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	[
	# 2107 Guidelines for Examination of Applications for Compliance with the
	Utility Requirement [R-11.2013]

	I. INTRODUCTIONThe following Guidelines establish the policies and procedures to be
	followed by Office personnel in the evaluation of any patent application for compliance
	with the utility requirements of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) and **[35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5), or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph. These Guidelines have been promulgated to assist Office personnel in their
	review of applications for compliance with the utility requirement. The Guidelines do
	not alter the substantive requirements of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) and [35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824), nor
	are they designed to obviate the examiner’s review of applications for compliance with
	all other statutory requirements for patentability. The Guidelines do not constitute
	substantive rulemaking and hence do not have the force and effect of law. Rejections
	will be based upon the substantive law, and it is these rejections which are appealable.
	Consequently, any perceived failure by Office personnel to follow these Guidelines is
	neither appealable nor petitionable.


	II. EXAMINATION GUIDELINES FOR THE UTILITY REQUIREMENT Office personnel are to adhere to the following procedures when
	reviewing patent applications for compliance with the "useful invention" ("utility")
	requirement of **[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376) and [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** or
	**[pre-AIA 35 U.S.C.
	112](mpep-9015-appx-l.html#d0e302824)**, first paragraph.



	* (A) Read the claims and the supporting written description.
	+ (1) Determine what the applicant has claimed, noting any
	specific embodiments of the invention.
	+ (2) Ensure that the claims define statutory subject matter
	(i.e., a process, machine, manufacture, composition of matter, or
	improvement thereof).
	+ (3) If at any time during the examination, it becomes readily
	apparent that the claimed invention has a well-established utility, do not
	impose a rejection based on lack of utility. An invention has a
	well-established utility if (i) a person of ordinary skill in the art would
	immediately appreciate why the invention is useful based on the
	characteristics of the invention (e.g., properties or applications of a
	product or process), and (ii) the utility is specific, substantial, and
	credible.
	* (B) Review the claims and the supporting written description to
	determine if the applicant has asserted for the claimed invention any specific and
	substantial utility that is credible:
	+ (1) If the applicant has asserted that the claimed invention is
	useful for any particular practical purpose (i.e., it has a "specific and
	substantial utility") and the assertion would be considered credible by a
	person of ordinary skill in the art, do not impose a rejection based on lack
	of utility.
	- (i) A claimed invention must have a specific and
	substantial utility. This requirement excludes "throw-away,"
	"insubstantial," or "nonspecific" utilities, such as the use of a
	complex invention as landfill, as a way of satisfying the utility
	requirement of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376).
	- (ii) Credibility is assessed from the perspective of one
	of ordinary skill in the art in view of the disclosure and any other
	evidence of record (e.g., test data, affidavits or declarations from
	experts in the art, patents or printed publications) that is probative
	of the applicant’s assertions. An applicant need only provide one
	credible assertion of specific and substantial utility for each
	claimed invention to satisfy the utility requirement.
	+ (2) If no assertion of specific and substantial utility for the
	claimed invention made by the applicant is credible, and the claimed
	invention does not have a readily apparent well-established utility, reject
	the claim(s) under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) on the
	grounds that the invention as claimed lacks utility. Also reject the claims
	under [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or
	**[pre-AIA
	35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph, on the basis that the
	disclosure fails to teach how to use the invention as claimed. The
	[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or
	[pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824912), first paragraph, rejection
	imposed in conjunction with a [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) rejection
	should incorporate by reference the grounds of the corresponding
	**[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** rejection.
	+ (3) If the applicant has not asserted any specific and
	substantial utility for the claimed invention and it does not have a readily
	apparent well-established utility, impose a rejection under
	**[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**, emphasizing that the applicant has not
	disclosed a specific and substantial utility for the invention. Also impose
	a separate rejection under [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or
	[pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824912), first paragraph, on the basis
	that the applicant has not disclosed how to use the invention due to the
	lack of a specific and substantial utility. The **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376) and [35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)** rejections
	shift the burden of coming forward with evidence to the applicant to:
	- (i) Explicitly identify a specific and substantial
	utility for the claimed invention; and
	- (ii) Provide evidence that one of ordinary skill in the
	art would have recognized that the identified specific and substantial
	utility was well-established at the time of filing. The examiner
	should review any subsequently submitted evidence of utility using the
	criteria outlined above. The examiner should also ensure that there is
	an adequate nexus between the evidence and the properties of the now
	claimed subject matter as disclosed in the application as filed. That
	is, the applicant has the burden to establish a probative relation
	between the submitted evidence and the originally disclosed properties
	of the claimed invention.
	+ (C) Any rejection based on lack of utility should include a
	detailed explanation why the claimed invention has no specific and
	substantial credible utility. Whenever possible, the examiner should provide
	documentary evidence regardless of publication date (e.g., scientific or
	technical journals, excerpts from treatises or books, or U.S. or foreign
	patents) to support the factual basis for the prima facie
	showing of no specific and substantial credible utility. If documentary
	evidence is not available, the examiner should specifically explain the
	scientific basis for his or her factual conclusions.
	- (1) Where the asserted utility is not specific or
	substantial, a prima facie showing must establish
	that it is more likely than not that a person of ordinary skill in the
	art would not consider that any utility asserted by the applicant
	would be specific and substantial. The prima facie
	showing must contain the following elements:
	* (i) An explanation that clearly sets forth the
	reasoning used in concluding that the asserted utility for the
	claimed invention is not both specific and substantial nor
	well-established;
	* (ii) Support for factual findings relied upon in
	reaching this conclusion; and
	* (iii) An evaluation of all relevant evidence of
	record, including utilities taught in the closest prior art.
	- (2) Where the asserted specific and substantial utility
	is not credible, a prima facie showing of no
	specific and substantial credible utility must establish that it is
	more likely than not that a person skilled in the art would not
	consider credible any specific and substantial utility asserted by the
	applicant for the claimed invention. The *prima
	facie* showing must contain the following elements:
	* (i) An explanation that clearly sets forth the
	reasoning used in concluding that the asserted specific and
	substantial utility is not credible;
	* (ii) Support for factual findings relied upon in
	reaching this conclusion; and
	* (iii) An evaluation of all relevant evidence of
	record, including utilities taught in the closest prior art.
	- (3) Where no specific and substantial utility is
	disclosed or is well-established, a prima facie showing of no specific and substantial utility need only
	establish that applicant has not asserted a utility and that, on the
	record before the examiner, there is no known well-established
	utility.
	+ (D) A rejection based on lack of utility should not be
	maintained if an asserted utility for the claimed invention would be
	considered specific, substantial, and credible by a person of ordinary skill
	in the art in view of all evidence of record.


	Office personnel are reminded that they must treat as true a statement
	of fact made by an applicant in relation to an asserted utility, unless countervailing
	evidence can be provided that shows that one of ordinary skill in the art would have a
	legitimate basis to doubt the credibility of such a statement. Similarly, Office
	personnel must accept an opinion from a qualified expert that is based upon relevant
	facts whose accuracy is not being questioned; it is improper to disregard the opinion
	solely because of a disagreement over the significance or meaning of the facts
	offered.



	Once a prima facie showing of no specific and
	substantial credible utility has been properly established, the applicant bears the
	burden of rebutting it. The applicant can do this by amending the claims, by providing
	reasoning or arguments, or by providing evidence in the form of a declaration under
	**[37 CFR
	1.132](mpep-9020-appx-r.html#d0e323552)** or a patent or a printed publication that rebuts the basis
	or logic of the prima facie showing. If the applicant responds to the
	prima facie rejection, the Office personnel should review the
	original disclosure, any evidence relied upon in establishing the *prima
	facie* showing, any claim amendments, and any new reasoning or evidence
	provided by the applicant in support of an asserted specific and substantial credible
	utility. It is essential for Office personnel to recognize, fully consider and respond
	to each substantive element of any response to a rejection based on lack of utility.
	Only where the totality of the record continues to show that the asserted utility is not
	specific, substantial, and credible should a rejection based on lack of utility be
	maintained.



	If the applicant satisfactorily rebuts a prima facie
	rejection based on lack of utility under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376), withdraw the
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** rejection and the corresponding rejection imposed under
	**[35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824912)**, first
	paragraph.




	# 2107.01 General Principles Governing Utility Rejections [R-10.2019]



	#### *35 U.S.C. 101
	Inventions patentable*


	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.




	See **[MPEP
	§ 2107](s2107.html#d0e198469)** for guidelines for the examination of applications for
	compliance with the utility requirement of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376).



	The Office must examine each application to ensure compliance with the
	"useful invention" or utility requirement of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376). In discharging this
	obligation, however, Office personnel must keep in mind several general principles that
	control application of the utility requirement. [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) has been interpreted
	as imposing four purposes. First, [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) limits an inventor to
	ONE patent for a claimed invention. If more than one patent is sought, a patent
	applicant will receive a statutory double patenting rejection for claims included in
	more than one application that are directed to the same invention. See
	**[MPEP §
	804](s804.html#d0e98894)**. Second, the inventor(s) must be the applicant in an
	application filed before September 16, 2012, (except as otherwise provided in
	**[pre-AIA 37 CFR
	1.41(b)](mpep-9020-appx-r.html#d0e317757)**) and the inventor or each joint inventor must be
	identified in an application filed on or after September 16, 2012. See
	**[MPEP §
	2109](s2109.html#ch2100_d2c183_22374_28b)** for a detailed discussion of inventorship,
	**[MPEP §
	602.01(c)](s602.html#d0e4830ss602)**et seq. for details regarding correction of inventorship,
	**[MPEP §
	2157](s2157.html#ch2100_d20034_1bb92_e7) for rejections under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) and [115](mpep-9015-appx-l.html#d0e302875912)** for failure
	to set forth the correct inventorship, and [MPEP § 2137](s2137.html#d0e206570) for rejections under
	**[pre-AIA 35 U.S.C.
	102(f)](mpep-9015-appx-l.html#d0e302420) (for applications subject to [pre-AIA 35 U.S.C.
	102](mpep-9015-appx-l.html#d0e302383)**) for failure to set forth the correct inventorship. Third,
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** defines which categories of inventions are eligible for patent
	protection. An invention that is not a machine, an article of manufacture, a composition
	or a process cannot be patented. See Diamondv.Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980);
	Diamondv.Diehr, 450 U.S. 175, 209 USPQ 1 (1981); *In re
	Nuijten,* 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007).
	Fourth, **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** serves to ensure that patents are granted on only those
	inventions that are "useful." This second purpose has a Constitutional footing — Article
	I, Section 8 of the Constitution authorizes Congress to provide exclusive rights to
	inventors to promote the "useful arts." See Carl Zeiss Stiftungv.Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991). Thus,
	to satisfy the requirements of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376), an applicant must
	claim an invention that is statutory subject matter and must show that the claimed
	invention is "useful" for some purpose either explicitly or implicitly. Application of
	this latter element of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) is the focus of these guidelines.



	Deficiencies under the "useful invention" requirement of
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** will arise in one of two forms. The first is where it is not
	apparent why the invention is "useful." This can occur when an applicant fails to
	identify any specific and substantial utility for the invention or fails to disclose
	enough information about the invention to make its usefulness immediately apparent to
	those familiar with the technological field of the invention. Brennerv.Manson, 383 U.S. 519, 148 USPQ 689 (1966); *In re
	Fisher,* 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); *In re
	Ziegler,* 992 F.2d 1197, 26 USPQ2d 1600 (Fed. Cir. 1993). The second type of
	deficiency arises in the rare instance where an assertion of specific and substantial
	utility for the invention made by an applicant is not credible.


	I. SPECIFIC AND SUBSTANTIAL REQUIREMENTSTo satisfy [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376), an invention must
	be "useful." Courts have recognized that the term "useful" used with reference to the
	utility requirement can be a difficult term to define. Brennerv.Manson, 383 U.S. 519, 529, 148 USPQ 689, 693 (1966) (simple
	everyday word like "useful" can be "pregnant with ambiguity when applied to the facts
	of life."). Where an applicant has set forth a specific and substantial utility,
	courts have been reluctant to uphold a rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	solely on the basis that the applicant’s opinion as to the nature of the specific and
	substantial utility was inaccurate. For example, in Nelsonv.Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980), the court reversed
	a finding by the Office that the applicant had not set forth a "practical" utility
	under **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)**. In this case the applicant asserted that the composition
	was "useful" in a particular pharmaceutical application and provided evidence to
	support that assertion. Courts have used the labels "practical utility," "substantial
	utility," or "specific utility" to refer to this aspect of the "useful invention"
	requirement of **[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**. The Court of Customs and Patent Appeals has
	stated:




	>
	> Practical utility is a shorthand way of attributing "real-world"
	> value to claimed subject matter. In other words, one skilled in the art can use a
	> claimed discovery in a manner which provides some immediate benefit to the
	> public.
	>
	>
	>
	>


	Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA
	1980).



