376)**." + *Bilski,* 561 U.S. at 607, 95 USPQ2d at 1008 (2010). See also + *Content Extraction and Transmission, LLC v. Wells Fargo Bank,* + 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357 (Fed. Cir. 2014) ("there is no categorical + business-method exception"). Likewise, software is not automatically an abstract + idea, even if performance of a software task involves an underlying mathematical + calculation or relationship. See, *e.g., Thales Visionix, Inc. v. United + States,* 850 F.3d 1343, 121 USPQ2d 1898, 1902 ("That a mathematical + equation is required to complete the claimed method and system does not doom the + claims to abstraction."); *McRO, Inc. v. Bandai Namco Games Am. + Inc.,* 837 F.3d 1299, 1316, 120 USPQ2d 1091, 1103 (Fed. Cir. 2016) + (methods of automatic lip synchronization and facial expression animation using + computer-implemented rules were not directed to an abstract idea); *Enfish,* 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016) (claims to + self-referential table for a computer database were not directed to an abstract + idea). + + + +To facilitate examination, the Office has set forth an + approach to identifying abstract ideas that distills the relevant case law into + enumerated groupings of abstract ideas. The enumerated groupings are firmly rooted in + Supreme Court precedent as well as Federal Circuit decisions interpreting that + precedent, as is explained in **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**. This approach + represents a shift from the former case-comparison approach that required examiners + to rely on individual judicial cases when determining whether a claim recites an + abstract idea. By grouping the abstract ideas, the examiners’ focus has been shifted + from relying on individual cases to generally applying the wide body of case law + spanning all technologies and claim types. + + + +The enumerated groupings of abstract ideas are + defined as: + + + +* 1) Mathematical concepts – mathematical + relationships, mathematical formulas or equations, mathematical calculations + (see **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, + subsection I); +* 2) Certain methods of organizing human activity – + fundamental economic principles or practices (including hedging, insurance, + mitigating risk); commercial or legal interactions (including agreements in the + form of contracts; legal obligations; advertising, marketing or sales + activities or behaviors; business relations); managing personal behavior or + relationships or interactions between people (including social activities, + teaching, and following rules or instructions) (see **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, subsection II); and +* 3) Mental processes – concepts performed in the + human mind (including an observation, evaluation, judgment, opinion) (see + **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, subsection III). + + +Examiners should determine whether a claim recites an + abstract idea by (1) identifying the specific limitation(s) in the claim under + examination that the examiner believes recites an abstract idea, and (2) determining + whether the identified limitations(s) fall within at least one of the groupings of + abstract ideas listed above. The groupings of abstract ideas, and their relationship + to the body of judicial precedent, are further discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**. + + + +If the identified limitation(s) falls within at least + one of the groupings of abstract ideas, it is reasonable to conclude that the claim + recites an abstract idea in Step 2A Prong One. The claim then requires further + analysis in Step 2A Prong Two, to determine whether any additional elements in the + claim integrate the abstract idea into a practical application, see + **[MPEP + § 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)**. + + + +If the identified limitation(s) do not fall within + any of the groupings of abstract ideas, it is reasonable to find that the claim does + not recite an abstract idea. This concludes the abstract idea judicial exception + eligibility analysis, except in the rare circumstance discussed in 2106.04(a)(3), + below. The claim is thus eligible at Pathway B unless the claim recites, and is + directed to, another exception (such as a law of nature or natural phenomenon). + + + +If the claims recites another judicial exception (i.e. + law of nature or natural phenomenon), see **[MPEP §§ + 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)** and **[2106.04(c)](s2106.html#ch2100_d29a1b_13bc1_b1)** for more information on Step 2A analysis. + + + +**[MPEP § 2106.04(a)(1)](s2106.html#ch2100_d29a1b_13b3e_21)** provides + examples of claims that do not recite abstract ideas (or other judicial exceptions) + and thus are eligible at Step 2A Prong One. + + + +**[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** provides + further explanation on the abstract idea groupings. It should be noted that these + groupings are not mutually exclusive, i.e., some claims recite limitations that fall + within more than one grouping or sub-grouping. For example, a claim reciting + performing mathematical calculations using a formula that could be practically + performed in the human mind may be considered to fall within the mathematical + concepts grouping and the mental process grouping. Accordingly, examiners should + identify at least one abstract idea grouping, but preferably identify all groupings + to the extent possible, if a claim limitation(s) is determined to fall within + multiple groupings and proceed with the analysis in Step 2A Prong Two. + + + + +# 2106.04(a)(1) Examples of Claims That Do Not Recite + Abstract Ideas [R-10.2019] + + +When evaluating a claim to determine whether it + recites an abstract idea, examiners should keep in mind that while "all inventions + at some level embody, use, reflect, rest upon, or apply laws of nature, natural + phenomenon, or abstract ideas", not all claims recite an abstract idea. See + *Alice Corp. Pty. Ltd. v. CLS Bank, Int’l,* 573 U.S. 208, 217, + 110 USPQ2d 1976, 1980-81 (2014) (citing *Mayo Collaborative Servs. v. + Prometheus Labs. Inc.,* 566 US 66, 71, 101 USPQ2d 1961, 1965 (2012)). + The Step 2A Prong One analysis articulated in **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)** accounts for this cautionary principle by + requiring a claim to recite (*i.e.,* set forth or describe) an + abstract idea in Prong One before proceeding to the Prong Two inquiry about + whether the claim is directed to that idea, thereby separating claims reciting + abstract ideas from those that are merely based on or involve an abstract + idea. + + + +Some claims are not directed to an abstract idea + because they do not recite an abstract idea, although it may be apparent that at + some level they are based on or involve an abstract idea. Because these claims do + not recite an abstract idea (or other judicial exception), they are eligible at + Step 2A Prong One (Pathway B). + + + +Non-limiting hypothetical examples of claims that + do not recite (set forth or describe) an abstract idea include: + + + +* i. a printer comprising a belt, a roller, a + printhead and at least one ink cartridge; +* ii. a washing machine comprising a tub, a drive + motor operatively connected to the tub, a controller for controlling the + drive motor, and a housing for containing the tub, drive motor, and + controller; +* iii. an earring comprising a sensor for taking + periodic blood glucose measurements and a memory for storing measurement + data from the sensor; +* iv. a method for sequencing BRCA1 gene sequences + comprising: amplifying by a polymerization chain reaction technique all or + part of a BRCA1 gene from a tissue sample from a human subject using a set + of primers to produce amplified nucleic acids; and sequencing the amplified + nucleic acids; and +* v. a method for loading BIOS into a local + computer system which has a system processor and volatile memory and + non-volatile memory, the method comprising the steps of: responding to + powering up of the local computer system by requesting from a memory + location remote from the local computer system the transfer to and storage + in the volatile memory of the local computer system of BIOS configured for + effective use of the local computer system, transferring and storing such + BIOS, and transferring control of the local computer system to such + BIOS; +* vi. a method of rearranging icons on a graphical + user interface (GUI) comprising the steps of: receiving a user selection to + organize each icon based on the amount of use of each icon, determining the + amount of use of each icon by using a processor to track the amount of + memory allocated to the application associated with the icon over a period + of time, and automatically moving the most used icons to a position in the + GUI closest to the start icon of the computer system based on the determined + amount of use; and +* vii. a method of training a neural network for + facial detection comprising: collecting a set of digital facial images, + applying one or more transformations to the digital images, creating a first + training set including the modified set of digital facial images; training + the neural network in a first stage using the first training set, creating a + second training set including digital non-facial images that are incorrectly + detected as facial images in the first stage of training; and training the + neural network in a second stage using the second training set. + + + + +# 2106.04(a)(2) Abstract Idea Groupings [R-10.2019] + +**I.** **MATHEMATICAL + CONCEPTS**The mathematical concepts grouping is defined + as mathematical relationships, mathematical formulas or equations, and + mathematical calculations. The Supreme Court has identified a number of + concepts falling within this grouping as abstract ideas including: a procedure + for converting binary-coded decimal numerals into pure binary form, + *Gottschalk v. Benson,* 409 U.S. 63, 65, 175 USPQ2d 673, + 674 (1972); a mathematical formula for calculating an alarm limit, + *Parker v. Flook,* 437 U.S. 584, 588-89, 198 USPQ2d 193, + 195 (1978); the Arrhenius equation, *Diamond v. Diehr,* 450 + U.S. 175, 191, 209 USPQ 1, 15 (1981); and a mathematical formula for hedging, + *Bilski v. Kappos,* 561 U.S. 593, 611, 95 USPQ 2d 1001, + 1004 (2010). + + + +The Court’s rationale for identifying these + "mathematical concepts" as judicial exceptions is that a ‘‘mathematical formula + as such is not accorded the protection of our patent laws,’’ + *Diehr,* 450 U.S. at 191, 209 USPQ at 15 (citing + *Benson,* 409 U.S. 63, 175 USPQ 673), and thus ‘‘the + discovery of [a mathematical formula] cannot support a patent unless there is + some other inventive concept in its application.’’ *Flook,* + 437 U.S. at 594, 198 USPQ at 199. In the past, the Supreme Court sometimes + described mathematical concepts as laws of nature, and at other times described + these concepts as judicial exceptions without specifying a particular type of + exception. See, *e.g., Benson,* 409 U.S. at 65, 175 USPQ2d at + 674; *Flook,* 437 U.S. at 589, 198 USPQ2d at 197; + *Mackay Radio & Telegraph Co. v. Radio Corp. of Am.,* + 306 U.S. 86, 94, 40 USPQ 199, 202 (1939) (‘‘[A] scientific truth, or the + mathematical expression of it, is not patentable invention[.]’’). More recent + opinions of the Supreme Court, however, have affirmatively characterized + mathematical relationships and formulas as abstract ideas. See, *e.g., + Alice Corp. Pty. Ltd. v. CLS Bank Int’l*, 573 U.S. 208, 218, 110 + USPQ2d 1976, 1981 (describing *Flook* as holding "that a + mathematical formula for computing ‘alarm limits’ in a catalytic conversion + process was also a patent-ineligible abstract idea."); *Bilski v. + Kappos,* 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (noting that + the claimed "concept of hedging, described in claim 1 and reduced to a + mathematical formula in claim 4, is an unpatentable abstract idea,"). + + + +When determining whether a claim recites a + mathematical concept (*i.e.,* mathematical relationships, + mathematical formulas or equations, and mathematical calculations), examiners + should consider whether the claim recites a mathematical concept or merely + limitations that are based on or involve a mathematical concept. A claim does + not recite a mathematical concept (*i.e.,* the claim + limitations do not fall within the mathematical concept grouping), if it is + only based on or involves a mathematical concept. See, *e.g., Thales + Visionix, Inc. v. United States,* 850 F.3d 1343, 1348-49, 121 + USPQ2d 1898, 1902-03 (Fed. Cir. 2017) (determining that the claims to a + particular configuration of inertial sensors and a particular method of using + the raw data from the sensors in order to more accurately calculate the + position and orientation of an object on a moving platform did not merely + recite "the abstract idea of using ‘mathematical equations for determining the + relative position of a moving object to a moving reference frame’."). For + example, a limitation that is merely based on or involves a mathematical + concept described in the specification may not be sufficient to fall into this + grouping, provided the mathematical concept itself is not recited in the claim. + + + +It is important to note that a mathematical + concept need not be expressed in mathematical symbols, because "[w]ords used in + a claim operating on data to solve a problem can serve the same purpose as a + formula." *In re Grams,* 888 F.2d 835, 837 and n.1, 12 USPQ2d + 1824, 1826 and n.1 (Fed. Cir. 1989). See, *e.g., SAP America, Inc. v. + InvestPic, LLC,* 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. + Cir. 2018) (holding that claims to a ‘‘series of mathematical calculations + based on selected information’’ are directed to abstract ideas); + *Digitech Image Techs., LLC v. Elecs. for Imaging, Inc.,* + 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that + claims to a ‘‘process of organizing information through mathematical + correlations’’ are directed to an abstract idea); and *Bancorp Servs., + LLC v. Sun Life Assurance Co. of Can. (U.S.),* 687 F.3d 1266, 1280, + 103 USPQ2d 1425, 1434 (Fed. Cir. 2012) (identifying the concept of ‘‘managing a + stable value protected life insurance policy by performing calculations and + manipulating the results’’ as an abstract idea). + + +***A.*** ***Mathematical Relationships***A mathematical relationship is a + relationship between variables or numbers. A mathematical relationship may + be expressed in words or using mathematical symbols. For example, pressure + (p) can be described as the ratio between the magnitude of the normal force + (F) and area of the surface on contact (A), or it can be set forth in the + form of an equation such as p = F/A. + + + +Examples of mathematical relationships + recited in a claim include: + + + +* i. a relationship between reaction rate + and temperature, which relationship can be expressed in the form of a + formula called the Arrhenius equation, *Diamond v. + Diehr;* 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at + 4-5 (1981); +* ii. a conversion between binary coded + decimal and pure binary, *Benson,* 409 U.S. at 64, + 175 USPQ at 674; +* iii. a mathematical relationship between + enhanced directional radio activity and antenna conductor arrangement + (*i.e.,* the length of the conductors with respect + to the operating wave length and the angle between the conductors), + *Mackay Radio & Tel. Co. v. Radio Corp. of + America,* 306 U.S. 86, 91, 40 USPQ 199, 201 (1939) (while + the litigated claims 15 and 16 of U.S. Patent No. 1,974,387 expressed + this mathematical relationship using a formula that described the + angle between the conductors, other claims in the patent + (*e.g.,* claim 1) expressed the mathematical + relationship in words); and +* iv. organizing information and + manipulating information through mathematical correlations, + *Digitech Image Techs., LLC v. Electronics for Imaging, + Inc.,* 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. + Cir. 2014). The patentee in *Digitech* claimed + methods of generating first and second data by taking existing + information, manipulating the data using mathematical functions, and + organizing this information into a new form. The court explained that + such claims were directed to an abstract idea because they described a + process of organizing information through mathematical correlations, + like *Flook's* method of calculating using a + mathematical formula. 758 F.3d at 1350, 111 USPQ2d at 1721. + +***B.*** ***Mathematical Formulas or Equations***A claim that recites a numerical formula or + equation will be considered as falling within the "mathematical concepts" + grouping. In addition, there are instances where a formula or equation is + written in text format that should also be considered as falling within this + grouping. For example, the phrase "determining a ratio of A to B" is merely + using a textual replacement for the particular equation (ratio = A/B). + Additionally, the phrase "calculating the force of the object by multiplying + its mass by its acceleration" is using a textual replacement for the + particular equation (F= ma). + + + +Examples of mathematical equations or formulas + recited in a claim include: + + + +* i. a formula describing certain + electromagnetic standing wave phenomena, *Mackay Radio & + Tel. Co. v. Radio Corp. of America,* 306 U.S. 86, 91, 40 + USPQ 199, 201 (1939) (50.9(l/lambda<-0.513>); +* ii. the Arrhenius equation, + *Diamond v. Diehr;* 450 U.S. 175, 178 n. 2, 179 + n.5, 191-92, 209 USPQ at 4-5 (1981) (ln v = CZ + x); +* iii. a formula for computing an alarm + limit, *Parker v. Flook,* 437 U.S. 584, 585, 198 USPQ + 193, 195 (1978) (B1=B0 (1.0–F) + PVL(F)); and +* iv. a mathematical formula for hedging + (claim 4), *Bilski v. Kappos,* 561 U.S. 593, 599, 95 + USPQ2d 1001, 1004 (2010) (Fixed Bill Price = Fi + [(Ci + Ti + LDi) x + (α + βE(Wi))]). + +***C.******Mathematical + calculations***A claim that recites a mathematical + calculation, when the claim is given its broadest reasonable interpretation + in light of the specification, will be considered as falling within the + "mathematical concepts" grouping. A mathematical calculation is a + mathematical operation (such as multiplication) or an act of calculating + using mathematical methods to determine a variable or number, + *e.g.,* performing an arithmetic operation such as + exponentiation. There is no particular word or set of words that indicates a + claim recites a mathematical calculation. That is, a claim does not have to + recite the word "calculating" in order to be considered a mathematical + calculation. For example, a step of "determining" a variable or number using + mathematical methods or "performing" a mathematical operation may also be + considered mathematical calculations when the broadest reasonable + interpretation of the claim in light of the specification encompasses a + mathematical calculation. + + + +Examples of mathematical calculations + recited in a claim include: + + + +* i. performing a resampled statistical + analysis to generate a resampled distribution, *SAP America, + Inc. v. Investpic, LLC,* 898 F.3d 1161, 1163-65, 127 + USPQ2d 1597, 1598-1600 (Fed. Cir. 2018), modifying *SAP + America, Inc. v. Investpic, LLC,* 890 F.3d 1016, 126 + USPQ2d 1638 (Fed. Cir. 2018); +* ii. calculating a number representing an + alarm limit value using the mathematical formula + ‘‘B1=B0 (1.0–F) + + PVL(F)’’, *Parker v. Flook,* 437 U.S. 584, 585, 198 + USPQ 193, 195 (1978); +* iii. using a formula to convert geospatial + coordinates into natural numbers, *Burnett v. Panasonic + Corp.,* 741 Fed. Appx. 777, 780 (Fed. Cir. 2018) + (non-precedential); +* iv. managing a stable value protected life + insurance policy via performing calculations, *Bancorp Servs., + LLC v. Sun Life Assur. Co. of Canada (U.S.)*, 687 F.3d + 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012); +* v. using an algorithm for determining the + optimal number of visits by a business representative to a client, + *In re Maucorps,* 609 F.2d 481, 482, 203 USPQ 812, + 813 (CCPA 1979); and +* vi. calculating the difference between + local and average data values, *In re Abele,* 684 + F.2d 902, 903, 214 USPQ 682, 683-84 (CCPA 1982). + +**II.** **CERTAIN METHODS OF ORGANIZING + HUMAN ACTIVITY**The phrase "methods of organizing human + activity" is used to describe concepts relating to: + + + +* • fundamental economic principles or + practices (including hedging, insurance, mitigating risk); +* • commercial or legal interactions + (including agreements in the form of contracts, legal obligations, + advertising, marketing or sales activities or behaviors, and business + relations); and +* • managing personal behavior or + relationships or interactions between people, (including social + activities, teaching, and following rules or instructions). + + +The Supreme Court has identified a number of + concepts falling within the "certain methods of organizing human activity" + grouping as abstract ideas. In particular, in *Alice,* the + Court concluded that the use of a third party to mediate settlement risk is a + ‘‘fundamental economic practice’’ and thus an abstract idea. 573 U.S. at + 219–20, 110 USPQ2d at 1982. In addition, the Court in *Alice* + described the concept of risk hedging identified as an abstract idea in + *Bilski* as ‘‘a method of organizing human activity’’. + *Id.* Previously, in *Bilski,* the Court + concluded that hedging is a ‘‘fundamental economic practice’’ and therefore an + abstract idea. 561 U.S. at 611–612, 95 USPQ2d at 1010. + + + +The term "certain" qualifies the "certain + methods of organizing human activity" grouping as a reminder of several + important points. First, not all methods of organizing human activity are + abstract ideas (*e.g.,* "a defined set of steps for combining + particular ingredients to create a drug formulation" is not a certain "method + of organizing human activity"), *In re Marco Guldenaar Holding + B.V.,* 911 F.3d 1157, 1160-61, 129 USPQ2d 1008, 1011 (Fed. Cir. + 2018). Second, this grouping is limited to activity that falls within the + enumerated sub-groupings of fundamental economic principles or practices, + commercial or legal interactions, and managing personal behavior and + relationships or interactions between people, and is not to be expanded beyond + these enumerated sub-groupings except in rare circumstances as explained in + **[MPEP § 2106.04(a)(3)](s2106.html#ch2100_d2ea80_199c8_1c1)**. Finally, the sub-groupings + encompass both activity of a single person (for example, a person following a + set of instructions or a person signing a contract online) and activity that + involves multiple people (such as a commercial interaction), and thus, certain + activity between a person and a computer (for example a method of anonymous + loan shopping that a person conducts using a mobile phone) may fall within the + "certain methods of organizing human activity" grouping. It is noted that the + number of people involved in the activity is not dispositive as to whether a + claim limitation falls within this grouping. Instead, the determination should + be based on whether the activity itself falls within one of the sub-groupings. + + +***A.******Fundamental Economic Practices or + Principles***The courts have used the phrases "fundamental + economic practices" or "fundamental economic principles" to describe + concepts relating to the economy and commerce. Fundamental economic + principles or practices include hedging, insurance, and mitigating + risks. + + + +The term "fundamental" is not used in the + sense of necessarily being "old" or "well-known." See, *e.g., OIP + Techs., Inc. v. Amazon.com, Inc.*, 788 F.3d 1359, 1364, 115 + U.S.P.Q.2d 1090, 1092 (Fed Cir. 2015) (a new method of price optimization + was found to be a fundamental economic concept); *In re + Smith,* 815 F.3d 816, 818-19, 118 USPQ2d 1245, 1247 (Fed. Cir. + 2016) (describing a new set of rules for conducting a wagering game as a + "fundamental economic practice"); *In re Greenstein,* 774 + Fed. Appx. 661, 664, 2019 USPQ2d 212400 (Fed Cir. 2019) (non-precedential) + (claims to a new method of allocating returns to different investors in an + investment fund was a fundamental economic concept). However, being old or + well-known may indicate that the practice is fundamental. See, + *e.g., Alice Corp. Pty. Ltd. v. CLS Bank Int’l,* 573 + U.S. 208, 219-20, 110 USPQ2d 1981-82 (2014) (describing the concept of + intermediated settlement, like the risk hedging in + *Bilski,* to be a "‘fundamental economic practice long + prevalent in our system of commerce’" and also as "a building block of the + modern economy") (citation omitted); *Bilski v. Kappos,* + 561 U.S. 593, 611, 95 USPQ2d 1001, 1010 (2010) (claims to the concept of + hedging are a "fundamental economic practice long prevalent in our system of + commerce and taught in any introductory finance class.") (citation omitted); + *Intellectual Ventures I LLC v. Symantec Corp.,* 838 + F.3d 1307, 1313, 120 USPQ2d 1353, 1356 (2016) ("The category of abstract + ideas embraces ‘fundamental economic practice[s] long prevalent in our + system of commerce,’ … including ‘longstanding commercial + practice[s]’"). + + + +An example of a case identifying a claim as + reciting a fundamental economic practice is *Bilski v. + Kappos,* 561 U.S. 593, 609, 95 USPQ2d 1001, 1009 (2010). The + fundamental economic practice at issue was hedging or protecting against + risk. The applicant in *Bilski* claimed "a series of steps + instructing how to hedge risk," *i.e.,* how to protect + against risk. 561 U.S. at 599, 95 USPQ2d at 1005. The method allowed energy + suppliers and consumers to minimize the risks resulting from fluctuations in + market demand for energy. The Supreme Court determined that hedging is + "fundamental economic practice" and therefore is an "unpatentable abstract + idea." 561 U.S. at 611-12, 95 USPQ2d at 1010. + + + +Another example of a case identifying a + claim as reciting a fundamental economic practice is *Bancorp + Services., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.),* + 687 F.3d 1266, 103 USPQ2d 1425 (Fed. Cir. 2012). The fundamental economic + practice at issue in *Bancorp* pertained to insurance. The + patentee in *Bancorp* claimed methods and systems for + managing a life insurance policy on behalf of a policy holder, which + comprised steps including generating a life insurance policy including a + stable value protected investment with an initial value based on a value of + underlying securities, calculating surrender value protected investment + credits for the life insurance policy; determining an investment value and a + value of the underlying securities for the current day; and calculating a + policy value and a policy unit value for the current day. 687 F.3d at + 1270-71, 103 USPQ2d at 1427. The court described the claims as an "attempt + to patent the use of the abstract idea of [managing a stable value protected + life insurance policy] and then instruct the use of well-known + [calculations] to help establish some of the inputs into the equation." 687 + F.3d at 1278, 103 USPQ2d at 1433 (alterations in original) (citing + *Bilski*). + + + + Other examples of "fundamental economic + principles or practices" include: + + + +* i. mitigating settlement risk, + *Alice Corp. v. CLS Bank,*573 U.S. 208, 218, 110 + USPQ2d 1976, 1982 (2014); +* ii. rules for conducting a wagering game, + *In re Smith,* 815 F.3d 816, 818-19, 118 USPQ2d + 1245, 1247 (Fed. Cir. 2016); +* iii. financial instruments that are + designed to protect against the risk of investing in financial + instruments, *In re Chorna,* 656 Fed. App'x 1016, + 1021 (Fed. Cir. 2016) (non-precedential); +* iv. offer-based price optimization, + *OIP Techs., Inc. v. Amazon.com, Inc.,* 788 F.3d + 1359, 1362–63, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015); +* v. local processing of payments for + remotely purchased goods, *Inventor Holdings, LLC v. Bed Bath + Beyond,* 876 F.3d 1372, 1378-79, 125 USPQ2d 1019, 1023 + (Fed. Cir. 2017); +* vi. using a marking affixed to the outside + of a mail object to communicate information about the mail object, + *i.e.,* the sender, recipient, and contents of the + mail object, *Secured Mail Solutions LLC v. Universal Wilde, + Inc.,* 873 F.3d 905, 911, 124 USPQ2d 1502, 1506 (Fed. Cir. + 2017); and +* vii. placing an order based on displayed + market information, *Trading Technologies Int’l, Inc. v. IBG + LLC,* 921 F.3d 1084, 1092, 2019 USPQ2d 138290 (Fed. Cir. + 2019). + +***B.*** ***Commercial or Legal Interactions***"Commercial interactions" or "legal + interactions" include agreements in the form of contracts, legal + obligations, advertising, marketing or sales activities or behaviors, and + business relations. + + + +An example of a claim reciting a commercial + or legal interaction, where the interaction is an agreement in the form of + contracts, is found in *buySAFE, Inc. v. Google, Inc.,* 765 + F.3d. 1350, 112 USPQ2d 1093 (Fed. Cir. 2014). The agreement at issue in + *buySAFE* was a transaction performance guaranty, which + is a contractual relationship. 765 F.3d at 1355, 112 USPQ2d at 1096. The + patentee claimed a method in which a computer operated by the provider of a + safe transaction service receives a request for a performance guarantee for + an online commercial transaction, the computer processes the request by + underwriting the requesting party in order to provide the transaction + guarantee service, and the computer offers, via a computer network, a + transaction guaranty that binds to the transaction upon the closing of the + transaction. 765 F.3d at 1351-52, 112 USPQ2d at 1094. The Federal Circuit + described the claims as directed to an abstract idea because they were + "squarely about creating a contractual relationship--a ‘transaction + performance guaranty’." 765 F.3d at 1355, 112 USPQ2d at 1096. + + + +Other examples of subject matter where the + commercial or legal interaction is an agreement in the form of contracts + include: + + + +* i. managing a stable value protected life + insurance policy via performing calculations, *Bancorp Servs., + LLC v. Sun Life Assur. Co. of Canada (U.S.),* 687 F.3d + 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012); and +* ii. processing insurance claims for a + covered loss or policy event under an insurance policy + (*i.e.,* an agreement in the form of a contract), + *Accenture Global Services v. Guidewire Software, + Inc.,* 728 F.3d 1336, 1338-39, 108 USPQ2d 1173, 1175-76 + (Fed. Cir. 2013). + + +An example of a claim reciting a commercial + or legal interaction in the form of a legal obligation is found in + *Fort Properties, Inc. v. American Master Lease, LLC,* + 671 F.3d 1317, 101 USPQ2d 1785 (Fed Cir. 2012). The patentee claimed a + method of "aggregating real property into a real estate portfolio, dividing + the interests in the portfolio into a number of deedshares, and subjecting + those shares to a master agreement." 671 F.3d at 1322, 101 USPQ2d at 1788. + The legal obligation at issue was the tax-free exchanges of real estate. The + Federal Circuit concluded that the real estate investment tool designed to + enable tax-free exchanges was an abstract concept. 671 F.3d at 1323, 101 + USPQ2d at 1789. + + + +Other examples of subject matter where the + commercial or legal interaction is a legal obligation include: + + + +* i. hedging, *Bilski v. + Kappos*, 561 U.S. 593, 595, 95 USPQ2d 1001, 1004 + (2010); +* ii. mitigating settlement risk, + *Alice Corp. Pty. Ltd. v. CLS Bank Int'l,* 573 + U.S. 208, 218, 110 USPQ2d 1976, 1979 (2014); and +* iii. arbitration, *In re + Comiskey*, 554 F.3d 967, 981, 89 USPQ2d 1655, 1665 (Fed. + Cir. 2009). + + +An example of a claim reciting advertising is + found in *Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, + 714-15, 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). The patentee in + *Ultramercial* claimed an eleven-step method for + displaying an advertisement (ad) in exchange for access to copyrighted + media, comprising steps of receiving copyrighted media, selecting an ad, + offering the media in exchange for watching the selected ad, displaying the + ad, allowing the consumer access to the media, and receiving payment from + the sponsor of the ad. 772 F.3d. at 715, 112 USPQ2d at 1754. The Federal + Circuit determined that the "combination of steps recites an abstraction—an + idea, having no particular concrete or tangible form" and thus was directed + to an abstract idea, which the court described as "using advertising as an + exchange or currency." *Id.* + + +Other examples of subject matter where the + commercial or legal interaction is advertising, marketing or sales + activities or behaviors include : + + + +* i. structuring a sales force or marketing + company, which pertains to marketing or sales activities or behaviors, + *In re Ferguson,* 558 F.3d 1359, 1364, 90 USPQ2d + 1035, 1038 (Fed. Cir. 2009); +* ii. using an algorithm for determining the + optimal number of visits by a business representative to a client, + *In re Maucorps,* 609 F.2d 481, 485, 203 USPQ 812, + 816 (CCPA 1979); and +* iii. offer-based price optimization, which + pertains to marketing, *OIP Techs., Inc. v. Amazon.com, + Inc.,* 788 F.3d 1359, 1362-63, 115 USPQ2d 1090, 1092 (Fed. + Cir. 2015). + + + An example of a claim reciting business + relations is found in *Credit Acceptance Corp. v. Westlake + Services,* 859 F.3d 1044, 123 USPQ2d 1100 (Fed. Cir. 2017). The + business relation at issue in *Credit Acceptance* is the + relationship between a customer and dealer when processing a credit + application to purchase a vehicle. The patentee claimed a "system for + maintaining a database of information about the items in a dealer’s + inventory, obtaining financial information about a customer from a user, + combining these two sources of information to create a financing package for + each of the inventoried items, and presenting the financing packages to the + user." 859 F.3d at 1054, 123 USPQ2d at 1108. The Federal Circuit described + the claims as directed to the abstract idea of "processing an application + for financing a loan" and found "no meaningful distinction between this type + of financial industry practice" and the concept of intermediated settlement + in *Alice* or the hedging concept in + *Bilski.* 859 F.3d at 1054, 123 USPQ2d at 1108. + + + +Another example of subject matter where the + commercial or legal interaction is business relations includes: + + + +* i. processing information through a + clearing-house, where the business relation is the relationship + between a party submitted a credit application + (*e.g.,* a car dealer) and funding sources + (*e.g.,* banks) when processing credit + applications, *Dealertrack v. Huber,* 674 F.3d 1315, + 1331, 101 USPQ2d 1325, 1339 (Fed. Cir. 2012). + +***C.*** ***Managing Personal Behavior or Relationships or Interactions + Between People***The sub-grouping "managing personal behavior + or relationships or interactions between people" include social activities, + teaching, and following rules or instructions. + + + +An example of a claim reciting managing + personal behavior is *Intellectual Ventures I LLC v. Capital One + Bank (USA),* 792 F.3d 1363, 115 USPQ2d 1636 (Fed. Cir. 2015). + The patentee in this case claimed methods comprising storing user-selected + pre-set limits on spending in a database, and when one of the limits is + reached, communicating a notification to the user via a device. 792 F.3d. at + 1367, 115 USPQ2d at 1639-40. The Federal Circuit determined that the claims + were directed to the abstract idea of "tracking financial transactions to + determine whether they exceed a pre-set spending limit + (*i.e.,* budgeting)", which "is not meaningfully + different from the ideas found to be abstract in other cases before the + Supreme Court and our court involving methods of organizing human activity." + 792 F.3d. at 1367-68, 115 USPQ2d at 1640. + + + +Other examples of managing personal behavior + recited in a claim include: + + + +* i. filtering content, *BASCOM + Global Internet v. AT&T Mobility, LLC,* 827 F.3d 1341, + 1345-46, 119 USPQ2d 1236, 1239 (Fed. Cir. 2016) (finding that + filtering content was an abstract idea under step 2A, but reversing an + invalidity judgment of ineligibility due to an inadequate step 2B + analysis); +* ii. considering historical usage + information while inputting data, *BSG Tech. LLC v. + Buyseasons, Inc.,* 899 F.3d 1281, 1286, 127 USPQ2d 1688, + 1691; and +* iii. a mental process that a neurologist + should follow when testing a patient for nervous system malfunctions, + *In re Meyer,* 688 F.2d 789, 791-93, 215 USPQ 193, + 194-96 (CCPA 1982). + + +An example of a claim reciting social + activities is *Voter Verified, Inc. v. Election Systems & + Software, LLC,* 887 F.3d 1376, 126 USPQ2d 1498 (Fed. Cir. 2018). + The social activity at issue in *Voter Verified* was + voting. The patentee claimed "[a] method for voting providing for + self-verification of a ballot comprising the steps of" presenting an + election ballot for voting, accepting input of the votes, storing the votes, + printing out the votes, comparing the printed votes to votes stored in the + computer, and determining whether the printed ballot is acceptable. 887 F.3d + at 1384-85, 126 USPQ2d at 1503-04. The Federal Circuit found that the claims + were directed to the abstract idea of "voting, verifying the vote, and + submitting the vote for tabulation", which is a "fundamental activity that + forms the basis of our democracy" and has been performed by humans for + hundreds of years. 887 F.3d at 1385-86, 126 USPQ2d at 1504-05. + + + +Another example of a claim reciting social + activities is *Interval Licensing LLC, v. AOL, Inc.,* 896 + F.3d 1335, 127 USPQ2d 1553 (Fed. Cir. 2018). The social activity at issue + was the social activity of "’providing information to a person without + interfering with the person’s primary activity.’" 896 F.3d at 1344, 127 + USPQ2d 1553 (citing *Interval Licensing LLC v. AOL, Inc.,* + 193 F. Supp.3d 1184, 1188 (W.D. 2014)). The patentee claimed an attention + manager for acquiring content from an information source, controlling the + timing of the display of acquired content, displaying the content, and + acquiring an updated version of the previously-acquired content when the + information source updates its content. 896 F.3d at 1339-40, 127 USPQ2d at + 1555. The Federal Circuit concluded that "[s]tanding alone, the act of + providing someone an additional set of information without disrupting the + ongoing provision of an initial set of information is an abstract idea," + observing that the district court "pointed to the nontechnical human + activity of passing a note to a person who is in the middle of a meeting or + conversation as further illustrating the basic, longstanding practice that + is the focus of the [patent ineligible] claimed invention." 896 F.3d at + 1344-45, 127 USPQ2d at 1559. + + + +An example of a claim reciting following + rules or instructions is *In re Marco Guldenaar Holding + B.V.,* 911 F.3d 1157, 1161, 129 USPQ2d 1008, 1011 (Fed. Cir. + 2018). The patentee claimed a method of playing a dice game including + placing wagers on whether certain die faces will appear face up. 911 F.3d at + 1160; 129 USPQ2d at 1011. The Federal Circuit determined that the claims + were directed to the abstract idea of "rules for playing games", which the + court characterized as a certain method of organizing human activity. 911 + F.3d at 1160-61; 129 USPQ2d at 1011. + + + +Other examples of following rules or + instructions recited in a claim include: + + + +* i. assigning hair designs to balance head + shape, *In re Brown*, 645 Fed. Appx. 1014, 1015-16 + (Fed. Cir. 2016) (non-precedential); and +* ii. a series of instructions of how to + hedge risk, *Bilski v. Kappos*, 561 U.S. 593, 595, 95 + USPQ2d 1001, 1004 (2010). + +**III.** **MENTAL + PROCESSES**The courts consider a mental process (thinking) + that "can be performed in the human mind, or by a human using a pen and paper" + to be an abstract idea. *CyberSource Corp. v. Retail Decisions, + Inc.,* 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). + As the Federal Circuit explained, "methods which can be performed mentally, or + which are the equivalent of human mental work, are unpatentable abstract ideas + the ‘basic tools of scientific and technological work’ that are open to all.’" + 654 F.3d at 1371, 99 USPQ2d at 1694 (citing *Gottschalk v. + Benson,* 409 U.S. 63, 175 USPQ 673 (1972)). See also *Mayo + Collaborative Servs. v. Prometheus Labs. Inc.,* 566 U.S. 66, 71, + 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual + concepts are not patentable, as they are the basic tools of scientific and + technological work’" (quoting *Benson,* 409 U.S. at 67, 175 + USPQ at 675)); *Parker v. Flook,* 437 U.S. 584, 589, 198 USPQ + 193, 197 (1978) (same). + + + +Accordingly, the "mental processes" abstract + idea grouping is defined as concepts performed in the human mind, and examples + of mental processes include observations, evaluations, judgments, and opinions. + A discussion of concepts performed in the human mind, as well as concepts that + cannot practically be performed in the human mind and thus are not "mental + processes", is provided below with respect to point A. + + + +The courts do not distinguish between mental + processes that are performed entirely in the human mind and mental processes + that require a human to use a physical aid (*e.g.,* pen and + paper or a slide rule) to perform the claim limitation. See, *e.g., + Benson,* 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that + the claimed "conversion of [binary-coded decimal] numerals to pure binary + numerals can be done mentally," *i.e.,* "as a person would do + it by head and hand."); *Synopsys, Inc. v. Mentor Graphics + Corp.,* 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) + (holding that claims to a mental process of "translating a functional + description of a logic circuit into a hardware component description of the + logic circuit" are directed to an abstract idea, because the claims "read on an + individual performing the claimed steps mentally or with pencil and paper"). + Mental processes performed by humans with the assistance of physical aids such + as pens or paper are explained further below with respect to point B. + + + +Nor do the courts distinguish between claims + that recite mental processes performed by humans and claims that recite mental + processes performed on a computer. As the Federal Circuit has explained, + "[c]ourts have examined claims that required the use of a computer and still + found that the underlying, patent-ineligible invention could be performed via + pen and paper or in a person’s mind." *Versata Dev. Group v. SAP Am., + Inc.,* 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). + See also *Intellectual Ventures I LLC v. Symantec Corp.,* 838 + F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception + of generic computer-implemented steps, there is nothing in the claims + themselves that foreclose them from being performed by a human, mentally or + with pen and paper.’’); *Mortgage Grader, Inc. v. First Choice Loan + Servs. Inc.,* 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. + 2016) (holding that computer-implemented method for "anonymous loan shopping" + was an abstract idea because it could be "performed by humans without a + computer"). Mental processes recited in claims that require computers are + explained further below with respect to point C. + + + +Because both product and process claims may + recite a "mental process", the phrase "mental processes" should be understood + as referring to the type of abstract idea, and not to the statutory category of + the claim. The courts have identified numerous product claims as reciting + mental process-type abstract ideas, for instance the product claims to computer + systems and computer-readable media in *Versata Dev. Group. v. SAP Am., + Inc.,* 793 F.3d 1306, 115 USPQ2d 1681 (Fed. Cir. 2015). This + concept is explained further below with respect to point D. + + + +The following discussion is meant to guide + examiners and provide more information on how to determine whether a claim + recites a mental process. Examiners should keep in mind the following points A, + B, C, and D when performing this evaluation. + + +***A.*** ***A Claim With Limitation(s) That Cannot Practically be Performed + in the Human Mind Does Not Recite a Mental + Process.***Claims do not recite a mental process when + they do not contain limitations that can practically be performed in the + human mind, for instance when the human mind is not equipped to perform the + claim limitations. See *SRI Int’l, Inc. v. Cisco Systems, + Inc.,* 930 F.3d 1295, 1304 (Fed. Cir. 2019) (declining to + identify the claimed collection and analysis of network data as abstract + because "the human mind is not equipped to detect suspicious activity by + using network monitors and analyzing network packets as recited by the + claims"); *CyberSource,* 654 F.3d at 1376, 99 USPQ2d at + 1699 (distinguishing *Research Corp. Techs. v. Microsoft + Corp.,* 627 F.3d 859, 97 USPQ2d 1274 (Fed. Cir. 2010), and + *SiRF Tech., Inc. v. Int’l Trade Comm’n,* 601 F.3d 1319, + 94 USPQ2d 1607 (Fed. Cir. 2010), as directed to inventions that ‘‘could not, + as a practical matter, be performed entirely in a human’s mind’’). + + + +Examples of claims that do not recite mental + processes because they cannot be practically performed in the human mind + include: + + + +* • a claim to a method for calculating + an absolute position of a GPS receiver and an absolute time of + reception of satellite signals, where the claimed GPS receiver + calculated pseudoranges that estimated the distance from the GPS + receiver to a plurality of satellites, *SiRF Tech.,* + 601 F.3d at 1331-33, 94 USPQ2d at 1616-17; +* • a claim to detecting suspicious + activity by using network monitors and analyzing network packets, + *SRI Int’l,* 930 F.3d at 1304; +* • a claim to a specific data + encryption method for computer communication involving a several-step + manipulation of data, *Synopsys.,* 839 F.3d at 1148, + 120 USPQ2d at 1481 (distinguishing the claims in *TQP + Development, LLC v. Intuit Inc.,* 2014 WL 651935 (E.D. + Tex. Feb. 19, 2014)); and +* • a claim to a method for rendering a + halftone image of a digital image by comparing, pixel by pixel, the + digital image against a blue noise mask, where the method required the + manipulation of computer data structures (*e.g.,* the + pixels of a digital image and a two-dimensional array known as a mask) + and the output of a modified computer data structure (a halftoned + digital image), *Research Corp. Techs.,* 627 F.3d at + 868, 97 USPQ2d at 1280. + + +In contrast, claims do recite a mental + process when they contain limitations that can practically be performed in + the human mind, including for example, observations, evaluations, judgments, + and opinions. Examples of claims that recite mental processes include: + + + +* • a claim to "collecting information, + analyzing it, and displaying certain results of the collection and + analysis," where the data analysis steps are recited at a high level + of generality such that they could practically be performed in the + human mind, *Electric Power Group v. Alstom, S.A.,* + 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016); +* • claims to "comparing BRCA sequences + and determining the existence of alterations," where the claims cover + any way of comparing BRCA sequences such that the comparison steps can + practically be performed in the human mind, *University of + Utah Research Foundation v. Ambry Genetics,* 774 F.3d 755, + 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014); +* • a claim to collecting and comparing + known information (claim 1), which are steps that can be practically + performed in the human mind, *Classen Immunotherapies, Inc. v. + Biogen IDEC,* 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 + (Fed. Cir. 2011); and +* • a claim to identifying head shape + and applying hair designs, which is a process that can be practically + performed in the human mind, *In re Brown,* 645 Fed. + App'x 1014, 1016-17 (Fed. Cir. 2016) (non-precedential). + +***B.*** ***A Claim That Encompasses a Human Performing the Step(s) + Mentally With or Without a Physical Aid Recites a Mental + Process.***If a claim recites a limitation that can + practically be performed in the human mind, with or without the use of a + physical aid such as pen and paper, the limitation falls within the mental + processes grouping, and the claim recites an abstract idea. See, + *e.g., Benson,* 409 U.S. at 67, 65, 175 USPQ at 674-75, + 674 (noting that the claimed "conversion of [binary-coded decimal] numerals + to pure binary numerals can be done mentally," *i.e.,* "as + a person would do it by head and hand."); *Synopsys,* 839 + F.3d at 1139, 120 USPQ2d at 1474 (holding that claims to the mental process + of "translating a functional description of a logic circuit into a hardware + component description of the logic circuit" are directed to an abstract + idea, because the claims "read on an individual performing the claimed steps + mentally or with pencil and paper"). + + + +The use of a physical aid + (*e.g.,* pencil and paper or a slide rule) to help + perform a mental step (*e.g.,* a mathematical calculation) + does not negate the mental nature of the limitation, but simply accounts for + variations in memory capacity from one person to another. For instance, in + *CyberSource,* the court determined that the step of + "constructing a map of credit card numbers" was a limitation that was able + to be performed "by writing down a list of credit card transactions made + from a particular IP address." In making this determination, the court + looked to the specification, which explained that the claimed map was + nothing more than a listing of several (*e.g.,* four) + credit card transactions. The court concluded that this step was able to be + performed mentally with a pen and paper, and therefore, it qualified as a + mental process. 654 F.3d at 1372-73, 99 USPQ2d at 1695. See also + *Flook,* 437 U.S. at 586, 198 USPQ at 196 (claimed + "computations can be made by pencil and paper calculations"); + *University of Florida Research Foundation, Inc. v. General + Electric Co.,* 916 F.3d 1363, 1367, 129 USPQ2d 1409, 1411-12 + (Fed. Cir. 2019) (relying on specification’s description of the claimed + analysis and manipulation of data as being performed mentally "‘using pen + and paper methodologies, such as flowsheets and patient charts’"); + *Symantec,* 838 F.3d at 1318, 120 USPQ2d at 1360 + (although claimed as computer-implemented, steps of screening messages can + be "performed by a human, mentally or with pen and paper"). + + +***C.*** ***A Claim That Requires a Computer May Still Recite a Mental + Process.***Claims can recite a mental process even if + they are claimed as being performed on a computer. The Supreme Court + recognized this in *Benson,* determining that a + mathematical algorithm for converting binary coded decimal to pure binary + within a computer’s shift register was an abstract idea. The Court concluded + that the algorithm could be performed purely mentally even though the + claimed procedures "can be carried out in existing computers long in use, no + new machinery being necessary." 409 U.S at 67, 175 USPQ at 675. See also + *Mortgage Grader,* 811 F.3d at 1324, 117 USPQ2d at 1699 + (concluding that concept of "anonymous loan shopping" recited in a computer + system claim is an abstract idea because it could be "performed by humans + without a computer"). + + + +In evaluating whether a claim that requires a + computer recites a mental process, examiners should carefully consider the + broadest reasonable interpretation of the claim in light of the + specification. For instance, examiners should review the specification to + determine if the claimed invention is described as a concept that is + performed in the human mind and applicant is merely claiming that concept + performed 1) on a generic computer, or 2) in a computer environment, or 3) + is merely using a computer as a tool to perform the concept. In these + situations, the claim is considered to recite a mental process. + + + +* 1. **Performing a mental process on a + generic computer.** An example of a case identifying a mental + process performed on a generic computer as an abstract idea is + *Voter Verified, Inc. v. Election Systems & Software, + LLC,* 887 F.3d 1376, 1385, 126 USPQ2d 1498, 1504 (Fed. + Cir. 2018). In this case, the Federal Circuit relied upon the + specification in explaining that the claimed steps of voting, + verifying the vote, and submitting the vote for tabulation are "human + cognitive actions" that humans have performed for hundreds of years. + The claims therefore recited an abstract idea, despite the fact that + the claimed voting steps were performed on a computer. 887 F.3d at + 1385, 126 USPQ2d at 1504. Another example is + *Versata,* in which the patentee claimed a system + and method for determining a price of a product offered to a + purchasing organization that was implemented using general purpose + computer hardware. 793 F.3d at 1312-13, 1331, 115 USPQ2d at 1685, + 1699. The Federal Circuit acknowledged that the claims were performed + on a generic computer, but still described the claims as "directed to + the abstract idea of determining a price, using organizational and + product group hierarchies, in the same way that the claims in + *Alice* were directed to the abstract idea of + intermediated settlement, and the claims in Bilski were directed to + the abstract idea of risk hedging." 793 F.3d at 1333; 115 USPQ2d at + 1700-01. +* 2. **Performing a mental process in a + computer environment.** An example of a case identifying a + mental process performed in a computer environment as an abstract idea + is *Symantec Corp.,* 838 F.3d at 1316-18, 120 USPQ2d + at 1360. In this case, the Federal Circuit relied upon the + specification when explaining that the claimed electronic post office, + which recited limitations describing how the system would receive, + screen and distribute email on a computer network, was analogous to + how a person decides whether to read or dispose of a particular piece + of mail and that "with the exception of generic computer-implemented + steps, there is nothing in the claims themselves that foreclose them + from being performed by a human, mentally or with pen and paper". 838 + F.3d at 1318, 120 USPQ2d at 1360. Another example is + *FairWarning IP, LLC v. Iatric Sys., Inc.,* 839 + F.3d 1089, 120 USPQ2d 1293 (Fed. Cir. 2016). The patentee in + *FairWarning* claimed a system and method of + detecting fraud and/or misuse in a computer environment, in which + information regarding accesses of a patient’s personal health + information was analyzed according to one of several rules + (*i.e.,* related to accesses in excess of a + specific volume, accesses during a pre-determined time interval, or + accesses by a specific user) to determine if the activity indicates + improper access. 839 F.3d. at 1092, 120 USPQ2d at 1294. The court + determined that these claims were directed to a mental process of + detecting misuse, and that the claimed rules here were "the same + questions (though perhaps phrased with different words) that humans in + analogous situations detecting fraud have asked for decades, if not + centuries." 839 F.3d. at 1094-95, 120 USPQ2d at 1296. +* 3. **Using a computer as a tool to + perform a mental process.** An example of a case in which a + computer was used as a tool to perform a mental process is + *Mortgage Grader,* 811 F.3d. at 1324, 117 USPQ2d + at 1699. The patentee in *Mortgage Grader* claimed a + computer-implemented system for enabling borrowers to anonymously shop + for loan packages offered by a plurality of lenders, comprising a + database that stores loan package data from the lenders, and a + computer system providing an interface and a grading module. The + interface prompts a borrower to enter personal information, which the + grading module uses to calculate the borrower’s credit grading, and + allows the borrower to identify and compare loan packages in the + database using the credit grading. 811 F.3d. at 1318, 117 USPQ2d at + 1695. The Federal Circuit determined that these claims were directed + to the concept of "anonymous loan shopping", which was a concept that + could be "performed by humans without a computer." 811 F.3d. at 1324, + 117 USPQ2d at 1699. Another example is *Berkheimer v. HP, + Inc.,* 881 F.3d 1360, 125 USPQ2d 1649 (Fed. Cir. 2018), in + which the patentee claimed methods for parsing and evaluating data + using a computer processing system. The Federal Circuit determined + that these claims were directed to mental processes of parsing and + comparing data, because the steps were recited at a high level of + generality and merely used computers as a tool to perform the + processes. 881 F.3d at 1366, 125 USPQ2d at 1652-53. + +***D.*** ***Both Product and + Process Claims May Recite a Mental + Process.***Examiners should keep in mind that both + product claims (*e.g.,* computer system, computer-readable + medium, etc.) and process claims may recite mental processes. For example, + in *Mortgage Grader,* the patentee claimed a + computer-implemented system and a method for enabling borrowers to + anonymously shop for loan packages offered by a plurality of lenders, + comprising a database that stores loan package data from the lenders, and a + computer system providing an interface and a grading module. The Federal + Circuit determined that both the computer-implemented system and method + claims were directed to "anonymous loan shopping", which was an abstract + idea because it could be "performed by humans without a computer." 811 F.3d. + at 1318, 1324-25, 117 USPQ2d at 1695, 1699-1700. See also + *FairWarning IP,* 839 F.3d at 1092, 120 USPQ2d at 1294 + (identifying both system and process claims for detecting improper access of + a patient's protected health information in a health-care system computer + environment as directed to abstract idea of detecting fraud); + *Content Extraction & Transmission LLC v. Wells Fargo Bank, + N.A.,* 776 F.3d 1343, 1345, 113 USPQ2d 1354, 1356 (system and + method claims of inputting information from a hard copy document into a + computer program). Accordingly, the phrase "mental processes" should be + understood as referring to the type of abstract idea, and not to the + statutory category of the claim. + + + +Examples of product claims reciting mental + processes include: + + + +* • An application program interface for + extracting and processing information from a diversity of types of + hard copy documents – *Content Extraction,* 776 F.3d + at 1345, 113 USPQ2d at 1356; +* • A computer-implemented system for + enabling anonymous loan shopping – *Mortgage Grader,* + 811 F.3d at 1318, 117 USPQ2d at 1695; +* • A computer readable medium + containing program instructions for detecting fraud – + *CyberSource,* 654 F.3d at 1368 n. 1, 99 USPQ2d at + 1692 n.1; +* • A post office for receiving and + redistributing email messages on a computer network – + *Symantec,* 838 F.3d at 1316, 120 USPQ2d at 1359; +* • A self-verifying voting system – + *Voter Verified,* 887 F.3d at 1384-85, 126 USPQ2d + at 1504; +* • A wide-area real-time performance + monitoring system for monitoring and assessing dynamic stability of an + electric power grid – *Electric Power Group,* 830 + F.3d at 1351 and n.1, 119 USPQ2d at 1740 and n.1; and +* • Computer readable storage media + comprising computer instructions to implement a method for determining + a price of a product offered to a purchasing organization – + *Versata,* 793 F.3d at 1312-13, 115 USPQ2d at + 1685. + + +Examples of process claims reciting mental + process-type abstract ideas are discussed in the preceding subsections (A) + through (C). See, for example, the discussion of *Flook,* + 437 U.S. 584, 198 USPQ 193; *Benson,* 409 U.S. 63, 175 USPQ + 673; *Berkheimer,* 881 F.3d 1360, 125 USPQ2d 1649; + *Synopsys,* 839 F.3d 1138, 120 USPQ2d 1473; and + *Ambry Genetics,* 774 F.3d 755, 113 USPQ2d 1241, + *supra*. + + + + + + +# 2106.04(a)(3) **Tentative Abstract + Ideas** + + +There may be rare circumstances in which an examiner + believes a claim limitation should be treated as an abstract idea even though it does + not fall within any of the groupings of abstract ideas discussed in + **[MPEP + § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** (i.e., mathematical concepts, certain + methods of organizing human activity, mental processes). This type of claim + limitation is referred to as a "tentative abstract idea." + + + +In such circumstances, the examiner should evaluate + the claim under the subject matter eligibility framework: + + + +* • If the claim as a whole integrates the + tentative abstract idea into a practical application, the claim is not directed + to a judicial exception (Step 2A; NO) and thus is **eligible** at + Pathway B. This concludes the eligibility analysis. +* • If the claim as a whole does not integrate + the tentative abstract idea into a practical application, then the claim is + directed to a judicial exception (Step 2A: YES) and thus requires further + analysis at Step 2B. At Step 2B, if the claim as a whole provides an inventive + concept (Step 2B: YES), the claim is **eligible** at Pathway C. This + concludes the eligibility analysis. +* • If the claim as a whole does not provide an + inventive concept (Step 2B: NO), the application should be brought to the + attention of the Technology Center (TC) director. A rejection of a claim + reciting a tentative abstract idea must be approved by the TC director (which + approval will be indicated in the file record of the application) and must + provide a justification for why such claim limitation is being treated as + reciting an abstract idea. +The TC Director will give approval for a Step 2B + subject matter eligibility rejection of a claim reciting a tentative abstract + idea. The ensuing Office action will identify that the claim(s) are directed to a + previously non-enumerated abstract idea via form paragraph + **[7.05.017](#fp7.05.017)** and include the TC Director’s signature. + The TC Director will then inform Patents Management that this procedure has been + used so that the public can be notified, for example, on USPTO.GOV at the Subject + Matter Eligibility website. + + + +In response to a Step 2B rejection of a claim + reciting a tentative abstract idea, an interview with the examiner may be + conducted, which may help advance prosecution and identify patent eligible subject + matter. See **[MPEP § + 713](s713.html#d0e84376)**. For applications in which an abstract idea has been + identified using the tentative abstract idea procedure, an interview with the TC + Director that provided approval is not necessary because the examiner retains the + authority to withdraw or maintain a rejection upon consideration of applicant’s + reply. The examiner is not required to obtain TC Director approval to withdraw or + maintain such a **[§ 101](mpep-9015-appx-l.html#d0e302376)** subject matter eligibility rejection. + + + + + + +# 2106.04(b) Laws of Nature, Natural Phenomena & + Products of Nature [R-10.2019] + + +Laws of nature and natural phenomena, as identified by + the courts, include naturally occurring principles/relations and nature-based + products that are naturally occurring or that do not have markedly different + characteristics compared to what occurs in nature. The courts have often described + these exceptions using other terms, including "physical phenomena," "scientific + principles", "natural laws," and "products of nature." + + +**I.** **LAWS OF NATURE AND NATURAL + PHENOMENA, GENERALLY**The law of nature and natural phenomenon + exceptions reflect the Supreme Court's view that the basic tools of scientific and + technological work are not patentable, because the "manifestations of laws of + nature" are "part of the storehouse of knowledge," "free to all men and reserved + exclusively to none." *Funk Bros. Seed Co. v. Kalo Inoculant + Co.,* 333 U.S. 127, 130, 76 USPQ 280, 281 (1948). Thus, "a new mineral + discovered in the earth or a new plant found in the wild is not patentable subject + matter" under **[Section 101](mpep-9015-appx-l.html#d0e302376)**. *Diamond v. Chakrabarty,* 447 + U.S. 303, 309, 206 USPQ 193, 197 (1980). "Likewise, Einstein could not patent his + celebrated law that E=mc2; nor could Newton have + patented the law of gravity." *Id.* Nor can one patent "a novel + and useful mathematical formula," *Parker v. Flook,* 437 U.S. + 584, 585, 198 USPQ 193, 195 (1978); electromagnetism or steam power, + *O’Reilly v. Morse,* 56 U.S. (15 How.) 62, 113-114 (1853); or + "[t]he qualities of ... bacteria, ... the heat of the sun, electricity, or the + qualities of metals," *Funk,* 333 U.S. at 130, 76 USPQ at 281; + see also *Le Roy v. Tatham,* 55 U.S. (14 How.) 156, 175 + (1853). + + + + The courts have identified the following concepts + and products as examples of laws of nature or natural phenomena: + + + +* i. isolated DNA, *Ass’n for Molecular + Pathology v. Myriad Genetics, Inc.,* 569 U.S. 576, 589-91, 106 + USPQ2d 1972, 1978-79 (2013); +* ii. a cloned farm animal such as a sheep, + *In re Roslin Institute (Edinburgh),* 750 F.3d 1333, + 1337, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014); +* iii. a correlation between variations in + non-coding regions of DNA and allele presence in coding regions of DNA, + *Genetic Techs. Ltd. v. Merial LLC,* 818 F.3d 1369, + 1375, 118 USPQ2d 1541, 1545 (Fed. Cir. 2016); +* iv. a correlation that is the consequence of how + a certain compound is metabolized by the body, *Mayo Collaborative + Servs. v. Prometheus Labs.,* 566 U.S. 66, 75-77, 101 USPQ2d + 1961, 1967-68 (2012); +* v. a correlation between the presence of + myeloperoxidase in a bodily sample (such as blood or plasma) and + cardiovascular disease risk, *Cleveland Clinic Foundation v. True + Health Diagnostics, LLC,* 859 F.3d 1352, 1361, 123 USPQ2d 1081, + 1087 (Fed. Cir. 2017); +* vi. electromagnetism to transmit signals, + *O’Reilly v. Morse,* 56 U.S. 62, 113 (1853); +* vii. qualities of bacteria such as their ability + to create a state of inhibition or non-inhibition in other bacteria, + *Funk Bros.,* 333 U.S. at 130, 76 USPQ at 281; +* viii. single-stranded DNA fragments known as + "primers", *University of Utah Research Foundation v. Ambry Genetics + Corp.,* 774 F.3d 755, 761, 113 USPQ2d 1241, 1244 (Fed. Cir. + 2014); +* ix. the chemical principle underlying the union + between fatty elements and water, *Tilghman v. Proctor,* + 102 U.S. 707, 729 (1880); +* x. the existence of cell-free fetal DNA (cffDNA) + in maternal blood, *Ariosa Diagnostics, Inc. v. Sequenom,* + 788 F.3d 1371, 1373, 115 USPQ2d 1152, 1153 (Fed. Cir. 2015); and +* xi. the natural relationship between a patient’s + CYP2D6 metabolizer genotype and the risk that the patient will suffer QTc + prolongation after administration of a medication called iloperidone, + *Vanda Pharmaceuticals Inc. v. West-Ward + Pharmaceuticals,* 887 F.3d 1117, 1135-36, 126 USPQ2d 1266, 1281 + (Fed. Cir. 2018). + + +The courts have also noted, however, that not every + claim describing a natural ability or quality of a product, or describing a + natural process, necessarily recites a law of nature or natural phenomenon. See + *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d 1042, + 1048-49, 119 USPQ2d 1370, 1374 (Fed. Cir. 2016) (claims reciting process steps of + fractionating, recovering, and cryopreserving hepatocytes held to be eligible, + because they are not focused on merely observing or detecting the ability of + hepatocytes to survive multiple freeze-thaw cycles). Thus, in a claimed method of + treating cancer with chemotherapy, the cancer cells’ inability to survive + chemotherapy is not considered to be a law of nature. Similarly, in a claimed + method of treating headaches with aspirin, the human body’s natural response to + aspirin is not considered to be a law of nature. These claims are accordingly + eligible at Prong One unless they recite another exception, in which case they + require further analysis in Prong Two (and Step 2B, if needed) to determine their + eligibility. Similarly, a method of producing a new compound is not directed to + the individual components’ ability to combine to form the new compound. + *Id.* See also *Tilghman v. Proctor,* 102 + U.S. 707, 729 (1881) (claims reciting process steps for manufacturing fatty acids + and glycerol by hydrolyzing fat at high temperature and pressure were held to be + eligible, because they are not focused on the chemical principle that fat can be + hydrolyzed into its components). + + + +Even if a claim does recite a law of nature or + natural phenomenon, it may still be eligible at any of Pathways A through C. For + example, claims reciting a naturally occurring relationship between a patient’s + genotype and the risk of QTc prolongation (a law of nature) were held eligible as + not "directed to" that relationship because they also recited a step of treating + the patient with an amount of a particular medication that was tailored to the + patient’s genotype. *Vanda Pharms.,* 887 F.3d at 1134-36, 126 + USPQ2d at 1279-81. This particular treatment step applied the natural relationship + in a manner that integrated it into a practical application. The court’s analysis + in *Vanda* is equivalent to a finding of eligibility at Step 2A + Prong Two (Pathway B). + + + +As explained in **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, a claim that recites a law of nature or a + natural phenomenon requires further analysis in Step 2A Prong Two to determine + whether the claim integrates the exception into a practical application. + + + +A claim that does not recite a law of nature or + natural phenomenon is eligible at Pathway B (Step 2A: NO) unless the claim + recites, and is directed to, another exception (such as an abstract idea, or a + product of nature). + + +**II.** **PRODUCTS OF + NATURE**When a law of nature or natural phenomenon is + claimed as a physical product, the courts have often referred to the exception as + a "product of nature". For example, the isolated DNA of *Myriad* + and the primers of *Ambry Genetics* were described as products of + nature by the courts. *Ass’n for Molecular Pathology v. Myriad Genetics, + Inc.,* 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); + *University of Utah Research Foundation v. Ambry Genetics,* + 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in + those decisions, products of nature are considered to be an exception because they + tie up the use of naturally occurring things, but they have been labeled as both + laws of nature and natural phenomena. See *Myriad Genetics, + Inc.,* 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA + held ineligible because they "claim naturally occurring phenomena" and are + "squarely within the law of nature exception"); *Funk Bros. Seed Co. v. + Kalo Inoculant Co.,* 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) + (claims to bacterial mixtures held ineligible as "manifestations of laws of + nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis + uses the terms "law of nature" and "natural phenomenon" as inclusive of "products + of nature". + + + +It is important to keep in mind that product of + nature exceptions include both naturally occurring products and non-naturally + occurring products that lack markedly different characteristics from any naturally + occurring counterpart. See, *e.g.,**Ambry Genetics,* 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary + to *Myriad's* argument, it makes no difference that the + identified gene sequences are synthetically replicated. As the Supreme Court made + clear, neither naturally occurring compositions of matter, nor synthetically + created compositions that are structurally identical to the naturally occurring + compositions, are patent eligible."). Thus, a synthetic, artificial, or + non-naturally occurring product such as a cloned organism or a human-made hybrid + plant is not automatically eligible because it was created by human ingenuity or + intervention. See, *e.g.,**In re Roslin Institute (Edinburgh),* 750 F.3d 1333, 1337, 110 + USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. *J.E.M. Ag + Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc.,* 534 U.S. 130-132, 60 + USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all + non-naturally occurring products is whether they possess markedly different + characteristics from any naturally occurring counterpart. + + + +When a claim recites a nature-based product + limitation, examiners should use the markedly different characteristics analysis + discussed in **[MPEP § 2106.04(c)](s2106.html#ch2100_d29a1b_13bc1_b1)** to evaluate the + nature-based product limitation and determine the answer to Step 2A. Nature-based + products, as used herein, include both eligible and ineligible products and merely + refer to the types of products subject to the markedly different characteristics + analysis used to identify product of nature exceptions. Examples of nature-based + products include the isolated gene and cDNA sequences of + *Myriad,* the cloned farm animals of + *Roslin,* and the bacterium of *Chakrabarty*. + As is evident from these examples, and as further discussed in + **[MPEP § + 2105](s2105.html#d0e197008)**, a nature-based product that is a living organism + (*e.g.,* a plant, an animal, a bacterium, etc.) is not + excluded from patent protection merely because it is alive, and such a product is + eligible for patenting if it satisfies the markedly different characteristics + analysis. + + + +It is important to keep in mind that under the + broadest reasonable interpretation (BRI) of the claims, a nature-based product + limitation may encompass both eligible and ineligible products. For example, a + claim to a "cloned giraffe" may have a BRI encompassing cloned giraffes with + markedly different characteristics, as well as cloned giraffes that lack markedly + different characteristics and thus are products of nature. Cf. + *Roslin,* 750 F.3d at 1338-39, 110 USPQ2d at 1673 (applicant + could not rely on unclaimed features to distinguish claimed mammals from donor + mammals). + + + +Such a claim recites a product of nature, and thus + requires further analysis in Prong Two. If the claim is ultimately rejected as + failing to encompass an inventive concept (Step 2B: NO), it is a best practice for + the examiner to point out the broadest reasonable interpretation and recommend an + amendment, if possible, that would narrow the claim to those embodiments that are + not directed to products of nature, or that are otherwise eligible. + + + +For claims that recite a nature-based product + limitation (which may or may not be a product of nature exception) but which are + directed to inventions that clearly do not seek to tie up any judicial exception, + examiners should consider whether the streamlined eligibility analysis discussed + in **[MPEP § 2106.06](s2106.html#ch2100_d29a1b_13e6a_88)** is appropriate. In such cases, it would + not be necessary to conduct a markedly different characteristics analysis. + + + + + +# 2106.04(c) The Markedly Different Characteristics + Analysis [R-10.2019] + + +The markedly different characteristics analysis is + part of Step 2A Prong One, because the courts use this analysis to identify product + of nature exceptions. For example, *Chakrabarty* relied on a + comparison of the claimed bacterium to naturally occurring bacteria when determining + that the claimed bacterium was not a product of nature because it had "markedly + different characteristics from any found in nature". *Diamond v. + Chakrabarty,* 447 U.S. 303, 310, 206 USPQ 193, 197 (1980). Similarly, + *Roslin* relied on a comparison of the claimed sheep to naturally + occurring sheep when determining that the claimed sheep was a product of nature + because it "does not possess ‘markedly different characteristics from any [farm + animals] found in nature.’" *In re Roslin Institute (Edinburgh),* + 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (quoting + *Chakrabarty,* 447 U.S. at 310, 206 USPQ at 197 (alterations in + original)). + + + + This section sets forth guidelines for performing + the markedly different characteristics analysis, including information on when to + perform the analysis, and how to perform the analysis. Examiners should consult these + guidelines when performing an eligibility analysis of a claim that recites a + nature-based product limitation. Nature-based products, as used herein, include both + eligible and ineligible products and merely refer to the types of products subject to + the markedly different characteristics analysis used to identify product of nature + exceptions. + + + +If the claim includes a nature-based product that has + markedly different characteristics, then the claim does not recite a product of + nature exception and is eligible (Step 2A: NO) at Pathway B unless the claim recites + another exception (such as a law of nature or abstract idea, or a different natural + phenomenon). For claims where the entire claim is a single nature-based product + (e.g., a claim to "a *Lactobacillus* bacterium"), once a markedly + different characteristic in that product is shown, no further analysis would be + necessary for eligibility because no product of nature exception is recited (i.e., + Step 2B is not necessary because the answer to Step 2A is NO). For claims including + limitations in addition to the nature-based product, examiners should consider + whether the claim recites another exception and thus requires further eligibility + analysis. + + + + If the claim includes a nature-based product that + does not exhibit markedly different characteristics from its naturally occurring + counterpart in its natural state, then the claim recites a "product of nature" + exception, and requires further analysis in Step 2A Prong Two to determine whether + the claim as a whole integrates the exception into a practical application. + + +**I.** **WHEN TO PERFORM THE MARKEDLY + DIFFERENT CHARACTERISTICS ANALYSIS**Because a nature-based product can be claimed by + itself (*e.g.,* "a *Lactobacillus* bacterium") + or as one or more limitations of a claim (e.g., "a probiotic composition + comprising a mixture of *Lactobacillus* and milk in a + container"), care should be taken not to overly extend the markedly different + characteristics analysis to products that when viewed as a whole are not + nature-based. Instead, the markedly different characteristics analysis should be + applied only to the nature-based product limitations in the claim to determine + whether the nature-based products are "product of nature" exceptions. + + + +Examiners should keep in mind that if the + nature-based product limitation is naturally occurring, there is no need to + perform the markedly different characteristics analysis because the limitation is + by definition directed to a naturally occurring product and thus falls under the + product of nature exception. However, if the nature-based product limitation is + not naturally occurring, for example due to some human intervention, then the + markedly different characteristics analysis must be performed to determine whether + the claimed product limitation is a product of nature exception. + + +***A.*** ***Product Claims***Where the claim is to a nature-based product by + itself (*e.g.,* a claim to "a *Lactobacillus* + bacterium"), the markedly different characteristics analysis should be applied + to the entire product. See, *e.g., Chakrabarty,* 447 U.S. at + 305, 309-10, 206 USPQ at 195, 197-98 (applying analysis to entire claimed + "bacterium from the genus *Pseudomonas* containing therein at + least two stable energy-generating plasmids, each of said plasmids providing a + separate hydrocarbon degradative pathway"). + + + +Where the claim is to a nature-based product + produced by combining multiple components (*e.g.,* a claim to + "a probiotic composition comprising a mixture of + *Lactobacillus* and milk"), the markedly different + characteristics analysis should be applied to the resultant nature-based + combination, rather than its component parts. For instance, for the probiotic + composition example, the mixture of *Lactobacillus* and milk + should be analyzed for markedly different characteristics, rather than the + *Lactobacillus* separately and the milk separately. See + subsection II, below, for further guidance on the markedly different + characteristic analysis. + + + + Where the claim is to a nature-based product + in combination with non-nature based elements (*e.g.,* a claim + to "a yogurt starter kit comprising *Lactobacillus* in a + container with instructions for culturing *Lactobacillus* with + milk to produce yogurt"), the markedly different characteristics analysis + should be applied only to the nature-based product limitation. For instance, + for the yogurt starter kit example, the *Lactobacillus* would + be analyzed for markedly different characteristics. The container and + instructions would not be subject to the markedly different characteristics + analysis as they are not nature-based products, but would be evaluated as + additional elements in Prong Two (and Step 2B if needed) if it is determined + that the *Lactobacillus* does not have markedly different + characteristics from any naturally occurring counterpart and thus is a product + of nature exception. See, *e.g., Funk Bros. Seed Co. v. Kalo Inoculant + Co.,* 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (although claims + 7, 8, 13 and 14 recited an inoculant comprising a bacterial mixture and a + powder base, only the bacterial mixture was analyzed). + + +***B.*** ***Product-by-Process Claims***For a product-by-process claim + (*e.g.,* a claim to a cloned farm animal produced by a + nuclear transfer cloning method), the analysis turns on whether the + nature-based product in the claim has markedly different characteristics from + its naturally occurring counterpart. See **[MPEP § 2113](s2113.html#d0e201450)** + for more information on product-by-process claims. + + +***C.*** ***Process Claims***For a process claim, the general rule is that + the claim is not subject to the markedly different analysis for nature-based + products used in the process. This is because the analysis of a process claim + should focus on the active steps of the process rather than the products used + in those steps. For example, when evaluating a claimed process of + cryopreserving hepatocyte cells comprising performing density gradient + fractionation to separate viable and non-viable hepatocytes, recovering the + viable hepatocytes, and cryopreserving the recovered viable hepatocytes, the + court did not subject the claim to the markedly different characteristics + analysis for the nature-based products (the hepatocytes) used in the process. + *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d 1042, + 1049, 119 USPQ2d 1370, 1374 (Fed. Cir. 2016) (claims are directed to a process + of creating a preparation of multi-cryopreserved hepatocytes, not to the + preparation itself). + + + + However, in the limited situation where a + process claim reciting a nature-based product is drafted in such a way that + there is no difference in substance from a product claim, the claim is subject + to the markedly different analysis for the recited nature-based product. These + types of claims are drafted in a way that focuses on the product rather than + the process steps. For example, consider a claim that recites, in its entirety, + "a method of providing an apple." Under the broadest reasonable interpretation, + this claim is focused on the apple fruit itself, which is a nature-based + product. Similarly, claims to detecting naturally occurring cell-free fetal DNA + (cffDNA) in maternal blood were held to be directed to the cffDNA, because the + "existence and location of cffDNA is a natural phenomenon [and thus] + identifying its presence was merely claiming the natural phenomena itself." + *Rapid Litig. Mgmt.,* 827 F.3d at 1048, 119 USPQ2d at 1374, + (explaining the holding in *Ariosa Diagnostics, Inc. v. + Sequenom,* 788 F.3d 1371, 115 USPQ2d 1152 (Fed. Cir. 2015)). + + +**II.** **HOW TO PERFORM THE MARKEDLY + DIFFERENT CHARACTERISTICS ANALYSIS** The markedly different characteristics analysis + compares the nature-based product limitation to its naturally occurring + counterpart in its natural state. Markedly different characteristics can be + expressed as the product’s structure, function, and/or other properties, and are + evaluated based on what is recited in the claim on a case-by-case basis. If the + analysis indicates that a nature-based product limitation does not exhibit + markedly different characteristics, then that limitation is a product of nature + exception. If the analysis indicates that a nature-based product limitation does + have markedly different characteristics, then that limitation is not a product of + nature exception. + + + +This section sets forth guidelines for performing + the markedly different characteristics analysis, including information on (a) + selecting the appropriate naturally occurring counterpart(s) to the nature-based + product limitation, (b) identifying appropriate characteristics for analysis, and + (c) evaluating characteristics to determine whether they are "markedly different". + + +***A.*** ***Selecting The Appropriate + Counterpart(s)***Because the markedly different characteristics + analysis compares the nature-based product limitation to its naturally + occurring counterpart in its natural state, the first step in the analysis is + to select the appropriate counterpart(s) to the nature-based product. + + + + When the nature-based product is derived from + a naturally occurring thing, then the naturally occurring thing is the + counterpart. For example, assume that applicant claims deoxyacid A, which is a + chemical derivative of a naturally occurring chemical called acid A. Because + applicant created the claimed nature-based product (deoxyacid A) by modifying + the naturally occurring acid A, the closest natural counterpart for deoxyacid A + would be the natural product from which it was derived, + *i.e.,* acid A. See, *e.g.,**Chakrabarty,* 447 U.S. at 305 and n.1, 206 USPQ at 195 and + n.1 (counterpart to genetically modified *Pseudomonas* + bacterium containing multiple plasmids is the naturally occurring unmodified + *Pseudomonas* bacterium from which the claimed bacterium + was created); *Roslin,* 750 F.3d at 1337, 110 USPQ2d at + 1671-72 (counterparts to cloned sheep are naturally occurring sheep such as the + donor ewe from which the clone was created). + + + +Although the selected counterpart should be in + its natural state, examiners should take care not to confuse the counterpart + with other material that may occur naturally with, or adjacent to, the + counterpart. For example, assume that applicant claims a nucleic acid having a + nucleotide sequence derived from naturally occurring gene B. Although gene B + occurs in nature as part of a chromosome, the closest natural counterpart for + the claimed nucleic acid is gene B, and not the whole chromosome. See, + e.g., *Ass’n for Molecular Pathology v. Myriad Genetics, + Inc.,* 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013) + (comparing isolated BRCA1 genes and BRCA1 cDNA molecules to naturally occurring + BRCA1 gene); *Roche Molecular System, Inc. v. CEPHEID,* 905 + F.3d 1363, 1371, 128 USPQ2d 1221, 1227 (Fed. Cir. 2018) (comparing claimed + primers to "their corresponding nucleotide sequences on the naturally occurring + DNA"). Similarly, assume that applicant claims a single-stranded piece of DNA + (a primer) having a nucleotide sequence derived from the sense strand of + naturally occurring nucleic acid C. Although nucleic acid C occurs in nature as + a double-stranded molecule having a sense and an antisense strand, the closest + natural counterpart for the claimed nucleic acid is the sense strand of C only. + See, e.g., *University of Utah Research Foundation v. Ambry + Genetics,* 774 F.3d 755, 760, 113 USPQ2d 1241, 1241 (Fed. Cir. + 2014) (comparing single-stranded nucleic acid to the same strand found in + nature, even though "single-stranded DNA cannot be found in the human body"). + + + +When there are multiple counterparts to the + nature-based product, the comparison should be made to the closest naturally + occurring counterpart. For example, assume that applicant creates a cloned + sheep D by transferring nuclear DNA from a Finn-Dorset sheep into an egg cell + (which contains mitochondrial DNA) from a Scottish Blackface sheep. Applicant + then claims sheep D. Here, because sheep D was created via combining DNA from + two different naturally occurring sheep of different breeds, there is no single + closest natural counterpart. The examiner should therefore select the + counterpart most closely related to sheep D based on the examiner’s expertise + in the particular art. For the example discussed here, the closest counterparts + might be naturally occurring Finn-Dorset or Scottish Blackface sheep, as + opposed to sheep of a different breed such as Bighorn sheep. *Cf. + Roslin,* 750 F.3d at 1337, 110 USPQ2d at 1671-72 (claimed sheep + produced by nuclear transfer into an oocyte and subsequent manipulation of + natural embryonic development processes was compared to naturally occurring + sheep such as the donor ewe from which the nuclear material was obtained). When + the nature-based product is a combination produced from multiple components, + the closest counterpart may be the individual nature-based components of the + combination. For example, assume that applicant claims an inoculant comprising + a mixture of bacteria from different species, *e.g.,* some + bacteria of species E and some bacteria of species F. Because there is no + counterpart mixture in nature, the closest counterparts to the claimed mixture + are the individual components of the mixture, *i.e.,* each + naturally occurring species by itself. See, e.g., *Funk + Bros.,* 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture + of bacterial species to each species as it occurs in nature); *Ambry + Genetics,* 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as + a pair, individual primer molecules were compared to corresponding segments of + naturally occurring gene sequence); *In re Bhagat,* 726 Fed. + Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed + mixture of lipids with particular lipid profile to "naturally occurring lipid + profiles of walnut oil and olive oil"). See subsection II. C. + + + +If the claim is rejected as ineligible, it is a + "best practice" for the examiner to identify the selected counterpart in the + Office action if the record is not already clear. This practice assists the + applicant in responding, and clarifies the record as to how the examiner is + interpreting the claim. + + +***B.*** ***Identifying Appropriate Characteristics For + Analysis***Because the markedly different characteristics + analysis is based on comparing the characteristics of the claimed nature-based + product and its counterpart, the second step in the analysis is to identify + appropriate characteristics to compare. + + + +Appropriate characteristics must be possessed + by the claimed product, because it is the claim that must define the invention + to be patented. *Cf. Roslin,* 750 F.3d at 1338, 110 USPQ2d at + 1673 (unclaimed characteristics could not contribute to eligibility). Examiners + can identify the characteristics possessed by the claimed product by looking at + what is recited in the claim language and encompassed within the broadest + reasonable interpretation of the nature-based product. In some claims, a + characteristic may be explicitly recited. For example, in a claim to + "deoxyribose", the recited chemical name informs those in the art of the + structural characteristics of the product (*i.e.,* the "deoxy" + prefix indicates that a hydroxyl group has been removed as compared to ribose). + In other claims, the characteristic may be apparent from the broadest + reasonable interpretation even though it is not explicitly recited in the + claim. For example, in a claim to "isolated gene B," the examiner would need to + rely on the broadest reasonable interpretation of "isolated gene B" to + determine what characteristics the isolated gene has, *e.g.,* + what its nucleotide sequence is, and what, if any, protein it encodes. + + + + Appropriate characteristics can be expressed + as the nature-based product’s structure, function, and/or other properties, and + are evaluated on a case-by-case basis. Non-limiting examples of the types of + characteristics considered by the courts when determining whether there is a + marked difference include: + + + +* • Biological or pharmacological + functions or activities; +* • Chemical and physical properties; +* • Phenotype, including functional and + structural characteristics; and +* • Structure and form, whether chemical, + genetic or physical. + + +Examples of biological or pharmacological + functions or activities include, but are not limited to: + + + +* i. the protein-encoding information of a + nucleic acid, *Myriad,* 569 U.S. at 590-91, 106 USPQ2d + at 1979; +* ii. the ability of complementary nucleotide + sequences to bind to each other, *Ambry Genetics,* 774 + F.3d at 760-61, 113 USPQ2d at 1244; +* iii. the properties and functions of bacteria + such as the ability to infect certain leguminous plants, *Funk + Bros.,* 333 U.S. at 130-31, 76 USPQ2d at 281-82; +* iv. the ability to degrade certain + hydrocarbons, *Diamond v. Chakrabarty,* 447 U.S. at 310, + 206 USPQ2d at 195; and +* v. the ability of vitamin C to prevent and + treat scurvy, *In re King,* 107 F.2d 618, 27 CCPA 754, + 756-57, 43 USPQ 400, 401-402 (CCPA 1939). + + +Examples of chemical and physical properties + include, but are not limited to: + + + +* i. the alkalinity of a chemical compound, + *Parke-Davis & Co. v. H.K. Mulford Co.,* 189 F. + 95, 103-04 (S.D.N.Y. 1911); and +* ii. the ductility or malleability of metals, + *In re Marden,* 47 F.2d 958, 959, 18 CCPA 1057, 1059, + 8 USPQ 347, 349 (CCPA 1931). + + +Examples of phenotypic characteristics include, + but are not limited to: + + + +* i. functional and structural characteristics + such as the shape, size, color, and behavior of an organism, + *Roslin,* 750 F.3d at 1338, 110 USPQ2d at 1672. + + +Examples of structure and form include, but are + not limited to: + + + +* i. physical structure or form such as the + physical presence of plasmids in a bacterial cell, + *Chakrabarty,* 447 U.S. at 305 and n.1, 206 USPQ2d at + 195 and n.1; +* ii. chemical structure and form such as a + chemical being a "nonsalt" and a "crystalline substance", + *Parke-Davis,* 189 F. at 100, 103; +* iii. genetic structure such as the nucleotide + sequence of DNA, *Myriad,* 569 U.S. at 590, 594-95, 106 + USPQ2d at 1979, 1981; and +* iv. the genetic makeup (genotype) of a cell + or organism, *Roslin,* 750 F.3d at 1338-39, 110 USPQ2d + at 1672-73. + +***C.*** ***Evaluating Characteristics To Determine Whether They Are "Markedly + Different"***The final step in the markedly different + characteristics analysis is to compare the characteristics of the claimed + nature-based product to its naturally occurring counterpart in its natural + state, in order to determine whether the characteristics of the claimed product + are markedly different. The courts have emphasized that to show a marked + difference, a characteristic must be changed as compared to nature, and cannot + be an inherent or innate characteristic of the naturally occurring counterpart + or an incidental change in a characteristic of the naturally occurring + counterpart. *Myriad,* 569 U.S. at 580, 106 USPQ2d at 1974-75. + Thus, in order to be markedly different, applicant must have caused the claimed + product to possess at least one characteristic that is different from that of + the counterpart. + + + +If there is no change in any characteristic, + the claimed product lacks markedly different characteristics, and is a product + of nature exception. If there is a change in at least one characteristic as + compared to the counterpart, and the change came about or was produced by + applicant’s efforts or influences, then the change will generally be considered + a markedly different characteristic such that the claimed product is not a + product of nature exception. + + +**1.** **Examples of Products Having Markedly Different + Characteristics**In *Chakrabarty,* the + Supreme Court identified a claimed bacterium as a nature-based product + having markedly different characteristics. This bacterium had a changed + functional characteristic, *i.e.,* it was able to degrade + at least two different hydrocarbons as compared to naturally occurring + *Pseudomonas* bacteria that can only degrade a single + hydrocarbon. The claimed bacterium also had a different structural + characteristic, *i.e.,* it was genetically modified to + include more plasmids than are found in a single naturally occurring + *Pseudomonas* bacterium. The Supreme Court considered + these changed characteristics to be "markedly different characteristics from + any found in nature" due to the additional plasmids and resultant capacity + for degrading multiple hydrocarbon components of oil. Therefore, the + bacterium was eligible. *Diamond v. Chakrabarty*, 447 U.S. + 303, 310, 206 USPQ 193, 197 (1980). + + + +In *Myriad,* the Supreme + Court identified a claimed full-length complementary DNA (cDNA) of the BRCA1 + gene as a nature-based product having markedly different characteristics. + This claimed cDNA had the same functional characteristics (i.e., it encoded + the same protein) as the naturally occurring gene, but had a changed + structural characteristic, *i.e.,* a different nucleotide + sequence containing only exons, as compared to the naturally occurring + sequence containing both exons and introns. The Supreme Court concluded that + the "cDNA retains the naturally occurring exons of DNA, but it is distinct + from the DNA from which it was derived. As a result, [this] cDNA is not a + ‘product of nature’" and is eligible. *Myriad,* 569 U.S. at + 595, 106 USPQ2d at 1981. + + +**2.** **Examples of Products Lacking + Markedly Different Characteristics**In *Myriad,* the Supreme + Court made clear that not all changes in characteristics will rise to the + level of a marked difference, *e.g.,* the incidental + changes resulting from isolation of a gene sequence are not enough to make + the isolated gene markedly different. *Myriad,* 569 U.S. at + 580, 106 USPQ2d at 1974-75. The patentee in *Myriad* had + discovered the location of the BRCA1 and BRCA2 genes in the human genome, + and isolated them, *i.e.,* separated those specific genes + from the rest of the chromosome on which they exist in nature. As a result + of their isolation, the isolated genes had a different structural + characteristic than the natural genes, *i.e.*, the natural + genes had covalent bonds on their ends that connected them to the rest of + the chromosome, but the isolated genes lacked these bonds. However, the + claimed genes were otherwise structurally identical to the natural genes, + *e.g.,* they had the same genetic structure and + nucleotide sequence as the BRCA genes in nature. The Supreme Court concluded + that these isolated but otherwise unchanged genes were not eligible, because + they were not different enough from what exists in nature to avoid + improperly tying up the future use and study of the naturally occurring BRCA + genes. *See, e.g., Myriad,* 569 U.S. at 585, 106 USPQ2d at + 1977 ("Myriad's patents would, if valid, give it the exclusive right to + isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary + to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 + (describing how would-be infringers could not avoid the scope of Myriad’s + claims). In sum, the claimed genes were different, but not markedly + different, from their naturally occurring counterparts (the BRCA genes), and + thus were product of nature exceptions. + + + +In *Ambry Genetics,* the + court identified claimed DNA fragments known as "primers" as products of + nature, because they lacked markedly different characteristics. + *University of Utah Research Foundation v. Ambry Genetics + Corp.,* 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014). The + claimed primers were single-stranded pieces of DNA, each of which + corresponded to a naturally occurring double-stranded DNA sequence in or + near the BRCA genes. The patentee argued that these primers had markedly + different structural characteristics from the natural DNA, because the + primers were synthetically created and because "single-stranded DNA cannot + be found in the human body". The court disagreed, concluding that the + primers’ structural characteristics were not markedly different than the + corresponding strands of DNA in nature, because the primers and their + counterparts had the same genetic structure and nucleotide sequence. 774 + F.3d at 760, 113 USPQ2d at 1243-44. The patentee also argued that the + primers had a different function than when they are part of the DNA strand + because when isolated as a primer, a primer can be used as a starting + material for a DNA polymerization process. The court disagreed, because this + ability to serve as a starting material is innate to DNA itself, and was not + created or altered by the patentee: + + + + +> +> In fact, the naturally occurring genetic +> sequences at issue here do not perform a significantly new function. +> Rather, the naturally occurring material is used to form the first step +> in a chain reaction--a function that is performed because the primer +> maintains the exact same nucleotide sequence as the relevant portion of +> the naturally occurring sequence. One of the primary functions of DNA’s +> structure in nature is that complementary nucleotide sequences bind to +> each other. It is this same function that is exploited here--the primer +> binds to its complementary nucleotide sequence. Thus, just as in nature, +> primers utilize the innate ability of DNA to bind to itself. +> +> +> +> + + +*Ambry Genetics,* 774 F.3d at 760-61, 113 USPQ2d at 1244. + In sum, because the characteristics of the claimed primers were innate to + naturally occurring DNA, they lacked markedly different characteristics from + nature and were thus product of nature exceptions. A similar result was + reached in *Marden,* where the court held a claim to + ductile vanadium ineligible, because the "ductility or malleability of + vanadium is . . . one of its inherent characteristics and not a + characteristic given to it by virtue of a new combination with other + materials or which characteristic is brought about by some chemical reaction + or agency which changes its inherent characteristics". *In re + Marden,* 47 F.2d 958, 959, 18 CCPA 1057, 1060, 8 USPQ 347, 349 + (CCPA 1931). + + + +In *Roslin,* the court + concluded that claimed clones of farm animals were products of nature, + because they lacked markedly different characteristics from the counterpart + farm animals found in nature. *In re Roslin Institute + (Edinburgh),* 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671 (Fed. + Cir. 2014). Applicant created its clones (which included the famous cloned + sheep named Dolly) by transferring the genetic material of a donor into an + oocyte (egg cell), letting the oocyte develop into an embryo, and then + implanting the embryo into a surrogate animal where it developed into a baby + animal. The applicant argued that the clones, including Dolly, were eligible + because they were created via human ingenuity, and had phenotypic + differences such as shape, size and behavior compared to their donors. The + court was unpersuaded, explaining that the clones were exact genetic + replicas of the donors and thus did not possess markedly different + characteristics. 750 F.3d at 1337, 110 USPQ2d at 1671-72 ("Roslin’s chief + innovation was the preservation of the donor DNA such that the clone is an + exact copy of the mammal from which the somatic cell was taken. Such a copy + is not eligible for patent protection."). The court noted that the alleged + phenotypic differences (*e.g.,* the fact that Dolly may + have been taller or heavier than her donor) could not make the clones + markedly different because these differences were not claimed. 750 F.3d at + 1338, 110 USPQ2d at 1672. See also *Roche Molecular System, Inc. v. + CEPHEID,* 905 F.3d 1363, 1370, 128 USPQ2d 1221, 1226 (Fed. Cir. + 2018) (alleged structural differences between linear primers and their + counterparts on a circular chromosome were neither claimed nor relevant to + the eligibility inquiry). + + + + + +# 2106.04(d) Integration of a Judicial Exception Into A + Practical Application [R-10.2019] + + +The Supreme Court has long distinguished between + principles themselves (which are not patent eligible) and the integration of those + principles into practical applications (which are patent eligible). See, + *e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc.,* 566 + U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012) (noting that the Court in + *Diamond v. Diehr* found ‘‘the overall process patent eligible + because of the way the additional steps of the process integrated the equation into + the process as a whole,’’ but the Court in *Gottschalk v. Benson* + ‘‘held that simply implementing a mathematical principle on a physical machine, + namely a computer, was not a patentable application of that principle’’). Similarly, + in a growing body of decisions, the Federal Circuit has distinguished between claims + that are ‘‘directed to’’ a judicial exception (which require further analysis to + determine their eligibility) and those that are not (which are therefore patent + eligible), *e.g.,* claims that improve the functioning of a computer + or other technology or technological field. See *Diamond v. Diehr,* + 450 U.S. 175, 209 USPQ 1 (1981); *Gottschalk v. Benson,* 409 U.S. + 63, 175 USPQ 673 (1972). See, e.g., **[MPEP § + 2106.06(b)](s2106.html#ch2100_d29a1b_13ecb_2ce)** (summarizing *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016), *McRO, + Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, 120 USPQ2d 1091 + (Fed. Cir. 2016), and other cases that were eligible as improvements to technology or + computer functionality instead of being directed to abstract ideas). + + + +Accordingly, after determining that a claim recites a + judicial exception in Step 2A Prong One, examiners should evaluate whether the claim + as a whole integrates the recited judicial exception into a practical application of + the exception in Step 2A Prong Two. A claim that integrates a judicial exception into + a practical application will apply, rely on, or use the judicial exception in a + manner that imposes a meaningful limit on the judicial exception, such that the claim + is more than a drafting effort designed to monopolize the judicial exception. Whether + or not a claim integrates a judicial exception into a practical application is + evaluated using the considerations set forth in subsection I below, in accordance + with the procedure described below in subsection II. + + + +In the context of the flowchart in + **[MPEP § + 2106](s2106.html#d0e197244)**, subsection III, Step 2A Prong Two determines + whether: + + + +* • The claim as a whole integrates the judicial + exception into a practical application, in which case the claim is not directed + to a judicial exception (Step 2A: NO) and is eligible at Pathway B. This + concludes the eligibility analysis. +* • The claim as a whole does not integrate the + exception into a practical application, in which case the claim is directed to + the judicial exception (Step 2A: YES), and requires further analysis under Step + 2B (where it may still be eligible if it amounts to an inventive concept). See + **[MPEP § 2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)** for discussion of Step 2B. + +**I.** **RELEVANT CONSIDERATIONS FOR + EVALUATING WHETHER ADDITIONAL ELEMENTS INTEGRATE A JUDICIAL EXCEPTION INTO A + PRACTICAL APPLICATION**The Supreme Court and Federal Circuit have + identified a number of considerations as relevant to the evaluation of whether the + claimed additional elements demonstrate that a claim is directed to + patent-eligible subject matter. The list of considerations here is not intended to + be exclusive or limiting. Additional elements can often be analyzed based on more + than one type of consideration and the type of consideration is of no import to + the eligibility analysis. Additional discussion of these considerations, and how + they were applied in particular judicial decisions, is provided in + **[MPEP § 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** through **[(c)](s2106.html#ch2100_d29a1b_13cfb_2e)** and **[MPEP § + 2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)** through **[(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**. + + + +Limitations the courts have found indicative that + an additional element (or combination of elements) may have integrated the + exception into a practical application include: + + + +* • An improvement in the functioning of a + computer, or an improvement to other technology or technical field, as + discussed in **[MPEP §§ 2106.04(d)(1)](s2106.html#ch2100_d2e7df_24a6e_1bd)** and + **[2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**; +* • Applying or using a judicial exception to + effect a particular treatment or prophylaxis for a disease or medical + condition, as discussed in **[MPEP § + 2106.04(d)(2)](s2106.html#ch2100_d2e827_17196_6c)**; +* • Implementing a judicial exception with, or + using a judicial exception in conjunction with, a particular machine or + manufacture that is integral to the claim, as discussed in + **[MPEP § 2106.05(b)](s2106.html#ch2100_d29a1b_13ccf_18c)**; +* • Effecting a transformation or reduction of + a particular article to a different state or thing, as discussed in + **[MPEP § 2106.05(c)](s2106.html#ch2100_d29a1b_13cfb_2e)**; and +* • Applying or using the judicial exception + in some other meaningful way beyond generally linking the use of the + judicial exception to a particular technological environment, such that the + claim as a whole is more than a drafting effort designed to monopolize the + exception, as discussed in **[MPEP § + 2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)**. + + +The courts have also identified limitations that + did not integrate a judicial exception into a practical application: + + + +* • Merely reciting the words "apply it" (or + an equivalent) with the judicial exception, or merely including instructions + to implement an abstract idea on a computer, or merely using a computer as a + tool to perform an abstract idea, as discussed in **[MPEP § + 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**; +* • Adding insignificant extra-solution + activity to the judicial exception, as discussed in **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**; and +* • Generally linking the use of a judicial + exception to a particular technological environment or field of use, as + discussed in **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**. + + +Step 2A Prong Two is similar to Step 2B in that + both analyses involve evaluating a set of judicial considerations to determine if + the claim is eligible. See **[MPEP §§ 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** through + **[(h)](s2106.html#ch2100_d29a1b_13e1a_22c)** for the list of considerations that are evaluated + at Step 2B. Although most of these considerations overlap (i.e., they are + evaluated in both Step 2A Prong Two and Step 2B), Step 2A specifically excludes + consideration of whether the additional elements represent well-understood, + routine, conventional activity. Accordingly, in Step 2A Prong Two, examiners + should ensure that they give weight to all additional elements, whether or not + they are conventional, when evaluating whether a judicial exception has been + integrated into a practical application. Additional elements that represent + well-understood, routine, conventional activity may integrate a recited judicial + exception into a practical application. + + + +It is notable that mere physicality or tangibility + of an additional element or elements is not a relevant consideration in Step 2A + Prong Two. As the Supreme Court explained in *Alice Corp.,* mere + physical or tangible implementation of an exception does not guarantee + eligibility. *Alice Corp. Pty. Ltd. v. CLS Bank Int’l,* 573 U.S. + 208, 224, 110 USPQ2d 1976, 1983-84 (2014) ("The fact that a computer ‘necessarily + exist[s] in the physical, rather than purely conceptual, realm,’ is beside the + point"). See also *Genetic Technologies Ltd. v. Merial LLC,* 818 + F.3d 1369, 1377, 118 USPQ2d 1541, 1547 (Fed. Cir. 2016) (steps of DNA + amplification and analysis are not "sufficient" to render claim 1 patent eligible + merely because they are physical steps). Conversely, the presence of a + non-physical or intangible additional element does not doom the claims, because + tangibility is not necessary for eligibility under the + *Alice/Mayo* test. *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016) ("that the + improvement is not defined by reference to ‘physical’ components does not doom the + claims"). See also *McRO, Inc. v. Bandai Namco Games Am. Inc.,* + 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016), (holding that a + process producing an intangible result (a sequence of synchronized, animated + characters) was eligible because it improved an existing technological + process). + + + +In addition, a specific way of achieving a result + is not a stand-alone consideration in Step 2A Prong Two. However, the specificity + of the claim limitations is relevant to the evaluation of several considerations + including the use of a particular machine, particular transformation and whether + the limitations are mere instructions to apply an exception. See + **[MPEP §§ 2106.05(b)](s2106.html#ch2100_d29a1b_13ccf_18c)**, **[2106.05(c)](s2106.html#ch2100_d29a1b_13cfb_2e)**, and **[2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**. For example, in *Parker v. + Flook,* 437 U.S. 584, 198 USPQ 193 (1978), the Supreme Court noted + that the "patent application does not purport to explain how to select the + appropriate margin of safety, the weighting factor, or any of the other variables" + in the claimed mathematical formula, "[n]or does it purport to contain any + disclosure relating to the chemical processes at work, the monitoring of process + variables, or the means of setting off an alarm or adjusting an alarm system." 437 + U.S. at 586, 198 USPQ at 195. The Court found this failure to explain any + specifics of how to use the claimed formula informative when deciding that the + additional elements in the claim were insignificant post-solution activity and + thus not meaningful enough to render the claim eligible. 437 U.S. at 589-90, 198 + USPQ at 197. + + +**II.** **HOW TO EVALUATE WHETHER THE + ADDITIONAL ELEMENTS INTEGRATE THE JUDICIAL EXCEPTION INTO A PRACTICAL + APPLICATION**The analysis under Step 2A Prong Two is the same + for all claims reciting a judicial exception, whether the exception is an abstract + idea, a law of nature, or a natural phenomenon (including products of nature). + Examiners evaluate integration into a practical application by: (1) identifying + whether there are any additional elements recited in the claim beyond the judicial + exception(s); and (2) evaluating those additional elements individually and in + combination to determine whether they integrate the exception into a practical + application, using one or more of the considerations introduced in subsection I + supra, and discussed in more detail in **[MPEP §§ + 2106.04(d)(1)](s2106.html#ch2100_d2e7df_24a6e_1bd)**, **[2106.04(d)(2)](s2106.html#ch2100_d2e827_17196_6c)**, **[2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** through **[(c)](s2106.html#ch2100_d29a1b_13cfb_2e)** and **[2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)** through **[(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**. + + + +Many of these considerations overlap, and often + more than one consideration is relevant to analysis of an additional element. Not + all considerations will be relevant to every element, or every claim. Because the + evaluation in Prong Two is not a weighing test, it is not important how the + elements are characterized or how many considerations apply from the list. It is + important to evaluate the significance of the additional elements relative to + applicant’s invention, and to keep in mind the ultimate question of whether the + exception is integrated into a practical application. If the claim as a whole + integrates the judicial exception into a practical application based upon + evaluation of these considerations, the additional limitations impose a meaningful + limit on the judicial exception and the claim is eligible at Step 2A. + + + +Examiners should examine each claim for + eligibility separately, based on the particular elements recited therein. Claims + should not be judged to automatically stand or fall with similar claims in an + application. For instance, one claim may be ineligible because it is directed to a + judicial exception without amounting to significantly more, but another claim + dependent on the first may be eligible because it recites additional elements that + do amount to significantly more, or that integrate the exception into a practical + application. + + + +For more information on how to evaluate claims + reciting multiple judicial exceptions, see **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, subsection II.B. + + +**III.** **EXAMPLES OF HOW THE OFFICE + EVALUATES WHETHER THE CLAIM AS A WHOLE INTEGRATES THE JUDICIAL EXCEPTION INTO A + PRACTICAL APPLICATION**The Prong Two analysis considers the claim as a + whole. That is, the limitations containing the judicial exception as well as the + additional elements in the claim besides the judicial exception need to be + evaluated together to determine whether the claim integrates the judicial + exception into a practical application. Because a judicial exception alone is not + eligible subject matter, if there are no additional claim elements besides the + judicial exception, or if the additional claim elements merely recite another + judicial exception, that is insufficient to integrate the judicial exception into + a practical application. However, the way in which the additional elements use or + interact with the exception may integrate it into a practical application. + Accordingly, the additional limitations should not be evaluated in a vacuum, + completely separate from the recited judicial exception. Instead, the analysis + should take into consideration all the claim limitations and how those limitations + interact and impact each other when evaluating whether the exception is integrated + into a practical application. + + + +Two examples of how the Office evaluates whether + the claim as a whole integrates the recited judicial exception into a practical + application are provided. In *Solutran, Inc. v. Elavon, Inc.,* + 931 F.3d 1161, 2019 USPQ2d 281076 (Fed. Cir. 2019), the claims were to methods for + electronically processing paper checks, all of which contained limitations setting + forth receiving merchant transaction data from a merchant, crediting a merchant’s + account, and receiving and scanning paper checks after the merchant’s account is + credited. In part one of the *Alice/Mayo* test, the Federal + Circuit determined that the claims were directed to the abstract idea of crediting + the merchant’s account before the paper check is scanned. The court first + determined that the recited limitations of "crediting a merchant’s account as + early as possible while electronically processing a check" is a "long-standing + commercial practice" like in *Alice* and + *Bilski*. 931 F.3d at 1167, 2019 USPQ2d 281076, at \*5 (Fed. + Cir. 2019). The Federal Circuit then continued with its analysis under part one of + the *Alice/Mayo* test finding that the claims are not directed to + an improvement in the functioning of a computer or an improvement to another + technology. In particular, the court determined that the claims "did not improve + the technical capture of information from a check to create a digital file or the + technical step of electronically crediting a bank account" nor did the claims + "improve how a check is scanned." *Id.* This analysis is + equivalent to the Office’s analysis of determining that the exception is not + integrated into a practical application at Step 2A Prong Two, and thus that the + claims are directed to the judicial exception (Step 2A: YES). + + + +In *Finjan Inc. v. Blue Coat Systems, + Inc.,* 879 F.3d 1299, 125 USPQ2d 1282 (Fed. Cir. 2018), the claimed + invention was a method of virus scanning that scans an application program, + generates a security profile identifying any potentially suspicious code in the + program, and links the security profile to the application program. 879 F.3d at + 1303-04, 125 USPQ2d at 1285-86. The Federal Circuit noted that the recited virus + screening was an abstract idea, and that merely performing virus screening on a + computer does not render the claim eligible. 879 F.3d at 1304, 125 USPQ2d at 1286. + The court then continued with its analysis under part one of the + *Alice/Mayo* test by reviewing the patent’s specification, + which described the claimed security profile as identifying both hostile and + potentially hostile operations. The court noted that the security profile thus + enables the invention to protect the user against both previously unknown viruses + and "obfuscated code," as compared to traditional virus scanning, which only + recognized the presence of previously-identified viruses. The security profile + also enables more flexible virus filtering and greater user customization. 879 + F.3d at 1304, 125 USPQ2d at 1286. The court identified these benefits as improving + computer functionality, and verified that the claims recite additional elements + (*e.g.,* specific steps of using the security profile in a + particular way) that reflect this improvement. Accordingly, the court held the + claims eligible as not being directed to the recited abstract idea. 879 F.3d at + 1304-05, 125 USPQ2d at 1286-87. This analysis is equivalent to the Office’s + analysis of determining that the additional elements integrate the judicial + exception into a practical application at Step 2A Prong Two, and thus that the + claims were not directed to the judicial exception (Step 2A: NO). + + + + +# 2106.04(d)(1) Evaluating Improvements in the + Functioning of a Computer, or an Improvement to Any Other Technology or Technical + Field in Step 2A Prong Two [R-10.2019] + + +A claim reciting a judicial exception is not + directed to the judicial exception if it also recites additional elements + demonstrating that the claim as a whole integrates the exception into a practical + application. One way to demonstrate such integration is when the claimed invention + improves the functioning of a computer or improves another technology or technical + field. The application or use of the judicial exception in this manner + meaningfully limits the claim by going beyond generally linking the use of the + judicial exception to a particular technological environment, and thus transforms + a claim into patent-eligible subject matter. Such claims are eligible at Step 2A + because they are not "directed to" the recited judicial exception. + + + +The courts have not provided an explicit test for + this consideration, but have instead illustrated how it is evaluated in numerous + decisions. These decisions, and a detailed explanation of how examiners should + evaluate this consideration are provided in **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**. In short, first the specification should be + evaluated to determine if the disclosure provides sufficient details such that one + of ordinary skill in the art would recognize the claimed invention as providing an + improvement. The specification need not explicitly set forth the improvement, but + it must describe the invention such that the improvement would be apparent to one + of ordinary skill in the art. Conversely, if the specification explicitly sets + forth an improvement but in a conclusory manner (*i.e.,* a bare + assertion of an improvement without the detail necessary to be apparent to a + person of ordinary skill in the art), the examiner should not determine the claim + improves technology. Second, if the specification sets forth an improvement in + technology, the claim must be evaluated to ensure that the claim itself reflects + the disclosed improvement. That is, the claim includes the components or steps of + the invention that provide the improvement described in the specification. The + claim itself does not need to explicitly recite the improvement described in the + specification (*e.g.,* "thereby increasing the bandwidth of the + channel"). + + + +While the courts usually evaluate "improvements" as + part of the "directed to" inquiry in part one of the *Alice/Mayo* + test (equivalent to Step 2A), they have also performed this evaluation in part two + of the *Alice/Mayo* test (equivalent to Step 2B). See, + *e.g., BASCOM Global Internet v. AT&T Mobility LLC,* 827 + F.3d 1341, 1349-50, 119 USPQ2d 1236, 1241-42 (Fed. Cir. 2016). However, the + improvement analysis at Step 2A Prong Two differs in some respects from the + improvements analysis at Step 2B. Specifically, the "improvements" analysis in + Step 2A determines whether the claim pertains to an improvement to the functioning + of a computer or to another technology without reference to what is + well-understood, routine, conventional activity. That is, the claimed invention + may integrate the judicial exception into a practical application by demonstrating + that it improves the relevant existing technology although it may not be an + improvement over well-understood, routine, conventional activity. It should be + noted that while this consideration is often referred to in an abbreviated manner + as the "improvements consideration," the word "improvements" in the context of + this consideration is limited to improvements to the functioning of a computer or + any other technology/technical field, whether in Step 2A Prong Two or in Step + 2B. + + + +Examples of claims that improve technology and are + not directed to a judicial exception include: *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 1339, 118 USPQ2d 1684, 1691-92 (Fed. Cir. 2016) + (claims to a self-referential table for a computer database were directed to an + improvement in computer capabilities and not directed to an abstract idea); + *McRO, Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, + 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016) (claims to automatic lip + synchronization and facial expression animation were directed to an improvement in + computer-related technology and not directed to an abstract idea); *Visual + Memory LLC v. NVIDIA Corp.,* 867 F.3d 1253,1259-60, 123 USPQ2d 1712, + 1717 (Fed. Cir. 2017) (claims to an enhanced computer memory system were directed + to an improvement in computer capabilities and not an abstract idea); + *Finjan Inc. v. Blue Coat Systems, Inc.,* 879 F.3d 1299, 125 + USPQ2d 1282 (Fed. Cir. 2018) (claims to virus scanning were found to be an + improvement in computer technology and not directed to an abstract idea); + *SRI Int’l, Inc. v. Cisco Systems, Inc.,* 930 F.3d 1295, 1303 + (Fed. Cir. 2019) (claims to detecting suspicious activity by using network + monitors and analyzing network packets were found to be an improvement in computer + network technology and not directed to an abstract idea). Additional examples are + provided in **[MPEP § 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**. + + + + + +# 2106.04(d)(2) Particular Treatment and Prophylaxis in + Step 2A Prong Two + + +A claim reciting a judicial exception is not + directed to the judicial exception if it also recites additional element(s) + demonstrating that the claim as a whole integrates the exception into a practical + application. One way to demonstrate such integration is when the additional + elements apply or use the recited judicial exception to effect a particular + treatment or prophylaxis for a disease or medical condition. The application or + use of the judicial exception in this manner meaningfully limits the claim by + going beyond generally linking the use of the judicial exception to a particular + technological environment, and thus transforms a claim into patent-eligible + subject matter. Such claims are eligible at Step 2A, because they are not + "directed to" the recited judicial exception. + + + +The particular treatment or prophylaxis + consideration originated as part of the other meaningful limitations consideration + discussed in **[MPEP § 2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)** and shares the + same legal basis in Supreme Court jurisprudence as that consideration. However, + recent jurisprudence has provided additional guidance that is especially relevant + to only a subset of claims, thus warranting the elevation of the particular + treatment or prophylaxis consideration to become a stand-alone consideration in + the Step 2A Prong Two analysis. *Vanda Pharm. Inc. v. West-Ward Pharm. + Int’l Ltd.,* 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). The + claims in *Vanda* recited a method of treating a patient having + schizophrenia with iloperidone, a drug known to cause QTc prolongation (a + disruption of the heart’s normal rhythm that can lead to serious health problems) + in patients having a particular genotype associated with poor drug metabolism. 887 + F.3d at 1121, 126 USPQ2d at 1269-70. In particular, the claims recited steps of: + (1) performing a genotyping assay to determine if a patient has a genotype + associated with poor drug metabolism; and (2) administering iloperidone to the + patient in a dose range that depends on the patient’s genotype. + *Id.* Although *Vanda’s* claims recited a law + of nature (the naturally occurring relationship between the patient’s genotype and + the risk of QTc prolongation) like the claims in *Mayo Collaborative + Servs. v. Prometheus Labs., Inc.,* 566 U.S. 66, 101 USPQ2d 1961 + (2012), the Federal Circuit distinguished them from the *Mayo* + claims based on the differences in the administration steps. In particular, the + court explained that *Mayo’s* step of administering a drug to a + patient was performed in order to gather data about the recited laws of nature, + and this step was thus ancillary to the overall diagnostic focus of the claims. + 887 F.3d at 1134-35, 126 USPQ2d at 1280. In contrast, *Vanda’s* + claims used the recited law of nature to more safely treat the patients with the + drug, thereby reducing the patient’s risk of QTc prolongation. 887 F.3d at 1135, + 126 USPQ2d at 1280. Accordingly, the court held *Vanda’s* claims + eligible at the first part of the *Alice/Mayo* test (Step 2A) + because the claims were not "directed to" the recited judicial exception. 