	Practical considerations require the Office to rely on the
	inventor’s understanding of the invention in determining whether and in what regard
	an invention is believed to be "useful." Because of this, Office personnel should
	focus on and be receptive to assertions made by the applicant that an invention is
	"useful" for a particular reason.


	*A.**Specific UtilityA "specific utility" is specific* to the
	subject matter claimed and can "provide a well-defined and particular benefit to
	the public." In re Fisher, 421 F.3d 1365, 1371, 76 USPQ2d 1225,
	1230 (Fed. Cir. 2005). This contrasts with a general utility
	that would be applicable to the broad class of the invention. Office personnel
	should distinguish between situations where an applicant has disclosed a specific
	use for or application of the invention and situations where the applicant merely
	indicates that the invention may prove useful without identifying with specificity
	why it is considered useful. For example, indicating that a
	compound may be useful in treating unspecified disorders, or that the compound has
	"useful biological" properties, would not be sufficient to define a specific
	utility for the compound. See, e.g., In re Kirk, 376 F.2d 936,
	153 USPQ 48 (CCPA 1967); In re Joly, 376 F.2d 906, 153 USPQ 45
	(CCPA 1967). Similarly, a claim to a polynucleotide whose use is disclosed simply
	as a "gene probe" or "chromosome marker" would not be considered to be
	specific in the absence of a disclosure of a specific DNA
	target. See In re Fisher, 421 F.3d at 1374, 76 USPQ2d at 1232
	("Any EST [expressed sequence tag] transcribed from any gene in the maize genome
	has the potential to perform any one of the alleged uses…. Nothing about
	[applicant’s] seven alleged uses set the five claimed ESTs apart from the more
	than 32,000 ESTs disclosed in the [ ] application or indeed from any EST derived
	from any organism. Accordingly, we conclude that [applicant] has only disclosed
	general uses for its claimed ESTs, not specific ones that satisfy
	**[§
	101](mpep-9015-appx-l.html#d0e302376)**."). A general statement of diagnostic utility, such as
	diagnosing an unspecified disease, would ordinarily be insufficient absent a
	disclosure of what condition can be diagnosed. Contrast the situation where an
	applicant discloses a specific biological activity and reasonably correlates that
	activity to a disease condition. Assertions falling within the latter category are
	sufficient to identify a specific utility for the invention. Assertions that fall
	in the former category are insufficient to define a specific utility for the
	invention, especially if the assertion takes the form of a general statement that
	makes it clear that a "useful" invention may arise from
	what has been disclosed by the applicant. Knapp v.Anderson, 477 F.2d 588, 177 USPQ 688 (CCPA 1973).


	*B.**Substantial Utility* "[A]n application must show that an invention is useful to the
	public as disclosed in its current form, not that it may prove useful at some
	future date after further research. Simply put, to satisfy the ‘substantial’
	utility requirement, an asserted use must show that the claimed invention has a
	significant and presently available benefit to the public."
	Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230. The claims at
	issue in Fisher were directed to expressed sequence tags
	(ESTs), which are short nucleotide sequences that can be used to discover what
	genes and downstream proteins are expressed in a cell. The court held that "the
	claimed ESTs can be used only to gain further information about the underlying
	genes and the proteins encoded for by those genes. The claimed ESTs themselves are
	not an end of [applicant’s] research effort, but only tools to be used along the
	way in the search for a practical utility…. [Applicant] does not identify the
	function for the underlying protein-encoding genes. Absent such identification, we
	hold that the claimed ESTs have not been researched and understood to the point of
	providing an immediate, well-defined, real world benefit to the public meriting
	the grant of a patent." Id. at 1376, 76 USPQ2d at 1233-34).
	Thus a "substantial utility" defines a "real world" use. Utilities that require or
	constitute carrying out further research to identify or reasonably confirm a "real
	world" context of use are not substantial utilities. For example, both a
	therapeutic method of treating a known or newly discovered disease and an assay
	method for identifying compounds that themselves have a "substantial utility"
	define a "real world" context of use. An assay that measures the presence of a
	material which has a stated correlation to a predisposition to the onset of a
	particular disease condition would also define a "real world" context of use in
	identifying potential candidates for preventive measures or further monitoring. On
	the other hand, the following are examples of situations that require or
	constitute carrying out further research to identify or reasonably confirm a "real
	world" context of use and, therefore, do not define "substantial utilities":



	* (A) Basic research such as studying the properties of the
	claimed product itself or the mechanisms in which the material is
	involved;
	* (B) A method of treating an unspecified
	disease or condition;
	* (C) A method of assaying for or identifying a material that
	itself has no specific and/or substantial utility;
	* (D) A method of making a material that itself has no specific,
	substantial, and credible utility; and
	* (E) A claim to an intermediate product for use in making a
	final product that has no specific, substantial and credible utility.


	Office personnel must be careful not to interpret the phrase
	"immediate benefit to the public" or similar formulations in other cases to mean
	that products or services based on the claimed invention must be "currently
	available" to the public in order to satisfy the utility requirement. See, e.g.,
	Brenner v. Manson, 383 U.S. 519, 534-35, 148 USPQ 689, 695
	(1966). Rather, any reasonable use that an applicant has identified for the
	invention that can be viewed as providing a public benefit should be accepted as
	sufficient, at least with regard to defining a "substantial" utility.


	*C.**Research Tools*Some confusion can result when one attempts to label certain
	types of inventions as not being capable of having a specific and substantial
	utility based on the setting in which the invention is to be used. One example is
	inventions to be used in a research or laboratory setting. Many research tools
	such as gas chromatographs, screening assays, and nucleotide sequencing techniques
	have a clear, specific and unquestionable utility (e.g., they are useful in
	analyzing compounds). An assessment that focuses on whether an invention is useful
	only in a research setting thus does not address whether the invention is in fact
	"useful" in a patent sense. Instead, Office personnel must distinguish between
	inventions that have a specifically identified substantial utility and inventions
	whose asserted utility requires further research to identify or reasonably
	confirm. Labels such as "research tool," "intermediate" or "for research purposes"
	are not helpful in determining if an applicant has identified a specific and
	substantial utility for the invention.


	II. WHOLLY INOPERATIVE INVENTIONS; "INCREDIBLE" UTILITYAn invention that is "inoperative" (i.e., it does not operate to
	produce the results claimed by the patent applicant) is not a "useful" invention in
	the meaning of the patent law. See, e.g., Newmanv.Quigg, 877 F.2d 1575, 1581, 11 USPQ2d 1340, 1345 (Fed. Cir. 1989);
	In re Harwood, 390 F.2d 985, 989, 156 USPQ 673, 676 (CCPA 1968)
	("An inoperative invention, of course, does not satisfy the requirement of
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** that an invention be useful."). However, as the Federal
	Circuit has stated, "[t]o violate [[35 U.S.C.] 101](mpep-9015-appx-l.html#d0e302376) the claimed
	device must be totally incapable of achieving a useful
	result." Brooktree Corp.v.Advanced Micro Devices, Inc., 977 F.2d 1555, 1571, 24 USPQ2d 1401,
	1412 (Fed. Cir. 1992) (emphasis added). See also *E.I. du Pont De Nemours and
	Co.v.Berkley and Co.,* 620 F.2d 1247, 1260 n.17, 205 USPQ 1, 10 n.17
	(8th Cir. 1980) ("A small degree of utility is sufficient . . . The claimed invention
	must only be capable of performing some beneficial function . . . An invention does
	not lack utility merely because the particular embodiment disclosed in the patent
	lacks perfection or performs crudely . . . A commercially successful product is not
	required . . . Nor is it essential that the invention accomplish all its intended
	functions . . . or operate under all conditions . . . partial success being
	sufficient to demonstrate patentable utility . . . In short, the defense of
	non-utility cannot be sustained without proof of total incapacity." If an invention
	is only partially successful in achieving a useful result, a
	rejection of the claimed invention as a whole based on a lack of utility is not
	appropriate. See In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed.
	Cir. 1995); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA),
	reh’g denied, 480 F.2d 879 (CCPA 1973); *In re
	Marzocchi,* 439 F.2d 220, 169 USPQ 367 (CCPA 1971).



	Situations where an invention is found to be "inoperative" and
	therefore lacking in utility are rare, and rejections maintained solely on this
	ground by a federal court even rarer. In many of these cases, the utility asserted by
	the applicant was thought to be "incredible in the light of the knowledge of the art,
	or factually misleading" when initially considered by the Office. *In re
	Citron,* 325 F.2d 248, 253, 139 USPQ 516, 520 (CCPA 1963). Other cases
	suggest that on initial evaluation, the Office considered the asserted utility to be
	inconsistent with known scientific principles or "speculative at best" as to whether
	attributes of the invention necessary to impart the asserted utility were actually
	present in the invention. In re Sichert, 566 F.2d 1154, 196 USPQ
	209 (CCPA 1977). However cast, the underlying finding by the court in these cases was
	that, based on the factual record of the case, it was clear
	that the invention could not and did not work as the inventor claimed it did. Indeed,
	the use of many labels to describe a single problem (e.g., a false assertion
	regarding utility) has led to some of the confusion that exists today with regard to
	a rejection based on the "utility" requirement. Examples of such cases include: an
	invention asserted to change the taste of food using a magnetic field
	(Fregeauv.Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985)), a
	perpetual motion machine (Newmanv.Quigg, 877 F.2d 1575, 11 USPQ2d 1340 (Fed. Cir. 1989)), a flying
	machine operating on "flapping or flutter function" *(In re
	Houghton,* 433 F.2d 820, 167 USPQ 687 (CCPA 1970)), a "cold fusion"
	process for producing energy (In re Swartz, 232 F.3d 862, 56
	USPQ2d 1703 (Fed. Cir. 2000)), a method for increasing the energy output of fossil
	fuels upon combustion through exposure to a magnetic field *(In re
	Ruskin,* 354 F.2d 395, 148 USPQ 221 (CCPA 1966)), uncharacterized
	compositions for curing a wide array of cancers (In re Citron, 325
	F.2d 248, 139 USPQ 516 (CCPA 1963)), and a method of controlling the aging process
	(In re Eltgroth, 419 F.2d 918, 164 USPQ 221 (CCPA 1970)). These
	examples are fact specific and should not be applied as a
	per se rule. Thus, in view of the rare nature of such cases,
	Office personnel should not label an asserted utility "incredible," "speculative" or
	otherwise unless it is clear that a rejection based on "lack of utility" is
	proper.


	III. THERAPEUTIC OR PHARMACOLOGICAL UTILITYInventions asserted to have utility in the treatment of human or
	animal disorders are subject to the same legal requirements for utility as inventions
	in any other field of technology. In re Chilowsky, 229 F.2d 457,
	461-2, 108 USPQ 321, 325 (CCPA 1956) ("There appears to be no basis in the statutes
	or decisions for requiring any more conclusive evidence of operativeness in one type
	of case than another. The character and amount of evidence needed may vary, depending
	on whether the alleged operation described in the application appears to accord with
	or to contravene established scientific principles or to depend upon principles
	alleged but not generally recognized, but the degree of certainty as to the ultimate
	fact of operativeness or inoperativeness should be the same in all cases");
	In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967)
	("Thus, in the usual case where the mode of operation alleged can be readily
	understood and conforms to the known laws of physics and chemistry, operativeness is
	not questioned, and no further evidence is required."). As such, pharmacological or
	therapeutic inventions that provide any "immediate benefit to
	the public" satisfy [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376). The utility being asserted in
	Nelson related to a compound with pharmacological utility.
	Nelsonv.Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980). Office
	personnel should rely on Nelson and other cases as providing
	general guidance when evaluating the utility of an invention that is based on any
	therapeutic, prophylactic, or pharmacological activities of that invention.