887 F.3d + at 1136, 126 USPQ2d at 1281. + + + +Examples of "treatment" and prophylaxis" + limitations encompass limitations that treat or prevent a disease or medical + condition, including, e.g., acupuncture, administration of medication, dialysis, + organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and + the like. For example, an immunization step that integrates an abstract idea into + a specific process of immunizing that lowers the risk that immunized patients will + later develop chronic immune-mediated diseases is considered to be a particular + prophylaxis limitation that practically applies the abstract idea. See, + *e.g., Classen Immunotherapies, Inc. v. Biogen IDEC,* 659 F.3d + 1057, 1066–68, 100 USPQ2d 1492, 1500-01 (Fed. Cir. 2011). + + + +Examiners should keep in mind that in order to + qualify as a "treatment" or "prophylaxis" limitation for purposes of this + consideration, the claim limitation in question must affirmatively recite an + action that effects a particular treatment or prophylaxis for a disease or medical + condition. An example of such a limitation is a step of "administering amazonic + acid to a patient" or a step of "administering a course of plasmapheresis to a + patient." If the limitation does not actually provide a treatment or prophylaxis, + *e.g.,* it is merely an intended use of the claimed invention + or a field of use limitation, then it cannot integrate a judicial exception under + the "treatment or prophylaxis" consideration. For example, a step of "prescribing + a topical steroid to a patient with eczema" is not a positive limitation because + it does not require that the steroid actually be used by or on the patient, and a + recitation that a claimed product is a "pharmaceutical composition" or that a + "feed dispenser is operable to dispense a mineral supplement" are not affirmative + limitations because they are merely indicating how the claimed invention might be + used. + + + +When determining whether a claim applies or uses a + recited judicial exception to effect a particular treatment or prophylaxis for a + disease or medical condition, the following factors are relevant. + + + +* a. **The Particularity Or Generality Of The + Treatment Or Prophylaxis** +* The treatment or prophylaxis limitation must + be "particular," *i.e.,* specifically identified so that it + does not encompass all applications of the judicial exception(s). For + example, consider a claim that recites mentally analyzing information to + identify if a patient has a genotype associated with poor metabolism of beta + blocker medications. This falls within the mental process grouping of + abstract ideas enumerated in **[MPEP § + 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**. The claim also recites "administering + a lower than normal dosage of a beta blocker medication to a patient + identified as having the poor metabolizer genotype." This administration + step is particular, and it integrates the mental analysis step into a + practical application. Conversely, consider a claim that recites the same + abstract idea and "administering a suitable medication to a patient." This + administration step is not particular, and is instead merely instructions to + "apply" the exception in a generic way. Thus, the administration step does + not integrate the mental analysis step into a practical application. + Examiners may find it helpful to evaluate + other considerations such as the mere instructions to apply an exception + consideration (see **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), and the + field of use and technological environment consideration (see + **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when + making a determination of whether a treatment or prophylaxis limitation is + particular or general. +* b. **Whether The Limitation(s) Have More + Than A Nominal Or Insignificant Relationship To The + Exception(s)** +* The treatment or prophylaxis limitation must + have more than a nominal or insignificant relationship to the exception(s). + For example, consider a claim that recites a natural correlation (law of + nature) between blood glucose levels over 250 mg/dl and the risk of + developing ketoacidosis (a life-threatening medical condition). The claim + also recites "treating a patient having a blood glucose level over 250 mg/dl + with insulin". Insulin acts to lower blood glucose levels, and administering + insulin to a patient will reduce the patient’s blood glucose level, thereby + lowering the risk that the patient will develop ketoacidosis. Thus, in the + context of this claim, the administration step is significantly related to + the recited correlation between high blood glucose levels and the risk of + ketoacidosis. Because insulin is also a "particular" treatment, this + administration step integrates the law of nature into a practical + application. Alternatively, consider a claim that recites the same law of + nature and also recites "treating a patient having a blood glucose level + over 250 mg/dl with aspirin." Aspirin is not known in the art as a treatment + for ketoacidosis or diabetes, although some patients with diabetes may be on + aspirin therapy for other medical reasons (*e.g.,* to + control pain or inflammation, or to prevent blood clots). In the context of + this claim and the recited correlation between high blood glucose levels and + the risk of ketoacidosis, administration of aspirin has at best a nominal + connection to the law of nature, because aspirin does not treat or prevent + ketoacidosis. This step therefore does not apply or use the exception in any + meaningful way. Thus, this step of administering aspirin does not integrate + the law of nature into a practical application. + Examiners may find it helpful to evaluate + other considerations such as the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the + field of use and technological environment consideration (see + **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when + making a determination of whether a treatment or prophylaxis limitation has + more than a nominal or insignificant relationship to the exception(s). +* c. **Whether The Limitation(s) Are Merely + Extra-Solution Activity Or A Field Of Use** +* The treatment or prophylaxis limitation must + impose meaningful limits on the judicial exception, and cannot be + extra-solution activity or a field-of-use. For example, consider a claim + that recites (a) administering rabies and feline leukemia vaccines to a + first group of domestic cats in accordance with different vaccination + schedules, and (b) analyzing information about the vaccination schedules and + whether the cats later developed chronic immune-mediated disorders to + determine a lowest-risk vaccination schedule. Step (b) falls within the + mental process grouping of abstract ideas enumerated in + **[MPEP § 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**. While + step (a) administers vaccines to the cats, this administration is performed + in order to gather data for the mental analysis step, and is a necessary + precursor for all uses of the recited exception. It is thus extra-solution + activity, and does not integrate the judicial exception into a practical + application. Conversely, consider a claim reciting the same steps (a) and + (b), but also reciting step (c) "vaccinating a second group of domestic cats + in accordance with the lowest-risk vaccination schedule." Step (c) applies + the exception, in that the information from the mental analysis in step (b) + is used to alter the order and timing of the vaccinations so that the second + group of cats has a lower risk of developing chronic immune-mediated + disorders. Step (c) thus integrates the abstract idea into a practical + application. + Examiners may find it helpful to evaluate + other considerations such as the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the + field of use and technological environment consideration (see + **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), when + making a determination of whether a treatment or prophylaxis limitation is + merely extra-solution activity or a field of use. + + + + + + +# 2106.05 Eligibility Step 2B: Whether a Claim Amounts to + Significantly More [R-10.2019] + +**I.** **THE SEARCH FOR AN INVENTIVE + CONCEPT**The second part of the *Alice/Mayo* + test is often referred to as a search for an inventive concept. *Alice Corp. + Pty. Ltd. v. CLS Bank Int'l,* 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 + (2014) (citing *Mayo Collaborative Servs. v. Prometheus Labs., + Inc.,* 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). + + + + An inventive concept "cannot be furnished by the + unpatentable law of nature (or natural phenomenon or abstract idea) itself." + *Genetic Techs. v. Merial LLC,* 818 F.3d 1369, 1376, 118 USPQ2d + 1541, 1546 (Fed. Cir. 2016). See also *Alice Corp.,* 573 U.S. at + 21-18, 110 USPQ2d at 1981 (citing *Mayo,* 566 U.S. at 78, 101 USPQ2d + at 1968 (after determining that a claim is directed to a judicial exception, "we then + ask, ‘**[w]hat else** is there in the claims before us?") (emphasis added)); + *RecogniCorp, LLC v. Nintendo Co.,* 855 F.3d 1322, 1327, 122 + USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract + idea (encoding and decoding) does not render the claim non-abstract"). Instead, an + "inventive concept" is furnished by an element or combination of elements that is + recited in the claim in addition to (beyond) the judicial exception, and is + sufficient to ensure that the claim as a whole amounts to significantly more than the + judicial exception itself. *Alice Corp.,* 573 U.S. at 27-18, 110 + USPQ2d at 1981 (citing *Mayo,* 566 U.S. at 72-73, 101 USPQ2d at + 1966). + + + +Evaluating additional elements to determine whether + they amount to an inventive concept requires considering them both individually and + in combination to ensure that they amount to significantly more than the judicial + exception itself. Because this approach considers all claim elements, the Supreme + Court has noted that "it is consistent with the general rule that patent claims ‘must + be considered as a whole.’" *Alice Corp.,* 573 U.S. at 218 n.3, 110 + USPQ2d at 1981 (quoting *Diamond v. Diehr,* 450 U.S. 175, 188, 209 + USPQ 1, 8-9 (1981)). Consideration of the elements in combination is particularly + important, because even if an additional element does not amount to significantly + more on its own, it can still amount to significantly more when considered in + combination with the other elements of the claim. *See, e.g., Rapid Litig. + Mgmt. v. CellzDirect,* 827 F.3d 1042, 1051, 119 USPQ2d 1370, 1375 (Fed. + Cir. 2016) (process reciting combination of individually well-known freezing and + thawing steps was "far from routine and conventional" and thus eligible); + *BASCOM Global Internet Servs. v. AT&T Mobility LLC,* 827 + F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) (inventive concept may be + found in the non-conventional and non-generic arrangement of components that are + individually well-known and conventional). + + + +Although the courts often evaluate considerations such + as the conventionality of an additional element in the eligibility analysis, the + search for an inventive concept should not be confused with a novelty or + non-obviousness determination. See *Mayo,* 566 U.S. at 91, 101 + USPQ2d at 1973 (rejecting "the Government’s invitation to substitute + **[§§ + 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)**, **[103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)**, and **[112](mpep-9015-appx-l.html#d0e302824912)** + inquiries for the better established inquiry under **[§ 101](mpep-9015-appx-l.html#d0e302376)**"). As + made clear by the courts, the "‘novelty’ of any element or steps in a process, or + even of the process itself, is of ***no relevance*** in + determining whether the subject matter of a claim falls within the **[§ 101](mpep-9015-appx-l.html#d0e302376)** + categories of possibly patentable subject matter." *Intellectual Ventures I + v. Symantec Corp.,* 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. + 2016) (quoting *Diamond v. Diehr,* 450 U.S. at 188–89, 209 USPQ at + 9). See also *Synopsys, Inc. v. Mentor Graphics Corp.,* 839 F.3d + 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a claim for a + ***new*** abstract idea is still an abstract idea. + The search for a **[§ + 101](mpep-9015-appx-l.html#d0e302376)** inventive concept is thus distinct from demonstrating + **[§ + 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)** novelty."). In addition, the search for an inventive + concept is different from an obviousness analysis under **[35 U.S.C. + 103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)**. See, *e.g., BASCOM Global Internet v. AT&T + Mobility LLC,* 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. + 2016) ("The inventive concept inquiry requires more than recognizing that each claim + element, by itself, was known in the art. . . . [A]n inventive concept can be found + in the non-conventional and non-generic arrangement of known, conventional pieces."). + Specifically, lack of novelty under **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)** or obviousness + under **[35 + U.S.C. 103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)** of a claimed invention does not necessarily indicate + that additional elements are well-understood, routine, conventional elements. Because + they are separate and distinct requirements from eligibility, patentability of the + claimed invention under **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)** and + **[103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)** with respect to the prior art is neither required for, nor + a guarantee of, patent eligibility under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**. The distinction + between eligibility (under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**) and patentability + over the art (under **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)** and/or + **[103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)**) is further discussed in **[MPEP § + 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**. + + +***A.*** ***Relevant Considerations For Evaluating Whether Additional Elements + Amount To An Inventive Concept***The Supreme Court has identified a number of + considerations as relevant to the evaluation of whether the claimed additional + elements amount to an inventive concept. The list of considerations here is not + intended to be exclusive or limiting. Additional elements can often be analyzed + based on more than one type of consideration and the type of consideration is of + no import to the eligibility analysis. Additional discussion of these + considerations, and how they were applied in particular judicial decisions, is + provided in in **[MPEP § 2106.05(a) through (h)](s2106.html#ch2100_d29a1b_13c69_10)**. + + + +Limitations that the courts have found to qualify + as "significantly more" when recited in a claim with a judicial exception include: + + + +* i. Improvements to the functioning of a + computer, *e.g.,* a modification of conventional Internet + hyperlink protocol to dynamically produce a dual-source hybrid webpage, as + discussed in *DDR Holdings, LLC v. Hotels.com, L.P.,* 773 + F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014) (see + **[MPEP § 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**); +* ii. Improvements to any other technology or + technical field, *e.g.,* a modification of conventional + rubber-molding processes to utilize a thermocouple inside the mold to + constantly monitor the temperature and thus reduce under- and over-curing + problems common in the art, as discussed in *Diamond v. + Diehr,* 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981) (see + **[MPEP § 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**); +* iii. Applying the judicial exception with, or by + use of, a particular machine, *e.g.,* a Fourdrinier machine + (which is understood in the art to have a specific structure comprising a + headbox, a paper-making wire, and a series of rolls) that is arranged in a + particular way to optimize the speed of the machine while maintaining + quality of the formed paper web, as discussed in *Eibel Process Co. + v. Minn. & Ont. Paper Co.,* 261 U.S. 45, 64-65 (1923) (see + **[MPEP § 2106.05(b)](s2106.html#ch2100_d29a1b_13ccf_18c)**); +* iv. Effecting a transformation or reduction of a + particular article to a different state or thing, *e.g.,* a + process that transforms raw, uncured synthetic rubber into precision-molded + synthetic rubber products, as discussed in *Diehr,* 450 + U.S. at 184, 209 USPQ at 21 (see **[MPEP § + 2106.05(c)](s2106.html#ch2100_d29a1b_13cfb_2e)**); +* v. Adding a specific limitation other than what + is well-understood, routine, conventional activity in the field, or adding + unconventional steps that confine the claim to a particular useful + application, *e.g.,* a non-conventional and non-generic + arrangement of various computer components for filtering Internet content, + as discussed in *BASCOM Global Internet v. AT&T Mobility + LLC,* 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. + 2016) (see **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**); or +* vi. Other meaningful limitations beyond + generally linking the use of the judicial exception to a particular + technological environment, *e.g.,* an immunization step + that integrates an abstract idea of data comparison into a specific process + of immunizing that lowers the risk that immunized patients will later + develop chronic immune-mediated diseases, as discussed in *Classen + Immunotherapies Inc. v. Biogen IDEC,* 659 F.3d 1057, 1066-68, + 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (see **[MPEP § + 2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)**). + + + Limitations that the courts have found not to be + enough to qualify as "significantly more" when recited in a claim with a judicial + exception include: + + + +* i. Adding the words "apply it" (or an + equivalent) with the judicial exception, or mere instructions to implement + an abstract idea on a computer, *e.g.,* a limitation + indicating that a particular function such as creating and maintaining + electronic records is performed by a computer, as discussed in + *Alice Corp.,* 573 U.S. at 225-26, 110 USPQ2d at 1984 + (see **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**); +* ii. Simply appending well-understood, routine, + conventional activities previously known to the industry, specified at a + high level of generality, to the judicial exception, + *e.g.,* a claim to an abstract idea requiring no more + than a generic computer to perform generic computer functions that are + well-understood, routine and conventional activities previously known to the + industry, as discussed in *Alice Corp.,* 573 U.S. at 225, + 110 USPQ2d at 1984 (see **[MPEP § + 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**); +* iii. Adding insignificant extra-solution activity + to the judicial exception, *e.g.,* mere data gathering in + conjunction with a law of nature or abstract idea such as a step of + obtaining information about credit card transactions so that the information + can be analyzed by an abstract mental process, as discussed in + *CyberSource v. Retail Decisions, Inc.,* 654 F.3d 1366, + 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**); or +* iv. Generally linking the use of the judicial + exception to a particular technological environment or field of use, + *e.g.,* a claim describing how the abstract idea of + hedging could be used in the commodities and energy markets, as discussed in + *Bilski v. Kappos,* 561 U.S. 593, 595, 95 USPQ2d 1001, + 1010 (2010) or a claim limiting the use of a mathematical formula to the + petrochemical and oil-refining fields, as discussed in *Parker v. + Flook,* 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) + (**[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**). + + +It is notable that mere physicality or tangibility + of an additional element or elements is not a relevant consideration in Step 2B. + As the Supreme Court explained in *Alice Corp.,* mere physical or + tangible implementation of an exception is not in itself an inventive concept and + does not guarantee eligibility: + + + + +> +> The fact that a computer "necessarily exist[s] +> in the physical, rather than purely conceptual, realm," is beside the point. +> There is no dispute that a computer is a tangible system (in **[§ 101](mpep-9015-appx-l.html#d0e302376)** +> terms, a "machine"), or that many computer-implemented claims are formally +> addressed to patent-eligible subject matter. But if that were the end of the +> **[§ +> 101](mpep-9015-appx-l.html#d0e302376)** inquiry, an applicant could claim any principle of +> the physical or social sciences by reciting a computer system configured to +> implement the relevant concept. Such a result would make the determination of +> patent eligibility "depend simply on the draftsman’s art," *Flook, +> supra,* at 593, 98 S. Ct. 2522, 57 L. Ed. 2d 451, thereby +> eviscerating the rule that "‘[l]aws of nature, natural phenomena, and abstract +> ideas are not patentable,’" *Myriad,* 133 S. Ct. 1289, 186 L. +> Ed. 2d 124, 133). +> +> +> +> + + +*Alice Corp.,* 573 U.S. at 224, + 110 USPQ2d at 1983-84 (alterations in original). See also *Genetic + Technologies Ltd. v. Merial LLC,* 818 F.3d 1369, 1377, 118 USPQ2d + 1541, 1547 (Fed. Cir. 2016) (steps of DNA amplification and analysis "do not, + individually or in combination, provide sufficient inventive concept to render + claim 1 patent eligible" merely because they are physical steps). Conversely, the + presence of a non-physical or intangible additional element does not doom the + claims, because tangibility is not necessary for eligibility under the + *Alice/Mayo* test. *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016) ("that the + improvement is not defined by reference to ‘physical’ components does not doom the + claims"). See also *McRO, Inc. v. Bandai Namco Games Am. Inc.,* + 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016), (holding that a + process producing an intangible result (a sequence of synchronized, animated + characters) was eligible because it improved an existing technological process). + + + +***B.*** ***Examples Of How Courts Conduct The Search For An Inventive + Concept****Alice Corp.* provides an example + of how courts conduct the significantly more analysis. In this case, the Supreme + Court analyzed claims to computer systems, computer readable media, and + computer-implemented methods, all of which described a scheme for mitigating + "settlement risk," which is the risk that only one party to an agreed-upon + financial exchange will satisfy its obligation. In part one of the + *Alice/Mayo* test, the Court determined that the claims were + directed to the abstract idea of mitigating settlement risk. *Alice + Corp.,* 573 U.S. at 221, 110 USPQ2d at 1982. The Court then walked + through part two of the *Alice/Mayo* test, in which: + + + +* • The Court identified the additional + elements in the claim, *e.g.,* by noting that the method + claims recited steps of using a computer to "create electronic records, + track multiple transactions, and issue simultaneous instructions", and that + the product claims recited hardware such as a "data processing system" with + a "communications controller" and a "data storage unit" (573 U.S. at 224-26, + 110 USPQ2d at 1984-85); +* • The Court considered the additional + elements individually, noting that all the computer functions were + "‘well-understood, routine, conventional activit[ies]’ previously known to + the industry," each step "does no more than require a generic computer to + perform generic computer functions", and the recited hardware was "purely + functional and generic" (573 U.S. at 225-26, 110 USPQ2d at 1984-85); and +* • The Court considered the additional + elements "as an ordered combination," and determined that "the computer + components … ‘[a]dd nothing … that is not already present when the steps are + considered separately’" and simply recite intermediated settlement as + performed by a generic computer." 573 U.S. at 225 (citing + *Mayo,* 566 U.S. at 79, 101 USPQ2d at 1972). + + +Based on this analysis, the Court concluded that + the claims amounted to "‘nothing significantly more’ than an instruction to apply + the abstract idea of intermediated settlement using some unspecified, generic + computer", and therefore held the claims ineligible because they were directed to + a judicial exception and failed the second part of the + *Alice/Mayo* test. *Alice Corp.,* 573 U.S. at + 225-27, 110 USPQ2d at 1984. + + + +*BASCOM* provides another example + of how courts conduct the significantly more analysis, and of the critical + importance of considering the additional elements in combination. In this case, + the Federal Circuit vacated a judgment of ineligibility because the district court + failed to properly perform the second step of the *Alice/Mayo* + test when analyzing a claimed system for filtering content retrieved from an + Internet computer network. *BASCOM Global Internet v. AT&T Mobility + LLC,* 827 F.3d 1341, 119 USPQ2d 1236 (Fed. Cir. 2016). The Federal + Circuit agreed with the district court that the claims were directed to the + abstract idea of filtering Internet content, and then walked through the district + court’s analysis in part two of the *Alice/Mayo* test, noting + that: + + + +* • The district court properly identified + the additional elements in the claims, such as a "local client computer," + "remote ISP server," "Internet computer network," and "controlled access + network accounts" (827 F.3d at 1349, 119 USPQ2d at 1242); +* • The district court properly considered the + additional elements individually, for example by consulting the + specification, which described each of the additional elements as + "well-known generic computer components" (827 F.3d at 1349, 119 USPQ2d at + 1242); and +* • The district court should have considered + the additional elements in combination, because the "inventive concept + inquiry requires more than recognizing that each claim element, by itself, + was known in the art" (827 F.3d at 1350, 119 USPQ2d at 1242). + + +Based on this analysis, the Federal Circuit + concluded that the district court erred by failing to recognize that when + combined, an inventive concept may be found in the non-conventional and + non-generic arrangement of the additional elements, i.e., the installation of a + filtering tool at a specific location, remote from the end-users, with + customizable filtering features specific to each end user. 827 F.3d at 1350, 119 + USPQ2d at 1242. + + +**II.** **ELIGIBILITY STEP 2B: WHETHER THE + ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"**As described in **[MPEP § 2106](s2106.html#d0e197244)**, + subsection III, Step 2B of the Office’s eligibility analysis is the second part of + the *Alice/Mayo* test, *i.e.,* the Supreme Court’s + "framework for distinguishing patents that claim laws of nature, natural phenomena, + and abstract ideas from those that claim patent-eligible applications of those + concepts." *Alice Corp. Pty. Ltd. v. CLS Bank Int'l,* 573 U.S. 208, + 217, 110 USPQ2d 1976, 1981 (2014) (citing *Mayo,* 566 U.S. 66, 101 + USPQ2d 1961 (2012)). Like the other steps in the eligibility analysis, evaluation of + this step should be made after determining what applicant has invented by reviewing + the entire application disclosure and construing the claims in accordance with their + broadest reasonable interpretation. See **[MPEP § 2106](s2106.html#d0e197244)**, subsection II for more + information about the importance of understanding what the applicant has invented, + and **[MPEP § + 2111](s2111.html#d0e200352)** for more information about the broadest reasonable + interpretation. + + + +Step 2B asks: Does the claim recite additional + elements that amount to significantly more than the judicial exception? Examiners + should answer this question by first identifying whether there are any additional + elements (features/limitations/steps) recited in the claim beyond the judicial + exception(s), and then evaluating those additional elements individually + **and in combination** to determine whether + they contribute an inventive concept (*i.e.,* amount to + significantly more than the judicial exception(s)). + + + +This evaluation is made with respect to the + considerations that the Supreme Court has identified as relevant to the eligibility + analysis, which are introduced generally in Part I.A of this section, and discussed + in detail in **[MPEP § 2106.05(a) through (h)](s2106.html#ch2100_d29a1b_13c69_10)**. Many + of these considerations overlap, and often more than one consideration is relevant to + analysis of an additional element. Not all considerations will be relevant to every + element, or every claim. Because the evaluation in Step 2B is not a weighing test, it + is not important how the elements are characterized or how many considerations apply + from this list. It is important to evaluate the significance of the additional + elements relative to applicant’s invention, and to keep in mind the ultimate question + of whether the additional elements encompass an inventive concept. + + + +Although the conclusion of whether a claim is + eligible at Step 2B requires that all relevant considerations be evaluated, most of + these considerations were already evaluated in Step 2A Prong Two. Thus, in Step 2B, + examiners should: + + + +* • Carry over their identification of the + additional element(s) in the claim from Step 2A Prong Two; +* • Carry over their conclusions from Step 2A + Prong Two on the considerations discussed in **[MPEP §§ 2106.05(a) - + (c), (e) (f) and (h)](s2106.html#ch2100_d29a1b_13c69_10)**: +* • Re-evaluate any additional element or + combination of elements that was considered to be insignificant extra-solution + activity per **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**, because if + such re-evaluation finds that the element is unconventional or otherwise more + than what is well-understood, routine, conventional activity in the field, this + finding may indicate that the additional element is no longer considered to be + insignificant; and +* • Evaluate whether any additional element or + combination of elements are other than what is well-understood, routine, + conventional activity in the field, or simply append well-understood, routine, + conventional activities previously known to the industry, specified at a high + level of generality, to the judicial exception, per **[MPEP § + 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**. + + +In the context of the flowchart in + **[MPEP § + 2106](s2106.html#d0e197244)**, subsection III, Step 2B determines whether: + + + +* • The claim as a whole does not amount to + significantly more than the exception itself (there is no inventive concept in + the claim) (Step 2B: NO) and thus is not eligible, warranting a rejection for + lack of subject matter eligibility and concluding the eligibility analysis; or +* • The claim as a whole does amount to + significantly more than the exception (there is an inventive concept in the + claim) (Step 2B: YES), and thus is eligible at Pathway C, thereby concluding + the eligibility analysis. + + +Examiners should examine each claim for eligibility + separately, based on the particular elements recited therein. Claims should not be + judged to automatically stand or fall with similar claims in an application. For + instance, one claim may be ineligible because it is directed to a judicial exception + without amounting to significantly more, but another claim dependent on the first may + be eligible because it recites additional elements that do amount to significantly + more. + + + +For more information on how to evaluate claims + reciting multiple judicial exceptions, see **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, subsection II.B. + + + + If the claim as a whole does recite significantly + more than the exception itself, the claim is eligible (Step 2B: YES) at Pathway C, + and the eligibility analysis is complete. If there are no meaningful limitations in + the claim that transform the exception into a patent-eligible application, such that + the claim does not amount to significantly more than the exception itself, the claim + is not patent-eligible (Step 2B: NO) and should be rejected under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**. + See **[MPEP + § 2106.07](s2106.html#ch2100_d29a1b_13fb7_330)** for information on how to formulate an + ineligibility rejection. + + + + +# 2106.05(a) Improvements to the Functioning of a Computer + or To Any Other Technology or Technical Field [R-10.2019] + + +In determining patent eligibility, examiners should + consider whether the claim "purport(s) to improve the functioning of the computer + itself" or "any other technology or technical field." *Alice Corp. Pty. Ltd. + v. CLS Bank Int’l,* 573 U.S. 208, 225, 110 USPQ2d 1976, 1984 (2014). This + consideration has also been referred to as the search for a technological solution to + a technological problem. See e.g., *DDR Holdings, LLC. v. Hotels.com, + L.P.,* 773 F.3d 1245, 1257, 113 USPQ2d 1097, 1105 (Fed. Cir. 2014); + *Amdocs (Israel), Ltd. v. Openet Telecom, Inc.,* 841 F.3d 1288, + 1300-01, 120 USPQ2d 1527, 1537 (Fed. Cir. 2016). + + + +While improvements were evaluated in *Alice + Corp.* as relevant to the search for an inventive concept (Step 2B), + several decisions of the Federal Circuit have also evaluated this consideration when + determining whether a claim was directed to an abstract idea (Step 2A). See, + e.g., *Enfish, LLC v. Microsoft Corp.,* 822 F.3d 1327, 1335-36, + 118 USPQ2d 1684, 1689 (Fed. Cir. 2016); *McRO, Inc. v. Bandai Namco Games Am. + Inc.,* 837 F.3d 1299, 1314-16, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016); + *Visual Memory, LLC v. NVIDIA Corp.,* 867 F.3d 1253, 1259-60, 123 + USPQ2d 1712, 1717 (Fed. Cir. 2017). Thus, an examiner should evaluate whether a claim + contains an improvement to the functioning of a computer or to any other technology + or technical field at Step 2A Prong Two and Step 2B, as well as when considering + whether the claim has such self-evident eligibility that it qualifies for the + streamlined analysis. See **[MPEP § 2106.04(d)(1)](s2106.html#ch2100_d2e7df_24a6e_1bd)** for more + information about evaluating improvements in Step 2A Prong Two, and + **[MPEP + § 2106.07(b)](s2106.html#ch2100_d29a1b_14065_2a0)** for more information about improvements in the + streamlined analysis context. + + + +If it is asserted that the invention improves upon + conventional functioning of a computer, or upon conventional technology or + technological processes, a technical explanation as to how to implement the invention + should be present in the specification. That is, the disclosure must provide + sufficient details such that one of ordinary skill in the art would recognize the + claimed invention as providing an improvement. The specification need not explicitly + set forth the improvement, but it must describe the invention such that the + improvement would be apparent to one of ordinary skill in the art. Conversely, if the + specification explicitly sets forth an improvement but in a conclusory manner (i.e., + a bare assertion of an improvement without the detail necessary to be apparent to a + person of ordinary skill in the art), the examiner should not determine the claim + improves technology. An indication that the claimed invention provides an improvement + can include a discussion in the specification that identifies a technical problem and + explains the details of an unconventional technical solution expressed in the claim, + or identifies technical improvements realized by the claim over the prior art. For + example, in *McRO,* the court relied on the specification’s + explanation of how the particular rules recited in the claim enabled the automation + of specific animation tasks that previously could only be performed subjectively by + humans, when determining that the claims were directed to improvements in computer + animation instead of an abstract idea. *McRO,* 837 F.3d at 1313-14, + 120 USPQ2d at 1100-01. In contrast, the court in *Affinity Labs of Tex. v. + DirecTV, LLC* relied on the specification’s failure to provide details + regarding the manner in which the invention accomplished the alleged improvement when + holding the claimed methods of delivering broadcast content to cellphones ineligible. + 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016). + + + +After the examiner has consulted the specification + and determined that the disclosed invention improves technology, the claim must be + evaluated to ensure the claim itself reflects the disclosed improvement in + technology. *Intellectual Ventures I LLC v. Symantec Corp.,* 838 + F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (patent owner argued that the claimed email + filtering system improved technology by shrinking the protection gap and mooting the + volume problem, but the court disagreed because the claims themselves did not have + any limitations that addressed these issues). That is, the claim must include the + components or steps of the invention that provide the improvement described in the + specification. However, the claim itself does not need to explicitly recite the + improvement described in the specification (*e.g.,* "thereby + increasing the bandwidth of the channel"). The full scope of the claim under the BRI + should be considered to determine if the claim reflects an improvement in technology + (*e.g.,* the improvement described in the specification). In + making this determination, it is critical that examiners look at the claim "as a + whole," in other words, the claim should be evaluated "as an ordered combination, + without ignoring the requirements of the individual steps." When performing this + evaluation, examiners should be "careful to avoid oversimplifying the claims" by + looking at them generally and failing to account for the specific requirements of the + claims. *McRO,* 837 F.3d at 1313, 120 USPQ2d at 1100. + + + + An important consideration in determining whether a + claim improves technology is the extent to which the claim covers a particular + solution to a problem or a particular way to achieve a desired outcome, as opposed to + merely claiming the idea of a solution or outcome. *McRO,* 837 F.3d + at 1314-15, 120 USPQ2d at 1102-03; *DDR Holdings,* 773 F.3d at 1259, + 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with + other considerations, specifically the particular machine consideration (see + **[MPEP + § 2106.05(b)](s2106.html#ch2100_d29a1b_13ccf_18c)**), and the mere instructions to apply an + exception consideration (see **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**). Thus, evaluation + of those other considerations may assist examiners in making a determination of + whether a claim satisfies the improvement consideration. + + + +It is important to note, the judicial exception alone + cannot provide the improvement. The improvement can be provided by one or more + additional elements. See the discussion of *Diamond v. Diehr*, 450 + U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In + addition, the improvement can be provided by the additional element(s) in combination + with the recited judicial exception. See **[MPEP § + 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)** (discussing *Finjan, Inc. v. Blue Coat + Sys., Inc.,* 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. + 2018)). Thus, it is important for examiners to analyze the claim as a whole when + determining whether the claim provides an improvement to the functioning of computers + or an improvement to other technology or technical field. + + + +During examination, the examiner should analyze the + "improvements" consideration by evaluating the specification and the claims to ensure + that a technical explanation of the asserted improvement is present in the + specification, and that the claim reflects the asserted improvement. Generally, + examiners are not expected to make a qualitative judgement on the merits of the + asserted improvement. If the examiner concludes the disclosed invention does not + improve technology, the burden shifts to applicant to provide persuasive arguments + supported by any necessary evidence to demonstrate that one of ordinary skill in the + art would understand that the disclosed invention improves technology. Any such + evidence submitted under **[37 CFR 1.132](mpep-9020-appx-r.html#d0e323552)** must establish what + the specification would convey to one of ordinary skill in the art and cannot be used + to supplement the specification. See, *e.g.***[MPEP § + 716.09](s716.html#d0e93742)** on **[37 CFR 1.132](mpep-9020-appx-r.html#d0e323552)** practice with + respect to rejections under **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**. For example, in + response to a rejection under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**, an applicant could + submit a declaration under **[§ 1.132](mpep-9020-appx-r.html#d0e323552)** providing testimony on + how one of ordinary skill in the art would interpret the disclosed invention as + improving technology and the underlying factual basis for that conclusion. + + +**I.** **IMPROVEMENTS TO COMPUTER + FUNCTIONALITY**In computer-related technologies, the examiner + should determine whether the claim purports to improve computer capabilities or, + instead, invokes computers merely as a tool. *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). + In *Enfish,* the court evaluated the patent eligibility of claims + related to a self-referential database. *Id.* The court concluded + the claims were not directed to an abstract idea, but rather an improvement to + computer functionality. *Id.* It was the specification’s + discussion of the prior art and how the invention improved the way the computer + stores and retrieves data in memory in combination with the specific data + structure recited in the claims that demonstrated eligibility. 822 F.3d at 1339, + 118 USPQ2d at 1691. The claim was not simply the addition of general purpose + computers added post-hoc to an abstract idea, but a specific implementation of a + solution to a problem in the software arts. 822 F.3d at 1339, 118 USPQ2d at + 1691. + + + + Examples that the courts have indicated may show + an improvement in computer-functionality: + + + +* i. A modification of conventional Internet + hyperlink protocol to dynamically produce a dual-source hybrid webpage, + *DDR Holdings,* 773 F.3d at 1258-59, 113 USPQ2d at + 1106-07; +* ii. Inventive distribution of functionality + within a network to filter Internet content, *BASCOM Global Internet + v. AT&T Mobility LLC,* 827 F.3d 1341, 1350-51, 119 USPQ2d + 1236, 1243 (Fed. Cir. 2016); +* iii. A method of rendering a halftone digital + image, *Research Corp. Techs. v. Microsoft Corp.,* 627 F.3d + 859, 868-69, 97 USPQ2d 1274, 1380 (Fed. Cir. 2010); +* iv. A distributed network architecture operating + in an unconventional fashion to reduce network congestion while generating + networking accounting data records, *Amdocs (Israel), Ltd. v. Openet + Telecom, Inc.,* 841 F.3d 1288, 1300-01, 120 USPQ2d 1527, 1536-37 + (Fed. Cir. 2016); +* v. A memory system having programmable + operational characteristics that are configurable based on the type of + processor, which can be used with different types of processors without a + tradeoff in processor performance, *Visual Memory, LLC v. NVIDIA + Corp.,* 867 F.3d 1253, 1259-60, 123 USPQ2d 1712, 1717 (Fed. Cir. + 2017); +* vi. Technical details as to how to transmit + images over a cellular network or append classification information to + digital image data, *TLI Communications LLC v. AV Auto. + LLC,* 823 F.3d 607, 614-15, 118 USPQ2d 1744, 1749-50 (Fed. Cir. + 2016) (holding the claims ineligible because they fail to provide requisite + technical details necessary to carry out the function); +* vii. Particular structure of a server that stores + organized digital images, *TLI Communications,* 823 F.3d at + 612, 118 USPQ2d at 1747 (finding the use of a generic server insufficient to + add inventive concepts to an abstract idea); +* viii. A particular way of programming or designing + software to create menus, *Apple, Inc. v. Ameranth, Inc.,* + 842 F.3d 1229, 1241, 120 USPQ2d 1844, 1854 (Fed. Cir. 2016); +* ix. A method that generates a security profile + that identifies both hostile and potentially hostile operations, and can + protect the user against both previously unknown viruses and "obfuscated + code," which is an improvement over traditional virus scanning. + *Finjan Inc. v. Blue Coat Systems,* 879 F.3d 1299, 1304, + 125 USPQ2d 1282, 1286 (Fed. Cir. 2018); +* x. An improved user interface for electronic + devices that displays an application summary of unlaunched applications, + where the particular data in the summary is selectable by a user to launch + the respective application. *Core Wireless Licensing S.A.R.L., v. LG + Electronics, Inc.,* 880 F.3d 1356, 1362-63, 125 USPQ2d 1436, + 1440-41 (Fed. Cir. 2018); +* xi. Specific interface and implementation for + navigating complex three-dimensional spreadsheets using techniques unique to + computers; *Data Engine Techs., LLC v. Google LLC,* 906 + F.3d 999, 1009, 128 USPQ2d 1381, 1387 (Fed. Cir. 2018); and +* xii. A specific method of restricting software + operation within a license, *Ancora Tech., Inc. v. HTC America, + Inc.,* 908 F.3d 1343, 1345-46, 128 USPQ2d 1565, 1567 (Fed. Cir. + 2018). + + +It is important to note that in order for a method + claim to improve computer functionality, the broadest reasonable interpretation of + the claim must be limited to computer implementation. That is, a claim whose + entire scope can be performed mentally, cannot be said to improve computer + technology. *Synopsys, Inc. v. Mentor Graphics Corp.,* 839 F.3d + 1138, 120 USPQ2d 1473 (Fed. Cir. 2016) (a method of translating a logic circuit + into a hardware component description of a logic circuit was found to be + ineligible because the method did not employ a computer and a skilled artisan + could perform all the steps mentally). Similarly, a claimed process covering + embodiments that can be performed on a computer, as well as embodiments that can + be practiced verbally or with a telephone, cannot improve computer technology. See + *RecogniCorp, LLC v. Nintendo Co.,* 855 F.3d 1322, 1328, 122 + USPQ2d 1377, 1381 (Fed. Cir. 2017) (process for encoding/decoding facial data + using image codes assigned to particular facial features held ineligible because + the process did not require a computer). + + + +Examples that the courts have indicated may not be + sufficient to show an improvement in computer-functionality: + + + +* i. Generating restaurant menus with + functionally claimed features, *Ameranth,* 842 F.3d at + 1245, 120 USPQ2d at 1857; +* ii. Accelerating a process of analyzing audit + log data when the increased speed comes solely from the capabilities of a + general-purpose computer, *FairWarning IP, LLC v. Iatric Sys.,* 839 F.3d 1089, 1095, 120 USPQ2d 1293, 1296 (Fed. Cir. 2016); +* iii. Mere automation of manual processes, such as + using a generic computer to process an application for financing a purchase, + *Credit Acceptance Corp. v. Westlake Services,* 859 F.3d + 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) or speeding up a + loan-application process by enabling borrowers to avoid physically going to + or calling each lender and filling out a loan application, + *LendingTree, LLC v. Zillow, Inc.,* 656 Fed. App'x 991, + 996-97 (Fed. Cir. 2016) (non-precedential); +* iv. Recording, transmitting, and archiving + digital images by use of conventional or generic technology in a nascent but + well-known environment, without any assertion that the invention reflects an + inventive solution to any problem presented by combining a camera and a + cellular telephone, *TLI Communications,* 823 F.3d at + 611-12, 118 USPQ2d at 1747; +* v. Affixing a barcode to a mail object in order + to more reliably identify the sender and speed up mail processing, without + any limitations specifying the technical details of the barcode or how it is + generated or processed, *Secured Mail Solutions, LLC v. Universal + Wilde, Inc.,* 873 F.3d 905, 910-11, 124 USPQ2d 1502, 1505-06 + (Fed. Cir. 2017); +* vi. Instructions to display two sets of + information on a computer display in a non-interfering manner, without any + limitations specifying how to achieve the desired result, *Interval + Licensing LLC v. AOL, Inc.,* 896 F.3d 1335, 1344-45, 127 USPQ2d + 1553, 1559-60 (Fed. Cir. 2018); +* vii. Providing historical usage information to + users while they are inputting data, in order to improve the quality and + organization of information added to a database, because "an improvement to + the information stored by a database is not equivalent to an improvement in + the database’s functionality," *BSG Tech LLC v. Buyseasons, + Inc.,* 899 F.3d 1281, 1287-88, 127 USPQ2d 1688, 1693-94 (Fed. + Cir. 2018); and +* viii. Arranging transactional information on a + graphical user interface in a manner that assists traders in processing + information more quickly, *Trading Technologies v. IBG + LLC,* 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. + 2019). + +**II.** **IMPROVEMENTS TO ANY OTHER + TECHNOLOGY OR TECHNICAL FIELD**The courts have also found that improvements in + technology beyond computer functionality may demonstrate patent eligibility. In + *McRO,* the Federal Circuit held claimed methods of automatic + lip synchronization and facial expression animation using computer-implemented + rules to be patent eligible under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**, because they + were not directed to an abstract idea. *McRO,* 837 F.3d at 1316, + 120 USPQ2d at 1103. The basis for the *McRO* court's decision was + that the claims were directed to an improvement in computer animation and thus did + not recite a concept similar to previously identified abstract ideas. + *Id.* The court relied on the specification's explanation of + how the claimed rules enabled the automation of specific animation tasks that + previously could not be automated. 837 F.3d at 1313, 120 USPQ2d at 1101. The + *McRO* court indicated that it was the incorporation of the + particular claimed rules in computer animation that "improved [the] existing + technological process", unlike cases such as *Alice* where a + computer was merely used as a tool to perform an existing process. 837 F.3d at + 1314, 120 USPQ2d at 1102. The *McRO* court also noted that the + claims at issue described a specific way (use of particular rules to set morph + weights and transitions through phonemes) to solve the problem of producing + accurate and realistic lip synchronization and facial expressions in animated + characters, rather than merely claiming the idea of a solution or outcome, and + thus were not directed to an abstract idea. 837 F.3d at 1313, 120 USPQ2d at 1101. + + + +Consideration of improvements is relevant to the + eligibility analysis regardless of the technology of the claimed invention. That + is, the consideration applies equally whether it is a computer-implemented + invention, an invention in the life sciences, or any other technology. See, + *e.g., Rapid Litigation Management v. CellzDirect, Inc.,* 827 + F.3d 1042, 119 USPQ2d 1370 (Fed. Cir. 2016), in which the court noted that a + claimed process for preserving hepatocytes could be eligible as an improvement to + technology because the claim achieved a new and improved way for preserving + hepatocyte cells for later use, even though the claim is based on the discovery of + something natural. Notably, the court did not distinguish between the types of + technology when determining the invention improved technology. However, it is + important to keep in mind that an improvement in the abstract idea itself + (*e.g.* a recited fundamental economic concept) is not an + improvement in technology. For example, in *Trading Technologies Int’l v. + IBG,* 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the + court determined that the claimed user interface simply provided a trader with + more information to facilitate market trades, which improved the business process + of market trading but did not improve computers or technology. + + + +Examples that the courts have indicated may be + sufficient to show an improvement in existing technology include: + + + +* i. Particular computerized method of operating + a rubber molding press, *e.g.,* a modification of + conventional rubber-molding processes to utilize a thermocouple inside the + mold to constantly monitor the temperature and thus reduce under- and + over-curing problems common in the art, *Diamond v. Diehr,* + 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 8 and 10 (1981); +* ii. New telephone, server, or combination + thereof, *TLI Communications LLC v. AV Auto. LLC,* 823 F.3d + 607, 612, 118 USPQ2d 1744, 1747 (Fed. Cir. 2016); +* iii. An advance in the process of downloading + content for streaming, *Affinity Labs of Tex. v. DirecTV, + LLC,* 838 F.3d 1253, 1256, 120 USPQ2d 1201, 1202 (Fed. Cir. + 2016); +* iv. Improved, particular method of digital data + compression, *DDR Holdings, LLC. v. Hotels.com, L.P.,* 773 + F.3d 1245, 1259, 113 USPQ2d 1097, 1107 (Fed. Cir. 2014); + *Intellectual Ventures I v. Symantec Corp.,* 838 F.3d + 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016); +* v. Particular method of incorporating virus + screening into the Internet, *Symantec Corp.,* 838 F.3d at + 1321-22, 120 USPQ2d at 1362-63; +* vi. Components or methods, such as measurement + devices or techniques, that generate new data, *Electric Power + Group, LLC v. Alstom, S.A.,* 830 F.3d 1350, 1355, 119 USPQ2d + 1739, 1742 (Fed. Cir. 2016); +* vii. Particular configuration of inertial sensors + and a particular method of using the raw data from the sensors, + *Thales Visionix, Inc. v. United States,* 850 F.3d 1343, + 1348-49, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017); +* viii. A specific, structured graphical user + interface that improves the accuracy of trader transactions by displaying + bid and asked prices in a particular manner that prevents order entry at a + changed price, *Trading Techs. Int’l, Inc. v. CQG, Inc.,* + 675 Fed. App'x 1001 (Fed. Cir. 2017) (non-precedential); and +* ix. Improved process for preserving hepatocytes + for later use, *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* + 827 F.3d 1042, 1050, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016). + + +To show that the involvement of a computer assists + in improving the technology, the claims must recite the details regarding how a + computer aids the method, the extent to which the computer aids the method, or the + significance of a computer to the performance of the method. Merely adding generic + computer components to perform the method is not sufficient. Thus, the claim must + include more than mere instructions to perform the method on a generic component + or machinery to qualify as an improvement to an existing technology. See + **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)** for more information about mere + instructions to apply an exception. + + + +Examples that the courts have indicated may not be + sufficient to show an improvement to technology include: + + + +* i. A commonplace business method being applied + on a general purpose computer, *Alice Corp.,* 573 U.S. at + 223, 110 USPQ2d at 1976; *Versata Dev. Group, Inc. v. SAP Am., + Inc.,* 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. + 2015); +* ii. Using well-known standard laboratory + techniques to detect enzyme levels in a bodily sample such as blood or + plasma, *Cleveland Clinic Foundation v. True Health Diagnostics, + LLC,* 859 F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83, 1088 + (Fed. Cir. 2017); +* iii. Gathering and analyzing information using + conventional techniques and displaying the result, *TLI + Communications,* 823 F.3d at 612-13, 118 USPQ2d at 1747-48; +* iv. Delivering broadcast content to a portable + electronic device such as a cellular telephone, when claimed at a high level + of generality, *Affinity Labs of Tex. v. Amazon.com,* 838 + F.3d 1266, 1270, 120 USPQ2d 1210, 1213 (Fed. Cir. 2016); *Affinity + Labs of Tex. v. DirecTV, LLC,* 838 F.3d 1253, 1262, 120 USPQ2d + 1201, 1207 (Fed. Cir. 2016); +* v. A general method of screening emails on a + generic computer, *Symantec,* 838 F.3d at 1315-16, 120 + USPQ2d at 1358-59; +* vi. An advance in the informational content of a + download for streaming, *Affinity Labs of Tex. v. DirecTV, + LLC,* 838 F.3d 1253, 1263, 120 USPQ2d 1201, 1208 (Fed. Cir. + 2016); and +* vii. Selecting one type of content + (*e.g.,* FM radio content) from within a range of + existing broadcast content types, or selecting a particular generic function + for computer hardware to perform (e.g., buffering content) from within a + range of well-known, routine, conventional functions performed by the + hardware, *Affinity Labs of Tex. v. DirecTV, LLC,* 838 F.3d + 1253, 1264, 120 USPQ2d 1201, 1208 (Fed. Cir. 2016). + + + + +# 2106.05(b) Particular Machine [R-10.2019] + + +When determining whether a claim integrates a + judicial exception, into a practical application in Step 2A Prong Two and whether a + claim recites significantly more than a judicial exception in Step 2B, examiners + should consider whether the judicial exception is applied with, or by use of, a + particular machine. "The machine-or-transformation test is a useful and important + clue, and investigative tool" for determining whether a claim is patent eligible + under **[§ + 101](mpep-9015-appx-l.html#d0e302376)**. *Bilski v. Kappos,* 561 U.S. 593, 604, 95 + USPQ2d 1001, 1007 (2010). + + + +It is noted that while the application of a judicial + exception by or with a particular machine is an important clue, it is + not a stand-alone test for eligibility. + *Id.* + + +All claims must be evaluated for eligibility using the + two-part test from *Alice/Mayo*. If a claim passes the + *Alice/Mayo* test (*i.e.,* is not directed to an + exception at Step 2A, or amounts to significantly more than any recited exception in + Step 2B), then the claim is eligible even if it fails the machine-or-transformation + test ("M-or-T test"). *Bilski v. Kappos,* 561 U.S. 593, 604, 95 + USPQ2d 1001, 1007 (2010) (explaining that a claim may be eligible even if it does not + satisfy the M-or-T test); *McRO, Inc. v. Bandai Namco Games Am. + Inc.,* 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) + ("[T]here is nothing that requires a method ‘be tied to a machine or transform an + article’ to be patentable"). And if a claim fails the *Alice/Mayo* + test (*i.e.,* is directed to an exception at Step 2A and does not + amount to significantly more than the exception in Step 2B), then the claim is + ineligible even if it passes the M-or-T test. *DDR Holdings, LLC v. + Hotels.com, L.P.,* 773 F.3d 1245, 1256, 113 USPQ2d 1097, 1104 (Fed. Cir. + 2014) ("[I]n *Mayo,* the Supreme Court emphasized that satisfying + the machine-or-transformation test, by itself, is not sufficient to render a claim + patent-eligible, as not all transformations or machine implementations infuse an + otherwise ineligible claim with an 'inventive concept.'"). + + + +Examiners may find it helpful to evaluate other + considerations such as the mere instructions to apply an exception consideration (see + **[MPEP § + 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the field of + use and technological environment consideration (see **[MPEP § + 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when making a determination of whether an + element (or combination of elements) is a particular machine. For information on the + definition of the term "machine," see **[MPEP § + 2106.03](s2106.html#ch2100_d29a1b_139b2_397)**. + + + +When determining whether a machine recited in a claim + provides significantly more, the following factors are relevant. + + +**I.** **THE PARTICULARITY OR GENERALITY OF + THE ELEMENTS OF THE MACHINE OR APPARATUS**The particularity or generality of the elements of + the machine or apparatus, *i.e.,* the degree to which the machine + in the claim can be specifically identified (not any and all machines). One + example of applying a judicial exception with a particular machine is + *Mackay Radio & Tel. Co. v. Radio Corp. of America,* 306 + U.S. 86, 40 USPQ 199 (1939). In this case, a mathematical formula was employed to + use standing wave phenomena in an antenna system. The claim recited the particular + type of antenna and included details as to the shape of the antenna and the + conductors, particularly the length and angle at which they were arranged. 306 + U.S. at 95-96; 40 USPQ at 203. Another example is *Eibel + Process,* in which gravity (a law of nature or natural phenomenon) was + applied by a Fourdrinier machine (which was understood in the art to have a + specific structure comprising a headbox, a paper-making wire, and a series of + rolls) arranged in a particular way to optimize the speed of the machine while + maintaining quality of the formed paper web. *Eibel Process Co. v. Minn. + & Ont. Paper Co.,* 261 U.S. 45, 64-65 (1923). + + + +It is important to note that a general purpose + computer that applies a judicial exception, such as an abstract idea, by use of + conventional computer functions does not qualify as a particular machine. + *Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, 716-17, 112 + USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also *TLI Communications LLC v. + AV Automotive LLC,* 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. + Cir. 2016) (mere recitation of concrete or tangible components is not an inventive + concept); *Eon Corp. IP Holdings LLC v. AT&T Mobility LLC,* + 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that + *Alappat*’s rationale that an otherwise ineligible algorithm + or software could be made patent-eligible by merely adding a generic computer to + the claim was superseded by the Supreme Court’s *Bilski* and + *Alice Corp.* decisions). If applicant amends a claim to add a + generic computer or generic computer components and asserts that the claim recites + significantly more because the generic computer is 'specially programmed' (as in + *Alappat,* now considered superseded) or is a 'particular + machine' (as in *Bilski*), the examiner should look at whether + the added elements integrate the exception into a practical application or provide + significantly more than the judicial exception. Merely adding a generic computer, + generic computer components, or a programmed computer to perform generic computer + functions does not automatically overcome an eligibility rejection. *Alice + Corp. Pty. Ltd. v. CLS Bank Int’l,* 573 U.S. 208, 223-24, 110 USPQ2d + 1976, 1983-84 (2014). See *In re Alappat*, 33 F.3d 1526, 1545 + (Fed. Cir. 1994); *In re Bilski*, 545 F.3d 943 (Fed. Cir. + 2008) + + +**II.** **WHETHER THE MACHINE OR APPARATUS + IMPLEMENTS THE STEPS OF THE METHOD**Integral use of a machine to achieve performance + of a method may integrate the recited judicial exception into a practical + application or provide significantly more, in contrast to where the machine is + merely an object on which the method operates, which does not integrate the + exception into a practical application or provide significantly more. See + *CyberSource v. Retail Decisions,* 654 F.3d 1366, 1370, 99 + USPQ2d 1690, 1694 (Fed. Cir. 2011) ("We are not persuaded by the appellant's + argument that the claimed method is tied to a particular machine because it ‘would + not be necessary or possible without the Internet.’ . . . Regardless of whether + "the Internet" can be viewed as a machine, it is clear that the Internet cannot + perform the fraud detection steps of the claimed method"). For example, as + described in **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**, additional + elements that invoke computers or other machinery merely as a tool to perform an + existing process will generally not amount to significantly more than a judicial + exception. See, e.g., *Versata Development Group v. SAP America,* + 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015) (explaining that in + order for a machine to add significantly more, it must "play a significant part in + permitting the claimed method to be performed, rather than function solely as an + obvious mechanism for permitting a solution to be achieved more quickly"). + + +**III.** **WHETHER ITS INVOLVEMENT IS + EXTRA-SOLUTION ACTIVITY OR A FIELD-OF-USE**Whether its involvement is extra-solution activity + or a field-of-use, *i.e.,* the extent to which (or how) the + machine or apparatus imposes meaningful limits on the claim. Use of a machine that + contributes only nominally or insignificantly to the execution of the claimed + method (e.g., in a data gathering step or in a field-of-use limitation) would not + integrate a judicial exception or provide significantly more. See + *Bilski,* 561 U.S. at 610, 95 USPQ2d at 1009 (citing + *Parker v. Flook,* 437 U.S. 584, 590, 198 USPQ 193, 197 + (1978)), and *CyberSource v. Retail Decisions,* 654 F.3d 1366, + 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted) ("[N]othing in claim 3 + requires an infringer to use the Internet to obtain that data. The Internet is + merely described as the source of the data. We have held that mere + ‘[data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.’" + 654 F.3d at 1375, 99 USPQ2d at 1694 (citation omitted)). See **[MPEP § 2106.05(g) & + (h)](s2106.html#ch2100_d29a1b_13df8_3d4)** for more information on insignificant extra-solution + activity and field of use, respectively. + + + + + +# 2106.05(c) Particular Transformation [R-10.2019] + + +Another consideration when determining whether a + claim integrates a judicial exception into a practical application in Step 2A Prong + Two and whether a claim recites significantly more in Step 2B is whether the claim + effects a transformation or reduction of a particular article to a different state or + thing. "[T]ransformation and reduction of an article ‘to a different state or thing’ + is the clue to patentability of a process claim that does not include particular + machines." *Bilski v. Kappos,* 561 U.S. 593, 658, 95 USPQ2d 1001, + 1007 (2010) (quoting *Gottschalk v. Benson,* 409 U.S. 63, 70, 175 + USPQ 673, 676 (1972)). If such a transformation exists, the claims are likely to be + significantly more than any recited judicial exception or to integrate any recited + judicial exception into a practical application. + + + +It is noted that while the transformation of an + article is an important clue, it is not a stand-alone test for + eligibility. *Id.* + + +All claims must be evaluated for eligibility using + the two-part test from *Alice/Mayo*. If a claim passes the + *Alice/Mayo* test (*i.e.,* is not directed to an + exception at Step 2A, or amounts to significantly more than any recited exception in + Step 2B), then the claim is eligible even if it "fails" the M-or-T test. + *Bilski v. Kappos,* 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 + (2010) (explaining that a claim may be eligible even if it does not satisfy the + M-or-T test); *McRO, Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d + 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) ("[T]here is nothing that requires + a method ‘be tied to a machine or transform an article’ to be patentable"). And if a + claim fails the *Alice/Mayo* test (*i.e.,* is + directed to an exception at Step 2A and does not amount to significantly more than + the exception in Step 2B), then the claim is ineligible even if it passes the M-or-T + test. *DDR Holdings, LLC v. Hotels.com, L.P.,* 773 F.3d 1245, 1256, + 113 USPQ2d 1097, 1104 (Fed. Cir. 2014) ("[I]n *Mayo,* the Supreme + Court emphasized that satisfying the machine-or-transformation test, by itself, is + not sufficient to render a claim patent-eligible, as not all transformations or + machine implementations infuse an otherwise ineligible claim with an "inventive + concept."). + + + +Examiners may find it helpful to evaluate other + considerations such as the mere instructions to apply an exception consideration (see + **[MPEP § + 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the field of + use and technological environment consideration (see **[MPEP § + 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when making a determination of whether a claim + satisfies the particular transformation consideration. + + + +An "article" includes a physical object or substance. + The physical object or substance must be particular, meaning it can be specifically + identified. "Transformation" of an article means that the "article" has changed to a + different state or thing. Changing to a different state or thing usually means more + than simply using an article or changing the location of an article. A new or + different function or use can be evidence that an article has been transformed. + Purely mental processes in which thoughts or human based actions are "changed" are + not considered an eligible transformation. For data, mere "manipulation of basic + mathematical constructs [i.e.,] the paradigmatic ‘abstract idea,’" has not been + deemed a transformation. *CyberSource v. Retail Decisions,* 654 F.3d + 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting *In re + Warmerdam,* 33 F.3d 1354, 1355, 1360 (Fed. Cir. 1994)). + + + +*Tilghman v. Proctor,* 102 U.S. 707 + (1881), provides an example of effecting a transformation of a particular article to + a different state or thing. In that case, the claim was directed to a process of + subjecting a mixture of fat and water to a high degree of heat and included + additional parameters relating to the level of heat, the quantities of fat and water, + and the strength of the mixing vessel. The claimed process, which used the natural + principle that the elements of neutral fat require that they be severally united with + an atomic equivalent of water in order to separate and become free, resulted in the + transformation of the fatty bodies into fat acids and glycerine. *Id. at + 729*. + + + +Where a transformation is recited in a claim, the + following factors are relevant to the analysis: + + + +* 1. **The particularity or generality of the + transformation.** According to the Supreme Court, inventions + comprising processes of "‘tanning, dyeing, making waterproof cloth, vulcanizing + India rubber [or] smelting ores’ . . . are instances . . . where the use of + chemical substances or physical acts, such as temperature control, changes + articles or materials [in such a manner that is] sufficiently definite to + confine the patent monopoly within rather definite bounds." *Gottschalk + v. Benson,* 409 U.S. 63, 70, 175 USPQ 673, 676 (1972) (discussing + *Corning v. Burden,* 15 How. (56 U.S.) 252, 267-68 (1854)). + Therefore, a more particular transformation would likely provide significantly + more. +* 2. **The degree to which the recited article is + particular.** A transformation applied to a generically recited + article or to any and all articles would likely not provide significantly more + than the judicial exception. A transformation that can be specifically + identified, or that applies to only particular articles, is more likely to + provide significantly more (or integrates a judicial exception into a practical + application). +* 3. **The nature of the transformation in terms + of the type or extent of change in state or thing.** A transformation + resulting in the transformed article having a different function or use, would + likely provide significantly more, but a transformation resulting in the + transformed article merely having a different location, would likely not + provide significantly more (or integrate a judicial exception into a practical + application). For example, a process that transforms raw, uncured synthetic + rubber into precision-molded synthetic rubber products, as discussed in + *Diamond v. Diehr,* 450 U.S. 175, 184, 209 USPQ 1, 21 + (1981)), provides significantly more (or integrate a judicial exception into a + practical application). +* 4. **The nature of the article transformed.** Transformation of a physical or tangible object or substance is more + likely to provide significantly more (or integrate a judicial exception into a + practical application) than the transformation of an intangible concept such as + a contractual obligation or mental judgment. +* 5. **Whether the transformation is + extra-solution activity or a field-of-use (*i.e.,* the + extent to which (or how) the transformation imposes meaningful limits on the + execution of the claimed method steps).** A transformation that + contributes only nominally or insignificantly to the execution of the claimed + method (*e.g.,* in a data gathering step or in a field-of-use + limitation) would not provide significantly more (or integrate a judicial + exception into a practical application). For example, in + *Mayo* the Supreme Court found claims regarding calibrating + the proper dosage of thiopurine drugs to be patent ineligible subject matter. + The Federal Circuit had held that the step of administering the thiopurine drug + demonstrated a transformation of the human body and blood. + *Mayo,* 566 U.S. at 76, 101 USPQ2d at 1967. The Supreme + Court disagreed, finding that this step was only a field-of-use limitation and + did not provide significantly more than the judicial exception. + *Id.* See **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)** **[& + (h)](s2106.html#ch2100_d29a1b_13e1a_22c)** for more information on insignificant + extra-solution activity and field of use, respectively. + + + + +# 2106.05(d) Well-Understood, Routine, Conventional + Activity [R-10.2019] + + +Another consideration when determining whether a claim + recites significantly more than a judicial exception is whether the additional + element(s) are well-understood, routine, conventional activities previously known to + the industry. This consideration is only evaluated in Step 2B of the eligibility + analysis. + + + +If the additional element (or combination of elements) + is a specific limitation other than what is well-understood, routine and conventional + in the field, for instance because it is an unconventional step that confines the + claim to a particular useful application of the judicial exception, then this + consideration favors eligibility. If, however, the additional element (or combination + of elements) is no more than well-understood, routine, conventional activities + previously known to the industry, which is recited at a high level of generality, + then this consideration does not favor eligibility. + + + + *DDR Holdings, LLC v. Hotels.com, + L.P.,* 773 F.3d 1245, 113 USPQ2d 1097 (Fed. Cir. 2014), provides an + example of additional elements that favored eligibility because they were more than + well-understood, routine conventional activities in the field. The claims in + *DDR Holdings* were directed to systems and methods of generating + a composite webpage that combines certain visual elements of a host website with the + content of a third-party merchant. 773 F.3d at 1248, 113 USPQ2d at 1099. The court + found that the claim had additional elements that amounted to significantly more than + the abstract idea, because they modified conventional Internet hyperlink protocol to + dynamically produce a dual-source hybrid webpage, which differed from the + conventional operation of Internet hyperlink protocol that transported the user away + from the host’s webpage to the third party’s webpage when the hyperlink was + activated. 773 F.3d at 1258-59, 113 USPQ2d at 1106-07. Thus, the claims in + *DDR Holdings* were eligible. + + + +On the other hand, *Mayo Collaborative Servs. + v. Prometheus Labs.,* Inc., 566 U.S. 66, 67, 101 USPQ2d 1961, 1964 (2010) + provides an example of additional elements that were not an inventive concept because + they were merely well-understood, routine, conventional activity previously known to + the industry, which were not by themselves sufficient to transform a judicial + exception into a patent eligible invention. *Mayo Collaborative Servs. v. + Prometheus Labs., Inc.,* 566 U.S. 66, 79-80, 101 USPQ2d 1969 (2012) + (citing *Parker v. Flook,* 437 U.S. 584, 590, 198 USPQ 193, 199 + (1978) (the additional elements were "well known" and, thus, did not amount to a + patentable application of the mathematical formula)). In *Mayo*, the + claims at issue recited naturally occurring correlations (the relationships between + the concentration in the blood of certain thiopurine metabolites and the likelihood + that a drug dosage will be ineffective or induce harmful side effects) along with + additional elements including telling a doctor to measure thiopurine metabolite + levels in the blood using any known process. 566 U.S. at 77-79, 101 USPQ2d at + 1967-68. The Court found this additional step of measuring metabolite levels to be + well-understood, routine, conventional activity already engaged in by the scientific + community because scientists "routinely measured metabolites as part of their + investigations into the relationships between metabolite levels and efficacy and + toxicity of thiopurine compounds." 566 U.S. at 79, 101 USPQ2d at 1968. Even when + considered in combination with the other additional elements, the step of measuring + metabolite levels did not amount to an inventive concept, and thus the claims in + *Mayo* were not eligible. 566 U.S. at 79-80, 101 USPQ2d at + 1968-69. + + +**I.** **EVALUATING WHETHER THE ADDITIONAL + ELEMENTS ARE WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY**When making a determination whether the additional + elements in a claim amount to significantly more than a judicial exception, the + examiner should evaluate whether the elements define only well-understood, + routine, conventional activity. In this respect, the well-understood, routine, + conventional consideration overlaps with other Step 2B considerations, + particularly the improvement consideration (see **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**), the mere instructions to apply an exception + consideration (see **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), and the + insignificant extra-solution activity consideration (see **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**). Thus, evaluation of those other + considerations may assist examiners in making a determination of whether a + particular element or combination of elements is well-understood, routine, + conventional activity. + + + +In addition, examiners should keep in mind the + following points when determining whether additional elements define only + well-understood, routine, conventional activity. + + + +* 1. **An additional element (or combination + of additional elements) that is known in the art can still be + unconventional or non-routine.** The question of whether a + particular claimed invention is novel or obvious is "fully apart" from the + question of whether it is eligible. *Diamond v. Diehr,* 450 + U.S. 175, 190, 209 USPQ 1, 9 (1981). For example, claims may exhibit an + improvement over conventional computer functionality even if the improvement + lacks novelty over the prior art. Compare, *e.g.,**Enfish, LLC v. Microsoft Corp.,* 822 F.3d 1327, 118 USPQ2d + 1684 (Fed. Cir. 2016) (holding several claims from U.S. Patent Nos. + 6,151,604 and 6,163,775 eligible) with *Microsoft Corp. v. Enfish, + LLC,* 662 Fed. App'x 981 (Fed. Cir. 2016) (holding some of the + same claims to be anticipated by prior art). The eligible claims in + *Enfish* recited a self-referential database having two + key features: all entity types can be stored in a single table; and the + table rows can contain information defining the table columns. + *Enfish,* 822 F.3d at 1332, 118 USPQ2d at 1687. Although + these features were taught by a single prior art reference (thus + anticipating the claims), *Microsoft Corp.,* 662 Fed. App'x + at 986, the features were not conventional and thus were considered to + reflect an improvement to existing technology. In particular, they enabled + the claimed table to achieve benefits over conventional databases, such as + increased flexibility, faster search times, and smaller memory requirements. + *Enfish,* 822 F.3d at 1337, 118 USPQ2d at 1690. +* 2. **A factual determination is required to + support a conclusion that an additional element (or combination of + additional elements) is well-understood, routine, conventional + activity.***Berkheimer v. HP, Inc.,* 881 F.3d 1360, 1368, 125 USPQ2d + 1649, 1654 (Fed. Cir. 2018). However, this does not mean that a prior art + search is necessary to resolve this inquiry. Instead, examiners should rely + on what the courts have recognized, or those in the art would recognize, as + elements that are well-understood, routine, conventional activity in the + relevant field when making the required determination. For example, in many + instances, the specification of the application may indicate that additional + elements are well-known or conventional. See, *e.g., Intellectual + Ventures v. Symantec,* 838 F.3d at 1317; 120 USPQ2d at 1359 + ("The written description is particularly useful in determining what is + well-known or conventional"); *Internet Patents Corp. v. Active + Network, Inc.,* 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. + Cir. 2015) (relying on specification’s description of additional elements as + "well-known", "common" and "conventional"); *TLI Communications LLC + v. AV Auto. LLC,* 823 F.3d 607, 614, 118 USPQ2d 1744, 1748 (Fed. + Cir. 2016) (Specification described additional elements as "either + performing basic computer functions such as sending and receiving data, or + performing functions ‘known’ in the art."). + As such, an examiner should determine that + an element (or combination of elements) is well-understood, routine, + conventional activity only when the examiner can readily conclude, based on + their expertise in the art, that the element is widely prevalent or in + common use in the relevant industry. The analysis as to whether an element + (or combination of elements) is widely prevalent or in common use is the + same as the analysis under **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** as to + whether an element is so well-known that it need not be described in detail + in the patent specification. See *Genetic Techs. Ltd. v. Merial + LLC,* 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1546 ( Fed. Cir. + 2016) (supporting the position that amplification was well-understood, + routine, conventional for purposes of subject matter eligibility by + observing that the patentee expressly argued during prosecution of the + application that amplification was a technique readily practiced by those + skilled in the art to overcome the rejection of the claim under + **[35 + U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph); see also + *Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick + Co.,* 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984) + ("[T]he specification need not disclose what is well known in the art."); + *In re Myers,* 410 F.2d 420, 424, 161 USPQ 668, 671 + (CCPA 1969) ("A specification is directed to those skilled in the art and + need not teach or point out in detail that which is well-known in the + art."); *Exergen Corp.,* 725 Fed. App’x. 959, 965 (Fed. + Cir. 2018) (holding that "[l]ike indefiniteness, enablement, or obviousness, + whether a claim is directed to patent eligible subject matter is a question + of law based on underlying facts," and noting that the Supreme Court has + recognized that "the inquiry 'might sometimes overlap' with other + fact-intensive inquiries like novelty under **[35 U.S.C. § + 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)**"). If the element is not widely prevalent or in + common use, or is otherwise beyond those elements recognized in the art or + by the courts as being well-understood, routine or conventional, then the + element will in most cases favor eligibility. For example, even if a + particular technique (*e.g.,* measuring blood glucose via + an earring worn by a person with diabetes) would have been obvious to one of + ordinary skill in the art because it was discussed in several widely-read + scientific journals or used by a few scientists, mere knowledge of the + particular technique or use of the particular technique by a few scientists + is not necessarily sufficient to make the use of the particular technique + routine or conventional in the relevant field. The examiner in this + situation would already know, based on the examiner's expertise in the + field, that blood glucose is routinely and conventionally monitored by other + techniques (*e.g.,* via placing a small droplet of blood on + a diagnostic test strip, or via an implanted insulin pump with a glucose + sensor). Thus, the examiner would not need to perform a prior art search in + order to determine that the particular claimed technique using the + glucose-sensing earring was not well-understood, routine, conventional + activity previously engaged in by scientists in the field. + + + +The required factual determination must be + expressly supported in writing, as discussed in **[MPEP § + 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. Appropriate forms of support include + one or more of the following: (a) A citation to an express statement in the + specification or to a statement made by an applicant during prosecution that + demonstrates the well-understood, routine, conventional nature of the + additional element(s); (b) A citation to one or more of the court decisions + discussed in Subsection II below as noting the well-understood, routine, + conventional nature of the additional element(s); (c) A citation to a + publication that demonstrates the well-understood, routine, conventional + nature of the additional element(s); and (d) A statement that the examiner + is taking official notice of the well-understood, routine, conventional + nature of the additional element(s). For more information on supporting a + conclusion that an additional element (or combination of additional + elements) is well-understood, routine, conventional activity, see + **[MPEP § 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**, + subsection III. +* 3. **Even if one or more additional elements + are well-understood, routine, conventional activity when considered + individually, the combination of additional elements may amount to an + inventive concept.***Diamond v. Diehr,* 450 U.S. at 188, 209 USPQ at 9 (1981) + ("[A] new combination of steps in a process may be patentable even though + all the constituents of the combination were well known and in common use + before the combination was made."). For example, a microprocessor that + performs mathematical calculations and a clock that produces time data may + individually be generic computer components that perform merely generic + computer functions, but when combined may perform functions that are not + generic computer functions and thus be an inventive concept. See, + *e.g. Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d + 1042, 1051, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016) (holding that while the + additional steps of freezing and thawing hepatocytes were well known, + repeating those steps, contrary to what was taught in the art, was not + routine or conventional). For example, in *BASCOM,* even + though the court found that all of the additional elements in the claim + recited generic computer network or Internet components, the elements in + combination amounted to significantly more because of the non-conventional + and non-generic arrangement that provided a technical improvement in the + art. *BASCOM Global Internet Servs. v. AT&T Mobility + LLC,* 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243-44 + (2016). + + + A rejection should only be made if an examiner + relying on the examiner's expertise in the art can conclude in the Step 2B inquiry + that the additional elements do not amount to significantly more (Step 2B: NO). If + the elements or functions are beyond those recognized in the art or by the courts + as being well‐understood, routine, conventional activity, then the elements or + functions will in most cases amount to significantly more (Step 2B: YES). For more + information on formulating a subject matter eligibility rejection involving + well-understood, routine, conventional activity, see **[MPEP § + 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. + + +**II.** **ELEMENTS THAT THE COURTS HAVE + RECOGNIZED AS WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY IN PARTICULAR + FIELDS** Because examiners should rely on what the courts + have recognized, or those of ordinary skill in the art would recognize, as + elements that describe well‐understood, routine activities, the following section + provides examples of elements that have been recognized by the courts as + well-understood, routine, conventional activity in particular fields. It should be + noted, however, that many of these examples failed to satisfy other considerations + (*e.g.,* because they were recited at a high level of + generality and thus were mere instructions to apply an exception, or were + insignificant extra-solution activity). Thus, examiners should carefully analyze + additional elements in a claim with respect to all relevant Step 2B + considerations, including this consideration, before making a conclusion as to + whether they amount to an inventive concept. + + + +The courts have recognized the following computer + functions as well‐understood, routine, and conventional functions when they are + claimed in a merely generic manner (*e.g.,* at a high level of + generality) or as insignificant extra-solution activity. + + + +* i. Receiving or transmitting data over a + network, *e.g.,* using the Internet to gather data, + *Symantec,* 838 F.3d at 1321, 120 USPQ2d at 1362 + (utilizing an intermediary computer to forward information); *TLI + Communications LLC v. AV Auto. LLC,* 823 F.3d 607, 610, 118 + USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image + transmission); *OIP Techs., Inc., v. Amazon.com, Inc.,* 788 + F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages + over a network); *buySAFE, Inc. v. Google, Inc.,* 765 F.3d + 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and + sends information over a network); but see *DDR Holdings, LLC v. + Hotels.com, L.P.,* 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 + (Fed. Cir. 2014) ("Unlike the claims in *Ultramercial,* the + claims at issue here specify ***how*** + interactions with the Internet are manipulated to yield a desired result‐‐a + result that overrides the routine and conventional sequence of events + ordinarily triggered by the click of a hyperlink." (emphasis added)); +* ii. Performing repetitive calculations, + *Flook,* 437 U.S. at 594, 198 USPQ2d at 199 (recomputing + or readjusting alarm limit values); *Bancorp Services v. Sun + Life,* 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. + 2012) ("The computer required by some of *Bancorp*’s claims + is employed only for its most basic function, the performance of repetitive + calculations, and as such does not impose meaningful limits on the scope of + those claims."); +* iii. Electronic recordkeeping, *Alice + Corp. Pty. Ltd. v. CLS Bank Int'l,* 573 U.S. 208, 225, 110 + USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); + *Ultramercial,* 772 F.3d at 716, 112 USPQ2d at 1755 + (updating an activity log); +* iv. Storing and retrieving information in + memory, *Versata Dev. Group, Inc. v. SAP Am., Inc.,* 793 + F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); *OIP + Techs.,* 788 F.3d at 1363, 115 USPQ2d at 1092-93; +* v. Electronically scanning or extracting data + from a physical document, *Content Extraction and Transmission, LLC + v. Wells Fargo Bank,* 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 + (Fed. Cir. 2014) (optical character recognition); and +* vi. A Web browser’s back and forward button + functionality, *Internet Patent Corp. v. Active Network, + Inc.,* 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. + 2015). + + +This listing is not meant to imply that all + computer functions are well‐understood, routine, conventional activities, or that + a claim reciting a generic computer component performing a generic computer + function is necessarily ineligible. See e.g. *Amdocs (Israel), Ltd. v. + Openet Telecom, Inc.,* 841 F.3d 1288, 1316, 120 USPQ2d 1527, 1549 + (Fed. Cir. 2016), *BASCOM Global Internet Servs. v. AT&T Mobility + LLC,* 827 F.3d 1341, 1348, 119 USPQ2d 1236, 1241 (Fed. Cir. 2016). + Courts have held computer‐implemented processes not to be significantly more than + an abstract idea (and thus ineligible) where the claim as a whole amounts to + nothing more than generic computer functions merely used to implement an abstract + idea, such as an idea that could be done by a human analog (i.e., by hand or by + merely thinking). On the other hand, courts have held computer-implemented + processes to be significantly more than an abstract idea (and thus eligible), + where generic computer components are able in combination to perform functions + that are not merely generic. *DDR Holdings, LLC v. Hotels.com, + L.P.,* 773 F.3d 1245, 1257-59, 113 USPQ2d 1097, 1105-07 (Fed. Cir. + 2014). + + + +The courts have recognized the following + laboratory techniques as well-understood, routine, conventional activity in the + life science arts when they are claimed in a merely generic manner + (*e.g.,* at a high level of generality) or as insignificant + extra-solution activity: + + + +* i. Determining the level of a biomarker in + blood by any means, *Mayo,* 566 U.S. at 79, 101 USPQ2d at + 1968; *Cleveland Clinic Foundation v. True Health Diagnostics, + LLC,* 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. + 2017); +* ii. Using polymerase chain reaction to amplify + and detect DNA, *Genetic Techs. v. Merial LLC,* 818 F.3d + 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); *Ariosa + Diagnostics, Inc. v. Sequenom, Inc.,* 788 F.3d 1371, 1377, 115 + USPQ2d 1152, 1157 (Fed. Cir. 2015); +* iii. Detecting DNA or enzymes in a sample, + *Sequenom,* 788 F.3d at 1377-78, 115 USPQ2d at 1157); + *Cleveland Clinic Foundation* 859 F.3d at 1362, 123 + USPQ2d at 1088 (Fed. Cir. 2017); +* iv. Immunizing a patient against a disease, + *Classen Immunotherapies, Inc. v. Biogen IDEC,* 659 F.3d + 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011); +* v. Analyzing DNA to provide sequence information + or detect allelic variants, *Genetic Techs.,* 818 F.3d at + 1377; 118 USPQ2d at 1546; +* vi. Freezing and thawing cells, *Rapid + Litig. Mgmt.* 827 F.3d at 1051, 119 USPQ2d at 1375; +* vii. Amplifying and sequencing nucleic acid + sequences, *University of Utah Research Foundation v. Ambry + Genetics,* 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. + 2014); and +* viii. Hybridizing a gene probe, *Ambry + Genetics,* 774 F.3d at 764, 113 USPQ2d at 1247. + + + Below are examples of other types of activity + that the courts have found to be well-understood, routine, conventional activity + when they are claimed in a merely generic manner (*e.g.,* at a + high level of generality) or as insignificant extra-solution activity: + + + +* i. Recording a customer’s order, + *Apple, Inc. v. Ameranth, Inc.,* 842 F.3d 1229, 1244, + 120 USPQ2d 1844, 1856 (Fed. Cir. 2016); +* ii. Shuffling and dealing a standard deck of + cards, *In re Smith,* 815 F.3d 816, 819, 118 USPQ2d 1245, + 1247 (Fed. Cir. 2016); +* iii. Restricting public access to media by + requiring a consumer to view an advertisement, *Ultramercial, Inc. + v. Hulu, LLC,* 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 + (Fed. Cir. 2014); +* iv. Presenting offers and gathering statistics, + *OIP Techs.,* 788 F.3d at 1362-63, 115 USPQ2d at + 1092-93; +* v. Determining an estimated outcome and setting + a price, *OIP Techs.,* 788 F.3d at 1362-63, 115 USPQ2d at + 1092-93; and +* vi. Arranging a hierarchy of groups, sorting + information, eliminating less restrictive pricing information and + determining the price, *Versata Dev. Group, Inc. v. SAP Am., + Inc.,* 793 F.3d 1306, 1331, 115 USPQ2d 1681, 1699 (Fed. Cir. + 2015). + + + + +# 2106.05(e) Other Meaningful Limitations [R-10.2019] + + +The analysis of whether the claim includes other + meaningful limitations may be relevant for both eligibility analysis Step 2A Prong + Two, and Step 2B. + + + + The claim should add meaningful limitations beyond + generally linking the use of the judicial exception to a particular technological + environment to transform the judicial exception into patent-eligible subject matter. + The phrase "meaningful limitations" has been used by the courts even before Alice and + Mayo in various contexts to describe additional elements that provide an inventive + concept to the claim as a whole. The considerations described in + **[MPEP § + 2106.05(a)-(d)](s2106.html#ch2100_d29a1b_13c69_10)** are meaningful limitations when they amount + to significantly more than the judicial exception, or when they integrate a judicial + exception into a practical application. This broad label signals that there can be + other considerations besides those described in **[MPEP § + 2106.05(a)-(d)](s2106.html#ch2100_d29a1b_13c69_10)** that when added to a judicial exception + amount to meaningful limitations that can transform a claim into patent-eligible + subject matter. + + + +*Diamond v. Diehr* provides an + example of a claim that recited meaningful limitations beyond generally linking the + use of the judicial exception to a particular technological environment. 450 U.S. + 175, 209 USPQ 1 (1981). In *Diehr,* the claim was directed to the + use of the Arrhenius equation (an abstract idea or law of nature) in an automated + process for operating a rubber-molding press. 450 U.S. at 177-78, 209 USPQ at 4. The + Court evaluated additional elements such as the steps of installing rubber in a + press, closing the mold, constantly measuring the temperature in the mold, and + automatically opening the press at the proper time, and found them to be meaningful + because they sufficiently limited the use of the mathematical equation to the + practical application of molding rubber products. 450 U.S. at 184, 187, 209 USPQ at + 7, 8. In contrast, the claims in *Alice Corp. v. CLS Bank + International* did not meaningfully limit the abstract idea of mitigating + settlement risk. 573 U.S. 208, 110 USPQ2d 1976 (2014). In particular, the Court + concluded that the additional elements such as the data processing system and + communications controllers recited in the system claims did not meaningfully limit + the abstract idea because they merely linked the use of the abstract idea to a + particular technological environment (i.e., "implementation via computers") or were + well-understood, routine, conventional activity recited at a high level of + generality. 573 U.S. at 225-26, 110 USPQ2d at 1984-85. + + + +*Classen Immunotherapies Inc. v. Biogen IDEC* provides another + example of claims that recited meaningful limitations. 659 F.3d 1057, 100 USPQ2d 1492 + (Fed. Cir. 2011) (decision on remand from the Supreme Court, which had vacated the + lower court’s prior holding of ineligibility in view of *Bilski v. + Kappos*, 561 U.S. 593, 95 USPQ2d 1001 (2010)). In + *Classen,* the claims recited methods that gathered and analyzed + the effects of particular immunization schedules on the later development of chronic + immune-mediated disorders in mammals in order to identify a lower risk immunization + schedule, and then immunized mammalian subjects in accordance with the identified + lower risk schedule (thereby lowering the risk that the immunized subject would later + develop chronic immune-mediated diseases). 659 F.3d at 1060-61; 100 USPQ2d at + 1495-96. Although the analysis step was an abstract mental process that collected and + compared known information, the immunization step was meaningful because it + integrated the results of the analysis into a specific and tangible method that + resulted in the method "moving from abstract scientific principle to specific + application." 659 F.3d at 1066-68; 100 USPQ2d at 1500-01. In contrast, in + *OIP Technologies, Inc. v. Amazon.com, Inc.,* the court + determined that the additional steps to "test prices and collect data based on the + customer reactions" did not meaningfully limit the abstract idea of offer-based price + optimization, because the steps were well-understood, routine, conventional + data-gathering activities. 788 F.3d 1359, 1363-64, 115 USPQ2d 1090, 1093 (Fed. Cir. + 2015). + + + +With respect to treatment or prophylaxis limitations, + such as the immunization step in *Classen,* examiners should note + that the other meaningful limitations consideration overlaps with the particular + treatment or prophylaxis consideration that is evaluated in Step 2A Prong Two (see + **[MPEP § + 2106.04(d)(2)](s2106.html#ch2100_d2e827_17196_6c)**). + + + +When evaluating whether additional elements + meaningfully limit the judicial exception, it is particularly critical that examiners + consider the additional elements both individually and as a combination. When an + additional element is considered individually by an examiner, the additional element + may be enough to qualify as "significantly more" if it meaningfully limits the + judicial exception, and may also add a meaningful limitation by integrating the + judicial exception into a practical application. However, even in the situation where + the individually-viewed elements do not add significantly more or integrate the + exception, those additional elements when viewed in combination may render the claim + eligible. See *Diamond v. Diehr,* 450 U.S. 175, 188, 209 USPQ2d 1, 9 + (1981) ("a new combination of steps in a process may be patentable even though all + the constituents of the combination were well known and in common use before the + combination was made"); *BASCOM Global Internet Servs. v. AT&T Mobility + LLC,* 827 F.3d 1341, 1349, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016). It is + important to note that, when appropriate, an examiner may explain on the record why + the additional elements meaningfully limit the judicial exception. + + + + + +# 2106.05(f) Mere Instructions To Apply An + Exception [R-10.2019] + + +Another consideration when determining whether a + claim integrates a judicial exception into a practical application in Step 2A Prong + Two or recites significantly more than a judicial exception in Step 2B is whether the + additional elements amount to more than a recitation of the words "apply it" (or an + equivalent) or are more than mere instructions to implement an abstract idea or other + exception on a computer. As explained by the Supreme Court, in order to make a claim + directed to a judicial exception patent-eligible, the additional element or + combination of elements must do "‘more than simply stat[e] the [judicial exception] + while adding the words ‘apply it’". *Alice Corp. v. CLS Bank,* 573 + U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting *Mayo Collaborative + Servs. V. Prometheus Labs., Inc.,* 566 U.S. 66, 72, 101 USPQ2d 1961, + 1965). Thus, for example, claims that amount to nothing more than an instruction to + apply the abstract idea using a generic computer do not render an abstract idea + eligible. *Alice Corp.,* 573 U.S. at 223, 110 USPQ2d at 1983. See + also 573 U.S. at 224, 110 USPQ2d at 1984 (warning against a **[§ 101](mpep-9015-appx-l.html#d0e302376)** analysis + that turns on "the draftsman’s art"). + + + +The Supreme Court has identified additional elements + as mere instructions to apply an exception in several cases. For instance, in + *Mayo*, the Supreme Court concluded that a step of determining + thiopurine metabolite levels in patients’ blood did not amount to significantly more + than the recited laws of nature, because this additional element simply instructed + doctors to apply the laws by measuring the metabolites in any way the doctors (or + medical laboratories) chose to use. 566 U.S. at 79, 101 USPQ2d at 1968. In + *Alice Corp.,* the claim recited the concept of intermediated + settlement as performed by a generic computer. The Court found that the recitation of + the computer in the claim amounted to mere instructions to apply the abstract idea on + a generic computer. 573 U.S. at 225-26, 110 USPQ2d at 1984. The Supreme Court also + discussed this concept in an earlier case, *Gottschalk v. Benson,* + 409 U.S. 63, 70, 175 USPQ 673, 676 (1972), where the claim recited a process for + converting binary-coded-decimal (BCD) numerals into pure binary numbers. The Court + found that the claimed process had no meaningful practical application except in + connection with a computer. *Benson,* 409 U.S. at 71-72, 175 USPQ at + 676. The claim simply stated a judicial exception (*e.g.,* law of + nature or abstract idea) while effectively adding words that "apply it" in a + computer. *Id.* + + +Requiring more than mere instructions to apply an + exception does not mean that the claim must be narrow in order to be eligible. The + courts have identified some broad claims as eligible see, *e.g.,**McRO, Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, 120 + USPQ2d 1091 (Fed. Cir. 2016); *Thales Visionix Inc. v. United + States,* 850 F.3d. 1343, 121 USPQ2d 1898 (Fed. Cir. 2017), and some + narrow claims as ineligible see *e.g.,**Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, 112 USPQ2d 1750 + (Fed. Cir. 2014); *Electric Power Group, LLC v. Alstom, S.A.,* 830 + F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016). Thus, examiners should carefully + consider each claim on its own merits, as well as evaluate all other relevant + considerations, before making a determination of whether an element (or combination + of elements) is more than mere instructions to apply an exception. For example, + because this consideration often overlaps with the improvement consideration (see + **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**), the particular machine and particular + transformation considerations (see **[MPEP § 2106.05(b) and + (c)](s2106.html#ch2100_d29a1b_13ccf_18c)**, respectively), and the well-understood, routine, + conventional consideration (see **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**), evaluation of + those other considerations may assist examiners in making a determination of whether + an element (or combination of elements) is more than mere instructions to apply an + exception. Note, however, that examiners should not evaluate the well-understood, + routine, conventional consideration in the Step 2A Prong Two analysis, because that + consideration is only evaluated in Step 2B. + + + +For claim limitations that do not amount to more than + a recitation of the words "apply it" (or an equivalent), such as mere instructions to + implement an abstract idea on a computer, examiners should explain why they do not + meaningfully limit the claim in an eligibility rejection. For example, an examiner + could explain that implementing an abstract idea on a generic computer, does not + integrate the abstract idea into a practical application in Step 2A Prong Two or add + significantly more in Step 2B, similar to how the recitation of the computer in the + claim in *Alice* amounted to mere instructions to apply the abstract + idea of intermediated settlement on a generic computer. For more information on + formulating a subject matter eligibility rejection. See **[MPEP § + 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. + + + +When determining whether a claim simply recites a + judicial exception with the words "apply it" (or an equivalent), such as mere + instructions to implement an abstract idea on a computer, examiners may consider the + following: + + + +**(1) Whether the claim recites only the idea of a solution or outcome + *i.e.,* the claim fails to recite details of how a solution to + a problem is accomplished.** The recitation of claim limitations that attempt + to cover any solution to an identified problem with no restriction on how the result + is accomplished and no description of the mechanism for accomplishing the result, + does not integrate a judicial exception into a practical application or provide + significantly more because this type of recitation is equivalent to the words "apply + it". See *Electric Power Group, LLC v. Alstom, S.A.,* 830 F.3d 1350, + 1356, 119 USPQ2d 1739, 1743-44 (Fed. Cir. 2016); *Intellectual Ventures I v. + Symantec,* 838 F.3d 1307, 1327, 120 USPQ2d 1353, 1366 (Fed. Cir. 2016); + *Internet Patents Corp. v. Active Network, Inc.,* 790 F.3d 1343, + 1348, 115 USPQ2d 1414, 1417 (Fed. Cir. 2015). In contrast, claiming a particular + solution to a problem or a particular way to achieve a desired outcome may integrate + the judicial exception into a practical application or provide significantly more. + See *Electric Power,* 830 F.3d at 1356, 119 USPQ2d at 1743. + + + +By way of example, in *Intellectual Ventures + I v. Capital One Fin. Corp.,* 850 F.3d 1332, 121 USPQ2d 1940 (Fed. Cir. + 2017), the steps in the claims described "the creation of a dynamic document based + upon ‘management record types’ and ‘primary record types.’" 850 F.3d at 1339-40; 121 + USPQ2d at 1945-46. The claims were found to be directed to the abstract idea of + "collecting, displaying, and manipulating data." 850 F.3d at 1340; 121 USPQ2d at + 1946. In addition to the abstract idea, the claims also recited the additional + element of modifying the underlying XML document in response to modifications made in + the dynamic document. 850 F.3d at 1342; 121 USPQ2d at 1947-48. Although the claims + purported to modify the underlying XML document in response to modifications made in + the dynamic document, nothing in the claims indicated what specific steps were + undertaken other than merely using the abstract idea in the context of XML documents. + The court thus held the claims ineligible, because the additional limitations + provided only a result-oriented solution and lacked details as to how the computer + performed the modifications, which was equivalent to the words "apply it". 850 F.3d + at 1341-42; 121 USPQ2d at 1947-48 (citing *Electric Power Group.,* + 830 F.3d at 1356, 1356, USPQ2d at 1743-44 (cautioning against claims "so result + focused, so functional, as to effectively cover any solution to an identified + problem")). + + + +Other examples where the courts have found the + additional elements to be mere instructions to apply an exception, because they + recite no more than an idea of a solution or outcome include: + + + +* i. Remotely accessing user-specific information + through a mobile interface and pointers to retrieve the information without any + description of how the mobile interface and pointers accomplish the result of + retrieving previously inaccessible information, *Intellectual Ventures + v. Erie Indem. Co.,* 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 + (Fed. Cir. 2017); +* ii. A general method of screening emails on a + generic computer without any limitations that addressed the issues of shrinking + the protection gap and mooting the volume problem, *Intellectual + Ventures I v. Symantec Corp.,* 838 F.3d 1307, 1319, 120 USPQ2d + 1353, 1361 (Fed. Cir. 2016); and +* iii. Wireless delivery of out-of-region broadcasting + content to a cellular telephone via a network without any details of how the + delivery is accomplished, *Affinity Labs of Texas v. DirecTV, + LLC,* 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. + 2016). + + +In contrast, other cases have found that additional + elements are more than "apply it" or are not "mere instructions" when the claim + recites a technological solution to a technological problem. In *DDR + Holdings,* the court found that the additional elements did amount to + more than merely instructing that the abstract idea should be applied on the + Internet. *DDR Holdings, LLC v. Hotels.com, L.P.,* 773 F.3d 1245, + 1259, 113 USPQ2d 1097, 1107 (Fed. Cir. 2014). The claims at issue specified how + interactions with the Internet were manipulated to yield a desired result—a result + that overrode the routine and conventional sequence of events ordinarily triggered by + the click of a hyperlink. 773 F.3d at 1258; 113 USPQ2d at 1106. In + *BASCOM,* the court determined that the claimed combination of + limitations did not simply recite an instruction to apply the abstract idea of + filtering content on the Internet. *BASCOM Global Internet Servs. v. AT&T + Mobility, LLC,* 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1243 (Fed. Cir. + 2016). Instead, the claim recited a "technology based solution" of filtering content + on the Internet that overcome the disadvantages of prior art filtering systems. 827 + F.3d at 1350-51, 119 USPQ2d at 1243. Finally, in *Thales Visionix,* + the particular configuration of inertial sensors and the particular method of using + the raw data from the sensors was more than simply applying a law of nature. + *Thales Visionix, Inc. v. United States,* 850 F.3d 1343, 1348-49, + 121 USPQ2d 1898, 1902 (Fed. Cir. 2017). The court found that the claims provided a + system and method that "eliminate[d] many ‘complications’ inherent in previous + solutions for determining position and orientation of an object on a moving + platform." In other words, the claim recited a technological solution to a + technological problem. *Id.* + + +**(2) Whether the claim invokes computers or + other machinery merely as a tool to perform an existing process.** Use of a + computer or other machinery in its ordinary capacity for economic or other tasks + (*e.g.,* to receive, store, or transmit data) or simply adding a + general purpose computer or computer components after the fact to an abstract idea + (*e.g.,* a fundamental economic practice or mathematical + equation) does not integrate a judicial exception into a practical application or + provide significantly more. See *Affinity Labs v. DirecTV,* 838 F.3d + 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); *TLI + Communications LLC v. AV Auto, LLC,* 823 F.3d 607, 613, 118 USPQ2d 1744, + 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the + improved speed or efficiency inherent with applying the abstract idea on a computer" + does not integrate a judicial exception into a practical application or provide an + inventive concept. *Intellectual Ventures I LLC v. Capital One Bank + (USA),* 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). In + contrast, a claim that purports to improve computer capabilities or to improve an + existing technology may integrate a judicial exception into a practical application + or provide significantly more. *McRO, Inc. v. Bandai Namco Games Am. + Inc.,* 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); + *Enfish, LLC v. Microsoft Corp.,* 822 F.3d 1327, 1335-36, 118 + USPQ2d 1684, 1688-89 (Fed. Cir. 2016). See **[MPEP §§ + 2106.04(d)(1)](s2106.html#ch2100_d2e7df_24a6e_1bd)** and **[2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** for a discussion of improvements to the + functioning of a computer or to another technology or technical field. + + + + *TLI Communications* provides an + example of a claim invoking computers and other machinery merely as a tool to perform + an existing process. The court stated that the claims describe steps of recording, + administration and archiving of digital images, and found them to be directed to the + abstract idea of classifying and storing digital images in an organized manner. 823 + F.3d at 612, 118 USPQ2d at 1747. The court then turned to the additional elements of + performing these functions using a telephone unit and a server and noted that these + elements were being used in their ordinary capacity (*i.e.,* the + telephone unit is used to make calls and operate as a digital camera including + compressing images and transmitting those images, and the server simply receives + data, extracts classification information from the received data, and stores the + digital images based on the extracted information). 823 F.3d at 612-13, 118 USPQ2d at + 1747-48. In other words, the claims invoked the telephone unit and server merely as + tools to execute the abstract idea. Thus, the court found that the additional + elements did not add significantly more to the abstract idea because they were simply + applying the abstract idea on a telephone network without any recitation of details + of how to carry out the abstract idea. + + + +Other examples where the courts have found the + additional elements to be mere instructions to apply an exception, because they do no + more than merely invoke computers or machinery as a tool to perform an existing + process include: + + + +* i. A commonplace business method or mathematical + algorithm being applied on a general purpose computer, *Alice Corp. + Pty. Ltd. V. CLS Bank Int’l,* 573 U.S. 208, 223, 110 USPQ2d 1976, + 1983 (2014); *Gottschalk v. Benson,* 409 U.S. 63, 64, 175 USPQ + 673, 674 (1972); *Versata Dev. Group, Inc. v. SAP Am., Inc.,* + 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); +* ii. Generating a second menu from a first menu and + sending the second menu to another location as performed by generic computer + components, *Apple, Inc. v. Ameranth, Inc.,* 842 F.3d 1229, + 1243-44, 120 USPQ2d 1844, 1855-57 (Fed. Cir. 2016); +* iii. A process for monitoring audit log data that is + executed on a general-purpose computer where the increased speed in the process + comes solely from the capabilities of the general-purpose computer, + *FairWarning IP, LLC v. Iatric Sys.,* 839 F.3d 1089, 1095, + 120 USPQ2d 1293, 1296 (Fed. Cir. 2016); +* iv. A method of using advertising as an exchange or + currency being applied or implemented on the Internet, *Ultramercial, + Inc. v. Hulu, LLC,* 772 F.3d 709, 715, 112 USPQ2d 1750, 1754 (Fed. + Cir. 2014); +* v. Requiring the use of software to tailor + information and provide it to the user on a generic computer, + *Intellectual Ventures I LLC v. Capital One Bank (USA),* + 792 F.3d 1363, 1370-71, 115 USPQ2d 1636, 1642 (Fed. Cir. 2015); and +* vi. A method of assigning hair designs to balance + head shape with a final step of using a tool (scissors) to cut the hair, + *In re Brown,* 645 Fed. App'x 1014, 1017 (Fed. Cir. 2016) + (non-precedential). + + + **(3) The particularity or generality of the + application of the judicial exception.** A claim having broad applicability + across many fields of endeavor may not provide meaningful limitations that integrate + a judicial exception into a practical application or amount to significantly more. + For instance, a claim that generically recites an effect of the judicial exception or + claims every mode of accomplishing that effect, amounts to a claim that is merely + adding the words "apply it" to the judicial exception. See *Internet Patents + Corporation v. Active Network, Inc.,* 790 F.3d 1343, 1348, 115 USPQ2d + 1414, 1418 (Fed. Cir. 2015) (The recitation of maintaining the state of data in an + online form without restriction on how the state is maintained and with no + description of the mechanism for maintaining the state describes "the effect or + result dissociated from any method by which maintaining the state is accomplished" + and does not provide a meaningful limitation because it merely states that the + abstract idea should be applied to achieve a desired result). See also + *O’Reilly v. Morse,* 56 U.S. 62 (1854) (finding ineligible a + claim for "the use of electromagnetism for transmitting signals at a distance"); The + *Telephone Cases,* 126 U.S. 1, 209 (1888) (finding a method of + "transmitting vocal or other sound telegraphically ... by causing electrical + undulations, similar in form to the vibrations of the air accompanying the said vocal + or other sounds," to be ineligible, because it "monopolize[d] a natural force" and + "the right to avail of that law by any means whatever."). + + + +In contrast, limitations that confine the judicial + exception to a particular, practical application of the judicial exception may amount + to significantly more or integrate the judicial exception into a practical + application. For example, in *BASCOM,* the combination of additional + elements, and specifically "the installation of a filtering tool at a specific + location, remote from the end‐users, with customizable filtering features specific to + each end user" where the filtering tool at the ISP was able to "identify individual + accounts that communicate with the ISP server, and to associate a request for + Internet content with a specific individual account," were held to be meaningful + limitations because they confined the abstract idea of content filtering to a + particular, practical application of the abstract idea. 827 F.3d at 1350-51, 119 + USPQ2d at 1243. + + + + + +# 2106.05(g) Insignificant Extra-Solution + Activity [R-10.2019] + + +Another consideration when determining whether a + claim integrates the judicial exception into a practical application in Step 2A Prong + Two or recites significantly more in Step 2B is whether the additional elements add + more than insignificant extra-solution activity to the judicial exception. The term + "extra-solution activity" can be understood as activities incidental to the primary + process or product that are merely a nominal or tangential addition to the claim. + Extra-solution activity includes both pre-solution and post-solution activity. An + example of pre-solution activity is a step of gathering data for use in a claimed + process, *e.g.,* a step of obtaining information about credit card + transactions, which is recited as part of a claimed process of analyzing and + manipulating the gathered information by a series of steps in order to detect whether + the transactions were fraudulent. An example of post-solution activity is an element + that is not integrated into the claim as a whole, *e.g.,* a printer + that is used to output a report of fraudulent transactions, which is recited in a + claim to a computer programmed to analyze and manipulate information about credit + card transactions in order to detect whether the transactions were fraudulent. + + + +As explained by the Supreme Court, the addition of + insignificant extra-solution activity does not amount to an inventive concept, + particularly when the activity is well-understood or conventional. *Parker v. + Flook,* 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). In + *Flook,* the Court reasoned that "[t]he notion that post-solution + activity, no matter how conventional or obvious in itself, can transform an + unpatentable principle into a patentable process exalts form over substance. A + competent draftsman could attach some form of post-solution activity to almost any + mathematical formula". 437 U.S. at 590; 198 USPQ at 197; *Id.* + (holding that step of adjusting an alarm limit variable to a figure computed + according to a mathematical formula was "post-solution activity"). See also + *Mayo Collaborative Servs. v. Prometheus Labs. Inc.,* 566 U.S. + 66, 79, 101 USPQ2d 1961, 1968 (2012) (additional element of measuring metabolites of + a drug administered to a patient was insignificant extra-solution activity). + + + + Examiners should carefully consider each claim on + its own merits, as well as evaluate all other relevant considerations, before making + a determination of whether an element (or combination of elements) is insignificant + extra-solution activity. In particular, evaluation of the particular machine and + particular transformation considerations (see **[MPEP § 2106.05(b) and + (c)](s2106.html#ch2100_d29a1b_13ccf_18c)**, respectively), the well-understood, routine, + conventional consideration (see **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**), and the field of + use and technological environment consideration (see **[MPEP § + 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**) may assist examiners in making a determination + of whether an element (or combination of elements) is insignificant extra-solution + activity. Note, however, that examiners should not evaluate the well-understood, + routine, conventional consideration in the Step 2A Prong Two analysis, because that + consideration is only evaluated in Step 2B. + + + +This consideration is similar to factors used in past + Office guidance (for example, the now superseded *Bilski* and + *Mayo* analyses) that were described as mere data gathering in + conjunction with a law of nature or abstract idea. When determining whether an + additional element is insignificant extra-solution activity, examiners may consider + the following: + + + +**(1) Whether the extra-solution limitation is well + known.** See *Bilski v. Kappos,* 561 U.S. 593, 611-12, 95 + USPQ2d 1001, 1010 (2010) (well-known random analysis techniques to establish the + inputs of an equation were token extra-solution activity); *Flook,* + 437 U.S. at 593-95, 198 USPQ at 197 (a formula would not be patentable by only + indicating that is could be usefully applied to existing surveying techniques); + *Intellectual Ventures I LLC v. Erie Indem. Co.,* 850 F.3d 1315, + 1328-29, 121 USPQ2d 1928, 1937 (Fed. Cir. 2017) (the use of a well-known XML tag to + form an index was deemed token extra-solution activity). Because this overlaps with + the well-understood, routine, conventional consideration, it should not be considered + in the Step 2A Prong Two extra-solution activity analysis. + + + +**(2) Whether the limitation is significant + (*i.e.* it imposes meaningful limits on the claim such that it + is not nominally or tangentially related to the invention).** See *Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, 715-16, 112 USPQ2d 1750, + 1755 (Fed. Cir. 2014) (restricting public access to media was found to be + insignificant extra-solution activity); *Apple, Inc. v. Ameranth, + Inc.,* 842 F.3d 1229, 1242, 120 USPQ2d 1844, 1855 (Fed. Cir. 2016) (in + patents regarding electronic menus, features related to types of ordering were found + to be insignificant extra-solution activity). This is considered in Step 2A Prong Two + and Step 2B. + + + +**(3) Whether the limitation amounts to necessary + data gathering and outputting, (*i.e.,* all uses of the recited + judicial exception require such data gathering or data output).** See + *Mayo,* 566 U.S. at 79, 101 USPQ2d at 1968; *OIP Techs., + Inc. v. Amazon.com, Inc.,* 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 + (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data + gathering). This is considered in Step 2A Prong Two and Step 2B. + + + +Below are examples of activities that the courts have + found to be insignificant extra-solution activity: + + + +* **• Mere Data Gathering:** + + i. Performing clinical tests on individuals to + obtain input for an equation, *In re Grams,* 888 F.2d + 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); + + ii. Testing a system for a response, the + response being used to determine system malfunction, *In re + Meyers,* 688 F.2d 789, 794; 215 USPQ 193, 196-97 (CCPA 1982); + + iii. Presenting offers to potential customers + and gathering statistics generated based on the testing about how + potential customers responded to the offers; the statistics are then used + to calculate an optimized price, *OIP Technologies,* 788 + F.3d at 1363, 115 USPQ2d at 1092-93; + + iv. Obtaining information about transactions + using the Internet to verify credit card transactions, + *CyberSource v. Retail Decisions, Inc.,* 654 F.3d + 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011); + + v. Consulting and updating an activity log, + *Ultramercial,* 772 F.3d at 715, 112 USPQ2d at 1754; + and + + vi. Determining the level of a biomarker in + blood, *Mayo,* 566 U.S. at 79, 101 USPQ2d at 1968. See + also *PerkinElmer, Inc. v. Intema Ltd.,* 496 Fed. App'x + 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring + data derived from an ultrasound scan, to be used in a diagnosis). +* **• Selecting a particular data source or type of data to be + manipulated:** + + i. Limiting a database index to XML tags, + *Intellectual Ventures I LLC v. Erie Indem. Co.,* 850 + F.3d at 1328-29, 121 USPQ2d at 1937; + + ii. Taking food orders from only table-based + customers or drive-through customers, *Ameranth,* 842 + F.3d at 1241-43, 120 USPQ2d at 1854-55; + + iii. Selecting information, based on types of + information and availability of information in a power-grid environment, + for collection, analysis and display, *Electric Power Group, LLC + v. Alstom S.A.,* 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, + 1742 (Fed. Cir. 2016); and + + iv. Requiring a request from a user to view + an advertisement and restricting public access, + *Ultramercial,* 772 F.3d at 715-16, 112 USPQ2d at + 1754. +* **• Insignificant application:** + + i. Cutting hair after first determining the + hair style, *In re Brown,* 645 Fed. App'x 1014, + 1016-1017 (Fed. Cir. 2016) (non-precedential); and + + ii. Printing or downloading generated menus, + *Ameranth,* 842 F.3d at 1241-42, 120 USPQ2d at + 1854-55. + + +Some cases have identified insignificant computer + implementation as an example of insignificant extra-solution activity. See + *e.g., Fort Props., Inc. v. Am. Master Lease LLC,* 671 F.3d 1317, + 1323-24, 101 USPQ2d 1785, 1789-90 (Fed. Cir. 2012); *Bancorp Servs., LLC v. + Sun Life Assur. Co. of Canada,* 687 F.3d 1266, 1280-81, 103 USPQ2d 1425, + 1434-35 (Fed. Cir. 2012). Other cases have considered these types of limitations as + mere instructions to apply a judicial exception. See **[MPEP § + 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)** for more information about insignificant + computer implementation. + + + +For claim limitations that add insignificant + extra-solution activity to the judicial exception (*e.g.,* mere data + gathering in conjunction with a law of nature or abstract idea), examiners should + explain in an eligibility rejection why they do not meaningfully limit the claim. For + example, an examiner could explain that adding a final step of storing data to a + process that only recites computing the area of a space (a mathematical relationship) + does not add a meaningful limitation to the process of computing the area. For more + information on formulating a subject matter eligibility rejection, see + **[MPEP + § 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. + + + + + +# 2106.05(h) Field of Use and Technological + Environment [R-10.2019] + + +Another consideration when determining whether a + claim integrates the judicial exception into a practical application in Step 2A Prong + Two or recites significantly more than a judicial exception in Step 2B is whether the + additional elements amount to more than generally linking the use of a judicial + exception to a particular technological environment or field of use. As explained by + the Supreme Court, a claim directed to a judicial exception cannot be made eligible + "simply by having the applicant acquiesce to limiting the reach of the patent for the + formula to a particular technological use." *Diamond v. Diehr,* 450 + U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to + merely indicating a field of use or technological environment in which to apply a + judicial exception do not amount to significantly more than the exception itself, and + cannot integrate a judicial exception into a practical application. + + + +The courts often cite to *Parker v. + Flook* as providing a classic example of a field of use limitation. See, + *e.g., Bilski v. Kappos,* 561 U.S. 593, 612, 95 USPQ2d 1001, 1010 + (2010) ("*Flook* established that limiting an abstract idea to one + field of use or adding token postsolution components did not make the concept + patentable") (citing *Parker v. Flook,* 437 U.S. 584, 198 USPQ 193 + (1978)). In *Flook,* the claim recited steps of calculating an + updated value for an alarm limit (a numerical limit on a process variable such as + temperature, pressure or flow rate) according to a mathematical formula "in a process + comprising the catalytic chemical conversion of hydrocarbons." 437 U.S. at 586, 198 + USPQ at 196. Processes for the catalytic chemical conversion of hydrocarbons were + used in the petrochemical and oil-refining fields. *Id.* Although + the applicant argued that limiting the use of the formula to the petrochemical and + oil-refining fields should make the claim eligible because this limitation ensured + that the claim did not preempt all uses of the formula, the Supreme Court disagreed. + 437 U.S. at 588-90, 198 USPQ at 197-98. Instead, the additional element in + *Flook* regarding the catalytic chemical conversion of + hydrocarbons was not sufficient to make the claim eligible, because it was merely an + incidental or token addition to the claim that did not alter or affect how the + process steps of calculating the alarm limit value were performed. Further, the + Supreme Court found that this limitation did not amount to an inventive concept. 437 + U.S. at 588-90, 198 USPQ at 197-98. The Court reasoned that to hold otherwise would + "exalt[] form over substance", because a competent claim drafter could attach a + similar type of limitation to almost any mathematical formula. 437 U.S. at 590, 198 + USPQ at 197. + + + + In contrast, the additional elements in + *Diamond v. Diehr* as a whole provided eligibility and did not + merely recite calculating a cure time using the Arrhenius equation "in a rubber + molding process". Instead, the claim in *Diehr* recited specific + limitations such as monitoring the elapsed time since the mold was closed, constantly + measuring the temperature in the mold cavity, repetitively calculating a cure time by + inputting the measured temperature into the Arrhenius equation, and opening the press + automatically when the calculated cure time and the elapsed time are equivalent. 450 + U.S. at 179, 209 USPQ at 5, n. 5. These specific limitations act in concert to + transform raw, uncured rubber into cured molded rubber. 450 U.S. at 177-78, 209 USPQ + at 4. + + + +A more recent example of a limitation that does no + more than generally link a judicial exception to a particular technological + environment is *Affinity Labs of Texas v. DirecTV, LLC,* 838 F.3d + 1253, 120 USPQ2d 1201 (Fed. Cir. 2016). In *Affinity Labs,* the + claim recited a broadcast system in which a cellular telephone located outside the + range of a regional broadcaster (1) requests and receives network-based content from + the broadcaster via a streaming signal, (2) is configured to wirelessly download an + application for performing those functions, and (3) contains a display that allows + the user to select particular content. 838 F.3d at 1255-56, 120 USPQ2d at 1202. The + court identified the claimed concept of providing out-of-region access to regional + broadcast content as an abstract idea, and noted that the additional elements limited + the wireless delivery of regional broadcast content to cellular telephones (as + opposed to any and all electronic devices such as televisions, cable boxes, + computers, or the like). 838 F.3d at 1258-59, 120 USPQ2d at 1204. Although the + additional elements did limit the use of the abstract idea, the court explained that + this type of limitation merely confines the use of the abstract idea to a particular + technological environment (cellular telephones) and thus fails to add an inventive + concept to the claims. 838 F.3d at 1259, 120 USPQ2d at 1204. + + + +Examples of limitations that the courts have + described as merely indicating a field of use or technological environment in which + to apply a judicial exception include: + + + +* i. A step of administering a drug providing + 6-thioguanine to patients with an immune-mediated gastrointestinal disorder, + because limiting drug administration to this patient population did no more + than simply refer to the relevant pre-existing audience of doctors who used + thiopurine drugs to treat patients suffering from autoimmune disorders, + *Mayo Collaborative Servs. v. Prometheus Labs. Inc.,* 566 + U.S. 66, 78, 101 USPQ2d 1961, 1968 (2012); +* ii. Identifying the participants in a process for + hedging risk as commodity providers and commodity consumers, because limiting + the use of the process to these participants did no more than describe how the + abstract idea of hedging risk could be used in the commodities and energy + markets, *Bilski,* 561 U.S. at 595, 95 USPQ2d at 1010; +* iii. Limiting the use of the formula C = 2 (pi) r to + determining the circumference of a wheel as opposed to other circular objects, + because this limitation represents a mere token acquiescence to limiting the + reach of the claim, *Flook,* 437 U.S. at 595, 198 USPQ at + 199; +* iv. Specifying that the abstract idea of monitoring + audit log data relates to transactions or activities that are executed in a + computer environment, because this requirement merely limits the claims to the + computer field, *i.e.,* to execution on a generic computer, + *FairWarning v. Iatric Sys.,* 839 F.3d 1089, 1094-95, 120 + USPQ2d 1293, 1295 (Fed. Cir. 2016); +* v. Language specifying that the process steps of + virus screening were used within a telephone network or the Internet, because + limiting the use of the process to these technological environments did not + provide meaningful limits on the claim, *Intellectual Ventures I v. + Symantec Corp.,* 838 F.3d 1307, 1319-20, 120 USPQ2d 1353, 1361 + (2016); +* vi. Limiting the abstract idea of collecting + information, analyzing it, and displaying certain results of the collection and + analysis to data related to the electric power grid, because limiting + application of the abstract idea to power-grid monitoring is simply an attempt + to limit the use of the abstract idea to a particular technological + environment, *Electric Power Group, LLC v. Alstom S.A.,* 830 + F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016); +* vii. Language informing doctors to apply a law of + nature (linkage disequilibrium) for purposes of detecting a genetic + polymorphism, because this language merely informs the relevant audience that + the law of nature can be used in this manner, *Genetic Techs. Ltd. v. + Merial LLC,* 818 F.3d 1369, 1379, 118 USPQ2d 1541, 1549 (Fed. Cir. + 2016); +* viii. Language specifying that the abstract idea of + budgeting was to be implemented using a "communication medium" that broadly + included the Internet and telephone networks, because this limitation merely + limited the use of the exception to a particular technological environment, + *Intellectual Ventures I v. Capital One Bank,* 792 F.3d + 1363, 1367, 115 USPQ2d 1636, 1640 (Fed. Cir. 2015); +* ix. Specifying that the abstract idea of using + advertising as currency is used on the Internet, because this narrowing + limitation is merely an attempt to limit the use of the abstract idea to a + particular technological environment, *Ultramercial, Inc. v. Hulu, + LLC,* 772 F.3d 709, 716, 112 USPQ2d 1750, 1755 (Fed. Cir. 2014); + and +* x. Requiring that the abstract idea of creating a + contractual relationship that guarantees performance of a transaction (a) be + performed using a computer that receives and sends information over a network, + or (b) be limited to guaranteeing online transactions, because these + limitations simply attempted to limit the use of the abstract idea to computer + environments, *buySAFE Inc. v. Google, Inc.,* 765 F.3d 1350, + 1354, 112 USPQ2d 1093, 1095-96 (Fed. Cir. 2014). + + +Examiners should be aware that the courts often use + the terms "technological environment" and "field of use" interchangeably, and thus + for purposes of the eligibility analysis examiners should consider these terms + interchangeable. Examiners should also keep in mind that this consideration overlaps + with other considerations, particularly insignificant extra-solution activity (see + **[MPEP + § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**). For instance, a data gathering step that is + limited to a particular data source (such as the Internet) or a particular type of + data (such as power grid data or XML tags) could be considered to be both + insignificant extra-solution activity and a field of use limitation. See, + *e.g., Ultramercial,* 772 F.3d at 716, 112 USPQ2d at 1755 + (limiting use of abstract idea to the Internet); *Electric Power,* + 830 F.3d at 1354, 119 USPQ2d at 1742 (limiting application of abstract idea to power + grid data); *Intellectual Ventures I LLC v. Erie Indem. Co.,* 850 + F.3d 1315, 1328-29, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017) (limiting use of abstract + idea to use with XML tags). Thus, examiners should carefully consider each claim on + its own merits, as well as evaluate all other relevant considerations, before making + a determination on this consideration. + + + +For claim limitations that generally link the use of + the judicial exception to a particular technological environment or field of use, + examiners should explain in an eligibility rejection why they do not meaningfully + limit the claim. For example, an examiner could explain that employing generic + computer functions to execute an abstract idea, even when limiting the use of the + idea to one particular environment, does not add significantly more, similar to how + limiting the abstract idea in *Flook* to petrochemical and + oil-refining industries was insufficient. For more information on formulating a + subject matter eligibility rejection, see **[MPEP § + 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. + + + + + + +# 2106.06 Streamlined Analysis [R-10.2019] + + +For purposes of efficiency in examination, examiners may + use a streamlined eligibility analysis (Pathway A) when the eligibility of the claim is + self-evident, *e.g.,* because the claim clearly improves a technology + or computer functionality. However, if there is doubt as to whether the applicant is + effectively seeking coverage for a judicial exception itself, the full eligibility + analysis (the *Alice/Mayo* test described in **[MPEP § 2106](s2106.html#d0e197244)**, + subsection III) should be conducted to determine whether the claim integrates the + judicial exception into a practical application or recites significantly more than the + judicial exception. + + + + The results of the streamlined analysis will always be + the same as the full analysis, thus the streamlined analysis is not a means of avoiding + a finding of ineligibility that would occur if a claim were to undergo the full + eligibility analysis. Similarly, a claim that qualifies as eligible after Step 2A + (Pathway B) or Step 2B (Pathway C) of the full analysis would also be eligible if the + streamlined analysis (Pathway A) were applied to that claim. It may not be apparent that + an examiner employed the streamlined analysis because the result is a conclusion that + the claim is eligible, and there will be no rejection of the claim on eligibility + grounds. In practice, the record may reflect the conclusion of eligibility simply by the + absence of an eligibility rejection or may include clarifying remarks, when appropriate. + + + +In the context of the flowchart in **[MPEP § 2106](s2106.html#d0e197244)**, + subsection III, if, when viewed as a whole, the eligibility of the claim is self-evident + (e.g., because the claim clearly improves a technology or computer functionality), the + claim is eligible at Pathway A, thereby concluding the eligibility analysis. + + + + +# 2106.06(a) Eligibility is Self Evident [R-08.2017] + + +A streamlined eligibility analysis can be used for a + claim that may or may not recite a judicial exception but, when viewed as a whole, + clearly does not seek to tie up any judicial exception such that others cannot + practice it. Such claims do not need to proceed through the full analysis herein as + their eligibility will be self-evident. On the other hand, a claim that does not + qualify as eligible after Step 2B of the full analysis would not be suitable for the + streamlined analysis, because the claim lacks self‐evident eligibility. + + + +For instance, a claim directed to a complex + manufactured industrial product or process that recites meaningful limitations along + with a judicial exception may sufficiently limit its practical application so that a + full eligibility analysis is not needed. As an example, a robotic arm assembly having + a control system that operates using certain mathematical relationships is clearly + not an attempt to tie up use of the mathematical relationships and would not require + a full analysis to determine eligibility. Also, a claim that recites a nature-based + product, but clearly does not attempt to tie up the nature-based product, does not + require a markedly different characteristics analysis to identify a "product of + nature" exception. As an example, a claim directed to an artificial hip prosthesis + coated with a naturally occurring mineral is not an attempt to tie up the mineral. + Similarly, claimed products that merely include ancillary nature-based components, + such as a claim that is directed to a cellphone with an electrical contact made of + gold or a plastic chair with wood trim, would not require analysis of the + nature-based component to determine whether the claims are directed to a "product of + nature" exception because such claims do not attempt to improperly tie up the + nature-based product. + + + + + +# 2106.06(b) Clear Improvement to a Technology or to + Computer Functionality [R-08.2017] + + +As explained by the Federal Circuit, some + improvements to technology or to computer functionality are not abstract when + appropriately claimed, and thus claims to such improvements do not always need to + undergo the full eligibility analysis. *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). + **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** provides details regarding improvements to a + technology or computer functionality. + + + +For instance, claims directed to clear improvements + to computer-related technology do not need the full eligibility analysis. + *Enfish,* 822 F.3d at 1339, 118 USPQ2d at 1691-92 (claims to a + self-referential table for a computer database held eligible at step 1 of the + *Alice/Mayo* test as not directed to an abstract idea). Claims + directed to improvements to other technologies or technological processes, beyond + computer improvements, may also avoid the full eligibility analysis. *McRO, + Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, 1316, 120 USPQ2d + 1091, 1103 (Fed. Cir. 2016) (claims to automatic lip synchronization and facial + expression animation found eligible at Step 1 of the *Alice/Mayo* + test as directed to an improvement in computer-related technology). In these cases, + when the claims were viewed as a whole, their eligibility was self-evident based on + the clear improvement, so no further analysis was needed. Although the Federal + Circuit held these claims eligible at Step 2A as not being directed to abstract + ideas, it would be reasonable for an examiner to have found these claims eligible at + Pathway A based on the clear improvement, or at Pathway B (Step 2A) as not being + directed to an abstract idea. + + + +If the claims are a "close call" such that it is + unclear whether the claims improve technology or computer functionality, a full + eligibility analysis should be performed to determine eligibility. See + *BASCOM Global Internet v. AT&T Mobility LLC,* 827 F.3d 1341, + 1349, 119 USPQ2d 1236, 1241 (Fed Cir. 2016). Only when the claims clearly improve + technology or computer functionality, or otherwise have self-evident eligibility, + should the streamlined analysis be used. For example, because the claims in + *BASCOM* described the concept of filtering content, which is a + method of organizing human behavior previously found to be abstract, the Federal + Circuit considered them to present a "close call" in the first step of the + *Alice/Mayo* test (Step 2A), and thus proceeded to the second + step of the *Alice/Mayo* test (Step 2B) to determine their + eligibility. *Id.* Although the Federal Circuit held these claims + eligible at Step 2B (Pathway C) because they presented a "technology-based solution" + of filtering content on the Internet that overcame the disadvantages of prior art + filtering systems and that amounted to significantly more than the recited abstract + idea, it also would be reasonable for an examiner to have found these claims eligible + at Pathway A or B if the examiner had considered the technology-based solution to be + an improvement to computer functionality. + + + + + + +# 2106.07 Formulating and Supporting Rejections For Lack + Of Subject Matter Eligibility [R-10.2019] + + +Eligibility rejections must be based on failure to + comply with the substantive law under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** as interpreted by + judicial precedent. The substantive law on eligibility is discussed in + **[MPEP §§ + 2106.03](s2106.html#ch2100_d29a1b_139b2_397)** through **[2106.06](s2106.html#ch2100_d29a1b_13e6a_88)**. + Examination guidance, training, and explanatory examples discuss the substantive law and + establish the policies and procedures to be followed by examiners in evaluating patent + applications for compliance with the substantive law, but do not serve as a basis for a + rejection. Accordingly, while it would be acceptable for applicants to cite training + materials or examples in support of an argument for finding eligibility in an + appropriate factual situation, applicants should not be required to model their claims + or responses after the training materials or examples to attain eligibility. + + + +When evaluating a claimed invention for compliance with + the substantive law on eligibility, examiners should review the record as a whole + (*e.g.,* the specification, claims, the prosecution history, and any + relevant case law precedent or prior art) before reaching a conclusion with regard to + whether the claimed invention sets forth patent eligible subject matter. The evaluation + of whether the claimed invention qualifies as patent-eligible subject matter should be + made on a claim-by-claim basis, because claims do not automatically rise or fall with + similar claims in an application. For example, even if an independent claim is + determined to be ineligible, the dependent claims may be eligible because they add + limitations that integrate the judicial exception into a practical application or amount + to significantly more than the judicial exception recited in the independent claim. And + conversely, even if an independent claim is determined to be eligible, a dependent claim + may be ineligible because it adds a judicial exception without also adding limitations + that integrate the judicial exception or provide significantly more. Thus, each claim in + an application should be considered separately based on the particular elements recited + therein. + + + +If the evaluation of the claimed invention results in a + conclusion that it is more likely than not that the claim as a whole does not satisfy + both criteria for eligibility (Step 1: NO and/or Step 2B: NO), then examiners should + formulate an appropriate rejection of that claim under Step 1 and/or Step 2B. The + rejection should set forth a *prima facie* case of ineligibility under + the substantive law. The concept of the prima facie case is a procedural tool of patent + examination, which allocates the burdens going forward between the examiner and + applicant. In particular, the initial burden is on the examiner to explain why a claim + or claims are ineligible for patenting clearly and specifically, so that applicant has + sufficient notice and is able to effectively respond. + + + + When an examiner determines a claim does not fall + within a statutory category (Step 1: NO), the rejection should provide an explanation of + why the claim does not fall within one of the four statutory categories of invention. + See **[MPEP § + 2106.03](s2106.html#ch2100_d29a1b_139b2_397)** for a discussion of Step 1 and the statutory + categories of invention. + + + +When an examiner determines that a claim is directed to + a judicial exception (Step 2A: YES) and does not provide an inventive concept (Step 2B: + NO), the rejection should provide an explanation for each part of the Step 2 analysis. + For example, the rejection should identify the judicial exception by referring to what + is recited (*i.e.,* set forth or described) in the claim and explain + why it is considered an exception, identify any additional elements (specifically point + to claim features/limitations/steps) recited in the claim beyond the identified judicial + exception, and explain the reason(s) that the additional elements taken individually, + and also taken as a combination, 1) do not integrate the judicial exception into a + practical application and 2) do not result in the claim as a whole amounting to + significantly more than the judicial exception. See **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)***et seq.* for a discussion of Step 2A and the judicial exceptions, + **[MPEP § + 2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)***et seq.* for a discussion of Step 2B and the search for an inventive + concept, and **[MPEP § 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)** for more information + on formulating an ineligibility rejection. + + + +If the evaluation of the claimed invention results in a + conclusion that it is more likely than not that the claimed invention falls within a + statutory category (Step 1: YES) and is either not directed to a judicial exception + (Step 2A: NO) or is directed to a judicial exception and amounts to significantly more + than the judicial exception (Step 2B: YES), then the examiner should not reject the + claim. When evaluating a response by applicant to a subject matter eligibility + rejection, examiners must carefully consider all of applicant’s arguments and evidence + presented to rebut the rejection. If applicant properly challenges the examiner’s + findings, the rejection should be withdrawn or, if the examiner deems it appropriate to + maintain the rejection, a rebuttal must be provided in the next Office action. This is + discussed in greater detail in **[MPEP § 2106.07(b)](s2106.html#ch2100_d29a1b_14065_2a0)**. + + + + +# 2106.07(a) Formulating a Rejection For Lack of Subject + Matter Eligibility [R-10.2019] + + +After determining what the applicant invented and + establishing the broadest reasonable interpretation of the claimed invention (see + **[MPEP § + 2111](s2111.html#d0e200352)**), the eligibility of each claim should be evaluated as + a whole using the analysis detailed in **[MPEP § 2106](s2106.html#d0e197244)**. If it is determined + that the claim does not recite eligible subject matter, a rejection under + **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)** is appropriate. When making the rejection, the Office + action must provide an explanation as to why each claim is unpatentable, which must + be sufficiently clear and specific to provide applicant sufficient notice of the + reasons for ineligibility and enable the applicant to effectively respond. + + + +Subject matter eligibility rejections under Step 1 + are discussed in **[MPEP § 2106.03](s2106.html#ch2100_d29a1b_139b2_397)**. + + + + A subject matter eligibility rejection under Step 2 + should provide an explanation for each part of the Step 2 analysis: + + + +* • For Step 2A Prong One, the rejection should + identify the judicial exception by referring to **what is recited** + (*i.e.,* set forth or described) in the claim and + **explain why** it is considered an exception. For example, if the + claim is directed to an **abstract idea**, the rejection should + identify the abstract idea as it is recited (*i.e.,* set forth + or described) in the claim and explain why it is an abstract idea. Similarly, + if the claim is directed to a **law of nature** or a **natural + phenomenon**, the rejection should identify the law of nature or + natural phenomenon as it is recited (*i.e.,* set forth or + described) in the claim and explain using a reasoned rationale why it is + considered a law of nature or natural phenomenon. +* • For Step 2A Prong Two, the rejection should + identify any additional elements (specifically point to claim + features/limitations/steps) recited in the claim beyond the identified judicial + exception; and **evaluate** the integration of the judicial exception + into a practical application **by explaining** that 1) there are no + additional elements in the claim; or 2) the claim as a whole, looking at the + additional elements individually and in combination, does not integrate the + judicial exception into a practical application using the considerations set + forth in **[MPEP §§ 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)**, + **[2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**- **[(c)](s2106.html#ch2100_d29a1b_13cfb_2e)** and **[(e)](s2106.html#ch2100_d29a1b_13d61_1a8)**- **[(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**. Examiners should give weight to all of the + claimed additional elements in Prong Two, even if those elements represent + well-understood, routine, conventional activity. +* • For Step 2B, the rejection should + **explain why** the additional elements, taken individually and in + combination, do not result in the claim, as a whole, amounting to significantly + more than the identified judicial exception. For instance, when the examiner + has concluded that certain claim elements recite well understood, routine, + conventional activities in the relevant field, the examiner must expressly + support the rejection in writing with one of the four options specified in + Subsection III. + + + Under the principles of compact prosecution, + regardless of whether a rejection under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** is made based on + lack of subject matter eligibility, a complete examination should be made for every + claim under each of the other patentability requirements: **[35 U.S.C. + 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)**, **[103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)**, **[112](mpep-9015-appx-l.html#d0e302824912)**, and + **[101](mpep-9015-appx-l.html#d0e302376)** (utility, inventorship and double patenting) and + non-statutory double patenting. Thus, examiners should state all non-cumulative + reasons and bases for rejecting claims in the first Office action. + + +**I.** **WHEN MAKING A REJECTION, IDENTIFY + AND EXPLAIN THE JUDICIAL EXCEPTION RECITED IN THE CLAIM (STEP 2A PRONG + ONE)**A subject matter eligibility rejection should + point to the specific claim limitation(s) that recites (*i.e.,* + sets forth or describes) the judicial exception. The rejection must explain why + those claim limitations set forth or describe a judicial exception + (*e.g.,* a law of nature). Where the claim describes, but does + not expressly set forth, the judicial exception, the rejection must also explain + what subject matter those limitations describe, and why the described subject + matter is a judicial exception. See **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)** for more information about Step 2A of the + eligibility analysis. + + + +When the examiner has determined the claim recites + an **abstract idea**, the rejection should identify the abstract idea as + it is recited (*i.e.,* set forth or described) in the claim, and + explain why it falls within one of the groupings of abstract ideas + (*i.e.,* mathematical concepts, mental processes, or certain + methods of organizing human activity) enumerated in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**. Alternatively, the examiner should + provide justification for why a specific limitation(s) recited in the claim is + being treated as an abstract idea if it does not fall within the groupings of + abstract ideas in accordance with the "tentative abstract idea" procedure (see + **[MPEP § 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, subsection (IV)). While not required, + this explanation or justification may include citing to an appropriate court + decision that supports the identification of the subject matter recited in the + claim language as an abstract idea within one of the groupings. Examiners should + be familiar with any cited decision relied upon in making or maintaining a + rejection to ensure that the rejection is reasonably tied to the facts of the case + and to avoid relying upon language taken out of context. Examiners should not go + beyond those concepts that are enumerated as abstract ideas in + **[MPEP § 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, unless they are identifying a tentative + abstract idea in the claim, and should avoid relying upon or citing + non-precedential decisions unless the facts of the application under examination + uniquely match the facts at issue in the non-precedential decisions. Examiners are + reminded that a chart of court decisions is available on the USPTO’s Internet + website (**[www.uspto.gov/ PatentEligibility](http://www.uspto.gov/PatentEligibility)**). + + + + +Sample explanation: The + claim recites the step of comparing collected information to a predefined + threshold, which is an act of evaluating information that can be practically + performed in the human mind. Thus, this step is an abstract idea in the "mental + process" grouping. + + + + +When the examiner has determined the claim recites + a **law of nature** or a **natural phenomenon**, the rejection + should identify the law of nature or natural phenomenon as it is recited + (*i.e.,* set forth or described) in the claim and explain + using a reasoned rationale why it is considered a law of nature or natural + phenomenon. See **[MPEP § 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)** for more + information about laws of nature and natural phenomena. + + + + +Sample explanation: The + claim recites the correlation of X, and X is a law of nature because it + describes a consequence of natural processes in the human body, e.g., the + naturally-occurring relationship between the presence of Y and the + manifestation of Z. + + + + + +Sample explanation: The + claim recites X, which is a natural phenomenon because it occurs in nature and + exists in principle apart from any human action. + + + + +When the examiner has determined the claim recites + a **product of nature,** the rejection should identify the exception as + it is recited (*i.e.,* set forth or described) in the claim, and + explain using a reasoned rationale why the product does not have markedly + different characteristics from its naturally occurring counterpart in its natural + state. See **[MPEP § 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)** for more + information about products of nature, and **[MPEP § + 2106.04(c)](s2106.html#ch2100_d29a1b_13bc1_b1)** for more information about the markedly + different characteristics analysis. + + + + +Sample explanation: The + claim recites X, which as explained in the specification was isolated from + naturally occurring Y. X is a nature-based product, so it is compared to its + closest naturally occurring counterpart (X in its natural state) to determine + if it has markedly different characteristics. Because there is no indication in + the record that isolation of X has resulted in a marked difference in + structure, function, or other properties as compared to its counterpart, X is a + product of nature exception. + + + +**II.** **WHEN MAKING A REJECTION, EXPLAIN + WHY THE ADDITIONAL CLAIM ELEMENTS DO NOT RESULT IN THE CLAIM AS A WHOLE + INTEGRATING THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION OR AMOUNTING TO + SIGNIFICANTLY MORE THAN THE JUDICIAL EXCEPTION (STEP 2A PRONG TWO AND STEP + 2B)**After identifying the judicial exception in the + rejection, identify any additional elements (features/limitations/steps) recited + in the claim beyond the judicial exception and explain why they do not integrate + the judicial exception into a practical application and do not add significantly + more to the exception. The explanation should address the additional elements both + individually and as a combination when determining whether the claim as whole + recites eligible subject matter. It is important to remember that a new + combination of steps in a process may be patent eligible even though all the steps + of the combination were individually well known and in common use before the + combination was made. *Diamond v. Diehr,* 450 U.S. 175, 188, 209 + USPQ 1, 9 (1981). Thus, it is particularly critical to address the combination of + additional elements, because while individually-viewed elements may not appear to + integrate an exception into a practical application or add significantly more, + those additional elements when viewed in combination may amount to significantly + more than the exception by meaningfully limiting the judicial exception. See + **[MPEP § 2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)** for more information about Step 2B of + the eligibility analysis. + + + +A rejection should be made only if it is readily + apparent to an examiner relying on the examiner's expertise in the art in the Step + 2A Prong Two inquiry and Step 2B inquiry that the additional elements do not + integrate the exception into a practical application and do not amount to claiming + significantly more than the recited judicial exception. When making a rejection, + it is important for the examiner to explain the rationale underlying the + conclusion so that applicant can effectively respond. On the other hand, when + appropriate, the examiner should explain why the additional elements integrate an + exception into a practical application or provide an inventive concept by adding a + meaningful limitation to the claimed exception. See **[MPEP §§ + 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)** and **[2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)** for a listing of considerations that qualify, + and to not qualify, as integrating an exception or providing significantly more + than an exception , and **[MPEP § 2106.07(c)](s2106.html#ch2100_d29a1b_1407f_384)** for more + information on clarifying the record when a claim is found eligible. + + + +In the Step 2B inquiry, if the examiner has + concluded that particular claim limitations are well understood, routine, + conventional activities (or elements) to those in the relevant field, the + rejection should support this conclusion in writing with a factual determination + in accordance with Subsection III below. See **[MPEP § + 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)** for more information about well understood, + routine, conventional activities and elements, and Subsection III below for more + information about how to support a conclusion that a claim limitation is well + understood, routine, conventional activity. + + + +For claim limitations that recite a generic + computer component performing generic computer functions at a high level of + generality, such as using the Internet to gather data, examiners can explain why + these generic computing functions do not meaningfully limit the claim. Examiners + should keep in mind that the courts have held computer-implemented processes to be + significantly more than an abstract idea (and thus eligible), where generic + computer components are able in combination to perform functions that are not + merely generic. *DDR Holdings, LLC v. Hotels.com, LP,* 773 F.3d + 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014). See + **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)** for more information about generic + computing functions that the courts have found to be mere instructions to + implement a judicial exception on a computer, and **[MPEP § + 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)** for more information about well understood, + routine, conventional activities and elements (a relevant consideration only in + Step 2B). + + + +For claim limitations that add insignificant + extra-solution activity to the judicial exception (e.g., mere data gathering in + conjunction with a law of nature or abstract idea), or that generally link the use + of the judicial exception to a particular technological environment or field of + use, examiners should explain why they do not meaningfully limit the claim. For + example, adding a final step of storing data to a process that only recites + computing the area of a two dimensional space (a mathematical relationship) does + not add a meaningful limitation to the process of computing the area. As another + example, employing well-known computer functions to execute an abstract idea, even + when limiting the use of the idea to one particular environment, does not + integrate the exception into a practical application or add significantly more, + similar to how limiting the computer implemented abstract idea in Flook to + petrochemical and oil-refining industries was insufficient. See *e.g., + Parker v. Flook,* 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) + (limiting use of mathematical formula to use in particular industries did not + amount to an inventive concept). See **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)** for more information about insignificant + extra-solution activity, and **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)** for more + information about generally linking use of a judicial exception to a particular + technological environment or field of use. + + + +In the event a rejection is made, it is a best + practice for the examiner to consult the specification to determine if there are + elements that could be added to the claim to make it eligible. If so, the examiner + should identify those elements in the Office action and suggest them as a way to + overcome the rejection. + + +**III.** **EVIDENTIARY REQUIREMENTS IN MAKING + A § 101 REJECTION**The courts consider the determination of whether a + claim is eligible (which involves identifying whether an exception such as an + abstract idea is being claimed) to be a question of law. *Rapid Litig. + Mgmt. v. CellzDirect,* 827 F.3d 1042, 1047, 119 USPQ2d 1370, 1372 + (Fed. Cir. 2016); *OIP Techs. v. Amazon.com,* 788 F.3d 1359, + 1362, 115 USPQ2d 1090, 1092 (Fed. Cir. 2015); *DDR Holdings v. + Hotels.com,* 773 F.3d 1245, 1255, 113 USPQ2d 1097, 1104 (Fed. Cir. + 2014); *In re Roslin Institute (Edinburgh),* 750 F.3d 1333, 1335, + 110 USPQ2d 1668, 1670 (Fed. Cir. 2014); *In re Bilski,* 545 F.3d + 943, 951, 88 USPQ2d 1385, 1388 (Fed. Cir. 2008) (*en banc*), + aff’d by *Bilski v. Kappos,* 561 U.S. 593, 95 USPQ2d 1001 (2010). + Thus, the court does not require "evidence" that a claimed concept is a judicial + exception, and generally decides the legal conclusion of eligibility without + resolving any factual issues. *FairWarning IP, LLC v. Iatric + Sys.,* 839 F.3d 1089, 1097, 120 USPQ2d 1293, 1298 (Fed. Cir. 2016) + (citing *Genetic Techs. Ltd. v. Merial LLC,* 818 F.3d 1369, 1373, + 118 USPQ2d 1541, 1544 (Fed. Cir. 2016)); *OIP Techs.,* 788 F.3d + at 1362, 115 USPQ2d at 1092; *Content Extraction & Transmission LLC v. + Wells Fargo Bank, N.A.,* 776 F.3d 1343, 1349, 113 USPQ2d 1354, 1359 + (Fed. Cir. 2014). In some cases, however, the courts have characterized the issue + of whether additional elements are well-understood, routine, conventional activity + as an underlying factual issue upon which the legal conclusion of eligibility may + be based. See, *e.g., Interval Licensing LLC v. AOL, Inc.,* 896 + F.3d. 1335, 1342, 127 USPQ2d 1553, 1557 (Fed. Cir. 2018) (patent eligibility is a + question of law that may contain underlying issues of fact), *Berkheimer + v. HP, Inc.,* 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. + 2018) (issue of whether additional elements are well-understood, routine, + conventional activity is factual). + + + +When performing the analysis at Step 2A Prong One, + it is sufficient for the examiner to provide a reasoned rationale that identifies + the judicial exception recited in the claim and explains why it is considered a + judicial exception (e.g., that the claim limitation(s) falls within one of the + abstract idea groupings). Therefore, there is no requirement for the examiner to + rely on evidence, such as publications or an affidavit or declaration under + **[37 CFR + 1.104(d)(2)](mpep-9020-appx-r.html#d0e322249)**, to find that a claim recites a judicial + exception. *Cf. Affinity Labs of Tex., LLC v. Amazon.com Inc.,* + 838 F.3d 1266, 1271-72, 120 USPQ2d 1210, 1214-15 (Fed. Cir. 2016) (affirming + district court decision that identified an abstract idea in the claims without + relying on evidence); *OIP Techs., Inc. v. Amazon.com, Inc.,* 788 + F.3d 1359, 1362-64, 115 USPQ2d 1090, 1092-94 (Fed. Cir. 2015) (same); + *Content Extraction & Transmission LLC v. Wells Fargo + Bank,* N.A., 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357-58 (Fed. Cir. + 2014) (same). + + + +At Step 2A Prong Two or Step 2B, there is no + requirement for evidence to support a finding that the exception is not integrated + into a practical application or that the additional elements do not amount to + significantly more than the exception unless the examiner asserts that additional + limitations are well-understood, routine, conventional activities in Step 2B. + + + +Examiners should not assert that an additional + element (or combination of elements) is well-understood, routine, or conventional + unless the examiner finds, and expressly supports the rejection in writing with + one or more of the following: + + + +* (A) A citation to an express statement in the + specification or to a statement made by an applicant during prosecution that + demonstrates the well-understood, routine, conventional nature of the + additional element(s). A specification demonstrates the well-understood, + routine, conventional nature of additional elements when it describes the + additional elements as well-understood or routine or conventional (or an + equivalent term), as a commercially available product, or in a manner that + indicates that the additional elements are sufficiently well-known that the + specification does not need to describe the particulars of such additional + elements to satisfy **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**. A + finding that an element is well-understood, routine, or conventional cannot + be based only on the fact that the specification is silent with respect to + describing such element. +* (B) A citation to one or more of the court + decisions discussed in **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**, + subsection II, as noting the well-understood, routine, conventional nature + of the additional element(s). Examiners should be careful to ensure the + claim limitations before the examiner are the same as those found to be + well-understood, routine, conventional by the courts. The additional + elements under examination should be recited in the same manner, meaning + they should be recited at the same high level of generality as in those + court decisions. It is not enough that the additional elements are similar + to the elements at issue in those cases. In addition, the court decisions + discussed in **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**, + subsection II, are not meant to imply that all computer functions are + well-understood, routine, conventional functions, or that a claim reciting a + generic computer component performing a generic computer function is + necessarily ineligible. Examiners should keep in mind that the courts have + held computer-implemented processes to be significantly more than an + abstract idea (and thus eligible), where generic computer components are + able in combination to perform functions that are not merely generic. + *DDR Holdings, LLC v. Hotels.com, LP,* 773 F.3d 1245, + 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014). See + **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)** for more + information about generic computing functions that the courts have found to + be mere instructions to implement a judicial exception on a computer. +* (C) A citation to a publication that + demonstrates the well-understood, routine, conventional nature of the + additional element(s). An appropriate publication could include a book, + manual, review article, or other source that describes the state of the art + and discusses what is well-known and in common use in the relevant industry. + It does not include all items that might otherwise qualify as a "printed + publication" as used in **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)**. Whether + something is disclosed in a document that is considered a "printed + publication" under **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)** is a + distinct inquiry from whether something is well-known, routine, conventional + activity. A document may be a printed publication but still fail to + establish that something it describes is well-understood, routine, + conventional activity. See *Exergen Corp. v. Kaz USA,* 725 + Fed. App’x. at 959, 966 (Fed. Cir. 2018) (the single copy of a thesis, + written in German and located in a German university library, considered to + be a "printed publication" in *In re Hall,* 781 F.2d 897, + 228 USPQ 453 (Fed. Cir. 1986) "would not suffice to establish that something + is 'well-understood, routine, and conventional activity previously engaged + in by scientists who work in the field'"). The nature of the publication and + the description of the additional elements in the publication would need to + demonstrate that the additional elements are widely prevalent or in common + use in the relevant field, comparable to the types of activity or elements + that are so well-known that they do not need to be described in detail in a + patent application to satisfy **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**. For + example, while U.S. patents and published applications are publications, + merely finding the additional element in a single patent or published + application would not be sufficient to demonstrate that the additional + element is well-understood, routine, conventional, unless the patent or + published application demonstrates that the additional element is widely + prevalent or in common use in the relevant field. +* (D) A statement that the examiner is taking + official notice of the well-understood, routine, conventional nature of the + additional element(s). This option should be used only when examiners are + certain, based upon their personal knowledge, that the additional element(s) + represents well-understood, routine, conventional activity engaged in by + those in the relevant art, in that the additional elements are widely + prevalent or in common use in the relevant field, comparable to the types of + activity or elements that are so well-known that they do not need to be + described in detail in a patent application to satisfy **[35 U.S.C. + 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**. For example, the examiner could take official + notice that a generic computer component performing generic computer + functions at a high level of generality, such as using the Internet to + gather data, is well-understood, routine, conventional. Procedures for + taking official notice and addressing an applicant’s challenge to official + notice are discussed in **[MPEP § 2144.03](s2144.html#d0e210752)**. + + + +# 2106.07(a)(1) Form Paragraphs for use in Lack of + Subject Matter Eligibility Rejections [R-10.2019] + + +Use form paragraphs **[7.04.01](#fp7.04.01)**, + **[7.05](#fp7.05)**, + and **[7.05.01](#fp7.05.01)** for rejections based on a failure to + claim an invention that falls within the statutory categories of invention (i.e., + the claim is not to one of the four statutory categories of invention and is thus + rejected at Step 1 of the eligibility analysis). + + + +Use form paragraphs **[7.04.01](#fp7.04.01)**, + **[7.05](#fp7.05)**, + and **[7.05.016](#fp7.05.016)** for rejections based on a failure to + claim an invention that is directed to patent-eligible subject matter, i.e., the + claim is directed to a judicial exception without providing an inventive + concept/significantly more, and is thus rejected at Step 2B of the eligibility + analysis. If the judicial exception to which the claim is directed is a "tentative + abstract idea," i.e., an abstract idea that does not fall within any of the + groupings of abstract ideas discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, then the Step 2B rejection must also use + form paragraph **[7.05.017](#fp7.05.017)** (in addition to form paragraphs + **[7.04.01](#fp7.04.01)**, **[7.05](#fp7.05)**, and + **[7.05.016](#fp7.05.016)**) and include the TC Director's + signature. + + + +# ¶ 7.04.01 Statement of Statutory Basis, 35 U.S.C. 101 + + +35 U.S.C. 101 reads as follows: + + +Whoever invents or discovers any new and useful process, machine, + manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a + patent therefor, subject to the conditions and requirements of this title. + + + +### Examiner Note: + + * This form paragraph must precede the first use of + **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)** in all first actions on the merits and final rejections. + + + +# ¶ 7.05 Rejection, 35 U.S.C. 101, -Heading Only- (Utility, Nonstatutory, + Inoperative) + + +Claim **[1]** rejected under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** because + + + +### Examiner Note: + + * 1. This form paragraph must be preceded by form paragraph + **[7.04.01](#fp7.04.01)** in + first actions and final rejections. +* 2. This form paragraph must be followed by a detailed explanation of + the grounds of rejection using one or more of form paragraphs + **[7.05.01](#fp7.05.01)**, + **[7.05.016](#fp7.05.016)**, + **[7.05.017](#fp7.05.017)**, + **[7.05.02](#fp7.05.02)**, + **[7.05.03](#fp7.05.03)**, + or another appropriate reason. +* 3. See **[MPEP §§ 2105](s2105.html#d0e197008)** - **[2107.03](s2107.html#d0e199419)** for additional guidance. + + + +# ¶ 7.05.01 Rejection, 35 U.S.C. 101, Nonstatutory (Not One of the Four + Statutory Categories) + + +the claimed invention is directed to nonstatutory subject matter. The + claim(s) does/do not fall within at least one of the four categories of patent eligible + subject matter because **[1]** + + +### Examiner Note: + + * 1. This form paragraph should be preceded by form paragraph + **[7.05](#fp0705)**. +* 2. In bracket 1, explain why the claimed invention is not patent + eligible subject matter by identifying what the claim(s) is/are directed to and explain + why it does not fall within at least one of the four categories of patent eligible + subject matter recited in **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** (process, machine, + manufacture, or composition of matter), e.g., the claim(s) is/are directed to a signal + *per se,* mere information in the form of data, a contract between + two parties, or a human being (see **[MPEP § 2106](s2106.html#d0e197244)**, subsection I). +* 3. For a claim that is directed to a judicial exception and is + nonstatutory, use form paragraph **[7.05.016](#fp7.05.016)**. + + + +# ¶ 7.05.016 Rejection, 35 U.S.C. 101, Nonstatutory (Directed to a Judicial + Exception without an Inventive Concept/Significantly More) + + +the claimed invention is directed to **[1]** without + significantly more. The claim(s) recite(s) **[2]**. This judicial exception is not + integrated into a practical application because **[3]**. The claim(s) does/do not + include additional elements that are sufficient to amount to significantly more than the + judicial exception because **[4]**. + + + +### Examiner Note: + + * 1. This form paragraph should be preceded by form paragraph + **[7.05](#fp7.05)**. For + claims that recite a tentative abstract idea (i.e., a limitation identified as an + abstract idea even though it does not fall within the groupings of abstract ideas + discussed in **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**), this form + paragraph should be accompanied by form paragraph **[7.05.017](#fp7.05.017)**. +* 2. This form paragraph is for use with all product (machine, + manufacture, and composition of matter) and process claims, and for all claims directed + to a law of nature, natural phenomenon (including a product of nature), or abstract + idea. +* 3. In bracket 1, identify whether the claim(s) are directed to a + law of nature, a natural phenomenon (including a product of nature), or an abstract + idea. +* 4. In bracket 2, identify the exception by referring to how it is + recited in the claim and explain why it is considered an exception (e.g., for an + abstract idea, identify the abstract idea grouping in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** into which the recited exception falls). For + example, "the Arrhenius equation, which is a law of nature and a mathematical concept + which describes the relationship between temperature and reaction rate" or "the series + of steps instructing how to hedge risk, which is a fundamental economic practice and + thus grouped as a certain method of organizing human interactions." For a product of + nature exception, refer to how it is recited in the claim and explain why its + characteristics are not markedly different from the product’s naturally occurring + counterpart in its natural state. For example, "the naturally occurring DNA segment, + which is not markedly different from its naturally occurring counterpart because it + conveys the same genetic information." Provide additional explanation regarding the + exception and how it has been identified when appropriate. +* 5. In bracket 3, explain why the combination of additional + elements fails to integrate the judicial exception into a practical application. For + example, if the claim is directed to an abstract idea with additional generic computer + elements, explain that the generically recited computer elements do not add a meaningful + limitation to the abstract idea because they amount to simply implementing the abstract + idea on a computer; or, if the claim is directed to a method of using a naturally + occurring correlation, explain that data gathering steps required to use the correlation + do not add a meaningful limitation to the method as they are insignificant + extra-solution activity. Similarly, if the claim recites a "naturally occurring DNA + segment" with an additional element of a test tube, explain that merely placing the + product of nature into a generic container such as a test tube does not add a meaningful + limitation as it is merely a nominal or token extra-solution component of the claim, and + is nothing more than an attempt to generally link the product of nature to a particular + technological environment. +* 6. In bracket 4, identify the additional elements and explain why, + when considered separately and in combination, they do not add significantly more (also + known as an "inventive concept") to the exception. For example, if the additional + limitations only store and retrieve information in memory, explain that these are + well-understood, routine, conventional computer functions as recognized by the court + decisions listed in **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**. + + + +# ¶ 7.05.017 Rejection, 35 U.S.C. 101, TC Director Approval for + "Tentative Abstract Idea" + + +The identified claim limitation(s) that recite(s) an abstract idea + do/does not fall within the groupings of abstract ideas discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, i.e., mathematical concepts, mental processes, or + certain methods of organizing human activity. Nonetheless, the claim limitation(s) is/are + being treated as reciting an abstract idea because **[1]**. + + + +This rejection has been approved by the Technology Center Director + signing below. + + + +**[2]** + + +### Examiner Note: + + * 1. This form paragraph should be preceded by form paragraph + **[7.05.016](#fp7.05.016)**. +* 2. Approval from the TC Director is required to treat a tentative + abstract idea (i.e., a claim limitation(s) that does not fall within the groupings of + abstract ideas discussed in **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**) as an abstract + idea. This form paragraph should be used to demonstrate that this approval has been + obtained. +* 3. In bracket 1, provide the justification for why the claim + limitation(s) is/are being treated as an abstract idea. For example, provide an + explanation of why the claim limitation is among the "basic tools of scientific and + technological work." +* 4. In bracket 2, insert the TC Director's signature. Approval of + the TC Director is required to treat a claim limitation that does not fall within the + groupings of abstract ideas discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** as reciting an abstract idea. See + **[MPEP § + 2106.04(a)(3)](s2106.html#ch2100_d2ea80_199c8_1c1)**. + + + + + + +# 2106.07(b) Evaluating Applicant's Response [R-10.2019] + + +After examiners identify and explain in the record + the reasons why a claim is directed to an abstract idea, natural phenomenon, or law + of nature without significantly more, then the burden shifts to the applicant to + either amend the claim or make a showing of why the claim is eligible for patent + protection. + + + + In response to a rejection based on failure to claim + patent-eligible subject matter, applicant may: (i) amend the claim, e.g., to add + additional elements or modify existing elements so that the claim as a whole amounts + to significantly more than the judicial exception, (or integrates the judicial + exception into a practical application), (ii) present persuasive arguments based on a + good faith belief as to why the rejection is in error and/or (iii) submit evidence + traversing a subject matter eligibility rejection according to the procedures set + forth in **[MPEP § + 716.01](s716.html#d0e92469)** and **[37 CFR 1.132](mpep-9020-appx-r.html#d0e323552)**. When evaluating a + response, examiners must carefully consider all of applicant's arguments and evidence + rebutting the subject matter eligibility rejection. If applicant has amended the + claim, examiners should determine the amended claim’s broadest reasonable + interpretation and again perform the subject matter eligibility analysis. + + + +If applicant's claim amendment(s), evidence, and/or + argument(s) persuasively establish that the claim is not directed to a judicial + exception or is directed to significantly more than a judicial exception, the + rejection should be withdrawn. Applicant may argue that a claim is eligible because + the claim as a whole integrates the judicial exception into a practical application + or amounts to significantly more than the judicial exception when the additional + elements are considered both individually and in combination. When an additional + element is considered individually by the examiner, the additional element may be + enough to integrate the judicial exception into a practical application or to qualify + as "significantly more" if it meaningfully limits the judicial exception, + *e.g.,* it improves another technology or technical field, + improves the functioning of a computer itself. + + + +In addition, even if an element does not integrate a + judicial exception into a practical application or amount to significantly more on + its own (*e.g.,* because it is merely a generic computer component + performing generic computer functions), it can still integrate or amount to + significantly more when considered in combination with the other elements of the + claim. For example, generic computer components that individually perform merely + generic computer functions (*e.g.,* a CPU that performs mathematical + calculations or a clock that produces time data) in some instances are able in + combination to perform functions that are not generic computer functions and + therefore integrate or amount to significantly more than an abstract idea (and are + thus eligible). + + + +If applicant properly challenges the examiner's + findings but the examiner deems it appropriate to maintain the rejection, a rebuttal + must be provided in the next Office action. Several examples of appropriate examiner + responses are provided below. + + + +* (1) If applicant challenges the identification of a + tentative abstract idea that was based on a court case and the challenge is not + persuasive, an appropriate response would be an explanation as to why the + abstract idea identified in the claim is similar to the concept in the cited + case. +* (2) If applicant responds to an examiner's assertion + that something is well-known, routine, conventional activity with a specific + argument or evidence that the additional elements in a claim are not + well-understood, routine, conventional activities previously engaged in by + those in the relevant art, the examiner should reevaluate whether the + additional elements are in actuality well-known, routine, conventional + activities to those who work in the relevant field. It is especially necessary + for the examiner to fully reevaluate their position when such additional + elements are not discussed in the specification as being known generic + functions/components/activities or are not treated by the courts as + well-understood, routine, conventional activities. If the rejection is to be + maintained, the examiner should consider whether evidence should be provided to + further support the rejection and clarify the record for appeal. See + **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)** for examples of elements that the + courts have found to be well understood, routine and conventional activity. If + the examiner has taken official notice per item (D) of subsection III above + that an element(s) is well-understood, routine, conventional activity, and the + applicant challenges the examiner's position, specifically stating that such + element(s) is not well-understood, routine, conventional activity, the examiner + must then provide one of the items discussed in paragraphs (A) through (C) of + subsection III above, or an affidavit or declaration under **[37 CFR + 1.104(d)(2)](mpep-9020-appx-r.html#d0e322249)** setting forth specific factual statements and + explanation to support the examiner’s position. See also **[MPEP § + 2106.07(b)](s2106.html#ch2100_d29a1b_14065_2a0)**, item (2). +* (3) If applicant amends a claim to add a generic + computer or generic computer components and asserts that the claim is + integrated into a practical application or recites significantly more because + the generic computer is 'specially programmed' (as in + *Alappat*, now considered superseded) or is a 'particular + machine' (as in *Bilski*), the examiner should look at whether + the added elements integrate the judicial exception into a practical + application or provide significantly more than the judicial exception. Merely + adding a generic computer, generic computer components, or a programmed + computer to perform generic computer functions does not automatically overcome + an eligibility rejection. *Alice Corp. Pty. Ltd. v. CLS Bank + Int'l,* 573 U.S. 208, 224, 110 USPQ2d 1976, 1984 (2014). See also + *OIP Techs. v. Amazon.com,* 788 F.3d 1359, 1364, 115 USPQ2d + 1090, 1093-94 (Fed. Cir. 2015) ("Just as *Diehr* could not + save the claims in *Alice*, which were directed to + ‘implement[ing] the abstract idea of intermediated settlement on a generic + computer’, it cannot save *OIP*'s claims directed to + implementing the abstract idea of price optimization on a generic computer.") + (citations omitted). +* (4) If applicant argues that the claim is specific + and does not preempt all applications of the exception, the examiner should + reconsider Step 2A of the eligibility analysis, *e.g.,* to + determine whether the claim is directed to an improvement to the functioning of + a computer or to any other technology or technical field. If an examiner still + determines that the claim is directed to a judicial exception, the examiner + should then reconsider in Step 2B whether the additional elements in + combination (as well as individually) amount to an inventive concept, + *e.g.,* because they are more than the non-conventional and + non-generic arrangement of known, conventional elements. Such reconsideration + is appropriate because, although preemption is not a standalone test for + eligibility, it remains the underlying concern that drives the two-part + framework from *Alice Corp.* and *Mayo* + (Steps 2A and 2B). *Synopsys, Inc. v. Mentor Graphics Corp.,* + 839 F.3d 1138, 1150, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016); *Rapid + Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d 1042, 1052, 119 USPQ2d + 1370, 1376 (Fed. Cir. 2016); *Ariosa Diagnostics, Inc. v. Sequenom, + Inc.,* 788 F.3d 1371, 1379, 115 USPQ2d 1152, 1158 (Fed. Cir. 2015). + + + + +# 2106.07(c) Clarifying the Record [R-08.2017] + + +When the claims are deemed patent eligible, the + examiner may make clarifying remarks on the record. For example, if a claim is found + eligible because it improves upon existing technology, the examiner could reference + the portion of the specification that describes the claimed improvement and note the + claim elements that produce that improvement. The clarifying remarks may be made at + any point during prosecution as well as with a notice of allowance. + + + +Clarifying remarks may be useful in explaining the + rationale for a rejection as well. For instance, explaining the broadest reasonable + interpretation (BRI) of a claim will assist applicant in understanding and responding + to a rejection. As an example, a rejection for failure to recite patent eligible + subject matter in a claim to a computer readable medium could include an explanation + that the broadest reasonable interpretation of the claim covers a carrier wave, which + does not fall within one of the four categories of invention, and a suggestion to + overcome the rejection by submitting a narrowing amendment to cover the statutory + embodiments. + + + + + +[[top]](#top) + + +, +# 2106.01 [Reserved] + + +, +# 2106.02 [Reserved] + + +, +# 2106.03 Eligibility Step 1: The Four Categories of + Statutory Subject Matter [R-10.2019] + +**I.** **THE FOUR + CATEGORIES****[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** enumerates four + categories of subject matter that Congress deemed to be appropriate subject matter + for a patent: processes, machines, manufactures and compositions of matter. As + explained by the courts, these "four categories together describe the exclusive reach + of patentable subject matter. If a claim covers material not found in any of the four + statutory categories, that claim falls outside the plainly expressed scope of + **[§ + 101](mpep-9015-appx-l.html#d0e302376)** even if the subject matter is otherwise new and useful." + *In re Nuijten,* 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. + Cir. 2007). + + + +A process defines "actions", *i.e.,* + an invention that is claimed as an act or step, or a series of acts or steps. As + explained by the Supreme Court, a "process" is "a mode of treatment of certain + materials to produce a given result. It is an *act, or a series of + acts,* performed upon the subject-matter to be transformed and reduced to + a different state or thing." *Gottschalk v. Benson,* 409 U.S. 63, + 70, 175 USPQ 673, 676 (1972) (italics added) (quoting *Cochrane v. + Deener,* 94 U.S. 780, 788, 24 L. Ed. 139, 141 (1876)). See also + *Nuijten,* 500 F.3d at 1355, 84 USPQ2d at 1501 ("The Supreme + Court and this court have consistently interpreted the statutory term ‘process’ to + require action"); *NTP, Inc. v. Research in Motion, Ltd.,* 418 F.3d + 1282, 1316, 75 USPQ2d 1763, 1791 (Fed. Cir. 2005) ("[A] process is a series of + acts.") (quoting *Minton v. Natl. Ass’n. of Securities Dealers,* 336 + F.3d 1373, 1378, 67 USPQ2d 1614, 1681 (Fed. Cir. 2003)). As defined in + **[35 U.S.C. + 100(b)](mpep-9015-appx-l.html#d0e302350)**, the term "process" is synonymous with "method." + + + +The other three categories (machines, manufactures + and compositions of matter) define the types of physical or tangible "things" or + "products" that Congress deemed appropriate to patent. *Digitech Image Techs. + v. Electronics for Imaging,* 758 F.3d 1344, 1348, 111 USPQ2d 1717, 1719 + (Fed. Cir. 2014) ("For all categories except process claims, the eligible subject + matter must exist in some physical or tangible form."). Thus, when determining + whether a claimed invention falls within one of these three categories, examiners + should verify that the invention is to at least one of the following categories + **and** is claimed in a physical or tangible form. + + + +* • A machine is a "concrete thing, consisting of + parts, or of certain devices and combination of devices." + *Digitech,* 758 F.3d at 1348-49, 111 USPQ2d at 1719 + (quoting *Burr v. Duryee,* 68 U.S. 531, 570, 17 L. Ed. 650, + 657 (1863)). This category "includes every mechanical device or combination of + mechanical powers and devices to perform some function and produce a certain + effect or result." *Nuijten,* 500 F.3d at 1355, 84 USPQ2d at + 1501 (quoting *Corning v. Burden,* 56 U.S. 252, 267, 14 L. Ed. + 683, 690 (1854)). +* • A manufacture is "a tangible article that is + given a new form, quality, property, or combination through man-made or + artificial means." *Digitech,* 758 F.3d at 1349, 111 USPQ2d at + 1719-20 (citing *Diamond v. Chakrabarty,* 447 U.S. 303, 308, + 206 USPQ 193, 197 (1980)). As the courts have explained, manufactures are + articles that result from the process of manufacturing, + *i.e.,* they were produced "from raw or prepared materials + by giving to these materials new forms, qualities, properties, or combinations, + whether by hand-labor or by machinery." *Samsung Electronics Co. v. + Apple Inc.,* 580 U.S. \_\_, 120 USPQ2d 1749, 1752-3 (2016) (quoting + *Diamond v. Chakrabarty,* 447 U. S. 303, 308, 206 USPQ 193, + 196-97 (1980)); *Nuijten,* 500 F.3d at 1356-57, 84 USPQ2d at + 1502. Manufactures also include "the parts of a machine considered separately + from the machine itself." *Samsung Electronics,* 137 S. Ct. at + 435, 120 USPQ2d at 1753 (quoting 1 W. Robinson, The Law of Patents for Useful + Inventions §183, p. 270 (1890)). +* • A composition of matter is a "combination of + two or more substances and includes all composite articles." + *Digitech,* 758 F.3d at 1348-49, 111 USPQ2d at 1719 + (citation omitted). This category includes all compositions of two or more + substances and all composite articles, "'whether they be the results of + chemical union or of mechanical mixture, or whether they be gases, fluids, + powders or solids.'" *Chakrabarty,* 447 U.S. at 308, 206 USPQ + at 197 (quoting *Shell Dev. Co. v. Watson,* 149 F. Supp. 279, + 280 (D.D.C. 1957); *id.* at 310 holding genetically modified + microorganism to be a manufacture or composition of matter). + + +It is not necessary to identify a single category into + which a claim falls, so long as it is clear that the claim falls into at least one + category. For example, because a microprocessor is generally understood to be a + manufacture, a product claim to the microprocessor or a system comprising the + microprocessor satisfies Step 1 regardless of whether the claim falls within any + other statutory category (such as a machine). It is also not necessary to identify a + "correct" category into which the claim falls, because although in many instances it + is clear within which category a claimed invention falls, a claim may satisfy the + requirements of more than one category. For example, a bicycle satisfies both the + machine and manufacture categories, because it is a tangible product that is concrete + and consists of parts such as a frame and wheels (thus satisfying the machine + category), and it is an article that was produced from raw materials such as aluminum + ore and liquid rubber by giving them a new form (thus satisfying the manufacture + category). Similarly, a genetically modified bacterium satisfies both the composition + of matter and manufacture categories, because it is a tangible product that is a + combination of two or more substances such as proteins, carbohydrates and other + chemicals (thus satisfying the composition of matter category), and it is an article + that was genetically modified by humans to have new properties such as the ability to + digest multiple types of hydrocarbons (thus satisfying the manufacture category). + + + +Non-limiting examples of claims that are not directed + to any of the statutory categories include: + + + +* • Products that do not have a physical or + tangible form, such as information (often referred to as "data per se") or a + computer program per se (often referred to as "software per se") when claimed + as a product without any structural recitations; +* • Transitory forms of signal transmission + (often referred to as "signals per se"), such as a propagating electrical or + electromagnetic signal or carrier wave; and +* • Subject matter that the statute expressly + prohibits from being patented, such as humans per se, which are excluded under + The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33, 125 + Stat. 284 (September 16, 2011). + + +As the courts' definitions of machines, manufactures + and compositions of matter indicate, a product must have a physical or tangible form + in order to fall within one of these statutory categories. + *Digitech,* 758 F.3d at 1348, 111 USPQ2d at 1719. Thus, the + Federal Circuit has held that a product claim to an intangible collection of + information, even if created by human effort, does not fall within any statutory + category. *Digitech,* 758 F.3d at 1350, 111 USPQ2d at 1720 (claimed + "device profile" comprising two sets of data did not meet any of the categories + because it was neither a process nor a tangible product). Similarly, software + expressed as code or a set of instructions detached from any medium is an idea + without physical embodiment. See *Microsoft Corp. v. AT&T + Corp.,* 550 U.S. 437, 449, 82 USPQ2d 1400, 1407 (2007); see also + *Benson,* 409 U.S. 67, 175 USPQ2d 675 (An "idea" is not patent + eligible). Thus, a product claim to a software program that does not also contain at + least one structural limitation (such as a "means plus function" limitation) has no + physical or tangible form, and thus does not fall within any statutory category. + Another example of an intangible product that does not fall within a statutory + category is a paradigm or business model for a marketing company. *In re + Ferguson,* 558 F.3d 1359, 1364, 90 USPQ2d 1035, 1039-40 (Fed. Cir. 2009). + + + +Even when a product has a physical or tangible form, + it may not fall within a statutory category. For instance, a transitory signal, while + physical and real, does not possess concrete structure that would qualify as a device + or part under the definition of a machine, is not a tangible article or commodity + under the definition of a manufacture (even though it is man-made and physical in + that it exists in the real world and has tangible causes and effects), and is not + composed of matter such that it would qualify as a composition of matter. + *Nuijten,* 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03. As such, + a transitory, propagating signal does not fall within any statutory category. + *Mentor Graphics Corp. v. EVE-USA, Inc.,* 851 F.3d 1275, 1294, + 112 USPQ2d 1120, 1133 (Fed. Cir. 2017); *Nuijten,* 500 F.3d at + 1356-1357, 84 USPQ2d at 1501-03. + + +**II.** **ELIGIBILITY STEP 1: WHETHER A CLAIM + IS TO A STATUTORY CATEGORY**As described in **[MPEP § 2106](s2106.html#d0e197244)**, + subsection III, Step 1 of the eligibility analysis asks: Is the claim to a process, + machine, manufacture or composition of matter? Like the other steps in the + eligibility analysis, evaluation of this step should be made after determining what + applicant has invented by reviewing the entire application disclosure and construing + the claims in accordance with their broadest reasonable interpretation (BRI). See + **[MPEP § + 2106](s2106.html#d0e197244)**, subsection II, for more information about the + importance of understanding what the applicant has invented, and + **[MPEP § + 2111](s2111.html#d0e200352)** for more information about the BRI. + + + +In the context of the flowchart in + **[MPEP § + 2106](s2106.html#d0e197244)**, subsection III, Step 1 determines whether: + + + +* • The claim as a whole does not fall within any + statutory category (Step 1: NO) and thus is non-statutory, warranting a + rejection for failure to claim statutory subject matter; or +* • The claim as a whole falls within one or + more statutory categories (Step 1: YES), and thus must be further analyzed to + determine whether it qualifies as eligible at Pathway A or requires further + analysis at Step 2A to determine if the claim is directed to a judicial + exception. + + +A claim whose BRI covers both statutory and + non-statutory embodiments embraces subject matter that is not eligible for patent + protection and therefore is directed to non-statutory subject matter. Such claims + fail the first step (Step 1: NO) and should be rejected under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**, + for at least this reason. In such a case, it is a best practice for the examiner to + point out the BRI and recommend an amendment, if possible, that would narrow the + claim to those embodiments that fall within a statutory category. + + + +For example, the BRI of machine readable media can + encompass non-statutory transitory forms of signal transmission, such as a + propagating electrical or electromagnetic signal per se. See *In re + Nuijten,* 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the BRI + encompasses transitory forms of signal transmission, a rejection under + **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)** as failing to claim statutory subject matter would be + appropriate. Thus, a claim to a computer readable medium that can be a compact disc + or a carrier wave covers a non-statutory embodiment and therefore should be rejected + under **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)** as being directed to non-statutory subject matter. See, + *e.g., Mentor Graphics v. EVE-USA, Inc.,* 851 F.3d at 1294-95, + 112 USPQ2d at 1134 (claims to a "machine-readable medium" were non-statutory, because + their scope encompassed both statutory random-access memory and non-statutory carrier + waves). + + + +If a claim is clearly not within one of the four + categories (Step 1: NO), then a rejection under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** must be made + indicating that the claim is directed to non-statutory subject matter. Form + paragraphs **[7.05](#fp7.05)** and **[7.05.01](#fp7.05.01)** should be used; see + **[MPEP + § 2106.07(a)(1)](s2106.html#ch2100_d2c183_20b8d_1b9)**. However, as shown in the flowchart in + **[MPEP § + 2106](s2106.html#d0e197244)** subsection III, when a claim fails under Step 1 (Step + 1: NO), but it appears from applicant’s disclosure that the claim could be amended to + fall within a statutory category (Step 1: YES), the analysis should proceed to + determine whether such an amended claim would qualify as eligible at Pathway A, B or + C. In such a case, it is a best practice for the examiner to recommend an amendment, + if possible, that would resolve eligibility of the claim. + + + +, +# 2106.04 Eligibility Step 2A: Whether a Claim is Directed + to a Judicial Exception [R-10.2019] + +**I.** **JUDICIAL EXCEPTIONS**Determining that a claim falls within one of the four + enumerated categories of patentable subject matter recited in **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** + (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not + end the eligibility analysis, because claims directed to nothing more than abstract + ideas (such as a mathematical formula or equation), natural phenomena, and laws of + nature are not eligible for patent protection. *Diamond v. Diehr,* + 450 U.S. 175, 185, 209 USPQ 1, 7 (1981). *Alice Corp. Pty. Ltd. v. CLS Bank + Int'l,* 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing + *Association for Molecular Pathology v. Myriad Genetics, Inc.,* + 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013)); *Diamond v. + Chakrabarty,* 447 U.S. 303, 309, 206 USPQ 193, 197 (1980); + *Parker v. Flook,* 437 U.S. 584, 589, 198 USPQ 193, 197 (1978); + *Gottschalk v. Benson,* 409 U.S. 63, 67-68, 175 USPQ 673, 675 + (1972). See also *Bilski v. Kappos,* 561 U.S. 593, 601, 95 USPQ2d + 1001, 1005-06 (2010) ("The Court’s precedents provide three specific exceptions to + **[§ + 101's](mpep-9015-appx-l.html#d0e302376)** broad patent-eligibility principles: ‘laws of nature, + physical phenomena, and abstract ideas’") (quoting *Chakrabarty,* + 447 U.S. at 309, 206 USPQ at 197 (1980)). + + + +In addition to the terms "laws of nature," "natural + phenomena," and "abstract ideas," judicially recognized exceptions have been + described using various other terms, including "physical phenomena," "products of + nature," "scientific principles," "systems that depend on human intelligence alone," + "disembodied concepts," "mental processes," and "disembodied mathematical algorithms + and formulas." It should be noted that there are no bright lines between the types of + exceptions, and that many of the concepts identified by the courts as exceptions can + fall under several exceptions. For example, mathematical formulas are considered to + be a judicial exception as they express a scientific truth, but have been labelled by + the courts as both abstract ideas and laws of nature. Likewise, "products of nature" + are considered to be an exception because they tie up the use of naturally occurring + things, but have been labelled as both laws of nature and natural phenomena. Thus, it + is sufficient for this analysis for the examiner to identify that the claimed concept + (the specific claim limitation(s) that the examiner believes may recite an exception) + aligns with at least one judicial exception. + + + +The Supreme Court has explained that the judicial + exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural + phenomena are "the basic tools of scientific and technological work", and are thus + excluded from patentability because "monopolization of those tools through the grant + of a patent might tend to impede innovation more than it would tend to promote it." + *Alice Corp.,* 573 U.S. at 216, 110 USPQ2d at 1980 (quoting + *Myriad,* 569 U.S. at 589, 106 USPQ2d at 1978 and *Mayo + Collaborative Servs. v. Prometheus Labs. Inc.,* 566 U.S. 66, 71, 101 + USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary + principle" is pre-emption. *Alice Corp.,* 573 U.S. at 216, 110 + USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws + of nature, or natural phenomena, even if the judicial exception is narrow (e.g., a + particular mathematical formula such as the Arrhenius equation). See, *e.g., + Mayo,* 566 U.S. at 79-80, 86-87, 101 USPQ2d at 1968-69, 1971 (claims + directed to "narrow laws that may have limited applications" held ineligible); + *Flook,* 437 U.S. at 589-90, 198 USPQ at 197 (claims that did not + "wholly preempt the mathematical formula" held ineligible). This is because such a + patent would "in practical effect [] be a patent on the [abstract idea, law of nature + or natural phenomenon] itself." *Benson,* 409 U.S. at 71- 72, 175 + USPQ at 676. The concern over preemption was expressed as early as 1852. See + *Le Roy v. Tatham,* 55 U.S. (14 How.) 156, 175 (1852) ("A + principle, in the abstract, is a fundamental truth; an original cause; a motive; + these cannot be patented, as no one can claim in either of them an exclusive + right."). + + + +While preemption is the concern underlying the + judicial exceptions, it is not a standalone test for determining eligibility. + *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d 1042, 1052, + 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent + in and resolved by the two-part framework from *Alice Corp. and + Mayo* (the *Alice/Mayo* test referred to by the Office + as Steps 2A and 2B). *Synopsys, Inc. v. Mentor Graphics Corp.,* 839 + F.3d 1138, 1150, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016); *Ariosa Diagnostics, + Inc. v. Sequenom, Inc.,* 788 F.3d 1371, 1379, 115 USPQ2d 1152, 1158 (Fed. + Cir. 2015). It is necessary to evaluate eligibility using the + *Alice/Mayo* test, because while a preemptive claim may be + ineligible, the absence of complete preemption does not demonstrate that a claim is + eligible. *Diamond v. Diehr,* 450 U.S. 175, 191-92 n.14, 209 USPQ 1, + 10-11 n.14 (1981) ("We rejected in *Flook* the argument that because + all possible uses of the mathematical formula were not pre-empted, the claim should + be eligible for patent protection"). See also *Synopsys v. Mentor + Graphics,* 839 F.3d at 1150, 120 USPQ2d at 1483; *FairWarning IP, + LLC v. Iatric Sys., Inc.,* 839 F.3d 1089, 1098, 120 USPQ2d 1293, 1299 + (Fed. Cir. 2016); *Intellectual Ventures I LLC v. Symantec Corp.,* + 838 F.3d 1307, 1320-21, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); + *Sequenom,* 788 F.3d at 1379, 115 USPQ2d at 1158. Several Federal + Circuit decisions, however, have noted the absence of preemption when finding claims + eligible under the *Alice/Mayo* test. *McRO, Inc. v. Bandai + Namco Games Am. Inc.,* 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-03 + (Fed. Cir. 2016); *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 + F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016); *BASCOM Global + Internet v. AT&T Mobility, LLC,* 827 F.3d 1341, 1350-52, 119 USPQ2d + 1236, 1243-44 (Fed. Cir. 2016). + + + +The Supreme Court’s decisions make it clear that + judicial exceptions need not be old or long-prevalent, and that even newly discovered + or novel judicial exceptions are still exceptions. For example, the mathematical + formula in *Flook,* the laws of nature in *Mayo,* + and the isolated DNA in *Myriad* were all novel or newly discovered, + but nonetheless were considered by the Supreme Court to be judicial exceptions + because they were "‘basic tools of scientific and technological work’ that lie beyond + the domain of patent protection." *Myriad,* 569 U.S. 576, 589, 106 + USPQ2d at 1976, 1978 (noting that *Myriad* discovered the BRCA1 and + BRCA1 genes and quoting *Mayo,* 566 U.S. 71, 101 USPQ2d at 1965); + *Flook,* 437 U.S. at 591-92, 198 USPQ2d at 198 ("the novelty of + the mathematical algorithm is not a determining factor at all"); + *Mayo,* 566 U.S. 73-74, 78, 101 USPQ2d 1966, 1968 (noting that + the claims embody the researcher's discoveries of laws of nature). The Supreme + Court’s cited rationale for considering even "just discovered" judicial exceptions as + exceptions stems from the concern that "without this exception, there would be + considerable danger that the grant of patents would ‘tie up’ the use of such tools + and thereby ‘inhibit future innovation premised upon them.’" + *Myriad,* 569 U.S. at 589, 106 USPQ2d at 1978-79 (quoting + *Mayo,* 566 U.S. at 86, 101 USPQ2d at 1971). See also + *Myriad,* 569 U.S. at 591, 106 USPQ2d at 1979 ("Groundbreaking, + innovative, or even brilliant discovery does not by itself satisfy the + **[§101](mpep-9015-appx-l.html#d0e302376)** inquiry."). The Federal Circuit has also applied this + principle, for example, when holding a concept of using advertising as an exchange or + currency to be an abstract idea, despite the patentee’s arguments that the concept + was "new". *Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, 714-15, + 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). *Cf. Synopsys, Inc. v. Mentor + Graphics Corp.,* 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. + 2016) ("a ***new*** abstract idea is still an abstract + idea") (emphasis in original). + + + + For a detailed discussion of abstract ideas, see + **[MPEP + § 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**; for a detailed discussion of laws of nature, + natural phenomena and products of nature, see **[MPEP § + 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)**. + + +**II.** **ELIGIBILITY STEP 2A: WHETHER A CLAIM + IS DIRECTED TO A JUDICIAL EXCEPTION**As described in **[MPEP § 2106](s2106.html#d0e197244)**, + subsection III, Step 2A of the Office’s eligibility analysis is the first part of the + *Alice/Mayo* test, *i.e.,* the Supreme Court’s + "framework for distinguishing patents that claim laws of nature, natural phenomena, + and abstract ideas from those that claim patent-eligible applications of those + concepts." *Alice Corp. Pty. Ltd. v. CLS Bank Int'l,* 573 U.S. 208, + 217-18, 110 USPQ2d 1976, 1981 (2014) (citing *Mayo,* 566 U.S. at + 77-78, 101 USPQ2d at 1967-68). Like the other steps in the eligibility analysis, + evaluation of this step should be made after determining what applicant has invented + by reviewing the entire application disclosure and construing the claims in + accordance with their broadest reasonable interpretation. See **[MPEP § 2106](s2106.html#d0e197244)**, + subsection II for more information about the importance of understanding what the + applicant has invented, and **[MPEP § 2111](s2111.html#d0e200352)** for more information + about the broadest reasonable interpretation. + + + +Step 2A asks: Is the claim directed to a law of + nature, a natural phenomenon (product of nature) or an abstract idea? In the context + of the flowchart in **[MPEP § 2106](s2106.html#d0e197244)**, subsection III, Step 2A determines whether: + + + +* • The claim as a whole is not directed to a + judicial exception (Step 2A: NO) and thus is eligible at Pathway B, thereby + concluding the eligibility analysis; or +* • The claim as a whole is directed to a + judicial exception (Step 2A: YES) and thus requires further analysis at Step 2B + to determine if the claim as a whole amounts to significantly more than the + exception itself. + +**A.*****Step 2A Is a Two Prong Inquiry***Step 2A is a two-prong inquiry, in which examiners + determine in Prong One whether a claim recites a judicial exception, and if so, then + determine in Prong Two if the recited judicial exception is integrated into a + practical application of that exception. Together, these prongs represent the first + part of the *Alice/Mayo* test, which determines whether a claim is + directed to a judicial exception. + + + +The flowchart below depicts the two-prong analysis + that is performed in order to answer the Step 2A inquiry. + + + +![Subject Matter Eligibility Flowchart](graphics/210604_step_2a.png)**1.** **Prong One**Prong One asks does the claim recite an abstract + idea, law of nature, or natural phenomenon? In Prong One examiners evaluate + whether the claim recites a judicial exception, i.e. whether a law of nature, + natural phenomenon, or abstract idea is **set forth** or + **described** in the claim. While the terms "set forth" and + "described" are thus both equated with "recite", their different language is + intended to indicate that there are two ways in which an exception can be recited + in a claim. For instance, the claims in *Diehr,* 450 U.S. at 178 + n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical + equation in the repetitively calculating step, and the claims in + *Mayo,* 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), + clearly stated laws of nature in the wherein clause, such that the claims "set + forth" an identifiable judicial exception. Alternatively, the claims in + *Alice Corp.,* 573 U.S. at 218, 110 USPQ2d at 1982, described + the concept of intermediated settlement without ever explicitly using the words + "intermediated" or "settlement." + + + +The Supreme Court has held that Section 101 + contains an implicit exception for ‘‘[l]aws of nature, natural phenomena, and + abstract ideas,’’ which are ‘‘the basic tools of scientific and technological + work.’’ *Alice Corp.,* 573 U.S. at 216, 110 USPQ2d at 1980 + (citing *Mayo,* 566 US at 71, 101 USPQ2d at 1965). Yet, the Court + has explained that ‘‘[a]t some level, all inventions embody, use, reflect, rest + upon, or apply laws of nature, natural phenomena, or abstract ideas,’’ and has + cautioned ‘‘to tread carefully in construing this exclusionary principle lest it + swallow all of patent law.’’ *Id.* See also *Enfish, LLC + v. Microsoft Corp.,* 822 F.3d 1327, 1335, 118 USPQ2d 1684, 1688 (Fed. + Cir. 2016) ("The ‘directed to’ inquiry, therefore, cannot simply ask whether the + claims involve a patent-ineligible concept, because essentially every routinely + patent-eligible claim involving physical products and actions involves a law of + nature and/or natural phenomenon"). Examiners should accordingly be careful to + distinguish claims that **recite** an exception (which require further + eligibility analysis) and claims that merely **involve** an exception + (which are eligible and do not require further eligibility analysis). + + + +An example of a claim that recites a judicial + exception is "A machine comprising elements that operate in accordance with F=ma." + This claim sets forth the principle that force equals mass times acceleration + (F=ma) and therefore recites a law of nature exception. Because F=ma represents a + mathematical formula, the claim could alternatively be considered as reciting an + abstract idea. Because this claim recites a judicial exception, it requires + further analysis in Prong Two in order to answer the Step 2A inquiry. An example + of a claim that merely involves, or is based on, an exception is a claim to "A + teeter-totter comprising an elongated member pivotably attached to a base member, + having seats and handles attached at opposing sides of the elongated member." This + claim is based on the concept of a lever pivoting on a fulcrum, which involves the + natural principles of mechanical advantage and the law of the lever. However, this + claim does not recite these natural principles and therefore is not directed to a + judicial exception (Step 2A: NO). Thus, the claim is eligible at Pathway B without + further analysis. + + + +If the claim recites a judicial exception + (*i.e.,* an abstract idea enumerated in **[MPEP § + 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**, a law of nature, or a natural phenomenon), + the claim requires further analysis in Prong Two. If the claim does not recite a + judicial exception (a law of nature, natural phenomenon, or abstract idea), then + the claim cannot be directed to a judicial exception (Step 2A: NO), and thus the + claim is eligible at Pathway B without further analysis. + + + +For more information how to determine if a claim + recites an abstract idea, see **[MPEP § + 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**. For more information on how to determine if + a claim recites a law of nature or natural phenomenon, see **[MPEP § + 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)**. For more information on how to determine if + a claim recites a product of nature, see **[MPEP § + 2106.04(c)](s2106.html#ch2100_d29a1b_13bc1_b1)**. + + +**2.** **Prong Two**Prong Two asks does the claim recite additional + elements that integrate the judicial exception into a practical application? In + Prong Two, examiners evaluate whether the claim as a whole integrates the + exception into a practical application of that exception. If the additional + elements in the claim integrate the recited exception into a practical application + of the exception, then the claim is not directed to the judicial exception (Step + 2A: NO) and thus is eligible at Pathway B. This concludes the eligibility + analysis. If, however, the additional elements do not integrate the exception into + a practical application, then the claim is directed to the recited judicial + exception (Step 2A: YES), and requires further analysis under Step 2B (where it + may still be eligible if it amounts to an ‘‘inventive concept’’). For more + information on how to evaluate whether a judicial exception is integrated into a + practical application, see **[MPEP § 2106.04(d)(2)](s2106.html#ch2100_d2e827_17196_6c)**. + + + +The mere inclusion of a judicial exception such as + a mathematical formula (which is one of the mathematical concepts identified as an + abstract idea in **[MPEP § 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**) in a claim + means that the claim "recites" a judicial exception under Step 2A Prong One. + However, mere recitation of a judicial exception does not mean that the claim is + "directed to" that judicial exception under Step 2A Prong Two. Instead, under + Prong Two, a claim that recites a judicial exception is not directed to that + judicial exception, if the claim as a whole integrates the recited judicial + exception into a practical application of that exception. Prong Two thus + distinguishes claims that are "directed to" the recited judicial exception from + claims that are not "directed to" the recited judicial exception. + + + +Because a judicial exception is not eligible + subject matter, *Bilski,* 561 U.S. at 601, 95 USPQ2d at 1005-06 + (quoting *Chakrabarty,* 447 U.S. at 309, 206 USPQ at 197 (1980)), + if there are no additional claim elements besides the judicial exception, or if + the additional claim elements merely recite another judicial exception, that is + insufficient to integrate the judicial exception into a practical application. + See, *e.g., RecogniCorp, LLC v. Nintendo Co.,* 855 F.3d 1322, + 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to + another abstract idea (encoding and decoding) does not render the claim + non-abstract"); *Genetic Techs. v. Merial LLC,* 818 F.3d 1369, + 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by + the unpatentable law of nature (or natural phenomenon or abstract idea) itself."). + For a claim reciting a judicial exception to be eligible, the additional elements + (if any) in the claim must "transform the nature of the claim" into a + patent-eligible application of the judicial exception, *Alice + Corp.,* 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in + Step 2B. If there are no additional elements in the claim, then it cannot be + eligible. In such a case, after making the appropriate rejection (see + **[MPEP § 2106.07](s2106.html#ch2100_d29a1b_13fb7_330)** for more information on formulating a + rejection for lack of eligibility), it is a best practice for the examiner to + recommend an amendment, if possible, that would resolve eligibility of the claim. + + + +**B.*****Evaluating Claims Reciting Multiple Judicial + Exceptions***A claim may recite multiple judicial exceptions. + For example, claim 4 at issue in *Bilski v. Kappos,* 561 U.S. + 593, 95 USPQ2d 1001 (2010) recited two abstract ideas, and the claims at issue in + *Mayo Collaborative Servs. v. Prometheus Labs. Inc.,* 566 U.S. + 66, 101 USPQ2d 1961 (2012) recited two laws of nature. However, these claims were + analyzed by the Supreme Court in the same manner as claims reciting a single + judicial exception, such as those in *Alice Corp.,* 573 U.S. 208, + 110 USPQ2d 1976. + + + +During examination, examiners should apply the + same eligibility analysis to all claims regardless of the number of exceptions + recited therein. Unless it is clear that a claim recites distinct exceptions, such + as a law of nature and an abstract idea, care should be taken not to parse the + claim into multiple exceptions, particularly in claims involving abstract ideas. + Accordingly, if possible examiners should treat the claim for Prong Two and Step + 2B purposes as containing a single judicial exception. + + + +In some claims, the multiple exceptions are + distinct from each other, *e.g.,* a first limitation describes a + law of nature, and a second limitation elsewhere in the claim recites an abstract + idea. In these cases, for purposes of examination efficiency, examiners should + select one of the exceptions and conduct the eligibility analysis for that + selected exception. If the analysis indicates that the claim recites an additional + element or combination of elements that integrate the selected exception into a + practical application or that amount to significantly more than the selected + exception, then the claim should be considered patent eligible. On the other hand, + if the claim does not recite any additional element or combination of elements + that integrate the selected exception into a practical application, and also does + not recite any additional element or combination of elements that amounts to + significantly more than the selected exception, then the claim should be + considered ineligible. *University of Utah Research Foundation v. Ambry + Genetics,* 774 F.3d 755, 762, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014) + (because claims did not amount to significantly more than the recited abstract + idea, court "need not decide" if claims also recited a law of nature). + + + +In other claims, multiple abstract ideas, which + may fall in the same or different groupings, or multiple laws of nature may be + recited. In these cases, examiners should not parse the claim. For example, in a + claim that includes a series of steps that recite mental steps as well as a + mathematical calculation, an examiner should identify the claim as reciting both a + mental process and a mathematical concept for Step 2A Prong One to make the + analysis clear on the record. However, if possible, the examiner should consider + the limitations together as a single abstract idea for Step 2A Prong Two and Step + 2B (if necessary) rather than as a plurality of separate abstract ideas to be + analyzed individually. + + + + +# 2106.04(a) Abstract Ideas [R-10.2019] + + +The abstract idea exception has deep roots in the + Supreme Court’s jurisprudence. See *Bilski v. Kappos,* 561 U.S. 593, + 601-602, 95 USPQ2d 1001, 1006 (2010) (citing *Le Roy v. Tatham,* 55 + U.S. (14 How.) 156, 174–175 (1853)). Despite this long history, the courts have + declined to define abstract ideas. However, it is clear from the body of judicial + precedent that software and business methods are not excluded categories of subject + matter. For example, the Supreme Court concluded that business methods are not + "categorically outside of **[§ 101's](mpep-9015-appx-l.html#d0e302376)** scope," stating that "a + business method is simply one kind of ‘method’ that is, at least in some + circumstances, eligible for patenting under **[§ 101](mpep-9015-appx-l.html#d0e302376)**." + *Bilski,* 561 U.S. at 607, 95 USPQ2d at 1008 (2010). See also + *Content Extraction and Transmission, LLC v. Wells Fargo Bank,* + 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357 (Fed. Cir. 2014) ("there is no categorical + business-method exception"). Likewise, software is not automatically an abstract + idea, even if performance of a software task involves an underlying mathematical + calculation or relationship. See, *e.g., Thales Visionix, Inc. v. United + States,* 850 F.3d 1343, 121 USPQ2d 1898, 1902 ("That a mathematical + equation is required to complete the claimed method and system does not doom the + claims to abstraction."); *McRO, Inc. v. Bandai Namco Games Am. + Inc.,* 837 F.3d 1299, 1316, 120 USPQ2d 1091, 1103 (Fed. Cir. 2016) + (methods of automatic lip synchronization and facial expression animation using + computer-implemented rules were not directed to an abstract idea); *Enfish,* 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016) (claims to + self-referential table for a computer database were not directed to an abstract + idea). + + + +To facilitate examination, the Office has set forth an + approach to identifying abstract ideas that distills the relevant case law into + enumerated groupings of abstract ideas. The enumerated groupings are firmly rooted in + Supreme Court precedent as well as Federal Circuit decisions interpreting that + precedent, as is explained in **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**. This approach + represents a shift from the former case-comparison approach that required examiners + to rely on individual judicial cases when determining whether a claim recites an + abstract idea. By grouping the abstract ideas, the examiners’ focus has been shifted + from relying on individual cases to generally applying the wide body of case law + spanning all technologies and claim types. + + + +The enumerated groupings of abstract ideas are + defined as: + + + +* 1) Mathematical concepts – mathematical + relationships, mathematical formulas or equations, mathematical calculations + (see **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, + subsection I); +* 2) Certain methods of organizing human activity – + fundamental economic principles or practices (including hedging, insurance, + mitigating risk); commercial or legal interactions (including agreements in the + form of contracts; legal obligations; advertising, marketing or sales + activities or behaviors; business relations); managing personal behavior or + relationships or interactions between people (including social activities, + teaching, and following rules or instructions) (see **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, subsection II); and +* 3) Mental processes – concepts performed in the + human mind (including an observation, evaluation, judgment, opinion) (see + **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, subsection III). + + +Examiners should determine whether a claim recites an + abstract idea by (1) identifying the specific limitation(s) in the claim under + examination that the examiner believes recites an abstract idea, and (2) determining + whether the identified limitations(s) fall within at least one of the groupings of + abstract ideas listed above. The groupings of abstract ideas, and their relationship + to the body of judicial precedent, are further discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**. + + + +If the identified limitation(s) falls within at least + one of the groupings of abstract ideas, it is reasonable to conclude that the claim + recites an abstract idea in Step 2A Prong One. The claim then requires further + analysis in Step 2A Prong Two, to determine whether any additional elements in the + claim integrate the abstract idea into a practical application, see + **[MPEP + § 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)**. + + + +If the identified limitation(s) do not fall within + any of the groupings of abstract ideas, it is reasonable to find that the claim does + not recite an abstract idea. This concludes the abstract idea judicial exception + eligibility analysis, except in the rare circumstance discussed in 2106.04(a)(3), + below. The claim is thus eligible at Pathway B unless the claim recites, and is + directed to, another exception (such as a law of nature or natural phenomenon). + + + +If the claims recites another judicial exception (i.e. + law of nature or natural phenomenon), see **[MPEP §§ + 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)** and **[2106.04(c)](s2106.html#ch2100_d29a1b_13bc1_b1)** for more information on Step 2A analysis. + + + +**[MPEP § 2106.04(a)(1)](s2106.html#ch2100_d29a1b_13b3e_21)** provides + examples of claims that do not recite abstract ideas (or other judicial exceptions) + and thus are eligible at Step 2A Prong One. + + + +**[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** provides + further explanation on the abstract idea groupings. It should be noted that these + groupings are not mutually exclusive, i.e., some claims recite limitations that fall + within more than one grouping or sub-grouping. For example, a claim reciting + performing mathematical calculations using a formula that could be practically + performed in the human mind may be considered to fall within the mathematical + concepts grouping and the mental process grouping. Accordingly, examiners should + identify at least one abstract idea grouping, but preferably identify all groupings + to the extent possible, if a claim limitation(s) is determined to fall within + multiple groupings and proceed with the analysis in Step 2A Prong Two. + + + + +# 2106.04(a)(1) Examples of Claims That Do Not Recite + Abstract Ideas [R-10.2019] + + +When evaluating a claim to determine whether it + recites an abstract idea, examiners should keep in mind that while "all inventions + at some level embody, use, reflect, rest upon, or apply laws of nature, natural + phenomenon, or abstract ideas", not all claims recite an abstract idea. See + *Alice Corp. Pty. Ltd. v. CLS Bank, Int’l,* 573 U.S. 208, 217, + 110 USPQ2d 1976, 1980-81 (2014) (citing *Mayo Collaborative Servs. v. + Prometheus Labs. Inc.,* 566 US 66, 71, 101 USPQ2d 1961, 1965 (2012)). + The Step 2A Prong One analysis articulated in **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)** accounts for this cautionary principle by + requiring a claim to recite (*i.e.,* set forth or describe) an + abstract idea in Prong One before proceeding to the Prong Two inquiry about + whether the claim is directed to that idea, thereby separating claims reciting + abstract ideas from those that are merely based on or involve an abstract + idea. + + + +Some claims are not directed to an abstract idea + because they do not recite an abstract idea, although it may be apparent that at + some level they are based on or involve an abstract idea. Because these claims do + not recite an abstract idea (or other judicial exception), they are eligible at + Step 2A Prong One (Pathway B). + + + +Non-limiting hypothetical examples of claims that + do not recite (set forth or describe) an abstract idea include: + + + +* i. a printer comprising a belt, a roller, a + printhead and at least one ink cartridge; +* ii. a washing machine comprising a tub, a drive + motor operatively connected to the tub, a controller for controlling the + drive motor, and a housing for containing the tub, drive motor, and + controller; +* iii. an earring comprising a sensor for taking + periodic blood glucose measurements and a memory for storing measurement + data from the sensor; +* iv. a method for sequencing BRCA1 gene sequences + comprising: amplifying by a polymerization chain reaction technique all or + part of a BRCA1 gene from a tissue sample from a human subject using a set + of primers to produce amplified nucleic acids; and sequencing the amplified + nucleic acids; and +* v. a method for loading BIOS into a local + computer system which has a system processor and volatile memory and + non-volatile memory, the method comprising the steps of: responding to + powering up of the local computer system by requesting from a memory + location remote from the local computer system the transfer to and storage + in the volatile memory of the local computer system of BIOS configured for + effective use of the local computer system, transferring and storing such + BIOS, and transferring control of the local computer system to such + BIOS; +* vi. a method of rearranging icons on a graphical + user interface (GUI) comprising the steps of: receiving a user selection to + organize each icon based on the amount of use of each icon, determining the + amount of use of each icon by using a processor to track the amount of + memory allocated to the application associated with the icon over a period + of time, and automatically moving the most used icons to a position in the + GUI closest to the start icon of the computer system based on the determined + amount of use; and +* vii. a method of training a neural network for + facial detection comprising: collecting a set of digital facial images, + applying one or more transformations to the digital images, creating a first + training set including the modified set of digital facial images; training + the neural network in a first stage using the first training set, creating a + second training set including digital non-facial images that are incorrectly + detected as facial images in the first stage of training; and training the + neural network in a second stage using the second training set. + + + + +# 2106.04(a)(2) Abstract Idea Groupings [R-10.2019] + +**I.** **MATHEMATICAL + CONCEPTS**The mathematical concepts grouping is defined + as mathematical relationships, mathematical formulas or equations, and + mathematical calculations. The Supreme Court has identified a number of + concepts falling within this grouping as abstract ideas including: a procedure + for converting binary-coded decimal numerals into pure binary form, + *Gottschalk v. Benson,* 409 U.S. 63, 65, 175 USPQ2d 673, + 674 (1972); a mathematical formula for calculating an alarm limit, + *Parker v. Flook,* 437 U.S. 584, 588-89, 198 USPQ2d 193, + 195 (1978); the Arrhenius equation, *Diamond v. Diehr,* 450 + U.S. 175, 191, 209 USPQ 1, 15 (1981); and a mathematical formula for hedging, + *Bilski v. Kappos,* 561 U.S. 593, 611, 95 USPQ 2d 1001, + 1004 (2010). + + + +The Court’s rationale for identifying these + "mathematical concepts" as judicial exceptions is that a ‘‘mathematical formula + as such is not accorded the protection of our patent laws,’’ + *Diehr,* 450 U.S. at 191, 209 USPQ at 15 (citing + *Benson,* 409 U.S. 63, 175 USPQ 673), and thus ‘‘the + discovery of [a mathematical formula] cannot support a patent unless there is + some other inventive concept in its application.’’ *Flook,* + 437 U.S. at 594, 198 USPQ at 199. In the past, the Supreme Court sometimes + described mathematical concepts as laws of nature, and at other times described + these concepts as judicial exceptions without specifying a particular type of + exception. See, *e.g., Benson,* 409 U.S. at 65, 175 USPQ2d at + 674; *Flook,* 437 U.S. at 589, 198 USPQ2d at 197; + *Mackay Radio & Telegraph Co. v. Radio Corp. of Am.,* + 306 U.S. 86, 94, 40 USPQ 199, 202 (1939) (‘‘[A] scientific truth, or the + mathematical expression of it, is not patentable invention[.]’’). More recent + opinions of the Supreme Court, however, have affirmatively characterized + mathematical relationships and formulas as abstract ideas. See, *e.g., + Alice Corp. Pty. Ltd. v. CLS Bank Int’l*, 573 U.S. 208, 218, 110 + USPQ2d 1976, 1981 (describing *Flook* as holding "that a + mathematical formula for computing ‘alarm limits’ in a catalytic conversion + process was also a patent-ineligible abstract idea."); *Bilski v. + Kappos,* 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (noting that + the claimed "concept of hedging, described in claim 1 and reduced to a + mathematical formula in claim 4, is an unpatentable abstract idea,"). + + + +When determining whether a claim recites a + mathematical concept (*i.e.,* mathematical relationships, + mathematical formulas or equations, and mathematical calculations), examiners + should consider whether the claim recites a mathematical concept or merely + limitations that are based on or involve a mathematical concept. A claim does + not recite a mathematical concept (*i.e.,* the claim + limitations do not fall within the mathematical concept grouping), if it is + only based on or involves a mathematical concept. See, *e.g., Thales + Visionix, Inc. v. United States,* 850 F.3d 1343, 1348-49, 121 + USPQ2d 1898, 1902-03 (Fed. Cir. 2017) (determining that the claims to a + particular configuration of inertial sensors and a particular method of using + the raw data from the sensors in order to more accurately calculate the + position and orientation of an object on a moving platform did not merely + recite "the abstract idea of using ‘mathematical equations for determining the + relative position of a moving object to a moving reference frame’."). For + example, a limitation that is merely based on or involves a mathematical + concept described in the specification may not be sufficient to fall into this + grouping, provided the mathematical concept itself is not recited in the claim. + + + +It is important to note that a mathematical + concept need not be expressed in mathematical symbols, because "[w]ords used in + a claim operating on data to solve a problem can serve the same purpose as a + formula." *In re Grams,* 888 F.2d 835, 837 and n.1, 12 USPQ2d + 1824, 1826 and n.1 (Fed. Cir. 1989). See, *e.g., SAP America, Inc. v. + InvestPic, LLC,* 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. + Cir. 2018) (holding that claims to a ‘‘series of mathematical calculations + based on selected information’’ are directed to abstract ideas); + *Digitech Image Techs., LLC v. Elecs. for Imaging, Inc.,* + 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that + claims to a ‘‘process of organizing information through mathematical + correlations’’ are directed to an abstract idea); and *Bancorp Servs., + LLC v. Sun Life Assurance Co. of Can. (U.S.),* 687 F.3d 1266, 1280, + 103 USPQ2d 1425, 1434 (Fed. Cir. 2012) (identifying the concept of ‘‘managing a + stable value protected life insurance policy by performing calculations and + manipulating the results’’ as an abstract idea). + + +***A.*** ***Mathematical Relationships***A mathematical relationship is a + relationship between variables or numbers. A mathematical relationship may + be expressed in words or using mathematical symbols. For example, pressure + (p) can be described as the ratio between the magnitude of the normal force + (F) and area of the surface on contact (A), or it can be set forth in the + form of an equation such as p = F/A. + + + +Examples of mathematical relationships + recited in a claim include: + + + +* i. a relationship between reaction rate + and temperature, which relationship can be expressed in the form of a + formula called the Arrhenius equation, *Diamond v. + Diehr;* 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at + 4-5 (1981); +* ii. a conversion between binary coded + decimal and pure binary, *Benson,* 409 U.S. at 64, + 175 USPQ at 674; +* iii. a mathematical relationship between + enhanced directional radio activity and antenna conductor arrangement + (*i.e.,* the length of the conductors with respect + to the operating wave length and the angle between the conductors), + *Mackay Radio & Tel. Co. v. Radio Corp. of + America,* 306 U.S. 86, 91, 40 USPQ 199, 201 (1939) (while + the litigated claims 15 and 16 of U.S. Patent No. 1,974,387 expressed + this mathematical relationship using a formula that described the + angle between the conductors, other claims in the patent + (*e.g.,* claim 1) expressed the mathematical + relationship in words); and +* iv. organizing information and + manipulating information through mathematical correlations, + *Digitech Image Techs., LLC v. Electronics for Imaging, + Inc.,* 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. + Cir. 2014). The patentee in *Digitech* claimed + methods of generating first and second data by taking existing + information, manipulating the data using mathematical functions, and + organizing this information into a new form. The court explained that + such claims were directed to an abstract idea because they described a + process of organizing information through mathematical correlations, + like *Flook's* method of calculating using a + mathematical formula. 758 F.3d at 1350, 111 USPQ2d at 1721. + +***B.*** ***Mathematical Formulas or Equations***A claim that recites a numerical formula or + equation will be considered as falling within the "mathematical concepts" + grouping. In addition, there are instances where a formula or equation is + written in text format that should also be considered as falling within this + grouping. For example, the phrase "determining a ratio of A to B" is merely + using a textual replacement for the particular equation (ratio = A/B). + Additionally, the phrase "calculating the force of the object by multiplying + its mass by its acceleration" is using a textual replacement for the + particular equation (F= ma). + + + +Examples of mathematical equations or formulas + recited in a claim include: + + + +* i. a formula describing certain + electromagnetic standing wave phenomena, *Mackay Radio & + Tel. Co. v. Radio Corp. of America,* 306 U.S. 86, 91, 40 + USPQ 199, 201 (1939) (50.9(l/lambda<-0.513>); +* ii. the Arrhenius equation, + *Diamond v. Diehr;* 450 U.S. 175, 178 n. 2, 179 + n.5, 191-92, 209 USPQ at 4-5 (1981) (ln v = CZ + x); +* iii. a formula for computing an alarm + limit, *Parker v. Flook,* 437 U.S. 584, 585, 198 USPQ + 193, 195 (1978) (B1=B0 (1.0–F) + PVL(F)); and +* iv. a mathematical formula for hedging + (claim 4), *Bilski v. Kappos,* 561 U.S. 593, 599, 95 + USPQ2d 1001, 1004 (2010) (Fixed Bill Price = Fi + [(Ci + Ti + LDi) x + (α + βE(Wi))]). + +***C.******Mathematical + calculations***A claim that recites a mathematical + calculation, when the claim is given its broadest reasonable interpretation + in light of the specification, will be considered as falling within the + "mathematical concepts" grouping. A mathematical calculation is a + mathematical operation (such as multiplication) or an act of calculating + using mathematical methods to determine a variable or number, + *e.g.,* performing an arithmetic operation such as + exponentiation. There is no particular word or set of words that indicates a + claim recites a mathematical calculation. That is, a claim does not have to + recite the word "calculating" in order to be considered a mathematical + calculation. For example, a step of "determining" a variable or number using + mathematical methods or "performing" a mathematical operation may also be + considered mathematical calculations when the broadest reasonable + interpretation of the claim in light of the specification encompasses a + mathematical calculation. + + + +Examples of mathematical calculations + recited in a claim include: + + + +* i. performing a resampled statistical + analysis to generate a resampled distribution, *SAP America, + Inc. v. Investpic, LLC,* 898 F.3d 1161, 1163-65, 127 + USPQ2d 1597, 1598-1600 (Fed. Cir. 2018), modifying *SAP + America, Inc. v. Investpic, LLC,* 890 F.3d 1016, 126 + USPQ2d 1638 (Fed. Cir. 2018); +* ii. calculating a number representing an + alarm limit value using the mathematical formula + ‘‘B1=B0 (1.0–F) + + PVL(F)’’, *Parker v. Flook,* 437 U.S. 584, 585, 198 + USPQ 193, 195 (1978); +* iii. using a formula to convert geospatial + coordinates into natural numbers, *Burnett v. Panasonic + Corp.,* 741 Fed. Appx. 777, 780 (Fed. Cir. 2018) + (non-precedential); +* iv. managing a stable value protected life + insurance policy via performing calculations, *Bancorp Servs., + LLC v. Sun Life Assur. Co. of Canada (U.S.)*, 687 F.3d + 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012); +* v. using an algorithm for determining the + optimal number of visits by a business representative to a client, + *In re Maucorps,* 609 F.2d 481, 482, 203 USPQ 812, + 813 (CCPA 1979); and +* vi. calculating the difference between + local and average data values, *In re Abele,* 684 + F.2d 902, 903, 214 USPQ 682, 683-84 (CCPA 1982). + +**II.** **CERTAIN METHODS OF ORGANIZING + HUMAN ACTIVITY**The phrase "methods of organizing human + activity" is used to describe concepts relating to: + + + +* • fundamental economic principles or + practices (including hedging, insurance, mitigating risk); +* • commercial or legal interactions + (including agreements in the form of contracts, legal obligations, + advertising, marketing or sales activities or behaviors, and business + relations); and +* • managing personal behavior or + relationships or interactions between people, (including social + activities, teaching, and following rules or instructions). + + +The Supreme Court has identified a number of + concepts falling within the "certain methods of organizing human activity" + grouping as abstract ideas. In particular, in *Alice,* the + Court concluded that the use of a third party to mediate settlement risk is a + ‘‘fundamental economic practice’’ and thus an abstract idea. 573 U.S. at + 219–20, 110 USPQ2d at 1982. In addition, the Court in *Alice* + described the concept of risk hedging identified as an abstract idea in + *Bilski* as ‘‘a method of organizing human activity’’. + *Id.* Previously, in *Bilski,* the Court + concluded that hedging is a ‘‘fundamental economic practice’’ and therefore an + abstract idea. 561 U.S. at 611–612, 95 USPQ2d at 1010. + + + +The term "certain" qualifies the "certain + methods of organizing human activity" grouping as a reminder of several + important points. First, not all methods of organizing human activity are + abstract ideas (*e.g.,* "a defined set of steps for combining + particular ingredients to create a drug formulation" is not a certain "method + of organizing human activity"), *In re Marco Guldenaar Holding + B.V.,* 911 F.3d 1157, 1160-61, 129 USPQ2d 1008, 1011 (Fed. Cir. + 2018). Second, this grouping is limited to activity that falls within the + enumerated sub-groupings of fundamental economic principles or practices, + commercial or legal interactions, and managing personal behavior and + relationships or interactions between people, and is not to be expanded beyond + these enumerated sub-groupings except in rare circumstances as explained in + **[MPEP § 2106.04(a)(3)](s2106.html#ch2100_d2ea80_199c8_1c1)**. Finally, the sub-groupings + encompass both activity of a single person (for example, a person following a + set of instructions or a person signing a contract online) and activity that + involves multiple people (such as a commercial interaction), and thus, certain + activity between a person and a computer (for example a method of anonymous + loan shopping that a person conducts using a mobile phone) may fall within the + "certain methods of organizing human activity" grouping. It is noted that the + number of people involved in the activity is not dispositive as to whether a + claim limitation falls within this grouping. Instead, the determination should + be based on whether the activity itself falls within one of the sub-groupings. + + +***A.******Fundamental Economic Practices or + Principles***The courts have used the phrases "fundamental + economic practices" or "fundamental economic principles" to describe + concepts relating to the economy and commerce. Fundamental economic + principles or practices include hedging, insurance, and mitigating + risks. + + + +The term "fundamental" is not used in the + sense of necessarily being "old" or "well-known." See, *e.g., OIP + Techs., Inc. v. Amazon.com, Inc.*, 788 F.3d 1359, 1364, 115 + U.S.P.Q.2d 1090, 1092 (Fed Cir. 2015) (a new method of price optimization + was found to be a fundamental economic concept); *In re + Smith,* 815 F.3d 816, 818-19, 118 USPQ2d 1245, 1247 (Fed. Cir. + 2016) (describing a new set of rules for conducting a wagering game as a + "fundamental economic practice"); *In re Greenstein,* 774 + Fed. Appx. 661, 664, 2019 USPQ2d 212400 (Fed Cir. 2019) (non-precedential) + (claims to a new method of allocating returns to different investors in an + investment fund was a fundamental economic concept). However, being old or + well-known may indicate that the practice is fundamental. See, + *e.g., Alice Corp. Pty. Ltd. v. CLS Bank Int’l,* 573 + U.S. 208, 219-20, 110 USPQ2d 1981-82 (2014) (describing the concept of + intermediated settlement, like the risk hedging in + *Bilski,* to be a "‘fundamental economic practice long + prevalent in our system of commerce’" and also as "a building block of the + modern economy") (citation omitted); *Bilski v. Kappos,* + 561 U.S. 593, 611, 95 USPQ2d 1001, 1010 (2010) (claims to the concept of + hedging are a "fundamental economic practice long prevalent in our system of + commerce and taught in any introductory finance class.") (citation omitted); + *Intellectual Ventures I LLC v. Symantec Corp.,* 838 + F.3d 1307, 1313, 120 USPQ2d 1353, 1356 (2016) ("The category of abstract + ideas embraces ‘fundamental economic practice[s] long prevalent in our + system of commerce,’ … including ‘longstanding commercial + practice[s]’"). + + + +An example of a case identifying a claim as + reciting a fundamental economic practice is *Bilski v. + Kappos,* 561 U.S. 593, 609, 95 USPQ2d 1001, 1009 (2010). The + fundamental economic practice at issue was hedging or protecting against + risk. The applicant in *Bilski* claimed "a series of steps + instructing how to hedge risk," *i.e.,* how to protect + against risk. 561 U.S. at 599, 95 USPQ2d at 1005. The method allowed energy + suppliers and consumers to minimize the risks resulting from fluctuations in + market demand for energy. The Supreme Court determined that hedging is + "fundamental economic practice" and therefore is an "unpatentable abstract + idea." 561 U.S. at 611-12, 95 USPQ2d at 1010. + + + +Another example of a case identifying a + claim as reciting a fundamental economic practice is *Bancorp + Services., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.),* + 687 F.3d 1266, 103 USPQ2d 1425 (Fed. Cir. 2012). The fundamental economic + practice at issue in *Bancorp* pertained to insurance. The + patentee in *Bancorp* claimed methods and systems for + managing a life insurance policy on behalf of a policy holder, which + comprised steps including generating a life insurance policy including a + stable value protected investment with an initial value based on a value of + underlying securities, calculating surrender value protected investment + credits for the life insurance policy; determining an investment value and a + value of the underlying securities for the current day; and calculating a + policy value and a policy unit value for the current day. 687 F.3d at + 1270-71, 103 USPQ2d at 1427. The court described the claims as an "attempt + to patent the use of the abstract idea of [managing a stable value protected + life insurance policy] and then instruct the use of well-known + [calculations] to help establish some of the inputs into the equation." 687 + F.3d at 1278, 103 USPQ2d at 1433 (alterations in original) (citing + *Bilski*). + + + + Other examples of "fundamental economic + principles or practices" include: + + + +* i. mitigating settlement risk, + *Alice Corp. v. CLS Bank,*573 U.S. 208, 218, 110 + USPQ2d 1976, 1982 (2014); +* ii. rules for conducting a wagering game, + *In re Smith,* 815 F.3d 816, 818-19, 118 USPQ2d + 1245, 1247 (Fed. Cir. 2016); +* iii. financial instruments that are + designed to protect against the risk of investing in financial + instruments, *In re Chorna,* 656 Fed. App'x 1016, + 1021 (Fed. Cir. 2016) (non-precedential); +* iv. offer-based price optimization, + *OIP Techs., Inc. v. Amazon.com, Inc.,* 788 F.3d + 1359, 1362–63, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015); +* v. local processing of payments for + remotely purchased goods, *Inventor Holdings, LLC v. Bed Bath + Beyond,* 876 F.3d 1372, 1378-79, 125 USPQ2d 1019, 1023 + (Fed. Cir. 2017); +* vi. using a marking affixed to the outside + of a mail object to communicate information about the mail object, + *i.e.,* the sender, recipient, and contents of the + mail object, *Secured Mail Solutions LLC v. Universal Wilde, + Inc.,* 873 F.3d 905, 911, 124 USPQ2d 1502, 1506 (Fed. Cir. + 2017); and +* vii. placing an order based on displayed + market information, *Trading Technologies Int’l, Inc. v. IBG + LLC,* 921 F.3d 1084, 1092, 2019 USPQ2d 138290 (Fed. Cir. + 2019). + +***B.*** ***Commercial or Legal Interactions***"Commercial interactions" or "legal + interactions" include agreements in the form of contracts, legal + obligations, advertising, marketing or sales activities or behaviors, and + business relations. + + + +An example of a claim reciting a commercial + or legal interaction, where the interaction is an agreement in the form of + contracts, is found in *buySAFE, Inc. v. Google, Inc.,* 765 + F.3d. 1350, 112 USPQ2d 1093 (Fed. Cir. 2014). The agreement at issue in + *buySAFE* was a transaction performance guaranty, which + is a contractual relationship. 765 F.3d at 1355, 112 USPQ2d at 1096. The + patentee claimed a method in which a computer operated by the provider of a + safe transaction service receives a request for a performance guarantee for + an online commercial transaction, the computer processes the request by + underwriting the requesting party in order to provide the transaction + guarantee service, and the computer offers, via a computer network, a + transaction guaranty that binds to the transaction upon the closing of the + transaction. 765 F.3d at 1351-52, 112 USPQ2d at 1094. The Federal Circuit + described the claims as directed to an abstract idea because they were + "squarely about creating a contractual relationship--a ‘transaction + performance guaranty’." 765 F.3d at 1355, 112 USPQ2d at 1096. + + + +Other examples of subject matter where the + commercial or legal interaction is an agreement in the form of contracts + include: + + + +* i. managing a stable value protected life + insurance policy via performing calculations, *Bancorp Servs., + LLC v. Sun Life Assur. Co. of Canada (U.S.),* 687 F.3d + 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012); and +* ii. processing insurance claims for a + covered loss or policy event under an insurance policy + (*i.e.,* an agreement in the form of a contract), + *Accenture Global Services v. Guidewire Software, + Inc.,* 728 F.3d 1336, 1338-39, 108 USPQ2d 1173, 1175-76 + (Fed. Cir. 2013). + + +An example of a claim reciting a commercial + or legal interaction in the form of a legal obligation is found in + *Fort Properties, Inc. v. American Master Lease, LLC,* + 671 F.3d 1317, 101 USPQ2d 1785 (Fed Cir. 2012). The patentee claimed a + method of "aggregating real property into a real estate portfolio, dividing + the interests in the portfolio into a number of deedshares, and subjecting + those shares to a master agreement." 671 F.3d at 1322, 101 USPQ2d at 1788. + The legal obligation at issue was the tax-free exchanges of real estate. The + Federal Circuit concluded that the real estate investment tool designed to + enable tax-free exchanges was an abstract concept. 671 F.3d at 1323, 101 + USPQ2d at 1789. + + + +Other examples of subject matter where the + commercial or legal interaction is a legal obligation include: + + + +* i. hedging, *Bilski v. + Kappos*, 561 U.S. 593, 595, 95 USPQ2d 1001, 1004 + (2010); +* ii. mitigating settlement risk, + *Alice Corp. Pty. Ltd. v. CLS Bank Int'l,* 573 + U.S. 208, 218, 110 USPQ2d 1976, 1979 (2014); and +* iii. arbitration, *In re + Comiskey*, 554 F.3d 967, 981, 89 USPQ2d 1655, 1665 (Fed. + Cir. 2009). + + +An example of a claim reciting advertising is + found in *Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, + 714-15, 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). The patentee in + *Ultramercial* claimed an eleven-step method for + displaying an advertisement (ad) in exchange for access to copyrighted + media, comprising steps of receiving copyrighted media, selecting an ad, + offering the media in exchange for watching the selected ad, displaying the + ad, allowing the consumer access to the media, and receiving payment from + the sponsor of the ad. 772 F.3d. at 715, 112 USPQ2d at 1754. The Federal + Circuit determined that the "combination of steps recites an abstraction—an + idea, having no particular concrete or tangible form" and thus was directed + to an abstract idea, which the court described as "using advertising as an + exchange or currency." *Id.* + + +Other examples of subject matter where the + commercial or legal interaction is advertising, marketing or sales + activities or behaviors include : + + + +* i. structuring a sales force or marketing + company, which pertains to marketing or sales activities or behaviors, + *In re Ferguson,* 558 F.3d 1359, 1364, 90 USPQ2d + 1035, 1038 (Fed. Cir. 2009); +* ii. using an algorithm for determining the + optimal number of visits by a business representative to a client, + *In re Maucorps,* 609 F.2d 481, 485, 203 USPQ 812, + 816 (CCPA 1979); and +* iii. offer-based price optimization, which + pertains to marketing, *OIP Techs., Inc. v. Amazon.com, + Inc.,* 788 F.3d 1359, 1362-63, 115 USPQ2d 1090, 1092 (Fed. + Cir. 2015). + + + An example of a claim reciting business + relations is found in *Credit Acceptance Corp. v. Westlake + Services,* 859 F.3d 1044, 123 USPQ2d 1100 (Fed. Cir. 2017). The + business relation at issue in *Credit Acceptance* is the + relationship between a customer and dealer when processing a credit + application to purchase a vehicle. The patentee claimed a "system for + maintaining a database of information about the items in a dealer’s + inventory, obtaining financial information about a customer from a user, + combining these two sources of information to create a financing package for + each of the inventoried items, and presenting the financing packages to the + user." 859 F.3d at 1054, 123 USPQ2d at 1108. The Federal Circuit described + the claims as directed to the abstract idea of "processing an application + for financing a loan" and found "no meaningful distinction between this type + of financial industry practice" and the concept of intermediated settlement + in *Alice* or the hedging concept in + *Bilski.* 859 F.3d at 1054, 123 USPQ2d at 1108. + + + +Another example of subject matter where the + commercial or legal interaction is business relations includes: + + + +* i. processing information through a + clearing-house, where the business relation is the relationship + between a party submitted a credit application + (*e.g.,* a car dealer) and funding sources + (*e.g.,* banks) when processing credit + applications, *Dealertrack v. Huber,* 674 F.3d 1315, + 1331, 101 USPQ2d 1325, 1339 (Fed. Cir. 2012). + +***C.*** ***Managing Personal Behavior or Relationships or Interactions + Between People***The sub-grouping "managing personal behavior + or relationships or interactions between people" include social activities, + teaching, and following rules or instructions. + + + +An example of a claim reciting managing + personal behavior is *Intellectual Ventures I LLC v. Capital One + Bank (USA),* 792 F.3d 1363, 115 USPQ2d 1636 (Fed. Cir. 2015). + The patentee in this case claimed methods comprising storing user-selected + pre-set limits on spending in a database, and when one of the limits is + reached, communicating a notification to the user via a device. 792 F.3d. at + 1367, 115 USPQ2d at 1639-40. The Federal Circuit determined that the claims + were directed to the abstract idea of "tracking financial transactions to + determine whether they exceed a pre-set spending limit + (*i.e.,* budgeting)", which "is not meaningfully + different from the ideas found to be abstract in other cases before the + Supreme Court and our court involving methods of organizing human activity." + 792 F.3d. at 1367-68, 115 USPQ2d at 1640. + + + +Other examples of managing personal behavior + recited in a claim include: + + + +* i. filtering content, *BASCOM + Global Internet v. AT&T Mobility, LLC,* 827 F.3d 1341, + 1345-46, 119 USPQ2d 1236, 1239 (Fed. Cir. 2016) (finding that + filtering content was an abstract idea under step 2A, but reversing an + invalidity judgment of ineligibility due to an inadequate step 2B + analysis); +* ii. considering historical usage + information while inputting data, *BSG Tech. LLC v. + Buyseasons, Inc.,* 899 F.3d 1281, 1286, 127 USPQ2d 1688, + 1691; and +* iii. a mental process that a neurologist + should follow when testing a patient for nervous system malfunctions, + *In re Meyer,* 688 F.2d 789, 791-93, 215 USPQ 193, + 194-96 (CCPA 1982). + + +An example of a claim reciting social + activities is *Voter Verified, Inc. v. Election Systems & + Software, LLC,* 887 F.3d 1376, 126 USPQ2d 1498 (Fed. Cir. 2018). + The social activity at issue in *Voter Verified* was + voting. The patentee claimed "[a] method for voting providing for + self-verification of a ballot comprising the steps of" presenting an + election ballot for voting, accepting input of the votes, storing the votes, + printing out the votes, comparing the printed votes to votes stored in the + computer, and determining whether the printed ballot is acceptable. 