	Courts have repeatedly found that the mere
	identification of a pharmacological activity of a compound
	that is relevant to an asserted pharmacological use provides an "immediate benefit to
	the public" and thus satisfies the utility requirement. As the Court of Customs and
	Patent Appeals held in Nelsonv.Bowler:




	>
	> Knowledge of the pharmacological activity of any compound is
	> obviously beneficial to the public. It is inherently faster and easier to combat
	> illnesses and alleviate symptoms when the medical profession is armed with an
	> arsenal of chemicals having known pharmacological activities. Since it is crucial
	> to provide researchers with an incentive to disclose pharmacological activities in
	> as many compounds as possible, we conclude that adequate proof of any such
	> activity constitutes a showing of practical utility.
	>
	>
	>
	>


	Nelsonv.Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980).



	In Nelsonv.Bowler, the court addressed the practical utility requirement in
	the context of an interference proceeding. Bowler challenged the patentability of the
	invention claimed by Nelson on the basis that Nelson had failed to sufficiently and
	persuasively disclose in his application a practical utility for the invention.
	Nelson had developed and claimed a class of synthetic prostaglandins modeled on
	naturally occurring prostaglandins. Naturally occurring prostaglandins are bioactive
	compounds that, at the time of Nelson’s application, had a recognized value in
	pharmacology (e.g., the stimulation of uterine smooth muscle which resulted in labor
	induction or abortion, the ability to raise or lower blood pressure, etc.). To
	support the utility he identified in his disclosure, Nelson included in his
	application the results of tests demonstrating the bioactivity of his new substituted
	prostaglandins relative to the bioactivity of naturally occurring prostaglandins. The
	court concluded that Nelson had satisfied the practical utility requirement in
	identifying the synthetic prostaglandins as pharmacologically active compounds. In
	reaching this conclusion, the court considered and rejected arguments advanced by
	Bowler that attacked the evidentiary basis for Nelson’s assertions that the compounds
	were pharmacologically active.



	In In re Jolles, 628 F.2d 1322, 206 USPQ 885
	(CCPA 1980), an inventor claimed protection for pharmaceutical compositions for
	treating leukemia. The active ingredient in the compositions was a structural analog
	to a known anticancer agent. The applicant provided evidence showing that the claimed
	analogs had the same general pharmaceutical activity as the known anticancer agents.
	The court reversed the Board’s finding that the asserted pharmaceutical utility was
	"incredible," pointing to the evidence that showed the relevant pharmacological
	activity.



	In Crossv.Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985), the Federal
	Circuit affirmed a finding by the Board of Patent Appeals and Interferences that a
	pharmacological utility had been disclosed in the application of one party to an
	interference proceeding. The invention that was the subject of the interference count
	was a chemical compound used for treating blood disorders. Cross had challenged the
	evidence in Iizuka’s specification that supported the claimed utility. However, the
	Federal Circuit relied extensively on Nelsonv.Bowler in finding that Iizuka’s application had sufficiently
	disclosed a pharmacological utility for the compounds. It distinguished the case from
	cases where only a generalized "nebulous" expression, such as "biological
	properties," had been disclosed in a specification. Such statements, the court held,
	"convey little explicit indication regarding the utility of a compound."
	Cross, 753 F.2d at 1048, 224 USPQ at 745 (citing *In re
	Kirk,* 376 F.2d 936, 941, 153 USPQ 48, 52 (CCPA 1967)).



	Similarly, courts have found utility for therapeutic inventions
	despite the fact that an applicant is at a very early stage in the development of a
	pharmaceutical product or therapeutic regimen based on a claimed pharmacological or
	bioactive compound or composition. The Federal Circuit, in Crossv.Iizuka, 753 F.2d 1040, 1051, 224 USPQ 739, 747-48 (Fed. Cir.
	1985), commented on the significance of data from in vitro testing
	that showed pharmacological activity:




	>
	> We perceive no insurmountable difficulty, under appropriate
	> circumstances, in finding that the first link in the screening chain, *in
	> vitro* testing, may establish a practical utility for the compound in
	> question. Successful in vitro testing will marshal resources
	> and direct the expenditure of effort to further in vivo testing
	> of the most potent compounds, thereby providing an immediate benefit to the
	> public, analogous to the benefit provided by the showing of an *in
	> vivo* utility.
	>
	>
	>
	>


	The Federal Circuit has reiterated that therapeutic utility
	sufficient under the patent laws is not to be confused with the requirements of the
	FDA with regard to safety and efficacy of drugs to marketed in the United States.




	>
	> FDA approval, however, is not a prerequisite for finding a
	> compound useful within the meaning of the patent laws. Scott v.Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 [(Fed.Cir.
	> 1994)]. Usefulness in patent law, and in particular in the context of
	> pharmaceutical inventions, necessarily includes the expectation of further
	> research and development. The stage at which an invention in this field becomes
	> useful is well before it is ready to be administered to humans. Were we to require
	> Phase II testing in order to prove utility, the associated costs would prevent
	> many companies from obtaining patent protection on promising new inventions,
	> thereby eliminating an incentive to pursue, through research and development,
	> potential cures in many crucial areas such as the treatment of cancer.
	>
	>
	>
	>


	In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995).
	Accordingly, Office personnel should not construe [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376), under the logic of
	"practical" utility or otherwise, to require that an applicant demonstrate that a
	therapeutic agent based on a claimed invention is a safe or fully effective drug for
	humans. See, e.g., In re Sichert, 566 F.2d 1154, 196 USPQ 209
	(CCPA 1977); In re Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA 1962);
	In re Anthony, 414 F.2d 1383, 162 USPQ 594 (CCPA 1969);
	In re Watson, 517 F.2d 465, 186 USPQ 11 (CCPA 1975).



	These general principles are equally applicable to situations where
	an applicant has claimed a process for treating a human or animal disorder. In such
	cases, the asserted utility is usually clear — the invention is asserted to be useful
	in treating the particular disorder. If the asserted utility is
	credible, there is no basis to challenge such a claim on
	the basis that it lacks utility under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376).



	See [MPEP § 2107.03](s2107.html#d0e200058) for special considerations for asserted
	therapeutic or pharmacological utilities.


	IV. **RELATIONSHIP BETWEEN 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, FIRST
	PARAGRAPH, AND 35 U.S.C. 101 A deficiency under the utility prong of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**
	also creates a deficiency under [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824)*, first paragraph. See In re
	Brana,* 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995); *In re
	Jolles,* 628 F.2d 1322, 1326 n.10, 206 USPQ 885, 889 n.11 (CCPA 1980);
	In re Fouche, 439 F.2d 1237, 1243, 169 USPQ 429, 434 (CCPA
	1971) ("If such compositions are in fact useless, appellant’s specification cannot
	have taught how to use them."). Courts have also cast the **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)/[35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)** relationship such
	that **[35 U.S.C.
	112](mpep-9015-appx-l.html#d0e302824) presupposes compliance with [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**.
	See In re Ziegler, 992 F.2d 1197, 1200-1201, 26 USPQ2d 1600, 1603
	(Fed. Cir. 1993) ("The how to use prong of [section 112](mpep-9015-appx-l.html#d0e302824) incorporates as a
	matter of law the requirement of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) that the
	specification disclose as a matter of fact a practical utility for the invention. ...
	If the application fails as a matter of fact to satisfy **[35 U.S.C. §
	101](mpep-9015-appx-l.html#d0e302376)**, then the application also fails as a matter of law to enable
	one of ordinary skill in the art to use the invention under **[35 U.S.C. §
	112](mpep-9015-appx-l.html#d0e302824)*."); In re Kirk,* 376 F.2d 936, 942, 153 USPQ
	48, 53 (CCPA 1967) ("Necessarily, compliance with [§ 112](mpep-9015-appx-l.html#d0e302824) requires a description of
	how to use presently useful inventions, otherwise an applicant would anomalously be
	required to teach how to use a useless invention."). For example, the Federal Circuit
	noted, "[o]bviously, if a claimed invention does not have utility, the specification
	cannot enable one to use it." In re Brana, 51 F.3d 1560, 34 USPQ2d
	1436 (Fed. Cir. 1995). As such, a rejection properly imposed under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	for lack of utility should be accompanied with a rejection under **[35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph. It is equally clear that a rejection based on "lack of utility," whether
	grounded upon **[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376) or [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824912)**, first paragraph, rests on the same basis (i.e., the
	asserted utility is not credible). To avoid confusion, any lack of utility rejection
	that is imposed on the basis of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) should be
	accompanied by a rejection based on [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824), first paragraph. The [35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, rejection should be set out as a separate rejection that incorporates by
	reference the factual basis and conclusions set forth in the [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	rejection. The [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or
	**[pre-AIA
	35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph, rejection should indicate that
	because the invention as claimed does not have utility, a person skilled in the art
	would not be able to use the invention as claimed, and as such, the claim is
	defective under [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824), first paragraph. A [35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, rejection based on lack of utility should not be imposed or maintained
	unless an appropriate basis exists for imposing a utility rejection under
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)**. In other words, Office personnel should not impose a
	**[35
	U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, rejection grounded on a "lack of utility" basis unless a [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	rejection is proper. In particular, the factual showing needed to impose a rejection
	under **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376) must be provided if a rejection under [35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, is to be imposed on "lack of utility" grounds.



	It is important to recognize that **[35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, addresses matters other than those related to the question of whether or
	not an invention lacks utility. These matters include whether the claims are fully
	supported by the disclosure (In re Vaeck, 947 F.2d 488, 495, 20
	USPQ2d 1438, 1444 (Fed. Cir. 1991)), whether the applicant has provided an enabling
	disclosure of the claimed subject matter (In re Wright, 999 F.2d
	1557, 1561-1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)), whether the applicant has
	provided an adequate written description of the invention and whether the applicant
	has disclosed the best mode of practicing the claimed invention *(Chemcast
	Corp.v.Arco Indus. Corp.,* 913 F.2d 923, 927-928, 16 USPQ2d 1033,
	1036-1037 (Fed. Cir. 1990)). See also Transco Products Inc.v. Performance Contracting Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed.
	Cir. 1994); Glaxo Inc.v.Novopharm Ltd., 52 F.3d 1043, 34 USPQ2d 1565 (Fed. Cir. 1995). The
	fact that an applicant has disclosed a specific utility for an invention and provided
	a credible basis supporting that specific utility does not provide a basis for
	concluding that the claims comply with all the requirements of **[35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph. For example, if an applicant has claimed a process of treating a certain
	disease condition with a certain compound and provided a credible basis for asserting
	that the compound is useful in that regard, but to actually practice the invention as
	claimed a person skilled in the relevant art would have to engage in an undue amount
	of experimentation, the claim may be defective under [35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824),
	but not **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)**. To avoid confusion during examination, any rejection under
	**[35
	U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, based on grounds other than "lack of utility" should be imposed separately
	from any rejection imposed due to "lack of utility" under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	and **[35
	U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph.





	# 2107.02 Procedural Considerations Related to Rejections for Lack of
	Utility [R-10.2019]

	I. THE CLAIMED INVENTION IS THE FOCUS OF THE UTILITY REQUIREMENTThe claimed invention is the focus of the assessment of whether an
	applicant has satisfied the utility requirement. Each claim (i.e., each "invention"),
	therefore, must be evaluated on its own merits for compliance with all statutory
	requirements. Generally speaking, however, a dependent claim will define an invention
	that has utility if the independent claim from which the dependent claim depends is
	drawn to the same statutory class of invention as the dependent claim and the
	independent claim defines an invention having utility. An exception to this general
	rule is where the utility specified for the invention defined in a dependent claim
	differs from that indicated for the invention defined in the independent claim from
	which the dependent claim depends. Where an applicant has established utility for a
	species that falls within an identified genus of compounds, and presents a generic
	claim covering the genus, as a general matter, that claim should be treated as being
	sufficient under **[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**. Only where it can be established that other species
	clearly encompassed by the claim do not have utility should a rejection be imposed on
	the generic claim. In such cases, the applicant should be encouraged to amend the
	generic claim so as to exclude the species that lack utility.



	It is common and sensible for an applicant to identify several
	specific utilities for an invention, particularly where the invention is a product
	(e.g., a machine, an article of manufacture or a composition of matter). However,
	regardless of the category of invention that is claimed (e.g., product or process),
	an applicant need only make one credible assertion of specific utility for the
	claimed invention to satisfy [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) and
	**[35 U.S.C.
	112](mpep-9015-appx-l.html#d0e302824)**; additional statements of utility, even if not "credible,"
	do not render the claimed invention lacking in utility. See, e.g.,
	Raytheonv.Roper, 724 F.2d 951, 958, 220 USPQ 592, 598 (Fed. Cir. 1983),
	cert. denied, 469 U.S. 835 (1984) ("When a properly claimed
	invention meets at least one stated objective, utility under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	is clearly shown."); In re Gottlieb, 328 F.2d 1016, 1019, 140 USPQ
	665, 668 (CCPA 1964) ("Having found that the antibiotic is useful for some purpose,
	it becomes unnecessary to decide whether it is in fact useful for the other purposes
	‘indicated’ in the specification as possibly useful."); *In re
	Malachowski,* 530 F.2d 1402, 189 USPQ 432 (CCPA 1976);
	Hoffmanv.Klaus, 9 USPQ2d 1657 (Bd. Pat. App. & Inter. 1988). Thus, if
	applicant makes one credible assertion of utility, utility for the claimed invention
	as a whole is established.



	Statements made by the applicant in the specification or incident to
	prosecution of the application before the Office cannot, standing alone, be the basis
	for a lack of utility rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) or
	**[35 U.S.C.
	112](mpep-9015-appx-l.html#d0e302824)*. Tol-O-Matic, Inc.v.Proma Produkt-Und Mktg. Gesellschaft m.b.h.,* 945 F.2d 1546, 1553,
	20 USPQ2d 1332, 1338 (Fed. Cir. 1991) (It is not required that a particular
	characteristic set forth in the prosecution history be achieved in order to satisfy
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)**.). An applicant may include statements in the specification
	whose technical accuracy cannot be easily confirmed if those statements are not
	necessary to support the patentability of an invention with regard to any statutory
	basis. Thus, the Office should not require an applicant to strike nonessential
	statements relating to utility from a patent disclosure, regardless of the technical
	accuracy of the statement or assertion it presents. Office personnel should also be
	especially careful not to read into a claim unclaimed results, limitations or
	embodiments of an invention. See Carl Zeiss Stiftungv.Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991);
	In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Doing so
	can inappropriately change the relationship of an asserted utility to the claimed
	invention and raise issues not relevant to examination of that claim.


	II. **IS THERE AN ASSERTED OR WELL-ESTABLISHED UTILITY FOR THE CLAIMED
	INVENTION?**Upon initial examination, the examiner should review the
	specification to determine if there are any statements asserting that the claimed
	invention is useful for any particular purpose. A complete disclosure should include
	a statement which identifies a specific and substantial utility for the invention.


	*A.**An Asserted Utility Must Be Specific and Substantial*A statement of specific and substantial utility should fully and
	clearly explain why the applicant believes the invention is useful. Such
	statements will usually explain the purpose of or how the invention may be used
	(e.g., a compound is believed to be useful in the treatment of a particular
	disorder). Regardless of the form of statement of utility, it must enable one
	ordinarily skilled in the art to understand why the applicant believes the claimed
	invention is useful.



	Except where an invention has a well-established utility, the
	failure of an applicant to specifically identify why an invention is believed to
	be useful renders the claimed invention deficient under **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376) and [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph. In such cases, the applicant
	has failed to identify a "specific and substantial utility" for the claimed
	invention. For example, a statement that a composition has an unspecified
	"biological activity" or that does not explain why a composition with that
	activity is believed to be useful fails to set forth a "specific and substantial
	utility." Brennerv.Manson, 383 US 519, 148 USPQ 689 (1966) (general assertion of
	similarities to known compounds known to be useful without sufficient
	corresponding explanation why claimed compounds are believed to be similarly
	useful insufficient under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)); *In re
	Ziegler,* 992 F.2d 1197, 1201, 26 USPQ2d 1600, 1604 (Fed. Cir. 1993)
	(disclosure that composition is "plastic-like" and can form "films" not sufficient
	to identify specific and substantial utility for invention); *In re
	Kirk,* 376 F.2d 936, 153 USPQ 48 (CCPA 1967) (indication that compound
	is "biologically active" or has "biological properties" insufficient standing
	alone). See also In re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA
	1967); Kawaiv.Metlesics, 480 F.2d 880, 890, 178 USPQ 158, 165 (CCPA 1973)
	(contrasting description of invention as sedative which did suggest specific
	utility to general suggestion of "pharmacological effects on the central nervous
	system" which did not). In contrast, a disclosure that identifies a particular
	biological activity of a compound and explains how that activity can be utilized
	in a particular therapeutic application of the compound does contain an assertion
	of specific and substantial utility for the invention.



	Situations where an applicant either fails to indicate why an
	invention is considered useful, or where the applicant inaccurately describes the
	utility should rarely arise. One reason for this is that applicants are required
	to disclose the best mode known to them of practicing the invention at the time
	they file their application. An applicant who omits a description of the specific
	and substantial utility of the invention, or who incompletely describes that
	utility, may encounter problems with respect to the best mode requirement of
	**[35
	U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph.


	*B.****No Statement of Utility for the Claimed Invention in the Specification
	Does Not Per Se Negate Utility***Occasionally, an applicant will not explicitly state in the
	specification or otherwise assert a specific and substantial utility for the
	claimed invention. If no statements can be found asserting a specific and
	substantial utility for the claimed invention in the specification, Office
	personnel should determine if the claimed invention has a well-established
	utility. An invention has a well-established utility if (i) a person of ordinary
	skill in the art would immediately appreciate why the invention is useful based on
	the characteristics of the invention (e.g., properties or applications of a
	product or process), and (ii) the utility is specific, substantial, and credible.
	If an invention has a well- established utility, rejections under
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376) and [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph, based on lack of utility should
	not be imposed. In re Folkers, 344 F.2d 970, 145 USPQ 390 (CCPA
	1965). For example, if an application teaches the cloning and characterization of
	the nucleotide sequence of a well-known protein such as insulin, and those skilled
	in the art at the time of filing knew that insulin had a well-established use, it
	would be improper to reject the claimed invention as lacking utility solely
	because of the omitted statement of specific and substantial utility.



	If a person of ordinary skill would not immediately recognize a
	specific and substantial utility for the claimed invention (i.e., why it would be
	useful) based on the characteristics of the invention or statements made by the
	applicant, the examiner should reject the application under **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376) and under [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph, as failing to identify a
	specific and substantial utility for the claimed invention. The rejection should
	clearly indicate that the basis of the rejection is that the application fails to
	identify a specific and substantial utility for the invention. The rejection
	should also specify that the applicant must reply by indicating why the invention
	is believed useful and where support for any subsequently asserted utility can be
	found in the specification as filed. See [MPEP § 2701](s2701.html#d0e271945).



	If the applicant subsequently indicates why the invention is
	useful, Office personnel should review that assertion according to the standards
	articulated below for review of the credibility of an asserted utility.


	III. EVALUATING THE CREDIBILITY OF AN ASSERTED UTILITY*

	*A.**An Asserted Utility Creates a Presumption of Utility*In most cases, an applicant’s assertion of utility creates a
	presumption of utility that will be sufficient to satisfy the utility requirement
	of **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)*. See, e.g., In re Jolles,* 628 F.2d
	1322, 206 USPQ 885 (CCPA 1980); In re Irons, 340 F.2d 974, 144
	USPQ 351 (CCPA 1965); In re Langer, 503 F.2d 1380, 183 USPQ 288
	(CCPA 1974); In re Sichert, 566 F.2d 1154, 1159, 196 USPQ 209,
	212-13 (CCPA 1977). As the Court of Customs and Patent Appeals stated in
	In re Langer:




	>
	> As a matter of Patent Office practice, a specification which
	> contains a disclosure of utility which corresponds in scope to the subject
	> matter sought to be patented must be taken as sufficient
	> to satisfy the utility requirement of [§ 101](mpep-9015-appx-l.html#d0e302376) for the entire
	> claimed subject matter unless there is a reason for one
	> skilled in the art to question the objective truth of the statement of utility
	> or its scope.
	>
	>
	>
	>


	In re Langer, 503 F.2d at 1391, 183 USPQ at 297 (emphasis in
	original). The "Langer" test for utility has been used by both the Federal Circuit
	and the Court of Customs and Patent Appeals in evaluation of rejections under
	**[35
	U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, where the rejection is based on a deficiency under **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)*. In In re Brana,* 51 F.3d 1560, 34
	USPQ2d 1436 (Fed. Cir. 1995), the Federal Circuit explicitly adopted the Court of
	Customs and Patent Appeals formulation of the "Langer" standard for
	**[35
	U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph rejections, as it was expressed in a slightly reworded format in
	In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA
	1971), namely:




	>
	> [A] specification disclosure which contains a teaching of the
	> manner and process of making and using the invention in terms which correspond
	> in scope to those used in describing and defining the subject matter sought to
	> be patented must be taken as in compliance with the
	> enabling requirement of the first paragraph of [§ 112](mpep-9015-appx-l.html#d0e302824)
	> unless there is reason to doubt the objective truth of the statements contained
	> therein which must be relied on for enabling support. (emphasis added).
	>
	>
	>
	>


	Thus, Langer and subsequent cases direct the
	Office to presume that a statement of utility made by an applicant is true. See
	In re Langer, 503 F.2d at 1391, 183 USPQ at 297; *In
	re Malachowski,* 530 F.2d 1402, 1404, 189 USPQ 432, 435 (CCPA 1976);
	In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995).
	For obvious reasons of efficiency and in deference to an applicant’s understanding
	of the invention, when a statement of utility is evaluated, Office personnel
	should not begin by questioning the truth of the statement of utility. Instead,
	any inquiry must start by asking if there is any reason to question the truth of
	the statement of utility. This can be done by simply evaluating the logic of the
	statements made, taking into consideration any evidence cited by the applicant. If
	the asserted utility is credible (i.e., believable based on the record or the
	nature of the invention), a rejection based on "lack of utility" is not
	appropriate. Clearly, Office personnel should not begin an evaluation of utility
	by assuming that an asserted utility is likely to be false, based on the technical
	field of the invention or for other general reasons.



	Compliance with [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) is a question of
	fact. Raytheonv.Roper, 724 F.2d 951, 956, 220 USPQ 592, 596 (Fed. Cir. 1983)
	cert. denied, 469 U.S. 835 (1984). Thus, to overcome the
	presumption of truth that an assertion of utility by the applicant enjoys, Office
	personnel must establish that it is more likely than not that one of ordinary
	skill in the art would doubt (i.e., "question") the truth of the statement of
	utility. The evidentiary standard to be used throughout *ex
	parte* examination in setting forth a rejection is a preponderance of
	the totality of the evidence under consideration. *In re
	Oetiker,* 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992)
	("After evidence or argument is submitted by the applicant in response,
	patentability is determined on the totality of the record, by a preponderance of
	evidence with due consideration to persuasiveness of argument."); *In re
	Corkill,* 771 F.2d 1496, 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). A
	preponderance of the evidence exists when it suggests that it is more likely than
	not that the assertion in question is true. Hermanv.Huddleston, 459 U.S. 375, 390 (1983). To do this, Office
	personnel must provide evidence sufficient to show that the statement of asserted
	utility would be considered "false" by a person of ordinary skill in the art. Of
	course, a person of ordinary skill must have the benefit of both facts and
	reasoning in order to assess the truth of a statement. This means that if the
	applicant has presented facts that support the reasoning used in asserting a
	utility, Office personnel must present countervailing facts and reasoning
	sufficient to establish that a person of ordinary skill would not believe the
	applicant’s assertion of utility. In re Brana, 51 F.3d 1560, 34
	USPQ2d 1436 (Fed. Cir. 1995). The initial evidentiary standard used during
	evaluation of this question is a preponderance of the evidence (i.e., the totality
	of facts and reasoning suggest that it is more likely than not that the statement
	of the applicant is false).