887 F.3d + at 1384-85, 126 USPQ2d at 1503-04. The Federal Circuit found that the claims + were directed to the abstract idea of "voting, verifying the vote, and + submitting the vote for tabulation", which is a "fundamental activity that + forms the basis of our democracy" and has been performed by humans for + hundreds of years. 887 F.3d at 1385-86, 126 USPQ2d at 1504-05. + + + +Another example of a claim reciting social + activities is *Interval Licensing LLC, v. AOL, Inc.,* 896 + F.3d 1335, 127 USPQ2d 1553 (Fed. Cir. 2018). The social activity at issue + was the social activity of "’providing information to a person without + interfering with the person’s primary activity.’" 896 F.3d at 1344, 127 + USPQ2d 1553 (citing *Interval Licensing LLC v. AOL, Inc.,* + 193 F. Supp.3d 1184, 1188 (W.D. 2014)). The patentee claimed an attention + manager for acquiring content from an information source, controlling the + timing of the display of acquired content, displaying the content, and + acquiring an updated version of the previously-acquired content when the + information source updates its content. 896 F.3d at 1339-40, 127 USPQ2d at + 1555. The Federal Circuit concluded that "[s]tanding alone, the act of + providing someone an additional set of information without disrupting the + ongoing provision of an initial set of information is an abstract idea," + observing that the district court "pointed to the nontechnical human + activity of passing a note to a person who is in the middle of a meeting or + conversation as further illustrating the basic, longstanding practice that + is the focus of the [patent ineligible] claimed invention." 896 F.3d at + 1344-45, 127 USPQ2d at 1559. + + + +An example of a claim reciting following + rules or instructions is *In re Marco Guldenaar Holding + B.V.,* 911 F.3d 1157, 1161, 129 USPQ2d 1008, 1011 (Fed. Cir. + 2018). The patentee claimed a method of playing a dice game including + placing wagers on whether certain die faces will appear face up. 911 F.3d at + 1160; 129 USPQ2d at 1011. The Federal Circuit determined that the claims + were directed to the abstract idea of "rules for playing games", which the + court characterized as a certain method of organizing human activity. 911 + F.3d at 1160-61; 129 USPQ2d at 1011. + + + +Other examples of following rules or + instructions recited in a claim include: + + + +* i. assigning hair designs to balance head + shape, *In re Brown*, 645 Fed. Appx. 1014, 1015-16 + (Fed. Cir. 2016) (non-precedential); and +* ii. a series of instructions of how to + hedge risk, *Bilski v. Kappos*, 561 U.S. 593, 595, 95 + USPQ2d 1001, 1004 (2010). + +**III.** **MENTAL + PROCESSES**The courts consider a mental process (thinking) + that "can be performed in the human mind, or by a human using a pen and paper" + to be an abstract idea. *CyberSource Corp. v. Retail Decisions, + Inc.,* 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). + As the Federal Circuit explained, "methods which can be performed mentally, or + which are the equivalent of human mental work, are unpatentable abstract ideas + the ‘basic tools of scientific and technological work’ that are open to all.’" + 654 F.3d at 1371, 99 USPQ2d at 1694 (citing *Gottschalk v. + Benson,* 409 U.S. 63, 175 USPQ 673 (1972)). See also *Mayo + Collaborative Servs. v. Prometheus Labs. Inc.,* 566 U.S. 66, 71, + 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual + concepts are not patentable, as they are the basic tools of scientific and + technological work’" (quoting *Benson,* 409 U.S. at 67, 175 + USPQ at 675)); *Parker v. Flook,* 437 U.S. 584, 589, 198 USPQ + 193, 197 (1978) (same). + + + +Accordingly, the "mental processes" abstract + idea grouping is defined as concepts performed in the human mind, and examples + of mental processes include observations, evaluations, judgments, and opinions. + A discussion of concepts performed in the human mind, as well as concepts that + cannot practically be performed in the human mind and thus are not "mental + processes", is provided below with respect to point A. + + + +The courts do not distinguish between mental + processes that are performed entirely in the human mind and mental processes + that require a human to use a physical aid (*e.g.,* pen and + paper or a slide rule) to perform the claim limitation. See, *e.g., + Benson,* 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that + the claimed "conversion of [binary-coded decimal] numerals to pure binary + numerals can be done mentally," *i.e.,* "as a person would do + it by head and hand."); *Synopsys, Inc. v. Mentor Graphics + Corp.,* 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) + (holding that claims to a mental process of "translating a functional + description of a logic circuit into a hardware component description of the + logic circuit" are directed to an abstract idea, because the claims "read on an + individual performing the claimed steps mentally or with pencil and paper"). + Mental processes performed by humans with the assistance of physical aids such + as pens or paper are explained further below with respect to point B. + + + +Nor do the courts distinguish between claims + that recite mental processes performed by humans and claims that recite mental + processes performed on a computer. As the Federal Circuit has explained, + "[c]ourts have examined claims that required the use of a computer and still + found that the underlying, patent-ineligible invention could be performed via + pen and paper or in a person’s mind." *Versata Dev. Group v. SAP Am., + Inc.,* 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). + See also *Intellectual Ventures I LLC v. Symantec Corp.,* 838 + F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception + of generic computer-implemented steps, there is nothing in the claims + themselves that foreclose them from being performed by a human, mentally or + with pen and paper.’’); *Mortgage Grader, Inc. v. First Choice Loan + Servs. Inc.,* 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. + 2016) (holding that computer-implemented method for "anonymous loan shopping" + was an abstract idea because it could be "performed by humans without a + computer"). Mental processes recited in claims that require computers are + explained further below with respect to point C. + + + +Because both product and process claims may + recite a "mental process", the phrase "mental processes" should be understood + as referring to the type of abstract idea, and not to the statutory category of + the claim. The courts have identified numerous product claims as reciting + mental process-type abstract ideas, for instance the product claims to computer + systems and computer-readable media in *Versata Dev. Group. v. SAP Am., + Inc.,* 793 F.3d 1306, 115 USPQ2d 1681 (Fed. Cir. 2015). This + concept is explained further below with respect to point D. + + + +The following discussion is meant to guide + examiners and provide more information on how to determine whether a claim + recites a mental process. Examiners should keep in mind the following points A, + B, C, and D when performing this evaluation. + + +***A.*** ***A Claim With Limitation(s) That Cannot Practically be Performed + in the Human Mind Does Not Recite a Mental + Process.***Claims do not recite a mental process when + they do not contain limitations that can practically be performed in the + human mind, for instance when the human mind is not equipped to perform the + claim limitations. See *SRI Int’l, Inc. v. Cisco Systems, + Inc.,* 930 F.3d 1295, 1304 (Fed. Cir. 2019) (declining to + identify the claimed collection and analysis of network data as abstract + because "the human mind is not equipped to detect suspicious activity by + using network monitors and analyzing network packets as recited by the + claims"); *CyberSource,* 654 F.3d at 1376, 99 USPQ2d at + 1699 (distinguishing *Research Corp. Techs. v. Microsoft + Corp.,* 627 F.3d 859, 97 USPQ2d 1274 (Fed. Cir. 2010), and + *SiRF Tech., Inc. v. Int’l Trade Comm’n,* 601 F.3d 1319, + 94 USPQ2d 1607 (Fed. Cir. 2010), as directed to inventions that ‘‘could not, + as a practical matter, be performed entirely in a human’s mind’’). + + + +Examples of claims that do not recite mental + processes because they cannot be practically performed in the human mind + include: + + + +* • a claim to a method for calculating + an absolute position of a GPS receiver and an absolute time of + reception of satellite signals, where the claimed GPS receiver + calculated pseudoranges that estimated the distance from the GPS + receiver to a plurality of satellites, *SiRF Tech.,* + 601 F.3d at 1331-33, 94 USPQ2d at 1616-17; +* • a claim to detecting suspicious + activity by using network monitors and analyzing network packets, + *SRI Int’l,* 930 F.3d at 1304; +* • a claim to a specific data + encryption method for computer communication involving a several-step + manipulation of data, *Synopsys.,* 839 F.3d at 1148, + 120 USPQ2d at 1481 (distinguishing the claims in *TQP + Development, LLC v. Intuit Inc.,* 2014 WL 651935 (E.D. + Tex. Feb. 19, 2014)); and +* • a claim to a method for rendering a + halftone image of a digital image by comparing, pixel by pixel, the + digital image against a blue noise mask, where the method required the + manipulation of computer data structures (*e.g.,* the + pixels of a digital image and a two-dimensional array known as a mask) + and the output of a modified computer data structure (a halftoned + digital image), *Research Corp. Techs.,* 627 F.3d at + 868, 97 USPQ2d at 1280. + + +In contrast, claims do recite a mental + process when they contain limitations that can practically be performed in + the human mind, including for example, observations, evaluations, judgments, + and opinions. Examples of claims that recite mental processes include: + + + +* • a claim to "collecting information, + analyzing it, and displaying certain results of the collection and + analysis," where the data analysis steps are recited at a high level + of generality such that they could practically be performed in the + human mind, *Electric Power Group v. Alstom, S.A.,* + 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016); +* • claims to "comparing BRCA sequences + and determining the existence of alterations," where the claims cover + any way of comparing BRCA sequences such that the comparison steps can + practically be performed in the human mind, *University of + Utah Research Foundation v. Ambry Genetics,* 774 F.3d 755, + 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014); +* • a claim to collecting and comparing + known information (claim 1), which are steps that can be practically + performed in the human mind, *Classen Immunotherapies, Inc. v. + Biogen IDEC,* 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 + (Fed. Cir. 2011); and +* • a claim to identifying head shape + and applying hair designs, which is a process that can be practically + performed in the human mind, *In re Brown,* 645 Fed. + App'x 1014, 1016-17 (Fed. Cir. 2016) (non-precedential). + +***B.*** ***A Claim That Encompasses a Human Performing the Step(s) + Mentally With or Without a Physical Aid Recites a Mental + Process.***If a claim recites a limitation that can + practically be performed in the human mind, with or without the use of a + physical aid such as pen and paper, the limitation falls within the mental + processes grouping, and the claim recites an abstract idea. See, + *e.g., Benson,* 409 U.S. at 67, 65, 175 USPQ at 674-75, + 674 (noting that the claimed "conversion of [binary-coded decimal] numerals + to pure binary numerals can be done mentally," *i.e.,* "as + a person would do it by head and hand."); *Synopsys,* 839 + F.3d at 1139, 120 USPQ2d at 1474 (holding that claims to the mental process + of "translating a functional description of a logic circuit into a hardware + component description of the logic circuit" are directed to an abstract + idea, because the claims "read on an individual performing the claimed steps + mentally or with pencil and paper"). + + + +The use of a physical aid + (*e.g.,* pencil and paper or a slide rule) to help + perform a mental step (*e.g.,* a mathematical calculation) + does not negate the mental nature of the limitation, but simply accounts for + variations in memory capacity from one person to another. For instance, in + *CyberSource,* the court determined that the step of + "constructing a map of credit card numbers" was a limitation that was able + to be performed "by writing down a list of credit card transactions made + from a particular IP address." In making this determination, the court + looked to the specification, which explained that the claimed map was + nothing more than a listing of several (*e.g.,* four) + credit card transactions. The court concluded that this step was able to be + performed mentally with a pen and paper, and therefore, it qualified as a + mental process. 654 F.3d at 1372-73, 99 USPQ2d at 1695. See also + *Flook,* 437 U.S. at 586, 198 USPQ at 196 (claimed + "computations can be made by pencil and paper calculations"); + *University of Florida Research Foundation, Inc. v. General + Electric Co.,* 916 F.3d 1363, 1367, 129 USPQ2d 1409, 1411-12 + (Fed. Cir. 2019) (relying on specification’s description of the claimed + analysis and manipulation of data as being performed mentally "‘using pen + and paper methodologies, such as flowsheets and patient charts’"); + *Symantec,* 838 F.3d at 1318, 120 USPQ2d at 1360 + (although claimed as computer-implemented, steps of screening messages can + be "performed by a human, mentally or with pen and paper"). + + +***C.*** ***A Claim That Requires a Computer May Still Recite a Mental + Process.***Claims can recite a mental process even if + they are claimed as being performed on a computer. The Supreme Court + recognized this in *Benson,* determining that a + mathematical algorithm for converting binary coded decimal to pure binary + within a computer’s shift register was an abstract idea. The Court concluded + that the algorithm could be performed purely mentally even though the + claimed procedures "can be carried out in existing computers long in use, no + new machinery being necessary." 409 U.S at 67, 175 USPQ at 675. See also + *Mortgage Grader,* 811 F.3d at 1324, 117 USPQ2d at 1699 + (concluding that concept of "anonymous loan shopping" recited in a computer + system claim is an abstract idea because it could be "performed by humans + without a computer"). + + + +In evaluating whether a claim that requires a + computer recites a mental process, examiners should carefully consider the + broadest reasonable interpretation of the claim in light of the + specification. For instance, examiners should review the specification to + determine if the claimed invention is described as a concept that is + performed in the human mind and applicant is merely claiming that concept + performed 1) on a generic computer, or 2) in a computer environment, or 3) + is merely using a computer as a tool to perform the concept. In these + situations, the claim is considered to recite a mental process. + + + +* 1. **Performing a mental process on a + generic computer.** An example of a case identifying a mental + process performed on a generic computer as an abstract idea is + *Voter Verified, Inc. v. Election Systems & Software, + LLC,* 887 F.3d 1376, 1385, 126 USPQ2d 1498, 1504 (Fed. + Cir. 2018). In this case, the Federal Circuit relied upon the + specification in explaining that the claimed steps of voting, + verifying the vote, and submitting the vote for tabulation are "human + cognitive actions" that humans have performed for hundreds of years. + The claims therefore recited an abstract idea, despite the fact that + the claimed voting steps were performed on a computer. 887 F.3d at + 1385, 126 USPQ2d at 1504. Another example is + *Versata,* in which the patentee claimed a system + and method for determining a price of a product offered to a + purchasing organization that was implemented using general purpose + computer hardware. 793 F.3d at 1312-13, 1331, 115 USPQ2d at 1685, + 1699. The Federal Circuit acknowledged that the claims were performed + on a generic computer, but still described the claims as "directed to + the abstract idea of determining a price, using organizational and + product group hierarchies, in the same way that the claims in + *Alice* were directed to the abstract idea of + intermediated settlement, and the claims in Bilski were directed to + the abstract idea of risk hedging." 793 F.3d at 1333; 115 USPQ2d at + 1700-01. +* 2. **Performing a mental process in a + computer environment.** An example of a case identifying a + mental process performed in a computer environment as an abstract idea + is *Symantec Corp.,* 838 F.3d at 1316-18, 120 USPQ2d + at 1360. In this case, the Federal Circuit relied upon the + specification when explaining that the claimed electronic post office, + which recited limitations describing how the system would receive, + screen and distribute email on a computer network, was analogous to + how a person decides whether to read or dispose of a particular piece + of mail and that "with the exception of generic computer-implemented + steps, there is nothing in the claims themselves that foreclose them + from being performed by a human, mentally or with pen and paper". 838 + F.3d at 1318, 120 USPQ2d at 1360. Another example is + *FairWarning IP, LLC v. Iatric Sys., Inc.,* 839 + F.3d 1089, 120 USPQ2d 1293 (Fed. Cir. 2016). The patentee in + *FairWarning* claimed a system and method of + detecting fraud and/or misuse in a computer environment, in which + information regarding accesses of a patient’s personal health + information was analyzed according to one of several rules + (*i.e.,* related to accesses in excess of a + specific volume, accesses during a pre-determined time interval, or + accesses by a specific user) to determine if the activity indicates + improper access. 839 F.3d. at 1092, 120 USPQ2d at 1294. The court + determined that these claims were directed to a mental process of + detecting misuse, and that the claimed rules here were "the same + questions (though perhaps phrased with different words) that humans in + analogous situations detecting fraud have asked for decades, if not + centuries." 839 F.3d. at 1094-95, 120 USPQ2d at 1296. +* 3. **Using a computer as a tool to + perform a mental process.** An example of a case in which a + computer was used as a tool to perform a mental process is + *Mortgage Grader,* 811 F.3d. at 1324, 117 USPQ2d + at 1699. The patentee in *Mortgage Grader* claimed a + computer-implemented system for enabling borrowers to anonymously shop + for loan packages offered by a plurality of lenders, comprising a + database that stores loan package data from the lenders, and a + computer system providing an interface and a grading module. The + interface prompts a borrower to enter personal information, which the + grading module uses to calculate the borrower’s credit grading, and + allows the borrower to identify and compare loan packages in the + database using the credit grading. 811 F.3d. at 1318, 117 USPQ2d at + 1695. The Federal Circuit determined that these claims were directed + to the concept of "anonymous loan shopping", which was a concept that + could be "performed by humans without a computer." 811 F.3d. at 1324, + 117 USPQ2d at 1699. Another example is *Berkheimer v. HP, + Inc.,* 881 F.3d 1360, 125 USPQ2d 1649 (Fed. Cir. 2018), in + which the patentee claimed methods for parsing and evaluating data + using a computer processing system. The Federal Circuit determined + that these claims were directed to mental processes of parsing and + comparing data, because the steps were recited at a high level of + generality and merely used computers as a tool to perform the + processes. 881 F.3d at 1366, 125 USPQ2d at 1652-53. + +***D.*** ***Both Product and + Process Claims May Recite a Mental + Process.***Examiners should keep in mind that both + product claims (*e.g.,* computer system, computer-readable + medium, etc.) and process claims may recite mental processes. For example, + in *Mortgage Grader,* the patentee claimed a + computer-implemented system and a method for enabling borrowers to + anonymously shop for loan packages offered by a plurality of lenders, + comprising a database that stores loan package data from the lenders, and a + computer system providing an interface and a grading module. The Federal + Circuit determined that both the computer-implemented system and method + claims were directed to "anonymous loan shopping", which was an abstract + idea because it could be "performed by humans without a computer." 811 F.3d. + at 1318, 1324-25, 117 USPQ2d at 1695, 1699-1700. See also + *FairWarning IP,* 839 F.3d at 1092, 120 USPQ2d at 1294 + (identifying both system and process claims for detecting improper access of + a patient's protected health information in a health-care system computer + environment as directed to abstract idea of detecting fraud); + *Content Extraction & Transmission LLC v. Wells Fargo Bank, + N.A.,* 776 F.3d 1343, 1345, 113 USPQ2d 1354, 1356 (system and + method claims of inputting information from a hard copy document into a + computer program). Accordingly, the phrase "mental processes" should be + understood as referring to the type of abstract idea, and not to the + statutory category of the claim. + + + +Examples of product claims reciting mental + processes include: + + + +* • An application program interface for + extracting and processing information from a diversity of types of + hard copy documents – *Content Extraction,* 776 F.3d + at 1345, 113 USPQ2d at 1356; +* • A computer-implemented system for + enabling anonymous loan shopping – *Mortgage Grader,* + 811 F.3d at 1318, 117 USPQ2d at 1695; +* • A computer readable medium + containing program instructions for detecting fraud – + *CyberSource,* 654 F.3d at 1368 n. 1, 99 USPQ2d at + 1692 n.1; +* • A post office for receiving and + redistributing email messages on a computer network – + *Symantec,* 838 F.3d at 1316, 120 USPQ2d at 1359; +* • A self-verifying voting system – + *Voter Verified,* 887 F.3d at 1384-85, 126 USPQ2d + at 1504; +* • A wide-area real-time performance + monitoring system for monitoring and assessing dynamic stability of an + electric power grid – *Electric Power Group,* 830 + F.3d at 1351 and n.1, 119 USPQ2d at 1740 and n.1; and +* • Computer readable storage media + comprising computer instructions to implement a method for determining + a price of a product offered to a purchasing organization – + *Versata,* 793 F.3d at 1312-13, 115 USPQ2d at + 1685. + + +Examples of process claims reciting mental + process-type abstract ideas are discussed in the preceding subsections (A) + through (C). See, for example, the discussion of *Flook,* + 437 U.S. 584, 198 USPQ 193; *Benson,* 409 U.S. 63, 175 USPQ + 673; *Berkheimer,* 881 F.3d 1360, 125 USPQ2d 1649; + *Synopsys,* 839 F.3d 1138, 120 USPQ2d 1473; and + *Ambry Genetics,* 774 F.3d 755, 113 USPQ2d 1241, + *supra*. + + + + + + +# 2106.04(a)(3) **Tentative Abstract + Ideas** + + +There may be rare circumstances in which an examiner + believes a claim limitation should be treated as an abstract idea even though it does + not fall within any of the groupings of abstract ideas discussed in + **[MPEP + § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** (i.e., mathematical concepts, certain + methods of organizing human activity, mental processes). This type of claim + limitation is referred to as a "tentative abstract idea." + + + +In such circumstances, the examiner should evaluate + the claim under the subject matter eligibility framework: + + + +* • If the claim as a whole integrates the + tentative abstract idea into a practical application, the claim is not directed + to a judicial exception (Step 2A; NO) and thus is **eligible** at + Pathway B. This concludes the eligibility analysis. +* • If the claim as a whole does not integrate + the tentative abstract idea into a practical application, then the claim is + directed to a judicial exception (Step 2A: YES) and thus requires further + analysis at Step 2B. At Step 2B, if the claim as a whole provides an inventive + concept (Step 2B: YES), the claim is **eligible** at Pathway C. This + concludes the eligibility analysis. +* • If the claim as a whole does not provide an + inventive concept (Step 2B: NO), the application should be brought to the + attention of the Technology Center (TC) director. A rejection of a claim + reciting a tentative abstract idea must be approved by the TC director (which + approval will be indicated in the file record of the application) and must + provide a justification for why such claim limitation is being treated as + reciting an abstract idea. +The TC Director will give approval for a Step 2B + subject matter eligibility rejection of a claim reciting a tentative abstract + idea. The ensuing Office action will identify that the claim(s) are directed to a + previously non-enumerated abstract idea via form paragraph + **[7.05.017](#fp7.05.017)** and include the TC Director’s signature. + The TC Director will then inform Patents Management that this procedure has been + used so that the public can be notified, for example, on USPTO.GOV at the Subject + Matter Eligibility website. + + + +In response to a Step 2B rejection of a claim + reciting a tentative abstract idea, an interview with the examiner may be + conducted, which may help advance prosecution and identify patent eligible subject + matter. See **[MPEP § + 713](s713.html#d0e84376)**. For applications in which an abstract idea has been + identified using the tentative abstract idea procedure, an interview with the TC + Director that provided approval is not necessary because the examiner retains the + authority to withdraw or maintain a rejection upon consideration of applicant’s + reply. The examiner is not required to obtain TC Director approval to withdraw or + maintain such a **[§ 101](mpep-9015-appx-l.html#d0e302376)** subject matter eligibility rejection. + + + + + + +# 2106.04(b) Laws of Nature, Natural Phenomena & + Products of Nature [R-10.2019] + + +Laws of nature and natural phenomena, as identified by + the courts, include naturally occurring principles/relations and nature-based + products that are naturally occurring or that do not have markedly different + characteristics compared to what occurs in nature. The courts have often described + these exceptions using other terms, including "physical phenomena," "scientific + principles", "natural laws," and "products of nature." + + +**I.** **LAWS OF NATURE AND NATURAL + PHENOMENA, GENERALLY**The law of nature and natural phenomenon + exceptions reflect the Supreme Court's view that the basic tools of scientific and + technological work are not patentable, because the "manifestations of laws of + nature" are "part of the storehouse of knowledge," "free to all men and reserved + exclusively to none." *Funk Bros. Seed Co. v. Kalo Inoculant + Co.,* 333 U.S. 127, 130, 76 USPQ 280, 281 (1948). Thus, "a new mineral + discovered in the earth or a new plant found in the wild is not patentable subject + matter" under **[Section 101](mpep-9015-appx-l.html#d0e302376)**. *Diamond v. Chakrabarty,* 447 + U.S. 303, 309, 206 USPQ 193, 197 (1980). "Likewise, Einstein could not patent his + celebrated law that E=mc2; nor could Newton have + patented the law of gravity." *Id.* Nor can one patent "a novel + and useful mathematical formula," *Parker v. Flook,* 437 U.S. + 584, 585, 198 USPQ 193, 195 (1978); electromagnetism or steam power, + *O’Reilly v. Morse,* 56 U.S. (15 How.) 62, 113-114 (1853); or + "[t]he qualities of ... bacteria, ... the heat of the sun, electricity, or the + qualities of metals," *Funk,* 333 U.S. at 130, 76 USPQ at 281; + see also *Le Roy v. Tatham,* 55 U.S. (14 How.) 156, 175 + (1853). + + + + The courts have identified the following concepts + and products as examples of laws of nature or natural phenomena: + + + +* i. isolated DNA, *Ass’n for Molecular + Pathology v. Myriad Genetics, Inc.,* 569 U.S. 576, 589-91, 106 + USPQ2d 1972, 1978-79 (2013); +* ii. a cloned farm animal such as a sheep, + *In re Roslin Institute (Edinburgh),* 750 F.3d 1333, + 1337, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014); +* iii. a correlation between variations in + non-coding regions of DNA and allele presence in coding regions of DNA, + *Genetic Techs. Ltd. v. Merial LLC,* 818 F.3d 1369, + 1375, 118 USPQ2d 1541, 1545 (Fed. Cir. 2016); +* iv. a correlation that is the consequence of how + a certain compound is metabolized by the body, *Mayo Collaborative + Servs. v. Prometheus Labs.,* 566 U.S. 66, 75-77, 101 USPQ2d + 1961, 1967-68 (2012); +* v. a correlation between the presence of + myeloperoxidase in a bodily sample (such as blood or plasma) and + cardiovascular disease risk, *Cleveland Clinic Foundation v. True + Health Diagnostics, LLC,* 859 F.3d 1352, 1361, 123 USPQ2d 1081, + 1087 (Fed. Cir. 2017); +* vi. electromagnetism to transmit signals, + *O’Reilly v. Morse,* 56 U.S. 62, 113 (1853); +* vii. qualities of bacteria such as their ability + to create a state of inhibition or non-inhibition in other bacteria, + *Funk Bros.,* 333 U.S. at 130, 76 USPQ at 281; +* viii. single-stranded DNA fragments known as + "primers", *University of Utah Research Foundation v. Ambry Genetics + Corp.,* 774 F.3d 755, 761, 113 USPQ2d 1241, 1244 (Fed. Cir. + 2014); +* ix. the chemical principle underlying the union + between fatty elements and water, *Tilghman v. Proctor,* + 102 U.S. 707, 729 (1880); +* x. the existence of cell-free fetal DNA (cffDNA) + in maternal blood, *Ariosa Diagnostics, Inc. v. Sequenom,* + 788 F.3d 1371, 1373, 115 USPQ2d 1152, 1153 (Fed. Cir. 2015); and +* xi. the natural relationship between a patient’s + CYP2D6 metabolizer genotype and the risk that the patient will suffer QTc + prolongation after administration of a medication called iloperidone, + *Vanda Pharmaceuticals Inc. v. West-Ward + Pharmaceuticals,* 887 F.3d 1117, 1135-36, 126 USPQ2d 1266, 1281 + (Fed. Cir. 2018). + + +The courts have also noted, however, that not every + claim describing a natural ability or quality of a product, or describing a + natural process, necessarily recites a law of nature or natural phenomenon. See + *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d 1042, + 1048-49, 119 USPQ2d 1370, 1374 (Fed. Cir. 2016) (claims reciting process steps of + fractionating, recovering, and cryopreserving hepatocytes held to be eligible, + because they are not focused on merely observing or detecting the ability of + hepatocytes to survive multiple freeze-thaw cycles). Thus, in a claimed method of + treating cancer with chemotherapy, the cancer cells’ inability to survive + chemotherapy is not considered to be a law of nature. Similarly, in a claimed + method of treating headaches with aspirin, the human body’s natural response to + aspirin is not considered to be a law of nature. These claims are accordingly + eligible at Prong One unless they recite another exception, in which case they + require further analysis in Prong Two (and Step 2B, if needed) to determine their + eligibility. Similarly, a method of producing a new compound is not directed to + the individual components’ ability to combine to form the new compound. + *Id.* See also *Tilghman v. Proctor,* 102 + U.S. 707, 729 (1881) (claims reciting process steps for manufacturing fatty acids + and glycerol by hydrolyzing fat at high temperature and pressure were held to be + eligible, because they are not focused on the chemical principle that fat can be + hydrolyzed into its components). + + + +Even if a claim does recite a law of nature or + natural phenomenon, it may still be eligible at any of Pathways A through C. For + example, claims reciting a naturally occurring relationship between a patient’s + genotype and the risk of QTc prolongation (a law of nature) were held eligible as + not "directed to" that relationship because they also recited a step of treating + the patient with an amount of a particular medication that was tailored to the + patient’s genotype. *Vanda Pharms.,* 887 F.3d at 1134-36, 126 + USPQ2d at 1279-81. This particular treatment step applied the natural relationship + in a manner that integrated it into a practical application. The court’s analysis + in *Vanda* is equivalent to a finding of eligibility at Step 2A + Prong Two (Pathway B). + + + +As explained in **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, a claim that recites a law of nature or a + natural phenomenon requires further analysis in Step 2A Prong Two to determine + whether the claim integrates the exception into a practical application. + + + +A claim that does not recite a law of nature or + natural phenomenon is eligible at Pathway B (Step 2A: NO) unless the claim + recites, and is directed to, another exception (such as an abstract idea, or a + product of nature). + + +**II.** **PRODUCTS OF + NATURE**When a law of nature or natural phenomenon is + claimed as a physical product, the courts have often referred to the exception as + a "product of nature". For example, the isolated DNA of *Myriad* + and the primers of *Ambry Genetics* were described as products of + nature by the courts. *Ass’n for Molecular Pathology v. Myriad Genetics, + Inc.,* 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); + *University of Utah Research Foundation v. Ambry Genetics,* + 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in + those decisions, products of nature are considered to be an exception because they + tie up the use of naturally occurring things, but they have been labeled as both + laws of nature and natural phenomena. See *Myriad Genetics, + Inc.,* 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA + held ineligible because they "claim naturally occurring phenomena" and are + "squarely within the law of nature exception"); *Funk Bros. Seed Co. v. + Kalo Inoculant Co.,* 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) + (claims to bacterial mixtures held ineligible as "manifestations of laws of + nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis + uses the terms "law of nature" and "natural phenomenon" as inclusive of "products + of nature". + + + +It is important to keep in mind that product of + nature exceptions include both naturally occurring products and non-naturally + occurring products that lack markedly different characteristics from any naturally + occurring counterpart. See, *e.g.,**Ambry Genetics,* 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary + to *Myriad's* argument, it makes no difference that the + identified gene sequences are synthetically replicated. As the Supreme Court made + clear, neither naturally occurring compositions of matter, nor synthetically + created compositions that are structurally identical to the naturally occurring + compositions, are patent eligible."). Thus, a synthetic, artificial, or + non-naturally occurring product such as a cloned organism or a human-made hybrid + plant is not automatically eligible because it was created by human ingenuity or + intervention. See, *e.g.,**In re Roslin Institute (Edinburgh),* 750 F.3d 1333, 1337, 110 + USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. *J.E.M. Ag + Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc.,* 534 U.S. 130-132, 60 + USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all + non-naturally occurring products is whether they possess markedly different + characteristics from any naturally occurring counterpart. + + + +When a claim recites a nature-based product + limitation, examiners should use the markedly different characteristics analysis + discussed in **[MPEP § 2106.04(c)](s2106.html#ch2100_d29a1b_13bc1_b1)** to evaluate the + nature-based product limitation and determine the answer to Step 2A. Nature-based + products, as used herein, include both eligible and ineligible products and merely + refer to the types of products subject to the markedly different characteristics + analysis used to identify product of nature exceptions. Examples of nature-based + products include the isolated gene and cDNA sequences of + *Myriad,* the cloned farm animals of + *Roslin,* and the bacterium of *Chakrabarty*. + As is evident from these examples, and as further discussed in + **[MPEP § + 2105](s2105.html#d0e197008)**, a nature-based product that is a living organism + (*e.g.,* a plant, an animal, a bacterium, etc.) is not + excluded from patent protection merely because it is alive, and such a product is + eligible for patenting if it satisfies the markedly different characteristics + analysis. + + + +It is important to keep in mind that under the + broadest reasonable interpretation (BRI) of the claims, a nature-based product + limitation may encompass both eligible and ineligible products. For example, a + claim to a "cloned giraffe" may have a BRI encompassing cloned giraffes with + markedly different characteristics, as well as cloned giraffes that lack markedly + different characteristics and thus are products of nature. Cf. + *Roslin,* 750 F.3d at 1338-39, 110 USPQ2d at 1673 (applicant + could not rely on unclaimed features to distinguish claimed mammals from donor + mammals). + + + +Such a claim recites a product of nature, and thus + requires further analysis in Prong Two. If the claim is ultimately rejected as + failing to encompass an inventive concept (Step 2B: NO), it is a best practice for + the examiner to point out the broadest reasonable interpretation and recommend an + amendment, if possible, that would narrow the claim to those embodiments that are + not directed to products of nature, or that are otherwise eligible. + + + +For claims that recite a nature-based product + limitation (which may or may not be a product of nature exception) but which are + directed to inventions that clearly do not seek to tie up any judicial exception, + examiners should consider whether the streamlined eligibility analysis discussed + in **[MPEP § 2106.06](s2106.html#ch2100_d29a1b_13e6a_88)** is appropriate. In such cases, it would + not be necessary to conduct a markedly different characteristics analysis. + + + + + +# 2106.04(c) The Markedly Different Characteristics + Analysis [R-10.2019] + + +The markedly different characteristics analysis is + part of Step 2A Prong One, because the courts use this analysis to identify product + of nature exceptions. For example, *Chakrabarty* relied on a + comparison of the claimed bacterium to naturally occurring bacteria when determining + that the claimed bacterium was not a product of nature because it had "markedly + different characteristics from any found in nature". *Diamond v. + Chakrabarty,* 447 U.S. 303, 310, 206 USPQ 193, 197 (1980). Similarly, + *Roslin* relied on a comparison of the claimed sheep to naturally + occurring sheep when determining that the claimed sheep was a product of nature + because it "does not possess ‘markedly different characteristics from any [farm + animals] found in nature.’" *In re Roslin Institute (Edinburgh),* + 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (quoting + *Chakrabarty,* 447 U.S. at 310, 206 USPQ at 197 (alterations in + original)). + + + + This section sets forth guidelines for performing + the markedly different characteristics analysis, including information on when to + perform the analysis, and how to perform the analysis. Examiners should consult these + guidelines when performing an eligibility analysis of a claim that recites a + nature-based product limitation. Nature-based products, as used herein, include both + eligible and ineligible products and merely refer to the types of products subject to + the markedly different characteristics analysis used to identify product of nature + exceptions. + + + +If the claim includes a nature-based product that has + markedly different characteristics, then the claim does not recite a product of + nature exception and is eligible (Step 2A: NO) at Pathway B unless the claim recites + another exception (such as a law of nature or abstract idea, or a different natural + phenomenon). For claims where the entire claim is a single nature-based product + (e.g., a claim to "a *Lactobacillus* bacterium"), once a markedly + different characteristic in that product is shown, no further analysis would be + necessary for eligibility because no product of nature exception is recited (i.e., + Step 2B is not necessary because the answer to Step 2A is NO). For claims including + limitations in addition to the nature-based product, examiners should consider + whether the claim recites another exception and thus requires further eligibility + analysis. + + + + If the claim includes a nature-based product that + does not exhibit markedly different characteristics from its naturally occurring + counterpart in its natural state, then the claim recites a "product of nature" + exception, and requires further analysis in Step 2A Prong Two to determine whether + the claim as a whole integrates the exception into a practical application. + + +**I.** **WHEN TO PERFORM THE MARKEDLY + DIFFERENT CHARACTERISTICS ANALYSIS**Because a nature-based product can be claimed by + itself (*e.g.,* "a *Lactobacillus* bacterium") + or as one or more limitations of a claim (e.g., "a probiotic composition + comprising a mixture of *Lactobacillus* and milk in a + container"), care should be taken not to overly extend the markedly different + characteristics analysis to products that when viewed as a whole are not + nature-based. Instead, the markedly different characteristics analysis should be + applied only to the nature-based product limitations in the claim to determine + whether the nature-based products are "product of nature" exceptions. + + + +Examiners should keep in mind that if the + nature-based product limitation is naturally occurring, there is no need to + perform the markedly different characteristics analysis because the limitation is + by definition directed to a naturally occurring product and thus falls under the + product of nature exception. However, if the nature-based product limitation is + not naturally occurring, for example due to some human intervention, then the + markedly different characteristics analysis must be performed to determine whether + the claimed product limitation is a product of nature exception. + + +***A.*** ***Product Claims***Where the claim is to a nature-based product by + itself (*e.g.,* a claim to "a *Lactobacillus* + bacterium"), the markedly different characteristics analysis should be applied + to the entire product. See, *e.g., Chakrabarty,* 447 U.S. at + 305, 309-10, 206 USPQ at 195, 197-98 (applying analysis to entire claimed + "bacterium from the genus *Pseudomonas* containing therein at + least two stable energy-generating plasmids, each of said plasmids providing a + separate hydrocarbon degradative pathway"). + + + +Where the claim is to a nature-based product + produced by combining multiple components (*e.g.,* a claim to + "a probiotic composition comprising a mixture of + *Lactobacillus* and milk"), the markedly different + characteristics analysis should be applied to the resultant nature-based + combination, rather than its component parts. For instance, for the probiotic + composition example, the mixture of *Lactobacillus* and milk + should be analyzed for markedly different characteristics, rather than the + *Lactobacillus* separately and the milk separately. See + subsection II, below, for further guidance on the markedly different + characteristic analysis. + + + + Where the claim is to a nature-based product + in combination with non-nature based elements (*e.g.,* a claim + to "a yogurt starter kit comprising *Lactobacillus* in a + container with instructions for culturing *Lactobacillus* with + milk to produce yogurt"), the markedly different characteristics analysis + should be applied only to the nature-based product limitation. For instance, + for the yogurt starter kit example, the *Lactobacillus* would + be analyzed for markedly different characteristics. The container and + instructions would not be subject to the markedly different characteristics + analysis as they are not nature-based products, but would be evaluated as + additional elements in Prong Two (and Step 2B if needed) if it is determined + that the *Lactobacillus* does not have markedly different + characteristics from any naturally occurring counterpart and thus is a product + of nature exception. See, *e.g., Funk Bros. Seed Co. v. Kalo Inoculant + Co.,* 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (although claims + 7, 8, 13 and 14 recited an inoculant comprising a bacterial mixture and a + powder base, only the bacterial mixture was analyzed). + + +***B.*** ***Product-by-Process Claims***For a product-by-process claim + (*e.g.,* a claim to a cloned farm animal produced by a + nuclear transfer cloning method), the analysis turns on whether the + nature-based product in the claim has markedly different characteristics from + its naturally occurring counterpart. See **[MPEP § 2113](s2113.html#d0e201450)** + for more information on product-by-process claims. + + +***C.*** ***Process Claims***For a process claim, the general rule is that + the claim is not subject to the markedly different analysis for nature-based + products used in the process. This is because the analysis of a process claim + should focus on the active steps of the process rather than the products used + in those steps. For example, when evaluating a claimed process of + cryopreserving hepatocyte cells comprising performing density gradient + fractionation to separate viable and non-viable hepatocytes, recovering the + viable hepatocytes, and cryopreserving the recovered viable hepatocytes, the + court did not subject the claim to the markedly different characteristics + analysis for the nature-based products (the hepatocytes) used in the process. + *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d 1042, + 1049, 119 USPQ2d 1370, 1374 (Fed. Cir. 2016) (claims are directed to a process + of creating a preparation of multi-cryopreserved hepatocytes, not to the + preparation itself). + + + + However, in the limited situation where a + process claim reciting a nature-based product is drafted in such a way that + there is no difference in substance from a product claim, the claim is subject + to the markedly different analysis for the recited nature-based product. These + types of claims are drafted in a way that focuses on the product rather than + the process steps. For example, consider a claim that recites, in its entirety, + "a method of providing an apple." Under the broadest reasonable interpretation, + this claim is focused on the apple fruit itself, which is a nature-based + product. Similarly, claims to detecting naturally occurring cell-free fetal DNA + (cffDNA) in maternal blood were held to be directed to the cffDNA, because the + "existence and location of cffDNA is a natural phenomenon [and thus] + identifying its presence was merely claiming the natural phenomena itself." + *Rapid Litig. Mgmt.,* 827 F.3d at 1048, 119 USPQ2d at 1374, + (explaining the holding in *Ariosa Diagnostics, Inc. v. + Sequenom,* 788 F.3d 1371, 115 USPQ2d 1152 (Fed. Cir. 2015)). + + +**II.** **HOW TO PERFORM THE MARKEDLY + DIFFERENT CHARACTERISTICS ANALYSIS** The markedly different characteristics analysis + compares the nature-based product limitation to its naturally occurring + counterpart in its natural state. Markedly different characteristics can be + expressed as the product’s structure, function, and/or other properties, and are + evaluated based on what is recited in the claim on a case-by-case basis. If the + analysis indicates that a nature-based product limitation does not exhibit + markedly different characteristics, then that limitation is a product of nature + exception. If the analysis indicates that a nature-based product limitation does + have markedly different characteristics, then that limitation is not a product of + nature exception. + + + +This section sets forth guidelines for performing + the markedly different characteristics analysis, including information on (a) + selecting the appropriate naturally occurring counterpart(s) to the nature-based + product limitation, (b) identifying appropriate characteristics for analysis, and + (c) evaluating characteristics to determine whether they are "markedly different". + + +***A.*** ***Selecting The Appropriate + Counterpart(s)***Because the markedly different characteristics + analysis compares the nature-based product limitation to its naturally + occurring counterpart in its natural state, the first step in the analysis is + to select the appropriate counterpart(s) to the nature-based product. + + + + When the nature-based product is derived from + a naturally occurring thing, then the naturally occurring thing is the + counterpart. For example, assume that applicant claims deoxyacid A, which is a + chemical derivative of a naturally occurring chemical called acid A. Because + applicant created the claimed nature-based product (deoxyacid A) by modifying + the naturally occurring acid A, the closest natural counterpart for deoxyacid A + would be the natural product from which it was derived, + *i.e.,* acid A. See, *e.g.,**Chakrabarty,* 447 U.S. at 305 and n.1, 206 USPQ at 195 and + n.1 (counterpart to genetically modified *Pseudomonas* + bacterium containing multiple plasmids is the naturally occurring unmodified + *Pseudomonas* bacterium from which the claimed bacterium + was created); *Roslin,* 750 F.3d at 1337, 110 USPQ2d at + 1671-72 (counterparts to cloned sheep are naturally occurring sheep such as the + donor ewe from which the clone was created). + + + +Although the selected counterpart should be in + its natural state, examiners should take care not to confuse the counterpart + with other material that may occur naturally with, or adjacent to, the + counterpart. For example, assume that applicant claims a nucleic acid having a + nucleotide sequence derived from naturally occurring gene B. Although gene B + occurs in nature as part of a chromosome, the closest natural counterpart for + the claimed nucleic acid is gene B, and not the whole chromosome. See, + e.g., *Ass’n for Molecular Pathology v. Myriad Genetics, + Inc.,* 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013) + (comparing isolated BRCA1 genes and BRCA1 cDNA molecules to naturally occurring + BRCA1 gene); *Roche Molecular System, Inc. v. CEPHEID,* 905 + F.3d 1363, 1371, 128 USPQ2d 1221, 1227 (Fed. Cir. 2018) (comparing claimed + primers to "their corresponding nucleotide sequences on the naturally occurring + DNA"). Similarly, assume that applicant claims a single-stranded piece of DNA + (a primer) having a nucleotide sequence derived from the sense strand of + naturally occurring nucleic acid C. Although nucleic acid C occurs in nature as + a double-stranded molecule having a sense and an antisense strand, the closest + natural counterpart for the claimed nucleic acid is the sense strand of C only. + See, e.g., *University of Utah Research Foundation v. Ambry + Genetics,* 774 F.3d 755, 760, 113 USPQ2d 1241, 1241 (Fed. Cir. + 2014) (comparing single-stranded nucleic acid to the same strand found in + nature, even though "single-stranded DNA cannot be found in the human body"). + + + +When there are multiple counterparts to the + nature-based product, the comparison should be made to the closest naturally + occurring counterpart. For example, assume that applicant creates a cloned + sheep D by transferring nuclear DNA from a Finn-Dorset sheep into an egg cell + (which contains mitochondrial DNA) from a Scottish Blackface sheep. Applicant + then claims sheep D. Here, because sheep D was created via combining DNA from + two different naturally occurring sheep of different breeds, there is no single + closest natural counterpart. The examiner should therefore select the + counterpart most closely related to sheep D based on the examiner’s expertise + in the particular art. For the example discussed here, the closest counterparts + might be naturally occurring Finn-Dorset or Scottish Blackface sheep, as + opposed to sheep of a different breed such as Bighorn sheep. *Cf. + Roslin,* 750 F.3d at 1337, 110 USPQ2d at 1671-72 (claimed sheep + produced by nuclear transfer into an oocyte and subsequent manipulation of + natural embryonic development processes was compared to naturally occurring + sheep such as the donor ewe from which the nuclear material was obtained). When + the nature-based product is a combination produced from multiple components, + the closest counterpart may be the individual nature-based components of the + combination. For example, assume that applicant claims an inoculant comprising + a mixture of bacteria from different species, *e.g.,* some + bacteria of species E and some bacteria of species F. Because there is no + counterpart mixture in nature, the closest counterparts to the claimed mixture + are the individual components of the mixture, *i.e.,* each + naturally occurring species by itself. See, e.g., *Funk + Bros.,* 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture + of bacterial species to each species as it occurs in nature); *Ambry + Genetics,* 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as + a pair, individual primer molecules were compared to corresponding segments of + naturally occurring gene sequence); *In re Bhagat,* 726 Fed. + Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed + mixture of lipids with particular lipid profile to "naturally occurring lipid + profiles of walnut oil and olive oil"). See subsection II. C. + + + +If the claim is rejected as ineligible, it is a + "best practice" for the examiner to identify the selected counterpart in the + Office action if the record is not already clear. This practice assists the + applicant in responding, and clarifies the record as to how the examiner is + interpreting the claim. + + +***B.*** ***Identifying Appropriate Characteristics For + Analysis***Because the markedly different characteristics + analysis is based on comparing the characteristics of the claimed nature-based + product and its counterpart, the second step in the analysis is to identify + appropriate characteristics to compare. + + + +Appropriate characteristics must be possessed + by the claimed product, because it is the claim that must define the invention + to be patented. *Cf. Roslin,* 750 F.3d at 1338, 110 USPQ2d at + 1673 (unclaimed characteristics could not contribute to eligibility). Examiners + can identify the characteristics possessed by the claimed product by looking at + what is recited in the claim language and encompassed within the broadest + reasonable interpretation of the nature-based product. In some claims, a + characteristic may be explicitly recited. For example, in a claim to + "deoxyribose", the recited chemical name informs those in the art of the + structural characteristics of the product (*i.e.,* the "deoxy" + prefix indicates that a hydroxyl group has been removed as compared to ribose). + In other claims, the characteristic may be apparent from the broadest + reasonable interpretation even though it is not explicitly recited in the + claim. For example, in a claim to "isolated gene B," the examiner would need to + rely on the broadest reasonable interpretation of "isolated gene B" to + determine what characteristics the isolated gene has, *e.g.,* + what its nucleotide sequence is, and what, if any, protein it encodes. + + + + Appropriate characteristics can be expressed + as the nature-based product’s structure, function, and/or other properties, and + are evaluated on a case-by-case basis. Non-limiting examples of the types of + characteristics considered by the courts when determining whether there is a + marked difference include: + + + +* • Biological or pharmacological + functions or activities; +* • Chemical and physical properties; +* • Phenotype, including functional and + structural characteristics; and +* • Structure and form, whether chemical, + genetic or physical. + + +Examples of biological or pharmacological + functions or activities include, but are not limited to: + + + +* i. the protein-encoding information of a + nucleic acid, *Myriad,* 569 U.S. at 590-91, 106 USPQ2d + at 1979; +* ii. the ability of complementary nucleotide + sequences to bind to each other, *Ambry Genetics,* 774 + F.3d at 760-61, 113 USPQ2d at 1244; +* iii. the properties and functions of bacteria + such as the ability to infect certain leguminous plants, *Funk + Bros.,* 333 U.S. at 130-31, 76 USPQ2d at 281-82; +* iv. the ability to degrade certain + hydrocarbons, *Diamond v. Chakrabarty,* 447 U.S. at 310, + 206 USPQ2d at 195; and +* v. the ability of vitamin C to prevent and + treat scurvy, *In re King,* 107 F.2d 618, 27 CCPA 754, + 756-57, 43 USPQ 400, 401-402 (CCPA 1939). + + +Examples of chemical and physical properties + include, but are not limited to: + + + +* i. the alkalinity of a chemical compound, + *Parke-Davis & Co. v. H.K. Mulford Co.,* 189 F. + 95, 103-04 (S.D.N.Y. 1911); and +* ii. the ductility or malleability of metals, + *In re Marden,* 47 F.2d 958, 959, 18 CCPA 1057, 1059, + 8 USPQ 347, 349 (CCPA 1931). + + +Examples of phenotypic characteristics include, + but are not limited to: + + + +* i. functional and structural characteristics + such as the shape, size, color, and behavior of an organism, + *Roslin,* 750 F.3d at 1338, 110 USPQ2d at 1672. + + +Examples of structure and form include, but are + not limited to: + + + +* i. physical structure or form such as the + physical presence of plasmids in a bacterial cell, + *Chakrabarty,* 447 U.S. at 305 and n.1, 206 USPQ2d at + 195 and n.1; +* ii. chemical structure and form such as a + chemical being a "nonsalt" and a "crystalline substance", + *Parke-Davis,* 189 F. at 100, 103; +* iii. genetic structure such as the nucleotide + sequence of DNA, *Myriad,* 569 U.S. at 590, 594-95, 106 + USPQ2d at 1979, 1981; and +* iv. the genetic makeup (genotype) of a cell + or organism, *Roslin,* 750 F.3d at 1338-39, 110 USPQ2d + at 1672-73. + +***C.*** ***Evaluating Characteristics To Determine Whether They Are "Markedly + Different"***The final step in the markedly different + characteristics analysis is to compare the characteristics of the claimed + nature-based product to its naturally occurring counterpart in its natural + state, in order to determine whether the characteristics of the claimed product + are markedly different. The courts have emphasized that to show a marked + difference, a characteristic must be changed as compared to nature, and cannot + be an inherent or innate characteristic of the naturally occurring counterpart + or an incidental change in a characteristic of the naturally occurring + counterpart. *Myriad,* 569 U.S. at 580, 106 USPQ2d at 1974-75. + Thus, in order to be markedly different, applicant must have caused the claimed + product to possess at least one characteristic that is different from that of + the counterpart. + + + +If there is no change in any characteristic, + the claimed product lacks markedly different characteristics, and is a product + of nature exception. If there is a change in at least one characteristic as + compared to the counterpart, and the change came about or was produced by + applicant’s efforts or influences, then the change will generally be considered + a markedly different characteristic such that the claimed product is not a + product of nature exception. + + +**1.** **Examples of Products Having Markedly Different + Characteristics**In *Chakrabarty,* the + Supreme Court identified a claimed bacterium as a nature-based product + having markedly different characteristics. This bacterium had a changed + functional characteristic, *i.e.,* it was able to degrade + at least two different hydrocarbons as compared to naturally occurring + *Pseudomonas* bacteria that can only degrade a single + hydrocarbon. The claimed bacterium also had a different structural + characteristic, *i.e.,* it was genetically modified to + include more plasmids than are found in a single naturally occurring + *Pseudomonas* bacterium. The Supreme Court considered + these changed characteristics to be "markedly different characteristics from + any found in nature" due to the additional plasmids and resultant capacity + for degrading multiple hydrocarbon components of oil. Therefore, the + bacterium was eligible. *Diamond v. Chakrabarty*, 447 U.S. + 303, 310, 206 USPQ 193, 197 (1980). + + + +In *Myriad,* the Supreme + Court identified a claimed full-length complementary DNA (cDNA) of the BRCA1 + gene as a nature-based product having markedly different characteristics. + This claimed cDNA had the same functional characteristics (i.e., it encoded + the same protein) as the naturally occurring gene, but had a changed + structural characteristic, *i.e.,* a different nucleotide + sequence containing only exons, as compared to the naturally occurring + sequence containing both exons and introns. The Supreme Court concluded that + the "cDNA retains the naturally occurring exons of DNA, but it is distinct + from the DNA from which it was derived. As a result, [this] cDNA is not a + ‘product of nature’" and is eligible. *Myriad,* 569 U.S. at + 595, 106 USPQ2d at 1981. + + +**2.** **Examples of Products Lacking + Markedly Different Characteristics**In *Myriad,* the Supreme + Court made clear that not all changes in characteristics will rise to the + level of a marked difference, *e.g.,* the incidental + changes resulting from isolation of a gene sequence are not enough to make + the isolated gene markedly different. *Myriad,* 569 U.S. at + 580, 106 USPQ2d at 1974-75. The patentee in *Myriad* had + discovered the location of the BRCA1 and BRCA2 genes in the human genome, + and isolated them, *i.e.,* separated those specific genes + from the rest of the chromosome on which they exist in nature. As a result + of their isolation, the isolated genes had a different structural + characteristic than the natural genes, *i.e.*, the natural + genes had covalent bonds on their ends that connected them to the rest of + the chromosome, but the isolated genes lacked these bonds. However, the + claimed genes were otherwise structurally identical to the natural genes, + *e.g.,* they had the same genetic structure and + nucleotide sequence as the BRCA genes in nature. The Supreme Court concluded + that these isolated but otherwise unchanged genes were not eligible, because + they were not different enough from what exists in nature to avoid + improperly tying up the future use and study of the naturally occurring BRCA + genes. *See, e.g., Myriad,* 569 U.S. at 585, 106 USPQ2d at + 1977 ("Myriad's patents would, if valid, give it the exclusive right to + isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary + to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 + (describing how would-be infringers could not avoid the scope of Myriad’s + claims). In sum, the claimed genes were different, but not markedly + different, from their naturally occurring counterparts (the BRCA genes), and + thus were product of nature exceptions. + + + +In *Ambry Genetics,* the + court identified claimed DNA fragments known as "primers" as products of + nature, because they lacked markedly different characteristics. + *University of Utah Research Foundation v. Ambry Genetics + Corp.,* 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014). The + claimed primers were single-stranded pieces of DNA, each of which + corresponded to a naturally occurring double-stranded DNA sequence in or + near the BRCA genes. The patentee argued that these primers had markedly + different structural characteristics from the natural DNA, because the + primers were synthetically created and because "single-stranded DNA cannot + be found in the human body". The court disagreed, concluding that the + primers’ structural characteristics were not markedly different than the + corresponding strands of DNA in nature, because the primers and their + counterparts had the same genetic structure and nucleotide sequence. 774 + F.3d at 760, 113 USPQ2d at 1243-44. The patentee also argued that the + primers had a different function than when they are part of the DNA strand + because when isolated as a primer, a primer can be used as a starting + material for a DNA polymerization process. The court disagreed, because this + ability to serve as a starting material is innate to DNA itself, and was not + created or altered by the patentee: + + + + +> +> In fact, the naturally occurring genetic +> sequences at issue here do not perform a significantly new function. +> Rather, the naturally occurring material is used to form the first step +> in a chain reaction--a function that is performed because the primer +> maintains the exact same nucleotide sequence as the relevant portion of +> the naturally occurring sequence. One of the primary functions of DNA’s +> structure in nature is that complementary nucleotide sequences bind to +> each other. It is this same function that is exploited here--the primer +> binds to its complementary nucleotide sequence. Thus, just as in nature, +> primers utilize the innate ability of DNA to bind to itself. +> +> +> +> + + +*Ambry Genetics,* 774 F.3d at 760-61, 113 USPQ2d at 1244. + In sum, because the characteristics of the claimed primers were innate to + naturally occurring DNA, they lacked markedly different characteristics from + nature and were thus product of nature exceptions. A similar result was + reached in *Marden,* where the court held a claim to + ductile vanadium ineligible, because the "ductility or malleability of + vanadium is . . . one of its inherent characteristics and not a + characteristic given to it by virtue of a new combination with other + materials or which characteristic is brought about by some chemical reaction + or agency which changes its inherent characteristics". *In re + Marden,* 47 F.2d 958, 959, 18 CCPA 1057, 1060, 8 USPQ 347, 349 + (CCPA 1931). + + + +In *Roslin,* the court + concluded that claimed clones of farm animals were products of nature, + because they lacked markedly different characteristics from the counterpart + farm animals found in nature. *In re Roslin Institute + (Edinburgh),* 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671 (Fed. + Cir. 2014). Applicant created its clones (which included the famous cloned + sheep named Dolly) by transferring the genetic material of a donor into an + oocyte (egg cell), letting the oocyte develop into an embryo, and then + implanting the embryo into a surrogate animal where it developed into a baby + animal. The applicant argued that the clones, including Dolly, were eligible + because they were created via human ingenuity, and had phenotypic + differences such as shape, size and behavior compared to their donors. The + court was unpersuaded, explaining that the clones were exact genetic + replicas of the donors and thus did not possess markedly different + characteristics. 750 F.3d at 1337, 110 USPQ2d at 1671-72 ("Roslin’s chief + innovation was the preservation of the donor DNA such that the clone is an + exact copy of the mammal from which the somatic cell was taken. Such a copy + is not eligible for patent protection."). The court noted that the alleged + phenotypic differences (*e.g.,* the fact that Dolly may + have been taller or heavier than her donor) could not make the clones + markedly different because these differences were not claimed. 750 F.3d at + 1338, 110 USPQ2d at 1672. See also *Roche Molecular System, Inc. v. + CEPHEID,* 905 F.3d 1363, 1370, 128 USPQ2d 1221, 1226 (Fed. Cir. + 2018) (alleged structural differences between linear primers and their + counterparts on a circular chromosome were neither claimed nor relevant to + the eligibility inquiry). + + + + + +# 2106.04(d) Integration of a Judicial Exception Into A + Practical Application [R-10.2019] + + +The Supreme Court has long distinguished between + principles themselves (which are not patent eligible) and the integration of those + principles into practical applications (which are patent eligible). See, + *e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc.,* 566 + U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012) (noting that the Court in + *Diamond v. Diehr* found ‘‘the overall process patent eligible + because of the way the additional steps of the process integrated the equation into + the process as a whole,’’ but the Court in *Gottschalk v. Benson* + ‘‘held that simply implementing a mathematical principle on a physical machine, + namely a computer, was not a patentable application of that principle’’). Similarly, + in a growing body of decisions, the Federal Circuit has distinguished between claims + that are ‘‘directed to’’ a judicial exception (which require further analysis to + determine their eligibility) and those that are not (which are therefore patent + eligible), *e.g.,* claims that improve the functioning of a computer + or other technology or technological field. See *Diamond v. Diehr,* + 450 U.S. 175, 209 USPQ 1 (1981); *Gottschalk v. Benson,* 409 U.S. + 63, 175 USPQ 673 (1972). See, e.g., **[MPEP § + 2106.06(b)](s2106.html#ch2100_d29a1b_13ecb_2ce)** (summarizing *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016), *McRO, + Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, 120 USPQ2d 1091 + (Fed. Cir. 2016), and other cases that were eligible as improvements to technology or + computer functionality instead of being directed to abstract ideas). + + + +Accordingly, after determining that a claim recites a + judicial exception in Step 2A Prong One, examiners should evaluate whether the claim + as a whole integrates the recited judicial exception into a practical application of + the exception in Step 2A Prong Two. A claim that integrates a judicial exception into + a practical application will apply, rely on, or use the judicial exception in a + manner that imposes a meaningful limit on the judicial exception, such that the claim + is more than a drafting effort designed to monopolize the judicial exception. Whether + or not a claim integrates a judicial exception into a practical application is + evaluated using the considerations set forth in subsection I below, in accordance + with the procedure described below in subsection II. + + + +In the context of the flowchart in + **[MPEP § + 2106](s2106.html#d0e197244)**, subsection III, Step 2A Prong Two determines + whether: + + + +* • The claim as a whole integrates the judicial + exception into a practical application, in which case the claim is not directed + to a judicial exception (Step 2A: NO) and is eligible at Pathway B. This + concludes the eligibility analysis. +* • The claim as a whole does not integrate the + exception into a practical application, in which case the claim is directed to + the judicial exception (Step 2A: YES), and requires further analysis under Step + 2B (where it may still be eligible if it amounts to an inventive concept). See + **[MPEP § 2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)** for discussion of Step 2B. + +**I.** **RELEVANT CONSIDERATIONS FOR + EVALUATING WHETHER ADDITIONAL ELEMENTS INTEGRATE A JUDICIAL EXCEPTION INTO A + PRACTICAL APPLICATION**The Supreme Court and Federal Circuit have + identified a number of considerations as relevant to the evaluation of whether the + claimed additional elements demonstrate that a claim is directed to + patent-eligible subject matter. The list of considerations here is not intended to + be exclusive or limiting. Additional elements can often be analyzed based on more + than one type of consideration and the type of consideration is of no import to + the eligibility analysis. Additional discussion of these considerations, and how + they were applied in particular judicial decisions, is provided in + **[MPEP § 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** through **[(c)](s2106.html#ch2100_d29a1b_13cfb_2e)** and **[MPEP § + 2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)** through **[(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**. + + + +Limitations the courts have found indicative that + an additional element (or combination of elements) may have integrated the + exception into a practical application include: + + + +* • An improvement in the functioning of a + computer, or an improvement to other technology or technical field, as + discussed in **[MPEP §§ 2106.04(d)(1)](s2106.html#ch2100_d2e7df_24a6e_1bd)** and + **[2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**; +* • Applying or using a judicial exception to + effect a particular treatment or prophylaxis for a disease or medical + condition, as discussed in **[MPEP § + 2106.04(d)(2)](s2106.html#ch2100_d2e827_17196_6c)**; +* • Implementing a judicial exception with, or + using a judicial exception in conjunction with, a particular machine or + manufacture that is integral to the claim, as discussed in + **[MPEP § 2106.05(b)](s2106.html#ch2100_d29a1b_13ccf_18c)**; +* • Effecting a transformation or reduction of + a particular article to a different state or thing, as discussed in + **[MPEP § 2106.05(c)](s2106.html#ch2100_d29a1b_13cfb_2e)**; and +* • Applying or using the judicial exception + in some other meaningful way beyond generally linking the use of the + judicial exception to a particular technological environment, such that the + claim as a whole is more than a drafting effort designed to monopolize the + exception, as discussed in **[MPEP § + 2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)**. + + +The courts have also identified limitations that + did not integrate a judicial exception into a practical application: + + + +* • Merely reciting the words "apply it" (or + an equivalent) with the judicial exception, or merely including instructions + to implement an abstract idea on a computer, or merely using a computer as a + tool to perform an abstract idea, as discussed in **[MPEP § + 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**; +* • Adding insignificant extra-solution + activity to the judicial exception, as discussed in **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**; and +* • Generally linking the use of a judicial + exception to a particular technological environment or field of use, as + discussed in **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**. + + +Step 2A Prong Two is similar to Step 2B in that + both analyses involve evaluating a set of judicial considerations to determine if + the claim is eligible. See **[MPEP §§ 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** through + **[(h)](s2106.html#ch2100_d29a1b_13e1a_22c)** for the list of considerations that are evaluated + at Step 2B. Although most of these considerations overlap (i.e., they are + evaluated in both Step 2A Prong Two and Step 2B), Step 2A specifically excludes + consideration of whether the additional elements represent well-understood, + routine, conventional activity. Accordingly, in Step 2A Prong Two, examiners + should ensure that they give weight to all additional elements, whether or not + they are conventional, when evaluating whether a judicial exception has been + integrated into a practical application. Additional elements that represent + well-understood, routine, conventional activity may integrate a recited judicial + exception into a practical application. + + + +It is notable that mere physicality or tangibility + of an additional element or elements is not a relevant consideration in Step 2A + Prong Two. As the Supreme Court explained in *Alice Corp.,* mere + physical or tangible implementation of an exception does not guarantee + eligibility. *Alice Corp. Pty. Ltd. v. CLS Bank Int’l,* 573 U.S. + 208, 224, 110 USPQ2d 1976, 1983-84 (2014) ("The fact that a computer ‘necessarily + exist[s] in the physical, rather than purely conceptual, realm,’ is beside the + point"). See also *Genetic Technologies Ltd. v. Merial LLC,* 818 + F.3d 1369, 1377, 118 USPQ2d 1541, 1547 (Fed. Cir. 2016) (steps of DNA + amplification and analysis are not "sufficient" to render claim 1 patent eligible + merely because they are physical steps). Conversely, the presence of a + non-physical or intangible additional element does not doom the claims, because + tangibility is not necessary for eligibility under the + *Alice/Mayo* test. *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016) ("that the + improvement is not defined by reference to ‘physical’ components does not doom the + claims"). See also *McRO, Inc. v. Bandai Namco Games Am. Inc.,* + 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016), (holding that a + process producing an intangible result (a sequence of synchronized, animated + characters) was eligible because it improved an existing technological + process). + + + +In addition, a specific way of achieving a result + is not a stand-alone consideration in Step 2A Prong Two. However, the specificity + of the claim limitations is relevant to the evaluation of several considerations + including the use of a particular machine, particular transformation and whether + the limitations are mere instructions to apply an exception. See + **[MPEP §§ 2106.05(b)](s2106.html#ch2100_d29a1b_13ccf_18c)**, **[2106.05(c)](s2106.html#ch2100_d29a1b_13cfb_2e)**, and **[2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**. For example, in *Parker v. + Flook,* 437 U.S. 584, 198 USPQ 193 (1978), the Supreme Court noted + that the "patent application does not purport to explain how to select the + appropriate margin of safety, the weighting factor, or any of the other variables" + in the claimed mathematical formula, "[n]or does it purport to contain any + disclosure relating to the chemical processes at work, the monitoring of process + variables, or the means of setting off an alarm or adjusting an alarm system." 437 + U.S. at 586, 198 USPQ at 195. The Court found this failure to explain any + specifics of how to use the claimed formula informative when deciding that the + additional elements in the claim were insignificant post-solution activity and + thus not meaningful enough to render the claim eligible. 437 U.S. at 589-90, 198 + USPQ at 197. + + +**II.** **HOW TO EVALUATE WHETHER THE + ADDITIONAL ELEMENTS INTEGRATE THE JUDICIAL EXCEPTION INTO A PRACTICAL + APPLICATION**The analysis under Step 2A Prong Two is the same + for all claims reciting a judicial exception, whether the exception is an abstract + idea, a law of nature, or a natural phenomenon (including products of nature). + Examiners evaluate integration into a practical application by: (1) identifying + whether there are any additional elements recited in the claim beyond the judicial + exception(s); and (2) evaluating those additional elements individually and in + combination to determine whether they integrate the exception into a practical + application, using one or more of the considerations introduced in subsection I + supra, and discussed in more detail in **[MPEP §§ + 2106.04(d)(1)](s2106.html#ch2100_d2e7df_24a6e_1bd)**, **[2106.04(d)(2)](s2106.html#ch2100_d2e827_17196_6c)**, **[2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** through **[(c)](s2106.html#ch2100_d29a1b_13cfb_2e)** and **[2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)** through **[(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**. + + + +Many of these considerations overlap, and often + more than one consideration is relevant to analysis of an additional element. Not + all considerations will be relevant to every element, or every claim. Because the + evaluation in Prong Two is not a weighing test, it is not important how the + elements are characterized or how many considerations apply from the list. It is + important to evaluate the significance of the additional elements relative to + applicant’s invention, and to keep in mind the ultimate question of whether the + exception is integrated into a practical application. If the claim as a whole + integrates the judicial exception into a practical application based upon + evaluation of these considerations, the additional limitations impose a meaningful + limit on the judicial exception and the claim is eligible at Step 2A. + + + +Examiners should examine each claim for + eligibility separately, based on the particular elements recited therein. Claims + should not be judged to automatically stand or fall with similar claims in an + application. For instance, one claim may be ineligible because it is directed to a + judicial exception without amounting to significantly more, but another claim + dependent on the first may be eligible because it recites additional elements that + do amount to significantly more, or that integrate the exception into a practical + application. + + + +For more information on how to evaluate claims + reciting multiple judicial exceptions, see **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, subsection II.B. + + +**III.** **EXAMPLES OF HOW THE OFFICE + EVALUATES WHETHER THE CLAIM AS A WHOLE INTEGRATES THE JUDICIAL EXCEPTION INTO A + PRACTICAL APPLICATION**The Prong Two analysis considers the claim as a + whole. That is, the limitations containing the judicial exception as well as the + additional elements in the claim besides the judicial exception need to be + evaluated together to determine whether the claim integrates the judicial + exception into a practical application. Because a judicial exception alone is not + eligible subject matter, if there are no additional claim elements besides the + judicial exception, or if the additional claim elements merely recite another + judicial exception, that is insufficient to integrate the judicial exception into + a practical application. However, the way in which the additional elements use or + interact with the exception may integrate it into a practical application. + Accordingly, the additional limitations should not be evaluated in a vacuum, + completely separate from the recited judicial exception. Instead, the analysis + should take into consideration all the claim limitations and how those limitations + interact and impact each other when evaluating whether the exception is integrated + into a practical application. + + + +Two examples of how the Office evaluates whether + the claim as a whole integrates the recited judicial exception into a practical + application are provided. In *Solutran, Inc. v. Elavon, Inc.,* + 931 F.3d 1161, 2019 USPQ2d 281076 (Fed. Cir. 2019), the claims were to methods for + electronically processing paper checks, all of which contained limitations setting + forth receiving merchant transaction data from a merchant, crediting a merchant’s + account, and receiving and scanning paper checks after the merchant’s account is + credited. In part one of the *Alice/Mayo* test, the Federal + Circuit determined that the claims were directed to the abstract idea of crediting + the merchant’s account before the paper check is scanned. The court first + determined that the recited limitations of "crediting a merchant’s account as + early as possible while electronically processing a check" is a "long-standing + commercial practice" like in *Alice* and + *Bilski*. 931 F.3d at 1167, 2019 USPQ2d 281076, at \*5 (Fed. + Cir. 2019). The Federal Circuit then continued with its analysis under part one of + the *Alice/Mayo* test finding that the claims are not directed to + an improvement in the functioning of a computer or an improvement to another + technology. In particular, the court determined that the claims "did not improve + the technical capture of information from a check to create a digital file or the + technical step of electronically crediting a bank account" nor did the claims + "improve how a check is scanned." *Id.* This analysis is + equivalent to the Office’s analysis of determining that the exception is not + integrated into a practical application at Step 2A Prong Two, and thus that the + claims are directed to the judicial exception (Step 2A: YES). + + + +In *Finjan Inc. v. Blue Coat Systems, + Inc.,* 879 F.3d 1299, 125 USPQ2d 1282 (Fed. Cir. 2018), the claimed + invention was a method of virus scanning that scans an application program, + generates a security profile identifying any potentially suspicious code in the + program, and links the security profile to the application program. 879 F.3d at + 1303-04, 125 USPQ2d at 1285-86. The Federal Circuit noted that the recited virus + screening was an abstract idea, and that merely performing virus screening on a + computer does not render the claim eligible. 879 F.3d at 1304, 125 USPQ2d at 1286. + The court then continued with its analysis under part one of the + *Alice/Mayo* test by reviewing the patent’s specification, + which described the claimed security profile as identifying both hostile and + potentially hostile operations. The court noted that the security profile thus + enables the invention to protect the user against both previously unknown viruses + and "obfuscated code," as compared to traditional virus scanning, which only + recognized the presence of previously-identified viruses. The security profile + also enables more flexible virus filtering and greater user customization. 879 + F.3d at 1304, 125 USPQ2d at 1286. The court identified these benefits as improving + computer functionality, and verified that the claims recite additional elements + (*e.g.,* specific steps of using the security profile in a + particular way) that reflect this improvement. Accordingly, the court held the + claims eligible as not being directed to the recited abstract idea. 879 F.3d at + 1304-05, 125 USPQ2d at 1286-87. This analysis is equivalent to the Office’s + analysis of determining that the additional elements integrate the judicial + exception into a practical application at Step 2A Prong Two, and thus that the + claims were not directed to the judicial exception (Step 2A: NO). + + + + +# 2106.04(d)(1) Evaluating Improvements in the + Functioning of a Computer, or an Improvement to Any Other Technology or Technical + Field in Step 2A Prong Two [R-10.2019] + + +A claim reciting a judicial exception is not + directed to the judicial exception if it also recites additional elements + demonstrating that the claim as a whole integrates the exception into a practical + application. One way to demonstrate such integration is when the claimed invention + improves the functioning of a computer or improves another technology or technical + field. The application or use of the judicial exception in this manner + meaningfully limits the claim by going beyond generally linking the use of the + judicial exception to a particular technological environment, and thus transforms + a claim into patent-eligible subject matter. Such claims are eligible at Step 2A + because they are not "directed to" the recited judicial exception. + + + +The courts have not provided an explicit test for + this consideration, but have instead illustrated how it is evaluated in numerous + decisions. These decisions, and a detailed explanation of how examiners should + evaluate this consideration are provided in **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**. In short, first the specification should be + evaluated to determine if the disclosure provides sufficient details such that one + of ordinary skill in the art would recognize the claimed invention as providing an + improvement. The specification need not explicitly set forth the improvement, but + it must describe the invention such that the improvement would be apparent to one + of ordinary skill in the art. Conversely, if the specification explicitly sets + forth an improvement but in a conclusory manner (*i.e.,* a bare + assertion of an improvement without the detail necessary to be apparent to a + person of ordinary skill in the art), the examiner should not determine the claim + improves technology. Second, if the specification sets forth an improvement in + technology, the claim must be evaluated to ensure that the claim itself reflects + the disclosed improvement. That is, the claim includes the components or steps of + the invention that provide the improvement described in the specification. The + claim itself does not need to explicitly recite the improvement described in the + specification (*e.g.,* "thereby increasing the bandwidth of the + channel"). + + + +While the courts usually evaluate "improvements" as + part of the "directed to" inquiry in part one of the *Alice/Mayo* + test (equivalent to Step 2A), they have also performed this evaluation in part two + of the *Alice/Mayo* test (equivalent to Step 2B). See, + *e.g., BASCOM Global Internet v. AT&T Mobility LLC,* 827 + F.3d 1341, 1349-50, 119 USPQ2d 1236, 1241-42 (Fed. Cir. 2016). However, the + improvement analysis at Step 2A Prong Two differs in some respects from the + improvements analysis at Step 2B. Specifically, the "improvements" analysis in + Step 2A determines whether the claim pertains to an improvement to the functioning + of a computer or to another technology without reference to what is + well-understood, routine, conventional activity. That is, the claimed invention + may integrate the judicial exception into a practical application by demonstrating + that it improves the relevant existing technology although it may not be an + improvement over well-understood, routine, conventional activity. It should be + noted that while this consideration is often referred to in an abbreviated manner + as the "improvements consideration," the word "improvements" in the context of + this consideration is limited to improvements to the functioning of a computer or + any other technology/technical field, whether in Step 2A Prong Two or in Step + 2B. + + + +Examples of claims that improve technology and are + not directed to a judicial exception include: *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 1339, 118 USPQ2d 1684, 1691-92 (Fed. Cir. 2016) + (claims to a self-referential table for a computer database were directed to an + improvement in computer capabilities and not directed to an abstract idea); + *McRO, Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, + 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016) (claims to automatic lip + synchronization and facial expression animation were directed to an improvement in + computer-related technology and not directed to an abstract idea); *Visual + Memory LLC v. NVIDIA Corp.,* 867 F.3d 1253,1259-60, 123 USPQ2d 1712, + 1717 (Fed. Cir. 2017) (claims to an enhanced computer memory system were directed + to an improvement in computer capabilities and not an abstract idea); + *Finjan Inc. v. Blue Coat Systems, Inc.,* 879 F.3d 1299, 125 + USPQ2d 1282 (Fed. Cir. 2018) (claims to virus scanning were found to be an + improvement in computer technology and not directed to an abstract idea); + *SRI Int’l, Inc. v. Cisco Systems, Inc.,* 930 F.3d 1295, 1303 + (Fed. Cir. 2019) (claims to detecting suspicious activity by using network + monitors and analyzing network packets were found to be an improvement in computer + network technology and not directed to an abstract idea). Additional examples are + provided in **[MPEP § 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**. + + + + + +# 2106.04(d)(2) Particular Treatment and Prophylaxis in + Step 2A Prong Two + + +A claim reciting a judicial exception is not + directed to the judicial exception if it also recites additional element(s) + demonstrating that the claim as a whole integrates the exception into a practical + application. One way to demonstrate such integration is when the additional + elements apply or use the recited judicial exception to effect a particular + treatment or prophylaxis for a disease or medical condition. The application or + use of the judicial exception in this manner meaningfully limits the claim by + going beyond generally linking the use of the judicial exception to a particular + technological environment, and thus transforms a claim into patent-eligible + subject matter. Such claims are eligible at Step 2A, because they are not + "directed to" the recited judicial exception. + + + +The particular treatment or prophylaxis + consideration originated as part of the other meaningful limitations consideration + discussed in **[MPEP § 2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)** and shares the + same legal basis in Supreme Court jurisprudence as that consideration. However, + recent jurisprudence has provided additional guidance that is especially relevant + to only a subset of claims, thus warranting the elevation of the particular + treatment or prophylaxis consideration to become a stand-alone consideration in + the Step 2A Prong Two analysis. *Vanda Pharm. Inc. v. West-Ward Pharm. + Int’l Ltd.,* 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). The + claims in *Vanda* recited a method of treating a patient having + schizophrenia with iloperidone, a drug known to cause QTc prolongation (a + disruption of the heart’s normal rhythm that can lead to serious health problems) + in patients having a particular genotype associated with poor drug metabolism. 887 + F.3d at 1121, 126 USPQ2d at 1269-70. In particular, the claims recited steps of: + (1) performing a genotyping assay to determine if a patient has a genotype + associated with poor drug metabolism; and (2) administering iloperidone to the + patient in a dose range that depends on the patient’s genotype. + *Id.* Although *Vanda’s* claims recited a law + of nature (the naturally occurring relationship between the patient’s genotype and + the risk of QTc prolongation) like the claims in *Mayo Collaborative + Servs. v. Prometheus Labs., Inc.,* 566 U.S. 66, 101 USPQ2d 1961 + (2012), the Federal Circuit distinguished them from the *Mayo* + claims based on the differences in the administration steps. In particular, the + court explained that *Mayo’s* step of administering a drug to a + patient was performed in order to gather data about the recited laws of nature, + and this step was thus ancillary to the overall diagnostic focus of the claims. + 887 F.3d at 1134-35, 126 USPQ2d at 1280. In contrast, *Vanda’s* + claims used the recited law of nature to more safely treat the patients with the + drug, thereby reducing the patient’s risk of QTc prolongation. 887 F.3d at 1135, + 126 USPQ2d at 1280. Accordingly, the court held *Vanda’s* claims + eligible at the first part of the *Alice/Mayo* test (Step 2A) + because the claims were not "directed to" the recited judicial exception. 887 F.3d + at 1136, 126 USPQ2d at 1281. + + + +Examples of "treatment" and prophylaxis" + limitations encompass limitations that treat or prevent a disease or medical + condition, including, e.g., acupuncture, administration of medication, dialysis, + organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and + the like. For example, an immunization step that integrates an abstract idea into + a specific process of immunizing that lowers the risk that immunized patients will + later develop chronic immune-mediated diseases is considered to be a particular + prophylaxis limitation that practically applies the abstract idea. See, + *e.g., Classen Immunotherapies, Inc. v. Biogen IDEC,* 659 F.3d + 1057, 1066–68, 100 USPQ2d 1492, 1500-01 (Fed. Cir. 2011). + + + +Examiners should keep in mind that in order to + qualify as a "treatment" or "prophylaxis" limitation for purposes of this + consideration, the claim limitation in question must affirmatively recite an + action that effects a particular treatment or prophylaxis for a disease or medical + condition. An example of such a limitation is a step of "administering amazonic + acid to a patient" or a step of "administering a course of plasmapheresis to a + patient." If the limitation does not actually provide a treatment or prophylaxis, + *e.g.,* it is merely an intended use of the claimed invention + or a field of use limitation, then it cannot integrate a judicial exception under + the "treatment or prophylaxis" consideration. For example, a step of "prescribing + a topical steroid to a patient with eczema" is not a positive limitation because + it does not require that the steroid actually be used by or on the patient, and a + recitation that a claimed product is a "pharmaceutical composition" or that a + "feed dispenser is operable to dispense a mineral supplement" are not affirmative + limitations because they are merely indicating how the claimed invention might be + used. + + + +When determining whether a claim applies or uses a + recited judicial exception to effect a particular treatment or prophylaxis for a + disease or medical condition, the following factors are relevant. + + + +* a. **The Particularity Or Generality Of The + Treatment Or Prophylaxis** +* The treatment or prophylaxis limitation must + be "particular," *i.e.,* specifically identified so that it + does not encompass all applications of the judicial exception(s). For + example, consider a claim that recites mentally analyzing information to + identify if a patient has a genotype associated with poor metabolism of beta + blocker medications. This falls within the mental process grouping of + abstract ideas enumerated in **[MPEP § + 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**. The claim also recites "administering + a lower than normal dosage of a beta blocker medication to a patient + identified as having the poor metabolizer genotype." This administration + step is particular, and it integrates the mental analysis step into a + practical application. Conversely, consider a claim that recites the same + abstract idea and "administering a suitable medication to a patient." This + administration step is not particular, and is instead merely instructions to + "apply" the exception in a generic way. Thus, the administration step does + not integrate the mental analysis step into a practical application. + Examiners may find it helpful to evaluate + other considerations such as the mere instructions to apply an exception + consideration (see **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), and the + field of use and technological environment consideration (see + **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when + making a determination of whether a treatment or prophylaxis limitation is + particular or general. +* b. **Whether The Limitation(s) Have More + Than A Nominal Or Insignificant Relationship To The + Exception(s)** +* The treatment or prophylaxis limitation must + have more than a nominal or insignificant relationship to the exception(s). + For example, consider a claim that recites a natural correlation (law of + nature) between blood glucose levels over 250 mg/dl and the risk of + developing ketoacidosis (a life-threatening medical condition). The claim + also recites "treating a patient having a blood glucose level over 250 mg/dl + with insulin". Insulin acts to lower blood glucose levels, and administering + insulin to a patient will reduce the patient’s blood glucose level, thereby + lowering the risk that the patient will develop ketoacidosis. Thus, in the + context of this claim, the administration step is significantly related to + the recited correlation between high blood glucose levels and the risk of + ketoacidosis. Because insulin is also a "particular" treatment, this + administration step integrates the law of nature into a practical + application. Alternatively, consider a claim that recites the same law of + nature and also recites "treating a patient having a blood glucose level + over 250 mg/dl with aspirin." Aspirin is not known in the art as a treatment + for ketoacidosis or diabetes, although some patients with diabetes may be on + aspirin therapy for other medical reasons (*e.g.,* to + control pain or inflammation, or to prevent blood clots). In the context of + this claim and the recited correlation between high blood glucose levels and + the risk of ketoacidosis, administration of aspirin has at best a nominal + connection to the law of nature, because aspirin does not treat or prevent + ketoacidosis. This step therefore does not apply or use the exception in any + meaningful way. Thus, this step of administering aspirin does not integrate + the law of nature into a practical application. + Examiners may find it helpful to evaluate + other considerations such as the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the + field of use and technological environment consideration (see + **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when + making a determination of whether a treatment or prophylaxis limitation has + more than a nominal or insignificant relationship to the exception(s). +* c. **Whether The Limitation(s) Are Merely + Extra-Solution Activity Or A Field Of Use** +* The treatment or prophylaxis limitation must + impose meaningful limits on the judicial exception, and cannot be + extra-solution activity or a field-of-use. For example, consider a claim + that recites (a) administering rabies and feline leukemia vaccines to a + first group of domestic cats in accordance with different vaccination + schedules, and (b) analyzing information about the vaccination schedules and + whether the cats later developed chronic immune-mediated disorders to + determine a lowest-risk vaccination schedule. Step (b) falls within the + mental process grouping of abstract ideas enumerated in + **[MPEP § 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**. While + step (a) administers vaccines to the cats, this administration is performed + in order to gather data for the mental analysis step, and is a necessary + precursor for all uses of the recited exception. It is thus extra-solution + activity, and does not integrate the judicial exception into a practical + application. Conversely, consider a claim reciting the same steps (a) and + (b), but also reciting step (c) "vaccinating a second group of domestic cats + in accordance with the lowest-risk vaccination schedule." Step (c) applies + the exception, in that the information from the mental analysis in step (b) + is used to alter the order and timing of the vaccinations so that the second + group of cats has a lower risk of developing chronic immune-mediated + disorders. Step (c) thus integrates the abstract idea into a practical + application. + Examiners may find it helpful to evaluate + other considerations such as the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the + field of use and technological environment consideration (see + **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), when + making a determination of whether a treatment or prophylaxis limitation is + merely extra-solution activity or a field of use. + + + + +, +# 2106.04(a) Abstract Ideas [R-10.2019] + + +The abstract idea exception has deep roots in the + Supreme Court’s jurisprudence. See *Bilski v. Kappos,* 561 U.S. 593, + 601-602, 95 USPQ2d 1001, 1006 (2010) (citing *Le Roy v. Tatham,* 55 + U.S. (14 How.) 156, 174–175 (1853)). Despite this long history, the courts have + declined to define abstract ideas. However, it is clear from the body of judicial + precedent that software and business methods are not excluded categories of subject + matter. For example, the Supreme Court concluded that business methods are not + "categorically outside of **[§ 101's](mpep-9015-appx-l.html#d0e302376)** scope," stating that "a + business method is simply one kind of ‘method’ that is, at least in some + circumstances, eligible for patenting under **[§ 101](mpep-9015-appx-l.html#d0e302376)**." + *Bilski,* 561 U.S. at 607, 95 USPQ2d at 1008 (2010). See also + *Content Extraction and Transmission, LLC v. Wells Fargo Bank,* + 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357 (Fed. Cir. 2014) ("there is no categorical + business-method exception"). Likewise, software is not automatically an abstract + idea, even if performance of a software task involves an underlying mathematical + calculation or relationship. See, *e.g., Thales Visionix, Inc. v. United + States,* 850 F.3d 1343, 121 USPQ2d 1898, 1902 ("That a mathematical + equation is required to complete the claimed method and system does not doom the + claims to abstraction."); *McRO, Inc. v. Bandai Namco Games Am. + Inc.,* 837 F.3d 1299, 1316, 120 USPQ2d 1091, 1103 (Fed. Cir. 2016) + (methods of automatic lip synchronization and facial expression animation using + computer-implemented rules were not directed to an abstract idea); *Enfish,* 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016) (claims to + self-referential table for a computer database were not directed to an abstract + idea). + + + +To facilitate examination, the Office has set forth an + approach to identifying abstract ideas that distills the relevant case law into + enumerated groupings of abstract ideas. The enumerated groupings are firmly rooted in + Supreme Court precedent as well as Federal Circuit decisions interpreting that + precedent, as is explained in **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**. This approach + represents a shift from the former case-comparison approach that required examiners + to rely on individual judicial cases when determining whether a claim recites an + abstract idea. By grouping the abstract ideas, the examiners’ focus has been shifted + from relying on individual cases to generally applying the wide body of case law + spanning all technologies and claim types. + + + +The enumerated groupings of abstract ideas are + defined as: + + + +* 1) Mathematical concepts – mathematical + relationships, mathematical formulas or equations, mathematical calculations + (see **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, + subsection I); +* 2) Certain methods of organizing human activity – + fundamental economic principles or practices (including hedging, insurance, + mitigating risk); commercial or legal interactions (including agreements in the + form of contracts; legal obligations; advertising, marketing or sales + activities or behaviors; business relations); managing personal behavior or + relationships or interactions between people (including social activities, + teaching, and following rules or instructions) (see **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, subsection II); and +* 3) Mental processes – concepts performed in the + human mind (including an observation, evaluation, judgment, opinion) (see + **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, subsection III). + + +Examiners should determine whether a claim recites an + abstract idea by (1) identifying the specific limitation(s) in the claim under + examination that the examiner believes recites an abstract idea, and (2) determining + whether the identified limitations(s) fall within at least one of the groupings of + abstract ideas listed above. The groupings of abstract ideas, and their relationship + to the body of judicial precedent, are further discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**. + + + +If the identified limitation(s) falls within at least + one of the groupings of abstract ideas, it is reasonable to conclude that the claim + recites an abstract idea in Step 2A Prong One. The claim then requires further + analysis in Step 2A Prong Two, to determine whether any additional elements in the + claim integrate the abstract idea into a practical application, see + **[MPEP + § 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)**. + + + +If the identified limitation(s) do not fall within + any of the groupings of abstract ideas, it is reasonable to find that the claim does + not recite an abstract idea. This concludes the abstract idea judicial exception + eligibility analysis, except in the rare circumstance discussed in 2106.04(a)(3), + below. The claim is thus eligible at Pathway B unless the claim recites, and is + directed to, another exception (such as a law of nature or natural phenomenon). + + + +If the claims recites another judicial exception (i.e. + law of nature or natural phenomenon), see **[MPEP §§ + 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)** and **[2106.04(c)](s2106.html#ch2100_d29a1b_13bc1_b1)** for more information on Step 2A analysis. + + + +**[MPEP § 2106.04(a)(1)](s2106.html#ch2100_d29a1b_13b3e_21)** provides + examples of claims that do not recite abstract ideas (or other judicial exceptions) + and thus are eligible at Step 2A Prong One. + + + +**[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** provides + further explanation on the abstract idea groupings. It should be noted that these + groupings are not mutually exclusive, i.e., some claims recite limitations that fall + within more than one grouping or sub-grouping. For example, a claim reciting + performing mathematical calculations using a formula that could be practically + performed in the human mind may be considered to fall within the mathematical + concepts grouping and the mental process grouping. Accordingly, examiners should + identify at least one abstract idea grouping, but preferably identify all groupings + to the extent possible, if a claim limitation(s) is determined to fall within + multiple groupings and proceed with the analysis in Step 2A Prong Two. + + + + +# 2106.04(a)(1) Examples of Claims That Do Not Recite + Abstract Ideas [R-10.2019] + + +When evaluating a claim to determine whether it + recites an abstract idea, examiners should keep in mind that while "all inventions + at some level embody, use, reflect, rest upon, or apply laws of nature, natural + phenomenon, or abstract ideas", not all claims recite an abstract idea. See + *Alice Corp. Pty. Ltd. v. CLS Bank, Int’l,* 573 U.S. 208, 217, + 110 USPQ2d 1976, 1980-81 (2014) (citing *Mayo Collaborative Servs. v. + Prometheus Labs. Inc.,* 566 US 66, 71, 101 USPQ2d 1961, 1965 (2012)). + The Step 2A Prong One analysis articulated in **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)** accounts for this cautionary principle by + requiring a claim to recite (*i.e.,* set forth or describe) an + abstract idea in Prong One before proceeding to the Prong Two inquiry about + whether the claim is directed to that idea, thereby separating claims reciting + abstract ideas from those that are merely based on or involve an abstract + idea. + + + +Some claims are not directed to an abstract idea + because they do not recite an abstract idea, although it may be apparent that at + some level they are based on or involve an abstract idea. Because these claims do + not recite an abstract idea (or other judicial exception), they are eligible at + Step 2A Prong One (Pathway B). + + + +Non-limiting hypothetical examples of claims that + do not recite (set forth or describe) an abstract idea include: + + + +* i. a printer comprising a belt, a roller, a + printhead and at least one ink cartridge; +* ii. a washing machine comprising a tub, a drive + motor operatively connected to the tub, a controller for controlling the + drive motor, and a housing for containing the tub, drive motor, and + controller; +* iii. an earring comprising a sensor for taking + periodic blood glucose measurements and a memory for storing measurement + data from the sensor; +* iv. a method for sequencing BRCA1 gene sequences + comprising: amplifying by a polymerization chain reaction technique all or + part of a BRCA1 gene from a tissue sample from a human subject using a set + of primers to produce amplified nucleic acids; and sequencing the amplified + nucleic acids; and +* v. a method for loading BIOS into a local + computer system which has a system processor and volatile memory and + non-volatile memory, the method comprising the steps of: responding to + powering up of the local computer system by requesting from a memory + location remote from the local computer system the transfer to and storage + in the volatile memory of the local computer system of BIOS configured for + effective use of the local computer system, transferring and storing such + BIOS, and transferring control of the local computer system to such + BIOS; +* vi. a method of rearranging icons on a graphical + user interface (GUI) comprising the steps of: receiving a user selection to + organize each icon based on the amount of use of each icon, determining the + amount of use of each icon by using a processor to track the amount of + memory allocated to the application associated with the icon over a period + of time, and automatically moving the most used icons to a position in the + GUI closest to the start icon of the computer system based on the determined + amount of use; and +* vii. a method of training a neural network for + facial detection comprising: collecting a set of digital facial images, + applying one or more transformations to the digital images, creating a first + training set including the modified set of digital facial images; training + the neural network in a first stage using the first training set, creating a + second training set including digital non-facial images that are incorrectly + detected as facial images in the first stage of training; and training the + neural network in a second stage using the second training set. + + + + +# 2106.04(a)(2) Abstract Idea Groupings [R-10.2019] + +**I.** **MATHEMATICAL + CONCEPTS**The mathematical concepts grouping is defined + as mathematical relationships, mathematical formulas or equations, and + mathematical calculations. The Supreme Court has identified a number of + concepts falling within this grouping as abstract ideas including: a procedure + for converting binary-coded decimal numerals into pure binary form, + *Gottschalk v. Benson,* 409 U.S. 63, 65, 175 USPQ2d 673, + 674 (1972); a mathematical formula for calculating an alarm limit, + *Parker v. Flook,* 437 U.S. 584, 588-89, 198 USPQ2d 193, + 195 (1978); the Arrhenius equation, *Diamond v. Diehr,* 450 + U.S. 175, 191, 209 USPQ 1, 15 (1981); and a mathematical formula for hedging, + *Bilski v. Kappos,* 561 U.S. 593, 611, 95 USPQ 2d 1001, + 1004 (2010). + + + +The Court’s rationale for identifying these + "mathematical concepts" as judicial exceptions is that a ‘‘mathematical formula + as such is not accorded the protection of our patent laws,’’ + *Diehr,* 450 U.S. at 191, 209 USPQ at 15 (citing + *Benson,* 409 U.S. 63, 175 USPQ 673), and thus ‘‘the + discovery of [a mathematical formula] cannot support a patent unless there is + some other inventive concept in its application.’’ *Flook,* + 437 U.S. at 594, 198 USPQ at 199. In the past, the Supreme Court sometimes + described mathematical concepts as laws of nature, and at other times described + these concepts as judicial exceptions without specifying a particular type of + exception. See, *e.g., Benson,* 409 U.S. at 65, 175 USPQ2d at + 674; *Flook,* 437 U.S. at 589, 198 USPQ2d at 197; + *Mackay Radio & Telegraph Co. v. Radio Corp. of Am.,* + 306 U.S. 86, 94, 40 USPQ 199, 202 (1939) (‘‘[A] scientific truth, or the + mathematical expression of it, is not patentable invention[.]’’). More recent + opinions of the Supreme Court, however, have affirmatively characterized + mathematical relationships and formulas as abstract ideas. See, *e.g., + Alice Corp. Pty. Ltd. v. CLS Bank Int’l*, 573 U.S. 208, 218, 110 + USPQ2d 1976, 1981 (describing *Flook* as holding "that a + mathematical formula for computing ‘alarm limits’ in a catalytic conversion + process was also a patent-ineligible abstract idea."); *Bilski v. + Kappos,* 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (noting that + the claimed "concept of hedging, described in claim 1 and reduced to a + mathematical formula in claim 4, is an unpatentable abstract idea,"). + + + +When determining whether a claim recites a + mathematical concept (*i.e.,* mathematical relationships, + mathematical formulas or equations, and mathematical calculations), examiners + should consider whether the claim recites a mathematical concept or merely + limitations that are based on or involve a mathematical concept. A claim does + not recite a mathematical concept (*i.e.,* the claim + limitations do not fall within the mathematical concept grouping), if it is + only based on or involves a mathematical concept. See, *e.g., Thales + Visionix, Inc. v. United States,* 850 F.3d 1343, 1348-49, 121 + USPQ2d 1898, 1902-03 (Fed. Cir. 2017) (determining that the claims to a + particular configuration of inertial sensors and a particular method of using + the raw data from the sensors in order to more accurately calculate the + position and orientation of an object on a moving platform did not merely + recite "the abstract idea of using ‘mathematical equations for determining the + relative position of a moving object to a moving reference frame’."). For + example, a limitation that is merely based on or involves a mathematical + concept described in the specification may not be sufficient to fall into this + grouping, provided the mathematical concept itself is not recited in the claim. + + + +It is important to note that a mathematical + concept need not be expressed in mathematical symbols, because "[w]ords used in + a claim operating on data to solve a problem can serve the same purpose as a + formula." *In re Grams,* 888 F.2d 835, 837 and n.1, 12 USPQ2d + 1824, 1826 and n.1 (Fed. Cir. 1989). See, *e.g., SAP America, Inc. v. + InvestPic, LLC,* 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. + Cir. 2018) (holding that claims to a ‘‘series of mathematical calculations + based on selected information’’ are directed to abstract ideas); + *Digitech Image Techs., LLC v. Elecs. for Imaging, Inc.,* + 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that + claims to a ‘‘process of organizing information through mathematical + correlations’’ are directed to an abstract idea); and *Bancorp Servs., + LLC v. Sun Life Assurance Co. of Can. (U.S.),* 687 F.3d 1266, 1280, + 103 USPQ2d 1425, 1434 (Fed. Cir. 2012) (identifying the concept of ‘‘managing a + stable value protected life insurance policy by performing calculations and + manipulating the results’’ as an abstract idea). + + +***A.*** ***Mathematical Relationships***A mathematical relationship is a + relationship between variables or numbers. A mathematical relationship may + be expressed in words or using mathematical symbols. For example, pressure + (p) can be described as the ratio between the magnitude of the normal force + (F) and area of the surface on contact (A), or it can be set forth in the + form of an equation such as p = F/A. + + + +Examples of mathematical relationships + recited in a claim include: + + + +* i. a relationship between reaction rate + and temperature, which relationship can be expressed in the form of a + formula called the Arrhenius equation, *Diamond v. + Diehr;* 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at + 4-5 (1981); +* ii. a conversion between binary coded + decimal and pure binary, *Benson,* 409 U.S. at 64, + 175 USPQ at 674; +* iii. a mathematical relationship between + enhanced directional radio activity and antenna conductor arrangement + (*i.e.,* the length of the conductors with respect + to the operating wave length and the angle between the conductors), + *Mackay Radio & Tel. Co. v. Radio Corp. of + America,* 306 U.S. 86, 91, 40 USPQ 199, 201 (1939) (while + the litigated claims 15 and 16 of U.S. Patent No. 1,974,387 expressed + this mathematical relationship using a formula that described the + angle between the conductors, other claims in the patent + (*e.g.,* claim 1) expressed the mathematical + relationship in words); and +* iv. organizing information and + manipulating information through mathematical correlations, + *Digitech Image Techs., LLC v. Electronics for Imaging, + Inc.,* 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. + Cir. 2014). The patentee in *Digitech* claimed + methods of generating first and second data by taking existing + information, manipulating the data using mathematical functions, and + organizing this information into a new form. The court explained that + such claims were directed to an abstract idea because they described a + process of organizing information through mathematical correlations, + like *Flook's* method of calculating using a + mathematical formula. 758 F.3d at 1350, 111 USPQ2d at 1721. + +***B.*** ***Mathematical Formulas or Equations***A claim that recites a numerical formula or + equation will be considered as falling within the "mathematical concepts" + grouping. In addition, there are instances where a formula or equation is + written in text format that should also be considered as falling within this + grouping. For example, the phrase "determining a ratio of A to B" is merely + using a textual replacement for the particular equation (ratio = A/B). + Additionally, the phrase "calculating the force of the object by multiplying + its mass by its acceleration" is using a textual replacement for the + particular equation (F= ma). + + + +Examples of mathematical equations or formulas + recited in a claim include: + + + +* i. a formula describing certain + electromagnetic standing wave phenomena, *Mackay Radio & + Tel. Co. v. Radio Corp. of America,* 306 U.S. 86, 91, 40 + USPQ 199, 201 (1939) (50.9(l/lambda<-0.513>); +* ii. the Arrhenius equation, + *Diamond v. Diehr;* 450 U.S. 175, 178 n. 2, 179 + n.5, 191-92, 209 USPQ at 4-5 (1981) (ln v = CZ + x); +* iii. a formula for computing an alarm + limit, *Parker v. Flook,* 437 U.S. 584, 585, 198 USPQ + 193, 195 (1978) (B1=B0 (1.0–F) + PVL(F)); and +* iv. a mathematical formula for hedging + (claim 4), *Bilski v. Kappos,* 561 U.S. 593, 599, 95 + USPQ2d 1001, 1004 (2010) (Fixed Bill Price = Fi + [(Ci + Ti + LDi) x + (α + βE(Wi))]). + +***C.******Mathematical + calculations***A claim that recites a mathematical + calculation, when the claim is given its broadest reasonable interpretation + in light of the specification, will be considered as falling within the + "mathematical concepts" grouping. A mathematical calculation is a + mathematical operation (such as multiplication) or an act of calculating + using mathematical methods to determine a variable or number, + *e.g.,* performing an arithmetic operation such as + exponentiation. There is no particular word or set of words that indicates a + claim recites a mathematical calculation. That is, a claim does not have to + recite the word "calculating" in order to be considered a mathematical + calculation. For example, a step of "determining" a variable or number using + mathematical methods or "performing" a mathematical operation may also be + considered mathematical calculations when the broadest reasonable + interpretation of the claim in light of the specification encompasses a + mathematical calculation. + + + +Examples of mathematical calculations + recited in a claim include: + + + +* i. performing a resampled statistical + analysis to generate a resampled distribution, *SAP America, + Inc. v. Investpic, LLC,* 898 F.3d 1161, 1163-65, 127 + USPQ2d 1597, 1598-1600 (Fed. Cir. 2018), modifying *SAP + America, Inc. v. Investpic, LLC,* 890 F.3d 1016, 126 + USPQ2d 1638 (Fed. Cir. 2018); +* ii. calculating a number representing an + alarm limit value using the mathematical formula + ‘‘B1=B0 (1.0–F) + + PVL(F)’’, *Parker v. Flook,* 437 U.S. 584, 585, 198 + USPQ 193, 195 (1978); +* iii. using a formula to convert geospatial + coordinates into natural numbers, *Burnett v. Panasonic + Corp.,* 741 Fed. Appx. 777, 780 (Fed. Cir. 2018) + (non-precedential); +* iv. managing a stable value protected life + insurance policy via performing calculations, *Bancorp Servs., + LLC v. Sun Life Assur. Co. of Canada (U.S.)*, 687 F.3d + 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012); +* v. using an algorithm for determining the + optimal number of visits by a business representative to a client, + *In re Maucorps,* 609 F.2d 481, 482, 203 USPQ 812, + 813 (CCPA 1979); and +* vi. calculating the difference between + local and average data values, *In re Abele,* 684 + F.2d 902, 903, 214 USPQ 682, 683-84 (CCPA 1982). + +**II.** **CERTAIN METHODS OF ORGANIZING + HUMAN ACTIVITY**The phrase "methods of organizing human + activity" is used to describe concepts relating to: + + + +* • fundamental economic principles or + practices (including hedging, insurance, mitigating risk); +* • commercial or legal interactions + (including agreements in the form of contracts, legal obligations, + advertising, marketing or sales activities or behaviors, and business + relations); and +* • managing personal behavior or + relationships or interactions between people, (including social + activities, teaching, and following rules or instructions). + + +The Supreme Court has identified a number of + concepts falling within the "certain methods of organizing human activity" + grouping as abstract ideas. In particular, in *Alice,* the + Court concluded that the use of a third party to mediate settlement risk is a + ‘‘fundamental economic practice’’ and thus an abstract idea. 573 U.S. at + 219–20, 110 USPQ2d at 1982. In addition, the Court in *Alice* + described the concept of risk hedging identified as an abstract idea in + *Bilski* as ‘‘a method of organizing human activity’’. + *Id.* Previously, in *Bilski,* the Court + concluded that hedging is a ‘‘fundamental economic practice’’ and therefore an + abstract idea. 561 U.S. at 611–612, 95 USPQ2d at 1010. + + + +The term "certain" qualifies the "certain + methods of organizing human activity" grouping as a reminder of several + important points. First, not all methods of organizing human activity are + abstract ideas (*e.g.,* "a defined set of steps for combining + particular ingredients to create a drug formulation" is not a certain "method + of organizing human activity"), *In re Marco Guldenaar Holding + B.V.,* 911 F.3d 1157, 1160-61, 129 USPQ2d 1008, 1011 (Fed. Cir. + 2018). Second, this grouping is limited to activity that falls within the + enumerated sub-groupings of fundamental economic principles or practices, + commercial or legal interactions, and managing personal behavior and + relationships or interactions between people, and is not to be expanded beyond + these enumerated sub-groupings except in rare circumstances as explained in + **[MPEP § 2106.04(a)(3)](s2106.html#ch2100_d2ea80_199c8_1c1)**. Finally, the sub-groupings + encompass both activity of a single person (for example, a person following a + set of instructions or a person signing a contract online) and activity that + involves multiple people (such as a commercial interaction), and thus, certain + activity between a person and a computer (for example a method of anonymous + loan shopping that a person conducts using a mobile phone) may fall within the + "certain methods of organizing human activity" grouping. It is noted that the + number of people involved in the activity is not dispositive as to whether a + claim limitation falls within this grouping. Instead, the determination should + be based on whether the activity itself falls within one of the sub-groupings. + + +***A.******Fundamental Economic Practices or + Principles***The courts have used the phrases "fundamental + economic practices" or "fundamental economic principles" to describe + concepts relating to the economy and commerce. Fundamental economic + principles or practices include hedging, insurance, and mitigating + risks. + + + +The term "fundamental" is not used in the + sense of necessarily being "old" or "well-known." See, *e.g., OIP + Techs., Inc. v. Amazon.com, Inc.*, 788 F.3d 1359, 1364, 115 + U.S.P.Q.2d 1090, 1092 (Fed Cir. 2015) (a new method of price optimization + was found to be a fundamental economic concept); *In re + Smith,* 815 F.3d 816, 818-19, 118 USPQ2d 1245, 1247 (Fed. Cir. + 2016) (describing a new set of rules for conducting a wagering game as a + "fundamental economic practice"); *In re Greenstein,* 774 + Fed. Appx. 661, 664, 2019 USPQ2d 212400 (Fed Cir. 2019) (non-precedential) + (claims to a new method of allocating returns to different investors in an + investment fund was a fundamental economic concept). However, being old or + well-known may indicate that the practice is fundamental. See, + *e.g., Alice Corp. Pty. Ltd. v. CLS Bank Int’l,* 573 + U.S. 208, 219-20, 110 USPQ2d 1981-82 (2014) (describing the concept of + intermediated settlement, like the risk hedging in + *Bilski,* to be a "‘fundamental economic practice long + prevalent in our system of commerce’" and also as "a building block of the + modern economy") (citation omitted); *Bilski v. Kappos,* + 561 U.S. 593, 611, 95 USPQ2d 1001, 1010 (2010) (claims to the concept of + hedging are a "fundamental economic practice long prevalent in our system of + commerce and taught in any introductory finance class.") (citation omitted); + *Intellectual Ventures I LLC v. Symantec Corp.,* 838 + F.3d 1307, 1313, 120 USPQ2d 1353, 1356 (2016) ("The category of abstract + ideas embraces ‘fundamental economic practice[s] long prevalent in our + system of commerce,’ … including ‘longstanding commercial + practice[s]’"). + + + +An example of a case identifying a claim as + reciting a fundamental economic practice is *Bilski v. + Kappos,* 561 U.S. 593, 609, 95 USPQ2d 1001, 1009 (2010). The + fundamental economic practice at issue was hedging or protecting against + risk. The applicant in *Bilski* claimed "a series of steps + instructing how to hedge risk," *i.e.,* how to protect + against risk. 561 U.S. at 599, 95 USPQ2d at 1005. The method allowed energy + suppliers and consumers to minimize the risks resulting from fluctuations in + market demand for energy. The Supreme Court determined that hedging is + "fundamental economic practice" and therefore is an "unpatentable abstract + idea." 561 U.S. at 611-12, 95 USPQ2d at 1010. + + + +Another example of a case identifying a + claim as reciting a fundamental economic practice is *Bancorp + Services., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.),* + 687 F.3d 1266, 103 USPQ2d 1425 (Fed. Cir. 2012). The fundamental economic + practice at issue in *Bancorp* pertained to insurance. The + patentee in *Bancorp* claimed methods and systems for + managing a life insurance policy on behalf of a policy holder, which + comprised steps including generating a life insurance policy including a + stable value protected investment with an initial value based on a value of + underlying securities, calculating surrender value protected investment + credits for the life insurance policy; determining an investment value and a + value of the underlying securities for the current day; and calculating a + policy value and a policy unit value for the current day. 687 F.3d at + 1270-71, 103 USPQ2d at 1427. The court described the claims as an "attempt + to patent the use of the abstract idea of [managing a stable value protected + life insurance policy] and then instruct the use of well-known + [calculations] to help establish some of the inputs into the equation." 687 + F.3d at 1278, 103 USPQ2d at 1433 (alterations in original) (citing + *Bilski*). + + + + Other examples of "fundamental economic + principles or practices" include: + + + +* i. mitigating settlement risk, + *Alice Corp. v. CLS Bank,*573 U.S. 208, 218, 110 + USPQ2d 1976, 1982 (2014); +* ii. rules for conducting a wagering game, + *In re Smith,* 815 F.3d 816, 818-19, 118 USPQ2d + 1245, 1247 (Fed. Cir. 2016); +* iii. financial instruments that are + designed to protect against the risk of investing in financial + instruments, *In re Chorna,* 656 Fed. App'x 1016, + 1021 (Fed. Cir. 2016) (non-precedential); +* iv. offer-based price optimization, + *OIP Techs., Inc. v. Amazon.com, Inc.,* 788 F.3d + 1359, 1362–63, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015); +* v. local processing of payments for + remotely purchased goods, *Inventor Holdings, LLC v. Bed Bath + Beyond,* 876 F.3d 1372, 1378-79, 125 USPQ2d 1019, 1023 + (Fed. Cir. 2017); +* vi. using a marking affixed to the outside + of a mail object to communicate information about the mail object, + *i.e.,* the sender, recipient, and contents of the + mail object, *Secured Mail Solutions LLC v. Universal Wilde, + Inc.,* 873 F.3d 905, 911, 124 USPQ2d 1502, 1506 (Fed. Cir. + 2017); and +* vii. placing an order based on displayed + market information, *Trading Technologies Int’l, Inc. v. IBG + LLC,* 921 F.3d 1084, 1092, 2019 USPQ2d 138290 (Fed. Cir. + 2019). + +***B.*** ***Commercial or Legal Interactions***"Commercial interactions" or "legal + interactions" include agreements in the form of contracts, legal + obligations, advertising, marketing or sales activities or behaviors, and + business relations. + + + +An example of a claim reciting a commercial + or legal interaction, where the interaction is an agreement in the form of + contracts, is found in *buySAFE, Inc. v. Google, Inc.,* 765 + F.3d. 1350, 112 USPQ2d 1093 (Fed. Cir. 2014). The agreement at issue in + *buySAFE* was a transaction performance guaranty, which + is a contractual relationship. 765 F.3d at 1355, 112 USPQ2d at 1096. The + patentee claimed a method in which a computer operated by the provider of a + safe transaction service receives a request for a performance guarantee for + an online commercial transaction, the computer processes the request by + underwriting the requesting party in order to provide the transaction + guarantee service, and the computer offers, via a computer network, a + transaction guaranty that binds to the transaction upon the closing of the + transaction. 765 F.3d at 1351-52, 112 USPQ2d at 1094. The Federal Circuit + described the claims as directed to an abstract idea because they were + "squarely about creating a contractual relationship--a ‘transaction + performance guaranty’." 765 F.3d at 1355, 112 USPQ2d at 1096. + + + +Other examples of subject matter where the + commercial or legal interaction is an agreement in the form of contracts + include: + + + +* i. managing a stable value protected life + insurance policy via performing calculations, *Bancorp Servs., + LLC v. Sun Life Assur. Co. of Canada (U.S.),* 687 F.3d + 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012); and +* ii. processing insurance claims for a + covered loss or policy event under an insurance policy + (*i.e.,* an agreement in the form of a contract), + *Accenture Global Services v. Guidewire Software, + Inc.,* 728 F.3d 1336, 1338-39, 108 USPQ2d 1173, 1175-76 + (Fed. Cir. 2013). + + +An example of a claim reciting a commercial + or legal interaction in the form of a legal obligation is found in + *Fort Properties, Inc. v. American Master Lease, LLC,* + 671 F.3d 1317, 101 USPQ2d 1785 (Fed Cir. 2012). The patentee claimed a + method of "aggregating real property into a real estate portfolio, dividing + the interests in the portfolio into a number of deedshares, and subjecting + those shares to a master agreement." 