	*B.**When Is an Asserted Utility Not Credible?*Where an applicant has specifically asserted that an invention
	has a particular utility, that assertion cannot simply be dismissed by Office
	personnel as being "wrong," even when there may be reason to believe that the
	assertion is not entirely accurate. Rather, Office personnel must determine if the
	assertion of utility is credible (i.e., whether the
	assertion of utility is believable to a person of ordinary skill in the art based
	on the totality of evidence and reasoning provided). An assertion is credible
	unless (A) the logic underlying the assertion is seriously flawed, or (B) the
	facts upon which the assertion is based are inconsistent with the logic underlying
	the assertion. Credibility as used in this context refers to the reliability of
	the statement based on the logic and facts that are offered by the applicant to
	support the assertion of utility.



	One situation where an assertion of utility would not be
	considered credible is where a person of ordinary skill would consider the
	assertion to be "incredible in view of contemporary knowledge" and where nothing
	offered by the applicant would counter what contemporary knowledge might otherwise
	suggest. Office personnel should be careful, however, not to label certain types
	of inventions as "incredible" or "speculative" as such labels do not provide the
	correct focus for the evaluation of an assertion of utility. "Incredible utility"
	is a conclusion, not a starting point for analysis under **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)**. A conclusion that an asserted utility is incredible can
	be reached only after the Office has evaluated both the assertion of the applicant
	regarding utility and any evidentiary basis of that
	assertion. The Office should be particularly careful not to start with a
	presumption that an asserted utility is, per se, "incredible"
	and then proceed to base a rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) on that
	presumption.



	Rejections under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) based on a lack
	of credible utility have been sustained by federal courts when, for example, the
	applicant failed to disclose any utility for the invention or asserted a utility
	that could only be true if it violated a scientific principle, such as the second
	law of thermodynamics, or a law of nature, or was wholly
	inconsistent with contemporary knowledge in the art. *In re
	Gazave,* 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967). Special care
	should be taken when assessing the credibility of an asserted therapeutic utility
	for a claimed invention. In such cases, a previous lack of success in treating a
	disease or condition, or the absence of a proven animal model for testing the
	effectiveness of drugs for treating a disorder in humans, should not, standing
	alone, serve as a basis for challenging the asserted utility under
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376). See [MPEP § 2107.03](s2107.html#d0e200058)** for additional
	guidance with regard to therapeutic or pharmacological utilities.


	IV. *INITIAL BURDEN IS ON THE OFFICE TO ESTABLISH A PRIMA FACIE*
	CASE AND PROVIDE EVIDENTIARY SUPPORT THEREOFTo properly reject a claimed invention under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**,
	the Office must (A) make a prima facie showing that the claimed
	invention lacks utility, and (B) provide a sufficient evidentiary basis for factual
	assumptions relied upon in establishing the prima facie showing.
	In re Gaubert, 524 F.2d 1222, 1224, 187 USPQ 664, 666 (CCPA
	1975) "Accordingly, the PTO must do more than merely question operability - it must
	set forth factual reasons which would lead one skilled in the art to question the
	objective truth of the statement of operability." If the Office cannot develop a
	proper prima facie case and provide evidentiary support for a
	rejection under **[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**, a rejection on this ground should not be imposed.
	See, e.g., In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443,
	1444 (Fed. Cir. 1992) ("[T]he examiner bears the initial burden, on review of the
	prior art or on any other ground, of presenting a prima facie case
	of unpatentability. If that burden is met, the burden of coming forward with evidence
	or argument shifts to the applicant.... If examination at the initial stage does not
	produce a prima facie case of unpatentability, then without more
	the applicant is entitled to grant of the patent."). See also
	Fregeauv.Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985)
	(applying prima facie case law to [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376));
	In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984).



	The prima facie showing must be set forth in a
	well-reasoned statement. Any rejection based on lack of utility should include a
	detailed explanation why the claimed invention has no specific and substantial
	credible utility. Whenever possible, the examiner should provide documentary evidence
	regardless of publication date (e.g., scientific or technical journals, excerpts from
	treatises or books, or U.S. or foreign patents) to support the factual basis for the
	prima facie showing of no specific and substantial credible
	utility. If documentary evidence is not available, the examiner should specifically
	explain the scientific basis for the examiner's factual conclusions.



	Where the asserted utility is not specific or substantial, a
	prima facie showing must establish that it is more likely than
	not that a person of ordinary skill in the art would not consider that any utility
	asserted by the applicant would be specific and substantial. The *prima
	facie* showing must contain the following elements:



	* (A) An explanation that clearly sets forth the reasoning used in
	concluding that the asserted utility for the claimed invention is neither both
	specific and substantial nor well-established;
	* (B) Support for factual findings relied upon in reaching this
	conclusion; and
	* (C) An evaluation of all relevant evidence of record, including
	utilities taught in the closest prior art.


	Where the asserted specific and substantial utility is not credible,
	a prima facie showing of no specific and substantial credible
	utility must establish that it is more likely than not that a person skilled in the
	art would not consider credible any specific and substantial utility asserted by the
	applicant for the claimed invention. The prima facie showing must
	contain the following elements:



	* (A) An explanation that clearly sets forth the reasoning used in
	concluding that the asserted specific and substantial utility is not
	credible;
	* (B) Support for factual findings relied upon in reaching this
	conclusion; and
	* (C) An evaluation of all relevant evidence of record, including
	utilities taught in the closest prior art.


	Where no specific and substantial utility is disclosed or is
	well-established, a prima facie showing of no specific and
	substantial utility need only establish that applicant has not asserted a utility and
	that, on the record before the examiner, there is no known well-established
	utility.



	It is imperative that Office personnel use specificity in setting
	forth and initial rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) and support any
	factual conclusions made in the prima facie showing.



	By using specificity, the applicant will be able to identify the
	assumptions made by the Office in setting forth the rejection and will be able to
	address those assumptions properly.



	Use form paragraphs [7.04.01](#fp7.04.01) and
	[7.05.02](#fp7.05.02)
	through [7.05.04](#fp.7.05.04) to reject claims under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	for failure to satisfy the utility requirement.



	# ¶ 7.05.02 Rejection, 35 U.S.C. 101, Utility Lacking


	the claimed invention lacks patentable utility. [1]


	### Examiner Note:


	In bracket 1, provide explanation of lack of utility. See
	[MPEP §§ 2105](s2105.html#d0e197008) - [2107.03](s2107.html#d0e200058).




	# ¶ 7.05.03 Rejection, 35 U.S.C. 101, Inoperative


	the disclosed invention is inoperative and therefore lacks utility. [1]


	### Examiner Note:


	In bracket 1, explain why invention is inoperative.



	# ¶ 7.05.04 Utility Rejections Under 35 U.S.C. 101 and 35 U.S.C. 112(a) or 35
	U.S.C. 112 (pre-AIA), First Paragraph


	Claim [1] rejected under
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** because the claimed invention is not supported by either a
	[2] asserted utility or a well established utility.



	[3]


	Claim [4] also rejected
	under **[35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph.
	Specifically, because the claimed invention is not supported by either a [5]
	asserted utility or a well established utility for the reasons set forth above, one skilled in
	the art clearly would not know how to use the claimed invention.



	### Examiner Note:

	* 1. Where the specification would not enable one skilled in the art to
	make the claimed invention, or where alternative reasons support the enablement
	rejection, a separate rejection under [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or **[pre-AIA 35 U.S.C.
	112](mpep-9015-appx-l.html#d0e302824)**, first paragraph, enablement should be made using the factors
	set forth in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir.
	1988) and an undue experimentation analysis. See [MPEP §§ 2164](s2164.html#d0e215224) - [2164.08(c)](s2164.html#d0e216899).
	* 2. Use Format A, B, or C below as
	appropriate.
	+ Format A:- (a) Insert the same claim numbers in
	brackets 1 and 4.
	- (b) Insert --specific and substantial--
	in inserts 2 and 5.
	- (c) In bracket 3, insert the explanation
	as to why the claimed invention is not supported by either a specific and
	substantial asserted utility or a well established
	utility.
	- (d) Format A is to be used when there is
	no asserted utility and when there is an asserted utility but that
	utility is not specific and substantial.
	+ Format B:- (a) Insert the same claim numbers in
	brackets 1 and 4.
	- (b) Insert --credible-- in inserts 2 and
	5.
	- (c) In bracket 3, insert the explanation
	as to why the claimed invention is not supported by either a credible
	asserted utility or a well established utility.
	+ Format C:- For claims that have multiple utilities, some of which
	are not specific and substantial, some of which are not credible, but none of
	which are specific, substantial and credible:
	* (a) Insert the same claim numbers in brackets 1 and
	4.
	* (b) Insert --specific and substantial asserted
	utility, a credible-- in inserts 2 and 5.
	* (c) In bracket 3, insert the explanation as to why the
	claimed invention is not supported by either a specific and substantial
	asserted utility, a credible asserted utility or a well established
	utility. Each utility should be addressed.


	V. EVIDENTIARY REQUESTS BY AN EXAMINER TO SUPPORT AN ASSERTED UTILITYIn appropriate situations the Office may require an applicant to
	substantiate an asserted utility for a claimed invention. See *In re
	Pottier,* 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) ("When the
	operativeness of any process would be deemed unlikely by one of ordinary skill in the
	art, it is not improper for the examiner to call for evidence of operativeness.").
	See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890
	(CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963);
	In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962).
	In In re Citron, the court held that when an "alleged utility
	appears to be incredible in the light of the knowledge of the art, or factually
	misleading, applicant must establish the asserted utility by acceptable proof." 325
	F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which
	affirmed the rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) "in view
	of the art knowledge of the lack of a cure for cancer and the absence of any
	clinical data to substantiate the allegation." 325 F.2d at 252, 139
	USPQ at 519 (emphasis in original). The court thus established a higher burden on the
	applicant where the statement of use is incredible or misleading. In such a case, the
	examiner should challenge the use and require sufficient evidence of operativeness.
	The purpose of this authority is to enable an applicant to cure an otherwise
	defective factual basis for the operability of an invention. Because this is a
	curative authority (e.g., evidence is requested to enable an applicant to support an
	assertion that is inconsistent with the facts of record in the application), Office
	personnel should indicate not only why the factual record is defective in relation to
	the assertions of the applicant, but also, where appropriate, what type of
	evidentiary showing can be provided by the applicant to remedy the problem.



	Requests for additional evidence should be imposed rarely, and only
	if necessary to support the scientific credibility of the asserted utility (e.g., if
	the asserted utility is not consistent with the evidence of record and current
	scientific knowledge). As the Federal Circuit recently noted, "[o]nly after the PTO
	provides evidence showing that one of ordinary skill in the art would reasonably
	doubt the asserted utility does the burden shift to the applicant to provide rebuttal
	evidence sufficient to convince such a person of the invention’s asserted utility."
	In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995)
	(citing In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA
	1981)). In Brana, the court pointed out that the purpose of
	treating cancer with chemical compounds does not
	suggest, per se, an incredible utility. Where the prior
	art disclosed "structurally similar compounds to those claimed by applicants which
	have been proven in vivo to be effective as chemotherapeutic
	agents against various tumor models . . ., one skilled in the art would be without
	basis to reasonably doubt applicants’ asserted utility on its face." 51 F.3d at 1566,
	34 USPQ2d at 1441. As courts have stated, "it is clearly improper for the examiner to
	make a demand for further test data, which as evidence would be essentially redundant
	and would seem to serve for nothing except perhaps to unduly burden the applicant."
	In re Isaacs, 347 F.2d 887, 890, 146 USPQ 193, 196 (CCPA
	1965).


	VI. *CONSIDERATION OF A REPLY TO A PRIMA FACIE* REJECTION FOR
	LACK OF UTILITYIf a rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** has been properly
	imposed, along with a corresponding rejection under **[35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, the burden shifts to the applicant to rebut the *prima
	facie* showing. In re Oetiker, 977 F.2d 1443, 1445, 24
	USPQ2d 1443, 1444 (Fed. Cir. 1992) ("The examiner bears the initial burden, on review
	of the prior art or on any other ground, of presenting a *prima
	facie* case of unpatentability. If that burden is met, the burden of
	coming forward with evidence or argument shifts to the applicant. . . After evidence
	or argument is submitted by the applicant in response, patentability is determined on
	the totality of the record, by a preponderance of evidence with due consideration to
	persuasiveness of argument."). An applicant can do this using any combination of the
	following: amendments to the claims, arguments or reasoning, or new evidence
	submitted in an affidavit or declaration under [37 CFR 1.132](mpep-9020-appx-r.html#d0e323552), or in a printed
	publication. New evidence provided by an applicant must be relevant to the issues
	raised in the rejection. For example, declarations in which conclusions are set forth
	without establishing a nexus between those conclusions and the supporting evidence,
	or which merely express opinions, may be of limited probative value with regard to
	rebutting a prima facie case. In re Grunwell,
	609 F.2d 486, 203 USPQ 1055 (CCPA 1979); In re Buchner, 929 F.2d
	660, 18 USPQ2d 1331 (Fed. Cir. 1991). See [MPEP § 716.01(a)](s716.html#d0e92557) through
	**[MPEP
	§ 716.01(c)](s716.html#d0e92659)**.