671 F.3d at 1322, 101 USPQ2d at 1788. + The legal obligation at issue was the tax-free exchanges of real estate. The + Federal Circuit concluded that the real estate investment tool designed to + enable tax-free exchanges was an abstract concept. 671 F.3d at 1323, 101 + USPQ2d at 1789. + + + +Other examples of subject matter where the + commercial or legal interaction is a legal obligation include: + + + +* i. hedging, *Bilski v. + Kappos*, 561 U.S. 593, 595, 95 USPQ2d 1001, 1004 + (2010); +* ii. mitigating settlement risk, + *Alice Corp. Pty. Ltd. v. CLS Bank Int'l,* 573 + U.S. 208, 218, 110 USPQ2d 1976, 1979 (2014); and +* iii. arbitration, *In re + Comiskey*, 554 F.3d 967, 981, 89 USPQ2d 1655, 1665 (Fed. + Cir. 2009). + + +An example of a claim reciting advertising is + found in *Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, + 714-15, 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). The patentee in + *Ultramercial* claimed an eleven-step method for + displaying an advertisement (ad) in exchange for access to copyrighted + media, comprising steps of receiving copyrighted media, selecting an ad, + offering the media in exchange for watching the selected ad, displaying the + ad, allowing the consumer access to the media, and receiving payment from + the sponsor of the ad. 772 F.3d. at 715, 112 USPQ2d at 1754. The Federal + Circuit determined that the "combination of steps recites an abstraction—an + idea, having no particular concrete or tangible form" and thus was directed + to an abstract idea, which the court described as "using advertising as an + exchange or currency." *Id.* + + +Other examples of subject matter where the + commercial or legal interaction is advertising, marketing or sales + activities or behaviors include : + + + +* i. structuring a sales force or marketing + company, which pertains to marketing or sales activities or behaviors, + *In re Ferguson,* 558 F.3d 1359, 1364, 90 USPQ2d + 1035, 1038 (Fed. Cir. 2009); +* ii. using an algorithm for determining the + optimal number of visits by a business representative to a client, + *In re Maucorps,* 609 F.2d 481, 485, 203 USPQ 812, + 816 (CCPA 1979); and +* iii. offer-based price optimization, which + pertains to marketing, *OIP Techs., Inc. v. Amazon.com, + Inc.,* 788 F.3d 1359, 1362-63, 115 USPQ2d 1090, 1092 (Fed. + Cir. 2015). + + + An example of a claim reciting business + relations is found in *Credit Acceptance Corp. v. Westlake + Services,* 859 F.3d 1044, 123 USPQ2d 1100 (Fed. Cir. 2017). The + business relation at issue in *Credit Acceptance* is the + relationship between a customer and dealer when processing a credit + application to purchase a vehicle. The patentee claimed a "system for + maintaining a database of information about the items in a dealer’s + inventory, obtaining financial information about a customer from a user, + combining these two sources of information to create a financing package for + each of the inventoried items, and presenting the financing packages to the + user." 859 F.3d at 1054, 123 USPQ2d at 1108. The Federal Circuit described + the claims as directed to the abstract idea of "processing an application + for financing a loan" and found "no meaningful distinction between this type + of financial industry practice" and the concept of intermediated settlement + in *Alice* or the hedging concept in + *Bilski.* 859 F.3d at 1054, 123 USPQ2d at 1108. + + + +Another example of subject matter where the + commercial or legal interaction is business relations includes: + + + +* i. processing information through a + clearing-house, where the business relation is the relationship + between a party submitted a credit application + (*e.g.,* a car dealer) and funding sources + (*e.g.,* banks) when processing credit + applications, *Dealertrack v. Huber,* 674 F.3d 1315, + 1331, 101 USPQ2d 1325, 1339 (Fed. Cir. 2012). + +***C.*** ***Managing Personal Behavior or Relationships or Interactions + Between People***The sub-grouping "managing personal behavior + or relationships or interactions between people" include social activities, + teaching, and following rules or instructions. + + + +An example of a claim reciting managing + personal behavior is *Intellectual Ventures I LLC v. Capital One + Bank (USA),* 792 F.3d 1363, 115 USPQ2d 1636 (Fed. Cir. 2015). + The patentee in this case claimed methods comprising storing user-selected + pre-set limits on spending in a database, and when one of the limits is + reached, communicating a notification to the user via a device. 792 F.3d. at + 1367, 115 USPQ2d at 1639-40. The Federal Circuit determined that the claims + were directed to the abstract idea of "tracking financial transactions to + determine whether they exceed a pre-set spending limit + (*i.e.,* budgeting)", which "is not meaningfully + different from the ideas found to be abstract in other cases before the + Supreme Court and our court involving methods of organizing human activity." + 792 F.3d. at 1367-68, 115 USPQ2d at 1640. + + + +Other examples of managing personal behavior + recited in a claim include: + + + +* i. filtering content, *BASCOM + Global Internet v. AT&T Mobility, LLC,* 827 F.3d 1341, + 1345-46, 119 USPQ2d 1236, 1239 (Fed. Cir. 2016) (finding that + filtering content was an abstract idea under step 2A, but reversing an + invalidity judgment of ineligibility due to an inadequate step 2B + analysis); +* ii. considering historical usage + information while inputting data, *BSG Tech. LLC v. + Buyseasons, Inc.,* 899 F.3d 1281, 1286, 127 USPQ2d 1688, + 1691; and +* iii. a mental process that a neurologist + should follow when testing a patient for nervous system malfunctions, + *In re Meyer,* 688 F.2d 789, 791-93, 215 USPQ 193, + 194-96 (CCPA 1982). + + +An example of a claim reciting social + activities is *Voter Verified, Inc. v. Election Systems & + Software, LLC,* 887 F.3d 1376, 126 USPQ2d 1498 (Fed. Cir. 2018). + The social activity at issue in *Voter Verified* was + voting. The patentee claimed "[a] method for voting providing for + self-verification of a ballot comprising the steps of" presenting an + election ballot for voting, accepting input of the votes, storing the votes, + printing out the votes, comparing the printed votes to votes stored in the + computer, and determining whether the printed ballot is acceptable. 887 F.3d + at 1384-85, 126 USPQ2d at 1503-04. The Federal Circuit found that the claims + were directed to the abstract idea of "voting, verifying the vote, and + submitting the vote for tabulation", which is a "fundamental activity that + forms the basis of our democracy" and has been performed by humans for + hundreds of years. 887 F.3d at 1385-86, 126 USPQ2d at 1504-05. + + + +Another example of a claim reciting social + activities is *Interval Licensing LLC, v. AOL, Inc.,* 896 + F.3d 1335, 127 USPQ2d 1553 (Fed. Cir. 2018). The social activity at issue + was the social activity of "’providing information to a person without + interfering with the person’s primary activity.’" 896 F.3d at 1344, 127 + USPQ2d 1553 (citing *Interval Licensing LLC v. AOL, Inc.,* + 193 F. Supp.3d 1184, 1188 (W.D. 2014)). The patentee claimed an attention + manager for acquiring content from an information source, controlling the + timing of the display of acquired content, displaying the content, and + acquiring an updated version of the previously-acquired content when the + information source updates its content. 896 F.3d at 1339-40, 127 USPQ2d at + 1555. The Federal Circuit concluded that "[s]tanding alone, the act of + providing someone an additional set of information without disrupting the + ongoing provision of an initial set of information is an abstract idea," + observing that the district court "pointed to the nontechnical human + activity of passing a note to a person who is in the middle of a meeting or + conversation as further illustrating the basic, longstanding practice that + is the focus of the [patent ineligible] claimed invention." 896 F.3d at + 1344-45, 127 USPQ2d at 1559. + + + +An example of a claim reciting following + rules or instructions is *In re Marco Guldenaar Holding + B.V.,* 911 F.3d 1157, 1161, 129 USPQ2d 1008, 1011 (Fed. Cir. + 2018). The patentee claimed a method of playing a dice game including + placing wagers on whether certain die faces will appear face up. 911 F.3d at + 1160; 129 USPQ2d at 1011. The Federal Circuit determined that the claims + were directed to the abstract idea of "rules for playing games", which the + court characterized as a certain method of organizing human activity. 911 + F.3d at 1160-61; 129 USPQ2d at 1011. + + + +Other examples of following rules or + instructions recited in a claim include: + + + +* i. assigning hair designs to balance head + shape, *In re Brown*, 645 Fed. Appx. 1014, 1015-16 + (Fed. Cir. 2016) (non-precedential); and +* ii. a series of instructions of how to + hedge risk, *Bilski v. Kappos*, 561 U.S. 593, 595, 95 + USPQ2d 1001, 1004 (2010). + +**III.** **MENTAL + PROCESSES**The courts consider a mental process (thinking) + that "can be performed in the human mind, or by a human using a pen and paper" + to be an abstract idea. *CyberSource Corp. v. Retail Decisions, + Inc.,* 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). + As the Federal Circuit explained, "methods which can be performed mentally, or + which are the equivalent of human mental work, are unpatentable abstract ideas + the ‘basic tools of scientific and technological work’ that are open to all.’" + 654 F.3d at 1371, 99 USPQ2d at 1694 (citing *Gottschalk v. + Benson,* 409 U.S. 63, 175 USPQ 673 (1972)). See also *Mayo + Collaborative Servs. v. Prometheus Labs. Inc.,* 566 U.S. 66, 71, + 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual + concepts are not patentable, as they are the basic tools of scientific and + technological work’" (quoting *Benson,* 409 U.S. at 67, 175 + USPQ at 675)); *Parker v. Flook,* 437 U.S. 584, 589, 198 USPQ + 193, 197 (1978) (same). + + + +Accordingly, the "mental processes" abstract + idea grouping is defined as concepts performed in the human mind, and examples + of mental processes include observations, evaluations, judgments, and opinions. + A discussion of concepts performed in the human mind, as well as concepts that + cannot practically be performed in the human mind and thus are not "mental + processes", is provided below with respect to point A. + + + +The courts do not distinguish between mental + processes that are performed entirely in the human mind and mental processes + that require a human to use a physical aid (*e.g.,* pen and + paper or a slide rule) to perform the claim limitation. See, *e.g., + Benson,* 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that + the claimed "conversion of [binary-coded decimal] numerals to pure binary + numerals can be done mentally," *i.e.,* "as a person would do + it by head and hand."); *Synopsys, Inc. v. Mentor Graphics + Corp.,* 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) + (holding that claims to a mental process of "translating a functional + description of a logic circuit into a hardware component description of the + logic circuit" are directed to an abstract idea, because the claims "read on an + individual performing the claimed steps mentally or with pencil and paper"). + Mental processes performed by humans with the assistance of physical aids such + as pens or paper are explained further below with respect to point B. + + + +Nor do the courts distinguish between claims + that recite mental processes performed by humans and claims that recite mental + processes performed on a computer. As the Federal Circuit has explained, + "[c]ourts have examined claims that required the use of a computer and still + found that the underlying, patent-ineligible invention could be performed via + pen and paper or in a person’s mind." *Versata Dev. Group v. SAP Am., + Inc.,* 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). + See also *Intellectual Ventures I LLC v. Symantec Corp.,* 838 + F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception + of generic computer-implemented steps, there is nothing in the claims + themselves that foreclose them from being performed by a human, mentally or + with pen and paper.’’); *Mortgage Grader, Inc. v. First Choice Loan + Servs. Inc.,* 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. + 2016) (holding that computer-implemented method for "anonymous loan shopping" + was an abstract idea because it could be "performed by humans without a + computer"). Mental processes recited in claims that require computers are + explained further below with respect to point C. + + + +Because both product and process claims may + recite a "mental process", the phrase "mental processes" should be understood + as referring to the type of abstract idea, and not to the statutory category of + the claim. The courts have identified numerous product claims as reciting + mental process-type abstract ideas, for instance the product claims to computer + systems and computer-readable media in *Versata Dev. Group. v. SAP Am., + Inc.,* 793 F.3d 1306, 115 USPQ2d 1681 (Fed. Cir. 2015). This + concept is explained further below with respect to point D. + + + +The following discussion is meant to guide + examiners and provide more information on how to determine whether a claim + recites a mental process. Examiners should keep in mind the following points A, + B, C, and D when performing this evaluation. + + +***A.*** ***A Claim With Limitation(s) That Cannot Practically be Performed + in the Human Mind Does Not Recite a Mental + Process.***Claims do not recite a mental process when + they do not contain limitations that can practically be performed in the + human mind, for instance when the human mind is not equipped to perform the + claim limitations. See *SRI Int’l, Inc. v. Cisco Systems, + Inc.,* 930 F.3d 1295, 1304 (Fed. Cir. 2019) (declining to + identify the claimed collection and analysis of network data as abstract + because "the human mind is not equipped to detect suspicious activity by + using network monitors and analyzing network packets as recited by the + claims"); *CyberSource,* 654 F.3d at 1376, 99 USPQ2d at + 1699 (distinguishing *Research Corp. Techs. v. Microsoft + Corp.,* 627 F.3d 859, 97 USPQ2d 1274 (Fed. Cir. 2010), and + *SiRF Tech., Inc. v. Int’l Trade Comm’n,* 601 F.3d 1319, + 94 USPQ2d 1607 (Fed. Cir. 2010), as directed to inventions that ‘‘could not, + as a practical matter, be performed entirely in a human’s mind’’). + + + +Examples of claims that do not recite mental + processes because they cannot be practically performed in the human mind + include: + + + +* • a claim to a method for calculating + an absolute position of a GPS receiver and an absolute time of + reception of satellite signals, where the claimed GPS receiver + calculated pseudoranges that estimated the distance from the GPS + receiver to a plurality of satellites, *SiRF Tech.,* + 601 F.3d at 1331-33, 94 USPQ2d at 1616-17; +* • a claim to detecting suspicious + activity by using network monitors and analyzing network packets, + *SRI Int’l,* 930 F.3d at 1304; +* • a claim to a specific data + encryption method for computer communication involving a several-step + manipulation of data, *Synopsys.,* 839 F.3d at 1148, + 120 USPQ2d at 1481 (distinguishing the claims in *TQP + Development, LLC v. Intuit Inc.,* 2014 WL 651935 (E.D. + Tex. Feb. 19, 2014)); and +* • a claim to a method for rendering a + halftone image of a digital image by comparing, pixel by pixel, the + digital image against a blue noise mask, where the method required the + manipulation of computer data structures (*e.g.,* the + pixels of a digital image and a two-dimensional array known as a mask) + and the output of a modified computer data structure (a halftoned + digital image), *Research Corp. Techs.,* 627 F.3d at + 868, 97 USPQ2d at 1280. + + +In contrast, claims do recite a mental + process when they contain limitations that can practically be performed in + the human mind, including for example, observations, evaluations, judgments, + and opinions. Examples of claims that recite mental processes include: + + + +* • a claim to "collecting information, + analyzing it, and displaying certain results of the collection and + analysis," where the data analysis steps are recited at a high level + of generality such that they could practically be performed in the + human mind, *Electric Power Group v. Alstom, S.A.,* + 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016); +* • claims to "comparing BRCA sequences + and determining the existence of alterations," where the claims cover + any way of comparing BRCA sequences such that the comparison steps can + practically be performed in the human mind, *University of + Utah Research Foundation v. Ambry Genetics,* 774 F.3d 755, + 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014); +* • a claim to collecting and comparing + known information (claim 1), which are steps that can be practically + performed in the human mind, *Classen Immunotherapies, Inc. v. + Biogen IDEC,* 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 + (Fed. Cir. 2011); and +* • a claim to identifying head shape + and applying hair designs, which is a process that can be practically + performed in the human mind, *In re Brown,* 645 Fed. + App'x 1014, 1016-17 (Fed. Cir. 2016) (non-precedential). + +***B.*** ***A Claim That Encompasses a Human Performing the Step(s) + Mentally With or Without a Physical Aid Recites a Mental + Process.***If a claim recites a limitation that can + practically be performed in the human mind, with or without the use of a + physical aid such as pen and paper, the limitation falls within the mental + processes grouping, and the claim recites an abstract idea. See, + *e.g., Benson,* 409 U.S. at 67, 65, 175 USPQ at 674-75, + 674 (noting that the claimed "conversion of [binary-coded decimal] numerals + to pure binary numerals can be done mentally," *i.e.,* "as + a person would do it by head and hand."); *Synopsys,* 839 + F.3d at 1139, 120 USPQ2d at 1474 (holding that claims to the mental process + of "translating a functional description of a logic circuit into a hardware + component description of the logic circuit" are directed to an abstract + idea, because the claims "read on an individual performing the claimed steps + mentally or with pencil and paper"). + + + +The use of a physical aid + (*e.g.,* pencil and paper or a slide rule) to help + perform a mental step (*e.g.,* a mathematical calculation) + does not negate the mental nature of the limitation, but simply accounts for + variations in memory capacity from one person to another. For instance, in + *CyberSource,* the court determined that the step of + "constructing a map of credit card numbers" was a limitation that was able + to be performed "by writing down a list of credit card transactions made + from a particular IP address." In making this determination, the court + looked to the specification, which explained that the claimed map was + nothing more than a listing of several (*e.g.,* four) + credit card transactions. The court concluded that this step was able to be + performed mentally with a pen and paper, and therefore, it qualified as a + mental process. 654 F.3d at 1372-73, 99 USPQ2d at 1695. See also + *Flook,* 437 U.S. at 586, 198 USPQ at 196 (claimed + "computations can be made by pencil and paper calculations"); + *University of Florida Research Foundation, Inc. v. General + Electric Co.,* 916 F.3d 1363, 1367, 129 USPQ2d 1409, 1411-12 + (Fed. Cir. 2019) (relying on specification’s description of the claimed + analysis and manipulation of data as being performed mentally "‘using pen + and paper methodologies, such as flowsheets and patient charts’"); + *Symantec,* 838 F.3d at 1318, 120 USPQ2d at 1360 + (although claimed as computer-implemented, steps of screening messages can + be "performed by a human, mentally or with pen and paper"). + + +***C.*** ***A Claim That Requires a Computer May Still Recite a Mental + Process.***Claims can recite a mental process even if + they are claimed as being performed on a computer. The Supreme Court + recognized this in *Benson,* determining that a + mathematical algorithm for converting binary coded decimal to pure binary + within a computer’s shift register was an abstract idea. The Court concluded + that the algorithm could be performed purely mentally even though the + claimed procedures "can be carried out in existing computers long in use, no + new machinery being necessary." 409 U.S at 67, 175 USPQ at 675. See also + *Mortgage Grader,* 811 F.3d at 1324, 117 USPQ2d at 1699 + (concluding that concept of "anonymous loan shopping" recited in a computer + system claim is an abstract idea because it could be "performed by humans + without a computer"). + + + +In evaluating whether a claim that requires a + computer recites a mental process, examiners should carefully consider the + broadest reasonable interpretation of the claim in light of the + specification. For instance, examiners should review the specification to + determine if the claimed invention is described as a concept that is + performed in the human mind and applicant is merely claiming that concept + performed 1) on a generic computer, or 2) in a computer environment, or 3) + is merely using a computer as a tool to perform the concept. In these + situations, the claim is considered to recite a mental process. + + + +* 1. **Performing a mental process on a + generic computer.** An example of a case identifying a mental + process performed on a generic computer as an abstract idea is + *Voter Verified, Inc. v. Election Systems & Software, + LLC,* 887 F.3d 1376, 1385, 126 USPQ2d 1498, 1504 (Fed. + Cir. 2018). In this case, the Federal Circuit relied upon the + specification in explaining that the claimed steps of voting, + verifying the vote, and submitting the vote for tabulation are "human + cognitive actions" that humans have performed for hundreds of years. + The claims therefore recited an abstract idea, despite the fact that + the claimed voting steps were performed on a computer. 887 F.3d at + 1385, 126 USPQ2d at 1504. Another example is + *Versata,* in which the patentee claimed a system + and method for determining a price of a product offered to a + purchasing organization that was implemented using general purpose + computer hardware. 793 F.3d at 1312-13, 1331, 115 USPQ2d at 1685, + 1699. The Federal Circuit acknowledged that the claims were performed + on a generic computer, but still described the claims as "directed to + the abstract idea of determining a price, using organizational and + product group hierarchies, in the same way that the claims in + *Alice* were directed to the abstract idea of + intermediated settlement, and the claims in Bilski were directed to + the abstract idea of risk hedging." 793 F.3d at 1333; 115 USPQ2d at + 1700-01. +* 2. **Performing a mental process in a + computer environment.** An example of a case identifying a + mental process performed in a computer environment as an abstract idea + is *Symantec Corp.,* 838 F.3d at 1316-18, 120 USPQ2d + at 1360. In this case, the Federal Circuit relied upon the + specification when explaining that the claimed electronic post office, + which recited limitations describing how the system would receive, + screen and distribute email on a computer network, was analogous to + how a person decides whether to read or dispose of a particular piece + of mail and that "with the exception of generic computer-implemented + steps, there is nothing in the claims themselves that foreclose them + from being performed by a human, mentally or with pen and paper". 838 + F.3d at 1318, 120 USPQ2d at 1360. Another example is + *FairWarning IP, LLC v. Iatric Sys., Inc.,* 839 + F.3d 1089, 120 USPQ2d 1293 (Fed. Cir. 2016). The patentee in + *FairWarning* claimed a system and method of + detecting fraud and/or misuse in a computer environment, in which + information regarding accesses of a patient’s personal health + information was analyzed according to one of several rules + (*i.e.,* related to accesses in excess of a + specific volume, accesses during a pre-determined time interval, or + accesses by a specific user) to determine if the activity indicates + improper access. 839 F.3d. at 1092, 120 USPQ2d at 1294. The court + determined that these claims were directed to a mental process of + detecting misuse, and that the claimed rules here were "the same + questions (though perhaps phrased with different words) that humans in + analogous situations detecting fraud have asked for decades, if not + centuries." 839 F.3d. at 1094-95, 120 USPQ2d at 1296. +* 3. **Using a computer as a tool to + perform a mental process.** An example of a case in which a + computer was used as a tool to perform a mental process is + *Mortgage Grader,* 811 F.3d. at 1324, 117 USPQ2d + at 1699. The patentee in *Mortgage Grader* claimed a + computer-implemented system for enabling borrowers to anonymously shop + for loan packages offered by a plurality of lenders, comprising a + database that stores loan package data from the lenders, and a + computer system providing an interface and a grading module. The + interface prompts a borrower to enter personal information, which the + grading module uses to calculate the borrower’s credit grading, and + allows the borrower to identify and compare loan packages in the + database using the credit grading. 811 F.3d. at 1318, 117 USPQ2d at + 1695. The Federal Circuit determined that these claims were directed + to the concept of "anonymous loan shopping", which was a concept that + could be "performed by humans without a computer." 811 F.3d. at 1324, + 117 USPQ2d at 1699. Another example is *Berkheimer v. HP, + Inc.,* 881 F.3d 1360, 125 USPQ2d 1649 (Fed. Cir. 2018), in + which the patentee claimed methods for parsing and evaluating data + using a computer processing system. The Federal Circuit determined + that these claims were directed to mental processes of parsing and + comparing data, because the steps were recited at a high level of + generality and merely used computers as a tool to perform the + processes. 881 F.3d at 1366, 125 USPQ2d at 1652-53. + +***D.*** ***Both Product and + Process Claims May Recite a Mental + Process.***Examiners should keep in mind that both + product claims (*e.g.,* computer system, computer-readable + medium, etc.) and process claims may recite mental processes. For example, + in *Mortgage Grader,* the patentee claimed a + computer-implemented system and a method for enabling borrowers to + anonymously shop for loan packages offered by a plurality of lenders, + comprising a database that stores loan package data from the lenders, and a + computer system providing an interface and a grading module. The Federal + Circuit determined that both the computer-implemented system and method + claims were directed to "anonymous loan shopping", which was an abstract + idea because it could be "performed by humans without a computer." 811 F.3d. + at 1318, 1324-25, 117 USPQ2d at 1695, 1699-1700. See also + *FairWarning IP,* 839 F.3d at 1092, 120 USPQ2d at 1294 + (identifying both system and process claims for detecting improper access of + a patient's protected health information in a health-care system computer + environment as directed to abstract idea of detecting fraud); + *Content Extraction & Transmission LLC v. Wells Fargo Bank, + N.A.,* 776 F.3d 1343, 1345, 113 USPQ2d 1354, 1356 (system and + method claims of inputting information from a hard copy document into a + computer program). Accordingly, the phrase "mental processes" should be + understood as referring to the type of abstract idea, and not to the + statutory category of the claim. + + + +Examples of product claims reciting mental + processes include: + + + +* • An application program interface for + extracting and processing information from a diversity of types of + hard copy documents – *Content Extraction,* 776 F.3d + at 1345, 113 USPQ2d at 1356; +* • A computer-implemented system for + enabling anonymous loan shopping – *Mortgage Grader,* + 811 F.3d at 1318, 117 USPQ2d at 1695; +* • A computer readable medium + containing program instructions for detecting fraud – + *CyberSource,* 654 F.3d at 1368 n. 1, 99 USPQ2d at + 1692 n.1; +* • A post office for receiving and + redistributing email messages on a computer network – + *Symantec,* 838 F.3d at 1316, 120 USPQ2d at 1359; +* • A self-verifying voting system – + *Voter Verified,* 887 F.3d at 1384-85, 126 USPQ2d + at 1504; +* • A wide-area real-time performance + monitoring system for monitoring and assessing dynamic stability of an + electric power grid – *Electric Power Group,* 830 + F.3d at 1351 and n.1, 119 USPQ2d at 1740 and n.1; and +* • Computer readable storage media + comprising computer instructions to implement a method for determining + a price of a product offered to a purchasing organization – + *Versata,* 793 F.3d at 1312-13, 115 USPQ2d at + 1685. + + +Examples of process claims reciting mental + process-type abstract ideas are discussed in the preceding subsections (A) + through (C). See, for example, the discussion of *Flook,* + 437 U.S. 584, 198 USPQ 193; *Benson,* 409 U.S. 63, 175 USPQ + 673; *Berkheimer,* 881 F.3d 1360, 125 USPQ2d 1649; + *Synopsys,* 839 F.3d 1138, 120 USPQ2d 1473; and + *Ambry Genetics,* 774 F.3d 755, 113 USPQ2d 1241, + *supra*. + + + + +, +# 2106.04(a)(1) Examples of Claims That Do Not Recite + Abstract Ideas [R-10.2019] + + +When evaluating a claim to determine whether it + recites an abstract idea, examiners should keep in mind that while "all inventions + at some level embody, use, reflect, rest upon, or apply laws of nature, natural + phenomenon, or abstract ideas", not all claims recite an abstract idea. See + *Alice Corp. Pty. Ltd. v. CLS Bank, Int’l,* 573 U.S. 208, 217, + 110 USPQ2d 1976, 1980-81 (2014) (citing *Mayo Collaborative Servs. v. + Prometheus Labs. Inc.,* 566 US 66, 71, 101 USPQ2d 1961, 1965 (2012)). + The Step 2A Prong One analysis articulated in **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)** accounts for this cautionary principle by + requiring a claim to recite (*i.e.,* set forth or describe) an + abstract idea in Prong One before proceeding to the Prong Two inquiry about + whether the claim is directed to that idea, thereby separating claims reciting + abstract ideas from those that are merely based on or involve an abstract + idea. + + + +Some claims are not directed to an abstract idea + because they do not recite an abstract idea, although it may be apparent that at + some level they are based on or involve an abstract idea. Because these claims do + not recite an abstract idea (or other judicial exception), they are eligible at + Step 2A Prong One (Pathway B). + + + +Non-limiting hypothetical examples of claims that + do not recite (set forth or describe) an abstract idea include: + + + +* i. a printer comprising a belt, a roller, a + printhead and at least one ink cartridge; +* ii. a washing machine comprising a tub, a drive + motor operatively connected to the tub, a controller for controlling the + drive motor, and a housing for containing the tub, drive motor, and + controller; +* iii. an earring comprising a sensor for taking + periodic blood glucose measurements and a memory for storing measurement + data from the sensor; +* iv. a method for sequencing BRCA1 gene sequences + comprising: amplifying by a polymerization chain reaction technique all or + part of a BRCA1 gene from a tissue sample from a human subject using a set + of primers to produce amplified nucleic acids; and sequencing the amplified + nucleic acids; and +* v. a method for loading BIOS into a local + computer system which has a system processor and volatile memory and + non-volatile memory, the method comprising the steps of: responding to + powering up of the local computer system by requesting from a memory + location remote from the local computer system the transfer to and storage + in the volatile memory of the local computer system of BIOS configured for + effective use of the local computer system, transferring and storing such + BIOS, and transferring control of the local computer system to such + BIOS; +* vi. a method of rearranging icons on a graphical + user interface (GUI) comprising the steps of: receiving a user selection to + organize each icon based on the amount of use of each icon, determining the + amount of use of each icon by using a processor to track the amount of + memory allocated to the application associated with the icon over a period + of time, and automatically moving the most used icons to a position in the + GUI closest to the start icon of the computer system based on the determined + amount of use; and +* vii. a method of training a neural network for + facial detection comprising: collecting a set of digital facial images, + applying one or more transformations to the digital images, creating a first + training set including the modified set of digital facial images; training + the neural network in a first stage using the first training set, creating a + second training set including digital non-facial images that are incorrectly + detected as facial images in the first stage of training; and training the + neural network in a second stage using the second training set. + + +, +# 2106.04(a)(2) Abstract Idea Groupings [R-10.2019] + +**I.** **MATHEMATICAL + CONCEPTS**The mathematical concepts grouping is defined + as mathematical relationships, mathematical formulas or equations, and + mathematical calculations. The Supreme Court has identified a number of + concepts falling within this grouping as abstract ideas including: a procedure + for converting binary-coded decimal numerals into pure binary form, + *Gottschalk v. Benson,* 409 U.S. 63, 65, 175 USPQ2d 673, + 674 (1972); a mathematical formula for calculating an alarm limit, + *Parker v. Flook,* 437 U.S. 584, 588-89, 198 USPQ2d 193, + 195 (1978); the Arrhenius equation, *Diamond v. Diehr,* 450 + U.S. 175, 191, 209 USPQ 1, 15 (1981); and a mathematical formula for hedging, + *Bilski v. Kappos,* 561 U.S. 593, 611, 95 USPQ 2d 1001, + 1004 (2010). + + + +The Court’s rationale for identifying these + "mathematical concepts" as judicial exceptions is that a ‘‘mathematical formula + as such is not accorded the protection of our patent laws,’’ + *Diehr,* 450 U.S. at 191, 209 USPQ at 15 (citing + *Benson,* 409 U.S. 63, 175 USPQ 673), and thus ‘‘the + discovery of [a mathematical formula] cannot support a patent unless there is + some other inventive concept in its application.’’ *Flook,* + 437 U.S. at 594, 198 USPQ at 199. In the past, the Supreme Court sometimes + described mathematical concepts as laws of nature, and at other times described + these concepts as judicial exceptions without specifying a particular type of + exception. See, *e.g., Benson,* 409 U.S. at 65, 175 USPQ2d at + 674; *Flook,* 437 U.S. at 589, 198 USPQ2d at 197; + *Mackay Radio & Telegraph Co. v. Radio Corp. of Am.,* + 306 U.S. 86, 94, 40 USPQ 199, 202 (1939) (‘‘[A] scientific truth, or the + mathematical expression of it, is not patentable invention[.]’’). More recent + opinions of the Supreme Court, however, have affirmatively characterized + mathematical relationships and formulas as abstract ideas. See, *e.g., + Alice Corp. Pty. Ltd. v. CLS Bank Int’l*, 573 U.S. 208, 218, 110 + USPQ2d 1976, 1981 (describing *Flook* as holding "that a + mathematical formula for computing ‘alarm limits’ in a catalytic conversion + process was also a patent-ineligible abstract idea."); *Bilski v. + Kappos,* 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (noting that + the claimed "concept of hedging, described in claim 1 and reduced to a + mathematical formula in claim 4, is an unpatentable abstract idea,"). + + + +When determining whether a claim recites a + mathematical concept (*i.e.,* mathematical relationships, + mathematical formulas or equations, and mathematical calculations), examiners + should consider whether the claim recites a mathematical concept or merely + limitations that are based on or involve a mathematical concept. A claim does + not recite a mathematical concept (*i.e.,* the claim + limitations do not fall within the mathematical concept grouping), if it is + only based on or involves a mathematical concept. See, *e.g., Thales + Visionix, Inc. v. United States,* 850 F.3d 1343, 1348-49, 121 + USPQ2d 1898, 1902-03 (Fed. Cir. 2017) (determining that the claims to a + particular configuration of inertial sensors and a particular method of using + the raw data from the sensors in order to more accurately calculate the + position and orientation of an object on a moving platform did not merely + recite "the abstract idea of using ‘mathematical equations for determining the + relative position of a moving object to a moving reference frame’."). For + example, a limitation that is merely based on or involves a mathematical + concept described in the specification may not be sufficient to fall into this + grouping, provided the mathematical concept itself is not recited in the claim. + + + +It is important to note that a mathematical + concept need not be expressed in mathematical symbols, because "[w]ords used in + a claim operating on data to solve a problem can serve the same purpose as a + formula." *In re Grams,* 888 F.2d 835, 837 and n.1, 12 USPQ2d + 1824, 1826 and n.1 (Fed. Cir. 1989). See, *e.g., SAP America, Inc. v. + InvestPic, LLC,* 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. + Cir. 2018) (holding that claims to a ‘‘series of mathematical calculations + based on selected information’’ are directed to abstract ideas); + *Digitech Image Techs., LLC v. Elecs. for Imaging, Inc.,* + 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that + claims to a ‘‘process of organizing information through mathematical + correlations’’ are directed to an abstract idea); and *Bancorp Servs., + LLC v. Sun Life Assurance Co. of Can. (U.S.),* 687 F.3d 1266, 1280, + 103 USPQ2d 1425, 1434 (Fed. Cir. 2012) (identifying the concept of ‘‘managing a + stable value protected life insurance policy by performing calculations and + manipulating the results’’ as an abstract idea). + + +***A.*** ***Mathematical Relationships***A mathematical relationship is a + relationship between variables or numbers. A mathematical relationship may + be expressed in words or using mathematical symbols. For example, pressure + (p) can be described as the ratio between the magnitude of the normal force + (F) and area of the surface on contact (A), or it can be set forth in the + form of an equation such as p = F/A. + + + +Examples of mathematical relationships + recited in a claim include: + + + +* i. a relationship between reaction rate + and temperature, which relationship can be expressed in the form of a + formula called the Arrhenius equation, *Diamond v. + Diehr;* 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at + 4-5 (1981); +* ii. a conversion between binary coded + decimal and pure binary, *Benson,* 409 U.S. at 64, + 175 USPQ at 674; +* iii. a mathematical relationship between + enhanced directional radio activity and antenna conductor arrangement + (*i.e.,* the length of the conductors with respect + to the operating wave length and the angle between the conductors), + *Mackay Radio & Tel. Co. v. Radio Corp. of + America,* 306 U.S. 86, 91, 40 USPQ 199, 201 (1939) (while + the litigated claims 15 and 16 of U.S. Patent No. 1,974,387 expressed + this mathematical relationship using a formula that described the + angle between the conductors, other claims in the patent + (*e.g.,* claim 1) expressed the mathematical + relationship in words); and +* iv. organizing information and + manipulating information through mathematical correlations, + *Digitech Image Techs., LLC v. Electronics for Imaging, + Inc.,* 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. + Cir. 2014). The patentee in *Digitech* claimed + methods of generating first and second data by taking existing + information, manipulating the data using mathematical functions, and + organizing this information into a new form. The court explained that + such claims were directed to an abstract idea because they described a + process of organizing information through mathematical correlations, + like *Flook's* method of calculating using a + mathematical formula. 758 F.3d at 1350, 111 USPQ2d at 1721. + +***B.*** ***Mathematical Formulas or Equations***A claim that recites a numerical formula or + equation will be considered as falling within the "mathematical concepts" + grouping. In addition, there are instances where a formula or equation is + written in text format that should also be considered as falling within this + grouping. For example, the phrase "determining a ratio of A to B" is merely + using a textual replacement for the particular equation (ratio = A/B). + Additionally, the phrase "calculating the force of the object by multiplying + its mass by its acceleration" is using a textual replacement for the + particular equation (F= ma). + + + +Examples of mathematical equations or formulas + recited in a claim include: + + + +* i. a formula describing certain + electromagnetic standing wave phenomena, *Mackay Radio & + Tel. Co. v. Radio Corp. of America,* 306 U.S. 86, 91, 40 + USPQ 199, 201 (1939) (50.9(l/lambda<-0.513>); +* ii. the Arrhenius equation, + *Diamond v. Diehr;* 450 U.S. 175, 178 n. 2, 179 + n.5, 191-92, 209 USPQ at 4-5 (1981) (ln v = CZ + x); +* iii. a formula for computing an alarm + limit, *Parker v. Flook,* 437 U.S. 584, 585, 198 USPQ + 193, 195 (1978) (B1=B0 (1.0–F) + PVL(F)); and +* iv. a mathematical formula for hedging + (claim 4), *Bilski v. Kappos,* 561 U.S. 593, 599, 95 + USPQ2d 1001, 1004 (2010) (Fixed Bill Price = Fi + [(Ci + Ti + LDi) x + (α + βE(Wi))]). + +***C.******Mathematical + calculations***A claim that recites a mathematical + calculation, when the claim is given its broadest reasonable interpretation + in light of the specification, will be considered as falling within the + "mathematical concepts" grouping. A mathematical calculation is a + mathematical operation (such as multiplication) or an act of calculating + using mathematical methods to determine a variable or number, + *e.g.,* performing an arithmetic operation such as + exponentiation. There is no particular word or set of words that indicates a + claim recites a mathematical calculation. That is, a claim does not have to + recite the word "calculating" in order to be considered a mathematical + calculation. For example, a step of "determining" a variable or number using + mathematical methods or "performing" a mathematical operation may also be + considered mathematical calculations when the broadest reasonable + interpretation of the claim in light of the specification encompasses a + mathematical calculation. + + + +Examples of mathematical calculations + recited in a claim include: + + + +* i. performing a resampled statistical + analysis to generate a resampled distribution, *SAP America, + Inc. v. Investpic, LLC,* 898 F.3d 1161, 1163-65, 127 + USPQ2d 1597, 1598-1600 (Fed. Cir. 2018), modifying *SAP + America, Inc. v. Investpic, LLC,* 890 F.3d 1016, 126 + USPQ2d 1638 (Fed. Cir. 2018); +* ii. calculating a number representing an + alarm limit value using the mathematical formula + ‘‘B1=B0 (1.0–F) + + PVL(F)’’, *Parker v. Flook,* 437 U.S. 584, 585, 198 + USPQ 193, 195 (1978); +* iii. using a formula to convert geospatial + coordinates into natural numbers, *Burnett v. Panasonic + Corp.,* 741 Fed. Appx. 777, 780 (Fed. Cir. 2018) + (non-precedential); +* iv. managing a stable value protected life + insurance policy via performing calculations, *Bancorp Servs., + LLC v. Sun Life Assur. Co. of Canada (U.S.)*, 687 F.3d + 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012); +* v. using an algorithm for determining the + optimal number of visits by a business representative to a client, + *In re Maucorps,* 609 F.2d 481, 482, 203 USPQ 812, + 813 (CCPA 1979); and +* vi. calculating the difference between + local and average data values, *In re Abele,* 684 + F.2d 902, 903, 214 USPQ 682, 683-84 (CCPA 1982). + +**II.** **CERTAIN METHODS OF ORGANIZING + HUMAN ACTIVITY**The phrase "methods of organizing human + activity" is used to describe concepts relating to: + + + +* • fundamental economic principles or + practices (including hedging, insurance, mitigating risk); +* • commercial or legal interactions + (including agreements in the form of contracts, legal obligations, + advertising, marketing or sales activities or behaviors, and business + relations); and +* • managing personal behavior or + relationships or interactions between people, (including social + activities, teaching, and following rules or instructions). + + +The Supreme Court has identified a number of + concepts falling within the "certain methods of organizing human activity" + grouping as abstract ideas. In particular, in *Alice,* the + Court concluded that the use of a third party to mediate settlement risk is a + ‘‘fundamental economic practice’’ and thus an abstract idea. 573 U.S. at + 219–20, 110 USPQ2d at 1982. In addition, the Court in *Alice* + described the concept of risk hedging identified as an abstract idea in + *Bilski* as ‘‘a method of organizing human activity’’. + *Id.* Previously, in *Bilski,* the Court + concluded that hedging is a ‘‘fundamental economic practice’’ and therefore an + abstract idea. 561 U.S. at 611–612, 95 USPQ2d at 1010. + + + +The term "certain" qualifies the "certain + methods of organizing human activity" grouping as a reminder of several + important points. First, not all methods of organizing human activity are + abstract ideas (*e.g.,* "a defined set of steps for combining + particular ingredients to create a drug formulation" is not a certain "method + of organizing human activity"), *In re Marco Guldenaar Holding + B.V.,* 911 F.3d 1157, 1160-61, 129 USPQ2d 1008, 1011 (Fed. Cir. + 2018). Second, this grouping is limited to activity that falls within the + enumerated sub-groupings of fundamental economic principles or practices, + commercial or legal interactions, and managing personal behavior and + relationships or interactions between people, and is not to be expanded beyond + these enumerated sub-groupings except in rare circumstances as explained in + **[MPEP § 2106.04(a)(3)](s2106.html#ch2100_d2ea80_199c8_1c1)**. Finally, the sub-groupings + encompass both activity of a single person (for example, a person following a + set of instructions or a person signing a contract online) and activity that + involves multiple people (such as a commercial interaction), and thus, certain + activity between a person and a computer (for example a method of anonymous + loan shopping that a person conducts using a mobile phone) may fall within the + "certain methods of organizing human activity" grouping. It is noted that the + number of people involved in the activity is not dispositive as to whether a + claim limitation falls within this grouping. Instead, the determination should + be based on whether the activity itself falls within one of the sub-groupings. + + +***A.******Fundamental Economic Practices or + Principles***The courts have used the phrases "fundamental + economic practices" or "fundamental economic principles" to describe + concepts relating to the economy and commerce. Fundamental economic + principles or practices include hedging, insurance, and mitigating + risks. + + + +The term "fundamental" is not used in the + sense of necessarily being "old" or "well-known." See, *e.g., OIP + Techs., Inc. v. Amazon.com, Inc.*, 788 F.3d 1359, 1364, 115 + U.S.P.Q.2d 1090, 1092 (Fed Cir. 2015) (a new method of price optimization + was found to be a fundamental economic concept); *In re + Smith,* 815 F.3d 816, 818-19, 118 USPQ2d 1245, 1247 (Fed. Cir. + 2016) (describing a new set of rules for conducting a wagering game as a + "fundamental economic practice"); *In re Greenstein,* 774 + Fed. Appx. 661, 664, 2019 USPQ2d 212400 (Fed Cir. 2019) (non-precedential) + (claims to a new method of allocating returns to different investors in an + investment fund was a fundamental economic concept). However, being old or + well-known may indicate that the practice is fundamental. See, + *e.g., Alice Corp. Pty. Ltd. v. CLS Bank Int’l,* 573 + U.S. 208, 219-20, 110 USPQ2d 1981-82 (2014) (describing the concept of + intermediated settlement, like the risk hedging in + *Bilski,* to be a "‘fundamental economic practice long + prevalent in our system of commerce’" and also as "a building block of the + modern economy") (citation omitted); *Bilski v. Kappos,* + 561 U.S. 593, 611, 95 USPQ2d 1001, 1010 (2010) (claims to the concept of + hedging are a "fundamental economic practice long prevalent in our system of + commerce and taught in any introductory finance class.") (citation omitted); + *Intellectual Ventures I LLC v. Symantec Corp.,* 838 + F.3d 1307, 1313, 120 USPQ2d 1353, 1356 (2016) ("The category of abstract + ideas embraces ‘fundamental economic practice[s] long prevalent in our + system of commerce,’ … including ‘longstanding commercial + practice[s]’"). + + + +An example of a case identifying a claim as + reciting a fundamental economic practice is *Bilski v. + Kappos,* 561 U.S. 593, 609, 95 USPQ2d 1001, 1009 (2010). The + fundamental economic practice at issue was hedging or protecting against + risk. The applicant in *Bilski* claimed "a series of steps + instructing how to hedge risk," *i.e.,* how to protect + against risk. 561 U.S. at 599, 95 USPQ2d at 1005. The method allowed energy + suppliers and consumers to minimize the risks resulting from fluctuations in + market demand for energy. The Supreme Court determined that hedging is + "fundamental economic practice" and therefore is an "unpatentable abstract + idea." 561 U.S. at 611-12, 95 USPQ2d at 1010. + + + +Another example of a case identifying a + claim as reciting a fundamental economic practice is *Bancorp + Services., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.),* + 687 F.3d 1266, 103 USPQ2d 1425 (Fed. Cir. 2012). The fundamental economic + practice at issue in *Bancorp* pertained to insurance. The + patentee in *Bancorp* claimed methods and systems for + managing a life insurance policy on behalf of a policy holder, which + comprised steps including generating a life insurance policy including a + stable value protected investment with an initial value based on a value of + underlying securities, calculating surrender value protected investment + credits for the life insurance policy; determining an investment value and a + value of the underlying securities for the current day; and calculating a + policy value and a policy unit value for the current day. 687 F.3d at + 1270-71, 103 USPQ2d at 1427. The court described the claims as an "attempt + to patent the use of the abstract idea of [managing a stable value protected + life insurance policy] and then instruct the use of well-known + [calculations] to help establish some of the inputs into the equation." 687 + F.3d at 1278, 103 USPQ2d at 1433 (alterations in original) (citing + *Bilski*). + + + + Other examples of "fundamental economic + principles or practices" include: + + + +* i. mitigating settlement risk, + *Alice Corp. v. CLS Bank,*573 U.S. 208, 218, 110 + USPQ2d 1976, 1982 (2014); +* ii. rules for conducting a wagering game, + *In re Smith,* 815 F.3d 816, 818-19, 118 USPQ2d + 1245, 1247 (Fed. Cir. 2016); +* iii. financial instruments that are + designed to protect against the risk of investing in financial + instruments, *In re Chorna,* 656 Fed. App'x 1016, + 1021 (Fed. Cir. 2016) (non-precedential); +* iv. offer-based price optimization, + *OIP Techs., Inc. v. Amazon.com, Inc.,* 788 F.3d + 1359, 1362–63, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015); +* v. local processing of payments for + remotely purchased goods, *Inventor Holdings, LLC v. Bed Bath + Beyond,* 876 F.3d 1372, 1378-79, 125 USPQ2d 1019, 1023 + (Fed. Cir. 2017); +* vi. using a marking affixed to the outside + of a mail object to communicate information about the mail object, + *i.e.,* the sender, recipient, and contents of the + mail object, *Secured Mail Solutions LLC v. Universal Wilde, + Inc.,* 873 F.3d 905, 911, 124 USPQ2d 1502, 1506 (Fed. Cir. + 2017); and +* vii. placing an order based on displayed + market information, *Trading Technologies Int’l, Inc. v. IBG + LLC,* 921 F.3d 1084, 1092, 2019 USPQ2d 138290 (Fed. Cir. + 2019). + +***B.*** ***Commercial or Legal Interactions***"Commercial interactions" or "legal + interactions" include agreements in the form of contracts, legal + obligations, advertising, marketing or sales activities or behaviors, and + business relations. + + + +An example of a claim reciting a commercial + or legal interaction, where the interaction is an agreement in the form of + contracts, is found in *buySAFE, Inc. v. Google, Inc.,* 765 + F.3d. 1350, 112 USPQ2d 1093 (Fed. Cir. 2014). The agreement at issue in + *buySAFE* was a transaction performance guaranty, which + is a contractual relationship. 765 F.3d at 1355, 112 USPQ2d at 1096. The + patentee claimed a method in which a computer operated by the provider of a + safe transaction service receives a request for a performance guarantee for + an online commercial transaction, the computer processes the request by + underwriting the requesting party in order to provide the transaction + guarantee service, and the computer offers, via a computer network, a + transaction guaranty that binds to the transaction upon the closing of the + transaction. 765 F.3d at 1351-52, 112 USPQ2d at 1094. The Federal Circuit + described the claims as directed to an abstract idea because they were + "squarely about creating a contractual relationship--a ‘transaction + performance guaranty’." 765 F.3d at 1355, 112 USPQ2d at 1096. + + + +Other examples of subject matter where the + commercial or legal interaction is an agreement in the form of contracts + include: + + + +* i. managing a stable value protected life + insurance policy via performing calculations, *Bancorp Servs., + LLC v. Sun Life Assur. Co. of Canada (U.S.),* 687 F.3d + 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012); and +* ii. processing insurance claims for a + covered loss or policy event under an insurance policy + (*i.e.,* an agreement in the form of a contract), + *Accenture Global Services v. Guidewire Software, + Inc.,* 728 F.3d 1336, 1338-39, 108 USPQ2d 1173, 1175-76 + (Fed. Cir. 2013). + + +An example of a claim reciting a commercial + or legal interaction in the form of a legal obligation is found in + *Fort Properties, Inc. v. American Master Lease, LLC,* + 671 F.3d 1317, 101 USPQ2d 1785 (Fed Cir. 2012). The patentee claimed a + method of "aggregating real property into a real estate portfolio, dividing + the interests in the portfolio into a number of deedshares, and subjecting + those shares to a master agreement." 671 F.3d at 1322, 101 USPQ2d at 1788. + The legal obligation at issue was the tax-free exchanges of real estate. The + Federal Circuit concluded that the real estate investment tool designed to + enable tax-free exchanges was an abstract concept. 671 F.3d at 1323, 101 + USPQ2d at 1789. + + + +Other examples of subject matter where the + commercial or legal interaction is a legal obligation include: + + + +* i. hedging, *Bilski v. + Kappos*, 561 U.S. 593, 595, 95 USPQ2d 1001, 1004 + (2010); +* ii. mitigating settlement risk, + *Alice Corp. Pty. Ltd. v. CLS Bank Int'l,* 573 + U.S. 208, 218, 110 USPQ2d 1976, 1979 (2014); and +* iii. arbitration, *In re + Comiskey*, 554 F.3d 967, 981, 89 USPQ2d 1655, 1665 (Fed. + Cir. 2009). + + +An example of a claim reciting advertising is + found in *Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, + 714-15, 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). The patentee in + *Ultramercial* claimed an eleven-step method for + displaying an advertisement (ad) in exchange for access to copyrighted + media, comprising steps of receiving copyrighted media, selecting an ad, + offering the media in exchange for watching the selected ad, displaying the + ad, allowing the consumer access to the media, and receiving payment from + the sponsor of the ad. 772 F.3d. at 715, 112 USPQ2d at 1754. The Federal + Circuit determined that the "combination of steps recites an abstraction—an + idea, having no particular concrete or tangible form" and thus was directed + to an abstract idea, which the court described as "using advertising as an + exchange or currency." *Id.* + + +Other examples of subject matter where the + commercial or legal interaction is advertising, marketing or sales + activities or behaviors include : + + + +* i. structuring a sales force or marketing + company, which pertains to marketing or sales activities or behaviors, + *In re Ferguson,* 558 F.3d 1359, 1364, 90 USPQ2d + 1035, 1038 (Fed. Cir. 2009); +* ii. using an algorithm for determining the + optimal number of visits by a business representative to a client, + *In re Maucorps,* 609 F.2d 481, 485, 203 USPQ 812, + 816 (CCPA 1979); and +* iii. offer-based price optimization, which + pertains to marketing, *OIP Techs., Inc. v. Amazon.com, + Inc.,* 788 F.3d 1359, 1362-63, 115 USPQ2d 1090, 1092 (Fed. + Cir. 2015). + + + An example of a claim reciting business + relations is found in *Credit Acceptance Corp. v. Westlake + Services,* 859 F.3d 1044, 123 USPQ2d 1100 (Fed. Cir. 2017). The + business relation at issue in *Credit Acceptance* is the + relationship between a customer and dealer when processing a credit + application to purchase a vehicle. The patentee claimed a "system for + maintaining a database of information about the items in a dealer’s + inventory, obtaining financial information about a customer from a user, + combining these two sources of information to create a financing package for + each of the inventoried items, and presenting the financing packages to the + user." 859 F.3d at 1054, 123 USPQ2d at 1108. The Federal Circuit described + the claims as directed to the abstract idea of "processing an application + for financing a loan" and found "no meaningful distinction between this type + of financial industry practice" and the concept of intermediated settlement + in *Alice* or the hedging concept in + *Bilski.* 859 F.3d at 1054, 123 USPQ2d at 1108. + + + +Another example of subject matter where the + commercial or legal interaction is business relations includes: + + + +* i. processing information through a + clearing-house, where the business relation is the relationship + between a party submitted a credit application + (*e.g.,* a car dealer) and funding sources + (*e.g.,* banks) when processing credit + applications, *Dealertrack v. Huber,* 674 F.3d 1315, + 1331, 101 USPQ2d 1325, 1339 (Fed. Cir. 2012). + +***C.*** ***Managing Personal Behavior or Relationships or Interactions + Between People***The sub-grouping "managing personal behavior + or relationships or interactions between people" include social activities, + teaching, and following rules or instructions. + + + +An example of a claim reciting managing + personal behavior is *Intellectual Ventures I LLC v. Capital One + Bank (USA),* 792 F.3d 1363, 115 USPQ2d 1636 (Fed. Cir. 2015). + The patentee in this case claimed methods comprising storing user-selected + pre-set limits on spending in a database, and when one of the limits is + reached, communicating a notification to the user via a device. 792 F.3d. at + 1367, 115 USPQ2d at 1639-40. The Federal Circuit determined that the claims + were directed to the abstract idea of "tracking financial transactions to + determine whether they exceed a pre-set spending limit + (*i.e.,* budgeting)", which "is not meaningfully + different from the ideas found to be abstract in other cases before the + Supreme Court and our court involving methods of organizing human activity." + 792 F.3d. at 1367-68, 115 USPQ2d at 1640. + + + +Other examples of managing personal behavior + recited in a claim include: + + + +* i. filtering content, *BASCOM + Global Internet v. AT&T Mobility, LLC,* 827 F.3d 1341, + 1345-46, 119 USPQ2d 1236, 1239 (Fed. Cir. 2016) (finding that + filtering content was an abstract idea under step 2A, but reversing an + invalidity judgment of ineligibility due to an inadequate step 2B + analysis); +* ii. considering historical usage + information while inputting data, *BSG Tech. LLC v. + Buyseasons, Inc.,* 899 F.3d 1281, 1286, 127 USPQ2d 1688, + 1691; and +* iii. a mental process that a neurologist + should follow when testing a patient for nervous system malfunctions, + *In re Meyer,* 688 F.2d 789, 791-93, 215 USPQ 193, + 194-96 (CCPA 1982). + + +An example of a claim reciting social + activities is *Voter Verified, Inc. v. Election Systems & + Software, LLC,* 887 F.3d 1376, 126 USPQ2d 1498 (Fed. Cir. 2018). + The social activity at issue in *Voter Verified* was + voting. The patentee claimed "[a] method for voting providing for + self-verification of a ballot comprising the steps of" presenting an + election ballot for voting, accepting input of the votes, storing the votes, + printing out the votes, comparing the printed votes to votes stored in the + computer, and determining whether the printed ballot is acceptable. 887 F.3d + at 1384-85, 126 USPQ2d at 1503-04. The Federal Circuit found that the claims + were directed to the abstract idea of "voting, verifying the vote, and + submitting the vote for tabulation", which is a "fundamental activity that + forms the basis of our democracy" and has been performed by humans for + hundreds of years. 887 F.3d at 1385-86, 126 USPQ2d at 1504-05. + + + +Another example of a claim reciting social + activities is *Interval Licensing LLC, v. AOL, Inc.,* 896 + F.3d 1335, 127 USPQ2d 1553 (Fed. Cir. 2018). The social activity at issue + was the social activity of "’providing information to a person without + interfering with the person’s primary activity.’" 896 F.3d at 1344, 127 + USPQ2d 1553 (citing *Interval Licensing LLC v. AOL, Inc.,* + 193 F. Supp.3d 1184, 1188 (W.D. 2014)). The patentee claimed an attention + manager for acquiring content from an information source, controlling the + timing of the display of acquired content, displaying the content, and + acquiring an updated version of the previously-acquired content when the + information source updates its content. 896 F.3d at 1339-40, 127 USPQ2d at + 1555. The Federal Circuit concluded that "[s]tanding alone, the act of + providing someone an additional set of information without disrupting the + ongoing provision of an initial set of information is an abstract idea," + observing that the district court "pointed to the nontechnical human + activity of passing a note to a person who is in the middle of a meeting or + conversation as further illustrating the basic, longstanding practice that + is the focus of the [patent ineligible] claimed invention." 896 F.3d at + 1344-45, 127 USPQ2d at 1559. + + + +An example of a claim reciting following + rules or instructions is *In re Marco Guldenaar Holding + B.V.,* 911 F.3d 1157, 1161, 129 USPQ2d 1008, 1011 (Fed. Cir. + 2018). The patentee claimed a method of playing a dice game including + placing wagers on whether certain die faces will appear face up. 911 F.3d at + 1160; 129 USPQ2d at 1011. The Federal Circuit determined that the claims + were directed to the abstract idea of "rules for playing games", which the + court characterized as a certain method of organizing human activity. 911 + F.3d at 1160-61; 129 USPQ2d at 1011. + + + +Other examples of following rules or + instructions recited in a claim include: + + + +* i. assigning hair designs to balance head + shape, *In re Brown*, 645 Fed. Appx. 1014, 1015-16 + (Fed. Cir. 2016) (non-precedential); and +* ii. a series of instructions of how to + hedge risk, *Bilski v. Kappos*, 561 U.S. 593, 595, 95 + USPQ2d 1001, 1004 (2010). + +**III.** **MENTAL + PROCESSES**The courts consider a mental process (thinking) + that "can be performed in the human mind, or by a human using a pen and paper" + to be an abstract idea. *CyberSource Corp. v. Retail Decisions, + Inc.,* 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). + As the Federal Circuit explained, "methods which can be performed mentally, or + which are the equivalent of human mental work, are unpatentable abstract ideas + the ‘basic tools of scientific and technological work’ that are open to all.’" + 654 F.3d at 1371, 99 USPQ2d at 1694 (citing *Gottschalk v. + Benson,* 409 U.S. 63, 175 USPQ 673 (1972)). See also *Mayo + Collaborative Servs. v. Prometheus Labs. Inc.,* 566 U.S. 66, 71, + 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual + concepts are not patentable, as they are the basic tools of scientific and + technological work’" (quoting *Benson,* 409 U.S. at 67, 175 + USPQ at 675)); *Parker v. Flook,* 437 U.S. 584, 589, 198 USPQ + 193, 197 (1978) (same). + + + +Accordingly, the "mental processes" abstract + idea grouping is defined as concepts performed in the human mind, and examples + of mental processes include observations, evaluations, judgments, and opinions. + A discussion of concepts performed in the human mind, as well as concepts that + cannot practically be performed in the human mind and thus are not "mental + processes", is provided below with respect to point A. + + + +The courts do not distinguish between mental + processes that are performed entirely in the human mind and mental processes + that require a human to use a physical aid (*e.g.,* pen and + paper or a slide rule) to perform the claim limitation. See, *e.g., + Benson,* 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that + the claimed "conversion of [binary-coded decimal] numerals to pure binary + numerals can be done mentally," *i.e.,* "as a person would do + it by head and hand."); *Synopsys, Inc. v. Mentor Graphics + Corp.,* 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) + (holding that claims to a mental process of "translating a functional + description of a logic circuit into a hardware component description of the + logic circuit" are directed to an abstract idea, because the claims "read on an + individual performing the claimed steps mentally or with pencil and paper"). + Mental processes performed by humans with the assistance of physical aids such + as pens or paper are explained further below with respect to point B. + + + +Nor do the courts distinguish between claims + that recite mental processes performed by humans and claims that recite mental + processes performed on a computer. As the Federal Circuit has explained, + "[c]ourts have examined claims that required the use of a computer and still + found that the underlying, patent-ineligible invention could be performed via + pen and paper or in a person’s mind." *Versata Dev. Group v. SAP Am., + Inc.,* 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). + See also *Intellectual Ventures I LLC v. Symantec Corp.,* 838 + F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception + of generic computer-implemented steps, there is nothing in the claims + themselves that foreclose them from being performed by a human, mentally or + with pen and paper.’’); *Mortgage Grader, Inc. v. First Choice Loan + Servs. Inc.,* 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. + 2016) (holding that computer-implemented method for "anonymous loan shopping" + was an abstract idea because it could be "performed by humans without a + computer"). Mental processes recited in claims that require computers are + explained further below with respect to point C. + + + +Because both product and process claims may + recite a "mental process", the phrase "mental processes" should be understood + as referring to the type of abstract idea, and not to the statutory category of + the claim. The courts have identified numerous product claims as reciting + mental process-type abstract ideas, for instance the product claims to computer + systems and computer-readable media in *Versata Dev. Group. v. SAP Am., + Inc.,* 793 F.3d 1306, 115 USPQ2d 1681 (Fed. Cir. 2015). This + concept is explained further below with respect to point D. + + + +The following discussion is meant to guide + examiners and provide more information on how to determine whether a claim + recites a mental process. Examiners should keep in mind the following points A, + B, C, and D when performing this evaluation. + + +***A.*** ***A Claim With Limitation(s) That Cannot Practically be Performed + in the Human Mind Does Not Recite a Mental + Process.***Claims do not recite a mental process when + they do not contain limitations that can practically be performed in the + human mind, for instance when the human mind is not equipped to perform the + claim limitations. See *SRI Int’l, Inc. v. Cisco Systems, + Inc.,* 930 F.3d 1295, 1304 (Fed. Cir. 2019) (declining to + identify the claimed collection and analysis of network data as abstract + because "the human mind is not equipped to detect suspicious activity by + using network monitors and analyzing network packets as recited by the + claims"); *CyberSource,* 654 F.3d at 1376, 99 USPQ2d at + 1699 (distinguishing *Research Corp. Techs. v. Microsoft + Corp.,* 627 F.3d 859, 97 USPQ2d 1274 (Fed. Cir. 2010), and + *SiRF Tech., Inc. v. Int’l Trade Comm’n,* 601 F.3d 1319, + 94 USPQ2d 1607 (Fed. Cir. 2010), as directed to inventions that ‘‘could not, + as a practical matter, be performed entirely in a human’s mind’’). + + + +Examples of claims that do not recite mental + processes because they cannot be practically performed in the human mind + include: + + + +* • a claim to a method for calculating + an absolute position of a GPS receiver and an absolute time of + reception of satellite signals, where the claimed GPS receiver + calculated pseudoranges that estimated the distance from the GPS + receiver to a plurality of satellites, *SiRF Tech.,* + 601 F.3d at 1331-33, 94 USPQ2d at 1616-17; +* • a claim to detecting suspicious + activity by using network monitors and analyzing network packets, + *SRI Int’l,* 930 F.3d at 1304; +* • a claim to a specific data + encryption method for computer communication involving a several-step + manipulation of data, *Synopsys.,* 839 F.3d at 1148, + 120 USPQ2d at 1481 (distinguishing the claims in *TQP + Development, LLC v. Intuit Inc.,* 2014 WL 651935 (E.D. + Tex. Feb. 19, 2014)); and +* • a claim to a method for rendering a + halftone image of a digital image by comparing, pixel by pixel, the + digital image against a blue noise mask, where the method required the + manipulation of computer data structures (*e.g.,* the + pixels of a digital image and a two-dimensional array known as a mask) + and the output of a modified computer data structure (a halftoned + digital image), *Research Corp. Techs.,* 627 F.3d at + 868, 97 USPQ2d at 1280. + + +In contrast, claims do recite a mental + process when they contain limitations that can practically be performed in + the human mind, including for example, observations, evaluations, judgments, + and opinions. Examples of claims that recite mental processes include: + + + +* • a claim to "collecting information, + analyzing it, and displaying certain results of the collection and + analysis," where the data analysis steps are recited at a high level + of generality such that they could practically be performed in the + human mind, *Electric Power Group v. Alstom, S.A.,* + 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016); +* • claims to "comparing BRCA sequences + and determining the existence of alterations," where the claims cover + any way of comparing BRCA sequences such that the comparison steps can + practically be performed in the human mind, *University of + Utah Research Foundation v. Ambry Genetics,* 774 F.3d 755, + 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014); +* • a claim to collecting and comparing + known information (claim 1), which are steps that can be practically + performed in the human mind, *Classen Immunotherapies, Inc. v. + Biogen IDEC,* 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 + (Fed. Cir. 2011); and +* • a claim to identifying head shape + and applying hair designs, which is a process that can be practically + performed in the human mind, *In re Brown,* 645 Fed. + App'x 1014, 1016-17 (Fed. Cir. 2016) (non-precedential). + +***B.*** ***A Claim That Encompasses a Human Performing the Step(s) + Mentally With or Without a Physical Aid Recites a Mental + Process.***If a claim recites a limitation that can + practically be performed in the human mind, with or without the use of a + physical aid such as pen and paper, the limitation falls within the mental + processes grouping, and the claim recites an abstract idea. See, + *e.g., Benson,* 409 U.S. at 67, 65, 175 USPQ at 674-75, + 674 (noting that the claimed "conversion of [binary-coded decimal] numerals + to pure binary numerals can be done mentally," *i.e.,* "as + a person would do it by head and hand."); *Synopsys,* 839 + F.3d at 1139, 120 USPQ2d at 1474 (holding that claims to the mental process + of "translating a functional description of a logic circuit into a hardware + component description of the logic circuit" are directed to an abstract + idea, because the claims "read on an individual performing the claimed steps + mentally or with pencil and paper"). + + + +The use of a physical aid + (*e.g.,* pencil and paper or a slide rule) to help + perform a mental step (*e.g.,* a mathematical calculation) + does not negate the mental nature of the limitation, but simply accounts for + variations in memory capacity from one person to another. For instance, in + *CyberSource,* the court determined that the step of + "constructing a map of credit card numbers" was a limitation that was able + to be performed "by writing down a list of credit card transactions made + from a particular IP address." In making this determination, the court + looked to the specification, which explained that the claimed map was + nothing more than a listing of several (*e.g.,* four) + credit card transactions. The court concluded that this step was able to be + performed mentally with a pen and paper, and therefore, it qualified as a + mental process. 654 F.3d at 1372-73, 99 USPQ2d at 1695. See also + *Flook,* 437 U.S. at 586, 198 USPQ at 196 (claimed + "computations can be made by pencil and paper calculations"); + *University of Florida Research Foundation, Inc. v. General + Electric Co.,* 916 F.3d 1363, 1367, 129 USPQ2d 1409, 1411-12 + (Fed. Cir. 2019) (relying on specification’s description of the claimed + analysis and manipulation of data as being performed mentally "‘using pen + and paper methodologies, such as flowsheets and patient charts’"); + *Symantec,* 838 F.3d at 1318, 120 USPQ2d at 1360 + (although claimed as computer-implemented, steps of screening messages can + be "performed by a human, mentally or with pen and paper"). + + +***C.*** ***A Claim That Requires a Computer May Still Recite a Mental + Process.***Claims can recite a mental process even if + they are claimed as being performed on a computer. The Supreme Court + recognized this in *Benson,* determining that a + mathematical algorithm for converting binary coded decimal to pure binary + within a computer’s shift register was an abstract idea. The Court concluded + that the algorithm could be performed purely mentally even though the + claimed procedures "can be carried out in existing computers long in use, no + new machinery being necessary." 409 U.S at 67, 175 USPQ at 675. See also + *Mortgage Grader,* 811 F.3d at 1324, 117 USPQ2d at 1699 + (concluding that concept of "anonymous loan shopping" recited in a computer + system claim is an abstract idea because it could be "performed by humans + without a computer"). + + + +In evaluating whether a claim that requires a + computer recites a mental process, examiners should carefully consider the + broadest reasonable interpretation of the claim in light of the + specification. For instance, examiners should review the specification to + determine if the claimed invention is described as a concept that is + performed in the human mind and applicant is merely claiming that concept + performed 1) on a generic computer, or 2) in a computer environment, or 3) + is merely using a computer as a tool to perform the concept. In these + situations, the claim is considered to recite a mental process. + + + +* 1. **Performing a mental process on a + generic computer.** An example of a case identifying a mental + process performed on a generic computer as an abstract idea is + *Voter Verified, Inc. v. Election Systems & Software, + LLC,* 887 F.3d 1376, 1385, 126 USPQ2d 1498, 1504 (Fed. + Cir. 2018). In this case, the Federal Circuit relied upon the + specification in explaining that the claimed steps of voting, + verifying the vote, and submitting the vote for tabulation are "human + cognitive actions" that humans have performed for hundreds of years. + The claims therefore recited an abstract idea, despite the fact that + the claimed voting steps were performed on a computer. 887 F.3d at + 1385, 126 USPQ2d at 1504. Another example is + *Versata,* in which the patentee claimed a system + and method for determining a price of a product offered to a + purchasing organization that was implemented using general purpose + computer hardware. 793 F.3d at 1312-13, 1331, 115 USPQ2d at 1685, + 1699. The Federal Circuit acknowledged that the claims were performed + on a generic computer, but still described the claims as "directed to + the abstract idea of determining a price, using organizational and + product group hierarchies, in the same way that the claims in + *Alice* were directed to the abstract idea of + intermediated settlement, and the claims in Bilski were directed to + the abstract idea of risk hedging." 793 F.3d at 1333; 115 USPQ2d at + 1700-01. +* 2. **Performing a mental process in a + computer environment.** An example of a case identifying a + mental process performed in a computer environment as an abstract idea + is *Symantec Corp.,* 838 F.3d at 1316-18, 120 USPQ2d + at 1360. In this case, the Federal Circuit relied upon the + specification when explaining that the claimed electronic post office, + which recited limitations describing how the system would receive, + screen and distribute email on a computer network, was analogous to + how a person decides whether to read or dispose of a particular piece + of mail and that "with the exception of generic computer-implemented + steps, there is nothing in the claims themselves that foreclose them + from being performed by a human, mentally or with pen and paper". 838 + F.3d at 1318, 120 USPQ2d at 1360. Another example is + *FairWarning IP, LLC v. Iatric Sys., Inc.,* 839 + F.3d 1089, 120 USPQ2d 1293 (Fed. Cir. 2016). The patentee in + *FairWarning* claimed a system and method of + detecting fraud and/or misuse in a computer environment, in which + information regarding accesses of a patient’s personal health + information was analyzed according to one of several rules + (*i.e.,* related to accesses in excess of a + specific volume, accesses during a pre-determined time interval, or + accesses by a specific user) to determine if the activity indicates + improper access. 839 F.3d. at 1092, 120 USPQ2d at 1294. The court + determined that these claims were directed to a mental process of + detecting misuse, and that the claimed rules here were "the same + questions (though perhaps phrased with different words) that humans in + analogous situations detecting fraud have asked for decades, if not + centuries." 839 F.3d. at 1094-95, 120 USPQ2d at 1296. +* 3. **Using a computer as a tool to + perform a mental process.** An example of a case in which a + computer was used as a tool to perform a mental process is + *Mortgage Grader,* 811 F.3d. at 1324, 117 USPQ2d + at 1699. The patentee in *Mortgage Grader* claimed a + computer-implemented system for enabling borrowers to anonymously shop + for loan packages offered by a plurality of lenders, comprising a + database that stores loan package data from the lenders, and a + computer system providing an interface and a grading module. The + interface prompts a borrower to enter personal information, which the + grading module uses to calculate the borrower’s credit grading, and + allows the borrower to identify and compare loan packages in the + database using the credit grading. 811 F.3d. at 1318, 117 USPQ2d at + 1695. The Federal Circuit determined that these claims were directed + to the concept of "anonymous loan shopping", which was a concept that + could be "performed by humans without a computer." 811 F.3d. at 1324, + 117 USPQ2d at 1699. Another example is *Berkheimer v. HP, + Inc.,* 881 F.3d 1360, 125 USPQ2d 1649 (Fed. Cir. 2018), in + which the patentee claimed methods for parsing and evaluating data + using a computer processing system. The Federal Circuit determined + that these claims were directed to mental processes of parsing and + comparing data, because the steps were recited at a high level of + generality and merely used computers as a tool to perform the + processes. 881 F.3d at 1366, 125 USPQ2d at 1652-53. + +***D.*** ***Both Product and + Process Claims May Recite a Mental + Process.***Examiners should keep in mind that both + product claims (*e.g.,* computer system, computer-readable + medium, etc.) and process claims may recite mental processes. For example, + in *Mortgage Grader,* the patentee claimed a + computer-implemented system and a method for enabling borrowers to + anonymously shop for loan packages offered by a plurality of lenders, + comprising a database that stores loan package data from the lenders, and a + computer system providing an interface and a grading module. The Federal + Circuit determined that both the computer-implemented system and method + claims were directed to "anonymous loan shopping", which was an abstract + idea because it could be "performed by humans without a computer." 811 F.3d. + at 1318, 1324-25, 117 USPQ2d at 1695, 1699-1700. See also + *FairWarning IP,* 839 F.3d at 1092, 120 USPQ2d at 1294 + (identifying both system and process claims for detecting improper access of + a patient's protected health information in a health-care system computer + environment as directed to abstract idea of detecting fraud); + *Content Extraction & Transmission LLC v. Wells Fargo Bank, + N.A.,* 776 F.3d 1343, 1345, 113 USPQ2d 1354, 1356 (system and + method claims of inputting information from a hard copy document into a + computer program). Accordingly, the phrase "mental processes" should be + understood as referring to the type of abstract idea, and not to the + statutory category of the claim. + + + +Examples of product claims reciting mental + processes include: + + + +* • An application program interface for + extracting and processing information from a diversity of types of + hard copy documents – *Content Extraction,* 776 F.3d + at 1345, 113 USPQ2d at 1356; +* • A computer-implemented system for + enabling anonymous loan shopping – *Mortgage Grader,* + 811 F.3d at 1318, 117 USPQ2d at 1695; +* • A computer readable medium + containing program instructions for detecting fraud – + *CyberSource,* 654 F.3d at 1368 n. 1, 99 USPQ2d at + 1692 n.1; +* • A post office for receiving and + redistributing email messages on a computer network – + *Symantec,* 838 F.3d at 1316, 120 USPQ2d at 1359; +* • A self-verifying voting system – + *Voter Verified,* 887 F.3d at 1384-85, 126 USPQ2d + at 1504; +* • A wide-area real-time performance + monitoring system for monitoring and assessing dynamic stability of an + electric power grid – *Electric Power Group,* 830 + F.3d at 1351 and n.1, 119 USPQ2d at 1740 and n.1; and +* • Computer readable storage media + comprising computer instructions to implement a method for determining + a price of a product offered to a purchasing organization – + *Versata,* 793 F.3d at 1312-13, 115 USPQ2d at + 1685. + + +Examples of process claims reciting mental + process-type abstract ideas are discussed in the preceding subsections (A) + through (C). See, for example, the discussion of *Flook,* + 437 U.S. 584, 198 USPQ 193; *Benson,* 409 U.S. 63, 175 USPQ + 673; *Berkheimer,* 881 F.3d 1360, 125 USPQ2d 1649; + *Synopsys,* 839 F.3d 1138, 120 USPQ2d 1473; and + *Ambry Genetics,* 774 F.3d 755, 113 USPQ2d 1241, + *supra*. + + + +, +# 2106.04(a)(3) **Tentative Abstract + Ideas** + + +There may be rare circumstances in which an examiner + believes a claim limitation should be treated as an abstract idea even though it does + not fall within any of the groupings of abstract ideas discussed in + **[MPEP + § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** (i.e., mathematical concepts, certain + methods of organizing human activity, mental processes). This type of claim + limitation is referred to as a "tentative abstract idea." + + + +In such circumstances, the examiner should evaluate + the claim under the subject matter eligibility framework: + + + +* • If the claim as a whole integrates the + tentative abstract idea into a practical application, the claim is not directed + to a judicial exception (Step 2A; NO) and thus is **eligible** at + Pathway B. This concludes the eligibility analysis. +* • If the claim as a whole does not integrate + the tentative abstract idea into a practical application, then the claim is + directed to a judicial exception (Step 2A: YES) and thus requires further + analysis at Step 2B. At Step 2B, if the claim as a whole provides an inventive + concept (Step 2B: YES), the claim is **eligible** at Pathway C. This + concludes the eligibility analysis. +* • If the claim as a whole does not provide an + inventive concept (Step 2B: NO), the application should be brought to the + attention of the Technology Center (TC) director. A rejection of a claim + reciting a tentative abstract idea must be approved by the TC director (which + approval will be indicated in the file record of the application) and must + provide a justification for why such claim limitation is being treated as + reciting an abstract idea. +The TC Director will give approval for a Step 2B + subject matter eligibility rejection of a claim reciting a tentative abstract + idea. The ensuing Office action will identify that the claim(s) are directed to a + previously non-enumerated abstract idea via form paragraph + **[7.05.017](#fp7.05.017)** and include the TC Director’s signature. + The TC Director will then inform Patents Management that this procedure has been + used so that the public can be notified, for example, on USPTO.GOV at the Subject + Matter Eligibility website. + + + +In response to a Step 2B rejection of a claim + reciting a tentative abstract idea, an interview with the examiner may be + conducted, which may help advance prosecution and identify patent eligible subject + matter. See **[MPEP § + 713](s713.html#d0e84376)**. For applications in which an abstract idea has been + identified using the tentative abstract idea procedure, an interview with the TC + Director that provided approval is not necessary because the examiner retains the + authority to withdraw or maintain a rejection upon consideration of applicant’s + reply. The examiner is not required to obtain TC Director approval to withdraw or + maintain such a **[§ 101](mpep-9015-appx-l.html#d0e302376)** subject matter eligibility rejection. + + + + +, +# 2106.04(b) Laws of Nature, Natural Phenomena & + Products of Nature [R-10.2019] + + +Laws of nature and natural phenomena, as identified by + the courts, include naturally occurring principles/relations and nature-based + products that are naturally occurring or that do not have markedly different + characteristics compared to what occurs in nature. The courts have often described + these exceptions using other terms, including "physical phenomena," "scientific + principles", "natural laws," and "products of nature." + + +**I.** **LAWS OF NATURE AND NATURAL + PHENOMENA, GENERALLY**The law of nature and natural phenomenon + exceptions reflect the Supreme Court's view that the basic tools of scientific and + technological work are not patentable, because the "manifestations of laws of + nature" are "part of the storehouse of knowledge," "free to all men and reserved + exclusively to none." *Funk Bros. Seed Co. v. Kalo Inoculant + Co.,* 333 U.S. 127, 130, 76 USPQ 280, 281 (1948). Thus, "a new mineral + discovered in the earth or a new plant found in the wild is not patentable subject + matter" under **[Section 101](mpep-9015-appx-l.html#d0e302376)**. *Diamond v. Chakrabarty,* 447 + U.S. 303, 309, 206 USPQ 193, 197 (1980). "Likewise, Einstein could not patent his + celebrated law that E=mc2; nor could Newton have + patented the law of gravity." *Id.* Nor can one patent "a novel + and useful mathematical formula," *Parker v. Flook,* 437 U.S. + 584, 585, 198 USPQ 193, 195 (1978); electromagnetism or steam power, + *O’Reilly v. Morse,* 56 U.S. (15 How.) 62, 113-114 (1853); or + "[t]he qualities of ... bacteria, ... the heat of the sun, electricity, or the + qualities of metals," *Funk,* 333 U.S. at 130, 76 USPQ at 281; + see also *Le Roy v. Tatham,* 55 U.S. (14 How.) 156, 175 + (1853). + + + + The courts have identified the following concepts + and products as examples of laws of nature or natural phenomena: + + + +* i. isolated DNA, *Ass’n for Molecular + Pathology v. Myriad Genetics, Inc.,* 569 U.S. 576, 589-91, 106 + USPQ2d 1972, 1978-79 (2013); +* ii. a cloned farm animal such as a sheep, + *In re Roslin Institute (Edinburgh),* 750 F.3d 1333, + 1337, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014); +* iii. a correlation between variations in + non-coding regions of DNA and allele presence in coding regions of DNA, + *Genetic Techs. Ltd. v. Merial LLC,* 818 F.3d 1369, + 1375, 118 USPQ2d 1541, 1545 (Fed. Cir. 2016); +* iv. a correlation that is the consequence of how + a certain compound is metabolized by the body, *Mayo Collaborative + Servs. v. Prometheus Labs.,* 566 U.S. 66, 75-77, 101 USPQ2d + 1961, 1967-68 (2012); +* v. a correlation between the presence of + myeloperoxidase in a bodily sample (such as blood or plasma) and + cardiovascular disease risk, *Cleveland Clinic Foundation v. True + Health Diagnostics, LLC,* 859 F.3d 1352, 1361, 123 USPQ2d 1081, + 1087 (Fed. Cir. 2017); +* vi. electromagnetism to transmit signals, + *O’Reilly v. Morse,* 56 U.S. 62, 113 (1853); +* vii. qualities of bacteria such as their ability + to create a state of inhibition or non-inhibition in other bacteria, + *Funk Bros.,* 333 U.S. at 130, 76 USPQ at 281; +* viii. single-stranded DNA fragments known as + "primers", *University of Utah Research Foundation v. Ambry Genetics + Corp.,* 774 F.3d 755, 761, 113 USPQ2d 1241, 1244 (Fed. Cir. + 2014); +* ix. the chemical principle underlying the union + between fatty elements and water, *Tilghman v. Proctor,* + 102 U.S. 707, 729 (1880); +* x. the existence of cell-free fetal DNA (cffDNA) + in maternal blood, *Ariosa Diagnostics, Inc. v. Sequenom,* + 788 F.3d 1371, 1373, 115 USPQ2d 1152, 1153 (Fed. Cir. 2015); and +* xi. the natural relationship between a patient’s + CYP2D6 metabolizer genotype and the risk that the patient will suffer QTc + prolongation after administration of a medication called iloperidone, + *Vanda Pharmaceuticals Inc. v. West-Ward + Pharmaceuticals,* 887 F.3d 1117, 1135-36, 126 USPQ2d 1266, 1281 + (Fed. Cir. 2018). + + +The courts have also noted, however, that not every + claim describing a natural ability or quality of a product, or describing a + natural process, necessarily recites a law of nature or natural phenomenon. See + *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d 1042, + 1048-49, 119 USPQ2d 1370, 1374 (Fed. Cir. 2016) (claims reciting process steps of + fractionating, recovering, and cryopreserving hepatocytes held to be eligible, + because they are not focused on merely observing or detecting the ability of + hepatocytes to survive multiple freeze-thaw cycles). Thus, in a claimed method of + treating cancer with chemotherapy, the cancer cells’ inability to survive + chemotherapy is not considered to be a law of nature. Similarly, in a claimed + method of treating headaches with aspirin, the human body’s natural response to + aspirin is not considered to be a law of nature. These claims are accordingly + eligible at Prong One unless they recite another exception, in which case they + require further analysis in Prong Two (and Step 2B, if needed) to determine their + eligibility. Similarly, a method of producing a new compound is not directed to + the individual components’ ability to combine to form the new compound. + *Id.* See also *Tilghman v. Proctor,* 102 + U.S. 707, 729 (1881) (claims reciting process steps for manufacturing fatty acids + and glycerol by hydrolyzing fat at high temperature and pressure were held to be + eligible, because they are not focused on the chemical principle that fat can be + hydrolyzed into its components). + + + +Even if a claim does recite a law of nature or + natural phenomenon, it may still be eligible at any of Pathways A through C. For + example, claims reciting a naturally occurring relationship between a patient’s + genotype and the risk of QTc prolongation (a law of nature) were held eligible as + not "directed to" that relationship because they also recited a step of treating + the patient with an amount of a particular medication that was tailored to the + patient’s genotype. *Vanda Pharms.,* 887 F.3d at 1134-36, 126 + USPQ2d at 1279-81. This particular treatment step applied the natural relationship + in a manner that integrated it into a practical application. The court’s analysis + in *Vanda* is equivalent to a finding of eligibility at Step 2A + Prong Two (Pathway B). + + + +As explained in **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, a claim that recites a law of nature or a + natural phenomenon requires further analysis in Step 2A Prong Two to determine + whether the claim integrates the exception into a practical application. + + + +A claim that does not recite a law of nature or + natural phenomenon is eligible at Pathway B (Step 2A: NO) unless the claim + recites, and is directed to, another exception (such as an abstract idea, or a + product of nature). + + +**II.** **PRODUCTS OF + NATURE**When a law of nature or natural phenomenon is + claimed as a physical product, the courts have often referred to the exception as + a "product of nature". For example, the isolated DNA of *Myriad* + and the primers of *Ambry Genetics* were described as products of + nature by the courts. *Ass’n for Molecular Pathology v. Myriad Genetics, + Inc.,* 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); + *University of Utah Research Foundation v. Ambry Genetics,* + 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in + those decisions, products of nature are considered to be an exception because they + tie up the use of naturally occurring things, but they have been labeled as both + laws of nature and natural phenomena. See *Myriad Genetics, + Inc.,* 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA + held ineligible because they "claim naturally occurring phenomena" and are + "squarely within the law of nature exception"); *Funk Bros. Seed Co. v. + Kalo Inoculant Co.,* 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) + (claims to bacterial mixtures held ineligible as "manifestations of laws of + nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis + uses the terms "law of nature" and "natural phenomenon" as inclusive of "products + of nature". + + + +It is important to keep in mind that product of + nature exceptions include both naturally occurring products and non-naturally + occurring products that lack markedly different characteristics from any naturally + occurring counterpart. See, *e.g.,**Ambry Genetics,* 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary + to *Myriad's* argument, it makes no difference that the + identified gene sequences are synthetically replicated. As the Supreme Court made + clear, neither naturally occurring compositions of matter, nor synthetically + created compositions that are structurally identical to the naturally occurring + compositions, are patent eligible."). Thus, a synthetic, artificial, or + non-naturally occurring product such as a cloned organism or a human-made hybrid + plant is not automatically eligible because it was created by human ingenuity or + intervention. See, *e.g.,**In re Roslin Institute (Edinburgh),* 750 F.3d 1333, 1337, 110 + USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. *J.E.M. Ag + Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc.,* 534 U.S. 130-132, 60 + USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all + non-naturally occurring products is whether they possess markedly different + characteristics from any naturally occurring counterpart. + + + +When a claim recites a nature-based product + limitation, examiners should use the markedly different characteristics analysis + discussed in **[MPEP § 2106.04(c)](s2106.html#ch2100_d29a1b_13bc1_b1)** to evaluate the + nature-based product limitation and determine the answer to Step 2A. Nature-based + products, as used herein, include both eligible and ineligible products and merely + refer to the types of products subject to the markedly different characteristics + analysis used to identify product of nature exceptions. Examples of nature-based + products include the isolated gene and cDNA sequences of + *Myriad,* the cloned farm animals of + *Roslin,* and the bacterium of *Chakrabarty*. + As is evident from these examples, and as further discussed in + **[MPEP § + 2105](s2105.html#d0e197008)**, a nature-based product that is a living organism + (*e.g.,* a plant, an animal, a bacterium, etc.) is not + excluded from patent protection merely because it is alive, and such a product is + eligible for patenting if it satisfies the markedly different characteristics + analysis. + + + +It is important to keep in mind that under the + broadest reasonable interpretation (BRI) of the claims, a nature-based product + limitation may encompass both eligible and ineligible products. For example, a + claim to a "cloned giraffe" may have a BRI encompassing cloned giraffes with + markedly different characteristics, as well as cloned giraffes that lack markedly + different characteristics and thus are products of nature. Cf. + *Roslin,* 750 F.3d at 1338-39, 110 USPQ2d at 1673 (applicant + could not rely on unclaimed features to distinguish claimed mammals from donor + mammals). + + + +Such a claim recites a product of nature, and thus + requires further analysis in Prong Two. If the claim is ultimately rejected as + failing to encompass an inventive concept (Step 2B: NO), it is a best practice for + the examiner to point out the broadest reasonable interpretation and recommend an + amendment, if possible, that would narrow the claim to those embodiments that are + not directed to products of nature, or that are otherwise eligible. + + + +For claims that recite a nature-based product + limitation (which may or may not be a product of nature exception) but which are + directed to inventions that clearly do not seek to tie up any judicial exception, + examiners should consider whether the streamlined eligibility analysis discussed + in **[MPEP § 2106.06](s2106.html#ch2100_d29a1b_13e6a_88)** is appropriate. In such cases, it would + not be necessary to conduct a markedly different characteristics analysis. + + + +, +# 2106.04(c) The Markedly Different Characteristics + Analysis [R-10.2019] + + +The markedly different characteristics analysis is + part of Step 2A Prong One, because the courts use this analysis to identify product + of nature exceptions. For example, *Chakrabarty* relied on a + comparison of the claimed bacterium to naturally occurring bacteria when determining + that the claimed bacterium was not a product of nature because it had "markedly + different characteristics from any found in nature". *Diamond v. + Chakrabarty,* 447 U.S. 303, 310, 206 USPQ 193, 197 (1980). Similarly, + *Roslin* relied on a comparison of the claimed sheep to naturally + occurring sheep when determining that the claimed sheep was a product of nature + because it "does not possess ‘markedly different characteristics from any [farm + animals] found in nature.’" *In re Roslin Institute (Edinburgh),* + 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (quoting + *Chakrabarty,* 447 U.S. at 310, 206 USPQ at 197 (alterations in + original)). + + + + This section sets forth guidelines for performing + the markedly different characteristics analysis, including information on when to + perform the analysis, and how to perform the analysis. Examiners should consult these + guidelines when performing an eligibility analysis of a claim that recites a + nature-based product limitation. Nature-based products, as used herein, include both + eligible and ineligible products and merely refer to the types of products subject to + the markedly different characteristics analysis used to identify product of nature + exceptions. + + + +If the claim includes a nature-based product that has + markedly different characteristics, then the claim does not recite a product of + nature exception and is eligible (Step 2A: NO) at Pathway B unless the claim recites + another exception (such as a law of nature or abstract idea, or a different natural + phenomenon). For claims where the entire claim is a single nature-based product + (e.g., a claim to "a *Lactobacillus* bacterium"), once a markedly + different characteristic in that product is shown, no further analysis would be + necessary for eligibility because no product of nature exception is recited (i.e., + Step 2B is not necessary because the answer to Step 2A is NO). For claims including + limitations in addition to the nature-based product, examiners should consider + whether the claim recites another exception and thus requires further eligibility + analysis. + + + + If the claim includes a nature-based product that + does not exhibit markedly different characteristics from its naturally occurring + counterpart in its natural state, then the claim recites a "product of nature" + exception, and requires further analysis in Step 2A Prong Two to determine whether + the claim as a whole integrates the exception into a practical application. + + +**I.** **WHEN TO PERFORM THE MARKEDLY + DIFFERENT CHARACTERISTICS ANALYSIS**Because a nature-based product can be claimed by + itself (*e.g.,* "a *Lactobacillus* bacterium") + or as one or more limitations of a claim (e.g., "a probiotic composition + comprising a mixture of *Lactobacillus* and milk in a + container"), care should be taken not to overly extend the markedly different + characteristics analysis to products that when viewed as a whole are not + nature-based. Instead, the markedly different characteristics analysis should be + applied only to the nature-based product limitations in the claim to determine + whether the nature-based products are "product of nature" exceptions. + + + +Examiners should keep in mind that if the + nature-based product limitation is naturally occurring, there is no need to + perform the markedly different characteristics analysis because the limitation is + by definition directed to a naturally occurring product and thus falls under the + product of nature exception. However, if the nature-based product limitation is + not naturally occurring, for example due to some human intervention, then the + markedly different characteristics analysis must be performed to determine whether + the claimed product limitation is a product of nature exception. + + +***A.*** ***Product Claims***Where the claim is to a nature-based product by + itself (*e.g.,* a claim to "a *Lactobacillus* + bacterium"), the markedly different characteristics analysis should be applied + to the entire product. See, *e.g., Chakrabarty,* 447 U.S. at + 305, 309-10, 206 USPQ at 195, 197-98 (applying analysis to entire claimed + "bacterium from the genus *Pseudomonas* containing therein at + least two stable energy-generating plasmids, each of said plasmids providing a + separate hydrocarbon degradative pathway"). + + + +Where the claim is to a nature-based product + produced by combining multiple components (*e.g.,* a claim to + "a probiotic composition comprising a mixture of + *Lactobacillus* and milk"), the markedly different + characteristics analysis should be applied to the resultant nature-based + combination, rather than its component parts. For instance, for the probiotic + composition example, the mixture of *Lactobacillus* and milk + should be analyzed for markedly different characteristics, rather than the + *Lactobacillus* separately and the milk separately. See + subsection II, below, for further guidance on the markedly different + characteristic analysis. + + + + Where the claim is to a nature-based product + in combination with non-nature based elements (*e.g.,* a claim + to "a yogurt starter kit comprising *Lactobacillus* in a + container with instructions for culturing *Lactobacillus* with + milk to produce yogurt"), the markedly different characteristics analysis + should be applied only to the nature-based product limitation. For instance, + for the yogurt starter kit example, the *Lactobacillus* would + be analyzed for markedly different characteristics. The container and + instructions would not be subject to the markedly different characteristics + analysis as they are not nature-based products, but would be evaluated as + additional elements in Prong Two (and Step 2B if needed) if it is determined + that the *Lactobacillus* does not have markedly different + characteristics from any naturally occurring counterpart and thus is a product + of nature exception. See, *e.g., Funk Bros. Seed Co. v. Kalo Inoculant + Co.,* 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (although claims + 7, 8, 13 and 14 recited an inoculant comprising a bacterial mixture and a + powder base, only the bacterial mixture was analyzed). + + +***B.*** ***Product-by-Process Claims***For a product-by-process claim + (*e.g.,* a claim to a cloned farm animal produced by a + nuclear transfer cloning method), the analysis turns on whether the + nature-based product in the claim has markedly different characteristics from + its naturally occurring counterpart. See **[MPEP § 2113](s2113.html#d0e201450)** + for more information on product-by-process claims. + + +***C.*** ***Process Claims***For a process claim, the general rule is that + the claim is not subject to the markedly different analysis for nature-based + products used in the process. This is because the analysis of a process claim + should focus on the active steps of the process rather than the products used + in those steps. For example, when evaluating a claimed process of + cryopreserving hepatocyte cells comprising performing density gradient + fractionation to separate viable and non-viable hepatocytes, recovering the + viable hepatocytes, and cryopreserving the recovered viable hepatocytes, the + court did not subject the claim to the markedly different characteristics + analysis for the nature-based products (the hepatocytes) used in the process. + *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d 1042, + 1049, 119 USPQ2d 1370, 1374 (Fed. Cir. 2016) (claims are directed to a process + of creating a preparation of multi-cryopreserved hepatocytes, not to the + preparation itself). + + + + However, in the limited situation where a + process claim reciting a nature-based product is drafted in such a way that + there is no difference in substance from a product claim, the claim is subject + to the markedly different analysis for the recited nature-based product. These + types of claims are drafted in a way that focuses on the product rather than + the process steps. For example, consider a claim that recites, in its entirety, + "a method of providing an apple." Under the broadest reasonable interpretation, + this claim is focused on the apple fruit itself, which is a nature-based + product. Similarly, claims to detecting naturally occurring cell-free fetal DNA + (cffDNA) in maternal blood were held to be directed to the cffDNA, because the + "existence and location of cffDNA is a natural phenomenon [and thus] + identifying its presence was merely claiming the natural phenomena itself." + *Rapid Litig. Mgmt.,* 827 F.3d at 1048, 119 USPQ2d at 1374, + (explaining the holding in *Ariosa Diagnostics, Inc. v. + Sequenom,* 788 F.3d 1371, 115 USPQ2d 1152 (Fed. Cir. 2015)). + + +**II.** **HOW TO PERFORM THE MARKEDLY + DIFFERENT CHARACTERISTICS ANALYSIS** The markedly different characteristics analysis + compares the nature-based product limitation to its naturally occurring + counterpart in its natural state. Markedly different characteristics can be + expressed as the product’s structure, function, and/or other properties, and are + evaluated based on what is recited in the claim on a case-by-case basis. If the + analysis indicates that a nature-based product limitation does not exhibit + markedly different characteristics, then that limitation is a product of nature + exception. If the analysis indicates that a nature-based product limitation does + have markedly different characteristics, then that limitation is not a product of + nature exception. + + + +This section sets forth guidelines for performing + the markedly different characteristics analysis, including information on (a) + selecting the appropriate naturally occurring counterpart(s) to the nature-based + product limitation, (b) identifying appropriate characteristics for analysis, and + (c) evaluating characteristics to determine whether they are "markedly different". + + +***A.*** ***Selecting The Appropriate + Counterpart(s)***Because the markedly different characteristics + analysis compares the nature-based product limitation to its naturally + occurring counterpart in its natural state, the first step in the analysis is + to select the appropriate counterpart(s) to the nature-based product. + + + + When the nature-based product is derived from + a naturally occurring thing, then the naturally occurring thing is the + counterpart. For example, assume that applicant claims deoxyacid A, which is a + chemical derivative of a naturally occurring chemical called acid A. Because + applicant created the claimed nature-based product (deoxyacid A) by modifying + the naturally occurring acid A, the closest natural counterpart for deoxyacid A + would be the natural product from which it was derived, + *i.e.,* acid A. See, *e.g.,**Chakrabarty,* 447 U.S. at 305 and n.1, 206 USPQ at 195 and + n.1 (counterpart to genetically modified *Pseudomonas* + bacterium containing multiple plasmids is the naturally occurring unmodified + *Pseudomonas* bacterium from which the claimed bacterium + was created); *Roslin,* 750 F.3d at 1337, 110 USPQ2d at + 1671-72 (counterparts to cloned sheep are naturally occurring sheep such as the + donor ewe from which the clone was created). + + + +Although the selected counterpart should be in + its natural state, examiners should take care not to confuse the counterpart + with other material that may occur naturally with, or adjacent to, the + counterpart. For example, assume that applicant claims a nucleic acid having a + nucleotide sequence derived from naturally occurring gene B. Although gene B + occurs in nature as part of a chromosome, the closest natural counterpart for + the claimed nucleic acid is gene B, and not the whole chromosome. See, + e.g., *Ass’n for Molecular Pathology v. Myriad Genetics, + Inc.,* 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013) + (comparing isolated BRCA1 genes and BRCA1 cDNA molecules to naturally occurring + BRCA1 gene); *Roche Molecular System, Inc. v. CEPHEID,* 905 + F.3d 1363, 1371, 128 USPQ2d 1221, 1227 (Fed. Cir. 2018) (comparing claimed + primers to "their corresponding nucleotide sequences on the naturally occurring + DNA"). Similarly, assume that applicant claims a single-stranded piece of DNA + (a primer) having a nucleotide sequence derived from the sense strand of + naturally occurring nucleic acid C. Although nucleic acid C occurs in nature as + a double-stranded molecule having a sense and an antisense strand, the closest + natural counterpart for the claimed nucleic acid is the sense strand of C only. + See, e.g., *University of Utah Research Foundation v. Ambry + Genetics,* 774 F.3d 755, 760, 113 USPQ2d 1241, 1241 (Fed. Cir. + 2014) (comparing single-stranded nucleic acid to the same strand found in + nature, even though "single-stranded DNA cannot be found in the human body"). + + + +When there are multiple counterparts to the + nature-based product, the comparison should be made to the closest naturally + occurring counterpart. For example, assume that applicant creates a cloned + sheep D by transferring nuclear DNA from a Finn-Dorset sheep into an egg cell + (which contains mitochondrial DNA) from a Scottish Blackface sheep. Applicant + then claims sheep D. Here, because sheep D was created via combining DNA from + two different naturally occurring sheep of different breeds, there is no single + closest natural counterpart. The examiner should therefore select the + counterpart most closely related to sheep D based on the examiner’s expertise + in the particular art. For the example discussed here, the closest counterparts + might be naturally occurring Finn-Dorset or Scottish Blackface sheep, as + opposed to sheep of a different breed such as Bighorn sheep. *Cf. + Roslin,* 750 F.3d at 1337, 110 USPQ2d at 1671-72 (claimed sheep + produced by nuclear transfer into an oocyte and subsequent manipulation of + natural embryonic development processes was compared to naturally occurring + sheep such as the donor ewe from which the nuclear material was obtained). When + the nature-based product is a combination produced from multiple components, + the closest counterpart may be the individual nature-based components of the + combination. For example, assume that applicant claims an inoculant comprising + a mixture of bacteria from different species, *e.g.,* some + bacteria of species E and some bacteria of species F. Because there is no + counterpart mixture in nature, the closest counterparts to the claimed mixture + are the individual components of the mixture, *i.e.,* each + naturally occurring species by itself. See, e.g., *Funk + Bros.,* 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture + of bacterial species to each species as it occurs in nature); *Ambry + Genetics,* 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as + a pair, individual primer molecules were compared to corresponding segments of + naturally occurring gene sequence); *In re Bhagat,* 726 Fed. + Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed + mixture of lipids with particular lipid profile to "naturally occurring lipid + profiles of walnut oil and olive oil"). See subsection II. C. + + + +If the claim is rejected as ineligible, it is a + "best practice" for the examiner to identify the selected counterpart in the + Office action if the record is not already clear. This practice assists the + applicant in responding, and clarifies the record as to how the examiner is + interpreting the claim. + + +***B.*** ***Identifying Appropriate Characteristics For + Analysis***Because the markedly different characteristics + analysis is based on comparing the characteristics of the claimed nature-based + product and its counterpart, the second step in the analysis is to identify + appropriate characteristics to compare. + + + +Appropriate characteristics must be possessed + by the claimed product, because it is the claim that must define the invention + to be patented. *Cf. Roslin,* 750 F.3d at 1338, 110 USPQ2d at + 1673 (unclaimed characteristics could not contribute to eligibility). Examiners + can identify the characteristics possessed by the claimed product by looking at + what is recited in the claim language and encompassed within the broadest + reasonable interpretation of the nature-based product. In some claims, a + characteristic may be explicitly recited. For example, in a claim to + "deoxyribose", the recited chemical name informs those in the art of the + structural characteristics of the product (*i.e.,* the "deoxy" + prefix indicates that a hydroxyl group has been removed as compared to ribose). + In other claims, the characteristic may be apparent from the broadest + reasonable interpretation even though it is not explicitly recited in the + claim. For example, in a claim to "isolated gene B," the examiner would need to + rely on the broadest reasonable interpretation of "isolated gene B" to + determine what characteristics the isolated gene has, *e.g.,* + what its nucleotide sequence is, and what, if any, protein it encodes. + + + + Appropriate characteristics can be expressed + as the nature-based product’s structure, function, and/or other properties, and + are evaluated on a case-by-case basis. Non-limiting examples of the types of + characteristics considered by the courts when determining whether there is a + marked difference include: + + + +* • Biological or pharmacological + functions or activities; +* • Chemical and physical properties; +* • Phenotype, including functional and + structural characteristics; and +* • Structure and form, whether chemical, + genetic or physical. + + +Examples of biological or pharmacological + functions or activities include, but are not limited to: + + + +* i. the protein-encoding information of a + nucleic acid, *Myriad,* 569 U.S. at 590-91, 106 USPQ2d + at 1979; +* ii. the ability of complementary nucleotide + sequences to bind to each other, *Ambry Genetics,* 774 + F.3d at 760-61, 113 USPQ2d at 1244; +* iii. the properties and functions of bacteria + such as the ability to infect certain leguminous plants, *Funk + Bros.,* 333 U.S. at 130-31, 76 USPQ2d at 281-82; +* iv. the ability to degrade certain + hydrocarbons, *Diamond v. Chakrabarty,* 447 U.S. at 310, + 206 USPQ2d at 195; and +* v. the ability of vitamin C to prevent and + treat scurvy, *In re King,* 107 F.2d 618, 27 CCPA 754, + 756-57, 43 USPQ 400, 401-402 (CCPA 1939). + + +Examples of chemical and physical properties + include, but are not limited to: + + + +* i. the alkalinity of a chemical compound, + *Parke-Davis & Co. v. H.K. Mulford Co.,* 189 F. + 95, 103-04 (S.D.N.Y. 1911); and +* ii. the ductility or malleability of metals, + *In re Marden,* 47 F.2d 958, 959, 18 CCPA 1057, 1059, + 8 USPQ 347, 349 (CCPA 1931). + + +Examples of phenotypic characteristics include, + but are not limited to: + + + +* i. functional and structural characteristics + such as the shape, size, color, and behavior of an organism, + *Roslin,* 750 F.3d at 1338, 110 USPQ2d at 1672. + + +Examples of structure and form include, but are + not limited to: + + + +* i. physical structure or form such as the + physical presence of plasmids in a bacterial cell, + *Chakrabarty,* 447 U.S. at 305 and n.1, 206 USPQ2d at + 195 and n.1; +* ii. chemical structure and form such as a + chemical being a "nonsalt" and a "crystalline substance", + *Parke-Davis,* 189 F. at 100, 103; +* iii. genetic structure such as the nucleotide + sequence of DNA, *Myriad,* 569 U.S. at 590, 594-95, 106 + USPQ2d at 1979, 1981; and +* iv. the genetic makeup (genotype) of a cell + or organism, *Roslin,* 750 F.3d at 1338-39, 110 USPQ2d + at 1672-73. + +***C.*** ***Evaluating Characteristics To Determine Whether They Are "Markedly + Different"***The final step in the markedly different + characteristics analysis is to compare the characteristics of the claimed + nature-based product to its naturally occurring counterpart in its natural + state, in order to determine whether the characteristics of the claimed product + are markedly different. The courts have emphasized that to show a marked + difference, a characteristic must be changed as compared to nature, and cannot + be an inherent or innate characteristic of the naturally occurring counterpart + or an incidental change in a characteristic of the naturally occurring + counterpart. *Myriad,* 569 U.S. at 580, 106 USPQ2d at 1974-75. + Thus, in order to be markedly different, applicant must have caused the claimed + product to possess at least one characteristic that is different from that of + the counterpart. + + + +If there is no change in any characteristic, + the claimed product lacks markedly different characteristics, and is a product + of nature exception. If there is a change in at least one characteristic as + compared to the counterpart, and the change came about or was produced by + applicant’s efforts or influences, then the change will generally be considered + a markedly different characteristic such that the claimed product is not a + product of nature exception. + + +**1.** **Examples of Products Having Markedly Different + Characteristics**In *Chakrabarty,* the + Supreme Court identified a claimed bacterium as a nature-based product + having markedly different characteristics. This bacterium had a changed + functional characteristic, *i.e.,* it was able to degrade + at least two different hydrocarbons as compared to naturally occurring + *Pseudomonas* bacteria that can only degrade a single + hydrocarbon. The claimed bacterium also had a different structural + characteristic, *i.e.,* it was genetically modified to + include more plasmids than are found in a single naturally occurring + *Pseudomonas* bacterium. The Supreme Court considered + these changed characteristics to be "markedly different characteristics from + any found in nature" due to the additional plasmids and resultant capacity + for degrading multiple hydrocarbon components of oil. Therefore, the + bacterium was eligible. *Diamond v. Chakrabarty*, 447 U.S. + 303, 310, 206 USPQ 193, 197 (1980). + + + +In *Myriad,* the Supreme + Court identified a claimed full-length complementary DNA (cDNA) of the BRCA1 + gene as a nature-based product having markedly different characteristics. + This claimed cDNA had the same functional characteristics (i.e., it encoded + the same protein) as the naturally occurring gene, but had a changed + structural characteristic, *i.e.,* a different nucleotide + sequence containing only exons, as compared to the naturally occurring + sequence containing both exons and introns. The Supreme Court concluded that + the "cDNA retains the naturally occurring exons of DNA, but it is distinct + from the DNA from which it was derived. As a result, [this] cDNA is not a + ‘product of nature’" and is eligible. *Myriad,* 569 U.S. at + 595, 106 USPQ2d at 1981. + + +**2.** **Examples of Products Lacking + Markedly Different Characteristics**In *Myriad,* the Supreme + Court made clear that not all changes in characteristics will rise to the + level of a marked difference, *e.g.,* the incidental + changes resulting from isolation of a gene sequence are not enough to make + the isolated gene markedly different. *Myriad,* 569 U.S. at + 580, 106 USPQ2d at 1974-75. The patentee in *Myriad* had + discovered the location of the BRCA1 and BRCA2 genes in the human genome, + and isolated them, *i.e.,* separated those specific genes + from the rest of the chromosome on which they exist in nature. As a result + of their isolation, the isolated genes had a different structural + characteristic than the natural genes, *i.e.*, the natural + genes had covalent bonds on their ends that connected them to the rest of + the chromosome, but the isolated genes lacked these bonds. However, the + claimed genes were otherwise structurally identical to the natural genes, + *e.g.,* they had the same genetic structure and + nucleotide sequence as the BRCA genes in nature. The Supreme Court concluded + that these isolated but otherwise unchanged genes were not eligible, because + they were not different enough from what exists in nature to avoid + improperly tying up the future use and study of the naturally occurring BRCA + genes. *See, e.g., Myriad,* 569 U.S. at 585, 106 USPQ2d at + 1977 ("Myriad's patents would, if valid, give it the exclusive right to + isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary + to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 + (describing how would-be infringers could not avoid the scope of Myriad’s + claims). In sum, the claimed genes were different, but not markedly + different, from their naturally occurring counterparts (the BRCA genes), and + thus were product of nature exceptions. + + + +In *Ambry Genetics,* the + court identified claimed DNA fragments known as "primers" as products of + nature, because they lacked markedly different characteristics. + *University of Utah Research Foundation v. Ambry Genetics + Corp.,* 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014). The + claimed primers were single-stranded pieces of DNA, each of which + corresponded to a naturally occurring double-stranded DNA sequence in or + near the BRCA genes. The patentee argued that these primers had markedly + different structural characteristics from the natural DNA, because the + primers were synthetically created and because "single-stranded DNA cannot + be found in the human body". The court disagreed, concluding that the + primers’ structural characteristics were not markedly different than the + corresponding strands of DNA in nature, because the primers and their + counterparts had the same genetic structure and nucleotide sequence. 774 + F.3d at 760, 113 USPQ2d at 1243-44. The patentee also argued that the + primers had a different function than when they are part of the DNA strand + because when isolated as a primer, a primer can be used as a starting + material for a DNA polymerization process. The court disagreed, because this + ability to serve as a starting material is innate to DNA itself, and was not + created or altered by the patentee: + + + + +> +> In fact, the naturally occurring genetic +> sequences at issue here do not perform a significantly new function. +> Rather, the naturally occurring material is used to form the first step +> in a chain reaction--a function that is performed because the primer +> maintains the exact same nucleotide sequence as the relevant portion of +> the naturally occurring sequence. One of the primary functions of DNA’s +> structure in nature is that complementary nucleotide sequences bind to +> each other. It is this same function that is exploited here--the primer +> binds to its complementary nucleotide sequence. Thus, just as in nature, +> primers utilize the innate ability of DNA to bind to itself. +> +> +> +> + + +*Ambry Genetics,* 774 F.3d at 760-61, 113 USPQ2d at 1244. + In sum, because the characteristics of the claimed primers were innate to + naturally occurring DNA, they lacked markedly different characteristics from + nature and were thus product of nature exceptions. A similar result was + reached in *Marden,* where the court held a claim to + ductile vanadium ineligible, because the "ductility or malleability of + vanadium is . . . one of its inherent characteristics and not a + characteristic given to it by virtue of a new combination with other + materials or which characteristic is brought about by some chemical reaction + or agency which changes its inherent characteristics". *In re + Marden,* 47 F.2d 958, 959, 18 CCPA 1057, 1060, 8 USPQ 347, 349 + (CCPA 1931). + + + +In *Roslin,* the court + concluded that claimed clones of farm animals were products of nature, + because they lacked markedly different characteristics from the counterpart + farm animals found in nature. *In re Roslin Institute + (Edinburgh),* 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671 (Fed. + Cir. 2014). Applicant created its clones (which included the famous cloned + sheep named Dolly) by transferring the genetic material of a donor into an + oocyte (egg cell), letting the oocyte develop into an embryo, and then + implanting the embryo into a surrogate animal where it developed into a baby + animal. The applicant argued that the clones, including Dolly, were eligible + because they were created via human ingenuity, and had phenotypic + differences such as shape, size and behavior compared to their donors. The + court was unpersuaded, explaining that the clones were exact genetic + replicas of the donors and thus did not possess markedly different + characteristics. 750 F.3d at 1337, 110 USPQ2d at 1671-72 ("Roslin’s chief + innovation was the preservation of the donor DNA such that the clone is an + exact copy of the mammal from which the somatic cell was taken. Such a copy + is not eligible for patent protection."). The court noted that the alleged + phenotypic differences (*e.g.,* the fact that Dolly may + have been taller or heavier than her donor) could not make the clones + markedly different because these differences were not claimed. 750 F.3d at + 1338, 110 USPQ2d at 1672. See also *Roche Molecular System, Inc. v. + CEPHEID,* 905 F.3d 1363, 1370, 128 USPQ2d 1221, 1226 (Fed. Cir. + 2018) (alleged structural differences between linear primers and their + counterparts on a circular chromosome were neither claimed nor relevant to + the eligibility inquiry). + + + +, +# 2106.04(d) Integration of a Judicial Exception Into A + Practical Application [R-10.2019] + + +The Supreme Court has long distinguished between + principles themselves (which are not patent eligible) and the integration of those + principles into practical applications (which are patent eligible). See, + *e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc.,* 566 + U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012) (noting that the Court in + *Diamond v. Diehr* found ‘‘the overall process patent eligible + because of the way the additional steps of the process integrated the equation into + the process as a whole,’’ but the Court in *Gottschalk v. Benson* + ‘‘held that simply implementing a mathematical principle on a physical machine, + namely a computer, was not a patentable application of that principle’’). Similarly, + in a growing body of decisions, the Federal Circuit has distinguished between claims + that are ‘‘directed to’’ a judicial exception (which require further analysis to + determine their eligibility) and those that are not (which are therefore patent + eligible), *e.g.,* claims that improve the functioning of a computer + or other technology or technological field. See *Diamond v. Diehr,* + 450 U.S. 175, 209 USPQ 1 (1981); *Gottschalk v. Benson,* 409 U.S. + 63, 175 USPQ 673 (1972). See, e.g., **[MPEP § + 2106.06(b)](s2106.html#ch2100_d29a1b_13ecb_2ce)** (summarizing *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016), *McRO, + Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, 120 USPQ2d 1091 + (Fed. Cir. 2016), and other cases that were eligible as improvements to technology or + computer functionality instead of being directed to abstract ideas). + + + +Accordingly, after determining that a claim recites a + judicial exception in Step 2A Prong One, examiners should evaluate whether the claim + as a whole integrates the recited judicial exception into a practical application of + the exception in Step 2A Prong Two. A claim that integrates a judicial exception into + a practical application will apply, rely on, or use the judicial exception in a + manner that imposes a meaningful limit on the judicial exception, such that the claim + is more than a drafting effort designed to monopolize the judicial exception. Whether + or not a claim integrates a judicial exception into a practical application is + evaluated using the considerations set forth in subsection I below, in accordance + with the procedure described below in subsection II. + + + +In the context of the flowchart in + **[MPEP § + 2106](s2106.html#d0e197244)**, subsection III, Step 2A Prong Two determines + whether: + + + +* • The claim as a whole integrates the judicial + exception into a practical application, in which case the claim is not directed + to a judicial exception (Step 2A: NO) and is eligible at Pathway B. This + concludes the eligibility analysis. +* • The claim as a whole does not integrate the + exception into a practical application, in which case the claim is directed to + the judicial exception (Step 2A: YES), and requires further analysis under Step + 2B (where it may still be eligible if it amounts to an inventive concept). See + **[MPEP § 2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)** for discussion of Step 2B. + +**I.