	If the applicant responds to the prima facie
	rejection, Office personnel should review the original disclosure, any evidence
	relied upon in establishing the prima facie showing, any claim
	amendments, and any new reasoning or evidence provided by the applicant in support of
	an asserted specific and substantial credible utility. It is essential for Office
	personnel to recognize, fully consider and respond to each substantive element of any
	response to a rejection based on lack of utility. Only where the totality of the
	record continues to show that the asserted utility is not specific, substantial, and
	credible should a rejection based on lack of utility be maintained. If the record as
	a whole would make it more likely than not that the asserted utility for the claimed
	invention would be considered credible by a person of ordinary skill in the art, the
	Office cannot maintain the rejection. In re Rinehart, 531 F.2d
	1048, 1052, 189 USPQ 143, 147 (CCPA 1976).


	VII. EVALUATION OF EVIDENCE RELATED TO UTILITYThere is no predetermined amount or character of evidence that must
	be provided by an applicant to support an asserted utility, therapeutic or otherwise.
	Rather, the character and amount of evidence needed to support an asserted utility
	will vary depending on what is claimed (Ex parte Ferguson, 117
	USPQ 229 (Bd. App. 1957)), and whether the asserted utility appears to contravene
	established scientific principles and beliefs. In re Gazave, 379
	F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967); In re Chilowsky,
	229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). Furthermore, the applicant does not
	have to provide evidence sufficient to establish that an asserted utility is true
	"beyond a reasonable doubt." In re Irons, 340 F.2d 974, 978, 144
	USPQ 351, 354 (CCPA 1965). Nor must an applicant provide evidence such that it
	establishes an asserted utility as a matter of statistical certainty.
	Nelsonv.Bowler, 626 F.2d 853, 856-57, 206 USPQ 881, 883-84 (CCPA 1980)
	(reversing the Board and rejecting Bowler’s arguments that the evidence of utility
	was statistically insignificant. The court pointed out that a rigorous correlation is
	not necessary when the test is reasonably predictive of the response). See also
	Rey-Belletv.Englehardt, 493 F.2d 1380, 181 USPQ 453 (CCPA 1974) (data from
	animal testing is relevant to asserted human therapeutic utility if there is a
	"satisfactory correlation between the effect on the animal and that ultimately
	observed in human beings"). Instead, evidence will be sufficient if, considered as a
	whole, it leads a person of ordinary skill in the art to conclude that the asserted
	utility is more likely than not true.





	# 2107.03 Special Considerations for Asserted Therapeutic or
	Pharmacological Utilities [R-08.2012]


	The federal courts have consistently reversed rejections by the Office
	asserting a lack of utility for inventions claiming a pharmacological or therapeutic
	utility where an applicant has provided evidence that reasonably supports such a
	utility. In view of this, Office personnel should be particularly careful in their
	review of evidence provided in support of an asserted therapeutic or pharmacological
	utility.


	I. **A REASONABLE CORRELATION BETWEEN THE EVIDENCE AND THE ASSERTED UTILITY IS
	SUFFICIENT**As a general matter, evidence of pharmacological or other biological
	activity of a compound will be relevant to an asserted therapeutic use if there is a
	reasonable correlation between the activity in question and
	the asserted utility. Crossv. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985);
	In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980);
	Nelsonv.Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980). An applicant can
	establish this reasonable correlation by relying on statistically relevant data
	documenting the activity of a compound or composition, arguments or reasoning,
	documentary evidence (e.g., articles in scientific journals), or any combination
	thereof. The applicant does not have to prove that a correlation exists between a
	particular activity and an asserted therapeutic use of a compound as a matter of
	statistical certainty, nor does he or she have to provide actual evidence of success
	in treating humans where such a utility is asserted. Instead, as the courts have
	repeatedly held, all that is required is a reasonable correlation between the
	activity and the asserted use. Nelsonv.Bowler, 626 F.2d 853, 857, 206 USPQ 881, 884 (CCPA 1980).


	II. STRUCTURAL SIMILARITY TO COMPOUNDS WITH ESTABLISHED UTILITYCourts have routinely found evidence of structural similarity to a
	compound known to have a particular therapeutic or pharmacological utility as being
	supportive of an assertion of therapeutic utility for a new compound. In *In
	re Jolles,* 628 F.2d 1322, 206 USPQ 885 (CCPA 1980), the claimed
	compounds were found to have utility based on a finding of a close structural
	relationship to daunorubicin and doxorubicin and shared pharmacological activity with
	those compounds, both of which were known to be useful in cancer chemotherapy. The
	evidence of close structural similarity with the known compounds was presented in
	conjunction with evidence demonstrating substantial activity of the claimed
	compounds in animals customarily employed for screening anticancer agents. Such
	evidence should be given appropriate weight in determining whether one skilled in the
	art would find the asserted utility credible. Office personnel should evaluate not
	only the existence of the structural relationship, but also the reasoning used by the
	applicant or a declarant to explain why that structural similarity is believed to be
	relevant to the applicant's assertion of utility.


	III. *DATA FROM IN VITRO* OR ANIMAL TESTING IS GENERALLY
	SUFFICIENT TO SUPPORT THERAPEUTIC UTILITY**If reasonably correlated to the particular therapeutic or
	pharmacological utility, data generated using in vitro assays, or
	from testing in an animal model or a combination thereof almost invariably will be
	sufficient to establish therapeutic or pharmacological utility for a compound,
	composition or process. A cursory review of cases involving therapeutic inventions
	where **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** was the dispositive issue illustrates the fact that the
	federal courts are not particularly receptive to rejections under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	based on inoperability. Most striking is the fact that in those cases where an
	applicant supplied a reasonable evidentiary showing supporting an asserted
	therapeutic utility, almost uniformly the [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)-based rejection was
	reversed. See, e.g., In re Brana, 51 F.3d 1560, 34 USPQ 1436 (Fed.
	Cir. 1995); Crossv. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985);
	In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980);
	Nelsonv.Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980);
	In re Malachowski, 530 F.2d 1402, 189 USPQ 432 (CCPA 1976);
	In re Gaubert, 530 F.2d 1402, 189 USPQ 432 (CCPA 1975);
	In re Gazave, 379 F.2d 973, 154 USPQ 92 (CCPA 1967);
	In re Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA 1962);
	In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Only in
	those cases where the applicant was unable to come forward with any relevant evidence
	to rebut a finding by the Office that the claimed invention was inoperative was a
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** rejection affirmed by the court. *In re
	Citron,* 325 F.2d 248, 253, 139 USPQ 516, 520 (CCPA 1963) (therapeutic
	utility for an uncharacterized biological extract not supported or scientifically
	credible); In re Buting, 418 F.2d 540, 543, 163 USPQ 689, 690
	(CCPA 1969) (record did not establish a credible basis for the assertion that the
	single class of compounds in question would be useful in treating disparate types of
	cancers); In re Novak, 306 F.2d 924, 134 USPQ 335 (CCPA 1962)
	(claimed compounds did not have capacity to effect physiological activity upon which
	utility claim based). Contrast, however, In re Buting to
	In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973),
	reh'g denied, 480 F.2d 879 (CCPA 1973), in which the court held
	that utility for a genus was found to be supported through a showing of utility for
	one species. In no case has a federal court required an applicant to support an
	asserted utility with data from human clinical trials.



	If an applicant provides data, whether from *in
	vitro* assays or animal tests or both, to support an asserted utility,
	and an explanation of why that data supports the asserted utility, the Office will
	determine if the data and the explanation would be viewed by one skilled in the art
	as being reasonably predictive of the asserted utility. See, e.g., *Ex parte
	Maas,* 9 USPQ2d 1746 (Bd. Pat. App. & Inter. 1987); *Ex parte
	Balzarini,* 21 USPQ2d 1892 (Bd. Pat. App. & Inter. 1991). Office
	personnel must be careful to evaluate all factors that might influence the
	conclusions of a person of ordinary skill in the art as to this question, including
	the test parameters, choice of animal, relationship of the activity to the particular
	disorder to be treated, characteristics of the compound or composition, relative
	significance of the data provided and, most importantly, the explanation offered by
	the applicant as to why the information provided is believed to support the asserted
	utility. If the data supplied is consistent with the asserted utility, the Office
	cannot maintain a rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376).



	Evidence does not have to be in the form of data from an
	art-recognized animal model for the particular disease or disease condition to which
	the asserted utility relates. Data from any test that the applicant reasonably
	correlates to the asserted utility should be evaluated substantively. Thus, an
	applicant may provide data generated using a particular animal model with an
	appropriate explanation as to why that data supports the asserted utility. The
	absence of a certification that the test in question is an industry-accepted model is
	not dispositive of whether data from an animal model is in fact relevant to the
	asserted utility. Thus, if one skilled in the art would accept the animal tests as
	being reasonably predictive of utility in humans, evidence
	from those tests should be considered sufficient to support the credibility of the
	asserted utility. In re Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA
	1962); In re Krimmel, 292 F.2d 948, 953, 130 USPQ 215, 219 (CCPA
	1961); Ex parte Krepelka, 231 USPQ 746 (Bd. Pat. App. & Inter.
	1986). Office personnel should be careful not to find evidence unpersuasive simply
	because no animal model for the human disease condition had been established prior to
	the filing of the application. See In re Chilowsky, 229 F.2d 457,
	461, 108 USPQ 321, 325 (CCPA 1956) ("The mere fact that something has not previously
	been done clearly is not, in itself, a sufficient basis for rejecting all
	applications purporting to disclose how to do it."); In re Wooddy,
	331 F.2d 636, 639, 141 USPQ 518, 520 (CCPA 1964) ("It appears that no one on earth is
	certain as of the present whether the process claimed will operate in the manner
	claimed. Yet absolute certainty is not required by the law. The mere fact that
	something has not previously been done clearly is not, in itself, a sufficient basis
	for rejecting all applications purporting to disclose how to do it.").


	IV. HUMAN CLINICAL DATAOffice personnel should not impose on applicants the unnecessary
	burden of providing evidence from human clinical trials. There is no decisional law
	that requires an applicant to provide data from human clinical trials to establish
	utility for an invention related to treatment of human disorders (see *In re
	Isaacs,* 347 F.2d 889, 146 USPQ 193 (CCPA 1963); *In re
	Langer,* 503 F.2d 1380, 183 USPQ 288 (CCPA 1974)), even with respect to
	situations where no art-recognized animal models existed for the human disease
	encompassed by the claims. Ex parte Balzarini, 21 USPQ2d 1892 (Bd.
	Pat. App. & Inter. 1991) (human clinical data is not required to demonstrate the
	utility of the claimed invention, even though those skilled in the art might not
	accept other evidence to establish the efficacy of the claimed therapeutic
	compositions and the operativeness of the claimed methods of treating humans). Before
	a drug can enter human clinical trials, the sponsor, often the
	applicant, must provide a convincing rationale to those
	especially skilled in the art (e.g., the Food and Drug
	Administration (FDA)) that the investigation may be successful. Such a rationale
	would provide a basis for the sponsor’s expectation that the investigation may be
	successful. In order to determine a protocol for phase I testing, the first phase of
	clinical investigation, some credible rationale of how the drug might be effective or
	could be effective would be necessary. Thus, as a general rule, if an
	applicant has initiated human clinical trials for a therapeutic product or
	process, Office personnel should presume that the applicant has established that
	the subject matter of that trial is reasonably predictive of having the asserted
	therapeutic utility.

	V. SAFETY AND EFFICACY CONSIDERATIONSThe Office must confine its review of patent applications to the
	statutory requirements of the patent law. Other agencies of the government have been
	assigned the responsibility of ensuring conformance to standards established by
	statute for the advertisement, use, sale or distribution of drugs. The FDA pursues a
	two-prong test to provide approval for testing. Under that test, a sponsor must show
	that the investigation does not pose an unreasonable and significant risk of illness
	or injury and that there is an acceptable rationale for the study. As a review
	matter, there must be a rationale for believing that the compound could be effective.
	If the use reviewed by the FDA is not set forth in the specification, FDA review may
	not satisfy **[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**. However, if the reviewed use is one set forth in
	the specification, Office personnel must be extremely hesitant to challenge utility.
	In such a situation, experts at the FDA have assessed the rationale for the drug or
	research study upon which an asserted utility is based and found it satisfactory.
	Thus, in challenging utility, Office personnel must be able to carry their burden
	that there is no sound rationale for the asserted utility even though experts
	designated by Congress to decide the issue have come to an opposite conclusion. "FDA
	approval, however, is not a prerequisite for finding a compound useful within the
	meaning of the patent laws." In re Brana, 51 F.3d 1560, 34 USPQ2d
	1436 (Fed. Cir. 1995) (citing Scottv.Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 (Fed. Cir.
	1994)).



	Thus, while an applicant may on occasion need to provide evidence to
	show that an invention will work as claimed, it is improper for Office personnel to
	request evidence of safety in the treatment of humans, or regarding the
	degree of effectiveness. See *In re
	Sichert,* 566 F.2d 1154, 196 USPQ 209 (CCPA 1977); *In re
	Hartop,* 311 F.2d 249, 135 USPQ 419 (CCPA 1962); *In re
	Anthony,* 414 F.2d 1383, 162 USPQ 594 (CCPA 1969); *In re
	Watson,* 517 F.2d 465, 186 USPQ 11 (CCPA 1975); *In re
	Krimmel,* 292 F.2d 948, 130 USPQ 215 (CCPA 1961); *Ex parte
	Jovanovics,* 211 USPQ 907 (Bd. Pat. App. & Inter. 1981).


	VI. TREATMENT OF SPECIFIC DISEASE CONDITIONSClaims directed to a method of treating or curing a disease for
	which there have been no previously successful treatments or cures warrant careful
	review for compliance with [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376). The credibility of
	an asserted utility for treating a human disorder may be more difficult to establish
	where current scientific understanding suggests that such a task would be impossible.
	Such a determination has always required a good understanding of the state of the art
	as of the time that the invention was made. For example, prior to the 1980’s, there
	were a number of cases where an asserted use in treating cancer in humans was viewed
	as "incredible." In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA
	1980); In re Buting, 418 F.2d 540, 163 USPQ 689 (CCPA 1969);
	Ex parte Stevens, 16 USPQ2d 1379 (Bd. Pat. App. & Inter.
	1990); Ex parte Busse, 1 USPQ2d 1908 (Bd. Pat. App. & Inter.
	1986); Ex parte Krepelka, 231 USPQ 746 (Bd. Pat. App. & Inter.
	1986); Ex parte Jovanovics, 211 USPQ 907 (Bd. Pat. App. &
	Inter. 1981). The fact that there is no known cure for a disease, however, cannot
	serve as the basis for a conclusion that such an invention lacks utility. Rather,
	Office personnel must determine if the asserted utility for the invention is credible
	based on the information disclosed in the application. Only those claims for which an
	asserted utility is not credible should be rejected. In such
	cases, the Office should carefully review what is being claimed by the applicant. An
	assertion that the claimed invention is useful in treating a symptom of an incurable
	disease may be considered credible by a person of ordinary skill in the art on the
	basis of a fairly modest amount of evidence or support. In contrast, an assertion
	that the claimed invention will be useful in "curing" the disease may require a
	significantly greater amount of evidentiary support to be considered credible by a
	person of ordinary skill in the art. In re Sichert, 566 F.2d 1154,
	196 USPQ 209 (CCPA 1977); In re Jolles, 628 F.2d 1322, 206 USPQ
	885 (CCPA 1980). See also Ex parte Ferguson, 117 USPQ 229 (Bd.
	Pat. App. & Inter. 1957).



	In these cases, it is important to note that the Food and Drug
	Administration has promulgated regulations that enable a party to conduct clinical
	trials for drugs used to treat life threatening and severely-debilitating illnesses,
	even where no alternative therapy exists. See 21 CFR 312.80-88 (1994). Implicit in
	these regulations is the recognition that experts qualified to evaluate the
	effectiveness of therapeutics can and often do find a sufficient basis to conduct
	clinical trials of drugs for incurable or previously untreatable illnesses. Thus,
	affidavit evidence from experts in the art indicating that there is a reasonable
	expectation of success, supported by sound reasoning, usually should be sufficient to
	establish that such a utility is credible.




	[[top]](#top)


	,
	# 2107.01 General Principles Governing Utility Rejections [R-10.2019]



	#### *35 U.S.C. 101
	Inventions patentable*


	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.




	See **[MPEP
	§ 2107](s2107.html#d0e198469)** for guidelines for the examination of applications for
	compliance with the utility requirement of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376).



	The Office must examine each application to ensure compliance with the
	"useful invention" or utility requirement of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376). In discharging this
	obligation, however, Office personnel must keep in mind several general principles that
	control application of the utility requirement. [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) has been interpreted
	as imposing four purposes. First, [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) limits an inventor to
	ONE patent for a claimed invention. If more than one patent is sought, a patent
	applicant will receive a statutory double patenting rejection for claims included in
	more than one application that are directed to the same invention. See
	**[MPEP §
	804](s804.html#d0e98894)**. Second, the inventor(s) must be the applicant in an
	application filed before September 16, 2012, (except as otherwise provided in
	**[pre-AIA 37 CFR
	1.41(b)](mpep-9020-appx-r.html#d0e317757)**) and the inventor or each joint inventor must be
	identified in an application filed on or after September 16, 2012. See
	**[MPEP §
	2109](s2109.html#ch2100_d2c183_22374_28b)** for a detailed discussion of inventorship,
	**[MPEP §
	602.01(c)](s602.html#d0e4830ss602)**et seq. for details regarding correction of inventorship,
	**[MPEP §
	2157](s2157.html#ch2100_d20034_1bb92_e7) for rejections under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) and [115](mpep-9015-appx-l.html#d0e302875912)** for failure
	to set forth the correct inventorship, and [MPEP § 2137](s2137.html#d0e206570) for rejections under
	**[pre-AIA 35 U.S.C.
	102(f)](mpep-9015-appx-l.html#d0e302420) (for applications subject to [pre-AIA 35 U.S.C.
	102](mpep-9015-appx-l.html#d0e302383)**) for failure to set forth the correct inventorship. Third,
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** defines which categories of inventions are eligible for patent
	protection. An invention that is not a machine, an article of manufacture, a composition
	or a process cannot be patented. See Diamondv.Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980);
	Diamondv.Diehr, 450 U.S. 175, 209 USPQ 1 (1981); *In re
	Nuijten,* 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007).
	Fourth, **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** serves to ensure that patents are granted on only those
	inventions that are "useful." This second purpose has a Constitutional footing — Article
	I, Section 8 of the Constitution authorizes Congress to provide exclusive rights to
	inventors to promote the "useful arts." See Carl Zeiss Stiftungv.Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991). Thus,
	to satisfy the requirements of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376), an applicant must
	claim an invention that is statutory subject matter and must show that the claimed
	invention is "useful" for some purpose either explicitly or implicitly. Application of
	this latter element of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) is the focus of these guidelines.



	Deficiencies under the "useful invention" requirement of
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** will arise in one of two forms. The first is where it is not
	apparent why the invention is "useful." This can occur when an applicant fails to
	identify any specific and substantial utility for the invention or fails to disclose
	enough information about the invention to make its usefulness immediately apparent to
	those familiar with the technological field of the invention. Brennerv.Manson, 383 U.S. 519, 148 USPQ 689 (1966); *In re
	Fisher,* 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); *In re
	Ziegler,* 992 F.2d 1197, 26 USPQ2d 1600 (Fed. Cir. 1993). The second type of
	deficiency arises in the rare instance where an assertion of specific and substantial
	utility for the invention made by an applicant is not credible.


	I. SPECIFIC AND SUBSTANTIAL REQUIREMENTSTo satisfy [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376), an invention must
	be "useful." Courts have recognized that the term "useful" used with reference to the
	utility requirement can be a difficult term to define. Brennerv.Manson, 383 U.S. 519, 529, 148 USPQ 689, 693 (1966) (simple
	everyday word like "useful" can be "pregnant with ambiguity when applied to the facts
	of life."). Where an applicant has set forth a specific and substantial utility,
	courts have been reluctant to uphold a rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	solely on the basis that the applicant’s opinion as to the nature of the specific and
	substantial utility was inaccurate. For example, in Nelsonv.Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980), the court reversed
	a finding by the Office that the applicant had not set forth a "practical" utility
	under **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)**. In this case the applicant asserted that the composition
	was "useful" in a particular pharmaceutical application and provided evidence to
	support that assertion. Courts have used the labels "practical utility," "substantial
	utility," or "specific utility" to refer to this aspect of the "useful invention"
	requirement of **[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**. The Court of Customs and Patent Appeals has
	stated:




	>
	> Practical utility is a shorthand way of attributing "real-world"
	> value to claimed subject matter. In other words, one skilled in the art can use a
	> claimed discovery in a manner which provides some immediate benefit to the
	> public.
	>
	>
	>
	>


	Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA
	1980).



	Practical considerations require the Office to rely on the
	inventor’s understanding of the invention in determining whether and in what regard
	an invention is believed to be "useful." Because of this, Office personnel should
	focus on and be receptive to assertions made by the applicant that an invention is
	"useful" for a particular reason.


	*A.**Specific UtilityA "specific utility" is specific* to the
	subject matter claimed and can "provide a well-defined and particular benefit to
	the public." In re Fisher, 421 F.3d 1365, 1371, 76 USPQ2d 1225,
	1230 (Fed. Cir. 2005). This contrasts with a general utility
	that would be applicable to the broad class of the invention. Office personnel
	should distinguish between situations where an applicant has disclosed a specific
	use for or application of the invention and situations where the applicant merely
	indicates that the invention may prove useful without identifying with specificity
	why it is considered useful. For example, indicating that a
	compound may be useful in treating unspecified disorders, or that the compound has
	"useful biological" properties, would not be sufficient to define a specific
	utility for the compound. See, e.g., In re Kirk, 376 F.2d 936,
	153 USPQ 48 (CCPA 1967); In re Joly, 376 F.2d 906, 153 USPQ 45
	(CCPA 1967). Similarly, a claim to a polynucleotide whose use is disclosed simply
	as a "gene probe" or "chromosome marker" would not be considered to be
	specific in the absence of a disclosure of a specific DNA
	target. See In re Fisher, 421 F.3d at 1374, 76 USPQ2d at 1232
	("Any EST [expressed sequence tag] transcribed from any gene in the maize genome
	has the potential to perform any one of the alleged uses…. Nothing about
	[applicant’s] seven alleged uses set the five claimed ESTs apart from the more
	than 32,000 ESTs disclosed in the [ ] application or indeed from any EST derived
	from any organism. Accordingly, we conclude that [applicant] has only disclosed
	general uses for its claimed ESTs, not specific ones that satisfy
	**[§
	101](mpep-9015-appx-l.html#d0e302376)**."). A general statement of diagnostic utility, such as
	diagnosing an unspecified disease, would ordinarily be insufficient absent a
	disclosure of what condition can be diagnosed. Contrast the situation where an
	applicant discloses a specific biological activity and reasonably correlates that
	activity to a disease condition. Assertions falling within the latter category are
	sufficient to identify a specific utility for the invention. Assertions that fall
	in the former category are insufficient to define a specific utility for the
	invention, especially if the assertion takes the form of a general statement that
	makes it clear that a "useful" invention may arise from
	what has been disclosed by the applicant. Knapp v.Anderson, 477 F.2d 588, 177 USPQ 688 (CCPA 1973).