** **RELEVANT CONSIDERATIONS FOR + EVALUATING WHETHER ADDITIONAL ELEMENTS INTEGRATE A JUDICIAL EXCEPTION INTO A + PRACTICAL APPLICATION**The Supreme Court and Federal Circuit have + identified a number of considerations as relevant to the evaluation of whether the + claimed additional elements demonstrate that a claim is directed to + patent-eligible subject matter. The list of considerations here is not intended to + be exclusive or limiting. Additional elements can often be analyzed based on more + than one type of consideration and the type of consideration is of no import to + the eligibility analysis. Additional discussion of these considerations, and how + they were applied in particular judicial decisions, is provided in + **[MPEP § 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** through **[(c)](s2106.html#ch2100_d29a1b_13cfb_2e)** and **[MPEP § + 2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)** through **[(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**. + + + +Limitations the courts have found indicative that + an additional element (or combination of elements) may have integrated the + exception into a practical application include: + + + +* • An improvement in the functioning of a + computer, or an improvement to other technology or technical field, as + discussed in **[MPEP §§ 2106.04(d)(1)](s2106.html#ch2100_d2e7df_24a6e_1bd)** and + **[2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**; +* • Applying or using a judicial exception to + effect a particular treatment or prophylaxis for a disease or medical + condition, as discussed in **[MPEP § + 2106.04(d)(2)](s2106.html#ch2100_d2e827_17196_6c)**; +* • Implementing a judicial exception with, or + using a judicial exception in conjunction with, a particular machine or + manufacture that is integral to the claim, as discussed in + **[MPEP § 2106.05(b)](s2106.html#ch2100_d29a1b_13ccf_18c)**; +* • Effecting a transformation or reduction of + a particular article to a different state or thing, as discussed in + **[MPEP § 2106.05(c)](s2106.html#ch2100_d29a1b_13cfb_2e)**; and +* • Applying or using the judicial exception + in some other meaningful way beyond generally linking the use of the + judicial exception to a particular technological environment, such that the + claim as a whole is more than a drafting effort designed to monopolize the + exception, as discussed in **[MPEP § + 2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)**. + + +The courts have also identified limitations that + did not integrate a judicial exception into a practical application: + + + +* • Merely reciting the words "apply it" (or + an equivalent) with the judicial exception, or merely including instructions + to implement an abstract idea on a computer, or merely using a computer as a + tool to perform an abstract idea, as discussed in **[MPEP § + 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**; +* • Adding insignificant extra-solution + activity to the judicial exception, as discussed in **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**; and +* • Generally linking the use of a judicial + exception to a particular technological environment or field of use, as + discussed in **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**. + + +Step 2A Prong Two is similar to Step 2B in that + both analyses involve evaluating a set of judicial considerations to determine if + the claim is eligible. See **[MPEP §§ 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** through + **[(h)](s2106.html#ch2100_d29a1b_13e1a_22c)** for the list of considerations that are evaluated + at Step 2B. Although most of these considerations overlap (i.e., they are + evaluated in both Step 2A Prong Two and Step 2B), Step 2A specifically excludes + consideration of whether the additional elements represent well-understood, + routine, conventional activity. Accordingly, in Step 2A Prong Two, examiners + should ensure that they give weight to all additional elements, whether or not + they are conventional, when evaluating whether a judicial exception has been + integrated into a practical application. Additional elements that represent + well-understood, routine, conventional activity may integrate a recited judicial + exception into a practical application. + + + +It is notable that mere physicality or tangibility + of an additional element or elements is not a relevant consideration in Step 2A + Prong Two. As the Supreme Court explained in *Alice Corp.,* mere + physical or tangible implementation of an exception does not guarantee + eligibility. *Alice Corp. Pty. Ltd. v. CLS Bank Int’l,* 573 U.S. + 208, 224, 110 USPQ2d 1976, 1983-84 (2014) ("The fact that a computer ‘necessarily + exist[s] in the physical, rather than purely conceptual, realm,’ is beside the + point"). See also *Genetic Technologies Ltd. v. Merial LLC,* 818 + F.3d 1369, 1377, 118 USPQ2d 1541, 1547 (Fed. Cir. 2016) (steps of DNA + amplification and analysis are not "sufficient" to render claim 1 patent eligible + merely because they are physical steps). Conversely, the presence of a + non-physical or intangible additional element does not doom the claims, because + tangibility is not necessary for eligibility under the + *Alice/Mayo* test. *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016) ("that the + improvement is not defined by reference to ‘physical’ components does not doom the + claims"). See also *McRO, Inc. v. Bandai Namco Games Am. Inc.,* + 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016), (holding that a + process producing an intangible result (a sequence of synchronized, animated + characters) was eligible because it improved an existing technological + process). + + + +In addition, a specific way of achieving a result + is not a stand-alone consideration in Step 2A Prong Two. However, the specificity + of the claim limitations is relevant to the evaluation of several considerations + including the use of a particular machine, particular transformation and whether + the limitations are mere instructions to apply an exception. See + **[MPEP §§ 2106.05(b)](s2106.html#ch2100_d29a1b_13ccf_18c)**, **[2106.05(c)](s2106.html#ch2100_d29a1b_13cfb_2e)**, and **[2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**. For example, in *Parker v. + Flook,* 437 U.S. 584, 198 USPQ 193 (1978), the Supreme Court noted + that the "patent application does not purport to explain how to select the + appropriate margin of safety, the weighting factor, or any of the other variables" + in the claimed mathematical formula, "[n]or does it purport to contain any + disclosure relating to the chemical processes at work, the monitoring of process + variables, or the means of setting off an alarm or adjusting an alarm system." 437 + U.S. at 586, 198 USPQ at 195. The Court found this failure to explain any + specifics of how to use the claimed formula informative when deciding that the + additional elements in the claim were insignificant post-solution activity and + thus not meaningful enough to render the claim eligible. 437 U.S. at 589-90, 198 + USPQ at 197. + + +**II.** **HOW TO EVALUATE WHETHER THE + ADDITIONAL ELEMENTS INTEGRATE THE JUDICIAL EXCEPTION INTO A PRACTICAL + APPLICATION**The analysis under Step 2A Prong Two is the same + for all claims reciting a judicial exception, whether the exception is an abstract + idea, a law of nature, or a natural phenomenon (including products of nature). + Examiners evaluate integration into a practical application by: (1) identifying + whether there are any additional elements recited in the claim beyond the judicial + exception(s); and (2) evaluating those additional elements individually and in + combination to determine whether they integrate the exception into a practical + application, using one or more of the considerations introduced in subsection I + supra, and discussed in more detail in **[MPEP §§ + 2106.04(d)(1)](s2106.html#ch2100_d2e7df_24a6e_1bd)**, **[2106.04(d)(2)](s2106.html#ch2100_d2e827_17196_6c)**, **[2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** through **[(c)](s2106.html#ch2100_d29a1b_13cfb_2e)** and **[2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)** through **[(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**. + + + +Many of these considerations overlap, and often + more than one consideration is relevant to analysis of an additional element. Not + all considerations will be relevant to every element, or every claim. Because the + evaluation in Prong Two is not a weighing test, it is not important how the + elements are characterized or how many considerations apply from the list. It is + important to evaluate the significance of the additional elements relative to + applicant’s invention, and to keep in mind the ultimate question of whether the + exception is integrated into a practical application. If the claim as a whole + integrates the judicial exception into a practical application based upon + evaluation of these considerations, the additional limitations impose a meaningful + limit on the judicial exception and the claim is eligible at Step 2A. + + + +Examiners should examine each claim for + eligibility separately, based on the particular elements recited therein. Claims + should not be judged to automatically stand or fall with similar claims in an + application. For instance, one claim may be ineligible because it is directed to a + judicial exception without amounting to significantly more, but another claim + dependent on the first may be eligible because it recites additional elements that + do amount to significantly more, or that integrate the exception into a practical + application. + + + +For more information on how to evaluate claims + reciting multiple judicial exceptions, see **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, subsection II.B. + + +**III.** **EXAMPLES OF HOW THE OFFICE + EVALUATES WHETHER THE CLAIM AS A WHOLE INTEGRATES THE JUDICIAL EXCEPTION INTO A + PRACTICAL APPLICATION**The Prong Two analysis considers the claim as a + whole. That is, the limitations containing the judicial exception as well as the + additional elements in the claim besides the judicial exception need to be + evaluated together to determine whether the claim integrates the judicial + exception into a practical application. Because a judicial exception alone is not + eligible subject matter, if there are no additional claim elements besides the + judicial exception, or if the additional claim elements merely recite another + judicial exception, that is insufficient to integrate the judicial exception into + a practical application. However, the way in which the additional elements use or + interact with the exception may integrate it into a practical application. + Accordingly, the additional limitations should not be evaluated in a vacuum, + completely separate from the recited judicial exception. Instead, the analysis + should take into consideration all the claim limitations and how those limitations + interact and impact each other when evaluating whether the exception is integrated + into a practical application. + + + +Two examples of how the Office evaluates whether + the claim as a whole integrates the recited judicial exception into a practical + application are provided. In *Solutran, Inc. v. Elavon, Inc.,* + 931 F.3d 1161, 2019 USPQ2d 281076 (Fed. Cir. 2019), the claims were to methods for + electronically processing paper checks, all of which contained limitations setting + forth receiving merchant transaction data from a merchant, crediting a merchant’s + account, and receiving and scanning paper checks after the merchant’s account is + credited. In part one of the *Alice/Mayo* test, the Federal + Circuit determined that the claims were directed to the abstract idea of crediting + the merchant’s account before the paper check is scanned. The court first + determined that the recited limitations of "crediting a merchant’s account as + early as possible while electronically processing a check" is a "long-standing + commercial practice" like in *Alice* and + *Bilski*. 931 F.3d at 1167, 2019 USPQ2d 281076, at \*5 (Fed. + Cir. 2019). The Federal Circuit then continued with its analysis under part one of + the *Alice/Mayo* test finding that the claims are not directed to + an improvement in the functioning of a computer or an improvement to another + technology. In particular, the court determined that the claims "did not improve + the technical capture of information from a check to create a digital file or the + technical step of electronically crediting a bank account" nor did the claims + "improve how a check is scanned." *Id.* This analysis is + equivalent to the Office’s analysis of determining that the exception is not + integrated into a practical application at Step 2A Prong Two, and thus that the + claims are directed to the judicial exception (Step 2A: YES). + + + +In *Finjan Inc. v. Blue Coat Systems, + Inc.,* 879 F.3d 1299, 125 USPQ2d 1282 (Fed. Cir. 2018), the claimed + invention was a method of virus scanning that scans an application program, + generates a security profile identifying any potentially suspicious code in the + program, and links the security profile to the application program. 879 F.3d at + 1303-04, 125 USPQ2d at 1285-86. The Federal Circuit noted that the recited virus + screening was an abstract idea, and that merely performing virus screening on a + computer does not render the claim eligible. 879 F.3d at 1304, 125 USPQ2d at 1286. + The court then continued with its analysis under part one of the + *Alice/Mayo* test by reviewing the patent’s specification, + which described the claimed security profile as identifying both hostile and + potentially hostile operations. The court noted that the security profile thus + enables the invention to protect the user against both previously unknown viruses + and "obfuscated code," as compared to traditional virus scanning, which only + recognized the presence of previously-identified viruses. The security profile + also enables more flexible virus filtering and greater user customization. 879 + F.3d at 1304, 125 USPQ2d at 1286. The court identified these benefits as improving + computer functionality, and verified that the claims recite additional elements + (*e.g.,* specific steps of using the security profile in a + particular way) that reflect this improvement. Accordingly, the court held the + claims eligible as not being directed to the recited abstract idea. 879 F.3d at + 1304-05, 125 USPQ2d at 1286-87. This analysis is equivalent to the Office’s + analysis of determining that the additional elements integrate the judicial + exception into a practical application at Step 2A Prong Two, and thus that the + claims were not directed to the judicial exception (Step 2A: NO). + + + + +# 2106.04(d)(1) Evaluating Improvements in the + Functioning of a Computer, or an Improvement to Any Other Technology or Technical + Field in Step 2A Prong Two [R-10.2019] + + +A claim reciting a judicial exception is not + directed to the judicial exception if it also recites additional elements + demonstrating that the claim as a whole integrates the exception into a practical + application. One way to demonstrate such integration is when the claimed invention + improves the functioning of a computer or improves another technology or technical + field. The application or use of the judicial exception in this manner + meaningfully limits the claim by going beyond generally linking the use of the + judicial exception to a particular technological environment, and thus transforms + a claim into patent-eligible subject matter. Such claims are eligible at Step 2A + because they are not "directed to" the recited judicial exception. + + + +The courts have not provided an explicit test for + this consideration, but have instead illustrated how it is evaluated in numerous + decisions. These decisions, and a detailed explanation of how examiners should + evaluate this consideration are provided in **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**. In short, first the specification should be + evaluated to determine if the disclosure provides sufficient details such that one + of ordinary skill in the art would recognize the claimed invention as providing an + improvement. The specification need not explicitly set forth the improvement, but + it must describe the invention such that the improvement would be apparent to one + of ordinary skill in the art. Conversely, if the specification explicitly sets + forth an improvement but in a conclusory manner (*i.e.,* a bare + assertion of an improvement without the detail necessary to be apparent to a + person of ordinary skill in the art), the examiner should not determine the claim + improves technology. Second, if the specification sets forth an improvement in + technology, the claim must be evaluated to ensure that the claim itself reflects + the disclosed improvement. That is, the claim includes the components or steps of + the invention that provide the improvement described in the specification. The + claim itself does not need to explicitly recite the improvement described in the + specification (*e.g.,* "thereby increasing the bandwidth of the + channel"). + + + +While the courts usually evaluate "improvements" as + part of the "directed to" inquiry in part one of the *Alice/Mayo* + test (equivalent to Step 2A), they have also performed this evaluation in part two + of the *Alice/Mayo* test (equivalent to Step 2B). See, + *e.g., BASCOM Global Internet v. AT&T Mobility LLC,* 827 + F.3d 1341, 1349-50, 119 USPQ2d 1236, 1241-42 (Fed. Cir. 2016). However, the + improvement analysis at Step 2A Prong Two differs in some respects from the + improvements analysis at Step 2B. Specifically, the "improvements" analysis in + Step 2A determines whether the claim pertains to an improvement to the functioning + of a computer or to another technology without reference to what is + well-understood, routine, conventional activity. That is, the claimed invention + may integrate the judicial exception into a practical application by demonstrating + that it improves the relevant existing technology although it may not be an + improvement over well-understood, routine, conventional activity. It should be + noted that while this consideration is often referred to in an abbreviated manner + as the "improvements consideration," the word "improvements" in the context of + this consideration is limited to improvements to the functioning of a computer or + any other technology/technical field, whether in Step 2A Prong Two or in Step + 2B. + + + +Examples of claims that improve technology and are + not directed to a judicial exception include: *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 1339, 118 USPQ2d 1684, 1691-92 (Fed. Cir. 2016) + (claims to a self-referential table for a computer database were directed to an + improvement in computer capabilities and not directed to an abstract idea); + *McRO, Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, + 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016) (claims to automatic lip + synchronization and facial expression animation were directed to an improvement in + computer-related technology and not directed to an abstract idea); *Visual + Memory LLC v. NVIDIA Corp.,* 867 F.3d 1253,1259-60, 123 USPQ2d 1712, + 1717 (Fed. Cir. 2017) (claims to an enhanced computer memory system were directed + to an improvement in computer capabilities and not an abstract idea); + *Finjan Inc. v. Blue Coat Systems, Inc.,* 879 F.3d 1299, 125 + USPQ2d 1282 (Fed. Cir. 2018) (claims to virus scanning were found to be an + improvement in computer technology and not directed to an abstract idea); + *SRI Int’l, Inc. v. Cisco Systems, Inc.,* 930 F.3d 1295, 1303 + (Fed. Cir. 2019) (claims to detecting suspicious activity by using network + monitors and analyzing network packets were found to be an improvement in computer + network technology and not directed to an abstract idea). Additional examples are + provided in **[MPEP § 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**. + + + + + +# 2106.04(d)(2) Particular Treatment and Prophylaxis in + Step 2A Prong Two + + +A claim reciting a judicial exception is not + directed to the judicial exception if it also recites additional element(s) + demonstrating that the claim as a whole integrates the exception into a practical + application. One way to demonstrate such integration is when the additional + elements apply or use the recited judicial exception to effect a particular + treatment or prophylaxis for a disease or medical condition. The application or + use of the judicial exception in this manner meaningfully limits the claim by + going beyond generally linking the use of the judicial exception to a particular + technological environment, and thus transforms a claim into patent-eligible + subject matter. Such claims are eligible at Step 2A, because they are not + "directed to" the recited judicial exception. + + + +The particular treatment or prophylaxis + consideration originated as part of the other meaningful limitations consideration + discussed in **[MPEP § 2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)** and shares the + same legal basis in Supreme Court jurisprudence as that consideration. However, + recent jurisprudence has provided additional guidance that is especially relevant + to only a subset of claims, thus warranting the elevation of the particular + treatment or prophylaxis consideration to become a stand-alone consideration in + the Step 2A Prong Two analysis. *Vanda Pharm. Inc. v. West-Ward Pharm. + Int’l Ltd.,* 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). The + claims in *Vanda* recited a method of treating a patient having + schizophrenia with iloperidone, a drug known to cause QTc prolongation (a + disruption of the heart’s normal rhythm that can lead to serious health problems) + in patients having a particular genotype associated with poor drug metabolism. 887 + F.3d at 1121, 126 USPQ2d at 1269-70. In particular, the claims recited steps of: + (1) performing a genotyping assay to determine if a patient has a genotype + associated with poor drug metabolism; and (2) administering iloperidone to the + patient in a dose range that depends on the patient’s genotype. + *Id.* Although *Vanda’s* claims recited a law + of nature (the naturally occurring relationship between the patient’s genotype and + the risk of QTc prolongation) like the claims in *Mayo Collaborative + Servs. v. Prometheus Labs., Inc.,* 566 U.S. 66, 101 USPQ2d 1961 + (2012), the Federal Circuit distinguished them from the *Mayo* + claims based on the differences in the administration steps. In particular, the + court explained that *Mayo’s* step of administering a drug to a + patient was performed in order to gather data about the recited laws of nature, + and this step was thus ancillary to the overall diagnostic focus of the claims. + 887 F.3d at 1134-35, 126 USPQ2d at 1280. In contrast, *Vanda’s* + claims used the recited law of nature to more safely treat the patients with the + drug, thereby reducing the patient’s risk of QTc prolongation. 887 F.3d at 1135, + 126 USPQ2d at 1280. Accordingly, the court held *Vanda’s* claims + eligible at the first part of the *Alice/Mayo* test (Step 2A) + because the claims were not "directed to" the recited judicial exception. 887 F.3d + at 1136, 126 USPQ2d at 1281. + + + +Examples of "treatment" and prophylaxis" + limitations encompass limitations that treat or prevent a disease or medical + condition, including, e.g., acupuncture, administration of medication, dialysis, + organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and + the like. For example, an immunization step that integrates an abstract idea into + a specific process of immunizing that lowers the risk that immunized patients will + later develop chronic immune-mediated diseases is considered to be a particular + prophylaxis limitation that practically applies the abstract idea. See, + *e.g., Classen Immunotherapies, Inc. v. Biogen IDEC,* 659 F.3d + 1057, 1066–68, 100 USPQ2d 1492, 1500-01 (Fed. Cir. 2011). + + + +Examiners should keep in mind that in order to + qualify as a "treatment" or "prophylaxis" limitation for purposes of this + consideration, the claim limitation in question must affirmatively recite an + action that effects a particular treatment or prophylaxis for a disease or medical + condition. An example of such a limitation is a step of "administering amazonic + acid to a patient" or a step of "administering a course of plasmapheresis to a + patient." If the limitation does not actually provide a treatment or prophylaxis, + *e.g.,* it is merely an intended use of the claimed invention + or a field of use limitation, then it cannot integrate a judicial exception under + the "treatment or prophylaxis" consideration. For example, a step of "prescribing + a topical steroid to a patient with eczema" is not a positive limitation because + it does not require that the steroid actually be used by or on the patient, and a + recitation that a claimed product is a "pharmaceutical composition" or that a + "feed dispenser is operable to dispense a mineral supplement" are not affirmative + limitations because they are merely indicating how the claimed invention might be + used. + + + +When determining whether a claim applies or uses a + recited judicial exception to effect a particular treatment or prophylaxis for a + disease or medical condition, the following factors are relevant. + + + +* a. **The Particularity Or Generality Of The + Treatment Or Prophylaxis** +* The treatment or prophylaxis limitation must + be "particular," *i.e.,* specifically identified so that it + does not encompass all applications of the judicial exception(s). For + example, consider a claim that recites mentally analyzing information to + identify if a patient has a genotype associated with poor metabolism of beta + blocker medications. This falls within the mental process grouping of + abstract ideas enumerated in **[MPEP § + 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**. The claim also recites "administering + a lower than normal dosage of a beta blocker medication to a patient + identified as having the poor metabolizer genotype." This administration + step is particular, and it integrates the mental analysis step into a + practical application. Conversely, consider a claim that recites the same + abstract idea and "administering a suitable medication to a patient." This + administration step is not particular, and is instead merely instructions to + "apply" the exception in a generic way. Thus, the administration step does + not integrate the mental analysis step into a practical application. + Examiners may find it helpful to evaluate + other considerations such as the mere instructions to apply an exception + consideration (see **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), and the + field of use and technological environment consideration (see + **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when + making a determination of whether a treatment or prophylaxis limitation is + particular or general. +* b. **Whether The Limitation(s) Have More + Than A Nominal Or Insignificant Relationship To The + Exception(s)** +* The treatment or prophylaxis limitation must + have more than a nominal or insignificant relationship to the exception(s). + For example, consider a claim that recites a natural correlation (law of + nature) between blood glucose levels over 250 mg/dl and the risk of + developing ketoacidosis (a life-threatening medical condition). The claim + also recites "treating a patient having a blood glucose level over 250 mg/dl + with insulin". Insulin acts to lower blood glucose levels, and administering + insulin to a patient will reduce the patient’s blood glucose level, thereby + lowering the risk that the patient will develop ketoacidosis. Thus, in the + context of this claim, the administration step is significantly related to + the recited correlation between high blood glucose levels and the risk of + ketoacidosis. Because insulin is also a "particular" treatment, this + administration step integrates the law of nature into a practical + application. Alternatively, consider a claim that recites the same law of + nature and also recites "treating a patient having a blood glucose level + over 250 mg/dl with aspirin." Aspirin is not known in the art as a treatment + for ketoacidosis or diabetes, although some patients with diabetes may be on + aspirin therapy for other medical reasons (*e.g.,* to + control pain or inflammation, or to prevent blood clots). In the context of + this claim and the recited correlation between high blood glucose levels and + the risk of ketoacidosis, administration of aspirin has at best a nominal + connection to the law of nature, because aspirin does not treat or prevent + ketoacidosis. This step therefore does not apply or use the exception in any + meaningful way. Thus, this step of administering aspirin does not integrate + the law of nature into a practical application. + Examiners may find it helpful to evaluate + other considerations such as the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the + field of use and technological environment consideration (see + **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when + making a determination of whether a treatment or prophylaxis limitation has + more than a nominal or insignificant relationship to the exception(s). +* c. **Whether The Limitation(s) Are Merely + Extra-Solution Activity Or A Field Of Use** +* The treatment or prophylaxis limitation must + impose meaningful limits on the judicial exception, and cannot be + extra-solution activity or a field-of-use. For example, consider a claim + that recites (a) administering rabies and feline leukemia vaccines to a + first group of domestic cats in accordance with different vaccination + schedules, and (b) analyzing information about the vaccination schedules and + whether the cats later developed chronic immune-mediated disorders to + determine a lowest-risk vaccination schedule. Step (b) falls within the + mental process grouping of abstract ideas enumerated in + **[MPEP § 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**. While + step (a) administers vaccines to the cats, this administration is performed + in order to gather data for the mental analysis step, and is a necessary + precursor for all uses of the recited exception. It is thus extra-solution + activity, and does not integrate the judicial exception into a practical + application. Conversely, consider a claim reciting the same steps (a) and + (b), but also reciting step (c) "vaccinating a second group of domestic cats + in accordance with the lowest-risk vaccination schedule." Step (c) applies + the exception, in that the information from the mental analysis in step (b) + is used to alter the order and timing of the vaccinations so that the second + group of cats has a lower risk of developing chronic immune-mediated + disorders. Step (c) thus integrates the abstract idea into a practical + application. + Examiners may find it helpful to evaluate + other considerations such as the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the + field of use and technological environment consideration (see + **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), when + making a determination of whether a treatment or prophylaxis limitation is + merely extra-solution activity or a field of use. + + + +, +# 2106.04(d)(1) Evaluating Improvements in the + Functioning of a Computer, or an Improvement to Any Other Technology or Technical + Field in Step 2A Prong Two [R-10.2019] + + +A claim reciting a judicial exception is not + directed to the judicial exception if it also recites additional elements + demonstrating that the claim as a whole integrates the exception into a practical + application. One way to demonstrate such integration is when the claimed invention + improves the functioning of a computer or improves another technology or technical + field. The application or use of the judicial exception in this manner + meaningfully limits the claim by going beyond generally linking the use of the + judicial exception to a particular technological environment, and thus transforms + a claim into patent-eligible subject matter. Such claims are eligible at Step 2A + because they are not "directed to" the recited judicial exception. + + + +The courts have not provided an explicit test for + this consideration, but have instead illustrated how it is evaluated in numerous + decisions. These decisions, and a detailed explanation of how examiners should + evaluate this consideration are provided in **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**. In short, first the specification should be + evaluated to determine if the disclosure provides sufficient details such that one + of ordinary skill in the art would recognize the claimed invention as providing an + improvement. The specification need not explicitly set forth the improvement, but + it must describe the invention such that the improvement would be apparent to one + of ordinary skill in the art. Conversely, if the specification explicitly sets + forth an improvement but in a conclusory manner (*i.e.,* a bare + assertion of an improvement without the detail necessary to be apparent to a + person of ordinary skill in the art), the examiner should not determine the claim + improves technology. Second, if the specification sets forth an improvement in + technology, the claim must be evaluated to ensure that the claim itself reflects + the disclosed improvement. That is, the claim includes the components or steps of + the invention that provide the improvement described in the specification. The + claim itself does not need to explicitly recite the improvement described in the + specification (*e.g.,* "thereby increasing the bandwidth of the + channel"). + + + +While the courts usually evaluate "improvements" as + part of the "directed to" inquiry in part one of the *Alice/Mayo* + test (equivalent to Step 2A), they have also performed this evaluation in part two + of the *Alice/Mayo* test (equivalent to Step 2B). See, + *e.g., BASCOM Global Internet v. AT&T Mobility LLC,* 827 + F.3d 1341, 1349-50, 119 USPQ2d 1236, 1241-42 (Fed. Cir. 2016). However, the + improvement analysis at Step 2A Prong Two differs in some respects from the + improvements analysis at Step 2B. Specifically, the "improvements" analysis in + Step 2A determines whether the claim pertains to an improvement to the functioning + of a computer or to another technology without reference to what is + well-understood, routine, conventional activity. That is, the claimed invention + may integrate the judicial exception into a practical application by demonstrating + that it improves the relevant existing technology although it may not be an + improvement over well-understood, routine, conventional activity. It should be + noted that while this consideration is often referred to in an abbreviated manner + as the "improvements consideration," the word "improvements" in the context of + this consideration is limited to improvements to the functioning of a computer or + any other technology/technical field, whether in Step 2A Prong Two or in Step + 2B. + + + +Examples of claims that improve technology and are + not directed to a judicial exception include: *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 1339, 118 USPQ2d 1684, 1691-92 (Fed. Cir. 2016) + (claims to a self-referential table for a computer database were directed to an + improvement in computer capabilities and not directed to an abstract idea); + *McRO, Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, + 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016) (claims to automatic lip + synchronization and facial expression animation were directed to an improvement in + computer-related technology and not directed to an abstract idea); *Visual + Memory LLC v. NVIDIA Corp.,* 867 F.3d 1253,1259-60, 123 USPQ2d 1712, + 1717 (Fed. Cir. 2017) (claims to an enhanced computer memory system were directed + to an improvement in computer capabilities and not an abstract idea); + *Finjan Inc. v. Blue Coat Systems, Inc.,* 879 F.3d 1299, 125 + USPQ2d 1282 (Fed. Cir. 2018) (claims to virus scanning were found to be an + improvement in computer technology and not directed to an abstract idea); + *SRI Int’l, Inc. v. Cisco Systems, Inc.,* 930 F.3d 1295, 1303 + (Fed. Cir. 2019) (claims to detecting suspicious activity by using network + monitors and analyzing network packets were found to be an improvement in computer + network technology and not directed to an abstract idea). Additional examples are + provided in **[MPEP § 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**. + + + +, +# 2106.04(d)(2) Particular Treatment and Prophylaxis in + Step 2A Prong Two + + +A claim reciting a judicial exception is not + directed to the judicial exception if it also recites additional element(s) + demonstrating that the claim as a whole integrates the exception into a practical + application. One way to demonstrate such integration is when the additional + elements apply or use the recited judicial exception to effect a particular + treatment or prophylaxis for a disease or medical condition. The application or + use of the judicial exception in this manner meaningfully limits the claim by + going beyond generally linking the use of the judicial exception to a particular + technological environment, and thus transforms a claim into patent-eligible + subject matter. Such claims are eligible at Step 2A, because they are not + "directed to" the recited judicial exception. + + + +The particular treatment or prophylaxis + consideration originated as part of the other meaningful limitations consideration + discussed in **[MPEP § 2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)** and shares the + same legal basis in Supreme Court jurisprudence as that consideration. However, + recent jurisprudence has provided additional guidance that is especially relevant + to only a subset of claims, thus warranting the elevation of the particular + treatment or prophylaxis consideration to become a stand-alone consideration in + the Step 2A Prong Two analysis. *Vanda Pharm. Inc. v. West-Ward Pharm. + Int’l Ltd.,* 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). The + claims in *Vanda* recited a method of treating a patient having + schizophrenia with iloperidone, a drug known to cause QTc prolongation (a + disruption of the heart’s normal rhythm that can lead to serious health problems) + in patients having a particular genotype associated with poor drug metabolism. 887 + F.3d at 1121, 126 USPQ2d at 1269-70. In particular, the claims recited steps of: + (1) performing a genotyping assay to determine if a patient has a genotype + associated with poor drug metabolism; and (2) administering iloperidone to the + patient in a dose range that depends on the patient’s genotype. + *Id.* Although *Vanda’s* claims recited a law + of nature (the naturally occurring relationship between the patient’s genotype and + the risk of QTc prolongation) like the claims in *Mayo Collaborative + Servs. v. Prometheus Labs., Inc.,* 566 U.S. 66, 101 USPQ2d 1961 + (2012), the Federal Circuit distinguished them from the *Mayo* + claims based on the differences in the administration steps. In particular, the + court explained that *Mayo’s* step of administering a drug to a + patient was performed in order to gather data about the recited laws of nature, + and this step was thus ancillary to the overall diagnostic focus of the claims. + 887 F.3d at 1134-35, 126 USPQ2d at 1280. In contrast, *Vanda’s* + claims used the recited law of nature to more safely treat the patients with the + drug, thereby reducing the patient’s risk of QTc prolongation. 887 F.3d at 1135, + 126 USPQ2d at 1280. Accordingly, the court held *Vanda’s* claims + eligible at the first part of the *Alice/Mayo* test (Step 2A) + because the claims were not "directed to" the recited judicial exception. 887 F.3d + at 1136, 126 USPQ2d at 1281. + + + +Examples of "treatment" and prophylaxis" + limitations encompass limitations that treat or prevent a disease or medical + condition, including, e.g., acupuncture, administration of medication, dialysis, + organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and + the like. For example, an immunization step that integrates an abstract idea into + a specific process of immunizing that lowers the risk that immunized patients will + later develop chronic immune-mediated diseases is considered to be a particular + prophylaxis limitation that practically applies the abstract idea. See, + *e.g., Classen Immunotherapies, Inc. v. Biogen IDEC,* 659 F.3d + 1057, 1066–68, 100 USPQ2d 1492, 1500-01 (Fed. Cir. 2011). + + + +Examiners should keep in mind that in order to + qualify as a "treatment" or "prophylaxis" limitation for purposes of this + consideration, the claim limitation in question must affirmatively recite an + action that effects a particular treatment or prophylaxis for a disease or medical + condition. An example of such a limitation is a step of "administering amazonic + acid to a patient" or a step of "administering a course of plasmapheresis to a + patient." If the limitation does not actually provide a treatment or prophylaxis, + *e.g.,* it is merely an intended use of the claimed invention + or a field of use limitation, then it cannot integrate a judicial exception under + the "treatment or prophylaxis" consideration. For example, a step of "prescribing + a topical steroid to a patient with eczema" is not a positive limitation because + it does not require that the steroid actually be used by or on the patient, and a + recitation that a claimed product is a "pharmaceutical composition" or that a + "feed dispenser is operable to dispense a mineral supplement" are not affirmative + limitations because they are merely indicating how the claimed invention might be + used. + + + +When determining whether a claim applies or uses a + recited judicial exception to effect a particular treatment or prophylaxis for a + disease or medical condition, the following factors are relevant. + + + +* a. **The Particularity Or Generality Of The + Treatment Or Prophylaxis** +* The treatment or prophylaxis limitation must + be "particular," *i.e.,* specifically identified so that it + does not encompass all applications of the judicial exception(s). For + example, consider a claim that recites mentally analyzing information to + identify if a patient has a genotype associated with poor metabolism of beta + blocker medications. This falls within the mental process grouping of + abstract ideas enumerated in **[MPEP § + 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**. The claim also recites "administering + a lower than normal dosage of a beta blocker medication to a patient + identified as having the poor metabolizer genotype." This administration + step is particular, and it integrates the mental analysis step into a + practical application. Conversely, consider a claim that recites the same + abstract idea and "administering a suitable medication to a patient." This + administration step is not particular, and is instead merely instructions to + "apply" the exception in a generic way. Thus, the administration step does + not integrate the mental analysis step into a practical application. + Examiners may find it helpful to evaluate + other considerations such as the mere instructions to apply an exception + consideration (see **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), and the + field of use and technological environment consideration (see + **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when + making a determination of whether a treatment or prophylaxis limitation is + particular or general. +* b. **Whether The Limitation(s) Have More + Than A Nominal Or Insignificant Relationship To The + Exception(s)** +* The treatment or prophylaxis limitation must + have more than a nominal or insignificant relationship to the exception(s). + For example, consider a claim that recites a natural correlation (law of + nature) between blood glucose levels over 250 mg/dl and the risk of + developing ketoacidosis (a life-threatening medical condition). The claim + also recites "treating a patient having a blood glucose level over 250 mg/dl + with insulin". Insulin acts to lower blood glucose levels, and administering + insulin to a patient will reduce the patient’s blood glucose level, thereby + lowering the risk that the patient will develop ketoacidosis. Thus, in the + context of this claim, the administration step is significantly related to + the recited correlation between high blood glucose levels and the risk of + ketoacidosis. Because insulin is also a "particular" treatment, this + administration step integrates the law of nature into a practical + application. Alternatively, consider a claim that recites the same law of + nature and also recites "treating a patient having a blood glucose level + over 250 mg/dl with aspirin." Aspirin is not known in the art as a treatment + for ketoacidosis or diabetes, although some patients with diabetes may be on + aspirin therapy for other medical reasons (*e.g.,* to + control pain or inflammation, or to prevent blood clots). In the context of + this claim and the recited correlation between high blood glucose levels and + the risk of ketoacidosis, administration of aspirin has at best a nominal + connection to the law of nature, because aspirin does not treat or prevent + ketoacidosis. This step therefore does not apply or use the exception in any + meaningful way. Thus, this step of administering aspirin does not integrate + the law of nature into a practical application. + Examiners may find it helpful to evaluate + other considerations such as the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the + field of use and technological environment consideration (see + **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when + making a determination of whether a treatment or prophylaxis limitation has + more than a nominal or insignificant relationship to the exception(s). +* c. **Whether The Limitation(s) Are Merely + Extra-Solution Activity Or A Field Of Use** +* The treatment or prophylaxis limitation must + impose meaningful limits on the judicial exception, and cannot be + extra-solution activity or a field-of-use. For example, consider a claim + that recites (a) administering rabies and feline leukemia vaccines to a + first group of domestic cats in accordance with different vaccination + schedules, and (b) analyzing information about the vaccination schedules and + whether the cats later developed chronic immune-mediated disorders to + determine a lowest-risk vaccination schedule. Step (b) falls within the + mental process grouping of abstract ideas enumerated in + **[MPEP § 2106.04(a)](s2106.html#ch2100_d29a1b_13a9e_2dc)**. While + step (a) administers vaccines to the cats, this administration is performed + in order to gather data for the mental analysis step, and is a necessary + precursor for all uses of the recited exception. It is thus extra-solution + activity, and does not integrate the judicial exception into a practical + application. Conversely, consider a claim reciting the same steps (a) and + (b), but also reciting step (c) "vaccinating a second group of domestic cats + in accordance with the lowest-risk vaccination schedule." Step (c) applies + the exception, in that the information from the mental analysis in step (b) + is used to alter the order and timing of the vaccinations so that the second + group of cats has a lower risk of developing chronic immune-mediated + disorders. Step (c) thus integrates the abstract idea into a practical + application. + Examiners may find it helpful to evaluate + other considerations such as the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the + field of use and technological environment consideration (see + **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), when + making a determination of whether a treatment or prophylaxis limitation is + merely extra-solution activity or a field of use. + + +, +# 2106.05 Eligibility Step 2B: Whether a Claim Amounts to + Significantly More [R-10.2019] + +**I.** **THE SEARCH FOR AN INVENTIVE + CONCEPT**The second part of the *Alice/Mayo* + test is often referred to as a search for an inventive concept. *Alice Corp. + Pty. Ltd. v. CLS Bank Int'l,* 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 + (2014) (citing *Mayo Collaborative Servs. v. Prometheus Labs., + Inc.,* 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). + + + + An inventive concept "cannot be furnished by the + unpatentable law of nature (or natural phenomenon or abstract idea) itself." + *Genetic Techs. v. Merial LLC,* 818 F.3d 1369, 1376, 118 USPQ2d + 1541, 1546 (Fed. Cir. 2016). See also *Alice Corp.,* 573 U.S. at + 21-18, 110 USPQ2d at 1981 (citing *Mayo,* 566 U.S. at 78, 101 USPQ2d + at 1968 (after determining that a claim is directed to a judicial exception, "we then + ask, ‘**[w]hat else** is there in the claims before us?") (emphasis added)); + *RecogniCorp, LLC v. Nintendo Co.,* 855 F.3d 1322, 1327, 122 + USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract + idea (encoding and decoding) does not render the claim non-abstract"). Instead, an + "inventive concept" is furnished by an element or combination of elements that is + recited in the claim in addition to (beyond) the judicial exception, and is + sufficient to ensure that the claim as a whole amounts to significantly more than the + judicial exception itself. *Alice Corp.,* 573 U.S. at 27-18, 110 + USPQ2d at 1981 (citing *Mayo,* 566 U.S. at 72-73, 101 USPQ2d at + 1966). + + + +Evaluating additional elements to determine whether + they amount to an inventive concept requires considering them both individually and + in combination to ensure that they amount to significantly more than the judicial + exception itself. Because this approach considers all claim elements, the Supreme + Court has noted that "it is consistent with the general rule that patent claims ‘must + be considered as a whole.’" *Alice Corp.,* 573 U.S. at 218 n.3, 110 + USPQ2d at 1981 (quoting *Diamond v. Diehr,* 450 U.S. 175, 188, 209 + USPQ 1, 8-9 (1981)). Consideration of the elements in combination is particularly + important, because even if an additional element does not amount to significantly + more on its own, it can still amount to significantly more when considered in + combination with the other elements of the claim. *See, e.g., Rapid Litig. + Mgmt. v. CellzDirect,* 827 F.3d 1042, 1051, 119 USPQ2d 1370, 1375 (Fed. + Cir. 2016) (process reciting combination of individually well-known freezing and + thawing steps was "far from routine and conventional" and thus eligible); + *BASCOM Global Internet Servs. v. AT&T Mobility LLC,* 827 + F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) (inventive concept may be + found in the non-conventional and non-generic arrangement of components that are + individually well-known and conventional). + + + +Although the courts often evaluate considerations such + as the conventionality of an additional element in the eligibility analysis, the + search for an inventive concept should not be confused with a novelty or + non-obviousness determination. See *Mayo,* 566 U.S. at 91, 101 + USPQ2d at 1973 (rejecting "the Government’s invitation to substitute + **[§§ + 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)**, **[103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)**, and **[112](mpep-9015-appx-l.html#d0e302824912)** + inquiries for the better established inquiry under **[§ 101](mpep-9015-appx-l.html#d0e302376)**"). As + made clear by the courts, the "‘novelty’ of any element or steps in a process, or + even of the process itself, is of ***no relevance*** in + determining whether the subject matter of a claim falls within the **[§ 101](mpep-9015-appx-l.html#d0e302376)** + categories of possibly patentable subject matter." *Intellectual Ventures I + v. Symantec Corp.,* 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. + 2016) (quoting *Diamond v. Diehr,* 450 U.S. at 188–89, 209 USPQ at + 9). See also *Synopsys, Inc. v. Mentor Graphics Corp.,* 839 F.3d + 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a claim for a + ***new*** abstract idea is still an abstract idea. + The search for a **[§ + 101](mpep-9015-appx-l.html#d0e302376)** inventive concept is thus distinct from demonstrating + **[§ + 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)** novelty."). In addition, the search for an inventive + concept is different from an obviousness analysis under **[35 U.S.C. + 103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)**. See, *e.g., BASCOM Global Internet v. AT&T + Mobility LLC,* 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. + 2016) ("The inventive concept inquiry requires more than recognizing that each claim + element, by itself, was known in the art. . . . [A]n inventive concept can be found + in the non-conventional and non-generic arrangement of known, conventional pieces."). + Specifically, lack of novelty under **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)** or obviousness + under **[35 + U.S.C. 103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)** of a claimed invention does not necessarily indicate + that additional elements are well-understood, routine, conventional elements. Because + they are separate and distinct requirements from eligibility, patentability of the + claimed invention under **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)** and + **[103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)** with respect to the prior art is neither required for, nor + a guarantee of, patent eligibility under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**. The distinction + between eligibility (under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**) and patentability + over the art (under **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)** and/or + **[103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)**) is further discussed in **[MPEP § + 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**. + + +***A.*** ***Relevant Considerations For Evaluating Whether Additional Elements + Amount To An Inventive Concept***The Supreme Court has identified a number of + considerations as relevant to the evaluation of whether the claimed additional + elements amount to an inventive concept. The list of considerations here is not + intended to be exclusive or limiting. Additional elements can often be analyzed + based on more than one type of consideration and the type of consideration is of + no import to the eligibility analysis. Additional discussion of these + considerations, and how they were applied in particular judicial decisions, is + provided in in **[MPEP § 2106.05(a) through (h)](s2106.html#ch2100_d29a1b_13c69_10)**. + + + +Limitations that the courts have found to qualify + as "significantly more" when recited in a claim with a judicial exception include: + + + +* i. Improvements to the functioning of a + computer, *e.g.,* a modification of conventional Internet + hyperlink protocol to dynamically produce a dual-source hybrid webpage, as + discussed in *DDR Holdings, LLC v. Hotels.com, L.P.,* 773 + F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014) (see + **[MPEP § 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**); +* ii. Improvements to any other technology or + technical field, *e.g.,* a modification of conventional + rubber-molding processes to utilize a thermocouple inside the mold to + constantly monitor the temperature and thus reduce under- and over-curing + problems common in the art, as discussed in *Diamond v. + Diehr,* 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981) (see + **[MPEP § 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**); +* iii. Applying the judicial exception with, or by + use of, a particular machine, *e.g.,* a Fourdrinier machine + (which is understood in the art to have a specific structure comprising a + headbox, a paper-making wire, and a series of rolls) that is arranged in a + particular way to optimize the speed of the machine while maintaining + quality of the formed paper web, as discussed in *Eibel Process Co. + v. Minn. & Ont. Paper Co.,* 261 U.S. 45, 64-65 (1923) (see + **[MPEP § 2106.05(b)](s2106.html#ch2100_d29a1b_13ccf_18c)**); +* iv. Effecting a transformation or reduction of a + particular article to a different state or thing, *e.g.,* a + process that transforms raw, uncured synthetic rubber into precision-molded + synthetic rubber products, as discussed in *Diehr,* 450 + U.S. at 184, 209 USPQ at 21 (see **[MPEP § + 2106.05(c)](s2106.html#ch2100_d29a1b_13cfb_2e)**); +* v. Adding a specific limitation other than what + is well-understood, routine, conventional activity in the field, or adding + unconventional steps that confine the claim to a particular useful + application, *e.g.,* a non-conventional and non-generic + arrangement of various computer components for filtering Internet content, + as discussed in *BASCOM Global Internet v. AT&T Mobility + LLC,* 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. + 2016) (see **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**); or +* vi. Other meaningful limitations beyond + generally linking the use of the judicial exception to a particular + technological environment, *e.g.,* an immunization step + that integrates an abstract idea of data comparison into a specific process + of immunizing that lowers the risk that immunized patients will later + develop chronic immune-mediated diseases, as discussed in *Classen + Immunotherapies Inc. v. Biogen IDEC,* 659 F.3d 1057, 1066-68, + 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (see **[MPEP § + 2106.05(e)](s2106.html#ch2100_d29a1b_13d61_1a8)**). + + + Limitations that the courts have found not to be + enough to qualify as "significantly more" when recited in a claim with a judicial + exception include: + + + +* i. Adding the words "apply it" (or an + equivalent) with the judicial exception, or mere instructions to implement + an abstract idea on a computer, *e.g.,* a limitation + indicating that a particular function such as creating and maintaining + electronic records is performed by a computer, as discussed in + *Alice Corp.,* 573 U.S. at 225-26, 110 USPQ2d at 1984 + (see **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**); +* ii. Simply appending well-understood, routine, + conventional activities previously known to the industry, specified at a + high level of generality, to the judicial exception, + *e.g.,* a claim to an abstract idea requiring no more + than a generic computer to perform generic computer functions that are + well-understood, routine and conventional activities previously known to the + industry, as discussed in *Alice Corp.,* 573 U.S. at 225, + 110 USPQ2d at 1984 (see **[MPEP § + 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**); +* iii. Adding insignificant extra-solution activity + to the judicial exception, *e.g.,* mere data gathering in + conjunction with a law of nature or abstract idea such as a step of + obtaining information about credit card transactions so that the information + can be analyzed by an abstract mental process, as discussed in + *CyberSource v. Retail Decisions, Inc.,* 654 F.3d 1366, + 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**); or +* iv. Generally linking the use of the judicial + exception to a particular technological environment or field of use, + *e.g.,* a claim describing how the abstract idea of + hedging could be used in the commodities and energy markets, as discussed in + *Bilski v. Kappos,* 561 U.S. 593, 595, 95 USPQ2d 1001, + 1010 (2010) or a claim limiting the use of a mathematical formula to the + petrochemical and oil-refining fields, as discussed in *Parker v. + Flook,* 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) + (**[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**). + + +It is notable that mere physicality or tangibility + of an additional element or elements is not a relevant consideration in Step 2B. + As the Supreme Court explained in *Alice Corp.,* mere physical or + tangible implementation of an exception is not in itself an inventive concept and + does not guarantee eligibility: + + + + +> +> The fact that a computer "necessarily exist[s] +> in the physical, rather than purely conceptual, realm," is beside the point. +> There is no dispute that a computer is a tangible system (in **[§ 101](mpep-9015-appx-l.html#d0e302376)** +> terms, a "machine"), or that many computer-implemented claims are formally +> addressed to patent-eligible subject matter. But if that were the end of the +> **[§ +> 101](mpep-9015-appx-l.html#d0e302376)** inquiry, an applicant could claim any principle of +> the physical or social sciences by reciting a computer system configured to +> implement the relevant concept. Such a result would make the determination of +> patent eligibility "depend simply on the draftsman’s art," *Flook, +> supra,* at 593, 98 S. Ct. 2522, 57 L. Ed. 2d 451, thereby +> eviscerating the rule that "‘[l]aws of nature, natural phenomena, and abstract +> ideas are not patentable,’" *Myriad,* 133 S. Ct. 1289, 186 L. +> Ed. 2d 124, 133). +> +> +> +> + + +*Alice Corp.,* 573 U.S. at 224, + 110 USPQ2d at 1983-84 (alterations in original). See also *Genetic + Technologies Ltd. v. Merial LLC,* 818 F.3d 1369, 1377, 118 USPQ2d + 1541, 1547 (Fed. Cir. 2016) (steps of DNA amplification and analysis "do not, + individually or in combination, provide sufficient inventive concept to render + claim 1 patent eligible" merely because they are physical steps). Conversely, the + presence of a non-physical or intangible additional element does not doom the + claims, because tangibility is not necessary for eligibility under the + *Alice/Mayo* test. *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016) ("that the + improvement is not defined by reference to ‘physical’ components does not doom the + claims"). See also *McRO, Inc. v. Bandai Namco Games Am. Inc.,* + 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016), (holding that a + process producing an intangible result (a sequence of synchronized, animated + characters) was eligible because it improved an existing technological process). + + + +***B.*** ***Examples Of How Courts Conduct The Search For An Inventive + Concept****Alice Corp.* provides an example + of how courts conduct the significantly more analysis. In this case, the Supreme + Court analyzed claims to computer systems, computer readable media, and + computer-implemented methods, all of which described a scheme for mitigating + "settlement risk," which is the risk that only one party to an agreed-upon + financial exchange will satisfy its obligation. In part one of the + *Alice/Mayo* test, the Court determined that the claims were + directed to the abstract idea of mitigating settlement risk. *Alice + Corp.,* 573 U.S. at 221, 110 USPQ2d at 1982. The Court then walked + through part two of the *Alice/Mayo* test, in which: + + + +* • The Court identified the additional + elements in the claim, *e.g.,* by noting that the method + claims recited steps of using a computer to "create electronic records, + track multiple transactions, and issue simultaneous instructions", and that + the product claims recited hardware such as a "data processing system" with + a "communications controller" and a "data storage unit" (573 U.S. at 224-26, + 110 USPQ2d at 1984-85); +* • The Court considered the additional + elements individually, noting that all the computer functions were + "‘well-understood, routine, conventional activit[ies]’ previously known to + the industry," each step "does no more than require a generic computer to + perform generic computer functions", and the recited hardware was "purely + functional and generic" (573 U.S. at 225-26, 110 USPQ2d at 1984-85); and +* • The Court considered the additional + elements "as an ordered combination," and determined that "the computer + components … ‘[a]dd nothing … that is not already present when the steps are + considered separately’" and simply recite intermediated settlement as + performed by a generic computer." 573 U.S. at 225 (citing + *Mayo,* 566 U.S. at 79, 101 USPQ2d at 1972). + + +Based on this analysis, the Court concluded that + the claims amounted to "‘nothing significantly more’ than an instruction to apply + the abstract idea of intermediated settlement using some unspecified, generic + computer", and therefore held the claims ineligible because they were directed to + a judicial exception and failed the second part of the + *Alice/Mayo* test. *Alice Corp.,* 573 U.S. at + 225-27, 110 USPQ2d at 1984. + + + +*BASCOM* provides another example + of how courts conduct the significantly more analysis, and of the critical + importance of considering the additional elements in combination. In this case, + the Federal Circuit vacated a judgment of ineligibility because the district court + failed to properly perform the second step of the *Alice/Mayo* + test when analyzing a claimed system for filtering content retrieved from an + Internet computer network. *BASCOM Global Internet v. AT&T Mobility + LLC,* 827 F.3d 1341, 119 USPQ2d 1236 (Fed. Cir. 2016). The Federal + Circuit agreed with the district court that the claims were directed to the + abstract idea of filtering Internet content, and then walked through the district + court’s analysis in part two of the *Alice/Mayo* test, noting + that: + + + +* • The district court properly identified + the additional elements in the claims, such as a "local client computer," + "remote ISP server," "Internet computer network," and "controlled access + network accounts" (827 F.3d at 1349, 119 USPQ2d at 1242); +* • The district court properly considered the + additional elements individually, for example by consulting the + specification, which described each of the additional elements as + "well-known generic computer components" (827 F.3d at 1349, 119 USPQ2d at + 1242); and +* • The district court should have considered + the additional elements in combination, because the "inventive concept + inquiry requires more than recognizing that each claim element, by itself, + was known in the art" (827 F.3d at 1350, 119 USPQ2d at 1242). + + +Based on this analysis, the Federal Circuit + concluded that the district court erred by failing to recognize that when + combined, an inventive concept may be found in the non-conventional and + non-generic arrangement of the additional elements, i.e., the installation of a + filtering tool at a specific location, remote from the end-users, with + customizable filtering features specific to each end user. 827 F.3d at 1350, 119 + USPQ2d at 1242. + + +**II.** **ELIGIBILITY STEP 2B: WHETHER THE + ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"**As described in **[MPEP § 2106](s2106.html#d0e197244)**, + subsection III, Step 2B of the Office’s eligibility analysis is the second part of + the *Alice/Mayo* test, *i.e.,* the Supreme Court’s + "framework for distinguishing patents that claim laws of nature, natural phenomena, + and abstract ideas from those that claim patent-eligible applications of those + concepts." *Alice Corp. Pty. Ltd. v. CLS Bank Int'l,* 573 U.S. 208, + 217, 110 USPQ2d 1976, 1981 (2014) (citing *Mayo,* 566 U.S. 66, 101 + USPQ2d 1961 (2012)). Like the other steps in the eligibility analysis, evaluation of + this step should be made after determining what applicant has invented by reviewing + the entire application disclosure and construing the claims in accordance with their + broadest reasonable interpretation. See **[MPEP § 2106](s2106.html#d0e197244)**, subsection II for more + information about the importance of understanding what the applicant has invented, + and **[MPEP § + 2111](s2111.html#d0e200352)** for more information about the broadest reasonable + interpretation. + + + +Step 2B asks: Does the claim recite additional + elements that amount to significantly more than the judicial exception? Examiners + should answer this question by first identifying whether there are any additional + elements (features/limitations/steps) recited in the claim beyond the judicial + exception(s), and then evaluating those additional elements individually + **and in combination** to determine whether + they contribute an inventive concept (*i.e.,* amount to + significantly more than the judicial exception(s)). + + + +This evaluation is made with respect to the + considerations that the Supreme Court has identified as relevant to the eligibility + analysis, which are introduced generally in Part I.A of this section, and discussed + in detail in **[MPEP § 2106.05(a) through (h)](s2106.html#ch2100_d29a1b_13c69_10)**. Many + of these considerations overlap, and often more than one consideration is relevant to + analysis of an additional element. Not all considerations will be relevant to every + element, or every claim. Because the evaluation in Step 2B is not a weighing test, it + is not important how the elements are characterized or how many considerations apply + from this list. It is important to evaluate the significance of the additional + elements relative to applicant’s invention, and to keep in mind the ultimate question + of whether the additional elements encompass an inventive concept. + + + +Although the conclusion of whether a claim is + eligible at Step 2B requires that all relevant considerations be evaluated, most of + these considerations were already evaluated in Step 2A Prong Two. Thus, in Step 2B, + examiners should: + + + +* • Carry over their identification of the + additional element(s) in the claim from Step 2A Prong Two; +* • Carry over their conclusions from Step 2A + Prong Two on the considerations discussed in **[MPEP §§ 2106.05(a) - + (c), (e) (f) and (h)](s2106.html#ch2100_d29a1b_13c69_10)**: +* • Re-evaluate any additional element or + combination of elements that was considered to be insignificant extra-solution + activity per **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**, because if + such re-evaluation finds that the element is unconventional or otherwise more + than what is well-understood, routine, conventional activity in the field, this + finding may indicate that the additional element is no longer considered to be + insignificant; and +* • Evaluate whether any additional element or + combination of elements are other than what is well-understood, routine, + conventional activity in the field, or simply append well-understood, routine, + conventional activities previously known to the industry, specified at a high + level of generality, to the judicial exception, per **[MPEP § + 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**. + + +In the context of the flowchart in + **[MPEP § + 2106](s2106.html#d0e197244)**, subsection III, Step 2B determines whether: + + + +* • The claim as a whole does not amount to + significantly more than the exception itself (there is no inventive concept in + the claim) (Step 2B: NO) and thus is not eligible, warranting a rejection for + lack of subject matter eligibility and concluding the eligibility analysis; or +* • The claim as a whole does amount to + significantly more than the exception (there is an inventive concept in the + claim) (Step 2B: YES), and thus is eligible at Pathway C, thereby concluding + the eligibility analysis. + + +Examiners should examine each claim for eligibility + separately, based on the particular elements recited therein. Claims should not be + judged to automatically stand or fall with similar claims in an application. For + instance, one claim may be ineligible because it is directed to a judicial exception + without amounting to significantly more, but another claim dependent on the first may + be eligible because it recites additional elements that do amount to significantly + more. + + + +For more information on how to evaluate claims + reciting multiple judicial exceptions, see **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, subsection II.B. + + + + If the claim as a whole does recite significantly + more than the exception itself, the claim is eligible (Step 2B: YES) at Pathway C, + and the eligibility analysis is complete. If there are no meaningful limitations in + the claim that transform the exception into a patent-eligible application, such that + the claim does not amount to significantly more than the exception itself, the claim + is not patent-eligible (Step 2B: NO) and should be rejected under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**. + See **[MPEP + § 2106.07](s2106.html#ch2100_d29a1b_13fb7_330)** for information on how to formulate an + ineligibility rejection. + + + + +# 2106.05(a) Improvements to the Functioning of a Computer + or To Any Other Technology or Technical Field [R-10.2019] + + +In determining patent eligibility, examiners should + consider whether the claim "purport(s) to improve the functioning of the computer + itself" or "any other technology or technical field." *Alice Corp. Pty. Ltd. + v. CLS Bank Int’l,* 573 U.S. 208, 225, 110 USPQ2d 1976, 1984 (2014). This + consideration has also been referred to as the search for a technological solution to + a technological problem. See e.g., *DDR Holdings, LLC. v. Hotels.com, + L.P.,* 773 F.3d 1245, 1257, 113 USPQ2d 1097, 1105 (Fed. Cir. 2014); + *Amdocs (Israel), Ltd. v. Openet Telecom, Inc.,* 841 F.3d 1288, + 1300-01, 120 USPQ2d 1527, 1537 (Fed. Cir. 2016). + + + +While improvements were evaluated in *Alice + Corp.* as relevant to the search for an inventive concept (Step 2B), + several decisions of the Federal Circuit have also evaluated this consideration when + determining whether a claim was directed to an abstract idea (Step 2A). See, + e.g., *Enfish, LLC v. Microsoft Corp.,* 822 F.3d 1327, 1335-36, + 118 USPQ2d 1684, 1689 (Fed. Cir. 2016); *McRO, Inc. v. Bandai Namco Games Am. + Inc.,* 837 F.3d 1299, 1314-16, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016); + *Visual Memory, LLC v. NVIDIA Corp.,* 867 F.3d 1253, 1259-60, 123 + USPQ2d 1712, 1717 (Fed. Cir. 2017). Thus, an examiner should evaluate whether a claim + contains an improvement to the functioning of a computer or to any other technology + or technical field at Step 2A Prong Two and Step 2B, as well as when considering + whether the claim has such self-evident eligibility that it qualifies for the + streamlined analysis. See **[MPEP § 2106.04(d)(1)](s2106.html#ch2100_d2e7df_24a6e_1bd)** for more + information about evaluating improvements in Step 2A Prong Two, and + **[MPEP + § 2106.07(b)](s2106.html#ch2100_d29a1b_14065_2a0)** for more information about improvements in the + streamlined analysis context. + + + +If it is asserted that the invention improves upon + conventional functioning of a computer, or upon conventional technology or + technological processes, a technical explanation as to how to implement the invention + should be present in the specification. That is, the disclosure must provide + sufficient details such that one of ordinary skill in the art would recognize the + claimed invention as providing an improvement. The specification need not explicitly + set forth the improvement, but it must describe the invention such that the + improvement would be apparent to one of ordinary skill in the art. Conversely, if the + specification explicitly sets forth an improvement but in a conclusory manner (i.e., + a bare assertion of an improvement without the detail necessary to be apparent to a + person of ordinary skill in the art), the examiner should not determine the claim + improves technology. An indication that the claimed invention provides an improvement + can include a discussion in the specification that identifies a technical problem and + explains the details of an unconventional technical solution expressed in the claim, + or identifies technical improvements realized by the claim over the prior art. For + example, in *McRO,* the court relied on the specification’s + explanation of how the particular rules recited in the claim enabled the automation + of specific animation tasks that previously could only be performed subjectively by + humans, when determining that the claims were directed to improvements in computer + animation instead of an abstract idea. *McRO,* 837 F.3d at 1313-14, + 120 USPQ2d at 1100-01. In contrast, the court in *Affinity Labs of Tex. v. + DirecTV, LLC* relied on the specification’s failure to provide details + regarding the manner in which the invention accomplished the alleged improvement when + holding the claimed methods of delivering broadcast content to cellphones ineligible. + 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016). + + + +After the examiner has consulted the specification + and determined that the disclosed invention improves technology, the claim must be + evaluated to ensure the claim itself reflects the disclosed improvement in + technology. *Intellectual Ventures I LLC v. Symantec Corp.,* 838 + F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (patent owner argued that the claimed email + filtering system improved technology by shrinking the protection gap and mooting the + volume problem, but the court disagreed because the claims themselves did not have + any limitations that addressed these issues). That is, the claim must include the + components or steps of the invention that provide the improvement described in the + specification. However, the claim itself does not need to explicitly recite the + improvement described in the specification (*e.g.,* "thereby + increasing the bandwidth of the channel"). The full scope of the claim under the BRI + should be considered to determine if the claim reflects an improvement in technology + (*e.g.,* the improvement described in the specification). In + making this determination, it is critical that examiners look at the claim "as a + whole," in other words, the claim should be evaluated "as an ordered combination, + without ignoring the requirements of the individual steps." When performing this + evaluation, examiners should be "careful to avoid oversimplifying the claims" by + looking at them generally and failing to account for the specific requirements of the + claims. *McRO,* 837 F.3d at 1313, 120 USPQ2d at 1100. + + + + An important consideration in determining whether a + claim improves technology is the extent to which the claim covers a particular + solution to a problem or a particular way to achieve a desired outcome, as opposed to + merely claiming the idea of a solution or outcome. *McRO,* 837 F.3d + at 1314-15, 120 USPQ2d at 1102-03; *DDR Holdings,* 773 F.3d at 1259, + 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with + other considerations, specifically the particular machine consideration (see + **[MPEP + § 2106.05(b)](s2106.html#ch2100_d29a1b_13ccf_18c)**), and the mere instructions to apply an + exception consideration (see **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**). Thus, evaluation + of those other considerations may assist examiners in making a determination of + whether a claim satisfies the improvement consideration. + + + +It is important to note, the judicial exception alone + cannot provide the improvement. The improvement can be provided by one or more + additional elements. See the discussion of *Diamond v. Diehr*, 450 + U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In + addition, the improvement can be provided by the additional element(s) in combination + with the recited judicial exception. See **[MPEP § + 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)** (discussing *Finjan, Inc. v. Blue Coat + Sys., Inc.,* 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. + 2018)). Thus, it is important for examiners to analyze the claim as a whole when + determining whether the claim provides an improvement to the functioning of computers + or an improvement to other technology or technical field. + + + +During examination, the examiner should analyze the + "improvements" consideration by evaluating the specification and the claims to ensure + that a technical explanation of the asserted improvement is present in the + specification, and that the claim reflects the asserted improvement. Generally, + examiners are not expected to make a qualitative judgement on the merits of the + asserted improvement. If the examiner concludes the disclosed invention does not + improve technology, the burden shifts to applicant to provide persuasive arguments + supported by any necessary evidence to demonstrate that one of ordinary skill in the + art would understand that the disclosed invention improves technology. Any such + evidence submitted under **[37 CFR 1.132](mpep-9020-appx-r.html#d0e323552)** must establish what + the specification would convey to one of ordinary skill in the art and cannot be used + to supplement the specification. See, *e.g.***[MPEP § + 716.09](s716.html#d0e93742)** on **[37 CFR 1.132](mpep-9020-appx-r.html#d0e323552)** practice with + respect to rejections under **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**. For example, in + response to a rejection under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**, an applicant could + submit a declaration under **[§ 1.132](mpep-9020-appx-r.html#d0e323552)** providing testimony on + how one of ordinary skill in the art would interpret the disclosed invention as + improving technology and the underlying factual basis for that conclusion. + + +**I.** **IMPROVEMENTS TO COMPUTER + FUNCTIONALITY**In computer-related technologies, the examiner + should determine whether the claim purports to improve computer capabilities or, + instead, invokes computers merely as a tool. *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). + In *Enfish,* the court evaluated the patent eligibility of claims + related to a self-referential database. *Id.* The court concluded + the claims were not directed to an abstract idea, but rather an improvement to + computer functionality. *Id.* It was the specification’s + discussion of the prior art and how the invention improved the way the computer + stores and retrieves data in memory in combination with the specific data + structure recited in the claims that demonstrated eligibility. 822 F.3d at 1339, + 118 USPQ2d at 1691. The claim was not simply the addition of general purpose + computers added post-hoc to an abstract idea, but a specific implementation of a + solution to a problem in the software arts. 822 F.3d at 1339, 118 USPQ2d at + 1691. + + + + Examples that the courts have indicated may show + an improvement in computer-functionality: + + + +* i. A modification of conventional Internet + hyperlink protocol to dynamically produce a dual-source hybrid webpage, + *DDR Holdings,* 773 F.3d at 1258-59, 113 USPQ2d at + 1106-07; +* ii. Inventive distribution of functionality + within a network to filter Internet content, *BASCOM Global Internet + v. AT&T Mobility LLC,* 827 F.3d 1341, 1350-51, 119 USPQ2d + 1236, 1243 (Fed. Cir. 2016); +* iii. A method of rendering a halftone digital + image, *Research Corp. Techs. v. Microsoft Corp.,* 627 F.3d + 859, 868-69, 97 USPQ2d 1274, 1380 (Fed. Cir. 2010); +* iv. A distributed network architecture operating + in an unconventional fashion to reduce network congestion while generating + networking accounting data records, *Amdocs (Israel), Ltd. v. Openet + Telecom, Inc.,* 841 F.3d 1288, 1300-01, 120 USPQ2d 1527, 1536-37 + (Fed. Cir. 2016); +* v. A memory system having programmable + operational characteristics that are configurable based on the type of + processor, which can be used with different types of processors without a + tradeoff in processor performance, *Visual Memory, LLC v. NVIDIA + Corp.,* 867 F.3d 1253, 1259-60, 123 USPQ2d 1712, 1717 (Fed. Cir. + 2017); +* vi. Technical details as to how to transmit + images over a cellular network or append classification information to + digital image data, *TLI Communications LLC v. AV Auto. + LLC,* 823 F.3d 607, 614-15, 118 USPQ2d 1744, 1749-50 (Fed. Cir. + 2016) (holding the claims ineligible because they fail to provide requisite + technical details necessary to carry out the function); +* vii. Particular structure of a server that stores + organized digital images, *TLI Communications,* 823 F.3d at + 612, 118 USPQ2d at 1747 (finding the use of a generic server insufficient to + add inventive concepts to an abstract idea); +* viii. A particular way of programming or designing + software to create menus, *Apple, Inc. v. Ameranth, Inc.,* + 842 F.3d 1229, 1241, 120 USPQ2d 1844, 1854 (Fed. Cir. 2016); +* ix. A method that generates a security profile + that identifies both hostile and potentially hostile operations, and can + protect the user against both previously unknown viruses and "obfuscated + code," which is an improvement over traditional virus scanning. + *Finjan Inc. v. Blue Coat Systems,* 879 F.3d 1299, 1304, + 125 USPQ2d 1282, 1286 (Fed. Cir. 2018); +* x. An improved user interface for electronic + devices that displays an application summary of unlaunched applications, + where the particular data in the summary is selectable by a user to launch + the respective application. *Core Wireless Licensing S.A.R.L., v. LG + Electronics, Inc.,* 880 F.3d 1356, 1362-63, 125 USPQ2d 1436, + 1440-41 (Fed. Cir. 2018); +* xi. Specific interface and implementation for + navigating complex three-dimensional spreadsheets using techniques unique to + computers; *Data Engine Techs., LLC v. Google LLC,* 906 + F.3d 999, 1009, 128 USPQ2d 1381, 1387 (Fed. Cir. 2018); and +* xii. A specific method of restricting software + operation within a license, *Ancora Tech., Inc. v. HTC America, + Inc.,* 908 F.3d 1343, 1345-46, 128 USPQ2d 1565, 1567 (Fed. Cir. + 2018). + + +It is important to note that in order for a method + claim to improve computer functionality, the broadest reasonable interpretation of + the claim must be limited to computer implementation. That is, a claim whose + entire scope can be performed mentally, cannot be said to improve computer + technology. *Synopsys, Inc. v. Mentor Graphics Corp.,* 839 F.3d + 1138, 120 USPQ2d 1473 (Fed. Cir. 2016) (a method of translating a logic circuit + into a hardware component description of a logic circuit was found to be + ineligible because the method did not employ a computer and a skilled artisan + could perform all the steps mentally). Similarly, a claimed process covering + embodiments that can be performed on a computer, as well as embodiments that can + be practiced verbally or with a telephone, cannot improve computer technology. See + *RecogniCorp, LLC v. Nintendo Co.,* 855 F.3d 1322, 1328, 122 + USPQ2d 1377, 1381 (Fed. Cir. 2017) (process for encoding/decoding facial data + using image codes assigned to particular facial features held ineligible because + the process did not require a computer). + + + +Examples that the courts have indicated may not be + sufficient to show an improvement in computer-functionality: + + + +* i. Generating restaurant menus with + functionally claimed features, *Ameranth,* 842 F.3d at + 1245, 120 USPQ2d at 1857; +* ii. Accelerating a process of analyzing audit + log data when the increased speed comes solely from the capabilities of a + general-purpose computer, *FairWarning IP, LLC v. Iatric Sys.,* 839 F.3d 1089, 1095, 120 USPQ2d 1293, 1296 (Fed. Cir. 2016); +* iii. Mere automation of manual processes, such as + using a generic computer to process an application for financing a purchase, + *Credit Acceptance Corp. v. Westlake Services,* 859 F.3d + 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) or speeding up a + loan-application process by enabling borrowers to avoid physically going to + or calling each lender and filling out a loan application, + *LendingTree, LLC v. Zillow, Inc.,* 656 Fed. App'x 991, + 996-97 (Fed. Cir. 2016) (non-precedential); +* iv. Recording, transmitting, and archiving + digital images by use of conventional or generic technology in a nascent but + well-known environment, without any assertion that the invention reflects an + inventive solution to any problem presented by combining a camera and a + cellular telephone, *TLI Communications,* 823 F.3d at + 611-12, 118 USPQ2d at 1747; +* v. Affixing a barcode to a mail object in order + to more reliably identify the sender and speed up mail processing, without + any limitations specifying the technical details of the barcode or how it is + generated or processed, *Secured Mail Solutions, LLC v. Universal + Wilde, Inc.,* 873 F.3d 905, 910-11, 124 USPQ2d 1502, 1505-06 + (Fed. Cir. 2017); +* vi. Instructions to display two sets of + information on a computer display in a non-interfering manner, without any + limitations specifying how to achieve the desired result, *Interval + Licensing LLC v. AOL, Inc.,* 896 F.3d 1335, 1344-45, 127 USPQ2d + 1553, 1559-60 (Fed. Cir. 2018); +* vii. Providing historical usage information to + users while they are inputting data, in order to improve the quality and + organization of information added to a database, because "an improvement to + the information stored by a database is not equivalent to an improvement in + the database’s functionality," *BSG Tech LLC v. Buyseasons, + Inc.,* 899 F.3d 1281, 1287-88, 127 USPQ2d 1688, 1693-94 (Fed. + Cir. 2018); and +* viii. Arranging transactional information on a + graphical user interface in a manner that assists traders in processing + information more quickly, *Trading Technologies v. IBG + LLC,* 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. + 2019). + +**II.** **IMPROVEMENTS TO ANY OTHER + TECHNOLOGY OR TECHNICAL FIELD**The courts have also found that improvements in + technology beyond computer functionality may demonstrate patent eligibility. In + *McRO,* the Federal Circuit held claimed methods of automatic + lip synchronization and facial expression animation using computer-implemented + rules to be patent eligible under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**, because they + were not directed to an abstract idea. *McRO,* 837 F.3d at 1316, + 120 USPQ2d at 1103. The basis for the *McRO* court's decision was + that the claims were directed to an improvement in computer animation and thus did + not recite a concept similar to previously identified abstract ideas. + *Id.* The court relied on the specification's explanation of + how the claimed rules enabled the automation of specific animation tasks that + previously could not be automated. 837 F.3d at 1313, 120 USPQ2d at 1101. The + *McRO* court indicated that it was the incorporation of the + particular claimed rules in computer animation that "improved [the] existing + technological process", unlike cases such as *Alice* where a + computer was merely used as a tool to perform an existing process. 837 F.3d at + 1314, 120 USPQ2d at 1102. The *McRO* court also noted that the + claims at issue described a specific way (use of particular rules to set morph + weights and transitions through phonemes) to solve the problem of producing + accurate and realistic lip synchronization and facial expressions in animated + characters, rather than merely claiming the idea of a solution or outcome, and + thus were not directed to an abstract idea. 837 F.3d at 1313, 120 USPQ2d at 1101. + + + +Consideration of improvements is relevant to the + eligibility analysis regardless of the technology of the claimed invention. That + is, the consideration applies equally whether it is a computer-implemented + invention, an invention in the life sciences, or any other technology. See, + *e.g., Rapid Litigation Management v. CellzDirect, Inc.,* 827 + F.3d 1042, 119 USPQ2d 1370 (Fed. Cir. 2016), in which the court noted that a + claimed process for preserving hepatocytes could be eligible as an improvement to + technology because the claim achieved a new and improved way for preserving + hepatocyte cells for later use, even though the claim is based on the discovery of + something natural. Notably, the court did not distinguish between the types of + technology when determining the invention improved technology. However, it is + important to keep in mind that an improvement in the abstract idea itself + (*e.g.* a recited fundamental economic concept) is not an + improvement in technology. For example, in *Trading Technologies Int’l v. + IBG,* 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the + court determined that the claimed user interface simply provided a trader with + more information to facilitate market trades, which improved the business process + of market trading but did not improve computers or technology. + + + +Examples that the courts have indicated may be + sufficient to show an improvement in existing technology include: + + + +* i. Particular computerized method of operating + a rubber molding press, *e.g.,* a modification of + conventional rubber-molding processes to utilize a thermocouple inside the + mold to constantly monitor the temperature and thus reduce under- and + over-curing problems common in the art, *Diamond v. Diehr,* + 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 8 and 10 (1981); +* ii. New telephone, server, or combination + thereof, *TLI Communications LLC v. AV Auto. LLC,* 823 F.3d + 607, 612, 118 USPQ2d 1744, 1747 (Fed. Cir. 2016); +* iii. An advance in the process of downloading + content for streaming, *Affinity Labs of Tex. v. DirecTV, + LLC,* 838 F.3d 1253, 1256, 120 USPQ2d 1201, 1202 (Fed. Cir. + 2016); +* iv. Improved, particular method of digital data + compression, *DDR Holdings, LLC. v. Hotels.com, L.P.,* 773 + F.3d 1245, 1259, 113 USPQ2d 1097, 1107 (Fed. Cir. 2014); + *Intellectual Ventures I v. Symantec Corp.,* 838 F.3d + 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016); +* v. Particular method of incorporating virus + screening into the Internet, *Symantec Corp.,* 838 F.3d at + 1321-22, 120 USPQ2d at 1362-63; +* vi. Components or methods, such as measurement + devices or techniques, that generate new data, *Electric Power + Group, LLC v. Alstom, S.A.,* 830 F.3d 1350, 1355, 119 USPQ2d + 1739, 1742 (Fed. Cir. 2016); +* vii. Particular configuration of inertial sensors + and a particular method of using the raw data from the sensors, + *Thales Visionix, Inc. v. United States,* 850 F.3d 1343, + 1348-49, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017); +* viii. A specific, structured graphical user + interface that improves the accuracy of trader transactions by displaying + bid and asked prices in a particular manner that prevents order entry at a + changed price, *Trading Techs. Int’l, Inc. v. CQG, Inc.,* + 675 Fed. App'x 1001 (Fed. Cir. 2017) (non-precedential); and +* ix. Improved process for preserving hepatocytes + for later use, *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* + 827 F.3d 1042, 1050, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016). + + +To show that the involvement of a computer assists + in improving the technology, the claims must recite the details regarding how a + computer aids the method, the extent to which the computer aids the method, or the + significance of a computer to the performance of the method. Merely adding generic + computer components to perform the method is not sufficient. Thus, the claim must + include more than mere instructions to perform the method on a generic component + or machinery to qualify as an improvement to an existing technology. See + **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)** for more information about mere + instructions to apply an exception. + + + +Examples that the courts have indicated may not be + sufficient to show an improvement to technology include: + + + +* i. A commonplace business method being applied + on a general purpose computer, *Alice Corp.,* 573 U.S. at + 223, 110 USPQ2d at 1976; *Versata Dev. Group, Inc. v. SAP Am., + Inc.,* 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. + 2015); +* ii. Using well-known standard laboratory + techniques to detect enzyme levels in a bodily sample such as blood or + plasma, *Cleveland Clinic Foundation v. True Health Diagnostics, + LLC,* 859 F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83, 1088 + (Fed. Cir. 2017); +* iii. Gathering and analyzing information using + conventional techniques and displaying the result, *TLI + Communications,* 823 F.3d at 612-13, 118 USPQ2d at 1747-48; +* iv. Delivering broadcast content to a portable + electronic device such as a cellular telephone, when claimed at a high level + of generality, *Affinity Labs of Tex. v. Amazon.com,* 838 + F.3d 1266, 1270, 120 USPQ2d 1210, 1213 (Fed. Cir. 2016); *Affinity + Labs of Tex. v. DirecTV, LLC,* 838 F.3d 1253, 1262, 120 USPQ2d + 1201, 1207 (Fed. Cir. 2016); +* v. A general method of screening emails on a + generic computer, *Symantec,* 838 F.3d at 1315-16, 120 + USPQ2d at 1358-59; +* vi. An advance in the informational content of a + download for streaming, *Affinity Labs of Tex. v. DirecTV, + LLC,* 838 F.3d 1253, 1263, 120 USPQ2d 1201, 1208 (Fed. Cir. + 2016); and +* vii. Selecting one type of content + (*e.g.,* FM radio content) from within a range of + existing broadcast content types, or selecting a particular generic function + for computer hardware to perform (e.g., buffering content) from within a + range of well-known, routine, conventional functions performed by the + hardware, *Affinity Labs of Tex. v. DirecTV, LLC,* 838 F.3d + 1253, 1264, 120 USPQ2d 1201, 1208 (Fed. Cir. 2016). + + + + +# 2106.05(b) Particular Machine [R-10.2019] + + +When determining whether a claim integrates a + judicial exception, into a practical application in Step 2A Prong Two and whether a + claim recites significantly more than a judicial exception in Step 2B, examiners + should consider whether the judicial exception is applied with, or by use of, a + particular machine. "The machine-or-transformation test is a useful and important + clue, and investigative tool" for determining whether a claim is patent eligible + under **[§ + 101](mpep-9015-appx-l.html#d0e302376)**. *Bilski v. Kappos,* 561 U.S. 593, 604, 95 + USPQ2d 1001, 1007 (2010). + + + +It is noted that while the application of a judicial + exception by or with a particular machine is an important clue, it is + not a stand-alone test for eligibility. + *Id.* + + +All claims must be evaluated for eligibility using the + two-part test from *Alice/Mayo*. If a claim passes the + *Alice/Mayo* test (*i.e.,* is not directed to an + exception at Step 2A, or amounts to significantly more than any recited exception in + Step 2B), then the claim is eligible even if it fails the machine-or-transformation + test ("M-or-T test"). *Bilski v. Kappos,* 561 U.S. 593, 604, 95 + USPQ2d 1001, 1007 (2010) (explaining that a claim may be eligible even if it does not + satisfy the M-or-T test); *McRO, Inc. v. Bandai Namco Games Am. + Inc.,* 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) + ("[T]here is nothing that requires a method ‘be tied to a machine or transform an + article’ to be patentable"). And if a claim fails the *Alice/Mayo* + test (*i.e.,* is directed to an exception at Step 2A and does not + amount to significantly more than the exception in Step 2B), then the claim is + ineligible even if it passes the M-or-T test. *DDR Holdings, LLC v. + Hotels.com, L.P.,* 773 F.3d 1245, 1256, 113 USPQ2d 1097, 1104 (Fed. Cir. + 2014) ("[I]n *Mayo,* the Supreme Court emphasized that satisfying + the machine-or-transformation test, by itself, is not sufficient to render a claim + patent-eligible, as not all transformations or machine implementations infuse an + otherwise ineligible claim with an 'inventive concept.'"). + + + +Examiners may find it helpful to evaluate other + considerations such as the mere instructions to apply an exception consideration (see + **[MPEP § + 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the field of + use and technological environment consideration (see **[MPEP § + 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when making a determination of whether an + element (or combination of elements) is a particular machine. For information on the + definition of the term "machine," see **[MPEP § + 2106.03](s2106.html#ch2100_d29a1b_139b2_397)**. + + + +When determining whether a machine recited in a claim + provides significantly more, the following factors are relevant. + + +**I.** **THE PARTICULARITY OR GENERALITY OF + THE ELEMENTS OF THE MACHINE OR APPARATUS**The particularity or generality of the elements of + the machine or apparatus, *i.e.,* the degree to which the machine + in the claim can be specifically identified (not any and all machines). One + example of applying a judicial exception with a particular machine is + *Mackay Radio & Tel. Co. v. Radio Corp. of America,* 306 + U.S. 86, 40 USPQ 199 (1939). In this case, a mathematical formula was employed to + use standing wave phenomena in an antenna system. The claim recited the particular + type of antenna and included details as to the shape of the antenna and the + conductors, particularly the length and angle at which they were arranged. 306 + U.S. at 95-96; 40 USPQ at 203. Another example is *Eibel + Process,* in which gravity (a law of nature or natural phenomenon) was + applied by a Fourdrinier machine (which was understood in the art to have a + specific structure comprising a headbox, a paper-making wire, and a series of + rolls) arranged in a particular way to optimize the speed of the machine while + maintaining quality of the formed paper web. *Eibel Process Co. v. Minn. + & Ont. Paper Co.,* 261 U.S. 45, 64-65 (1923). + + + +It is important to note that a general purpose + computer that applies a judicial exception, such as an abstract idea, by use of + conventional computer functions does not qualify as a particular machine. + *Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, 716-17, 112 + USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also *TLI Communications LLC v. + AV Automotive LLC,* 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. + Cir. 2016) (mere recitation of concrete or tangible components is not an inventive + concept); *Eon Corp. IP Holdings LLC v. AT&T Mobility LLC,* + 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that + *Alappat*’s rationale that an otherwise ineligible algorithm + or software could be made patent-eligible by merely adding a generic computer to + the claim was superseded by the Supreme Court’s *Bilski* and + *Alice Corp.* decisions). If applicant amends a claim to add a + generic computer or generic computer components and asserts that the claim recites + significantly more because the generic computer is 'specially programmed' (as in + *Alappat,* now considered superseded) or is a 'particular + machine' (as in *Bilski*), the examiner should look at whether + the added elements integrate the exception into a practical application or provide + significantly more than the judicial exception. Merely adding a generic computer, + generic computer components, or a programmed computer to perform generic computer + functions does not automatically overcome an eligibility rejection. *Alice + Corp. Pty. Ltd. v. CLS Bank Int’l,* 573 U.S. 208, 223-24, 110 USPQ2d + 1976, 1983-84 (2014). See *In re Alappat*, 33 F.3d 1526, 1545 + (Fed. Cir. 1994); *In re Bilski*, 545 F.3d 943 (Fed. Cir. + 2008) + + +**II.** **WHETHER THE MACHINE OR APPARATUS + IMPLEMENTS THE STEPS OF THE METHOD**Integral use of a machine to achieve performance + of a method may integrate the recited judicial exception into a practical + application or provide significantly more, in contrast to where the machine is + merely an object on which the method operates, which does not integrate the + exception into a practical application or provide significantly more. See + *CyberSource v. Retail Decisions,* 654 F.3d 1366, 1370, 99 + USPQ2d 1690, 1694 (Fed. Cir. 2011) ("We are not persuaded by the appellant's + argument that the claimed method is tied to a particular machine because it ‘would + not be necessary or possible without the Internet.’ . . . Regardless of whether + "the Internet" can be viewed as a machine, it is clear that the Internet cannot + perform the fraud detection steps of the claimed method"). For example, as + described in **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**, additional + elements that invoke computers or other machinery merely as a tool to perform an + existing process will generally not amount to significantly more than a judicial + exception. See, e.g., *Versata Development Group v. SAP America,* + 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015) (explaining that in + order for a machine to add significantly more, it must "play a significant part in + permitting the claimed method to be performed, rather than function solely as an + obvious mechanism for permitting a solution to be achieved more quickly"). + + +**III.** **WHETHER ITS INVOLVEMENT IS + EXTRA-SOLUTION ACTIVITY OR A FIELD-OF-USE**Whether its involvement is extra-solution activity + or a field-of-use, *i.e.,* the extent to which (or how) the + machine or apparatus imposes meaningful limits on the claim. Use of a machine that + contributes only nominally or insignificantly to the execution of the claimed + method (e.g., in a data gathering step or in a field-of-use limitation) would not + integrate a judicial exception or provide significantly more. See + *Bilski,* 561 U.S. at 610, 95 USPQ2d at 1009 (citing + *Parker v. Flook,* 437 U.S. 584, 590, 198 USPQ 193, 197 + (1978)), and *CyberSource v. Retail Decisions,* 654 F.3d 1366, + 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted) ("[N]othing in claim 3 + requires an infringer to use the Internet to obtain that data. The Internet is + merely described as the source of the data. We have held that mere + ‘[data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.’" + 654 F.3d at 1375, 99 USPQ2d at 1694 (citation omitted)). See **[MPEP § 2106.05(g) & + (h)](s2106.html#ch2100_d29a1b_13df8_3d4)** for more information on insignificant extra-solution + activity and field of use, respectively. + + + + + +# 2106.05(c) Particular Transformation [R-10.2019] + + +Another consideration when determining whether a + claim integrates a judicial exception into a practical application in Step 2A Prong + Two and whether a claim recites significantly more in Step 2B is whether the claim + effects a transformation or reduction of a particular article to a different state or + thing. "[T]ransformation and reduction of an article ‘to a different state or thing’ + is the clue to patentability of a process claim that does not include particular + machines." *Bilski v. Kappos,* 561 U.S. 593, 658, 95 USPQ2d 1001, + 1007 (2010) (quoting *Gottschalk v. Benson,* 409 U.S. 63, 70, 175 + USPQ 673, 676 (1972)). If such a transformation exists, the claims are likely to be + significantly more than any recited judicial exception or to integrate any recited + judicial exception into a practical application. + + + +It is noted that while the transformation of an + article is an important clue, it is not a stand-alone test for + eligibility. *Id.* + + +All claims must be evaluated for eligibility using + the two-part test from *Alice/Mayo*. If a claim passes the + *Alice/Mayo* test (*i.e.,* is not directed to an + exception at Step 2A, or amounts to significantly more than any recited exception in + Step 2B), then the claim is eligible even if it "fails" the M-or-T test. + *Bilski v. Kappos,* 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 + (2010) (explaining that a claim may be eligible even if it does not satisfy the + M-or-T test); *McRO, Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d + 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) ("[T]here is nothing that requires + a method ‘be tied to a machine or transform an article’ to be patentable"). And if a + claim fails the *Alice/Mayo* test (*i.e.,* is + directed to an exception at Step 2A and does not amount to significantly more than + the exception in Step 2B), then the claim is ineligible even if it passes the M-or-T + test. *DDR Holdings, LLC v. Hotels.com, L.P.,* 773 F.3d 1245, 1256, + 113 USPQ2d 1097, 1104 (Fed. Cir. 2014) ("[I]n *Mayo,* the Supreme + Court emphasized that satisfying the machine-or-transformation test, by itself, is + not sufficient to render a claim patent-eligible, as not all transformations or + machine implementations infuse an otherwise ineligible claim with an "inventive + concept."). + + + +Examiners may find it helpful to evaluate other + considerations such as the mere instructions to apply an exception consideration (see + **[MPEP § + 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the field of + use and technological environment consideration (see **[MPEP § + 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when making a determination of whether a claim + satisfies the particular transformation consideration. + + + +An "article" includes a physical object or substance. + The physical object or substance must be particular, meaning it can be specifically + identified. "Transformation" of an article means that the "article" has changed to a + different state or thing. Changing to a different state or thing usually means more + than simply using an article or changing the location of an article. A new or + different function or use can be evidence that an article has been transformed. + Purely mental processes in which thoughts or human based actions are "changed" are + not considered an eligible transformation. For data, mere "manipulation of basic + mathematical constructs [i.e.,] the paradigmatic ‘abstract idea,’" has not been + deemed a transformation. *CyberSource v. Retail Decisions,* 654 F.3d + 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting *In re + Warmerdam,* 33 F.3d 1354, 1355, 1360 (Fed. Cir. 1994)). + + + +*Tilghman v. Proctor,* 102 U.S. 707 + (1881), provides an example of effecting a transformation of a particular article to + a different state or thing. In that case, the claim was directed to a process of + subjecting a mixture of fat and water to a high degree of heat and included + additional parameters relating to the level of heat, the quantities of fat and water, + and the strength of the mixing vessel. The claimed process, which used the natural + principle that the elements of neutral fat require that they be severally united with + an atomic equivalent of water in order to separate and become free, resulted in the + transformation of the fatty bodies into fat acids and glycerine. *Id. at + 729*. + + + +Where a transformation is recited in a claim, the + following factors are relevant to the analysis: + + + +* 1. **The particularity or generality of the + transformation.** According to the Supreme Court, inventions + comprising processes of "‘tanning, dyeing, making waterproof cloth, vulcanizing + India rubber [or] smelting ores’ . . . are instances . . . where the use of + chemical substances or physical acts, such as temperature control, changes + articles or materials [in such a manner that is] sufficiently definite to + confine the patent monopoly within rather definite bounds." *Gottschalk + v. Benson,* 409 U.S. 63, 70, 175 USPQ 673, 676 (1972) (discussing + *Corning v. Burden,* 15 How. (56 U.S.) 252, 267-68 (1854)). + Therefore, a more particular transformation would likely provide significantly + more. +* 2. **The degree to which the recited article is + particular.** A transformation applied to a generically recited + article or to any and all articles would likely not provide significantly more + than the judicial exception. A transformation that can be specifically + identified, or that applies to only particular articles, is more likely to + provide significantly more (or integrates a judicial exception into a practical + application). +* 3. **The nature of the transformation in terms + of the type or extent of change in state or thing.** A transformation + resulting in the transformed article having a different function or use, would + likely provide significantly more, but a transformation resulting in the + transformed article merely having a different location, would likely not + provide significantly more (or integrate a judicial exception into a practical + application). For example, a process that transforms raw, uncured synthetic + rubber into precision-molded synthetic rubber products, as discussed in + *Diamond v. Diehr,* 450 U.S. 175, 184, 209 USPQ 1, 21 + (1981)), provides significantly more (or integrate a judicial exception into a + practical application). +* 4. **The nature of the article transformed.** Transformation of a physical or tangible object or substance is more + likely to provide significantly more (or integrate a judicial exception into a + practical application) than the transformation of an intangible concept such as + a contractual obligation or mental judgment. +* 5. **Whether the transformation is + extra-solution activity or a field-of-use (*i.e.,* the + extent to which (or how) the transformation imposes meaningful limits on the + execution of the claimed method steps).** A transformation that + contributes only nominally or insignificantly to the execution of the claimed + method (*e.g.,* in a data gathering step or in a field-of-use + limitation) would not provide significantly more (or integrate a judicial + exception into a practical application). For example, in + *Mayo* the Supreme Court found claims regarding calibrating + the proper dosage of thiopurine drugs to be patent ineligible subject matter. + The Federal Circuit had held that the step of administering the thiopurine drug + demonstrated a transformation of the human body and blood. + *Mayo,* 566 U.S. at 76, 101 USPQ2d at 1967. The Supreme + Court disagreed, finding that this step was only a field-of-use limitation and + did not provide significantly more than the judicial exception. + *Id.* See **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)** **[& + (h)](s2106.html#ch2100_d29a1b_13e1a_22c)** for more information on insignificant + extra-solution activity and field of use, respectively. + + + + +# 2106.05(d) Well-Understood, Routine, Conventional + Activity [R-10.2019] + + +Another consideration when determining whether a claim + recites significantly more than a judicial exception is whether the additional + element(s) are well-understood, routine, conventional activities previously known to + the industry. This consideration is only evaluated in Step 2B of the eligibility + analysis. + + + +If the additional element (or combination of elements) + is a specific limitation other than what is well-understood, routine and conventional + in the field, for instance because it is an unconventional step that confines the + claim to a particular useful application of the judicial exception, then this + consideration favors eligibility. If, however, the additional element (or combination + of elements) is no more than well-understood, routine, conventional activities + previously known to the industry, which is recited at a high level of generality, + then this consideration does not favor eligibility. + + + + *DDR Holdings, LLC v. Hotels.com, + L.P.,* 773 F.3d 1245, 113 USPQ2d 1097 (Fed. Cir. 2014), provides an + example of additional elements that favored eligibility because they were more than + well-understood, routine conventional activities in the field. The claims in + *DDR Holdings* were directed to systems and methods of generating + a composite webpage that combines certain visual elements of a host website with the + content of a third-party merchant. 773 F.3d at 1248, 113 USPQ2d at 1099. The court + found that the claim had additional elements that amounted to significantly more than + the abstract idea, because they modified conventional Internet hyperlink protocol to + dynamically produce a dual-source hybrid webpage, which differed from the + conventional operation of Internet hyperlink protocol that transported the user away + from the host’s webpage to the third party’s webpage when the hyperlink was + activated. 773 F.3d at 1258-59, 113 USPQ2d at 1106-07. Thus, the claims in + *DDR Holdings* were eligible. + + + +On the other hand, *Mayo Collaborative Servs. + v. Prometheus Labs.,* Inc., 566 U.S. 66, 67, 101 USPQ2d 1961, 1964 (2010) + provides an example of additional elements that were not an inventive concept because + they were merely well-understood, routine, conventional activity previously known to + the industry, which were not by themselves sufficient to transform a judicial + exception into a patent eligible invention. *Mayo Collaborative Servs. v. + Prometheus Labs., Inc.,* 566 U.S. 66, 79-80, 101 USPQ2d 1969 (2012) + (citing *Parker v. Flook,* 437 U.S. 584, 590, 198 USPQ 193, 199 + (1978) (the additional elements were "well known" and, thus, did not amount to a + patentable application of the mathematical formula)). In *Mayo*, the + claims at issue recited naturally occurring correlations (the relationships between + the concentration in the blood of certain thiopurine metabolites and the likelihood + that a drug dosage will be ineffective or induce harmful side effects) along with + additional elements including telling a doctor to measure thiopurine metabolite + levels in the blood using any known process. 566 U.S. at 77-79, 101 USPQ2d at + 1967-68. The Court found this additional step of measuring metabolite levels to be + well-understood, routine, conventional activity already engaged in by the scientific + community because scientists "routinely measured metabolites as part of their + investigations into the relationships between metabolite levels and efficacy and + toxicity of thiopurine compounds." 566 U.S. at 79, 101 USPQ2d at 1968. Even when + considered in combination with the other additional elements, the step of measuring + metabolite levels did not amount to an inventive concept, and thus the claims in + *Mayo* were not eligible. 566 U.S. at 79-80, 101 USPQ2d at + 1968-69. + + +**I.** **EVALUATING WHETHER THE ADDITIONAL + ELEMENTS ARE WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY**When making a determination whether the additional + elements in a claim amount to significantly more than a judicial exception, the + examiner should evaluate whether the elements define only well-understood, + routine, conventional activity. In this respect, the well-understood, routine, + conventional consideration overlaps with other Step 2B considerations, + particularly the improvement consideration (see **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**), the mere instructions to apply an exception + consideration (see **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), and the + insignificant extra-solution activity consideration (see **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**). Thus, evaluation of those other + considerations may assist examiners in making a determination of whether a + particular element or combination of elements is well-understood, routine, + conventional activity. + + + +In addition, examiners should keep in mind the + following points when determining whether additional elements define only + well-understood, routine, conventional activity. + + + +* 1. **An additional element (or combination + of additional elements) that is known in the art can still be + unconventional or non-routine.** The question of whether a + particular claimed invention is novel or obvious is "fully apart" from the + question of whether it is eligible. *Diamond v. Diehr,* 450 + U.S. 175, 190, 209 USPQ 1, 9 (1981). For example, claims may exhibit an + improvement over conventional computer functionality even if the improvement + lacks novelty over the prior art. Compare, *e.g.,**Enfish, LLC v. Microsoft Corp.,* 822 F.3d 1327, 118 USPQ2d + 1684 (Fed. Cir. 2016) (holding several claims from U.S. Patent Nos. + 6,151,604 and 6,163,775 eligible) with *Microsoft Corp. v. Enfish, + LLC,* 662 Fed. App'x 981 (Fed. Cir. 2016) (holding some of the + same claims to be anticipated by prior art). The eligible claims in + *Enfish* recited a self-referential database having two + key features: all entity types can be stored in a single table; and the + table rows can contain information defining the table columns. + *Enfish,* 822 F.3d at 1332, 118 USPQ2d at 1687. Although + these features were taught by a single prior art reference (thus + anticipating the claims), *Microsoft Corp.,* 662 Fed. App'x + at 986, the features were not conventional and thus were considered to + reflect an improvement to existing technology. In particular, they enabled + the claimed table to achieve benefits over conventional databases, such as + increased flexibility, faster search times, and smaller memory requirements. + *Enfish,* 822 F.3d at 1337, 118 USPQ2d at 1690. +* 2. **A factual determination is required to + support a conclusion that an additional element (or combination of + additional elements) is well-understood, routine, conventional + activity.***Berkheimer v. HP, Inc.,* 881 F.3d 1360, 1368, 125 USPQ2d + 1649, 1654 (Fed. Cir. 2018). However, this does not mean that a prior art + search is necessary to resolve this inquiry. Instead, examiners should rely + on what the courts have recognized, or those in the art would recognize, as + elements that are well-understood, routine, conventional activity in the + relevant field when making the required determination. For example, in many + instances, the specification of the application may indicate that additional + elements are well-known or conventional. See, *e.g., Intellectual + Ventures v. Symantec,* 838 F.3d at 1317; 120 USPQ2d at 1359 + ("The written description is particularly useful in determining what is + well-known or conventional"); *Internet Patents Corp. v. Active + Network, Inc.,* 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. + Cir. 2015) (relying on specification’s description of additional elements as + "well-known", "common" and "conventional"); *TLI Communications LLC + v. AV Auto. LLC,* 823 F.3d 607, 614, 118 USPQ2d 1744, 1748 (Fed. + Cir. 2016) (Specification described additional elements as "either + performing basic computer functions such as sending and receiving data, or + performing functions ‘known’ in the art."). + As such, an examiner should determine that + an element (or combination of elements) is well-understood, routine, + conventional activity only when the examiner can readily conclude, based on + their expertise in the art, that the element is widely prevalent or in + common use in the relevant industry. The analysis as to whether an element + (or combination of elements) is widely prevalent or in common use is the + same as the analysis under **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** as to + whether an element is so well-known that it need not be described in detail + in the patent specification. See *Genetic Techs. Ltd. v. Merial + LLC,* 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1546 ( Fed. Cir. + 2016) (supporting the position that amplification was well-understood, + routine, conventional for purposes of subject matter eligibility by + observing that the patentee expressly argued during prosecution of the + application that amplification was a technique readily practiced by those + skilled in the art to overcome the rejection of the claim under + **[35 + U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph); see also + *Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick + Co.,* 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984) + ("[T]he specification need not disclose what is well known in the art."); + *In re Myers,* 410 F.2d 420, 424, 161 USPQ 668, 671 + (CCPA 1969) ("A specification is directed to those skilled in the art and + need not teach or point out in detail that which is well-known in the + art."); *Exergen Corp.,* 725 Fed. App’x. 959, 965 (Fed. + Cir. 2018) (holding that "[l]ike indefiniteness, enablement, or obviousness, + whether a claim is directed to patent eligible subject matter is a question + of law based on underlying facts," and noting that the Supreme Court has + recognized that "the inquiry 'might sometimes overlap' with other + fact-intensive inquiries like novelty under **[35 U.S.C. § + 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)**"). If the element is not widely prevalent or in + common use, or is otherwise beyond those elements recognized in the art or + by the courts as being well-understood, routine or conventional, then the + element will in most cases favor eligibility. For example, even if a + particular technique (*e.g.,* measuring blood glucose via + an earring worn by a person with diabetes) would have been obvious to one of + ordinary skill in the art because it was discussed in several widely-read + scientific journals or used by a few scientists, mere knowledge of the + particular technique or use of the particular technique by a few scientists + is not necessarily sufficient to make the use of the particular technique + routine or conventional in the relevant field. The examiner in this + situation would already know, based on the examiner's expertise in the + field, that blood glucose is routinely and conventionally monitored by other + techniques (*e.g.,* via placing a small droplet of blood on + a diagnostic test strip, or via an implanted insulin pump with a glucose + sensor). Thus, the examiner would not need to perform a prior art search in + order to determine that the particular claimed technique using the + glucose-sensing earring was not well-understood, routine, conventional + activity previously engaged in by scientists in the field. + + + +The required factual determination must be + expressly supported in writing, as discussed in **[MPEP § + 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. Appropriate forms of support include + one or more of the following: (a) A citation to an express statement in the + specification or to a statement made by an applicant during prosecution that + demonstrates the well-understood, routine, conventional nature of the + additional element(s); (b) A citation to one or more of the court decisions + discussed in Subsection II below as noting the well-understood, routine, + conventional nature of the additional element(s); (c) A citation to a + publication that demonstrates the well-understood, routine, conventional + nature of the additional element(s); and (d) A statement that the examiner + is taking official notice of the well-understood, routine, conventional + nature of the additional element(s). For more information on supporting a + conclusion that an additional element (or combination of additional + elements) is well-understood, routine, conventional activity, see + **[MPEP § 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**, + subsection III. +* 3. **Even if one or more additional elements + are well-understood, routine, conventional activity when considered + individually, the combination of additional elements may amount to an + inventive concept.***Diamond v. Diehr,* 450 U.S. at 188, 209 USPQ at 9 (1981) + ("[A] new combination of steps in a process may be patentable even though + all the constituents of the combination were well known and in common use + before the combination was made."). For example, a microprocessor that + performs mathematical calculations and a clock that produces time data may + individually be generic computer components that perform merely generic + computer functions, but when combined may perform functions that are not + generic computer functions and thus be an inventive concept. See, + *e.g. Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d + 1042, 1051, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016) (holding that while the + additional steps of freezing and thawing hepatocytes were well known, + repeating those steps, contrary to what was taught in the art, was not + routine or conventional). For example, in *BASCOM,* even + though the court found that all of the additional elements in the claim + recited generic computer network or Internet components, the elements in + combination amounted to significantly more because of the non-conventional + and non-generic arrangement that provided a technical improvement in the + art. *BASCOM Global Internet Servs. v. AT&T Mobility + LLC,* 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243-44 + (2016). + + + A rejection should only be made if an examiner + relying on the examiner's expertise in the art can conclude in the Step 2B inquiry + that the additional elements do not amount to significantly more (Step 2B: NO). If + the elements or functions are beyond those recognized in the art or by the courts + as being well‐understood, routine, conventional activity, then the elements or + functions will in most cases amount to significantly more (Step 2B: YES). For more + information on formulating a subject matter eligibility rejection involving + well-understood, routine, conventional activity, see **[MPEP § + 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. + + +**II.** **ELEMENTS THAT THE COURTS HAVE + RECOGNIZED AS WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY IN PARTICULAR + FIELDS** Because examiners should rely on what the courts + have recognized, or those of ordinary skill in the art would recognize, as + elements that describe well‐understood, routine activities, the following section + provides examples of elements that have been recognized by the courts as + well-understood, routine, conventional activity in particular fields. It should be + noted, however, that many of these examples failed to satisfy other considerations + (*e.g.,* because they were recited at a high level of + generality and thus were mere instructions to apply an exception, or were + insignificant extra-solution activity). Thus, examiners should carefully analyze + additional elements in a claim with respect to all relevant Step 2B + considerations, including this consideration, before making a conclusion as to + whether they amount to an inventive concept. + + + +The courts have recognized the following computer + functions as well‐understood, routine, and conventional functions when they are + claimed in a merely generic manner (*e.g.,* at a high level of + generality) or as insignificant extra-solution activity. + + + +* i. Receiving or transmitting data over a + network, *e.g.,* using the Internet to gather data, + *Symantec,* 838 F.3d at 1321, 120 USPQ2d at 1362 + (utilizing an intermediary computer to forward information); *TLI + Communications LLC v. AV Auto. LLC,* 823 F.3d 607, 610, 118 + USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image + transmission); *OIP Techs., Inc., v. Amazon.com, Inc.,* 788 + F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages + over a network); *buySAFE, Inc. v. Google, Inc.,* 765 F.3d + 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and + sends information over a network); but see *DDR Holdings, LLC v. + Hotels.com, L.P.,* 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 + (Fed. Cir. 2014) ("Unlike the claims in *Ultramercial,* the + claims at issue here specify ***how*** + interactions with the Internet are manipulated to yield a desired result‐‐a + result that overrides the routine and conventional sequence of events + ordinarily triggered by the click of a hyperlink." (emphasis added)); +* ii. Performing repetitive calculations, + *Flook,* 437 U.S. at 594, 198 USPQ2d at 199 (recomputing + or readjusting alarm limit values); *Bancorp Services v. Sun + Life,* 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. + 2012) ("The computer required by some of *Bancorp*’s claims + is employed only for its most basic function, the performance of repetitive + calculations, and as such does not impose meaningful limits on the scope of + those claims."); +* iii. Electronic recordkeeping, *Alice + Corp. Pty. Ltd. v. CLS Bank Int'l,* 573 U.S. 208, 225, 110 + USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); + *Ultramercial,* 772 F.3d at 716, 112 USPQ2d at 1755 + (updating an activity log); +* iv. Storing and retrieving information in + memory, *Versata Dev. Group, Inc. v. SAP Am., Inc.,* 793 + F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); *OIP + Techs.,* 788 F.3d at 1363, 115 USPQ2d at 1092-93; +* v. Electronically scanning or extracting data + from a physical document, *Content Extraction and Transmission, LLC + v. Wells Fargo Bank,* 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 + (Fed. Cir. 2014) (optical character recognition); and +* vi. A Web browser’s back and forward button + functionality, *Internet Patent Corp. v. Active Network, + Inc.,* 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. + 2015). + + +This listing is not meant to imply that all + computer functions are well‐understood, routine, conventional activities, or that + a claim reciting a generic computer component performing a generic computer + function is necessarily ineligible. See e.g. *Amdocs (Israel), Ltd. v. + Openet Telecom, Inc.,* 841 F.3d 1288, 1316, 120 USPQ2d 1527, 1549 + (Fed. Cir. 2016), *BASCOM Global Internet Servs. v. AT&T Mobility + LLC,* 827 F.3d 1341, 1348, 119 USPQ2d 1236, 1241 (Fed. Cir. 2016). + Courts have held computer‐implemented processes not to be significantly more than + an abstract idea (and thus ineligible) where the claim as a whole amounts to + nothing more than generic computer functions merely used to implement an abstract + idea, such as an idea that could be done by a human analog (i.e., by hand or by + merely thinking). On the other hand, courts have held computer-implemented + processes to be significantly more than an abstract idea (and thus eligible), + where generic computer components are able in combination to perform functions + that are not merely generic. *DDR Holdings, LLC v. Hotels.com, + L.P.,* 773 F.3d 1245, 1257-59, 113 USPQ2d 1097, 1105-07 (Fed. Cir. + 2014). + + + +The courts have recognized the following + laboratory techniques as well-understood, routine, conventional activity in the + life science arts when they are claimed in a merely generic manner + (*e.g.,* at a high level of generality) or as insignificant + extra-solution activity: + + + +* i. Determining the level of a biomarker in + blood by any means, *Mayo,* 566 U.S. at 79, 101 USPQ2d at + 1968; *Cleveland Clinic Foundation v. True Health Diagnostics, + LLC,* 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. + 2017); +* ii. Using polymerase chain reaction to amplify + and detect DNA, *Genetic Techs. v. Merial LLC,* 818 F.3d + 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); *Ariosa + Diagnostics, Inc. v. Sequenom, Inc.,* 788 F.3d 1371, 1377, 115 + USPQ2d 1152, 1157 (Fed. Cir. 2015); +* iii. Detecting DNA or enzymes in a sample, + *Sequenom,* 788 F.3d at 1377-78, 115 USPQ2d at 1157); + *Cleveland Clinic Foundation* 859 F.3d at 1362, 123 + USPQ2d at 1088 (Fed. Cir. 2017); +* iv. Immunizing a patient against a disease, + *Classen Immunotherapies, Inc. v. Biogen IDEC,* 659 F.3d + 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011); +* v. Analyzing DNA to provide sequence information + or detect allelic variants, *Genetic Techs.,* 818 F.3d at + 1377; 118 USPQ2d at 1546; +* vi. Freezing and thawing cells, *Rapid + Litig. Mgmt.* 827 F.3d at 1051, 119 USPQ2d at 1375; +* vii. Amplifying and sequencing nucleic acid + sequences, *University of Utah Research Foundation v. Ambry + Genetics,* 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. + 2014); and +* viii. Hybridizing a gene probe, *Ambry + Genetics,* 774 F.3d at 764, 113 USPQ2d at 1247. + + + Below are examples of other types of activity + that the courts have found to be well-understood, routine, conventional activity + when they are claimed in a merely generic manner (*e.g.,* at a + high level of generality) or as insignificant extra-solution activity: + + + +* i. Recording a customer’s order, + *Apple, Inc. v. Ameranth, Inc.,* 842 F.3d 1229, 1244, + 120 USPQ2d 1844, 1856 (Fed. Cir. 2016); +* ii. Shuffling and dealing a standard deck of + cards, *In re Smith,* 815 F.3d 816, 819, 118 USPQ2d 1245, + 1247 (Fed. Cir. 2016); +* iii. Restricting public access to media by + requiring a consumer to view an advertisement, *Ultramercial, Inc. + v. Hulu, LLC,* 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 + (Fed. Cir. 2014); +* iv. Presenting offers and gathering statistics, + *OIP Techs.,* 788 F.3d at 1362-63, 115 USPQ2d at + 1092-93; +* v. Determining an estimated outcome and setting + a price, *OIP Techs.,* 788 F.3d at 1362-63, 115 USPQ2d at + 1092-93; and +* vi. Arranging a hierarchy of groups, sorting + information, eliminating less restrictive pricing information and + determining the price, *Versata Dev. Group, Inc. v. SAP Am., + Inc.,* 793 F.3d 1306, 1331, 115 USPQ2d 1681, 1699 (Fed. Cir. + 2015). + + + + +# 2106.05(e) Other Meaningful Limitations [R-10.2019] + + +The analysis of whether the claim includes other + meaningful limitations may be relevant for both eligibility analysis Step 2A Prong + Two, and Step 2B. + + + + The claim should add meaningful limitations beyond + generally linking the use of the judicial exception to a particular technological + environment to transform the judicial exception into patent-eligible subject matter. + The phrase "meaningful limitations" has been used by the courts even before Alice and + Mayo in various contexts to describe additional elements that provide an inventive + concept to the claim as a whole. The considerations described in + **[MPEP § + 2106.05(a)-(d)](s2106.html#ch2100_d29a1b_13c69_10)** are meaningful limitations when they amount + to significantly more than the judicial exception, or when they integrate a judicial + exception into a practical application. This broad label signals that there can be + other considerations besides those described in **[MPEP § + 2106.05(a)-(d)](s2106.html#ch2100_d29a1b_13c69_10)** that when added to a judicial exception + amount to meaningful limitations that can transform a claim into patent-eligible + subject matter. + + + +*Diamond v. Diehr* provides an + example of a claim that recited meaningful limitations beyond generally linking the + use of the judicial exception to a particular technological environment. 450 U.S. + 175, 209 USPQ 1 (1981). In *Diehr,* the claim was directed to the + use of the Arrhenius equation (an abstract idea or law of nature) in an automated + process for operating a rubber-molding press. 450 U.S. at 177-78, 209 USPQ at 4. The + Court evaluated additional elements such as the steps of installing rubber in a + press, closing the mold, constantly measuring the temperature in the mold, and + automatically opening the press at the proper time, and found them to be meaningful + because they sufficiently limited the use of the mathematical equation to the + practical application of molding rubber products. 450 U.S. at 184, 187, 209 USPQ at + 7, 8. In contrast, the claims in *Alice Corp. v. CLS Bank + International* did not meaningfully limit the abstract idea of mitigating + settlement risk. 573 U.S. 208, 110 USPQ2d 1976 (2014). In particular, the Court + concluded that the additional elements such as the data processing system and + communications controllers recited in the system claims did not meaningfully limit + the abstract idea because they merely linked the use of the abstract idea to a + particular technological environment (i.e., "implementation via computers") or were + well-understood, routine, conventional activity recited at a high level of + generality. 573 U.S. at 225-26, 110 USPQ2d at 1984-85. + + + +*Classen Immunotherapies Inc. v. Biogen IDEC* provides another + example of claims that recited meaningful limitations. 659 F.3d 1057, 100 USPQ2d 1492 + (Fed. Cir. 2011) (decision on remand from the Supreme Court, which had vacated the + lower court’s prior holding of ineligibility in view of *Bilski v. + Kappos*, 561 U.S. 593, 95 USPQ2d 1001 (2010)). In + *Classen,* the claims recited methods that gathered and analyzed + the effects of particular immunization schedules on the later development of chronic + immune-mediated disorders in mammals in order to identify a lower risk immunization + schedule, and then immunized mammalian subjects in accordance with the identified + lower risk schedule (thereby lowering the risk that the immunized subject would later + develop chronic immune-mediated diseases). 659 F.3d at 1060-61; 100 USPQ2d at + 1495-96. Although the analysis step was an abstract mental process that collected and + compared known information, the immunization step was meaningful because it + integrated the results of the analysis into a specific and tangible method that + resulted in the method "moving from abstract scientific principle to specific + application." 659 F.3d at 1066-68; 100 USPQ2d at 1500-01. In contrast, in + *OIP Technologies, Inc. v. Amazon.com, Inc.,* the court + determined that the additional steps to "test prices and collect data based on the + customer reactions" did not meaningfully limit the abstract idea of offer-based price + optimization, because the steps were well-understood, routine, conventional + data-gathering activities. 788 F.3d 1359, 1363-64, 115 USPQ2d 1090, 1093 (Fed. Cir. + 2015). + + + +With respect to treatment or prophylaxis limitations, + such as the immunization step in *Classen,* examiners should note + that the other meaningful limitations consideration overlaps with the particular + treatment or prophylaxis consideration that is evaluated in Step 2A Prong Two (see + **[MPEP § + 2106.04(d)(2)](s2106.html#ch2100_d2e827_17196_6c)**). + + + +When evaluating whether additional elements + meaningfully limit the judicial exception, it is particularly critical that examiners + consider the additional elements both individually and as a combination. When an + additional element is considered individually by an examiner, the additional element + may be enough to qualify as "significantly more" if it meaningfully limits the + judicial exception, and may also add a meaningful limitation by integrating the + judicial exception into a practical application. However, even in the situation where + the individually-viewed elements do not add significantly more or integrate the + exception, those additional elements when viewed in combination may render the claim + eligible. See *Diamond v. Diehr,* 450 U.S. 175, 188, 209 USPQ2d 1, 9 + (1981) ("a new combination of steps in a process may be patentable even though all + the constituents of the combination were well known and in common use before the + combination was made"); *BASCOM Global Internet Servs. v. AT&T Mobility + LLC,* 827 F.3d 1341, 1349, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016). It is + important to note that, when appropriate, an examiner may explain on the record why + the additional elements meaningfully limit the judicial exception. + + + + + +# 2106.05(f) Mere Instructions To Apply An + Exception [R-10.2019] + + +Another consideration when determining whether a + claim integrates a judicial exception into a practical application in Step 2A Prong + Two or recites significantly more than a judicial exception in Step 2B is whether the + additional elements amount to more than a recitation of the words "apply it" (or an + equivalent) or are more than mere instructions to implement an abstract idea or other + exception on a computer. As explained by the Supreme Court, in order to make a claim + directed to a judicial exception patent-eligible, the additional element or + combination of elements must do "‘more than simply stat[e] the [judicial exception] + while adding the words ‘apply it’". *Alice Corp. v. CLS Bank,* 573 + U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting *Mayo Collaborative + Servs. V. Prometheus Labs., Inc.,* 566 U.S. 66, 72, 101 USPQ2d 1961, + 1965). Thus, for example, claims that amount to nothing more than an instruction to + apply the abstract idea using a generic computer do not render an abstract idea + eligible. *Alice Corp.,* 573 U.S. at 223, 110 USPQ2d at 1983. See + also 573 U.S. at 224, 110 USPQ2d at 1984 (warning against a **[§ 101](mpep-9015-appx-l.html#d0e302376)** analysis + that turns on "the draftsman’s art"). + + + +The Supreme Court has identified additional elements + as mere instructions to apply an exception in several cases. For instance, in + *Mayo*, the Supreme Court concluded that a step of determining + thiopurine metabolite levels in patients’ blood did not amount to significantly more + than the recited laws of nature, because this additional element simply instructed + doctors to apply the laws by measuring the metabolites in any way the doctors (or + medical laboratories) chose to use. 566 U.S. at 79, 101 USPQ2d at 1968. In + *Alice Corp.,* the claim recited the concept of intermediated + settlement as performed by a generic computer. The Court found that the recitation of + the computer in the claim amounted to mere instructions to apply the abstract idea on + a generic computer. 573 U.S. at 225-26, 110 USPQ2d at 1984. The Supreme Court also + discussed this concept in an earlier case, *Gottschalk v. Benson,* + 409 U.S. 63, 70, 175 USPQ 673, 676 (1972), where the claim recited a process for + converting binary-coded-decimal (BCD) numerals into pure binary numbers. The Court + found that the claimed process had no meaningful practical application except in + connection with a computer. *Benson,* 409 U.S. at 71-72, 175 USPQ at + 676. The claim simply stated a judicial exception (*e.g.,* law of + nature or abstract idea) while effectively adding words that "apply it" in a + computer. *Id.* + + +Requiring more than mere instructions to apply an + exception does not mean that the claim must be narrow in order to be eligible. The + courts have identified some broad claims as eligible see, *e.g.,**McRO, Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, 120 + USPQ2d 1091 (Fed. Cir. 2016); *Thales Visionix Inc. v. United + States,* 850 F.3d. 1343, 121 USPQ2d 1898 (Fed. Cir. 2017), and some + narrow claims as ineligible see *e.g.,**Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, 112 USPQ2d 1750 + (Fed. Cir. 2014); *Electric Power Group, LLC v. Alstom, S.A.,* 830 + F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016). Thus, examiners should carefully + consider each claim on its own merits, as well as evaluate all other relevant + considerations, before making a determination of whether an element (or combination + of elements) is more than mere instructions to apply an exception. For example, + because this consideration often overlaps with the improvement consideration (see + **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**), the particular machine and particular + transformation considerations (see **[MPEP § 2106.05(b) and + (c)](s2106.html#ch2100_d29a1b_13ccf_18c)**, respectively), and the well-understood, routine, + conventional consideration (see **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**), evaluation of + those other considerations may assist examiners in making a determination of whether + an element (or combination of elements) is more than mere instructions to apply an + exception. Note, however, that examiners should not evaluate the well-understood, + routine, conventional consideration in the Step 2A Prong Two analysis, because that + consideration is only evaluated in Step 2B. + + + +For claim limitations that do not amount to more than + a recitation of the words "apply it" (or an equivalent), such as mere instructions to + implement an abstract idea on a computer, examiners should explain why they do not + meaningfully limit the claim in an eligibility rejection. For example, an examiner + could explain that implementing an abstract idea on a generic computer, does not + integrate the abstract idea into a practical application in Step 2A Prong Two or add + significantly more in Step 2B, similar to how the recitation of the computer in the + claim in *Alice* amounted to mere instructions to apply the abstract + idea of intermediated settlement on a generic computer. For more information on + formulating a subject matter eligibility rejection. See **[MPEP § + 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. + + + +When determining whether a claim simply recites a + judicial exception with the words "apply it" (or an equivalent), such as mere + instructions to implement an abstract idea on a computer, examiners may consider the + following: + + + +**(1) Whether the claim recites only the idea of a solution or outcome + *i.e.,* the claim fails to recite details of how a solution to + a problem is accomplished.** The recitation of claim limitations that attempt + to cover any solution to an identified problem with no restriction on how the result + is accomplished and no description of the mechanism for accomplishing the result, + does not integrate a judicial exception into a practical application or provide + significantly more because this type of recitation is equivalent to the words "apply + it". See *Electric Power Group, LLC v. Alstom, S.A.,* 830 F.3d 1350, + 1356, 119 USPQ2d 1739, 1743-44 (Fed. Cir. 2016); *Intellectual Ventures I v. + Symantec,* 838 F.3d 1307, 1327, 120 USPQ2d 1353, 1366 (Fed. Cir. 2016); + *Internet Patents Corp. v. Active Network, Inc.,* 790 F.3d 1343, + 1348, 115 USPQ2d 1414, 1417 (Fed. Cir. 2015). In contrast, claiming a particular + solution to a problem or a particular way to achieve a desired outcome may integrate + the judicial exception into a practical application or provide significantly more. + See *Electric Power,* 830 F.3d at 1356, 119 USPQ2d at 1743. + + + +By way of example, in *Intellectual Ventures + I v. Capital One Fin. Corp.,* 850 F.3d 1332, 121 USPQ2d 1940 (Fed. Cir. + 2017), the steps in the claims described "the creation of a dynamic document based + upon ‘management record types’ and ‘primary record types.’" 850 F.3d at 1339-40; 121 + USPQ2d at 1945-46. The claims were found to be directed to the abstract idea of + "collecting, displaying, and manipulating data." 850 F.3d at 1340; 121 USPQ2d at + 1946. In addition to the abstract idea, the claims also recited the additional + element of modifying the underlying XML document in response to modifications made in + the dynamic document. 850 F.3d at 1342; 121 USPQ2d at 1947-48. Although the claims + purported to modify the underlying XML document in response to modifications made in + the dynamic document, nothing in the claims indicated what specific steps were + undertaken other than merely using the abstract idea in the context of XML documents. + The court thus held the claims ineligible, because the additional limitations + provided only a result-oriented solution and lacked details as to how the computer + performed the modifications, which was equivalent to the words "apply it". 850 F.3d + at 1341-42; 121 USPQ2d at 1947-48 (citing *Electric Power Group.,* + 830 F.3d at 1356, 1356, USPQ2d at 1743-44 (cautioning against claims "so result + focused, so functional, as to effectively cover any solution to an identified + problem")). + + + +Other examples where the courts have found the + additional elements to be mere instructions to apply an exception, because they + recite no more than an idea of a solution or outcome include: + + + +* i. Remotely accessing user-specific information + through a mobile interface and pointers to retrieve the information without any + description of how the mobile interface and pointers accomplish the result of + retrieving previously inaccessible information, *Intellectual Ventures + v. Erie Indem. Co.,* 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 + (Fed. Cir. 2017); +* ii. A general method of screening emails on a + generic computer without any limitations that addressed the issues of shrinking + the protection gap and mooting the volume problem, *Intellectual + Ventures I v. Symantec Corp.,* 838 F.3d 1307, 1319, 120 USPQ2d + 1353, 1361 (Fed. Cir. 2016); and +* iii. Wireless delivery of out-of-region broadcasting + content to a cellular telephone via a network without any details of how the + delivery is accomplished, *Affinity Labs of Texas v. DirecTV, + LLC,* 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. + 2016). + + +In contrast, other cases have found that additional + elements are more than "apply it" or are not "mere instructions" when the claim + recites a technological solution to a technological problem. In *DDR + Holdings,* the court found that the additional elements did amount to + more than merely instructing that the abstract idea should be applied on the + Internet. *DDR Holdings, LLC v. Hotels.com, L.P.,* 773 F.3d 1245, + 1259, 113 USPQ2d 1097, 1107 (Fed. Cir. 2014). The claims at issue specified how + interactions with the Internet were manipulated to yield a desired result—a result + that overrode the routine and conventional sequence of events ordinarily triggered by + the click of a hyperlink. 773 F.3d at 1258; 113 USPQ2d at 1106. In + *BASCOM,* the court determined that the claimed combination of + limitations did not simply recite an instruction to apply the abstract idea of + filtering content on the Internet. *BASCOM Global Internet Servs. v. AT&T + Mobility, LLC,* 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1243 (Fed. Cir. + 2016). Instead, the claim recited a "technology based solution" of filtering content + on the Internet that overcome the disadvantages of prior art filtering systems. 827 + F.3d at 1350-51, 119 USPQ2d at 1243. Finally, in *Thales Visionix,* + the particular configuration of inertial sensors and the particular method of using + the raw data from the sensors was more than simply applying a law of nature. + *Thales Visionix, Inc. v. United States,* 850 F.3d 1343, 1348-49, + 121 USPQ2d 1898, 1902 (Fed. Cir. 2017). The court found that the claims provided a + system and method that "eliminate[d] many ‘complications’ inherent in previous + solutions for determining position and orientation of an object on a moving + platform." In other words, the claim recited a technological solution to a + technological problem. *Id.* + + +**(2) Whether the claim invokes computers or + other machinery merely as a tool to perform an existing process.** Use of a + computer or other machinery in its ordinary capacity for economic or other tasks + (*e.g.,* to receive, store, or transmit data) or simply adding a + general purpose computer or computer components after the fact to an abstract idea + (*e.g.,* a fundamental economic practice or mathematical + equation) does not integrate a judicial exception into a practical application or + provide significantly more. See *Affinity Labs v. DirecTV,* 838 F.3d + 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); *TLI + Communications LLC v. AV Auto, LLC,* 823 F.3d 607, 613, 118 USPQ2d 1744, + 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the + improved speed or efficiency inherent with applying the abstract idea on a computer" + does not integrate a judicial exception into a practical application or provide an + inventive concept. *Intellectual Ventures I LLC v. Capital One Bank + (USA),* 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). In + contrast, a claim that purports to improve computer capabilities or to improve an + existing technology may integrate a judicial exception into a practical application + or provide significantly more. *McRO, Inc. v. Bandai Namco Games Am. + Inc.,* 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); + *Enfish, LLC v. Microsoft Corp.,* 822 F.3d 1327, 1335-36, 118 + USPQ2d 1684, 1688-89 (Fed. Cir. 2016). See **[MPEP §§ + 2106.04(d)(1)](s2106.html#ch2100_d2e7df_24a6e_1bd)** and **[2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** for a discussion of improvements to the + functioning of a computer or to another technology or technical field. + + + + *TLI Communications* provides an + example of a claim invoking computers and other machinery merely as a tool to perform + an existing process. The court stated that the claims describe steps of recording, + administration and archiving of digital images, and found them to be directed to the + abstract idea of classifying and storing digital images in an organized manner. 823 + F.3d at 612, 118 USPQ2d at 1747. The court then turned to the additional elements of + performing these functions using a telephone unit and a server and noted that these + elements were being used in their ordinary capacity (*i.e.,* the + telephone unit is used to make calls and operate as a digital camera including + compressing images and transmitting those images, and the server simply receives + data, extracts classification information from the received data, and stores the + digital images based on the extracted information). 823 F.3d at 612-13, 118 USPQ2d at + 1747-48. In other words, the claims invoked the telephone unit and server merely as + tools to execute the abstract idea. Thus, the court found that the additional + elements did not add significantly more to the abstract idea because they were simply + applying the abstract idea on a telephone network without any recitation of details + of how to carry out the abstract idea. + + + +Other examples where the courts have found the + additional elements to be mere instructions to apply an exception, because they do no + more than merely invoke computers or machinery as a tool to perform an existing + process include: + + + +* i. A commonplace business method or mathematical + algorithm being applied on a general purpose computer, *Alice Corp. + Pty. Ltd. V. CLS Bank Int’l,* 573 U.S. 208, 223, 110 USPQ2d 1976, + 1983 (2014); *Gottschalk v. Benson,* 409 U.S. 63, 64, 175 USPQ + 673, 674 (1972); *Versata Dev. Group, Inc. v. SAP Am., Inc.,* + 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); +* ii. Generating a second menu from a first menu and + sending the second menu to another location as performed by generic computer + components, *Apple, Inc. v. Ameranth, Inc.,* 842 F.3d 1229, + 1243-44, 120 USPQ2d 1844, 1855-57 (Fed. Cir. 2016); +* iii. A process for monitoring audit log data that is + executed on a general-purpose computer where the increased speed in the process + comes solely from the capabilities of the general-purpose computer, + *FairWarning IP, LLC v. Iatric Sys.,* 839 F.3d 1089, 1095, + 120 USPQ2d 1293, 1296 (Fed. Cir. 2016); +* iv. A method of using advertising as an exchange or + currency being applied or implemented on the Internet, *Ultramercial, + Inc. v. Hulu, LLC,* 772 F.3d 709, 715, 112 USPQ2d 1750, 1754 (Fed. + Cir. 2014); +* v. Requiring the use of software to tailor + information and provide it to the user on a generic computer, + *Intellectual Ventures I LLC v. Capital One Bank (USA),* + 792 F.3d 1363, 1370-71, 115 USPQ2d 1636, 1642 (Fed. Cir. 2015); and +* vi. A method of assigning hair designs to balance + head shape with a final step of using a tool (scissors) to cut the hair, + *In re Brown,* 645 Fed. App'x 1014, 1017 (Fed. Cir. 2016) + (non-precedential). + + + **(3) The particularity or generality of the + application of the judicial exception.** A claim having broad applicability + across many fields of endeavor may not provide meaningful limitations that integrate + a judicial exception into a practical application or amount to significantly more. + For instance, a claim that generically recites an effect of the judicial exception or + claims every mode of accomplishing that effect, amounts to a claim that is merely + adding the words "apply it" to the judicial exception. See *Internet Patents + Corporation v. Active Network, Inc.,* 790 F.3d 1343, 1348, 115 USPQ2d + 1414, 1418 (Fed. Cir. 2015) (The recitation of maintaining the state of data in an + online form without restriction on how the state is maintained and with no + description of the mechanism for maintaining the state describes "the effect or + result dissociated from any method by which maintaining the state is accomplished" + and does not provide a meaningful limitation because it merely states that the + abstract idea should be applied to achieve a desired result). See also + *O’Reilly v. Morse,* 56 U.S. 62 (1854) (finding ineligible a + claim for "the use of electromagnetism for transmitting signals at a distance"); The + *Telephone Cases,* 126 U.S. 1, 209 (1888) (finding a method of + "transmitting vocal or other sound telegraphically ... by causing electrical + undulations, similar in form to the vibrations of the air accompanying the said vocal + or other sounds," to be ineligible, because it "monopolize[d] a natural force" and + "the right to avail of that law by any means whatever."). + + + +In contrast, limitations that confine the judicial + exception to a particular, practical application of the judicial exception may amount + to significantly more or integrate the judicial exception into a practical + application. For example, in *BASCOM,* the combination of additional + elements, and specifically "the installation of a filtering tool at a specific + location, remote from the end‐users, with customizable filtering features specific to + each end user" where the filtering tool at the ISP was able to "identify individual + accounts that communicate with the ISP server, and to associate a request for + Internet content with a specific individual account," were held to be meaningful + limitations because they confined the abstract idea of content filtering to a + particular, practical application of the abstract idea. 827 F.3d at 1350-51, 119 + USPQ2d at 1243. + + + + + +# 2106.05(g) Insignificant Extra-Solution + Activity [R-10.2019] + + +Another consideration when determining whether a + claim integrates the judicial exception into a practical application in Step 2A Prong + Two or recites significantly more in Step 2B is whether the additional elements add + more than insignificant extra-solution activity to the judicial exception. The term + "extra-solution activity" can be understood as activities incidental to the primary + process or product that are merely a nominal or tangential addition to the claim. + Extra-solution activity includes both pre-solution and post-solution activity. An + example of pre-solution activity is a step of gathering data for use in a claimed + process, *e.g.,* a step of obtaining information about credit card + transactions, which is recited as part of a claimed process of analyzing and + manipulating the gathered information by a series of steps in order to detect whether + the transactions were fraudulent. An example of post-solution activity is an element + that is not integrated into the claim as a whole, *e.g.,* a printer + that is used to output a report of fraudulent transactions, which is recited in a + claim to a computer programmed to analyze and manipulate information about credit + card transactions in order to detect whether the transactions were fraudulent. + + + +As explained by the Supreme Court, the addition of + insignificant extra-solution activity does not amount to an inventive concept, + particularly when the activity is well-understood or conventional. *Parker v. + Flook,* 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). In + *Flook,* the Court reasoned that "[t]he notion that post-solution + activity, no matter how conventional or obvious in itself, can transform an + unpatentable principle into a patentable process exalts form over substance. A + competent draftsman could attach some form of post-solution activity to almost any + mathematical formula". 437 U.S. at 590; 198 USPQ at 197; *Id.* + (holding that step of adjusting an alarm limit variable to a figure computed + according to a mathematical formula was "post-solution activity"). See also + *Mayo Collaborative Servs. v. Prometheus Labs. Inc.,* 566 U.S. + 66, 79, 101 USPQ2d 1961, 1968 (2012) (additional element of measuring metabolites of + a drug administered to a patient was insignificant extra-solution activity). + + + + Examiners should carefully consider each claim on + its own merits, as well as evaluate all other relevant considerations, before making + a determination of whether an element (or combination of elements) is insignificant + extra-solution activity. In particular, evaluation of the particular machine and + particular transformation considerations (see **[MPEP § 2106.05(b) and + (c)](s2106.html#ch2100_d29a1b_13ccf_18c)**, respectively), the well-understood, routine, + conventional consideration (see **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**), and the field of + use and technological environment consideration (see **[MPEP § + 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**) may assist examiners in making a determination + of whether an element (or combination of elements) is insignificant extra-solution + activity. Note, however, that examiners should not evaluate the well-understood, + routine, conventional consideration in the Step 2A Prong Two analysis, because that + consideration is only evaluated in Step 2B. + + + +This consideration is similar to factors used in past + Office guidance (for example, the now superseded *Bilski* and + *Mayo* analyses) that were described as mere data gathering in + conjunction with a law of nature or abstract idea. When determining whether an + additional element is insignificant extra-solution activity, examiners may consider + the following: + + + +**(1) Whether the extra-solution limitation is well + known.** See *Bilski v. Kappos,* 561 U.S. 593, 611-12, 95 + USPQ2d 1001, 1010 (2010) (well-known random analysis techniques to establish the + inputs of an equation were token extra-solution activity); *Flook,* + 437 U.S. at 593-95, 198 USPQ at 197 (a formula would not be patentable by only + indicating that is could be usefully applied to existing surveying techniques); + *Intellectual Ventures I LLC v. Erie Indem. Co.,* 850 F.3d 1315, + 1328-29, 121 USPQ2d 1928, 1937 (Fed. Cir. 2017) (the use of a well-known XML tag to + form an index was deemed token extra-solution activity). Because this overlaps with + the well-understood, routine, conventional consideration, it should not be considered + in the Step 2A Prong Two extra-solution activity analysis. + + + +**(2) Whether the limitation is significant + (*i.e.* it imposes meaningful limits on the claim such that it + is not nominally or tangentially related to the invention).** See *Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, 715-16, 112 USPQ2d 1750, + 1755 (Fed. Cir. 2014) (restricting public access to media was found to be + insignificant extra-solution activity); *Apple, Inc. v. Ameranth, + Inc.,* 842 F.3d 1229, 1242, 120 USPQ2d 1844, 1855 (Fed. Cir. 2016) (in + patents regarding electronic menus, features related to types of ordering were found + to be insignificant extra-solution activity). This is considered in Step 2A Prong Two + and Step 2B. + + + +**(3) Whether the limitation amounts to necessary + data gathering and outputting, (*i.e.,* all uses of the recited + judicial exception require such data gathering or data output).** See + *Mayo,* 566 U.S. at 79, 101 USPQ2d at 1968; *OIP Techs., + Inc. v. Amazon.com, Inc.,* 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 + (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data + gathering). This is considered in Step 2A Prong Two and Step 2B. + + + +Below are examples of activities that the courts have + found to be insignificant extra-solution activity: + + + +* **• Mere Data Gathering:** + + i. Performing clinical tests on individuals to + obtain input for an equation, *In re Grams,* 888 F.2d + 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); + + ii. Testing a system for a response, the + response being used to determine system malfunction, *In re + Meyers,* 688 F.2d 789, 794; 215 USPQ 193, 196-97 (CCPA 1982); + + iii. Presenting offers to potential customers + and gathering statistics generated based on the testing about how + potential customers responded to the offers; the statistics are then used + to calculate an optimized price, *OIP Technologies,* 788 + F.3d at 1363, 115 USPQ2d at 1092-93; + + iv. Obtaining information about transactions + using the Internet to verify credit card transactions, + *CyberSource v. Retail Decisions, Inc.,* 654 F.3d + 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011); + + v. Consulting and updating an activity log, + *Ultramercial,* 772 F.3d at 715, 112 USPQ2d at 1754; + and + + vi. Determining the level of a biomarker in + blood, *Mayo,* 566 U.S. at 79, 101 USPQ2d at 1968. See + also *PerkinElmer, Inc. v. Intema Ltd.,* 496 Fed. App'x + 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring + data derived from an ultrasound scan, to be used in a diagnosis). +* **• Selecting a particular data source or type of data to be + manipulated:** + + i. Limiting a database index to XML tags, + *Intellectual Ventures I LLC v. Erie Indem. Co.,* 850 + F.3d at 1328-29, 121 USPQ2d at 1937; + + ii. Taking food orders from only table-based + customers or drive-through customers, *Ameranth,* 842 + F.3d at 1241-43, 120 USPQ2d at 1854-55; + + iii. Selecting information, based on types of + information and availability of information in a power-grid environment, + for collection, analysis and display, *Electric Power Group, LLC + v. Alstom S.A.,* 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, + 1742 (Fed. Cir. 2016); and + + iv. Requiring a request from a user to view + an advertisement and restricting public access, + *Ultramercial,* 772 F.3d at 715-16, 112 USPQ2d at + 1754. +* **• Insignificant application:** + + i. Cutting hair after first determining the + hair style, *In re Brown,* 645 Fed. App'x 1014, + 1016-1017 (Fed. Cir. 2016) (non-precedential); and + + ii. Printing or downloading generated menus, + *Ameranth,* 842 F.3d at 1241-42, 120 USPQ2d at + 1854-55. + + +Some cases have identified insignificant computer + implementation as an example of insignificant extra-solution activity. See + *e.g., Fort Props., Inc. v. Am. Master Lease LLC,* 671 F.3d 1317, + 1323-24, 101 USPQ2d 1785, 1789-90 (Fed. Cir. 2012); *Bancorp Servs., LLC v. + Sun Life Assur. Co. of Canada,* 687 F.3d 1266, 1280-81, 103 USPQ2d 1425, + 1434-35 (Fed. Cir. 2012). Other cases have considered these types of limitations as + mere instructions to apply a judicial exception. See **[MPEP § + 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)** for more information about insignificant + computer implementation. + + + +For claim limitations that add insignificant + extra-solution activity to the judicial exception (*e.g.,* mere data + gathering in conjunction with a law of nature or abstract idea), examiners should + explain in an eligibility rejection why they do not meaningfully limit the claim. For + example, an examiner could explain that adding a final step of storing data to a + process that only recites computing the area of a space (a mathematical relationship) + does not add a meaningful limitation to the process of computing the area. For more + information on formulating a subject matter eligibility rejection, see + **[MPEP + § 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. + + + + + +# 2106.05(h) Field of Use and Technological + Environment [R-10.2019] + + +Another consideration when determining whether a + claim integrates the judicial exception into a practical application in Step 2A Prong + Two or recites significantly more than a judicial exception in Step 2B is whether the + additional elements amount to more than generally linking the use of a judicial + exception to a particular technological environment or field of use. As explained by + the Supreme Court, a claim directed to a judicial exception cannot be made eligible + "simply by having the applicant acquiesce to limiting the reach of the patent for the + formula to a particular technological use." *Diamond v. Diehr,* 450 + U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to + merely indicating a field of use or technological environment in which to apply a + judicial exception do not amount to significantly more than the exception itself, and + cannot integrate a judicial exception into a practical application. + + + +The courts often cite to *Parker v. + Flook* as providing a classic example of a field of use limitation. See, + *e.g., Bilski v. Kappos,* 561 U.S. 593, 612, 95 USPQ2d 1001, 1010 + (2010) ("*Flook* established that limiting an abstract idea to one + field of use or adding token postsolution components did not make the concept + patentable") (citing *Parker v. Flook,* 437 U.S. 584, 198 USPQ 193 + (1978)). In *Flook,* the claim recited steps of calculating an + updated value for an alarm limit (a numerical limit on a process variable such as + temperature, pressure or flow rate) according to a mathematical formula "in a process + comprising the catalytic chemical conversion of hydrocarbons." 437 U.S. at 586, 198 + USPQ at 196. Processes for the catalytic chemical conversion of hydrocarbons were + used in the petrochemical and oil-refining fields. *Id.* Although + the applicant argued that limiting the use of the formula to the petrochemical and + oil-refining fields should make the claim eligible because this limitation ensured + that the claim did not preempt all uses of the formula, the Supreme Court disagreed. + 437 U.S. at 588-90, 198 USPQ at 197-98. Instead, the additional element in + *Flook* regarding the catalytic chemical conversion of + hydrocarbons was not sufficient to make the claim eligible, because it was merely an + incidental or token addition to the claim that did not alter or affect how the + process steps of calculating the alarm limit value were performed. Further, the + Supreme Court found that this limitation did not amount to an inventive concept. 437 + U.S. at 588-90, 198 USPQ at 197-98. The Court reasoned that to hold otherwise would + "exalt[] form over substance", because a competent claim drafter could attach a + similar type of limitation to almost any mathematical formula. 437 U.S. at 590, 198 + USPQ at 197. + + + + In contrast, the additional elements in + *Diamond v. Diehr* as a whole provided eligibility and did not + merely recite calculating a cure time using the Arrhenius equation "in a rubber + molding process". Instead, the claim in *Diehr* recited specific + limitations such as monitoring the elapsed time since the mold was closed, constantly + measuring the temperature in the mold cavity, repetitively calculating a cure time by + inputting the measured temperature into the Arrhenius equation, and opening the press + automatically when the calculated cure time and the elapsed time are equivalent. 450 + U.S. at 179, 209 USPQ at 5, n. 5. These specific limitations act in concert to + transform raw, uncured rubber into cured molded rubber. 450 U.S. at 177-78, 209 USPQ + at 4. + + + +A more recent example of a limitation that does no + more than generally link a judicial exception to a particular technological + environment is *Affinity Labs of Texas v. DirecTV, LLC,* 838 F.3d + 1253, 120 USPQ2d 1201 (Fed. Cir. 2016). In *Affinity Labs,* the + claim recited a broadcast system in which a cellular telephone located outside the + range of a regional broadcaster (1) requests and receives network-based content from + the broadcaster via a streaming signal, (2) is configured to wirelessly download an + application for performing those functions, and (3) contains a display that allows + the user to select particular content. 838 F.3d at 1255-56, 120 USPQ2d at 1202. The + court identified the claimed concept of providing out-of-region access to regional + broadcast content as an abstract idea, and noted that the additional elements limited + the wireless delivery of regional broadcast content to cellular telephones (as + opposed to any and all electronic devices such as televisions, cable boxes, + computers, or the like). 838 F.3d at 1258-59, 120 USPQ2d at 1204. Although the + additional elements did limit the use of the abstract idea, the court explained that + this type of limitation merely confines the use of the abstract idea to a particular + technological environment (cellular telephones) and thus fails to add an inventive + concept to the claims. 838 F.3d at 1259, 120 USPQ2d at 1204. + + + +Examples of limitations that the courts have + described as merely indicating a field of use or technological environment in which + to apply a judicial exception include: + + + +* i. A step of administering a drug providing + 6-thioguanine to patients with an immune-mediated gastrointestinal disorder, + because limiting drug administration to this patient population did no more + than simply refer to the relevant pre-existing audience of doctors who used + thiopurine drugs to treat patients suffering from autoimmune disorders, + *Mayo Collaborative Servs. v. Prometheus Labs. Inc.,* 566 + U.S. 66, 78, 101 USPQ2d 1961, 1968 (2012); +* ii. Identifying the participants in a process for + hedging risk as commodity providers and commodity consumers, because limiting + the use of the process to these participants did no more than describe how the + abstract idea of hedging risk could be used in the commodities and energy + markets, *Bilski,* 561 U.S. at 595, 95 USPQ2d at 1010; +* iii. Limiting the use of the formula C = 2 (pi) r to + determining the circumference of a wheel as opposed to other circular objects, + because this limitation represents a mere token acquiescence to limiting the + reach of the claim, *Flook,* 437 U.S. at 595, 198 USPQ at + 199; +* iv. Specifying that the abstract idea of monitoring + audit log data relates to transactions or activities that are executed in a + computer environment, because this requirement merely limits the claims to the + computer field, *i.e.,* to execution on a generic computer, + *FairWarning v. Iatric Sys.,* 839 F.3d 1089, 1094-95, 120 + USPQ2d 1293, 1295 (Fed. Cir. 2016); +* v. Language specifying that the process steps of + virus screening were used within a telephone network or the Internet, because + limiting the use of the process to these technological environments did not + provide meaningful limits on the claim, *Intellectual Ventures I v. + Symantec Corp.,* 838 F.3d 1307, 1319-20, 120 USPQ2d 1353, 1361 + (2016); +* vi. Limiting the abstract idea of collecting + information, analyzing it, and displaying certain results of the collection and + analysis to data related to the electric power grid, because limiting + application of the abstract idea to power-grid monitoring is simply an attempt + to limit the use of the abstract idea to a particular technological + environment, *Electric Power Group, LLC v. Alstom S.A.,* 830 + F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016); +* vii. Language informing doctors to apply a law of + nature (linkage disequilibrium) for purposes of detecting a genetic + polymorphism, because this language merely informs the relevant audience that + the law of nature can be used in this manner, *Genetic Techs. Ltd. v. + Merial LLC,* 818 F.3d 1369, 1379, 118 USPQ2d 1541, 1549 (Fed. Cir. + 2016); +* viii. Language specifying that the abstract idea of + budgeting was to be implemented using a "communication medium" that broadly + included the Internet and telephone networks, because this limitation merely + limited the use of the exception to a particular technological environment, + *Intellectual Ventures I v. Capital One Bank,* 792 F.3d + 1363, 1367, 115 USPQ2d 1636, 1640 (Fed. Cir. 2015); +* ix. Specifying that the abstract idea of using + advertising as currency is used on the Internet, because this narrowing + limitation is merely an attempt to limit the use of the abstract idea to a + particular technological environment, *Ultramercial, Inc. v. Hulu, + LLC,* 772 F.3d 709, 716, 112 USPQ2d 1750, 1755 (Fed. Cir. 2014); + and +* x. Requiring that the abstract idea of creating a + contractual relationship that guarantees performance of a transaction (a) be + performed using a computer that receives and sends information over a network, + or (b) be limited to guaranteeing online transactions, because these + limitations simply attempted to limit the use of the abstract idea to computer + environments, *buySAFE Inc. v. Google, Inc.,* 765 F.3d 1350, + 1354, 112 USPQ2d 1093, 1095-96 (Fed. Cir. 2014). + + +Examiners should be aware that the courts often use + the terms "technological environment" and "field of use" interchangeably, and thus + for purposes of the eligibility analysis examiners should consider these terms + interchangeable. Examiners should also keep in mind that this consideration overlaps + with other considerations, particularly insignificant extra-solution activity (see + **[MPEP + § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**). For instance, a data gathering step that is + limited to a particular data source (such as the Internet) or a particular type of + data (such as power grid data or XML tags) could be considered to be both + insignificant extra-solution activity and a field of use limitation. See, + *e.g., Ultramercial,* 772 F.3d at 716, 112 USPQ2d at 1755 + (limiting use of abstract idea to the Internet); *Electric Power,* + 830 F.3d at 1354, 119 USPQ2d at 1742 (limiting application of abstract idea to power + grid data); *Intellectual Ventures I LLC v. Erie Indem. Co.,* 850 + F.3d 1315, 1328-29, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017) (limiting use of abstract + idea to use with XML tags). Thus, examiners should carefully consider each claim on + its own merits, as well as evaluate all other relevant considerations, before making + a determination on this consideration. + + + +For claim limitations that generally link the use of + the judicial exception to a particular technological environment or field of use, + examiners should explain in an eligibility rejection why they do not meaningfully + limit the claim. For example, an examiner could explain that employing generic + computer functions to execute an abstract idea, even when limiting the use of the + idea to one particular environment, does not add significantly more, similar to how + limiting the abstract idea in *Flook* to petrochemical and + oil-refining industries was insufficient. For more information on formulating a + subject matter eligibility rejection, see **[MPEP § + 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. + + + + +, +# 2106.05(a) Improvements to the Functioning of a Computer + or To Any Other Technology or Technical Field [R-10.2019] + + +In determining patent eligibility, examiners should + consider whether the claim "purport(s) to improve the functioning of the computer + itself" or "any other technology or technical field." *Alice Corp. Pty. Ltd. + v. CLS Bank Int’l,* 573 U.S. 208, 225, 110 USPQ2d 1976, 1984 (2014). This + consideration has also been referred to as the search for a technological solution to + a technological problem. See e.g., *DDR Holdings, LLC. v. Hotels.com, + L.P.,* 773 F.3d 1245, 1257, 113 USPQ2d 1097, 1105 (Fed. Cir. 2014); + *Amdocs (Israel), Ltd. v. Openet Telecom, Inc.,* 841 F.3d 1288, + 1300-01, 120 USPQ2d 1527, 1537 (Fed. Cir. 2016). + + + +While improvements were evaluated in *Alice + Corp.* as relevant to the search for an inventive concept (Step 2B), + several decisions of the Federal Circuit have also evaluated this consideration when + determining whether a claim was directed to an abstract idea (Step 2A). See, + e.g., *Enfish, LLC v. Microsoft Corp.,* 822 F.3d 1327, 1335-36, + 118 USPQ2d 1684, 1689 (Fed. Cir. 2016); *McRO, Inc. v. Bandai Namco Games Am. + Inc.,* 837 F.3d 1299, 1314-16, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016); + *Visual Memory, LLC v. NVIDIA Corp.,* 867 F.3d 1253, 1259-60, 123 + USPQ2d 1712, 1717 (Fed. Cir. 2017). Thus, an examiner should evaluate whether a claim + contains an improvement to the functioning of a computer or to any other technology + or technical field at Step 2A Prong Two and Step 2B, as well as when considering + whether the claim has such self-evident eligibility that it qualifies for the + streamlined analysis. See **[MPEP § 2106.04(d)(1)](s2106.html#ch2100_d2e7df_24a6e_1bd)** for more + information about evaluating improvements in Step 2A Prong Two, and + **[MPEP + § 2106.07(b)](s2106.html#ch2100_d29a1b_14065_2a0)** for more information about improvements in the + streamlined analysis context. + + + +If it is asserted that the invention improves upon + conventional functioning of a computer, or upon conventional technology or + technological processes, a technical explanation as to how to implement the invention + should be present in the specification. That is, the disclosure must provide + sufficient details such that one of ordinary skill in the art would recognize the + claimed invention as providing an improvement. The specification need not explicitly + set forth the improvement, but it must describe the invention such that the + improvement would be apparent to one of ordinary skill in the art. Conversely, if the + specification explicitly sets forth an improvement but in a conclusory manner (i.e., + a bare assertion of an improvement without the detail necessary to be apparent to a + person of ordinary skill in the art), the examiner should not determine the claim + improves technology. An indication that the claimed invention provides an improvement + can include a discussion in the specification that identifies a technical problem and + explains the details of an unconventional technical solution expressed in the claim, + or identifies technical improvements realized by the claim over the prior art. For + example, in *McRO,* the court relied on the specification’s + explanation of how the particular rules recited in the claim enabled the automation + of specific animation tasks that previously could only be performed subjectively by + humans, when determining that the claims were directed to improvements in computer + animation instead of an abstract idea. *McRO,* 837 F.3d at 1313-14, + 120 USPQ2d at 1100-01. In contrast, the court in *Affinity Labs of Tex. v. + DirecTV, LLC* relied on the specification’s failure to provide details + regarding the manner in which the invention accomplished the alleged improvement when + holding the claimed methods of delivering broadcast content to cellphones ineligible. + 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016). + + + +After the examiner has consulted the specification + and determined that the disclosed invention improves technology, the claim must be + evaluated to ensure the claim itself reflects the disclosed improvement in + technology. *Intellectual Ventures I LLC v. Symantec Corp.,* 838 + F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (patent owner argued that the claimed email + filtering system improved technology by shrinking the protection gap and mooting the + volume problem, but the court disagreed because the claims themselves did not have + any limitations that addressed these issues). That is, the claim must include the + components or steps of the invention that provide the improvement described in the + specification. However, the claim itself does not need to explicitly recite the + improvement described in the specification (*e.g.,* "thereby + increasing the bandwidth of the channel"). The full scope of the claim under the BRI + should be considered to determine if the claim reflects an improvement in technology + (*e.g.,* the improvement described in the specification). In + making this determination, it is critical that examiners look at the claim "as a + whole," in other words, the claim should be evaluated "as an ordered combination, + without ignoring the requirements of the individual steps." When performing this + evaluation, examiners should be "careful to avoid oversimplifying the claims" by + looking at them generally and failing to account for the specific requirements of the + claims. *McRO,* 837 F.3d at 1313, 120 USPQ2d at 1100. + + + + An important consideration in determining whether a + claim improves technology is the extent to which the claim covers a particular + solution to a problem or a particular way to achieve a desired outcome, as opposed to + merely claiming the idea of a solution or outcome. *McRO,* 837 F.3d + at 1314-15, 120 USPQ2d at 1102-03; *DDR Holdings,* 773 F.3d at 1259, + 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with + other considerations, specifically the particular machine consideration (see + **[MPEP + § 2106.05(b)](s2106.html#ch2100_d29a1b_13ccf_18c)**), and the mere instructions to apply an + exception consideration (see **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**). Thus, evaluation + of those other considerations may assist examiners in making a determination of + whether a claim satisfies the improvement consideration. + + + +It is important to note, the judicial exception alone + cannot provide the improvement. The improvement can be provided by one or more + additional elements. See the discussion of *Diamond v. Diehr*, 450 + U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In + addition, the improvement can be provided by the additional element(s) in combination + with the recited judicial exception. See **[MPEP § + 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)** (discussing *Finjan, Inc. v. Blue Coat + Sys., Inc.,* 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. + 2018)). Thus, it is important for examiners to analyze the claim as a whole when + determining whether the claim provides an improvement to the functioning of computers + or an improvement to other technology or technical field. + + + +During examination, the examiner should analyze the + "improvements" consideration by evaluating the specification and the claims to ensure + that a technical explanation of the asserted improvement is present in the + specification, and that the claim reflects the asserted improvement. Generally, + examiners are not expected to make a qualitative judgement on the merits of the + asserted improvement. If the examiner concludes the disclosed invention does not + improve technology, the burden shifts to applicant to provide persuasive arguments + supported by any necessary evidence to demonstrate that one of ordinary skill in the + art would understand that the disclosed invention improves technology. Any such + evidence submitted under **[37 CFR 1.132](mpep-9020-appx-r.html#d0e323552)** must establish what + the specification would convey to one of ordinary skill in the art and cannot be used + to supplement the specification. See, *e.g.***[MPEP § + 716.09](s716.html#d0e93742)** on **[37 CFR 1.132](mpep-9020-appx-r.html#d0e323552)** practice with + respect to rejections under **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**. For example, in + response to a rejection under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**, an applicant could + submit a declaration under **[§ 1.132](mpep-9020-appx-r.html#d0e323552)** providing testimony on + how one of ordinary skill in the art would interpret the disclosed invention as + improving technology and the underlying factual basis for that conclusion. + + +**I.** **IMPROVEMENTS TO COMPUTER + FUNCTIONALITY**In computer-related technologies, the examiner + should determine whether the claim purports to improve computer capabilities or, + instead, invokes computers merely as a tool. *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). + In *Enfish,* the court evaluated the patent eligibility of claims + related to a self-referential database. *Id.* The court concluded + the claims were not directed to an abstract idea, but rather an improvement to + computer functionality. *Id.* It was the specification’s + discussion of the prior art and how the invention improved the way the computer + stores and retrieves data in memory in combination with the specific data + structure recited in the claims that demonstrated eligibility. 822 F.3d at 1339, + 118 USPQ2d at 1691. The claim was not simply the addition of general purpose + computers added post-hoc to an abstract idea, but a specific implementation of a + solution to a problem in the software arts. 822 F.3d at 1339, 118 USPQ2d at + 1691. + + + + Examples that the courts have indicated may show + an improvement in computer-functionality: + + + +* i. A modification of conventional Internet + hyperlink protocol to dynamically produce a dual-source hybrid webpage, + *DDR Holdings,* 773 F.3d at 1258-59, 113 USPQ2d at + 1106-07; +* ii. Inventive distribution of functionality + within a network to filter Internet content, *BASCOM Global Internet + v. AT&T Mobility LLC,* 827 F.3d 1341, 1350-51, 119 USPQ2d + 1236, 1243 (Fed. Cir. 2016); +* iii. A method of rendering a halftone digital + image, *Research Corp. Techs. v. Microsoft Corp.,* 627 F.3d + 859, 868-69, 97 USPQ2d 1274, 1380 (Fed. Cir. 2010); +* iv. A distributed network architecture operating + in an unconventional fashion to reduce network congestion while generating + networking accounting data records, *Amdocs (Israel), Ltd. v. Openet + Telecom, Inc.,* 841 F.3d 1288, 1300-01, 120 USPQ2d 1527, 1536-37 + (Fed. Cir. 2016); +* v. A memory system having programmable + operational characteristics that are configurable based on the type of + processor, which can be used with different types of processors without a + tradeoff in processor performance, *Visual Memory, LLC v. NVIDIA + Corp.,* 867 F.3d 1253, 1259-60, 123 USPQ2d 1712, 1717 (Fed. Cir. + 2017); +* vi. Technical details as to how to transmit + images over a cellular network or append classification information to + digital image data, *TLI Communications LLC v. AV Auto. + LLC,* 823 F.3d 607, 614-15, 118 USPQ2d 1744, 1749-50 (Fed. Cir. + 2016) (holding the claims ineligible because they fail to provide requisite + technical details necessary to carry out the function); +* vii. Particular structure of a server that stores + organized digital images, *TLI Communications,* 823 F.3d at + 612, 118 USPQ2d at 1747 (finding the use of a generic server insufficient to + add inventive concepts to an abstract idea); +* viii. A particular way of programming or designing + software to create menus, *Apple, Inc. v. Ameranth, Inc.,* + 842 F.3d 1229, 1241, 120 USPQ2d 1844, 1854 (Fed. Cir. 2016); +* ix. A method that generates a security profile + that identifies both hostile and potentially hostile operations, and can + protect the user against both previously unknown viruses and "obfuscated + code," which is an improvement over traditional virus scanning. + *Finjan Inc. v. Blue Coat Systems,* 879 F.3d 1299, 1304, + 125 USPQ2d 1282, 1286 (Fed. Cir. 2018); +* x. An improved user interface for electronic + devices that displays an application summary of unlaunched applications, + where the particular data in the summary is selectable by a user to launch + the respective application. *Core Wireless Licensing S.A.R.L., v. LG + Electronics, Inc.,* 880 F.3d 1356, 1362-63, 125 USPQ2d 1436, + 1440-41 (Fed. Cir. 2018); +* xi. Specific interface and implementation for + navigating complex three-dimensional spreadsheets using techniques unique to + computers; *Data Engine Techs., LLC v. Google LLC,* 906 + F.3d 999, 1009, 128 USPQ2d 1381, 1387 (Fed. Cir. 2018); and +* xii. A specific method of restricting software + operation within a license, *Ancora Tech., Inc. v. HTC America, + Inc.,* 908 F.3d 1343, 1345-46, 128 USPQ2d 1565, 1567 (Fed. Cir. + 2018). + + +It is important to note that in order for a method + claim to improve computer functionality, the broadest reasonable interpretation of + the claim must be limited to computer implementation. That is, a claim whose + entire scope can be performed mentally, cannot be said to improve computer + technology. *Synopsys, Inc. v. Mentor Graphics Corp.,* 839 F.3d + 1138, 120 USPQ2d 1473 (Fed. Cir. 2016) (a method of translating a logic circuit + into a hardware component description of a logic circuit was found to be + ineligible because the method did not employ a computer and a skilled artisan + could perform all the steps mentally). Similarly, a claimed process covering + embodiments that can be performed on a computer, as well as embodiments that can + be practiced verbally or with a telephone, cannot improve computer technology. See + *RecogniCorp, LLC v. Nintendo Co.,* 855 F.3d 1322, 1328, 122 + USPQ2d 1377, 1381 (Fed. Cir. 2017) (process for encoding/decoding facial data + using image codes assigned to particular facial features held ineligible because + the process did not require a computer). + + + +Examples that the courts have indicated may not be + sufficient to show an improvement in computer-functionality: + + + +* i. Generating restaurant menus with + functionally claimed features, *Ameranth,* 842 F.3d at + 1245, 120 USPQ2d at 1857; +* ii. Accelerating a process of analyzing audit + log data when the increased speed comes solely from the capabilities of a + general-purpose computer, *FairWarning IP, LLC v. Iatric Sys.,* 839 F.3d 1089, 1095, 120 USPQ2d 1293, 1296 (Fed. Cir. 2016); +* iii. Mere automation of manual processes, such as + using a generic computer to process an application for financing a purchase, + *Credit Acceptance Corp. v. Westlake Services,* 859 F.3d + 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) or speeding up a + loan-application process by enabling borrowers to avoid physically going to + or calling each lender and filling out a loan application, + *LendingTree, LLC v. Zillow, Inc.,* 656 Fed. App'x 991, + 996-97 (Fed. Cir. 2016) (non-precedential); +* iv. Recording, transmitting, and archiving + digital images by use of conventional or generic technology in a nascent but + well-known environment, without any assertion that the invention reflects an + inventive solution to any problem presented by combining a camera and a + cellular telephone, *TLI Communications,* 823 F.3d at + 611-12, 118 USPQ2d at 1747; +* v. Affixing a barcode to a mail object in order + to more reliably identify the sender and speed up mail processing, without + any limitations specifying the technical details of the barcode or how it is + generated or processed, *Secured Mail Solutions, LLC v. Universal + Wilde, Inc.,* 873 F.3d 905, 910-11, 124 USPQ2d 1502, 1505-06 + (Fed. Cir. 2017); +* vi. Instructions to display two sets of + information on a computer display in a non-interfering manner, without any + limitations specifying how to achieve the desired result, *Interval + Licensing LLC v. AOL, Inc.,* 896 F.3d 1335, 1344-45, 127 USPQ2d + 1553, 1559-60 (Fed. Cir. 2018); +* vii. Providing historical usage information to + users while they are inputting data, in order to improve the quality and + organization of information added to a database, because "an improvement to + the information stored by a database is not equivalent to an improvement in + the database’s functionality," *BSG Tech LLC v. Buyseasons, + Inc.,* 899 F.3d 1281, 1287-88, 127 USPQ2d 1688, 1693-94 (Fed. + Cir. 2018); and +* viii. Arranging transactional information on a + graphical user interface in a manner that assists traders in processing + information more quickly, *Trading Technologies v. IBG + LLC,* 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. + 2019). + +**II.** **IMPROVEMENTS TO ANY OTHER + TECHNOLOGY OR TECHNICAL FIELD**The courts have also found that improvements in + technology beyond computer functionality may demonstrate patent eligibility. In + *McRO,* the Federal Circuit held claimed methods of automatic + lip synchronization and facial expression animation using computer-implemented + rules to be patent eligible under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**, because they + were not directed to an abstract idea. *McRO,* 837 F.3d at 1316, + 120 USPQ2d at 1103. The basis for the *McRO* court's decision was + that the claims were directed to an improvement in computer animation and thus did + not recite a concept similar to previously identified abstract ideas. + *Id.* The court relied on the specification's explanation of + how the claimed rules enabled the automation of specific animation tasks that + previously could not be automated. 837 F.3d at 1313, 120 USPQ2d at 1101. The + *McRO* court indicated that it was the incorporation of the + particular claimed rules in computer animation that "improved [the] existing + technological process", unlike cases such as *Alice* where a + computer was merely used as a tool to perform an existing process. 837 F.3d at + 1314, 120 USPQ2d at 1102. The *McRO* court also noted that the + claims at issue described a specific way (use of particular rules to set morph + weights and transitions through phonemes) to solve the problem of producing + accurate and realistic lip synchronization and facial expressions in animated + characters, rather than merely claiming the idea of a solution or outcome, and + thus were not directed to an abstract idea. 837 F.3d at 1313, 120 USPQ2d at 1101. + + + +Consideration of improvements is relevant to the + eligibility analysis regardless of the technology of the claimed invention. That + is, the consideration applies equally whether it is a computer-implemented + invention, an invention in the life sciences, or any other technology. See, + *e.g., Rapid Litigation Management v. CellzDirect, Inc.,* 827 + F.3d 1042, 119 USPQ2d 1370 (Fed. Cir. 2016), in which the court noted that a + claimed process for preserving hepatocytes could be eligible as an improvement to + technology because the claim achieved a new and improved way for preserving + hepatocyte cells for later use, even though the claim is based on the discovery of + something natural. Notably, the court did not distinguish between the types of + technology when determining the invention improved technology. However, it is + important to keep in mind that an improvement in the abstract idea itself + (*e.g.* a recited fundamental economic concept) is not an + improvement in technology. For example, in *Trading Technologies Int’l v. + IBG,* 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the + court determined that the claimed user interface simply provided a trader with + more information to facilitate market trades, which improved the business process + of market trading but did not improve computers or technology. + + + +Examples that the courts have indicated may be + sufficient to show an improvement in existing technology include: + + + +* i. Particular computerized method of operating + a rubber molding press, *e.g.,* a modification of + conventional rubber-molding processes to utilize a thermocouple inside the + mold to constantly monitor the temperature and thus reduce under- and + over-curing problems common in the art, *Diamond v. Diehr,* + 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 8 and 10 (1981); +* ii. New telephone, server, or combination + thereof, *TLI Communications LLC v. AV Auto. LLC,* 823 F.3d + 607, 612, 118 USPQ2d 1744, 1747 (Fed. Cir. 2016); +* iii. An advance in the process of downloading + content for streaming, *Affinity Labs of Tex. v. DirecTV, + LLC,* 838 F.3d 1253, 1256, 120 USPQ2d 1201, 1202 (Fed. Cir. + 2016); +* iv. Improved, particular method of digital data + compression, *DDR Holdings, LLC. v. Hotels.com, L.P.,* 773 + F.3d 1245, 1259, 113 USPQ2d 1097, 1107 (Fed. Cir. 2014); + *Intellectual Ventures I v. Symantec Corp.,* 838 F.3d + 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016); +* v. Particular method of incorporating virus + screening into the Internet, *Symantec Corp.,* 838 F.3d at + 1321-22, 120 USPQ2d at 1362-63; +* vi. Components or methods, such as measurement + devices or techniques, that generate new data, *Electric Power + Group, LLC v. Alstom, S.A.,* 830 F.3d 1350, 1355, 119 USPQ2d + 1739, 1742 (Fed. Cir. 2016); +* vii. Particular configuration of inertial sensors + and a particular method of using the raw data from the sensors, + *Thales Visionix, Inc. v. United States,* 850 F.3d 1343, + 1348-49, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017); +* viii. A specific, structured graphical user + interface that improves the accuracy of trader transactions by displaying + bid and asked prices in a particular manner that prevents order entry at a + changed price, *Trading Techs. Int’l, Inc. v. CQG, Inc.,* + 675 Fed. App'x 1001 (Fed. Cir. 2017) (non-precedential); and +* ix. Improved process for preserving hepatocytes + for later use, *Rapid Litig. Mgmt. v. CellzDirect, Inc.,* + 827 F.3d 1042, 1050, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016). + + +To show that the involvement of a computer assists + in improving the technology, the claims must recite the details regarding how a + computer aids the method, the extent to which the computer aids the method, or the + significance of a computer to the performance of the method. Merely adding generic + computer components to perform the method is not sufficient. Thus, the claim must + include more than mere instructions to perform the method on a generic component + or machinery to qualify as an improvement to an existing technology. See + **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)** for more information about mere + instructions to apply an exception. + + + +Examples that the courts have indicated may not be + sufficient to show an improvement to technology include: + + + +* i. A commonplace business method being applied + on a general purpose computer, *Alice Corp.,* 573 U.S. at + 223, 110 USPQ2d at 1976; *Versata Dev. Group, Inc. v. SAP Am., + Inc.,* 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. + 2015); +* ii. Using well-known standard laboratory + techniques to detect enzyme levels in a bodily sample such as blood or + plasma, *Cleveland Clinic Foundation v. True Health Diagnostics, + LLC,* 859 F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83, 1088 + (Fed. Cir. 2017); +* iii. Gathering and analyzing information using + conventional techniques and displaying the result, *TLI + Communications,* 823 F.3d at 612-13, 118 USPQ2d at 1747-48; +* iv. Delivering broadcast content to a portable + electronic device such as a cellular telephone, when claimed at a high level + of generality, *Affinity Labs of Tex. v. Amazon.com,* 838 + F.3d 1266, 1270, 120 USPQ2d 1210, 1213 (Fed. Cir. 2016); *Affinity + Labs of Tex. v. DirecTV, LLC,* 838 F.3d 1253, 1262, 120 USPQ2d + 1201, 1207 (Fed. Cir. 2016); +* v. A general method of screening emails on a + generic computer, *Symantec,* 838 F.3d at 1315-16, 120 + USPQ2d at 1358-59; +* vi. An advance in the informational content of a + download for streaming, *Affinity Labs of Tex. v. DirecTV, + LLC,* 838 F.3d 1253, 1263, 120 USPQ2d 1201, 1208 (Fed. Cir. + 2016); and +* vii. Selecting one type of content + (*e.g.,* FM radio content) from within a range of + existing broadcast content types, or selecting a particular generic function + for computer hardware to perform (e.g., buffering content) from within a + range of well-known, routine, conventional functions performed by the + hardware, *Affinity Labs of Tex. v. DirecTV, LLC,* 838 F.3d + 1253, 1264, 120 USPQ2d 1201, 1208 (Fed. Cir. 2016). + + +, +# 2106.05(b) Particular Machine [R-10.2019] + + +When determining whether a claim integrates a + judicial exception, into a practical application in Step 2A Prong Two and whether a + claim recites significantly more than a judicial exception in Step 2B, examiners + should consider whether the judicial exception is applied with, or by use of, a + particular machine. "The machine-or-transformation test is a useful and important + clue, and investigative tool" for determining whether a claim is patent eligible + under **[§ + 101](mpep-9015-appx-l.html#d0e302376)**. *Bilski v. Kappos,* 561 U.S. 593, 604, 95 + USPQ2d 1001, 1007 (2010). + + + +It is noted that while the application of a judicial + exception by or with a particular machine is an important clue, it is + not a stand-alone test for eligibility. + *Id.* + + +All claims must be evaluated for eligibility using the + two-part test from *Alice/Mayo*. If a claim passes the + *Alice/Mayo* test (*i.e.,* is not directed to an + exception at Step 2A, or amounts to significantly more than any recited exception in + Step 2B), then the claim is eligible even if it fails the machine-or-transformation + test ("M-or-T test"). *Bilski v. Kappos,* 561 U.S. 593, 604, 95 + USPQ2d 1001, 1007 (2010) (explaining that a claim may be eligible even if it does not + satisfy the M-or-T test); *McRO, Inc. v. Bandai Namco Games Am. + Inc.,* 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) + ("[T]here is nothing that requires a method ‘be tied to a machine or transform an + article’ to be patentable"). And if a claim fails the *Alice/Mayo* + test (*i.e.,* is directed to an exception at Step 2A and does not + amount to significantly more than the exception in Step 2B), then the claim is + ineligible even if it passes the M-or-T test. *DDR Holdings, LLC v. + Hotels.com, L.P.,* 773 F.3d 1245, 1256, 113 USPQ2d 1097, 1104 (Fed. Cir. + 2014) ("[I]n *Mayo,* the Supreme Court emphasized that satisfying + the machine-or-transformation test, by itself, is not sufficient to render a claim + patent-eligible, as not all transformations or machine implementations infuse an + otherwise ineligible claim with an 'inventive concept.'"). + + + +Examiners may find it helpful to evaluate other + considerations such as the mere instructions to apply an exception consideration (see + **[MPEP § + 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the field of + use and technological environment consideration (see **[MPEP § + 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when making a determination of whether an + element (or combination of elements) is a particular machine. For information on the + definition of the term "machine," see **[MPEP § + 2106.03](s2106.html#ch2100_d29a1b_139b2_397)**. + + + +When determining whether a machine recited in a claim + provides significantly more, the following factors are relevant. + + +**I.** **THE PARTICULARITY OR GENERALITY OF + THE ELEMENTS OF THE MACHINE OR APPARATUS**The particularity or generality of the elements of + the machine or apparatus, *i.e.,* the degree to which the machine + in the claim can be specifically identified (not any and all machines). One + example of applying a judicial exception with a particular machine is + *Mackay Radio & Tel. Co. v. Radio Corp. of America,* 306 + U.S. 86, 40 USPQ 199 (1939). In this case, a mathematical formula was employed to + use standing wave phenomena in an antenna system. The claim recited the particular + type of antenna and included details as to the shape of the antenna and the + conductors, particularly the length and angle at which they were arranged. 306 + U.S. at 95-96; 40 USPQ at 203. Another example is *Eibel + Process,* in which gravity (a law of nature or natural phenomenon) was + applied by a Fourdrinier machine (which was understood in the art to have a + specific structure comprising a headbox, a paper-making wire, and a series of + rolls) arranged in a particular way to optimize the speed of the machine while + maintaining quality of the formed paper web. *Eibel Process Co. v. Minn. + & Ont. Paper Co.,* 261 U.S. 45, 64-65 (1923). + + + +It is important to note that a general purpose + computer that applies a judicial exception, such as an abstract idea, by use of + conventional computer functions does not qualify as a particular machine. + *Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, 716-17, 112 + USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also *TLI Communications LLC v. + AV Automotive LLC,* 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. + Cir. 2016) (mere recitation of concrete or tangible components is not an inventive + concept); *Eon Corp. IP Holdings LLC v. AT&T Mobility LLC,* + 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that + *Alappat*’s rationale that an otherwise ineligible algorithm + or software could be made patent-eligible by merely adding a generic computer to + the claim was superseded by the Supreme Court’s *Bilski* and + *Alice Corp.* decisions). If applicant amends a claim to add a + generic computer or generic computer components and asserts that the claim recites + significantly more because the generic computer is 'specially programmed' (as in + *Alappat,* now considered superseded) or is a 'particular + machine' (as in *Bilski*), the examiner should look at whether + the added elements integrate the exception into a practical application or provide + significantly more than the judicial exception. Merely adding a generic computer, + generic computer components, or a programmed computer to perform generic computer + functions does not automatically overcome an eligibility rejection. *Alice + Corp. Pty. Ltd. v. CLS Bank Int’l,* 573 U.S. 208, 223-24, 110 USPQ2d + 1976, 1983-84 (2014). See *In re Alappat*, 33 F.3d 1526, 1545 + (Fed. Cir. 1994); *In re Bilski*, 545 F.3d 943 (Fed. Cir. + 2008) + + +**II.** **WHETHER THE MACHINE OR APPARATUS + IMPLEMENTS THE STEPS OF THE METHOD**Integral use of a machine to achieve performance + of a method may integrate the recited judicial exception into a practical + application or provide significantly more, in contrast to where the machine is + merely an object on which the method operates, which does not integrate the + exception into a practical application or provide significantly more. See + *CyberSource v. Retail Decisions,* 654 F.3d 1366, 1370, 99 + USPQ2d 1690, 1694 (Fed. Cir. 2011) ("We are not persuaded by the appellant's + argument that the claimed method is tied to a particular machine because it ‘would + not be necessary or possible without the Internet.’ . . . Regardless of whether + "the Internet" can be viewed as a machine, it is clear that the Internet cannot + perform the fraud detection steps of the claimed method"). For example, as + described in **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**, additional + elements that invoke computers or other machinery merely as a tool to perform an + existing process will generally not amount to significantly more than a judicial + exception. See, e.g., *Versata Development Group v. SAP America,* + 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015) (explaining that in + order for a machine to add significantly more, it must "play a significant part in + permitting the claimed method to be performed, rather than function solely as an + obvious mechanism for permitting a solution to be achieved more quickly"). + + +**III.** **WHETHER ITS INVOLVEMENT IS + EXTRA-SOLUTION ACTIVITY OR A FIELD-OF-USE**Whether its involvement is extra-solution activity + or a field-of-use, *i.e.,* the extent to which (or how) the + machine or apparatus imposes meaningful limits on the claim. Use of a machine that + contributes only nominally or insignificantly to the execution of the claimed + method (e.g., in a data gathering step or in a field-of-use limitation) would not + integrate a judicial exception or provide significantly more. See + *Bilski,* 561 U.S. at 610, 95 USPQ2d at 1009 (citing + *Parker v. Flook,* 437 U.S. 584, 590, 198 USPQ 193, 197 + (1978)), and *CyberSource v. Retail Decisions,* 654 F.3d 1366, + 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted) ("[N]othing in claim 3 + requires an infringer to use the Internet to obtain that data. The Internet is + merely described as the source of the data. We have held that mere + ‘[data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.’" + 654 F.3d at 1375, 99 USPQ2d at 1694 (citation omitted)). See **[MPEP § 2106.05(g) & + (h)](s2106.html#ch2100_d29a1b_13df8_3d4)** for more information on insignificant extra-solution + activity and field of use, respectively. + + + +, +# 2106.05(c) Particular Transformation [R-10.2019] + + +Another consideration when determining whether a + claim integrates a judicial exception into a practical application in Step 2A Prong + Two and whether a claim recites significantly more in Step 2B is whether the claim + effects a transformation or reduction of a particular article to a different state or + thing. "[T]ransformation and reduction of an article ‘to a different state or thing’ + is the clue to patentability of a process claim that does not include particular + machines." *Bilski v. Kappos,* 561 U.S. 593, 658, 95 USPQ2d 1001, + 1007 (2010) (quoting *Gottschalk v. Benson,* 409 U.S. 63, 70, 175 + USPQ 673, 676 (1972)). If such a transformation exists, the claims are likely to be + significantly more than any recited judicial exception or to integrate any recited + judicial exception into a practical application. + + + +It is noted that while the transformation of an + article is an important clue, it is not a stand-alone test for + eligibility. *Id.* + + +All claims must be evaluated for eligibility using + the two-part test from *Alice/Mayo*. If a claim passes the + *Alice/Mayo* test (*i.e.,* is not directed to an + exception at Step 2A, or amounts to significantly more than any recited exception in + Step 2B), then the claim is eligible even if it "fails" the M-or-T test. + *Bilski v. Kappos,* 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 + (2010) (explaining that a claim may be eligible even if it does not satisfy the + M-or-T test); *McRO, Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d + 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) ("[T]here is nothing that requires + a method ‘be tied to a machine or transform an article’ to be patentable"). And if a + claim fails the *Alice/Mayo* test (*i.e.,* is + directed to an exception at Step 2A and does not amount to significantly more than + the exception in Step 2B), then the claim is ineligible even if it passes the M-or-T + test. *DDR Holdings, LLC v. Hotels.com, L.P.,* 773 F.3d 1245, 1256, + 113 USPQ2d 1097, 1104 (Fed. Cir. 2014) ("[I]n *Mayo,* the Supreme + Court emphasized that satisfying the machine-or-transformation test, by itself, is + not sufficient to render a claim patent-eligible, as not all transformations or + machine implementations infuse an otherwise ineligible claim with an "inventive + concept."). + + + +Examiners may find it helpful to evaluate other + considerations such as the mere instructions to apply an exception consideration (see + **[MPEP § + 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), the insignificant extra-solution activity + consideration (see **[MPEP § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**), and the field of + use and technological environment consideration (see **[MPEP § + 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**), when making a determination of whether a claim + satisfies the particular transformation consideration. + + + +An "article" includes a physical object or substance. + The physical object or substance must be particular, meaning it can be specifically + identified. "Transformation" of an article means that the "article" has changed to a + different state or thing. Changing to a different state or thing usually means more + than simply using an article or changing the location of an article. A new or + different function or use can be evidence that an article has been transformed. + Purely mental processes in which thoughts or human based actions are "changed" are + not considered an eligible transformation. For data, mere "manipulation of basic + mathematical constructs [i.e.,] the paradigmatic ‘abstract idea,’" has not been + deemed a transformation. *CyberSource v. Retail Decisions,* 654 F.3d + 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting *In re + Warmerdam,* 33 F.3d 1354, 1355, 1360 (Fed. Cir. 1994)). + + + +*Tilghman v. Proctor,* 102 U.S. 707 + (1881), provides an example of effecting a transformation of a particular article to + a different state or thing. In that case, the claim was directed to a process of + subjecting a mixture of fat and water to a high degree of heat and included + additional parameters relating to the level of heat, the quantities of fat and water, + and the strength of the mixing vessel. The claimed process, which used the natural + principle that the elements of neutral fat require that they be severally united with + an atomic equivalent of water in order to separate and become free, resulted in the + transformation of the fatty bodies into fat acids and glycerine. *Id. at + 729*. + + + +Where a transformation is recited in a claim, the + following factors are relevant to the analysis: + + + +* 1. **The particularity or generality of the + transformation.** According to the Supreme Court, inventions + comprising processes of "‘tanning, dyeing, making waterproof cloth, vulcanizing + India rubber [or] smelting ores’ . . . are instances . . . where the use of + chemical substances or physical acts, such as temperature control, changes + articles or materials [in such a manner that is] sufficiently definite to + confine the patent monopoly within rather definite bounds." *Gottschalk + v. Benson,* 409 U.S. 63, 70, 175 USPQ 673, 676 (1972) (discussing + *Corning v. Burden,* 15 How. (56 U.S.) 252, 267-68 (1854)). + Therefore, a more particular transformation would likely provide significantly + more. +* 2. **The degree to which the recited article is + particular.** A transformation applied to a generically recited + article or to any and all articles would likely not provide significantly more + than the judicial exception. A transformation that can be specifically + identified, or that applies to only particular articles, is more likely to + provide significantly more (or integrates a judicial exception into a practical + application). +* 3. **The nature of the transformation in terms + of the type or extent of change in state or thing.** A transformation + resulting in the transformed article having a different function or use, would + likely provide significantly more, but a transformation resulting in the + transformed article merely having a different location, would likely not + provide significantly more (or integrate a judicial exception into a practical + application). For example, a process that transforms raw, uncured synthetic + rubber into precision-molded synthetic rubber products, as discussed in + *Diamond v. Diehr,* 450 U.S. 175, 184, 209 USPQ 1, 21 + (1981)), provides significantly more (or integrate a judicial exception into a + practical application). +* 4. **The nature of the article transformed.** Transformation of a physical or tangible object or substance is more + likely to provide significantly more (or integrate a judicial exception into a + practical application) than the transformation of an intangible concept such as + a contractual obligation or mental judgment. +* 5. **Whether the transformation is + extra-solution activity or a field-of-use (*i.e.,* the + extent to which (or how) the transformation imposes meaningful limits on the + execution of the claimed method steps).** A transformation that + contributes only nominally or insignificantly to the execution of the claimed + method (*e.g.,* in a data gathering step or in a field-of-use + limitation) would not provide significantly more (or integrate a judicial + exception into a practical application). For example, in + *Mayo* the Supreme Court found claims regarding calibrating + the proper dosage of thiopurine drugs to be patent ineligible subject matter. + The Federal Circuit had held that the step of administering the thiopurine drug + demonstrated a transformation of the human body and blood. + *Mayo,* 566 U.S. at 76, 101 USPQ2d at 1967. The Supreme + Court disagreed, finding that this step was only a field-of-use limitation and + did not provide significantly more than the judicial exception. + *Id.* See **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)** **[& + (h)](s2106.html#ch2100_d29a1b_13e1a_22c)** for more information on insignificant + extra-solution activity and field of use, respectively. + + +, +# 2106.05(d) Well-Understood, Routine, Conventional + Activity [R-10.2019] + + +Another consideration when determining whether a claim + recites significantly more than a judicial exception is whether the additional + element(s) are well-understood, routine, conventional activities previously known to + the industry. This consideration is only evaluated in Step 2B of the eligibility + analysis. + + + +If the additional element (or combination of elements) + is a specific limitation other than what is well-understood, routine and conventional + in the field, for instance because it is an unconventional step that confines the + claim to a particular useful application of the judicial exception, then this + consideration favors eligibility. If, however, the additional element (or combination + of elements) is no more than well-understood, routine, conventional activities + previously known to the industry, which is recited at a high level of generality, + then this consideration does not favor eligibility. + + + + *DDR Holdings, LLC v. Hotels.com, + L.P.,* 773 F.3d 1245, 113 USPQ2d 1097 (Fed. Cir. 2014), provides an + example of additional elements that favored eligibility because they were more than + well-understood, routine conventional activities in the field. The claims in + *DDR Holdings* were directed to systems and methods of generating + a composite webpage that combines certain visual elements of a host website with the + content of a third-party merchant. 773 F.3d at 1248, 113 USPQ2d at 1099. The court + found that the claim had additional elements that amounted to significantly more than + the abstract idea, because they modified conventional Internet hyperlink protocol to + dynamically produce a dual-source hybrid webpage, which differed from the + conventional operation of Internet hyperlink protocol that transported the user away + from the host’s webpage to the third party’s webpage when the hyperlink was + activated. 773 F.3d at 1258-59, 113 USPQ2d at 1106-07. Thus, the claims in + *DDR Holdings* were eligible. + + + +On the other hand, *Mayo Collaborative Servs. + v. Prometheus Labs.,* Inc., 566 U.S. 66, 67, 101 USPQ2d 1961, 1964 (2010) + provides an example of additional elements that were not an inventive concept because + they were merely well-understood, routine, conventional activity previously known to + the industry, which were not by themselves sufficient to transform a judicial + exception into a patent eligible invention. *Mayo Collaborative Servs. v. + Prometheus Labs., Inc.,* 566 U.S. 66, 79-80, 101 USPQ2d 1969 (2012) + (citing *Parker v. Flook,* 437 U.S. 584, 590, 198 USPQ 193, 199 + (1978) (the additional elements were "well known" and, thus, did not amount to a + patentable application of the mathematical formula)). In *Mayo*, the + claims at issue recited naturally occurring correlations (the relationships between + the concentration in the blood of certain thiopurine metabolites and the likelihood + that a drug dosage will be ineffective or induce harmful side effects) along with + additional elements including telling a doctor to measure thiopurine metabolite + levels in the blood using any known process. 566 U.S. at 77-79, 101 USPQ2d at + 1967-68. The Court found this additional step of measuring metabolite levels to be + well-understood, routine, conventional activity already engaged in by the scientific + community because scientists "routinely measured metabolites as part of their + investigations into the relationships between metabolite levels and efficacy and + toxicity of thiopurine compounds." 566 U.S. at 79, 101 USPQ2d at 1968. Even when + considered in combination with the other additional elements, the step of measuring + metabolite levels did not amount to an inventive concept, and thus the claims in + *Mayo* were not eligible. 566 U.S. at 79-80, 101 USPQ2d at + 1968-69. + + +**I.** **EVALUATING WHETHER THE ADDITIONAL + ELEMENTS ARE WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY**When making a determination whether the additional + elements in a claim amount to significantly more than a judicial exception, the + examiner should evaluate whether the elements define only well-understood, + routine, conventional activity. In this respect, the well-understood, routine, + conventional consideration overlaps with other Step 2B considerations, + particularly the improvement consideration (see **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**), the mere instructions to apply an exception + consideration (see **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)**), and the + insignificant extra-solution activity consideration (see **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**). Thus, evaluation of those other + considerations may assist examiners in making a determination of whether a + particular element or combination of elements is well-understood, routine, + conventional activity. + + + +In addition, examiners should keep in mind the + following points when determining whether additional elements define only + well-understood, routine, conventional activity. + + + +* 1. **An additional element (or combination + of additional elements) that is known in the art can still be + unconventional or non-routine.** The question of whether a + particular claimed invention is novel or obvious is "fully apart" from the + question of whether it is eligible. *Diamond v. Diehr,* 450 + U.S. 175, 190, 209 USPQ 1, 9 (1981). For example, claims may exhibit an + improvement over conventional computer functionality even if the improvement + lacks novelty over the prior art. Compare, *e.g.,**Enfish, LLC v. Microsoft Corp.,* 822 F.3d 1327, 118 USPQ2d + 1684 (Fed. Cir. 2016) (holding several claims from U.S. Patent Nos. + 6,151,604 and 6,163,775 eligible) with *Microsoft Corp. v. Enfish, + LLC,* 662 Fed. App'x 981 (Fed. Cir. 2016) (holding some of the + same claims to be anticipated by prior art). The eligible claims in + *Enfish* recited a self-referential database having two + key features: all entity types can be stored in a single table; and the + table rows can contain information defining the table columns. + *Enfish,* 822 F.3d at 1332, 118 USPQ2d at 1687. Although + these features were taught by a single prior art reference (thus + anticipating the claims), *Microsoft Corp.,* 662 Fed. App'x + at 986, the features were not conventional and thus were considered to + reflect an improvement to existing technology. In particular, they enabled + the claimed table to achieve benefits over conventional databases, such as + increased flexibility, faster search times, and smaller memory requirements. + *Enfish,* 822 F.3d at 1337, 118 USPQ2d at 1690. +* 2. **A factual determination is required to + support a conclusion that an additional element (or combination of + additional elements) is well-understood, routine, conventional + activity.***Berkheimer v. HP, Inc.,* 881 F.3d 1360, 1368, 125 USPQ2d + 1649, 1654 (Fed. Cir. 2018). However, this does not mean that a prior art + search is necessary to resolve this inquiry. Instead, examiners should rely + on what the courts have recognized, or those in the art would recognize, as + elements that are well-understood, routine, conventional activity in the + relevant field when making the required determination. For example, in many + instances, the specification of the application may indicate that additional + elements are well-known or conventional. See, *e.g., Intellectual + Ventures v. Symantec,* 838 F.3d at 1317; 120 USPQ2d at 1359 + ("The written description is particularly useful in determining what is + well-known or conventional"); *Internet Patents Corp. v. Active + Network, Inc.,* 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. + Cir. 2015) (relying on specification’s description of additional elements as + "well-known", "common" and "conventional"); *TLI Communications LLC + v. AV Auto. LLC,* 823 F.3d 607, 614, 118 USPQ2d 1744, 1748 (Fed. + Cir. 2016) (Specification described additional elements as "either + performing basic computer functions such as sending and receiving data, or + performing functions ‘known’ in the art."). + As such, an examiner should determine that + an element (or combination of elements) is well-understood, routine, + conventional activity only when the examiner can readily conclude, based on + their expertise in the art, that the element is widely prevalent or in + common use in the relevant industry. The analysis as to whether an element + (or combination of elements) is widely prevalent or in common use is the + same as the analysis under **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** as to + whether an element is so well-known that it need not be described in detail + in the patent specification. See *Genetic Techs. Ltd. v. Merial + LLC,* 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1546 ( Fed. Cir. + 2016) (supporting the position that amplification was well-understood, + routine, conventional for purposes of subject matter eligibility by + observing that the patentee expressly argued during prosecution of the + application that amplification was a technique readily practiced by those + skilled in the art to overcome the rejection of the claim under + **[35 + U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph); see also + *Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick + Co.,* 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984) + ("[T]he specification need not disclose what is well known in the art."); + *In re Myers,* 410 F.2d 420, 424, 161 USPQ 668, 671 + (CCPA 1969) ("A specification is directed to those skilled in the art and + need not teach or point out in detail that which is well-known in the + art."); *Exergen Corp.,* 725 Fed. App’x. 959, 965 (Fed. + Cir. 2018) (holding that "[l]ike indefiniteness, enablement, or obviousness, + whether a claim is directed to patent eligible subject matter is a question + of law based on underlying facts," and noting that the Supreme Court has + recognized that "the inquiry 'might sometimes overlap' with other + fact-intensive inquiries like novelty under **[35 U.S.C. § + 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)**"). If the element is not widely prevalent or in + common use, or is otherwise beyond those elements recognized in the art or + by the courts as being well-understood, routine or conventional, then the + element will in most cases favor eligibility. For example, even if a + particular technique (*e.g.,* measuring blood glucose via + an earring worn by a person with diabetes) would have been obvious to one of + ordinary skill in the art because it was discussed in several widely-read + scientific journals or used by a few scientists, mere knowledge of the + particular technique or use of the particular technique by a few scientists + is not necessarily sufficient to make the use of the particular technique + routine or conventional in the relevant field. The examiner in this + situation would already know, based on the examiner's expertise in the + field, that blood glucose is routinely and conventionally monitored by other + techniques (*e.g.,* via placing a small droplet of blood on + a diagnostic test strip, or via an implanted insulin pump with a glucose + sensor). Thus, the examiner would not need to perform a prior art search in + order to determine that the particular claimed technique using the + glucose-sensing earring was not well-understood, routine, conventional + activity previously engaged in by scientists in the field. + + + +The required factual determination must be + expressly supported in writing, as discussed in **[MPEP § + 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. Appropriate forms of support include + one or more of the following: (a) A citation to an express statement in the + specification or to a statement made by an applicant during prosecution that + demonstrates the well-understood, routine, conventional nature of the + additional element(s); (b) A citation to one or more of the court decisions + discussed in Subsection II below as noting the well-understood, routine, + conventional nature of the additional element(s); (c) A citation to a + publication that demonstrates the well-understood, routine, conventional + nature of the additional element(s); and (d) A statement that the examiner + is taking official notice of the well-understood, routine, conventional + nature of the additional element(s). For more information on supporting a + conclusion that an additional element (or combination of additional + elements) is well-understood, routine, conventional activity, see + **[MPEP § 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**, + subsection III. +* 3. **Even if one or more additional elements + are well-understood, routine, conventional activity when considered + individually, the combination of additional elements may amount to an + inventive concept.***Diamond v. Diehr,* 450 U.S. at 188, 209 USPQ at 9 (1981) + ("[A] new combination of steps in a process may be patentable even though + all the constituents of the combination were well known and in common use + before the combination was made."). For example, a microprocessor that + performs mathematical calculations and a clock that produces time data may + individually be generic computer components that perform merely generic + computer functions, but when combined may perform functions that are not + generic computer functions and thus be an inventive concept. See, + *e.g. Rapid Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d + 1042, 1051, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016) (holding that while the + additional steps of freezing and thawing hepatocytes were well known, + repeating those steps, contrary to what was taught in the art, was not + routine or conventional). For example, in *BASCOM,* even + though the court found that all of the additional elements in the claim + recited generic computer network or Internet components, the elements in + combination amounted to significantly more because of the non-conventional + and non-generic arrangement that provided a technical improvement in the + art. *BASCOM Global Internet Servs. v. AT&T Mobility + LLC,* 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243-44 + (2016). + + + A rejection should only be made if an examiner + relying on the examiner's expertise in the art can conclude in the Step 2B inquiry + that the additional elements do not amount to significantly more (Step 2B: NO). If + the elements or functions are beyond those recognized in the art or by the courts + as being well‐understood, routine, conventional activity, then the elements or + functions will in most cases amount to significantly more (Step 2B: YES). For more + information on formulating a subject matter eligibility rejection involving + well-understood, routine, conventional activity, see **[MPEP § + 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. + + +**II.** **ELEMENTS THAT THE COURTS HAVE + RECOGNIZED AS WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY IN PARTICULAR + FIELDS** Because examiners should rely on what the courts + have recognized, or those of ordinary skill in the art would recognize, as + elements that describe well‐understood, routine activities, the following section + provides examples of elements that have been recognized by the courts as + well-understood, routine, conventional activity in particular fields. It should be + noted, however, that many of these examples failed to satisfy other considerations + (*e.g.,* because they were recited at a high level of + generality and thus were mere instructions to apply an exception, or were + insignificant extra-solution activity). Thus, examiners should carefully analyze + additional elements in a claim with respect to all relevant Step 2B + considerations, including this consideration, before making a conclusion as to + whether they amount to an inventive concept. + + + +The courts have recognized the following computer + functions as well‐understood, routine, and conventional functions when they are + claimed in a merely generic manner (*e.g.,* at a high level of + generality) or as insignificant extra-solution activity. + + + +* i. Receiving or transmitting data over a + network, *e.g.,* using the Internet to gather data, + *Symantec,* 838 F.3d at 1321, 120 USPQ2d at 1362 + (utilizing an intermediary computer to forward information); *TLI + Communications LLC v. AV Auto. LLC,* 823 F.3d 607, 610, 118 + USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image + transmission); *OIP Techs., Inc., v. Amazon.com, Inc.,* 788 + F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages + over a network); *buySAFE, Inc. v. Google, Inc.,* 765 F.3d + 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and + sends information over a network); but see *DDR Holdings, LLC v. + Hotels.com, L.P.,* 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 + (Fed. Cir. 2014) ("Unlike the claims in *Ultramercial,* the + claims at issue here specify ***how*** + interactions with the Internet are manipulated to yield a desired result‐‐a + result that overrides the routine and conventional sequence of events + ordinarily triggered by the click of a hyperlink." (emphasis added)); +* ii. Performing repetitive calculations, + *Flook,* 437 U.S. at 594, 198 USPQ2d at 199 (recomputing + or readjusting alarm limit values); *Bancorp Services v. Sun + Life,* 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. + 2012) ("The computer required by some of *Bancorp*’s claims + is employed only for its most basic function, the performance of repetitive + calculations, and as such does not impose meaningful limits on the scope of + those claims."); +* iii. Electronic recordkeeping, *Alice + Corp. Pty. Ltd. v. CLS Bank Int'l,* 573 U.S. 208, 225, 110 + USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); + *Ultramercial,* 772 F.3d at 716, 112 USPQ2d at 1755 + (updating an activity log); +* iv. Storing and retrieving information in + memory, *Versata Dev. Group, Inc. v. SAP Am., Inc.,* 793 + F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); *OIP + Techs.,* 788 F.3d at 1363, 115 USPQ2d at 1092-93; +* v. Electronically scanning or extracting data + from a physical document, *Content Extraction and Transmission, LLC + v. Wells Fargo Bank,* 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 + (Fed. Cir. 2014) (optical character recognition); and +* vi. A Web browser’s back and forward button + functionality, *Internet Patent Corp. v. Active Network, + Inc.,* 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. + 2015). + + +This listing is not meant to imply that all + computer functions are well‐understood, routine, conventional activities, or that + a claim reciting a generic computer component performing a generic computer + function is necessarily ineligible. See e.g. *Amdocs (Israel), Ltd. v. + Openet Telecom, Inc.,* 841 F.3d 1288, 1316, 120 USPQ2d 1527, 1549 + (Fed. Cir. 2016), *BASCOM Global Internet Servs. v. AT&T Mobility + LLC,* 827 F.3d 1341, 1348, 119 USPQ2d 1236, 1241 (Fed. Cir. 2016). + Courts have held computer‐implemented processes not to be significantly more than + an abstract idea (and thus ineligible) where the claim as a whole amounts to + nothing more than generic computer functions merely used to implement an abstract + idea, such as an idea that could be done by a human analog (i.e., by hand or by + merely thinking). On the other hand, courts have held computer-implemented + processes to be significantly more than an abstract idea (and thus eligible), + where generic computer components are able in combination to perform functions + that are not merely generic. *DDR Holdings, LLC v. Hotels.com, + L.P.,* 773 F.3d 1245, 1257-59, 113 USPQ2d 1097, 1105-07 (Fed. Cir. + 2014). + + + +The courts have recognized the following + laboratory techniques as well-understood, routine, conventional activity in the + life science arts when they are claimed in a merely generic manner + (*e.g.,* at a high level of generality) or as insignificant + extra-solution activity: + + + +* i. Determining the level of a biomarker in + blood by any means, *Mayo,* 566 U.S. at 79, 101 USPQ2d at + 1968; *Cleveland Clinic Foundation v. True Health Diagnostics, + LLC,* 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. + 2017); +* ii. Using polymerase chain reaction to amplify + and detect DNA, *Genetic Techs. v. Merial LLC,* 818 F.3d + 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); *Ariosa + Diagnostics, Inc. v. Sequenom, Inc.,* 788 F.3d 1371, 1377, 115 + USPQ2d 1152, 1157 (Fed. Cir. 2015); +* iii. Detecting DNA or enzymes in a sample, + *Sequenom,* 788 F.3d at 1377-78, 115 USPQ2d at 1157); + *Cleveland Clinic Foundation* 859 F.3d at 1362, 123 + USPQ2d at 1088 (Fed. Cir. 2017); +* iv. Immunizing a patient against a disease, + *Classen Immunotherapies, Inc. v. Biogen IDEC,* 659 F.3d + 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011); +* v. Analyzing DNA to provide sequence information + or detect allelic variants, *Genetic Techs.,* 818 F.3d at + 1377; 118 USPQ2d at 1546; +* vi. Freezing and thawing cells, *Rapid + Litig. Mgmt.* 827 F.3d at 1051, 119 USPQ2d at 1375; +* vii. Amplifying and sequencing nucleic acid + sequences, *University of Utah Research Foundation v. Ambry + Genetics,* 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. + 2014); and +* viii. Hybridizing a gene probe, *Ambry + Genetics,* 774 F.3d at 764, 113 USPQ2d at 1247. + + + Below are examples of other types of activity + that the courts have found to be well-understood, routine, conventional activity + when they are claimed in a merely generic manner (*e.g.,* at a + high level of generality) or as insignificant extra-solution activity: + + + +* i. Recording a customer’s order, + *Apple, Inc. v. Ameranth, Inc.,* 842 F.3d 1229, 1244, + 120 USPQ2d 1844, 1856 (Fed. Cir. 2016); +* ii. Shuffling and dealing a standard deck of + cards, *In re Smith,* 815 F.3d 816, 819, 118 USPQ2d 1245, + 1247 (Fed. Cir. 2016); +* iii. Restricting public access to media by + requiring a consumer to view an advertisement, *Ultramercial, Inc. + v. Hulu, LLC,* 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 + (Fed. Cir. 2014); +* iv. Presenting offers and gathering statistics, + *OIP Techs.,* 788 F.3d at 1362-63, 115 USPQ2d at + 1092-93; +* v. Determining an estimated outcome and setting + a price, *OIP Techs.,* 788 F.3d at 1362-63, 115 USPQ2d at + 1092-93; and +* vi. Arranging a hierarchy of groups, sorting + information, eliminating less restrictive pricing information and + determining the price, *Versata Dev. Group, Inc. v. SAP Am., + Inc.,* 793 F.3d 1306, 1331, 115 USPQ2d 1681, 1699 (Fed. Cir. + 2015). + + +, +# 2106.05(e) Other Meaningful Limitations [R-10.2019] + + +The analysis of whether the claim includes other + meaningful limitations may be relevant for both eligibility analysis Step 2A Prong + Two, and Step 2B. + + + + The claim should add meaningful limitations beyond + generally linking the use of the judicial exception to a particular technological + environment to transform the judicial exception into patent-eligible subject matter. + The phrase "meaningful limitations" has been used by the courts even before Alice and + Mayo in various contexts to describe additional elements that provide an inventive + concept to the claim as a whole. The considerations described in + **[MPEP § + 2106.05(a)-(d)](s2106.html#ch2100_d29a1b_13c69_10)** are meaningful limitations when they amount + to significantly more than the judicial exception, or when they integrate a judicial + exception into a practical application. This broad label signals that there can be + other considerations besides those described in **[MPEP § + 2106.05(a)-(d)](s2106.html#ch2100_d29a1b_13c69_10)** that when added to a judicial exception + amount to meaningful limitations that can transform a claim into patent-eligible + subject matter. + + + +*Diamond v. Diehr* provides an + example of a claim that recited meaningful limitations beyond generally linking the + use of the judicial exception to a particular technological environment. 450 U.S. + 175, 209 USPQ 1 (1981). In *Diehr,* the claim was directed to the + use of the Arrhenius equation (an abstract idea or law of nature) in an automated + process for operating a rubber-molding press. 450 U.S. at 177-78, 209 USPQ at 4. The + Court evaluated additional elements such as the steps of installing rubber in a + press, closing the mold, constantly measuring the temperature in the mold, and + automatically opening the press at the proper time, and found them to be meaningful + because they sufficiently limited the use of the mathematical equation to the + practical application of molding rubber products. 450 U.S. at 184, 187, 209 USPQ at + 7, 8. In contrast, the claims in *Alice Corp. v. CLS Bank + International* did not meaningfully limit the abstract idea of mitigating + settlement risk. 573 U.S. 208, 110 USPQ2d 1976 (2014). In particular, the Court + concluded that the additional elements such as the data processing system and + communications controllers recited in the system claims did not meaningfully limit + the abstract idea because they merely linked the use of the abstract idea to a + particular technological environment (i.e., "implementation via computers") or were + well-understood, routine, conventional activity recited at a high level of + generality. 573 U.S. at 225-26, 110 USPQ2d at 1984-85. + + + +*Classen Immunotherapies Inc. v. Biogen IDEC* provides another + example of claims that recited meaningful limitations. 659 F.3d 1057, 100 USPQ2d 1492 + (Fed. Cir. 2011) (decision on remand from the Supreme Court, which had vacated the + lower court’s prior holding of ineligibility in view of *Bilski v. + Kappos*, 561 U.S. 593, 95 USPQ2d 1001 (2010)). In + *Classen,* the claims recited methods that gathered and analyzed + the effects of particular immunization schedules on the later development of chronic + immune-mediated disorders in mammals in order to identify a lower risk immunization + schedule, and then immunized mammalian subjects in accordance with the identified + lower risk schedule (thereby lowering the risk that the immunized subject would later + develop chronic immune-mediated diseases). 659 F.3d at 1060-61; 100 USPQ2d at + 1495-96. Although the analysis step was an abstract mental process that collected and + compared known information, the immunization step was meaningful because it + integrated the results of the analysis into a specific and tangible method that + resulted in the method "moving from abstract scientific principle to specific + application." 659 F.3d at 1066-68; 100 USPQ2d at 1500-01. In contrast, in + *OIP Technologies, Inc. v. Amazon.com, Inc.,* the court + determined that the additional steps to "test prices and collect data based on the + customer reactions" did not meaningfully limit the abstract idea of offer-based price + optimization, because the steps were well-understood, routine, conventional + data-gathering activities. 788 F.3d 1359, 1363-64, 115 USPQ2d 1090, 1093 (Fed. Cir. + 2015). + + + +With respect to treatment or prophylaxis limitations, + such as the immunization step in *Classen,* examiners should note + that the other meaningful limitations consideration overlaps with the particular + treatment or prophylaxis consideration that is evaluated in Step 2A Prong Two (see + **[MPEP § + 2106.04(d)(2)](s2106.html#ch2100_d2e827_17196_6c)**). + + + +When evaluating whether additional elements + meaningfully limit the judicial exception, it is particularly critical that examiners + consider the additional elements both individually and as a combination. When an + additional element is considered individually by an examiner, the additional element + may be enough to qualify as "significantly more" if it meaningfully limits the + judicial exception, and may also add a meaningful limitation by integrating the + judicial exception into a practical application. However, even in the situation where + the individually-viewed elements do not add significantly more or integrate the + exception, those additional elements when viewed in combination may render the claim + eligible. See *Diamond v. Diehr,* 450 U.S. 175, 188, 209 USPQ2d 1, 9 + (1981) ("a new combination of steps in a process may be patentable even though all + the constituents of the combination were well known and in common use before the + combination was made"); *BASCOM Global Internet Servs. v. AT&T Mobility + LLC,* 827 F.3d 1341, 1349, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016). It is + important to note that, when appropriate, an examiner may explain on the record why + the additional elements meaningfully limit the judicial exception. + + + +, +# 2106.05(f) Mere Instructions To Apply An + Exception [R-10.2019] + + +Another consideration when determining whether a + claim integrates a judicial exception into a practical application in Step 2A Prong + Two or recites significantly more than a judicial exception in Step 2B is whether the + additional elements amount to more than a recitation of the words "apply it" (or an + equivalent) or are more than mere instructions to implement an abstract idea or other + exception on a computer. As explained by the Supreme Court, in order to make a claim + directed to a judicial exception patent-eligible, the additional element or + combination of elements must do "‘more than simply stat[e] the [judicial exception] + while adding the words ‘apply it’". *Alice Corp. v. CLS Bank,* 573 + U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting *Mayo Collaborative + Servs. V. Prometheus Labs., Inc.,* 566 U.S. 66, 72, 101 USPQ2d 1961, + 1965). Thus, for example, claims that amount to nothing more than an instruction to + apply the abstract idea using a generic computer do not render an abstract idea + eligible. *Alice Corp.,* 573 U.S. at 223, 110 USPQ2d at 1983. See + also 573 U.S. at 224, 110 USPQ2d at 1984 (warning against a **[§ 101](mpep-9015-appx-l.html#d0e302376)** analysis + that turns on "the draftsman’s art"). + + + +The Supreme Court has identified additional elements + as mere instructions to apply an exception in several cases. For instance, in + *Mayo*, the Supreme Court concluded that a step of determining + thiopurine metabolite levels in patients’ blood did not amount to significantly more + than the recited laws of nature, because this additional element simply instructed + doctors to apply the laws by measuring the metabolites in any way the doctors (or + medical laboratories) chose to use. 566 U.S. at 79, 101 USPQ2d at 1968. In + *Alice Corp.,* the claim recited the concept of intermediated + settlement as performed by a generic computer. The Court found that the recitation of + the computer in the claim amounted to mere instructions to apply the abstract idea on + a generic computer. 573 U.S. at 225-26, 110 USPQ2d at 1984. The Supreme Court also + discussed this concept in an earlier case, *Gottschalk v. Benson,* + 409 U.S. 63, 70, 175 USPQ 673, 676 (1972), where the claim recited a process for + converting binary-coded-decimal (BCD) numerals into pure binary numbers. The Court + found that the claimed process had no meaningful practical application except in + connection with a computer. *Benson,* 409 U.S. at 71-72, 175 USPQ at + 676. The claim simply stated a judicial exception (*e.g.,* law of + nature or abstract idea) while effectively adding words that "apply it" in a + computer. *Id.* + + +Requiring more than mere instructions to apply an + exception does not mean that the claim must be narrow in order to be eligible. The + courts have identified some broad claims as eligible see, *e.g.,**McRO, Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, 120 + USPQ2d 1091 (Fed. Cir. 2016); *Thales Visionix Inc. v. United + States,* 850 F.3d. 1343, 121 USPQ2d 1898 (Fed. Cir. 2017), and some + narrow claims as ineligible see *e.g.,**Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, 112 USPQ2d 1750 + (Fed. Cir. 2014); *Electric Power Group, LLC v. Alstom, S.A.,* 830 + F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016). Thus, examiners should carefully + consider each claim on its own merits, as well as evaluate all other relevant + considerations, before making a determination of whether an element (or combination + of elements) is more than mere instructions to apply an exception. For example, + because this consideration often overlaps with the improvement consideration (see + **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**), the particular machine and particular + transformation considerations (see **[MPEP § 2106.05(b) and + (c)](s2106.html#ch2100_d29a1b_13ccf_18c)**, respectively), and the well-understood, routine, + conventional consideration (see **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**), evaluation of + those other considerations may assist examiners in making a determination of whether + an element (or combination of elements) is more than mere instructions to apply an + exception. Note, however, that examiners should not evaluate the well-understood, + routine, conventional consideration in the Step 2A Prong Two analysis, because that + consideration is only evaluated in Step 2B. + + + +For claim limitations that do not amount to more than + a recitation of the words "apply it" (or an equivalent), such as mere instructions to + implement an abstract idea on a computer, examiners should explain why they do not + meaningfully limit the claim in an eligibility rejection. For example, an examiner + could explain that implementing an abstract idea on a generic computer, does not + integrate the abstract idea into a practical application in Step 2A Prong Two or add + significantly more in Step 2B, similar to how the recitation of the computer in the + claim in *Alice* amounted to mere instructions to apply the abstract + idea of intermediated settlement on a generic computer. For more information on + formulating a subject matter eligibility rejection. See **[MPEP § + 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. + + + +When determining whether a claim simply recites a + judicial exception with the words "apply it" (or an equivalent), such as mere + instructions to implement an abstract idea on a computer, examiners may consider the + following: + + + +**(1) Whether the claim recites only the idea of a solution or outcome + *i.e.,* the claim fails to recite details of how a solution to + a problem is accomplished.** The recitation of claim limitations that attempt + to cover any solution to an identified problem with no restriction on how the result + is accomplished and no description of the mechanism for accomplishing the result, + does not integrate a judicial exception into a practical application or provide + significantly more because this type of recitation is equivalent to the words "apply + it". See *Electric Power Group, LLC v. Alstom, S.A.,* 830 F.3d 1350, + 1356, 119 USPQ2d 1739, 1743-44 (Fed. Cir. 2016); *Intellectual Ventures I v. + Symantec,* 838 F.3d 1307, 1327, 120 USPQ2d 1353, 1366 (Fed. Cir. 2016); + *Internet Patents Corp. v. Active Network, Inc.,* 790 F.3d 1343, + 1348, 115 USPQ2d 1414, 1417 (Fed. Cir. 2015). In contrast, claiming a particular + solution to a problem or a particular way to achieve a desired outcome may integrate + the judicial exception into a practical application or provide significantly more. + See *Electric Power,* 830 F.3d at 1356, 119 USPQ2d at 1743. + + + +By way of example, in *Intellectual Ventures + I v. Capital One Fin. Corp.,* 850 F.3d 1332, 121 USPQ2d 1940 (Fed. Cir. + 2017), the steps in the claims described "the creation of a dynamic document based + upon ‘management record types’ and ‘primary record types.’" 850 F.3d at 1339-40; 121 + USPQ2d at 1945-46. The claims were found to be directed to the abstract idea of + "collecting, displaying, and manipulating data." 850 F.3d at 1340; 121 USPQ2d at + 1946. In addition to the abstract idea, the claims also recited the additional + element of modifying the underlying XML document in response to modifications made in + the dynamic document. 850 F.3d at 1342; 121 USPQ2d at 1947-48. Although the claims + purported to modify the underlying XML document in response to modifications made in + the dynamic document, nothing in the claims indicated what specific steps were + undertaken other than merely using the abstract idea in the context of XML documents. + The court thus held the claims ineligible, because the additional limitations + provided only a result-oriented solution and lacked details as to how the computer + performed the modifications, which was equivalent to the words "apply it". 850 F.3d + at 1341-42; 121 USPQ2d at 1947-48 (citing *Electric Power Group.,* + 830 F.3d at 1356, 1356, USPQ2d at 1743-44 (cautioning against claims "so result + focused, so functional, as to effectively cover any solution to an identified + problem")). + + + +Other examples where the courts have found the + additional elements to be mere instructions to apply an exception, because they + recite no more than an idea of a solution or outcome include: + + + +* i. Remotely accessing user-specific information + through a mobile interface and pointers to retrieve the information without any + description of how the mobile interface and pointers accomplish the result of + retrieving previously inaccessible information, *Intellectual Ventures + v. Erie Indem. Co.,* 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 + (Fed. Cir. 2017); +* ii. A general method of screening emails on a + generic computer without any limitations that addressed the issues of shrinking + the protection gap and mooting the volume problem, *Intellectual + Ventures I v. Symantec Corp.,* 838 F.3d 1307, 1319, 120 USPQ2d + 1353, 1361 (Fed. Cir. 2016); and +* iii. Wireless delivery of out-of-region broadcasting + content to a cellular telephone via a network without any details of how the + delivery is accomplished, *Affinity Labs of Texas v. DirecTV, + LLC,* 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. + 2016). + + +In contrast, other cases have found that additional + elements are more than "apply it" or are not "mere instructions" when the claim + recites a technological solution to a technological problem. In *DDR + Holdings,* the court found that the additional elements did amount to + more than merely instructing that the abstract idea should be applied on the + Internet. *DDR Holdings, LLC v. Hotels.com, L.P.,* 773 F.3d 1245, + 1259, 113 USPQ2d 1097, 1107 (Fed. Cir. 2014). The claims at issue specified how + interactions with the Internet were manipulated to yield a desired result—a result + that overrode the routine and conventional sequence of events ordinarily triggered by + the click of a hyperlink. 773 F.3d at 1258; 113 USPQ2d at 1106. In + *BASCOM,* the court determined that the claimed combination of + limitations did not simply recite an instruction to apply the abstract idea of + filtering content on the Internet. *BASCOM Global Internet Servs. v. AT&T + Mobility, LLC,* 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1243 (Fed. Cir. + 2016). Instead, the claim recited a "technology based solution" of filtering content + on the Internet that overcome the disadvantages of prior art filtering systems. 827 + F.3d at 1350-51, 119 USPQ2d at 1243. Finally, in *Thales Visionix,* + the particular configuration of inertial sensors and the particular method of using + the raw data from the sensors was more than simply applying a law of nature. + *Thales Visionix, Inc. v. United States,* 850 F.3d 1343, 1348-49, + 121 USPQ2d 1898, 1902 (Fed. Cir. 2017). The court found that the claims provided a + system and method that "eliminate[d] many ‘complications’ inherent in previous + solutions for determining position and orientation of an object on a moving + platform." In other words, the claim recited a technological solution to a + technological problem. *Id.* + + +**(2) Whether the claim invokes computers or + other machinery merely as a tool to perform an existing process.** Use of a + computer or other machinery in its ordinary capacity for economic or other tasks + (*e.g.,* to receive, store, or transmit data) or simply adding a + general purpose computer or computer components after the fact to an abstract idea + (*e.g.,* a fundamental economic practice or mathematical + equation) does not integrate a judicial exception into a practical application or + provide significantly more. See *Affinity Labs v. DirecTV,* 838 F.3d + 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); *TLI + Communications LLC v. AV Auto, LLC,* 823 F.3d 607, 613, 118 USPQ2d 1744, + 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the + improved speed or efficiency inherent with applying the abstract idea on a computer" + does not integrate a judicial exception into a practical application or provide an + inventive concept. *Intellectual Ventures I LLC v. Capital One Bank + (USA),* 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). In + contrast, a claim that purports to improve computer capabilities or to improve an + existing technology may integrate a judicial exception into a practical application + or provide significantly more. *McRO, Inc. v. Bandai Namco Games Am. + Inc.,* 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); + *Enfish, LLC v. Microsoft Corp.,* 822 F.3d 1327, 1335-36, 118 + USPQ2d 1684, 1688-89 (Fed. Cir. 2016). See **[MPEP §§ + 2106.04(d)(1)](s2106.html#ch2100_d2e7df_24a6e_1bd)** and **[2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** for a discussion of improvements to the + functioning of a computer or to another technology or technical field. + + + + *TLI Communications* provides an + example of a claim invoking computers and other machinery merely as a tool to perform + an existing process. The court stated that the claims describe steps of recording, + administration and archiving of digital images, and found them to be directed to the + abstract idea of classifying and storing digital images in an organized manner. 823 + F.3d at 612, 118 USPQ2d at 1747. The court then turned to the additional elements of + performing these functions using a telephone unit and a server and noted that these + elements were being used in their ordinary capacity (*i.e.,* the + telephone unit is used to make calls and operate as a digital camera including + compressing images and transmitting those images, and the server simply receives + data, extracts classification information from the received data, and stores the + digital images based on the extracted information). 823 F.3d at 612-13, 118 USPQ2d at + 1747-48. In other words, the claims invoked the telephone unit and server merely as + tools to execute the abstract idea. Thus, the court found that the additional + elements did not add significantly more to the abstract idea because they were simply + applying the abstract idea on a telephone network without any recitation of details + of how to carry out the abstract idea. + + + +Other examples where the courts have found the + additional elements to be mere instructions to apply an exception, because they do no + more than merely invoke computers or machinery as a tool to perform an existing + process include: + + + +* i. A commonplace business method or mathematical + algorithm being applied on a general purpose computer, *Alice Corp. + Pty. Ltd. V. CLS Bank Int’l,* 573 U.S. 208, 223, 110 USPQ2d 1976, + 1983 (2014); *Gottschalk v. Benson,* 409 U.S. 63, 64, 175 USPQ + 673, 674 (1972); *Versata Dev. Group, Inc. v. SAP Am., Inc.,* + 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); +* ii. Generating a second menu from a first menu and + sending the second menu to another location as performed by generic computer + components, *Apple, Inc. v. Ameranth, Inc.,* 842 F.3d 1229, + 1243-44, 120 USPQ2d 1844, 1855-57 (Fed. Cir. 2016); +* iii. A process for monitoring audit log data that is + executed on a general-purpose computer where the increased speed in the process + comes solely from the capabilities of the general-purpose computer, + *FairWarning IP, LLC v. Iatric Sys.,* 839 F.3d 1089, 1095, + 120 USPQ2d 1293, 1296 (Fed. Cir. 2016); +* iv. A method of using advertising as an exchange or + currency being applied or implemented on the Internet, *Ultramercial, + Inc. v. Hulu, LLC,* 772 F.3d 709, 715, 112 USPQ2d 1750, 1754 (Fed. + Cir. 2014); +* v. Requiring the use of software to tailor + information and provide it to the user on a generic computer, + *Intellectual Ventures I LLC v. Capital One Bank (USA),* + 792 F.3d 1363, 1370-71, 115 USPQ2d 1636, 1642 (Fed. Cir. 2015); and +* vi. A method of assigning hair designs to balance + head shape with a final step of using a tool (scissors) to cut the hair, + *In re Brown,* 645 Fed. App'x 1014, 1017 (Fed. Cir. 2016) + (non-precedential). + + + **(3) The particularity or generality of the + application of the judicial exception.** A claim having broad applicability + across many fields of endeavor may not provide meaningful limitations that integrate + a judicial exception into a practical application or amount to significantly more. + For instance, a claim that generically recites an effect of the judicial exception or + claims every mode of accomplishing that effect, amounts to a claim that is merely + adding the words "apply it" to the judicial exception. See *Internet Patents + Corporation v. Active Network, Inc.,* 790 F.3d 1343, 1348, 115 USPQ2d + 1414, 1418 (Fed. Cir. 2015) (The recitation of maintaining the state of data in an + online form without restriction on how the state is maintained and with no + description of the mechanism for maintaining the state describes "the effect or + result dissociated from any method by which maintaining the state is accomplished" + and does not provide a meaningful limitation because it merely states that the + abstract idea should be applied to achieve a desired result). See also + *O’Reilly v. Morse,* 56 U.S. 62 (1854) (finding ineligible a + claim for "the use of electromagnetism for transmitting signals at a distance"); The + *Telephone Cases,* 126 U.S. 1, 209 (1888) (finding a method of + "transmitting vocal or other sound telegraphically ... by causing electrical + undulations, similar in form to the vibrations of the air accompanying the said vocal + or other sounds," to be ineligible, because it "monopolize[d] a natural force" and + "the right to avail of that law by any means whatever."). + + + +In contrast, limitations that confine the judicial + exception to a particular, practical application of the judicial exception may amount + to significantly more or integrate the judicial exception into a practical + application. For example, in *BASCOM,* the combination of additional + elements, and specifically "the installation of a filtering tool at a specific + location, remote from the end‐users, with customizable filtering features specific to + each end user" where the filtering tool at the ISP was able to "identify individual + accounts that communicate with the ISP server, and to associate a request for + Internet content with a specific individual account," were held to be meaningful + limitations because they confined the abstract idea of content filtering to a + particular, practical application of the abstract idea. 827 F.3d at 1350-51, 119 + USPQ2d at 1243. + + + +, +# 2106.05(g) Insignificant Extra-Solution + Activity [R-10.2019] + + +Another consideration when determining whether a + claim integrates the judicial exception into a practical application in Step 2A Prong + Two or recites significantly more in Step 2B is whether the additional elements add + more than insignificant extra-solution activity to the judicial exception. The term + "extra-solution activity" can be understood as activities incidental to the primary + process or product that are merely a nominal or tangential addition to the claim. + Extra-solution activity includes both pre-solution and post-solution activity. An + example of pre-solution activity is a step of gathering data for use in a claimed + process, *e.g.,* a step of obtaining information about credit card + transactions, which is recited as part of a claimed process of analyzing and + manipulating the gathered information by a series of steps in order to detect whether + the transactions were fraudulent. An example of post-solution activity is an element + that is not integrated into the claim as a whole, *e.g.,* a printer + that is used to output a report of fraudulent transactions, which is recited in a + claim to a computer programmed to analyze and manipulate information about credit + card transactions in order to detect whether the transactions were fraudulent. + + + +As explained by the Supreme Court, the addition of + insignificant extra-solution activity does not amount to an inventive concept, + particularly when the activity is well-understood or conventional. *Parker v. + Flook,* 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). In + *Flook,* the Court reasoned that "[t]he notion that post-solution + activity, no matter how conventional or obvious in itself, can transform an + unpatentable principle into a patentable process exalts form over substance. A + competent draftsman could attach some form of post-solution activity to almost any + mathematical formula". 437 U.S. at 590; 198 USPQ at 197; *Id.* + (holding that step of adjusting an alarm limit variable to a figure computed + according to a mathematical formula was "post-solution activity"). See also + *Mayo Collaborative Servs. v. Prometheus Labs. Inc.,* 566 U.S. + 66, 79, 101 USPQ2d 1961, 1968 (2012) (additional element of measuring metabolites of + a drug administered to a patient was insignificant extra-solution activity). + + + + Examiners should carefully consider each claim on + its own merits, as well as evaluate all other relevant considerations, before making + a determination of whether an element (or combination of elements) is insignificant + extra-solution activity. In particular, evaluation of the particular machine and + particular transformation considerations (see **[MPEP § 2106.05(b) and + (c)](s2106.html#ch2100_d29a1b_13ccf_18c)**, respectively), the well-understood, routine, + conventional consideration (see **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**), and the field of + use and technological environment consideration (see **[MPEP § + 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**) may assist examiners in making a determination + of whether an element (or combination of elements) is insignificant extra-solution + activity. Note, however, that examiners should not evaluate the well-understood, + routine, conventional consideration in the Step 2A Prong Two analysis, because that + consideration is only evaluated in Step 2B. + + + +This consideration is similar to factors used in past + Office guidance (for example, the now superseded *Bilski* and + *Mayo* analyses) that were described as mere data gathering in + conjunction with a law of nature or abstract idea. When determining whether an + additional element is insignificant extra-solution activity, examiners may consider + the following: + + + +**(1) Whether the extra-solution limitation is well + known.** See *Bilski v. Kappos,* 561 U.S. 593, 611-12, 95 + USPQ2d 1001, 1010 (2010) (well-known random analysis techniques to establish the + inputs of an equation were token extra-solution activity); *Flook,* + 437 U.S. at 593-95, 198 USPQ at 197 (a formula would not be patentable by only + indicating that is could be usefully applied to existing surveying techniques); + *Intellectual Ventures I LLC v. Erie Indem. Co.,* 850 F.3d 1315, + 1328-29, 121 USPQ2d 1928, 1937 (Fed. Cir. 2017) (the use of a well-known XML tag to + form an index was deemed token extra-solution activity). Because this overlaps with + the well-understood, routine, conventional consideration, it should not be considered + in the Step 2A Prong Two extra-solution activity analysis. + + + +**(2) Whether the limitation is significant + (*i.e.* it imposes meaningful limits on the claim such that it + is not nominally or tangentially related to the invention).** See *Ultramercial, Inc. v. Hulu, LLC,* 772 F.3d 709, 715-16, 112 USPQ2d 1750, + 1755 (Fed. Cir. 2014) (restricting public access to media was found to be + insignificant extra-solution activity); *Apple, Inc. v. Ameranth, + Inc.,* 842 F.3d 1229, 1242, 120 USPQ2d 1844, 1855 (Fed. Cir. 2016) (in + patents regarding electronic menus, features related to types of ordering were found + to be insignificant extra-solution activity). This is considered in Step 2A Prong Two + and Step 2B. + + + +**(3) Whether the limitation amounts to necessary + data gathering and outputting, (*i.e.,* all uses of the recited + judicial exception require such data gathering or data output).** See + *Mayo,* 566 U.S. at 79, 101 USPQ2d at 1968; *OIP Techs., + Inc. v. Amazon.com, Inc.,* 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 + (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data + gathering). This is considered in Step 2A Prong Two and Step 2B. + + + +Below are examples of activities that the courts have + found to be insignificant extra-solution activity: + + + +* **• Mere Data Gathering:** + + i. Performing clinical tests on individuals to + obtain input for an equation, *In re Grams,* 888 F.2d + 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); + + ii. Testing a system for a response, the + response being used to determine system malfunction, *In re + Meyers,* 688 F.2d 789, 794; 215 USPQ 193, 196-97 (CCPA 1982); + + iii. Presenting offers to potential customers + and gathering statistics generated based on the testing about how + potential customers responded to the offers; the statistics are then used + to calculate an optimized price, *OIP Technologies,* 788 + F.3d at 1363, 115 USPQ2d at 1092-93; + + iv. Obtaining information about transactions + using the Internet to verify credit card transactions, + *CyberSource v. Retail Decisions, Inc.,* 654 F.3d + 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011); + + v. Consulting and updating an activity log, + *Ultramercial,* 772 F.3d at 715, 112 USPQ2d at 1754; + and + + vi. Determining the level of a biomarker in + blood, *Mayo,* 566 U.S. at 79, 101 USPQ2d at 1968. See + also *PerkinElmer, Inc. v. Intema Ltd.,* 496 Fed. App'x + 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring + data derived from an ultrasound scan, to be used in a diagnosis). +* **• Selecting a particular data source or type of data to be + manipulated:** + + i. Limiting a database index to XML tags, + *Intellectual Ventures I LLC v. Erie Indem. Co.,* 850 + F.3d at 1328-29, 121 USPQ2d at 1937; + + ii. Taking food orders from only table-based + customers or drive-through customers, *Ameranth,* 842 + F.3d at 1241-43, 120 USPQ2d at 1854-55; + + iii. Selecting information, based on types of + information and availability of information in a power-grid environment, + for collection, analysis and display, *Electric Power Group, LLC + v. Alstom S.A.,* 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, + 1742 (Fed. Cir. 2016); and + + iv. Requiring a request from a user to view + an advertisement and restricting public access, + *Ultramercial,* 772 F.3d at 715-16, 112 USPQ2d at + 1754. +* **• Insignificant application:** + + i. Cutting hair after first determining the + hair style, *In re Brown,* 645 Fed. App'x 1014, + 1016-1017 (Fed. Cir. 2016) (non-precedential); and + + ii. Printing or downloading generated menus, + *Ameranth,* 842 F.3d at 1241-42, 120 USPQ2d at + 1854-55. + + +Some cases have identified insignificant computer + implementation as an example of insignificant extra-solution activity. See + *e.g., Fort Props., Inc. v. Am. Master Lease LLC,* 671 F.3d 1317, + 1323-24, 101 USPQ2d 1785, 1789-90 (Fed. Cir. 2012); *Bancorp Servs., LLC v. + Sun Life Assur. Co. of Canada,* 687 F.3d 1266, 1280-81, 103 USPQ2d 1425, + 1434-35 (Fed. Cir. 2012). Other cases have considered these types of limitations as + mere instructions to apply a judicial exception. See **[MPEP § + 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)** for more information about insignificant + computer implementation. + + + +For claim limitations that add insignificant + extra-solution activity to the judicial exception (*e.g.,* mere data + gathering in conjunction with a law of nature or abstract idea), examiners should + explain in an eligibility rejection why they do not meaningfully limit the claim. For + example, an examiner could explain that adding a final step of storing data to a + process that only recites computing the area of a space (a mathematical relationship) + does not add a meaningful limitation to the process of computing the area. For more + information on formulating a subject matter eligibility rejection, see + **[MPEP + § 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. + + + +, +# 2106.05(h) Field of Use and Technological + Environment [R-10.2019] + + +Another consideration when determining whether a + claim integrates the judicial exception into a practical application in Step 2A Prong + Two or recites significantly more than a judicial exception in Step 2B is whether the + additional elements amount to more than generally linking the use of a judicial + exception to a particular technological environment or field of use. As explained by + the Supreme Court, a claim directed to a judicial exception cannot be made eligible + "simply by having the applicant acquiesce to limiting the reach of the patent for the + formula to a particular technological use." *Diamond v. Diehr,* 450 + U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to + merely indicating a field of use or technological environment in which to apply a + judicial exception do not amount to significantly more than the exception itself, and + cannot integrate a judicial exception into a practical application. + + + +The courts often cite to *Parker v. + Flook* as providing a classic example of a field of use limitation. See, + *e.g., Bilski v. Kappos,* 561 U.S. 593, 612, 95 USPQ2d 1001, 1010 + (2010) ("*Flook* established that limiting an abstract idea to one + field of use or adding token postsolution components did not make the concept + patentable") (citing *Parker v. Flook,* 437 U.S. 584, 198 USPQ 193 + (1978)). In *Flook,* the claim recited steps of calculating an + updated value for an alarm limit (a numerical limit on a process variable such as + temperature, pressure or flow rate) according to a mathematical formula "in a process + comprising the catalytic chemical conversion of hydrocarbons." 437 U.S. at 586, 198 + USPQ at 196. Processes for the catalytic chemical conversion of hydrocarbons were + used in the petrochemical and oil-refining fields. *Id.* Although + the applicant argued that limiting the use of the formula to the petrochemical and + oil-refining fields should make the claim eligible because this limitation ensured + that the claim did not preempt all uses of the formula, the Supreme Court disagreed. + 437 U.S. at 588-90, 198 USPQ at 197-98. Instead, the additional element in + *Flook* regarding the catalytic chemical conversion of + hydrocarbons was not sufficient to make the claim eligible, because it was merely an + incidental or token addition to the claim that did not alter or affect how the + process steps of calculating the alarm limit value were performed. Further, the + Supreme Court found that this limitation did not amount to an inventive concept. 437 + U.S. at 588-90, 198 USPQ at 197-98. The Court reasoned that to hold otherwise would + "exalt[] form over substance", because a competent claim drafter could attach a + similar type of limitation to almost any mathematical formula. 437 U.S. at 590, 198 + USPQ at 197. + + + + In contrast, the additional elements in + *Diamond v. Diehr* as a whole provided eligibility and did not + merely recite calculating a cure time using the Arrhenius equation "in a rubber + molding process". Instead, the claim in *Diehr* recited specific + limitations such as monitoring the elapsed time since the mold was closed, constantly + measuring the temperature in the mold cavity, repetitively calculating a cure time by + inputting the measured temperature into the Arrhenius equation, and opening the press + automatically when the calculated cure time and the elapsed time are equivalent. 450 + U.S. at 179, 209 USPQ at 5, n. 5. These specific limitations act in concert to + transform raw, uncured rubber into cured molded rubber. 450 U.S. at 177-78, 209 USPQ + at 4. + + + +A more recent example of a limitation that does no + more than generally link a judicial exception to a particular technological + environment is *Affinity Labs of Texas v. DirecTV, LLC,* 838 F.3d + 1253, 120 USPQ2d 1201 (Fed. Cir. 2016). In *Affinity Labs,* the + claim recited a broadcast system in which a cellular telephone located outside the + range of a regional broadcaster (1) requests and receives network-based content from + the broadcaster via a streaming signal, (2) is configured to wirelessly download an + application for performing those functions, and (3) contains a display that allows + the user to select particular content. 838 F.3d at 1255-56, 120 USPQ2d at 1202. The + court identified the claimed concept of providing out-of-region access to regional + broadcast content as an abstract idea, and noted that the additional elements limited + the wireless delivery of regional broadcast content to cellular telephones (as + opposed to any and all electronic devices such as televisions, cable boxes, + computers, or the like). 838 F.3d at 1258-59, 120 USPQ2d at 1204. Although the + additional elements did limit the use of the abstract idea, the court explained that + this type of limitation merely confines the use of the abstract idea to a particular + technological environment (cellular telephones) and thus fails to add an inventive + concept to the claims. 838 F.3d at 1259, 120 USPQ2d at 1204. + + + +Examples of limitations that the courts have + described as merely indicating a field of use or technological environment in which + to apply a judicial exception include: + + + +* i. A step of administering a drug providing + 6-thioguanine to patients with an immune-mediated gastrointestinal disorder, + because limiting drug administration to this patient population did no more + than simply refer to the relevant pre-existing audience of doctors who used + thiopurine drugs to treat patients suffering from autoimmune disorders, + *Mayo Collaborative Servs. v. Prometheus Labs. Inc.,* 566 + U.S. 66, 78, 101 USPQ2d 1961, 1968 (2012); +* ii. Identifying the participants in a process for + hedging risk as commodity providers and commodity consumers, because limiting + the use of the process to these participants did no more than describe how the + abstract idea of hedging risk could be used in the commodities and energy + markets, *Bilski,* 561 U.S. at 595, 95 USPQ2d at 1010; +* iii. Limiting the use of the formula C = 2 (pi) r to + determining the circumference of a wheel as opposed to other circular objects, + because this limitation represents a mere token acquiescence to limiting the + reach of the claim, *Flook,* 437 U.S. at 595, 198 USPQ at + 199; +* iv. Specifying that the abstract idea of monitoring + audit log data relates to transactions or activities that are executed in a + computer environment, because this requirement merely limits the claims to the + computer field, *i.e.,* to execution on a generic computer, + *FairWarning v. Iatric Sys.,* 839 F.3d 1089, 1094-95, 120 + USPQ2d 1293, 1295 (Fed. Cir. 2016); +* v. Language specifying that the process steps of + virus screening were used within a telephone network or the Internet, because + limiting the use of the process to these technological environments did not + provide meaningful limits on the claim, *Intellectual Ventures I v. + Symantec Corp.,* 838 F.3d 1307, 1319-20, 120 USPQ2d 1353, 1361 + (2016); +* vi. Limiting the abstract idea of collecting + information, analyzing it, and displaying certain results of the collection and + analysis to data related to the electric power grid, because limiting + application of the abstract idea to power-grid monitoring is simply an attempt + to limit the use of the abstract idea to a particular technological + environment, *Electric Power Group, LLC v. Alstom S.A.,* 830 + F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016); +* vii. Language informing doctors to apply a law of + nature (linkage disequilibrium) for purposes of detecting a genetic + polymorphism, because this language merely informs the relevant audience that + the law of nature can be used in this manner, *Genetic Techs. Ltd. v. + Merial LLC,* 818 F.3d 1369, 1379, 118 USPQ2d 1541, 1549 (Fed. Cir. + 2016); +* viii. Language specifying that the abstract idea of + budgeting was to be implemented using a "communication medium" that broadly + included the Internet and telephone networks, because this limitation merely + limited the use of the exception to a particular technological environment, + *Intellectual Ventures I v. Capital One Bank,* 792 F.3d + 1363, 1367, 115 USPQ2d 1636, 1640 (Fed. Cir. 2015); +* ix. Specifying that the abstract idea of using + advertising as currency is used on the Internet, because this narrowing + limitation is merely an attempt to limit the use of the abstract idea to a + particular technological environment, *Ultramercial, Inc. v. Hulu, + LLC,* 772 F.3d 709, 716, 112 USPQ2d 1750, 1755 (Fed. Cir. 2014); + and +* x. Requiring that the abstract idea of creating a + contractual relationship that guarantees performance of a transaction (a) be + performed using a computer that receives and sends information over a network, + or (b) be limited to guaranteeing online transactions, because these + limitations simply attempted to limit the use of the abstract idea to computer + environments, *buySAFE Inc. v. Google, Inc.,* 765 F.3d 1350, + 1354, 112 USPQ2d 1093, 1095-96 (Fed. Cir. 2014). + + +Examiners should be aware that the courts often use + the terms "technological environment" and "field of use" interchangeably, and thus + for purposes of the eligibility analysis examiners should consider these terms + interchangeable. Examiners should also keep in mind that this consideration overlaps + with other considerations, particularly insignificant extra-solution activity (see + **[MPEP + § 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)**). For instance, a data gathering step that is + limited to a particular data source (such as the Internet) or a particular type of + data (such as power grid data or XML tags) could be considered to be both + insignificant extra-solution activity and a field of use limitation. See, + *e.g., Ultramercial,* 772 F.3d at 716, 112 USPQ2d at 1755 + (limiting use of abstract idea to the Internet); *Electric Power,* + 830 F.3d at 1354, 119 USPQ2d at 1742 (limiting application of abstract idea to power + grid data); *Intellectual Ventures I LLC v. Erie Indem. Co.,* 850 + F.3d 1315, 1328-29, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017) (limiting use of abstract + idea to use with XML tags). Thus, examiners should carefully consider each claim on + its own merits, as well as evaluate all other relevant considerations, before making + a determination on this consideration. + + + +For claim limitations that generally link the use of + the judicial exception to a particular technological environment or field of use, + examiners should explain in an eligibility rejection why they do not meaningfully + limit the claim. For example, an examiner could explain that employing generic + computer functions to execute an abstract idea, even when limiting the use of the + idea to one particular environment, does not add significantly more, similar to how + limiting the abstract idea in *Flook* to petrochemical and + oil-refining industries was insufficient. For more information on formulating a + subject matter eligibility rejection, see **[MPEP § + 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)**. + + + +, +# 2106.06 Streamlined Analysis [R-10.2019] + + +For purposes of efficiency in examination, examiners may + use a streamlined eligibility analysis (Pathway A) when the eligibility of the claim is + self-evident, *e.g.,* because the claim clearly improves a technology + or computer functionality. However, if there is doubt as to whether the applicant is + effectively seeking coverage for a judicial exception itself, the full eligibility + analysis (the *Alice/Mayo* test described in **[MPEP § 2106](s2106.html#d0e197244)**, + subsection III) should be conducted to determine whether the claim integrates the + judicial exception into a practical application or recites significantly more than the + judicial exception. + + + + The results of the streamlined analysis will always be + the same as the full analysis, thus the streamlined analysis is not a means of avoiding + a finding of ineligibility that would occur if a claim were to undergo the full + eligibility analysis. Similarly, a claim that qualifies as eligible after Step 2A + (Pathway B) or Step 2B (Pathway C) of the full analysis would also be eligible if the + streamlined analysis (Pathway A) were applied to that claim. It may not be apparent that + an examiner employed the streamlined analysis because the result is a conclusion that + the claim is eligible, and there will be no rejection of the claim on eligibility + grounds. In practice, the record may reflect the conclusion of eligibility simply by the + absence of an eligibility rejection or may include clarifying remarks, when appropriate. + + + +In the context of the flowchart in **[MPEP § 2106](s2106.html#d0e197244)**, + subsection III, if, when viewed as a whole, the eligibility of the claim is self-evident + (e.g., because the claim clearly improves a technology or computer functionality), the + claim is eligible at Pathway A, thereby concluding the eligibility analysis. + + + + +# 2106.06(a) Eligibility is Self Evident [R-08.2017] + + +A streamlined eligibility analysis can be used for a + claim that may or may not recite a judicial exception but, when viewed as a whole, + clearly does not seek to tie up any judicial exception such that others cannot + practice it. Such claims do not need to proceed through the full analysis herein as + their eligibility will be self-evident. On the other hand, a claim that does not + qualify as eligible after Step 2B of the full analysis would not be suitable for the + streamlined analysis, because the claim lacks self‐evident eligibility. + + + +For instance, a claim directed to a complex + manufactured industrial product or process that recites meaningful limitations along + with a judicial exception may sufficiently limit its practical application so that a + full eligibility analysis is not needed. As an example, a robotic arm assembly having + a control system that operates using certain mathematical relationships is clearly + not an attempt to tie up use of the mathematical relationships and would not require + a full analysis to determine eligibility. Also, a claim that recites a nature-based + product, but clearly does not attempt to tie up the nature-based product, does not + require a markedly different characteristics analysis to identify a "product of + nature" exception. As an example, a claim directed to an artificial hip prosthesis + coated with a naturally occurring mineral is not an attempt to tie up the mineral. + Similarly, claimed products that merely include ancillary nature-based components, + such as a claim that is directed to a cellphone with an electrical contact made of + gold or a plastic chair with wood trim, would not require analysis of the + nature-based component to determine whether the claims are directed to a "product of + nature" exception because such claims do not attempt to improperly tie up the + nature-based product. + + + + + +# 2106.06(b) Clear Improvement to a Technology or to + Computer Functionality [R-08.2017] + + +As explained by the Federal Circuit, some + improvements to technology or to computer functionality are not abstract when + appropriately claimed, and thus claims to such improvements do not always need to + undergo the full eligibility analysis. *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). + **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** provides details regarding improvements to a + technology or computer functionality. + + + +For instance, claims directed to clear improvements + to computer-related technology do not need the full eligibility analysis. + *Enfish,* 822 F.3d at 1339, 118 USPQ2d at 1691-92 (claims to a + self-referential table for a computer database held eligible at step 1 of the + *Alice/Mayo* test as not directed to an abstract idea). Claims + directed to improvements to other technologies or technological processes, beyond + computer improvements, may also avoid the full eligibility analysis. *McRO, + Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, 1316, 120 USPQ2d + 1091, 1103 (Fed. Cir. 2016) (claims to automatic lip synchronization and facial + expression animation found eligible at Step 1 of the *Alice/Mayo* + test as directed to an improvement in computer-related technology). In these cases, + when the claims were viewed as a whole, their eligibility was self-evident based on + the clear improvement, so no further analysis was needed. Although the Federal + Circuit held these claims eligible at Step 2A as not being directed to abstract + ideas, it would be reasonable for an examiner to have found these claims eligible at + Pathway A based on the clear improvement, or at Pathway B (Step 2A) as not being + directed to an abstract idea. + + + +If the claims are a "close call" such that it is + unclear whether the claims improve technology or computer functionality, a full + eligibility analysis should be performed to determine eligibility. See + *BASCOM Global Internet v. AT&T Mobility LLC,* 827 F.3d 1341, + 1349, 119 USPQ2d 1236, 1241 (Fed Cir. 2016). Only when the claims clearly improve + technology or computer functionality, or otherwise have self-evident eligibility, + should the streamlined analysis be used. For example, because the claims in + *BASCOM* described the concept of filtering content, which is a + method of organizing human behavior previously found to be abstract, the Federal + Circuit considered them to present a "close call" in the first step of the + *Alice/Mayo* test (Step 2A), and thus proceeded to the second + step of the *Alice/Mayo* test (Step 2B) to determine their + eligibility. *Id.* Although the Federal Circuit held these claims + eligible at Step 2B (Pathway C) because they presented a "technology-based solution" + of filtering content on the Internet that overcame the disadvantages of prior art + filtering systems and that amounted to significantly more than the recited abstract + idea, it also would be reasonable for an examiner to have found these claims eligible + at Pathway A or B if the examiner had considered the technology-based solution to be + an improvement to computer functionality. + + + + +, +# 2106.06(a) Eligibility is Self Evident [R-08.2017] + + +A streamlined eligibility analysis can be used for a + claim that may or may not recite a judicial exception but, when viewed as a whole, + clearly does not seek to tie up any judicial exception such that others cannot + practice it. Such claims do not need to proceed through the full analysis herein as + their eligibility will be self-evident. On the other hand, a claim that does not + qualify as eligible after Step 2B of the full analysis would not be suitable for the + streamlined analysis, because the claim lacks self‐evident eligibility. + + + +For instance, a claim directed to a complex + manufactured industrial product or process that recites meaningful limitations along + with a judicial exception may sufficiently limit its practical application so that a + full eligibility analysis is not needed. As an example, a robotic arm assembly having + a control system that operates using certain mathematical relationships is clearly + not an attempt to tie up use of the mathematical relationships and would not require + a full analysis to determine eligibility. Also, a claim that recites a nature-based + product, but clearly does not attempt to tie up the nature-based product, does not + require a markedly different characteristics analysis to identify a "product of + nature" exception. As an example, a claim directed to an artificial hip prosthesis + coated with a naturally occurring mineral is not an attempt to tie up the mineral. + Similarly, claimed products that merely include ancillary nature-based components, + such as a claim that is directed to a cellphone with an electrical contact made of + gold or a plastic chair with wood trim, would not require analysis of the + nature-based component to determine whether the claims are directed to a "product of + nature" exception because such claims do not attempt to improperly tie up the + nature-based product. + + + +, +# 2106.06(b) Clear Improvement to a Technology or to + Computer Functionality [R-08.2017] + + +As explained by the Federal Circuit, some + improvements to technology or to computer functionality are not abstract when + appropriately claimed, and thus claims to such improvements do not always need to + undergo the full eligibility analysis. *Enfish, LLC v. Microsoft + Corp.,* 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). + **[MPEP § + 2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)** provides details regarding improvements to a + technology or computer functionality. + + + +For instance, claims directed to clear improvements + to computer-related technology do not need the full eligibility analysis. + *Enfish,* 822 F.3d at 1339, 118 USPQ2d at 1691-92 (claims to a + self-referential table for a computer database held eligible at step 1 of the + *Alice/Mayo* test as not directed to an abstract idea). Claims + directed to improvements to other technologies or technological processes, beyond + computer improvements, may also avoid the full eligibility analysis. *McRO, + Inc. v. Bandai Namco Games Am. Inc.,* 837 F.3d 1299, 1316, 120 USPQ2d + 1091, 1103 (Fed. Cir. 2016) (claims to automatic lip synchronization and facial + expression animation found eligible at Step 1 of the *Alice/Mayo* + test as directed to an improvement in computer-related technology). In these cases, + when the claims were viewed as a whole, their eligibility was self-evident based on + the clear improvement, so no further analysis was needed. Although the Federal + Circuit held these claims eligible at Step 2A as not being directed to abstract + ideas, it would be reasonable for an examiner to have found these claims eligible at + Pathway A based on the clear improvement, or at Pathway B (Step 2A) as not being + directed to an abstract idea. + + + +If the claims are a "close call" such that it is + unclear whether the claims improve technology or computer functionality, a full + eligibility analysis should be performed to determine eligibility. See + *BASCOM Global Internet v. AT&T Mobility LLC,* 827 F.3d 1341, + 1349, 119 USPQ2d 1236, 1241 (Fed Cir. 2016). Only when the claims clearly improve + technology or computer functionality, or otherwise have self-evident eligibility, + should the streamlined analysis be used. For example, because the claims in + *BASCOM* described the concept of filtering content, which is a + method of organizing human behavior previously found to be abstract, the Federal + Circuit considered them to present a "close call" in the first step of the + *Alice/Mayo* test (Step 2A), and thus proceeded to the second + step of the *Alice/Mayo* test (Step 2B) to determine their + eligibility. *Id.* Although the Federal Circuit held these claims + eligible at Step 2B (Pathway C) because they presented a "technology-based solution" + of filtering content on the Internet that overcame the disadvantages of prior art + filtering systems and that amounted to significantly more than the recited abstract + idea, it also would be reasonable for an examiner to have found these claims eligible + at Pathway A or B if the examiner had considered the technology-based solution to be + an improvement to computer functionality. + + + +, +# 2106.07 Formulating and Supporting Rejections For Lack + Of Subject Matter Eligibility [R-10.2019] + + +Eligibility rejections must be based on failure to + comply with the substantive law under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** as interpreted by + judicial precedent. The substantive law on eligibility is discussed in + **[MPEP §§ + 2106.03](s2106.html#ch2100_d29a1b_139b2_397)** through **[2106.06](s2106.html#ch2100_d29a1b_13e6a_88)**. + Examination guidance, training, and explanatory examples discuss the substantive law and + establish the policies and procedures to be followed by examiners in evaluating patent + applications for compliance with the substantive law, but do not serve as a basis for a + rejection. Accordingly, while it would be acceptable for applicants to cite training + materials or examples in support of an argument for finding eligibility in an + appropriate factual situation, applicants should not be required to model their claims + or responses after the training materials or examples to attain eligibility. + + + +When evaluating a claimed invention for compliance with + the substantive law on eligibility, examiners should review the record as a whole + (*e.g.,* the specification, claims, the prosecution history, and any + relevant case law precedent or prior art) before reaching a conclusion with regard to + whether the claimed invention sets forth patent eligible subject matter. The evaluation + of whether the claimed invention qualifies as patent-eligible subject matter should be + made on a claim-by-claim basis, because claims do not automatically rise or fall with + similar claims in an application. For example, even if an independent claim is + determined to be ineligible, the dependent claims may be eligible because they add + limitations that integrate the judicial exception into a practical application or amount + to significantly more than the judicial exception recited in the independent claim. And + conversely, even if an independent claim is determined to be eligible, a dependent claim + may be ineligible because it adds a judicial exception without also adding limitations + that integrate the judicial exception or provide significantly more. Thus, each claim in + an application should be considered separately based on the particular elements recited + therein. + + + +If the evaluation of the claimed invention results in a + conclusion that it is more likely than not that the claim as a whole does not satisfy + both criteria for eligibility (Step 1: NO and/or Step 2B: NO), then examiners should + formulate an appropriate rejection of that claim under Step 1 and/or Step 2B. The + rejection should set forth a *prima facie* case of ineligibility under + the substantive law. The concept of the prima facie case is a procedural tool of patent + examination, which allocates the burdens going forward between the examiner and + applicant. In particular, the initial burden is on the examiner to explain why a claim + or claims are ineligible for patenting clearly and specifically, so that applicant has + sufficient notice and is able to effectively respond. + + + + When an examiner determines a claim does not fall + within a statutory category (Step 1: NO), the rejection should provide an explanation of + why the claim does not fall within one of the four statutory categories of invention. + See **[MPEP § + 2106.03](s2106.html#ch2100_d29a1b_139b2_397)** for a discussion of Step 1 and the statutory + categories of invention. + + + +When an examiner determines that a claim is directed to + a judicial exception (Step 2A: YES) and does not provide an inventive concept (Step 2B: + NO), the rejection should provide an explanation for each part of the Step 2 analysis. + For example, the rejection should identify the judicial exception by referring to what + is recited (*i.e.,* set forth or described) in the claim and explain + why it is considered an exception, identify any additional elements (specifically point + to claim features/limitations/steps) recited in the claim beyond the identified judicial + exception, and explain the reason(s) that the additional elements taken individually, + and also taken as a combination, 1) do not integrate the judicial exception into a + practical application and 2) do not result in the claim as a whole amounting to + significantly more than the judicial exception. See **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)***et seq.* for a discussion of Step 2A and the judicial exceptions, + **[MPEP § + 2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)***et seq.* for a discussion of Step 2B and the search for an inventive + concept, and **[MPEP § 2106.07(a)](s2106.html#ch2100_d29a1b_14011_176)** for more information + on formulating an ineligibility rejection. + + + +If the evaluation of the claimed invention results in a + conclusion that it is more likely than not that the claimed invention falls within a + statutory category (Step 1: YES) and is either not directed to a judicial exception + (Step 2A: NO) or is directed to a judicial exception and amounts to significantly more + than the judicial exception (Step 2B: YES), then the examiner should not reject the + claim. When evaluating a response by applicant to a subject matter eligibility + rejection, examiners must carefully consider all of applicant’s arguments and evidence + presented to rebut the rejection. If applicant properly challenges the examiner’s + findings, the rejection should be withdrawn or, if the examiner deems it appropriate to + maintain the rejection, a rebuttal must be provided in the next Office action. This is + discussed in greater detail in **[MPEP § 2106.07(b)](s2106.html#ch2100_d29a1b_14065_2a0)**. + + + + +# 2106.07(a) Formulating a Rejection For Lack of Subject + Matter Eligibility [R-10.2019] + + +After determining what the applicant invented and + establishing the broadest reasonable interpretation of the claimed invention (see + **[MPEP § + 2111](s2111.html#d0e200352)**), the eligibility of each claim should be evaluated as + a whole using the analysis detailed in **[MPEP § 2106](s2106.html#d0e197244)**. If it is determined + that the claim does not recite eligible subject matter, a rejection under + **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)** is appropriate. When making the rejection, the Office + action must provide an explanation as to why each claim is unpatentable, which must + be sufficiently clear and specific to provide applicant sufficient notice of the + reasons for ineligibility and enable the applicant to effectively respond. + + + +Subject matter eligibility rejections under Step 1 + are discussed in **[MPEP § 2106.03](s2106.html#ch2100_d29a1b_139b2_397)**. + + + + A subject matter eligibility rejection under Step 2 + should provide an explanation for each part of the Step 2 analysis: + + + +* • For Step 2A Prong One, the rejection should + identify the judicial exception by referring to **what is recited** + (*i.e.,* set forth or described) in the claim and + **explain why** it is considered an exception. For example, if the + claim is directed to an **abstract idea**, the rejection should + identify the abstract idea as it is recited (*i.e.,* set forth + or described) in the claim and explain why it is an abstract idea. Similarly, + if the claim is directed to a **law of nature** or a **natural + phenomenon**, the rejection should identify the law of nature or + natural phenomenon as it is recited (*i.e.,* set forth or + described) in the claim and explain using a reasoned rationale why it is + considered a law of nature or natural phenomenon. +* • For Step 2A Prong Two, the rejection should + identify any additional elements (specifically point to claim + features/limitations/steps) recited in the claim beyond the identified judicial + exception; and **evaluate** the integration of the judicial exception + into a practical application **by explaining** that 1) there are no + additional elements in the claim; or 2) the claim as a whole, looking at the + additional elements individually and in combination, does not integrate the + judicial exception into a practical application using the considerations set + forth in **[MPEP §§ 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)**, + **[2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**- **[(c)](s2106.html#ch2100_d29a1b_13cfb_2e)** and **[(e)](s2106.html#ch2100_d29a1b_13d61_1a8)**- **[(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**. Examiners should give weight to all of the + claimed additional elements in Prong Two, even if those elements represent + well-understood, routine, conventional activity. +* • For Step 2B, the rejection should + **explain why** the additional elements, taken individually and in + combination, do not result in the claim, as a whole, amounting to significantly + more than the identified judicial exception. For instance, when the examiner + has concluded that certain claim elements recite well understood, routine, + conventional activities in the relevant field, the examiner must expressly + support the rejection in writing with one of the four options specified in + Subsection III. + + + Under the principles of compact prosecution, + regardless of whether a rejection under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** is made based on + lack of subject matter eligibility, a complete examination should be made for every + claim under each of the other patentability requirements: **[35 U.S.C. + 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)**, **[103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)**, **[112](mpep-9015-appx-l.html#d0e302824912)**, and + **[101](mpep-9015-appx-l.html#d0e302376)** (utility, inventorship and double patenting) and + non-statutory double patenting. Thus, examiners should state all non-cumulative + reasons and bases for rejecting claims in the first Office action. + + +**I.** **WHEN MAKING A REJECTION, IDENTIFY + AND EXPLAIN THE JUDICIAL EXCEPTION RECITED IN THE CLAIM (STEP 2A PRONG + ONE)**A subject matter eligibility rejection should + point to the specific claim limitation(s) that recites (*i.e.,* + sets forth or describes) the judicial exception. The rejection must explain why + those claim limitations set forth or describe a judicial exception + (*e.g.,* a law of nature). Where the claim describes, but does + not expressly set forth, the judicial exception, the rejection must also explain + what subject matter those limitations describe, and why the described subject + matter is a judicial exception. See **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)** for more information about Step 2A of the + eligibility analysis. + + + +When the examiner has determined the claim recites + an **abstract idea**, the rejection should identify the abstract idea as + it is recited (*i.e.,* set forth or described) in the claim, and + explain why it falls within one of the groupings of abstract ideas + (*i.e.,* mathematical concepts, mental processes, or certain + methods of organizing human activity) enumerated in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**. Alternatively, the examiner should + provide justification for why a specific limitation(s) recited in the claim is + being treated as an abstract idea if it does not fall within the groupings of + abstract ideas in accordance with the "tentative abstract idea" procedure (see + **[MPEP § 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, subsection (IV)). While not required, + this explanation or justification may include citing to an appropriate court + decision that supports the identification of the subject matter recited in the + claim language as an abstract idea within one of the groupings. Examiners should + be familiar with any cited decision relied upon in making or maintaining a + rejection to ensure that the rejection is reasonably tied to the facts of the case + and to avoid relying upon language taken out of context. Examiners should not go + beyond those concepts that are enumerated as abstract ideas in + **[MPEP § 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, unless they are identifying a tentative + abstract idea in the claim, and should avoid relying upon or citing + non-precedential decisions unless the facts of the application under examination + uniquely match the facts at issue in the non-precedential decisions. Examiners are + reminded that a chart of court decisions is available on the USPTO’s Internet + website (**[www.uspto.gov/ PatentEligibility](http://www.uspto.gov/PatentEligibility)**). + + + + +Sample explanation: The + claim recites the step of comparing collected information to a predefined + threshold, which is an act of evaluating information that can be practically + performed in the human mind. Thus, this step is an abstract idea in the "mental + process" grouping. + + + + +When the examiner has determined the claim recites + a **law of nature** or a **natural phenomenon**, the rejection + should identify the law of nature or natural phenomenon as it is recited + (*i.e.,* set forth or described) in the claim and explain + using a reasoned rationale why it is considered a law of nature or natural + phenomenon. See **[MPEP § 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)** for more + information about laws of nature and natural phenomena. + + + + +Sample explanation: The + claim recites the correlation of X, and X is a law of nature because it + describes a consequence of natural processes in the human body, e.g., the + naturally-occurring relationship between the presence of Y and the + manifestation of Z. + + + + + +Sample explanation: The + claim recites X, which is a natural phenomenon because it occurs in nature and + exists in principle apart from any human action. + + + + +When the examiner has determined the claim recites + a **product of nature,** the rejection should identify the exception as + it is recited (*i.e.,* set forth or described) in the claim, and + explain using a reasoned rationale why the product does not have markedly + different characteristics from its naturally occurring counterpart in its natural + state. See **[MPEP § 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)** for more + information about products of nature, and **[MPEP § + 2106.04(c)](s2106.html#ch2100_d29a1b_13bc1_b1)** for more information about the markedly + different characteristics analysis. + + + + +Sample explanation: The + claim recites X, which as explained in the specification was isolated from + naturally occurring Y. X is a nature-based product, so it is compared to its + closest naturally occurring counterpart (X in its natural state) to determine + if it has markedly different characteristics. Because there is no indication in + the record that isolation of X has resulted in a marked difference in + structure, function, or other properties as compared to its counterpart, X is a + product of nature exception. + + + +**II.** **WHEN MAKING A REJECTION, EXPLAIN + WHY THE ADDITIONAL CLAIM ELEMENTS DO NOT RESULT IN THE CLAIM AS A WHOLE + INTEGRATING THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION OR AMOUNTING TO + SIGNIFICANTLY MORE THAN THE JUDICIAL EXCEPTION (STEP 2A PRONG TWO AND STEP + 2B)**After identifying the judicial exception in the + rejection, identify any additional elements (features/limitations/steps) recited + in the claim beyond the judicial exception and explain why they do not integrate + the judicial exception into a practical application and do not add significantly + more to the exception. The explanation should address the additional elements both + individually and as a combination when determining whether the claim as whole + recites eligible subject matter. It is important to remember that a new + combination of steps in a process may be patent eligible even though all the steps + of the combination were individually well known and in common use before the + combination was made. *Diamond v. Diehr,* 450 U.S. 175, 188, 209 + USPQ 1, 9 (1981). Thus, it is particularly critical to address the combination of + additional elements, because while individually-viewed elements may not appear to + integrate an exception into a practical application or add significantly more, + those additional elements when viewed in combination may amount to significantly + more than the exception by meaningfully limiting the judicial exception. See + **[MPEP § 2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)** for more information about Step 2B of + the eligibility analysis. + + + +A rejection should be made only if it is readily + apparent to an examiner relying on the examiner's expertise in the art in the Step + 2A Prong Two inquiry and Step 2B inquiry that the additional elements do not + integrate the exception into a practical application and do not amount to claiming + significantly more than the recited judicial exception. When making a rejection, + it is important for the examiner to explain the rationale underlying the + conclusion so that applicant can effectively respond. On the other hand, when + appropriate, the examiner should explain why the additional elements integrate an + exception into a practical application or provide an inventive concept by adding a + meaningful limitation to the claimed exception. See **[MPEP §§ + 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)** and **[2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)** for a listing of considerations that qualify, + and to not qualify, as integrating an exception or providing significantly more + than an exception , and **[MPEP § 2106.07(c)](s2106.html#ch2100_d29a1b_1407f_384)** for more + information on clarifying the record when a claim is found eligible. + + + +In the Step 2B inquiry, if the examiner has + concluded that particular claim limitations are well understood, routine, + conventional activities (or elements) to those in the relevant field, the + rejection should support this conclusion in writing with a factual determination + in accordance with Subsection III below. See **[MPEP § + 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)** for more information about well understood, + routine, conventional activities and elements, and Subsection III below for more + information about how to support a conclusion that a claim limitation is well + understood, routine, conventional activity. + + + +For claim limitations that recite a generic + computer component performing generic computer functions at a high level of + generality, such as using the Internet to gather data, examiners can explain why + these generic computing functions do not meaningfully limit the claim. Examiners + should keep in mind that the courts have held computer-implemented processes to be + significantly more than an abstract idea (and thus eligible), where generic + computer components are able in combination to perform functions that are not + merely generic. *DDR Holdings, LLC v. Hotels.com, LP,* 773 F.3d + 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014). See + **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)** for more information about generic + computing functions that the courts have found to be mere instructions to + implement a judicial exception on a computer, and **[MPEP § + 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)** for more information about well understood, + routine, conventional activities and elements (a relevant consideration only in + Step 2B). + + + +For claim limitations that add insignificant + extra-solution activity to the judicial exception (e.g., mere data gathering in + conjunction with a law of nature or abstract idea), or that generally link the use + of the judicial exception to a particular technological environment or field of + use, examiners should explain why they do not meaningfully limit the claim. For + example, adding a final step of storing data to a process that only recites + computing the area of a two dimensional space (a mathematical relationship) does + not add a meaningful limitation to the process of computing the area. As another + example, employing well-known computer functions to execute an abstract idea, even + when limiting the use of the idea to one particular environment, does not + integrate the exception into a practical application or add significantly more, + similar to how limiting the computer implemented abstract idea in Flook to + petrochemical and oil-refining industries was insufficient. See *e.g., + Parker v. Flook,* 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) + (limiting use of mathematical formula to use in particular industries did not + amount to an inventive concept). See **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)** for more information about insignificant + extra-solution activity, and **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)** for more + information about generally linking use of a judicial exception to a particular + technological environment or field of use. + + + +In the event a rejection is made, it is a best + practice for the examiner to consult the specification to determine if there are + elements that could be added to the claim to make it eligible. If so, the examiner + should identify those elements in the Office action and suggest them as a way to + overcome the rejection. + + +**III.** **EVIDENTIARY REQUIREMENTS IN MAKING + A § 101 REJECTION**The courts consider the determination of whether a + claim is eligible (which involves identifying whether an exception such as an + abstract idea is being claimed) to be a question of law. *Rapid Litig. + Mgmt. v. CellzDirect,* 827 F.3d 1042, 1047, 119 USPQ2d 1370, 1372 + (Fed. Cir. 2016); *OIP Techs. v. Amazon.com,* 788 F.3d 1359, + 1362, 115 USPQ2d 1090, 1092 (Fed. Cir. 2015); *DDR Holdings v. + Hotels.com,* 773 F.3d 1245, 1255, 113 USPQ2d 1097, 1104 (Fed. Cir. + 2014); *In re Roslin Institute (Edinburgh),* 750 F.3d 1333, 1335, + 110 USPQ2d 1668, 1670 (Fed. Cir. 2014); *In re Bilski,* 545 F.3d + 943, 951, 88 USPQ2d 1385, 1388 (Fed. Cir. 2008) (*en banc*), + aff’d by *Bilski v. Kappos,* 561 U.S. 593, 95 USPQ2d 1001 (2010). + Thus, the court does not require "evidence" that a claimed concept is a judicial + exception, and generally decides the legal conclusion of eligibility without + resolving any factual issues. *FairWarning IP, LLC v. Iatric + Sys.,* 839 F.3d 1089, 1097, 120 USPQ2d 1293, 1298 (Fed. Cir. 2016) + (citing *Genetic Techs. Ltd. v. Merial LLC,* 818 F.3d 1369, 1373, + 118 USPQ2d 1541, 1544 (Fed. Cir. 2016)); *OIP Techs.,* 788 F.3d + at 1362, 115 USPQ2d at 1092; *Content Extraction & Transmission LLC v. + Wells Fargo Bank, N.A.,* 776 F.3d 1343, 1349, 113 USPQ2d 1354, 1359 + (Fed. Cir. 2014). In some cases, however, the courts have characterized the issue + of whether additional elements are well-understood, routine, conventional activity + as an underlying factual issue upon which the legal conclusion of eligibility may + be based. See, *e.g., Interval Licensing LLC v. AOL, Inc.,* 896 + F.3d. 1335, 1342, 127 USPQ2d 1553, 1557 (Fed. Cir. 2018) (patent eligibility is a + question of law that may contain underlying issues of fact), *Berkheimer + v. HP, Inc.,* 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. + 2018) (issue of whether additional elements are well-understood, routine, + conventional activity is factual). + + + +When performing the analysis at Step 2A Prong One, + it is sufficient for the examiner to provide a reasoned rationale that identifies + the judicial exception recited in the claim and explains why it is considered a + judicial exception (e.g., that the claim limitation(s) falls within one of the + abstract idea groupings). Therefore, there is no requirement for the examiner to + rely on evidence, such as publications or an affidavit or declaration under + **[37 CFR + 1.104(d)(2)](mpep-9020-appx-r.html#d0e322249)**, to find that a claim recites a judicial + exception. *Cf. Affinity Labs of Tex., LLC v. Amazon.com Inc.,* + 838 F.3d 1266, 1271-72, 120 USPQ2d 1210, 1214-15 (Fed. Cir. 2016) (affirming + district court decision that identified an abstract idea in the claims without + relying on evidence); *OIP Techs., Inc. v. Amazon.com, Inc.,* 788 + F.3d 1359, 1362-64, 115 USPQ2d 1090, 1092-94 (Fed. Cir. 2015) (same); + *Content Extraction & Transmission LLC v. Wells Fargo + Bank,* N.A., 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357-58 (Fed. Cir. + 2014) (same). + + + +At Step 2A Prong Two or Step 2B, there is no + requirement for evidence to support a finding that the exception is not integrated + into a practical application or that the additional elements do not amount to + significantly more than the exception unless the examiner asserts that additional + limitations are well-understood, routine, conventional activities in Step 2B. + + + +Examiners should not assert that an additional + element (or combination of elements) is well-understood, routine, or conventional + unless the examiner finds, and expressly supports the rejection in writing with + one or more of the following: + + + +* (A) A citation to an express statement in the + specification or to a statement made by an applicant during prosecution that + demonstrates the well-understood, routine, conventional nature of the + additional element(s). A specification demonstrates the well-understood, + routine, conventional nature of additional elements when it describes the + additional elements as well-understood or routine or conventional (or an + equivalent term), as a commercially available product, or in a manner that + indicates that the additional elements are sufficiently well-known that the + specification does not need to describe the particulars of such additional + elements to satisfy **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**. A + finding that an element is well-understood, routine, or conventional cannot + be based only on the fact that the specification is silent with respect to + describing such element. +* (B) A citation to one or more of the court + decisions discussed in **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**, + subsection II, as noting the well-understood, routine, conventional nature + of the additional element(s). Examiners should be careful to ensure the + claim limitations before the examiner are the same as those found to be + well-understood, routine, conventional by the courts. The additional + elements under examination should be recited in the same manner, meaning + they should be recited at the same high level of generality as in those + court decisions. It is not enough that the additional elements are similar + to the elements at issue in those cases. In addition, the court decisions + discussed in **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**, + subsection II, are not meant to imply that all computer functions are + well-understood, routine, conventional functions, or that a claim reciting a + generic computer component performing a generic computer function is + necessarily ineligible. Examiners should keep in mind that the courts have + held computer-implemented processes to be significantly more than an + abstract idea (and thus eligible), where generic computer components are + able in combination to perform functions that are not merely generic. + *DDR Holdings, LLC v. Hotels.com, LP,* 773 F.3d 1245, + 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014). See + **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)** for more + information about generic computing functions that the courts have found to + be mere instructions to implement a judicial exception on a computer. +* (C) A citation to a publication that + demonstrates the well-understood, routine, conventional nature of the + additional element(s). An appropriate publication could include a book, + manual, review article, or other source that describes the state of the art + and discusses what is well-known and in common use in the relevant industry. + It does not include all items that might otherwise qualify as a "printed + publication" as used in **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)**. Whether + something is disclosed in a document that is considered a "printed + publication" under **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)** is a + distinct inquiry from whether something is well-known, routine, conventional + activity. A document may be a printed publication but still fail to + establish that something it describes is well-understood, routine, + conventional activity. See *Exergen Corp. v. Kaz USA,* 725 + Fed. App’x. at 959, 966 (Fed. Cir. 2018) (the single copy of a thesis, + written in German and located in a German university library, considered to + be a "printed publication" in *In re Hall,* 781 F.2d 897, + 228 USPQ 453 (Fed. Cir. 1986) "would not suffice to establish that something + is 'well-understood, routine, and conventional activity previously engaged + in by scientists who work in the field'"). The nature of the publication and + the description of the additional elements in the publication would need to + demonstrate that the additional elements are widely prevalent or in common + use in the relevant field, comparable to the types of activity or elements + that are so well-known that they do not need to be described in detail in a + patent application to satisfy **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**. For + example, while U.S. patents and published applications are publications, + merely finding the additional element in a single patent or published + application would not be sufficient to demonstrate that the additional + element is well-understood, routine, conventional, unless the patent or + published application demonstrates that the additional element is widely + prevalent or in common use in the relevant field. +* (D) A statement that the examiner is taking + official notice of the well-understood, routine, conventional nature of the + additional element(s). This option should be used only when examiners are + certain, based upon their personal knowledge, that the additional element(s) + represents well-understood, routine, conventional activity engaged in by + those in the relevant art, in that the additional elements are widely + prevalent or in common use in the relevant field, comparable to the types of + activity or elements that are so well-known that they do not need to be + described in detail in a patent application to satisfy **[35 U.S.C. + 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**. For example, the examiner could take official + notice that a generic computer component performing generic computer + functions at a high level of generality, such as using the Internet to + gather data, is well-understood, routine, conventional. Procedures for + taking official notice and addressing an applicant’s challenge to official + notice are discussed in **[MPEP § 2144.03](s2144.html#d0e210752)**. + + + +# 2106.07(a)(1) Form Paragraphs for use in Lack of + Subject Matter Eligibility Rejections [R-10.2019] + + +Use form paragraphs **[7.04.01](#fp7.04.01)**, + **[7.05](#fp7.05)**, + and **[7.05.01](#fp7.05.01)** for rejections based on a failure to + claim an invention that falls within the statutory categories of invention (i.e., + the claim is not to one of the four statutory categories of invention and is thus + rejected at Step 1 of the eligibility analysis). + + + +Use form paragraphs **[7.04.01](#fp7.04.01)**, + **[7.05](#fp7.05)**, + and **[7.05.016](#fp7.05.016)** for rejections based on a failure to + claim an invention that is directed to patent-eligible subject matter, i.e., the + claim is directed to a judicial exception without providing an inventive + concept/significantly more, and is thus rejected at Step 2B of the eligibility + analysis. If the judicial exception to which the claim is directed is a "tentative + abstract idea," i.e., an abstract idea that does not fall within any of the + groupings of abstract ideas discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, then the Step 2B rejection must also use + form paragraph **[7.05.017](#fp7.05.017)** (in addition to form paragraphs + **[7.04.01](#fp7.04.01)**, **[7.05](#fp7.05)**, and + **[7.05.016](#fp7.05.016)**) and include the TC Director's + signature. + + + +# ¶ 7.04.01 Statement of Statutory Basis, 35 U.S.C. 101 + + +35 U.S.C. 101 reads as follows: + + +Whoever invents or discovers any new and useful process, machine, + manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a + patent therefor, subject to the conditions and requirements of this title. + + + +### Examiner Note: + + * This form paragraph must precede the first use of + **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)** in all first actions on the merits and final rejections. + + + +# ¶ 7.05 Rejection, 35 U.S.C. 101, -Heading Only- (Utility, Nonstatutory, + Inoperative) + + +Claim **[1]** rejected under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** because + + + +### Examiner Note: + + * 1. This form paragraph must be preceded by form paragraph + **[7.04.01](#fp7.04.01)** in + first actions and final rejections. +* 2. This form paragraph must be followed by a detailed explanation of + the grounds of rejection using one or more of form paragraphs + **[7.05.01](#fp7.05.01)**, + **[7.05.016](#fp7.05.016)**, + **[7.05.017](#fp7.05.017)**, + **[7.05.02](#fp7.05.02)**, + **[7.05.03](#fp7.05.03)**, + or another appropriate reason. +* 3. See **[MPEP §§ 2105](s2105.html#d0e197008)** - **[2107.03](s2107.html#d0e199419)** for additional guidance. + + + +# ¶ 7.05.01 Rejection, 35 U.S.C. 101, Nonstatutory (Not One of the Four + Statutory Categories) + + +the claimed invention is directed to nonstatutory subject matter. The + claim(s) does/do not fall within at least one of the four categories of patent eligible + subject matter because **[1]** + + +### Examiner Note: + + * 1. This form paragraph should be preceded by form paragraph + **[7.05](#fp0705)**. +* 2. In bracket 1, explain why the claimed invention is not patent + eligible subject matter by identifying what the claim(s) is/are directed to and explain + why it does not fall within at least one of the four categories of patent eligible + subject matter recited in **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** (process, machine, + manufacture, or composition of matter), e.g., the claim(s) is/are directed to a signal + *per se,* mere information in the form of data, a contract between + two parties, or a human being (see **[MPEP § 2106](s2106.html#d0e197244)**, subsection I). +* 3. For a claim that is directed to a judicial exception and is + nonstatutory, use form paragraph **[7.05.016](#fp7.05.016)**. + + + +# ¶ 7.05.016 Rejection, 35 U.S.C. 101, Nonstatutory (Directed to a Judicial + Exception without an Inventive Concept/Significantly More) + + +the claimed invention is directed to **[1]** without + significantly more. The claim(s) recite(s) **[2]**. This judicial exception is not + integrated into a practical application because **[3]**. The claim(s) does/do not + include additional elements that are sufficient to amount to significantly more than the + judicial exception because **[4]**. + + + +### Examiner Note: + + * 1. This form paragraph should be preceded by form paragraph + **[7.05](#fp7.05)**. For + claims that recite a tentative abstract idea (i.e., a limitation identified as an + abstract idea even though it does not fall within the groupings of abstract ideas + discussed in **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**), this form + paragraph should be accompanied by form paragraph **[7.05.017](#fp7.05.017)**. +* 2. This form paragraph is for use with all product (machine, + manufacture, and composition of matter) and process claims, and for all claims directed + to a law of nature, natural phenomenon (including a product of nature), or abstract + idea. +* 3. In bracket 1, identify whether the claim(s) are directed to a + law of nature, a natural phenomenon (including a product of nature), or an abstract + idea. +* 4. In bracket 2, identify the exception by referring to how it is + recited in the claim and explain why it is considered an exception (e.g., for an + abstract idea, identify the abstract idea grouping in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** into which the recited exception falls). For + example, "the Arrhenius equation, which is a law of nature and a mathematical concept + which describes the relationship between temperature and reaction rate" or "the series + of steps instructing how to hedge risk, which is a fundamental economic practice and + thus grouped as a certain method of organizing human interactions." For a product of + nature exception, refer to how it is recited in the claim and explain why its + characteristics are not markedly different from the product’s naturally occurring + counterpart in its natural state. For example, "the naturally occurring DNA segment, + which is not markedly different from its naturally occurring counterpart because it + conveys the same genetic information." Provide additional explanation regarding the + exception and how it has been identified when appropriate. +* 5. In bracket 3, explain why the combination of additional + elements fails to integrate the judicial exception into a practical application. For + example, if the claim is directed to an abstract idea with additional generic computer + elements, explain that the generically recited computer elements do not add a meaningful + limitation to the abstract idea because they amount to simply implementing the abstract + idea on a computer; or, if the claim is directed to a method of using a naturally + occurring correlation, explain that data gathering steps required to use the correlation + do not add a meaningful limitation to the method as they are insignificant + extra-solution activity. Similarly, if the claim recites a "naturally occurring DNA + segment" with an additional element of a test tube, explain that merely placing the + product of nature into a generic container such as a test tube does not add a meaningful + limitation as it is merely a nominal or token extra-solution component of the claim, and + is nothing more than an attempt to generally link the product of nature to a particular + technological environment. +* 6. In bracket 4, identify the additional elements and explain why, + when considered separately and in combination, they do not add significantly more (also + known as an "inventive concept") to the exception. For example, if the additional + limitations only store and retrieve information in memory, explain that these are + well-understood, routine, conventional computer functions as recognized by the court + decisions listed in **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**. + + + +# ¶ 7.05.017 Rejection, 35 U.S.C. 101, TC Director Approval for + "Tentative Abstract Idea" + + +The identified claim limitation(s) that recite(s) an abstract idea + do/does not fall within the groupings of abstract ideas discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, i.e., mathematical concepts, mental processes, or + certain methods of organizing human activity. Nonetheless, the claim limitation(s) is/are + being treated as reciting an abstract idea because **[1]**. + + + +This rejection has been approved by the Technology Center Director + signing below. + + + +**[2]** + + +### Examiner Note: + + * 1. This form paragraph should be preceded by form paragraph + **[7.05.016](#fp7.05.016)**. +* 2. Approval from the TC Director is required to treat a tentative + abstract idea (i.e., a claim limitation(s) that does not fall within the groupings of + abstract ideas discussed in **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**) as an abstract + idea. This form paragraph should be used to demonstrate that this approval has been + obtained. +* 3. In bracket 1, provide the justification for why the claim + limitation(s) is/are being treated as an abstract idea. For example, provide an + explanation of why the claim limitation is among the "basic tools of scientific and + technological work." +* 4. In bracket 2, insert the TC Director's signature. Approval of + the TC Director is required to treat a claim limitation that does not fall within the + groupings of abstract ideas discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** as reciting an abstract idea. See + **[MPEP § + 2106.04(a)(3)](s2106.html#ch2100_d2ea80_199c8_1c1)**. + + + + + + +# 2106.07(b) Evaluating Applicant's Response [R-10.2019] + + +After examiners identify and explain in the record + the reasons why a claim is directed to an abstract idea, natural phenomenon, or law + of nature without significantly more, then the burden shifts to the applicant to + either amend the claim or make a showing of why the claim is eligible for patent + protection. + + + + In response to a rejection based on failure to claim + patent-eligible subject matter, applicant may: (i) amend the claim, e.g., to add + additional elements or modify existing elements so that the claim as a whole amounts + to significantly more than the judicial exception, (or integrates the judicial + exception into a practical application), (ii) present persuasive arguments based on a + good faith belief as to why the rejection is in error and/or (iii) submit evidence + traversing a subject matter eligibility rejection according to the procedures set + forth in **[MPEP § + 716.01](s716.html#d0e92469)** and **[37 CFR 1.132](mpep-9020-appx-r.html#d0e323552)**. When evaluating a + response, examiners must carefully consider all of applicant's arguments and evidence + rebutting the subject matter eligibility rejection. If applicant has amended the + claim, examiners should determine the amended claim’s broadest reasonable + interpretation and again perform the subject matter eligibility analysis. + + + +If applicant's claim amendment(s), evidence, and/or + argument(s) persuasively establish that the claim is not directed to a judicial + exception or is directed to significantly more than a judicial exception, the + rejection should be withdrawn. Applicant may argue that a claim is eligible because + the claim as a whole integrates the judicial exception into a practical application + or amounts to significantly more than the judicial exception when the additional + elements are considered both individually and in combination. When an additional + element is considered individually by the examiner, the additional element may be + enough to integrate the judicial exception into a practical application or to qualify + as "significantly more" if it meaningfully limits the judicial exception, + *e.g.,* it improves another technology or technical field, + improves the functioning of a computer itself. + + + +In addition, even if an element does not integrate a + judicial exception into a practical application or amount to significantly more on + its own (*e.g.,* because it is merely a generic computer component + performing generic computer functions), it can still integrate or amount to + significantly more when considered in combination with the other elements of the + claim. For example, generic computer components that individually perform merely + generic computer functions (*e.g.,* a CPU that performs mathematical + calculations or a clock that produces time data) in some instances are able in + combination to perform functions that are not generic computer functions and + therefore integrate or amount to significantly more than an abstract idea (and are + thus eligible). + + + +If applicant properly challenges the examiner's + findings but the examiner deems it appropriate to maintain the rejection, a rebuttal + must be provided in the next Office action. Several examples of appropriate examiner + responses are provided below. + + + +* (1) If applicant challenges the identification of a + tentative abstract idea that was based on a court case and the challenge is not + persuasive, an appropriate response would be an explanation as to why the + abstract idea identified in the claim is similar to the concept in the cited + case. +* (2) If applicant responds to an examiner's assertion + that something is well-known, routine, conventional activity with a specific + argument or evidence that the additional elements in a claim are not + well-understood, routine, conventional activities previously engaged in by + those in the relevant art, the examiner should reevaluate whether the + additional elements are in actuality well-known, routine, conventional + activities to those who work in the relevant field. It is especially necessary + for the examiner to fully reevaluate their position when such additional + elements are not discussed in the specification as being known generic + functions/components/activities or are not treated by the courts as + well-understood, routine, conventional activities. If the rejection is to be + maintained, the examiner should consider whether evidence should be provided to + further support the rejection and clarify the record for appeal. See + **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)** for examples of elements that the + courts have found to be well understood, routine and conventional activity. If + the examiner has taken official notice per item (D) of subsection III above + that an element(s) is well-understood, routine, conventional activity, and the + applicant challenges the examiner's position, specifically stating that such + element(s) is not well-understood, routine, conventional activity, the examiner + must then provide one of the items discussed in paragraphs (A) through (C) of + subsection III above, or an affidavit or declaration under **[37 CFR + 1.104(d)(2)](mpep-9020-appx-r.html#d0e322249)** setting forth specific factual statements and + explanation to support the examiner’s position. See also **[MPEP § + 2106.07(b)](s2106.html#ch2100_d29a1b_14065_2a0)**, item (2). +* (3) If applicant amends a claim to add a generic + computer or generic computer components and asserts that the claim is + integrated into a practical application or recites significantly more because + the generic computer is 'specially programmed' (as in + *Alappat*, now considered superseded) or is a 'particular + machine' (as in *Bilski*), the examiner should look at whether + the added elements integrate the judicial exception into a practical + application or provide significantly more than the judicial exception. Merely + adding a generic computer, generic computer components, or a programmed + computer to perform generic computer functions does not automatically overcome + an eligibility rejection. *Alice Corp. Pty. Ltd. v. CLS Bank + Int'l,* 573 U.S. 208, 224, 110 USPQ2d 1976, 1984 (2014). See also + *OIP Techs. v. Amazon.com,* 788 F.3d 1359, 1364, 115 USPQ2d + 1090, 1093-94 (Fed. Cir. 2015) ("Just as *Diehr* could not + save the claims in *Alice*, which were directed to + ‘implement[ing] the abstract idea of intermediated settlement on a generic + computer’, it cannot save *OIP*'s claims directed to + implementing the abstract idea of price optimization on a generic computer.") + (citations omitted). +* (4) If applicant argues that the claim is specific + and does not preempt all applications of the exception, the examiner should + reconsider Step 2A of the eligibility analysis, *e.g.,* to + determine whether the claim is directed to an improvement to the functioning of + a computer or to any other technology or technical field. If an examiner still + determines that the claim is directed to a judicial exception, the examiner + should then reconsider in Step 2B whether the additional elements in + combination (as well as individually) amount to an inventive concept, + *e.g.,* because they are more than the non-conventional and + non-generic arrangement of known, conventional elements. Such reconsideration + is appropriate because, although preemption is not a standalone test for + eligibility, it remains the underlying concern that drives the two-part + framework from *Alice Corp.* and *Mayo* + (Steps 2A and 2B). *Synopsys, Inc. v. Mentor Graphics Corp.,* + 839 F.3d 1138, 1150, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016); *Rapid + Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d 1042, 1052, 119 USPQ2d + 1370, 1376 (Fed. Cir. 2016); *Ariosa Diagnostics, Inc. v. Sequenom, + Inc.,* 788 F.3d 1371, 1379, 115 USPQ2d 1152, 1158 (Fed. Cir. 2015). + + + + +# 2106.07(c) Clarifying the Record [R-08.2017] + + +When the claims are deemed patent eligible, the + examiner may make clarifying remarks on the record. For example, if a claim is found + eligible because it improves upon existing technology, the examiner could reference + the portion of the specification that describes the claimed improvement and note the + claim elements that produce that improvement. The clarifying remarks may be made at + any point during prosecution as well as with a notice of allowance. + + + +Clarifying remarks may be useful in explaining the + rationale for a rejection as well. For instance, explaining the broadest reasonable + interpretation (BRI) of a claim will assist applicant in understanding and responding + to a rejection. As an example, a rejection for failure to recite patent eligible + subject matter in a claim to a computer readable medium could include an explanation + that the broadest reasonable interpretation of the claim covers a carrier wave, which + does not fall within one of the four categories of invention, and a suggestion to + overcome the rejection by submitting a narrowing amendment to cover the statutory + embodiments. + + + + +, +# 2106.07(a) Formulating a Rejection For Lack of Subject + Matter Eligibility [R-10.2019] + + +After determining what the applicant invented and + establishing the broadest reasonable interpretation of the claimed invention (see + **[MPEP § + 2111](s2111.html#d0e200352)**), the eligibility of each claim should be evaluated as + a whole using the analysis detailed in **[MPEP § 2106](s2106.html#d0e197244)**. If it is determined + that the claim does not recite eligible subject matter, a rejection under + **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)** is appropriate. When making the rejection, the Office + action must provide an explanation as to why each claim is unpatentable, which must + be sufficiently clear and specific to provide applicant sufficient notice of the + reasons for ineligibility and enable the applicant to effectively respond. + + + +Subject matter eligibility rejections under Step 1 + are discussed in **[MPEP § 2106.03](s2106.html#ch2100_d29a1b_139b2_397)**. + + + + A subject matter eligibility rejection under Step 2 + should provide an explanation for each part of the Step 2 analysis: + + + +* • For Step 2A Prong One, the rejection should + identify the judicial exception by referring to **what is recited** + (*i.e.,* set forth or described) in the claim and + **explain why** it is considered an exception. For example, if the + claim is directed to an **abstract idea**, the rejection should + identify the abstract idea as it is recited (*i.e.,* set forth + or described) in the claim and explain why it is an abstract idea. Similarly, + if the claim is directed to a **law of nature** or a **natural + phenomenon**, the rejection should identify the law of nature or + natural phenomenon as it is recited (*i.e.,* set forth or + described) in the claim and explain using a reasoned rationale why it is + considered a law of nature or natural phenomenon. +* • For Step 2A Prong Two, the rejection should + identify any additional elements (specifically point to claim + features/limitations/steps) recited in the claim beyond the identified judicial + exception; and **evaluate** the integration of the judicial exception + into a practical application **by explaining** that 1) there are no + additional elements in the claim; or 2) the claim as a whole, looking at the + additional elements individually and in combination, does not integrate the + judicial exception into a practical application using the considerations set + forth in **[MPEP §§ 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)**, + **[2106.05(a)](s2106.html#ch2100_d29a1b_13c69_10)**- **[(c)](s2106.html#ch2100_d29a1b_13cfb_2e)** and **[(e)](s2106.html#ch2100_d29a1b_13d61_1a8)**- **[(h)](s2106.html#ch2100_d29a1b_13e1a_22c)**. Examiners should give weight to all of the + claimed additional elements in Prong Two, even if those elements represent + well-understood, routine, conventional activity. +* • For Step 2B, the rejection should + **explain why** the additional elements, taken individually and in + combination, do not result in the claim, as a whole, amounting to significantly + more than the identified judicial exception. For instance, when the examiner + has concluded that certain claim elements recite well understood, routine, + conventional activities in the relevant field, the examiner must expressly + support the rejection in writing with one of the four options specified in + Subsection III. + + + Under the principles of compact prosecution, + regardless of whether a rejection under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** is made based on + lack of subject matter eligibility, a complete examination should be made for every + claim under each of the other patentability requirements: **[35 U.S.C. + 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)**, **[103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)**, **[112](mpep-9015-appx-l.html#d0e302824912)**, and + **[101](mpep-9015-appx-l.html#d0e302376)** (utility, inventorship and double patenting) and + non-statutory double patenting. Thus, examiners should state all non-cumulative + reasons and bases for rejecting claims in the first Office action. + + +**I.** **WHEN MAKING A REJECTION, IDENTIFY + AND EXPLAIN THE JUDICIAL EXCEPTION RECITED IN THE CLAIM (STEP 2A PRONG + ONE)**A subject matter eligibility rejection should + point to the specific claim limitation(s) that recites (*i.e.,* + sets forth or describes) the judicial exception. The rejection must explain why + those claim limitations set forth or describe a judicial exception + (*e.g.,* a law of nature). Where the claim describes, but does + not expressly set forth, the judicial exception, the rejection must also explain + what subject matter those limitations describe, and why the described subject + matter is a judicial exception. See **[MPEP § + 2106.04](s2106.html#ch2100_d29a1b_139db_e0)** for more information about Step 2A of the + eligibility analysis. + + + +When the examiner has determined the claim recites + an **abstract idea**, the rejection should identify the abstract idea as + it is recited (*i.e.,* set forth or described) in the claim, and + explain why it falls within one of the groupings of abstract ideas + (*i.e.,* mathematical concepts, mental processes, or certain + methods of organizing human activity) enumerated in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**. Alternatively, the examiner should + provide justification for why a specific limitation(s) recited in the claim is + being treated as an abstract idea if it does not fall within the groupings of + abstract ideas in accordance with the "tentative abstract idea" procedure (see + **[MPEP § 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, subsection (IV)). While not required, + this explanation or justification may include citing to an appropriate court + decision that supports the identification of the subject matter recited in the + claim language as an abstract idea within one of the groupings. Examiners should + be familiar with any cited decision relied upon in making or maintaining a + rejection to ensure that the rejection is reasonably tied to the facts of the case + and to avoid relying upon language taken out of context. Examiners should not go + beyond those concepts that are enumerated as abstract ideas in + **[MPEP § 2106.04](s2106.html#ch2100_d29a1b_139db_e0)**, unless they are identifying a tentative + abstract idea in the claim, and should avoid relying upon or citing + non-precedential decisions unless the facts of the application under examination + uniquely match the facts at issue in the non-precedential decisions. Examiners are + reminded that a chart of court decisions is available on the USPTO’s Internet + website (**[www.uspto.gov/ PatentEligibility](http://www.uspto.gov/PatentEligibility)**). + + + + +Sample explanation: The + claim recites the step of comparing collected information to a predefined + threshold, which is an act of evaluating information that can be practically + performed in the human mind. Thus, this step is an abstract idea in the "mental + process" grouping. + + + + +When the examiner has determined the claim recites + a **law of nature** or a **natural phenomenon**, the rejection + should identify the law of nature or natural phenomenon as it is recited + (*i.e.,* set forth or described) in the claim and explain + using a reasoned rationale why it is considered a law of nature or natural + phenomenon. See **[MPEP § 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)** for more + information about laws of nature and natural phenomena. + + + + +Sample explanation: The + claim recites the correlation of X, and X is a law of nature because it + describes a consequence of natural processes in the human body, e.g., the + naturally-occurring relationship between the presence of Y and the + manifestation of Z. + + + + + +Sample explanation: The + claim recites X, which is a natural phenomenon because it occurs in nature and + exists in principle apart from any human action. + + + + +When the examiner has determined the claim recites + a **product of nature,** the rejection should identify the exception as + it is recited (*i.e.,* set forth or described) in the claim, and + explain using a reasoned rationale why the product does not have markedly + different characteristics from its naturally occurring counterpart in its natural + state. See **[MPEP § 2106.04(b)](s2106.html#ch2100_d29a1b_13b6b_4c)** for more + information about products of nature, and **[MPEP § + 2106.04(c)](s2106.html#ch2100_d29a1b_13bc1_b1)** for more information about the markedly + different characteristics analysis. + + + + +Sample explanation: The + claim recites X, which as explained in the specification was isolated from + naturally occurring Y. X is a nature-based product, so it is compared to its + closest naturally occurring counterpart (X in its natural state) to determine + if it has markedly different characteristics. Because there is no indication in + the record that isolation of X has resulted in a marked difference in + structure, function, or other properties as compared to its counterpart, X is a + product of nature exception. + + + +**II.** **WHEN MAKING A REJECTION, EXPLAIN + WHY THE ADDITIONAL CLAIM ELEMENTS DO NOT RESULT IN THE CLAIM AS A WHOLE + INTEGRATING THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION OR AMOUNTING TO + SIGNIFICANTLY MORE THAN THE JUDICIAL EXCEPTION (STEP 2A PRONG TWO AND STEP + 2B)**After identifying the judicial exception in the + rejection, identify any additional elements (features/limitations/steps) recited + in the claim beyond the judicial exception and explain why they do not integrate + the judicial exception into a practical application and do not add significantly + more to the exception. The explanation should address the additional elements both + individually and as a combination when determining whether the claim as whole + recites eligible subject matter. It is important to remember that a new + combination of steps in a process may be patent eligible even though all the steps + of the combination were individually well known and in common use before the + combination was made. *Diamond v. Diehr,* 450 U.S. 175, 188, 209 + USPQ 1, 9 (1981). Thus, it is particularly critical to address the combination of + additional elements, because while individually-viewed elements may not appear to + integrate an exception into a practical application or add significantly more, + those additional elements when viewed in combination may amount to significantly + more than the exception by meaningfully limiting the judicial exception. See + **[MPEP § 2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)** for more information about Step 2B of + the eligibility analysis. + + + +A rejection should be made only if it is readily + apparent to an examiner relying on the examiner's expertise in the art in the Step + 2A Prong Two inquiry and Step 2B inquiry that the additional elements do not + integrate the exception into a practical application and do not amount to claiming + significantly more than the recited judicial exception. When making a rejection, + it is important for the examiner to explain the rationale underlying the + conclusion so that applicant can effectively respond. On the other hand, when + appropriate, the examiner should explain why the additional elements integrate an + exception into a practical application or provide an inventive concept by adding a + meaningful limitation to the claimed exception. See **[MPEP §§ + 2106.04(d)](s2106.html#ch2100_d2e7df_235a2_338)** and **[2106.05](s2106.html#ch2100_d29a1b_13c11_1cb)** for a listing of considerations that qualify, + and to not qualify, as integrating an exception or providing significantly more + than an exception , and **[MPEP § 2106.07(c)](s2106.html#ch2100_d29a1b_1407f_384)** for more + information on clarifying the record when a claim is found eligible. + + + +In the Step 2B inquiry, if the examiner has + concluded that particular claim limitations are well understood, routine, + conventional activities (or elements) to those in the relevant field, the + rejection should support this conclusion in writing with a factual determination + in accordance with Subsection III below. See **[MPEP § + 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)** for more information about well understood, + routine, conventional activities and elements, and Subsection III below for more + information about how to support a conclusion that a claim limitation is well + understood, routine, conventional activity. + + + +For claim limitations that recite a generic + computer component performing generic computer functions at a high level of + generality, such as using the Internet to gather data, examiners can explain why + these generic computing functions do not meaningfully limit the claim. Examiners + should keep in mind that the courts have held computer-implemented processes to be + significantly more than an abstract idea (and thus eligible), where generic + computer components are able in combination to perform functions that are not + merely generic. *DDR Holdings, LLC v. Hotels.com, LP,* 773 F.3d + 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014). See + **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)** for more information about generic + computing functions that the courts have found to be mere instructions to + implement a judicial exception on a computer, and **[MPEP § + 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)** for more information about well understood, + routine, conventional activities and elements (a relevant consideration only in + Step 2B). + + + +For claim limitations that add insignificant + extra-solution activity to the judicial exception (e.g., mere data gathering in + conjunction with a law of nature or abstract idea), or that generally link the use + of the judicial exception to a particular technological environment or field of + use, examiners should explain why they do not meaningfully limit the claim. For + example, adding a final step of storing data to a process that only recites + computing the area of a two dimensional space (a mathematical relationship) does + not add a meaningful limitation to the process of computing the area. As another + example, employing well-known computer functions to execute an abstract idea, even + when limiting the use of the idea to one particular environment, does not + integrate the exception into a practical application or add significantly more, + similar to how limiting the computer implemented abstract idea in Flook to + petrochemical and oil-refining industries was insufficient. See *e.g., + Parker v. Flook,* 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) + (limiting use of mathematical formula to use in particular industries did not + amount to an inventive concept). See **[MPEP § + 2106.05(g)](s2106.html#ch2100_d29a1b_13df8_3d4)** for more information about insignificant + extra-solution activity, and **[MPEP § 2106.05(h)](s2106.html#ch2100_d29a1b_13e1a_22c)** for more + information about generally linking use of a judicial exception to a particular + technological environment or field of use. + + + +In the event a rejection is made, it is a best + practice for the examiner to consult the specification to determine if there are + elements that could be added to the claim to make it eligible. If so, the examiner + should identify those elements in the Office action and suggest them as a way to + overcome the rejection. + + +**III.** **EVIDENTIARY REQUIREMENTS IN MAKING + A § 101 REJECTION**The courts consider the determination of whether a + claim is eligible (which involves identifying whether an exception such as an + abstract idea is being claimed) to be a question of law. *Rapid Litig. + Mgmt. v. CellzDirect,* 827 F.3d 1042, 1047, 119 USPQ2d 1370, 1372 + (Fed. Cir. 2016); *OIP Techs. v. Amazon.com,* 788 F.3d 1359, + 1362, 115 USPQ2d 1090, 1092 (Fed. Cir. 2015); *DDR Holdings v. + Hotels.com,* 773 F.3d 1245, 1255, 113 USPQ2d 1097, 1104 (Fed. Cir. + 2014); *In re Roslin Institute (Edinburgh),* 750 F.3d 1333, 1335, + 110 USPQ2d 1668, 1670 (Fed. Cir. 2014); *In re Bilski,* 545 F.3d + 943, 951, 88 USPQ2d 1385, 1388 (Fed. Cir. 2008) (*en banc*), + aff’d by *Bilski v. Kappos,* 561 U.S. 593, 95 USPQ2d 1001 (2010). + Thus, the court does not require "evidence" that a claimed concept is a judicial + exception, and generally decides the legal conclusion of eligibility without + resolving any factual issues. *FairWarning IP, LLC v. Iatric + Sys.,* 839 F.3d 1089, 1097, 120 USPQ2d 1293, 1298 (Fed. Cir. 2016) + (citing *Genetic Techs. Ltd. v. Merial LLC,* 818 F.3d 1369, 1373, + 118 USPQ2d 1541, 1544 (Fed. Cir. 2016)); *OIP Techs.,* 788 F.3d + at 1362, 115 USPQ2d at 1092; *Content Extraction & Transmission LLC v. + Wells Fargo Bank, N.A.,* 776 F.3d 1343, 1349, 113 USPQ2d 1354, 1359 + (Fed. Cir. 2014). In some cases, however, the courts have characterized the issue + of whether additional elements are well-understood, routine, conventional activity + as an underlying factual issue upon which the legal conclusion of eligibility may + be based. See, *e.g., Interval Licensing LLC v. AOL, Inc.,* 896 + F.3d. 1335, 1342, 127 USPQ2d 1553, 1557 (Fed. Cir. 2018) (patent eligibility is a + question of law that may contain underlying issues of fact), *Berkheimer + v. HP, Inc.,* 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. + 2018) (issue of whether additional elements are well-understood, routine, + conventional activity is factual). + + + +When performing the analysis at Step 2A Prong One, + it is sufficient for the examiner to provide a reasoned rationale that identifies + the judicial exception recited in the claim and explains why it is considered a + judicial exception (e.g., that the claim limitation(s) falls within one of the + abstract idea groupings). Therefore, there is no requirement for the examiner to + rely on evidence, such as publications or an affidavit or declaration under + **[37 CFR + 1.104(d)(2)](mpep-9020-appx-r.html#d0e322249)**, to find that a claim recites a judicial + exception. *Cf. Affinity Labs of Tex., LLC v. Amazon.com Inc.,* + 838 F.3d 1266, 1271-72, 120 USPQ2d 1210, 1214-15 (Fed. Cir. 2016) (affirming + district court decision that identified an abstract idea in the claims without + relying on evidence); *OIP Techs., Inc. v. Amazon.com, Inc.,* 788 + F.3d 1359, 1362-64, 115 USPQ2d 1090, 1092-94 (Fed. Cir. 2015) (same); + *Content Extraction & Transmission LLC v. Wells Fargo + Bank,* N.A., 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357-58 (Fed. Cir. + 2014) (same). + + + +At Step 2A Prong Two or Step 2B, there is no + requirement for evidence to support a finding that the exception is not integrated + into a practical application or that the additional elements do not amount to + significantly more than the exception unless the examiner asserts that additional + limitations are well-understood, routine, conventional activities in Step 2B. + + + +Examiners should not assert that an additional + element (or combination of elements) is well-understood, routine, or conventional + unless the examiner finds, and expressly supports the rejection in writing with + one or more of the following: + + + +* (A) A citation to an express statement in the + specification or to a statement made by an applicant during prosecution that + demonstrates the well-understood, routine, conventional nature of the + additional element(s). A specification demonstrates the well-understood, + routine, conventional nature of additional elements when it describes the + additional elements as well-understood or routine or conventional (or an + equivalent term), as a commercially available product, or in a manner that + indicates that the additional elements are sufficiently well-known that the + specification does not need to describe the particulars of such additional + elements to satisfy **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**. A + finding that an element is well-understood, routine, or conventional cannot + be based only on the fact that the specification is silent with respect to + describing such element. +* (B) A citation to one or more of the court + decisions discussed in **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**, + subsection II, as noting the well-understood, routine, conventional nature + of the additional element(s). Examiners should be careful to ensure the + claim limitations before the examiner are the same as those found to be + well-understood, routine, conventional by the courts. The additional + elements under examination should be recited in the same manner, meaning + they should be recited at the same high level of generality as in those + court decisions. It is not enough that the additional elements are similar + to the elements at issue in those cases. In addition, the court decisions + discussed in **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**, + subsection II, are not meant to imply that all computer functions are + well-understood, routine, conventional functions, or that a claim reciting a + generic computer component performing a generic computer function is + necessarily ineligible. Examiners should keep in mind that the courts have + held computer-implemented processes to be significantly more than an + abstract idea (and thus eligible), where generic computer components are + able in combination to perform functions that are not merely generic. + *DDR Holdings, LLC v. Hotels.com, LP,* 773 F.3d 1245, + 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014). See + **[MPEP § 2106.05(f)](s2106.html#ch2100_d29a1b_13da8_a5)** for more + information about generic computing functions that the courts have found to + be mere instructions to implement a judicial exception on a computer. +* (C) A citation to a publication that + demonstrates the well-understood, routine, conventional nature of the + additional element(s). An appropriate publication could include a book, + manual, review article, or other source that describes the state of the art + and discusses what is well-known and in common use in the relevant industry. + It does not include all items that might otherwise qualify as a "printed + publication" as used in **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)**. Whether + something is disclosed in a document that is considered a "printed + publication" under **[35 U.S.C. 102](mpep-9015-appx-l.html#al_d1fbe1_234ed_52)** is a + distinct inquiry from whether something is well-known, routine, conventional + activity. A document may be a printed publication but still fail to + establish that something it describes is well-understood, routine, + conventional activity. See *Exergen Corp. v. Kaz USA,* 725 + Fed. App’x. at 959, 966 (Fed. Cir. 2018) (the single copy of a thesis, + written in German and located in a German university library, considered to + be a "printed publication" in *In re Hall,* 781 F.2d 897, + 228 USPQ 453 (Fed. Cir. 1986) "would not suffice to establish that something + is 'well-understood, routine, and conventional activity previously engaged + in by scientists who work in the field'"). The nature of the publication and + the description of the additional elements in the publication would need to + demonstrate that the additional elements are widely prevalent or in common + use in the relevant field, comparable to the types of activity or elements + that are so well-known that they do not need to be described in detail in a + patent application to satisfy **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**. For + example, while U.S. patents and published applications are publications, + merely finding the additional element in a single patent or published + application would not be sufficient to demonstrate that the additional + element is well-understood, routine, conventional, unless the patent or + published application demonstrates that the additional element is widely + prevalent or in common use in the relevant field. +* (D) A statement that the examiner is taking + official notice of the well-understood, routine, conventional nature of the + additional element(s). This option should be used only when examiners are + certain, based upon their personal knowledge, that the additional element(s) + represents well-understood, routine, conventional activity engaged in by + those in the relevant art, in that the additional elements are widely + prevalent or in common use in the relevant field, comparable to the types of + activity or elements that are so well-known that they do not need to be + described in detail in a patent application to satisfy **[35 U.S.C. + 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**. For example, the examiner could take official + notice that a generic computer component performing generic computer + functions at a high level of generality, such as using the Internet to + gather data, is well-understood, routine, conventional. Procedures for + taking official notice and addressing an applicant’s challenge to official + notice are discussed in **[MPEP § 2144.03](s2144.html#d0e210752)**. + + + +# 2106.07(a)(1) Form Paragraphs for use in Lack of + Subject Matter Eligibility Rejections [R-10.2019] + + +Use form paragraphs **[7.04.01](#fp7.04.01)**, + **[7.05](#fp7.05)**, + and **[7.05.01](#fp7.05.01)** for rejections based on a failure to + claim an invention that falls within the statutory categories of invention (i.e., + the claim is not to one of the four statutory categories of invention and is thus + rejected at Step 1 of the eligibility analysis). + + + +Use form paragraphs **[7.04.01](#fp7.04.01)**, + **[7.05](#fp7.05)**, + and **[7.05.016](#fp7.05.016)** for rejections based on a failure to + claim an invention that is directed to patent-eligible subject matter, i.e., the + claim is directed to a judicial exception without providing an inventive + concept/significantly more, and is thus rejected at Step 2B of the eligibility + analysis. If the judicial exception to which the claim is directed is a "tentative + abstract idea," i.e., an abstract idea that does not fall within any of the + groupings of abstract ideas discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, then the Step 2B rejection must also use + form paragraph **[7.05.017](#fp7.05.017)** (in addition to form paragraphs + **[7.04.01](#fp7.04.01)**, **[7.05](#fp7.05)**, and + **[7.05.016](#fp7.05.016)**) and include the TC Director's + signature. + + + +# ¶ 7.04.01 Statement of Statutory Basis, 35 U.S.C. 101 + + +35 U.S.C. 101 reads as follows: + + +Whoever invents or discovers any new and useful process, machine, + manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a + patent therefor, subject to the conditions and requirements of this title. + + + +### Examiner Note: + + * This form paragraph must precede the first use of + **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)** in all first actions on the merits and final rejections. + + + +# ¶ 7.05 Rejection, 35 U.S.C. 101, -Heading Only- (Utility, Nonstatutory, + Inoperative) + + +Claim **[1]** rejected under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** because + + + +### Examiner Note: + + * 1. This form paragraph must be preceded by form paragraph + **[7.04.01](#fp7.04.01)** in + first actions and final rejections. +* 2. This form paragraph must be followed by a detailed explanation of + the grounds of rejection using one or more of form paragraphs + **[7.05.01](#fp7.05.01)**, + **[7.05.016](#fp7.05.016)**, + **[7.05.017](#fp7.05.017)**, + **[7.05.02](#fp7.05.02)**, + **[7.05.03](#fp7.05.03)**, + or another appropriate reason. +* 3. See **[MPEP §§ 2105](s2105.html#d0e197008)** - **[2107.03](s2107.html#d0e199419)** for additional guidance. + + + +# ¶ 7.05.01 Rejection, 35 U.S.C. 101, Nonstatutory (Not One of the Four + Statutory Categories) + + +the claimed invention is directed to nonstatutory subject matter. The + claim(s) does/do not fall within at least one of the four categories of patent eligible + subject matter because **[1]** + + +### Examiner Note: + + * 1. This form paragraph should be preceded by form paragraph + **[7.05](#fp0705)**. +* 2. In bracket 1, explain why the claimed invention is not patent + eligible subject matter by identifying what the claim(s) is/are directed to and explain + why it does not fall within at least one of the four categories of patent eligible + subject matter recited in **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** (process, machine, + manufacture, or composition of matter), e.g., the claim(s) is/are directed to a signal + *per se,* mere information in the form of data, a contract between + two parties, or a human being (see **[MPEP § 2106](s2106.html#d0e197244)**, subsection I). +* 3. For a claim that is directed to a judicial exception and is + nonstatutory, use form paragraph **[7.05.016](#fp7.05.016)**. + + + +# ¶ 7.05.016 Rejection, 35 U.S.C. 101, Nonstatutory (Directed to a Judicial + Exception without an Inventive Concept/Significantly More) + + +the claimed invention is directed to **[1]** without + significantly more. The claim(s) recite(s) **[2]**. This judicial exception is not + integrated into a practical application because **[3]**. The claim(s) does/do not + include additional elements that are sufficient to amount to significantly more than the + judicial exception because **[4]**. + + + +### Examiner Note: + + * 1. This form paragraph should be preceded by form paragraph + **[7.05](#fp7.05)**. For + claims that recite a tentative abstract idea (i.e., a limitation identified as an + abstract idea even though it does not fall within the groupings of abstract ideas + discussed in **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**), this form + paragraph should be accompanied by form paragraph **[7.05.017](#fp7.05.017)**. +* 2. This form paragraph is for use with all product (machine, + manufacture, and composition of matter) and process claims, and for all claims directed + to a law of nature, natural phenomenon (including a product of nature), or abstract + idea. +* 3. In bracket 1, identify whether the claim(s) are directed to a + law of nature, a natural phenomenon (including a product of nature), or an abstract + idea. +* 4. In bracket 2, identify the exception by referring to how it is + recited in the claim and explain why it is considered an exception (e.g., for an + abstract idea, identify the abstract idea grouping in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** into which the recited exception falls). For + example, "the Arrhenius equation, which is a law of nature and a mathematical concept + which describes the relationship between temperature and reaction rate" or "the series + of steps instructing how to hedge risk, which is a fundamental economic practice and + thus grouped as a certain method of organizing human interactions." For a product of + nature exception, refer to how it is recited in the claim and explain why its + characteristics are not markedly different from the product’s naturally occurring + counterpart in its natural state. For example, "the naturally occurring DNA segment, + which is not markedly different from its naturally occurring counterpart because it + conveys the same genetic information." Provide additional explanation regarding the + exception and how it has been identified when appropriate. +* 5. In bracket 3, explain why the combination of additional + elements fails to integrate the judicial exception into a practical application. For + example, if the claim is directed to an abstract idea with additional generic computer + elements, explain that the generically recited computer elements do not add a meaningful + limitation to the abstract idea because they amount to simply implementing the abstract + idea on a computer; or, if the claim is directed to a method of using a naturally + occurring correlation, explain that data gathering steps required to use the correlation + do not add a meaningful limitation to the method as they are insignificant + extra-solution activity. Similarly, if the claim recites a "naturally occurring DNA + segment" with an additional element of a test tube, explain that merely placing the + product of nature into a generic container such as a test tube does not add a meaningful + limitation as it is merely a nominal or token extra-solution component of the claim, and + is nothing more than an attempt to generally link the product of nature to a particular + technological environment. +* 6. In bracket 4, identify the additional elements and explain why, + when considered separately and in combination, they do not add significantly more (also + known as an "inventive concept") to the exception. For example, if the additional + limitations only store and retrieve information in memory, explain that these are + well-understood, routine, conventional computer functions as recognized by the court + decisions listed in **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**. + + + +# ¶ 7.05.017 Rejection, 35 U.S.C. 101, TC Director Approval for + "Tentative Abstract Idea" + + +The identified claim limitation(s) that recite(s) an abstract idea + do/does not fall within the groupings of abstract ideas discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, i.e., mathematical concepts, mental processes, or + certain methods of organizing human activity. Nonetheless, the claim limitation(s) is/are + being treated as reciting an abstract idea because **[1]**. + + + +This rejection has been approved by the Technology Center Director + signing below. + + + +**[2]** + + +### Examiner Note: + + * 1. This form paragraph should be preceded by form paragraph + **[7.05.016](#fp7.05.016)**. +* 2. Approval from the TC Director is required to treat a tentative + abstract idea (i.e., a claim limitation(s) that does not fall within the groupings of + abstract ideas discussed in **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**) as an abstract + idea. This form paragraph should be used to demonstrate that this approval has been + obtained. +* 3. In bracket 1, provide the justification for why the claim + limitation(s) is/are being treated as an abstract idea. For example, provide an + explanation of why the claim limitation is among the "basic tools of scientific and + technological work." +* 4. In bracket 2, insert the TC Director's signature. Approval of + the TC Director is required to treat a claim limitation that does not fall within the + groupings of abstract ideas discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** as reciting an abstract idea. See + **[MPEP § + 2106.04(a)(3)](s2106.html#ch2100_d2ea80_199c8_1c1)**. + + + + +, +# 2106.07(a)(1) Form Paragraphs for use in Lack of + Subject Matter Eligibility Rejections [R-10.2019] + + +Use form paragraphs **[7.04.01](#fp7.04.01)**, + **[7.05](#fp7.05)**, + and **[7.05.01](#fp7.05.01)** for rejections based on a failure to + claim an invention that falls within the statutory categories of invention (i.e., + the claim is not to one of the four statutory categories of invention and is thus + rejected at Step 1 of the eligibility analysis). + + + +Use form paragraphs **[7.04.01](#fp7.04.01)**, + **[7.05](#fp7.05)**, + and **[7.05.016](#fp7.05.016)** for rejections based on a failure to + claim an invention that is directed to patent-eligible subject matter, i.e., the + claim is directed to a judicial exception without providing an inventive + concept/significantly more, and is thus rejected at Step 2B of the eligibility + analysis. If the judicial exception to which the claim is directed is a "tentative + abstract idea," i.e., an abstract idea that does not fall within any of the + groupings of abstract ideas discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, then the Step 2B rejection must also use + form paragraph **[7.05.017](#fp7.05.017)** (in addition to form paragraphs + **[7.04.01](#fp7.04.01)**, **[7.05](#fp7.05)**, and + **[7.05.016](#fp7.05.016)**) and include the TC Director's + signature. + + + +# ¶ 7.04.01 Statement of Statutory Basis, 35 U.S.C. 101 + + +35 U.S.C. 101 reads as follows: + + +Whoever invents or discovers any new and useful process, machine, + manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a + patent therefor, subject to the conditions and requirements of this title. + + + +### Examiner Note: + + * This form paragraph must precede the first use of + **[35 U.S.C. + 101](mpep-9015-appx-l.html#d0e302376)** in all first actions on the merits and final rejections. + + + +# ¶ 7.05 Rejection, 35 U.S.C. 101, -Heading Only- (Utility, Nonstatutory, + Inoperative) + + +Claim **[1]** rejected under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** because + + + +### Examiner Note: + + * 1. This form paragraph must be preceded by form paragraph + **[7.04.01](#fp7.04.01)** in + first actions and final rejections. +* 2. This form paragraph must be followed by a detailed explanation of + the grounds of rejection using one or more of form paragraphs + **[7.05.01](#fp7.05.01)**, + **[7.05.016](#fp7.05.016)**, + **[7.05.017](#fp7.05.017)**, + **[7.05.02](#fp7.05.02)**, + **[7.05.03](#fp7.05.03)**, + or another appropriate reason. +* 3. See **[MPEP §§ 2105](s2105.html#d0e197008)** - **[2107.03](s2107.html#d0e199419)** for additional guidance. + + + +# ¶ 7.05.01 Rejection, 35 U.S.C. 101, Nonstatutory (Not One of the Four + Statutory Categories) + + +the claimed invention is directed to nonstatutory subject matter. The + claim(s) does/do not fall within at least one of the four categories of patent eligible + subject matter because **[1]** + + +### Examiner Note: + + * 1. This form paragraph should be preceded by form paragraph + **[7.05](#fp0705)**. +* 2. In bracket 1, explain why the claimed invention is not patent + eligible subject matter by identifying what the claim(s) is/are directed to and explain + why it does not fall within at least one of the four categories of patent eligible + subject matter recited in **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** (process, machine, + manufacture, or composition of matter), e.g., the claim(s) is/are directed to a signal + *per se,* mere information in the form of data, a contract between + two parties, or a human being (see **[MPEP § 2106](s2106.html#d0e197244)**, subsection I). +* 3. For a claim that is directed to a judicial exception and is + nonstatutory, use form paragraph **[7.05.016](#fp7.05.016)**. + + + +# ¶ 7.05.016 Rejection, 35 U.S.C. 101, Nonstatutory (Directed to a Judicial + Exception without an Inventive Concept/Significantly More) + + +the claimed invention is directed to **[1]** without + significantly more. The claim(s) recite(s) **[2]**. This judicial exception is not + integrated into a practical application because **[3]**. The claim(s) does/do not + include additional elements that are sufficient to amount to significantly more than the + judicial exception because **[4]**. + + + +### Examiner Note: + + * 1. This form paragraph should be preceded by form paragraph + **[7.05](#fp7.05)**. For + claims that recite a tentative abstract idea (i.e., a limitation identified as an + abstract idea even though it does not fall within the groupings of abstract ideas + discussed in **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**), this form + paragraph should be accompanied by form paragraph **[7.05.017](#fp7.05.017)**. +* 2. This form paragraph is for use with all product (machine, + manufacture, and composition of matter) and process claims, and for all claims directed + to a law of nature, natural phenomenon (including a product of nature), or abstract + idea. +* 3. In bracket 1, identify whether the claim(s) are directed to a + law of nature, a natural phenomenon (including a product of nature), or an abstract + idea. +* 4. In bracket 2, identify the exception by referring to how it is + recited in the claim and explain why it is considered an exception (e.g., for an + abstract idea, identify the abstract idea grouping in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** into which the recited exception falls). For + example, "the Arrhenius equation, which is a law of nature and a mathematical concept + which describes the relationship between temperature and reaction rate" or "the series + of steps instructing how to hedge risk, which is a fundamental economic practice and + thus grouped as a certain method of organizing human interactions." For a product of + nature exception, refer to how it is recited in the claim and explain why its + characteristics are not markedly different from the product’s naturally occurring + counterpart in its natural state. For example, "the naturally occurring DNA segment, + which is not markedly different from its naturally occurring counterpart because it + conveys the same genetic information." Provide additional explanation regarding the + exception and how it has been identified when appropriate. +* 5. In bracket 3, explain why the combination of additional + elements fails to integrate the judicial exception into a practical application. For + example, if the claim is directed to an abstract idea with additional generic computer + elements, explain that the generically recited computer elements do not add a meaningful + limitation to the abstract idea because they amount to simply implementing the abstract + idea on a computer; or, if the claim is directed to a method of using a naturally + occurring correlation, explain that data gathering steps required to use the correlation + do not add a meaningful limitation to the method as they are insignificant + extra-solution activity. Similarly, if the claim recites a "naturally occurring DNA + segment" with an additional element of a test tube, explain that merely placing the + product of nature into a generic container such as a test tube does not add a meaningful + limitation as it is merely a nominal or token extra-solution component of the claim, and + is nothing more than an attempt to generally link the product of nature to a particular + technological environment. +* 6. In bracket 4, identify the additional elements and explain why, + when considered separately and in combination, they do not add significantly more (also + known as an "inventive concept") to the exception. For example, if the additional + limitations only store and retrieve information in memory, explain that these are + well-understood, routine, conventional computer functions as recognized by the court + decisions listed in **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)**. + + + +# ¶ 7.05.017 Rejection, 35 U.S.C. 101, TC Director Approval for + "Tentative Abstract Idea" + + +The identified claim limitation(s) that recite(s) an abstract idea + do/does not fall within the groupings of abstract ideas discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**, i.e., mathematical concepts, mental processes, or + certain methods of organizing human activity. Nonetheless, the claim limitation(s) is/are + being treated as reciting an abstract idea because **[1]**. + + + +This rejection has been approved by the Technology Center Director + signing below. + + + +**[2]** + + +### Examiner Note: + + * 1. This form paragraph should be preceded by form paragraph + **[7.05.016](#fp7.05.016)**. +* 2. Approval from the TC Director is required to treat a tentative + abstract idea (i.e., a claim limitation(s) that does not fall within the groupings of + abstract ideas discussed in **[MPEP § 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)**) as an abstract + idea. This form paragraph should be used to demonstrate that this approval has been + obtained. +* 3. In bracket 1, provide the justification for why the claim + limitation(s) is/are being treated as an abstract idea. For example, provide an + explanation of why the claim limitation is among the "basic tools of scientific and + technological work." +* 4. In bracket 2, insert the TC Director's signature. Approval of + the TC Director is required to treat a claim limitation that does not fall within the + groupings of abstract ideas discussed in **[MPEP § + 2106.04(a)(2)](s2106.html#ch2100_d29a1b_13ae3_321)** as reciting an abstract idea. See + **[MPEP § + 2106.04(a)(3)](s2106.html#ch2100_d2ea80_199c8_1c1)**. + + + +, +# 2106.07(b) Evaluating Applicant's Response [R-10.2019] + + +After examiners identify and explain in the record + the reasons why a claim is directed to an abstract idea, natural phenomenon, or law + of nature without significantly more, then the burden shifts to the applicant to + either amend the claim or make a showing of why the claim is eligible for patent + protection. + + + + In response to a rejection based on failure to claim + patent-eligible subject matter, applicant may: (i) amend the claim, e.g., to add + additional elements or modify existing elements so that the claim as a whole amounts + to significantly more than the judicial exception, (or integrates the judicial + exception into a practical application), (ii) present persuasive arguments based on a + good faith belief as to why the rejection is in error and/or (iii) submit evidence + traversing a subject matter eligibility rejection according to the procedures set + forth in **[MPEP § + 716.01](s716.html#d0e92469)** and **[37 CFR 1.132](mpep-9020-appx-r.html#d0e323552)**. When evaluating a + response, examiners must carefully consider all of applicant's arguments and evidence + rebutting the subject matter eligibility rejection. If applicant has amended the + claim, examiners should determine the amended claim’s broadest reasonable + interpretation and again perform the subject matter eligibility analysis. + + + +If applicant's claim amendment(s), evidence, and/or + argument(s) persuasively establish that the claim is not directed to a judicial + exception or is directed to significantly more than a judicial exception, the + rejection should be withdrawn. Applicant may argue that a claim is eligible because + the claim as a whole integrates the judicial exception into a practical application + or amounts to significantly more than the judicial exception when the additional + elements are considered both individually and in combination. When an additional + element is considered individually by the examiner, the additional element may be + enough to integrate the judicial exception into a practical application or to qualify + as "significantly more" if it meaningfully limits the judicial exception, + *e.g.,* it improves another technology or technical field, + improves the functioning of a computer itself. + + + +In addition, even if an element does not integrate a + judicial exception into a practical application or amount to significantly more on + its own (*e.g.,* because it is merely a generic computer component + performing generic computer functions), it can still integrate or amount to + significantly more when considered in combination with the other elements of the + claim. For example, generic computer components that individually perform merely + generic computer functions (*e.g.,* a CPU that performs mathematical + calculations or a clock that produces time data) in some instances are able in + combination to perform functions that are not generic computer functions and + therefore integrate or amount to significantly more than an abstract idea (and are + thus eligible). + + + +If applicant properly challenges the examiner's + findings but the examiner deems it appropriate to maintain the rejection, a rebuttal + must be provided in the next Office action. Several examples of appropriate examiner + responses are provided below. + + + +* (1) If applicant challenges the identification of a + tentative abstract idea that was based on a court case and the challenge is not + persuasive, an appropriate response would be an explanation as to why the + abstract idea identified in the claim is similar to the concept in the cited + case. +* (2) If applicant responds to an examiner's assertion + that something is well-known, routine, conventional activity with a specific + argument or evidence that the additional elements in a claim are not + well-understood, routine, conventional activities previously engaged in by + those in the relevant art, the examiner should reevaluate whether the + additional elements are in actuality well-known, routine, conventional + activities to those who work in the relevant field. It is especially necessary + for the examiner to fully reevaluate their position when such additional + elements are not discussed in the specification as being known generic + functions/components/activities or are not treated by the courts as + well-understood, routine, conventional activities. If the rejection is to be + maintained, the examiner should consider whether evidence should be provided to + further support the rejection and clarify the record for appeal. See + **[MPEP § 2106.05(d)](s2106.html#ch2100_d29a1b_13d41_124)** for examples of elements that the + courts have found to be well understood, routine and conventional activity. If + the examiner has taken official notice per item (D) of subsection III above + that an element(s) is well-understood, routine, conventional activity, and the + applicant challenges the examiner's position, specifically stating that such + element(s) is not well-understood, routine, conventional activity, the examiner + must then provide one of the items discussed in paragraphs (A) through (C) of + subsection III above, or an affidavit or declaration under **[37 CFR + 1.104(d)(2)](mpep-9020-appx-r.html#d0e322249)** setting forth specific factual statements and + explanation to support the examiner’s position. See also **[MPEP § + 2106.07(b)](s2106.html#ch2100_d29a1b_14065_2a0)**, item (2). +* (3) If applicant amends a claim to add a generic + computer or generic computer components and asserts that the claim is + integrated into a practical application or recites significantly more because + the generic computer is 'specially programmed' (as in + *Alappat*, now considered superseded) or is a 'particular + machine' (as in *Bilski*), the examiner should look at whether + the added elements integrate the judicial exception into a practical + application or provide significantly more than the judicial exception. Merely + adding a generic computer, generic computer components, or a programmed + computer to perform generic computer functions does not automatically overcome + an eligibility rejection. *Alice Corp. Pty. Ltd. v. CLS Bank + Int'l,* 573 U.S. 208, 224, 110 USPQ2d 1976, 1984 (2014). See also + *OIP Techs. v. Amazon.com,* 788 F.3d 1359, 1364, 115 USPQ2d + 1090, 1093-94 (Fed. Cir. 2015) ("Just as *Diehr* could not + save the claims in *Alice*, which were directed to + ‘implement[ing] the abstract idea of intermediated settlement on a generic + computer’, it cannot save *OIP*'s claims directed to + implementing the abstract idea of price optimization on a generic computer.") + (citations omitted). +* (4) If applicant argues that the claim is specific + and does not preempt all applications of the exception, the examiner should + reconsider Step 2A of the eligibility analysis, *e.g.,* to + determine whether the claim is directed to an improvement to the functioning of + a computer or to any other technology or technical field. If an examiner still + determines that the claim is directed to a judicial exception, the examiner + should then reconsider in Step 2B whether the additional elements in + combination (as well as individually) amount to an inventive concept, + *e.g.,* because they are more than the non-conventional and + non-generic arrangement of known, conventional elements. Such reconsideration + is appropriate because, although preemption is not a standalone test for + eligibility, it remains the underlying concern that drives the two-part + framework from *Alice Corp.* and *Mayo* + (Steps 2A and 2B). *Synopsys, Inc. v. Mentor Graphics Corp.,* + 839 F.3d 1138, 1150, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016); *Rapid + Litig. Mgmt. v. CellzDirect, Inc.,* 827 F.3d 1042, 1052, 119 USPQ2d + 1370, 1376 (Fed. Cir. 2016); *Ariosa Diagnostics, Inc. v. Sequenom, + Inc.,* 788 F.3d 1371, 1379, 115 USPQ2d 1152, 1158 (Fed. Cir. 2015). + + +, +# 2106.07(c) Clarifying the Record [R-08.2017] + + +When the claims are deemed patent eligible, the + examiner may make clarifying remarks on the record. For example, if a claim is found + eligible because it improves upon existing technology, the examiner could reference + the portion of the specification that describes the claimed improvement and note the + claim elements that produce that improvement. The clarifying remarks may be made at + any point during prosecution as well as with a notice of allowance. + + + +Clarifying remarks may be useful in explaining the + rationale for a rejection as well. For instance, explaining the broadest reasonable + interpretation (BRI) of a claim will assist applicant in understanding and responding + to a rejection. As an example, a rejection for failure to recite patent eligible + subject matter in a claim to a computer readable medium could include an explanation + that the broadest reasonable interpretation of the claim covers a carrier wave, which + does not fall within one of the four categories of invention, and a suggestion to + overcome the rejection by submitting a narrowing amendment to cover the statutory + embodiments. + + + +] \ No newline at end of file