	*B.**Substantial Utility* "[A]n application must show that an invention is useful to the
	public as disclosed in its current form, not that it may prove useful at some
	future date after further research. Simply put, to satisfy the ‘substantial’
	utility requirement, an asserted use must show that the claimed invention has a
	significant and presently available benefit to the public."
	Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230. The claims at
	issue in Fisher were directed to expressed sequence tags
	(ESTs), which are short nucleotide sequences that can be used to discover what
	genes and downstream proteins are expressed in a cell. The court held that "the
	claimed ESTs can be used only to gain further information about the underlying
	genes and the proteins encoded for by those genes. The claimed ESTs themselves are
	not an end of [applicant’s] research effort, but only tools to be used along the
	way in the search for a practical utility…. [Applicant] does not identify the
	function for the underlying protein-encoding genes. Absent such identification, we
	hold that the claimed ESTs have not been researched and understood to the point of
	providing an immediate, well-defined, real world benefit to the public meriting
	the grant of a patent." Id. at 1376, 76 USPQ2d at 1233-34).
	Thus a "substantial utility" defines a "real world" use. Utilities that require or
	constitute carrying out further research to identify or reasonably confirm a "real
	world" context of use are not substantial utilities. For example, both a
	therapeutic method of treating a known or newly discovered disease and an assay
	method for identifying compounds that themselves have a "substantial utility"
	define a "real world" context of use. An assay that measures the presence of a
	material which has a stated correlation to a predisposition to the onset of a
	particular disease condition would also define a "real world" context of use in
	identifying potential candidates for preventive measures or further monitoring. On
	the other hand, the following are examples of situations that require or
	constitute carrying out further research to identify or reasonably confirm a "real
	world" context of use and, therefore, do not define "substantial utilities":



	* (A) Basic research such as studying the properties of the
	claimed product itself or the mechanisms in which the material is
	involved;
	* (B) A method of treating an unspecified
	disease or condition;
	* (C) A method of assaying for or identifying a material that
	itself has no specific and/or substantial utility;
	* (D) A method of making a material that itself has no specific,
	substantial, and credible utility; and
	* (E) A claim to an intermediate product for use in making a
	final product that has no specific, substantial and credible utility.


	Office personnel must be careful not to interpret the phrase
	"immediate benefit to the public" or similar formulations in other cases to mean
	that products or services based on the claimed invention must be "currently
	available" to the public in order to satisfy the utility requirement. See, e.g.,
	Brenner v. Manson, 383 U.S. 519, 534-35, 148 USPQ 689, 695
	(1966). Rather, any reasonable use that an applicant has identified for the
	invention that can be viewed as providing a public benefit should be accepted as
	sufficient, at least with regard to defining a "substantial" utility.


	*C.**Research Tools*Some confusion can result when one attempts to label certain
	types of inventions as not being capable of having a specific and substantial
	utility based on the setting in which the invention is to be used. One example is
	inventions to be used in a research or laboratory setting. Many research tools
	such as gas chromatographs, screening assays, and nucleotide sequencing techniques
	have a clear, specific and unquestionable utility (e.g., they are useful in
	analyzing compounds). An assessment that focuses on whether an invention is useful
	only in a research setting thus does not address whether the invention is in fact
	"useful" in a patent sense. Instead, Office personnel must distinguish between
	inventions that have a specifically identified substantial utility and inventions
	whose asserted utility requires further research to identify or reasonably
	confirm. Labels such as "research tool," "intermediate" or "for research purposes"
	are not helpful in determining if an applicant has identified a specific and
	substantial utility for the invention.


	II. WHOLLY INOPERATIVE INVENTIONS; "INCREDIBLE" UTILITYAn invention that is "inoperative" (i.e., it does not operate to
	produce the results claimed by the patent applicant) is not a "useful" invention in
	the meaning of the patent law. See, e.g., Newmanv.Quigg, 877 F.2d 1575, 1581, 11 USPQ2d 1340, 1345 (Fed. Cir. 1989);
	In re Harwood, 390 F.2d 985, 989, 156 USPQ 673, 676 (CCPA 1968)
	("An inoperative invention, of course, does not satisfy the requirement of
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** that an invention be useful."). However, as the Federal
	Circuit has stated, "[t]o violate [[35 U.S.C.] 101](mpep-9015-appx-l.html#d0e302376) the claimed
	device must be totally incapable of achieving a useful
	result." Brooktree Corp.v.Advanced Micro Devices, Inc., 977 F.2d 1555, 1571, 24 USPQ2d 1401,
	1412 (Fed. Cir. 1992) (emphasis added). See also *E.I. du Pont De Nemours and
	Co.v.Berkley and Co.,* 620 F.2d 1247, 1260 n.17, 205 USPQ 1, 10 n.17
	(8th Cir. 1980) ("A small degree of utility is sufficient . . . The claimed invention
	must only be capable of performing some beneficial function . . . An invention does
	not lack utility merely because the particular embodiment disclosed in the patent
	lacks perfection or performs crudely . . . A commercially successful product is not
	required . . . Nor is it essential that the invention accomplish all its intended
	functions . . . or operate under all conditions . . . partial success being
	sufficient to demonstrate patentable utility . . . In short, the defense of
	non-utility cannot be sustained without proof of total incapacity." If an invention
	is only partially successful in achieving a useful result, a
	rejection of the claimed invention as a whole based on a lack of utility is not
	appropriate. See In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed.
	Cir. 1995); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA),
	reh’g denied, 480 F.2d 879 (CCPA 1973); *In re
	Marzocchi,* 439 F.2d 220, 169 USPQ 367 (CCPA 1971).



	Situations where an invention is found to be "inoperative" and
	therefore lacking in utility are rare, and rejections maintained solely on this
	ground by a federal court even rarer. In many of these cases, the utility asserted by
	the applicant was thought to be "incredible in the light of the knowledge of the art,
	or factually misleading" when initially considered by the Office. *In re
	Citron,* 325 F.2d 248, 253, 139 USPQ 516, 520 (CCPA 1963). Other cases
	suggest that on initial evaluation, the Office considered the asserted utility to be
	inconsistent with known scientific principles or "speculative at best" as to whether
	attributes of the invention necessary to impart the asserted utility were actually
	present in the invention. In re Sichert, 566 F.2d 1154, 196 USPQ
	209 (CCPA 1977). However cast, the underlying finding by the court in these cases was
	that, based on the factual record of the case, it was clear
	that the invention could not and did not work as the inventor claimed it did. Indeed,
	the use of many labels to describe a single problem (e.g., a false assertion
	regarding utility) has led to some of the confusion that exists today with regard to
	a rejection based on the "utility" requirement. Examples of such cases include: an
	invention asserted to change the taste of food using a magnetic field
	(Fregeauv.Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985)), a
	perpetual motion machine (Newmanv.Quigg, 877 F.2d 1575, 11 USPQ2d 1340 (Fed. Cir. 1989)), a flying
	machine operating on "flapping or flutter function" *(In re
	Houghton,* 433 F.2d 820, 167 USPQ 687 (CCPA 1970)), a "cold fusion"
	process for producing energy (In re Swartz, 232 F.3d 862, 56
	USPQ2d 1703 (Fed. Cir. 2000)), a method for increasing the energy output of fossil
	fuels upon combustion through exposure to a magnetic field *(In re
	Ruskin,* 354 F.2d 395, 148 USPQ 221 (CCPA 1966)), uncharacterized
	compositions for curing a wide array of cancers (In re Citron, 325
	F.2d 248, 139 USPQ 516 (CCPA 1963)), and a method of controlling the aging process
	(In re Eltgroth, 419 F.2d 918, 164 USPQ 221 (CCPA 1970)). These
	examples are fact specific and should not be applied as a
	per se rule. Thus, in view of the rare nature of such cases,
	Office personnel should not label an asserted utility "incredible," "speculative" or
	otherwise unless it is clear that a rejection based on "lack of utility" is
	proper.


	III. THERAPEUTIC OR PHARMACOLOGICAL UTILITYInventions asserted to have utility in the treatment of human or
	animal disorders are subject to the same legal requirements for utility as inventions
	in any other field of technology. In re Chilowsky, 229 F.2d 457,
	461-2, 108 USPQ 321, 325 (CCPA 1956) ("There appears to be no basis in the statutes
	or decisions for requiring any more conclusive evidence of operativeness in one type
	of case than another. The character and amount of evidence needed may vary, depending
	on whether the alleged operation described in the application appears to accord with
	or to contravene established scientific principles or to depend upon principles
	alleged but not generally recognized, but the degree of certainty as to the ultimate
	fact of operativeness or inoperativeness should be the same in all cases");
	In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967)
	("Thus, in the usual case where the mode of operation alleged can be readily
	understood and conforms to the known laws of physics and chemistry, operativeness is
	not questioned, and no further evidence is required."). As such, pharmacological or
	therapeutic inventions that provide any "immediate benefit to
	the public" satisfy [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376). The utility being asserted in
	Nelson related to a compound with pharmacological utility.
	Nelsonv.Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980). Office
	personnel should rely on Nelson and other cases as providing
	general guidance when evaluating the utility of an invention that is based on any
	therapeutic, prophylactic, or pharmacological activities of that invention.



	Courts have repeatedly found that the mere
	identification of a pharmacological activity of a compound
	that is relevant to an asserted pharmacological use provides an "immediate benefit to
	the public" and thus satisfies the utility requirement. As the Court of Customs and
	Patent Appeals held in Nelsonv.Bowler:




	>
	> Knowledge of the pharmacological activity of any compound is
	> obviously beneficial to the public. It is inherently faster and easier to combat
	> illnesses and alleviate symptoms when the medical profession is armed with an
	> arsenal of chemicals having known pharmacological activities. Since it is crucial
	> to provide researchers with an incentive to disclose pharmacological activities in
	> as many compounds as possible, we conclude that adequate proof of any such
	> activity constitutes a showing of practical utility.
	>
	>
	>
	>


	Nelsonv.Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980).



	In Nelsonv.Bowler, the court addressed the practical utility requirement in
	the context of an interference proceeding. Bowler challenged the patentability of the
	invention claimed by Nelson on the basis that Nelson had failed to sufficiently and
	persuasively disclose in his application a practical utility for the invention.
	Nelson had developed and claimed a class of synthetic prostaglandins modeled on
	naturally occurring prostaglandins. Naturally occurring prostaglandins are bioactive
	compounds that, at the time of Nelson’s application, had a recognized value in
	pharmacology (e.g., the stimulation of uterine smooth muscle which resulted in labor
	induction or abortion, the ability to raise or lower blood pressure, etc.). To
	support the utility he identified in his disclosure, Nelson included in his
	application the results of tests demonstrating the bioactivity of his new substituted
	prostaglandins relative to the bioactivity of naturally occurring prostaglandins. The
	court concluded that Nelson had satisfied the practical utility requirement in
	identifying the synthetic prostaglandins as pharmacologically active compounds. In
	reaching this conclusion, the court considered and rejected arguments advanced by
	Bowler that attacked the evidentiary basis for Nelson’s assertions that the compounds
	were pharmacologically active.



	In In re Jolles, 628 F.2d 1322, 206 USPQ 885
	(CCPA 1980), an inventor claimed protection for pharmaceutical compositions for
	treating leukemia. The active ingredient in the compositions was a structural analog
	to a known anticancer agent. The applicant provided evidence showing that the claimed
	analogs had the same general pharmaceutical activity as the known anticancer agents.
	The court reversed the Board’s finding that the asserted pharmaceutical utility was
	"incredible," pointing to the evidence that showed the relevant pharmacological
	activity.



	In Crossv.Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985), the Federal
	Circuit affirmed a finding by the Board of Patent Appeals and Interferences that a
	pharmacological utility had been disclosed in the application of one party to an
	interference proceeding. The invention that was the subject of the interference count
	was a chemical compound used for treating blood disorders. Cross had challenged the
	evidence in Iizuka’s specification that supported the claimed utility. However, the
	Federal Circuit relied extensively on Nelsonv.Bowler in finding that Iizuka’s application had sufficiently
	disclosed a pharmacological utility for the compounds. It distinguished the case from
	cases where only a generalized "nebulous" expression, such as "biological
	properties," had been disclosed in a specification. Such statements, the court held,
	"convey little explicit indication regarding the utility of a compound."
	Cross, 753 F.2d at 1048, 224 USPQ at 745 (citing *In re
	Kirk,* 376 F.2d 936, 941, 153 USPQ 48, 52 (CCPA 1967)).



	Similarly, courts have found utility for therapeutic inventions
	despite the fact that an applicant is at a very early stage in the development of a
	pharmaceutical product or therapeutic regimen based on a claimed pharmacological or
	bioactive compound or composition. The Federal Circuit, in Crossv.Iizuka, 753 F.2d 1040, 1051, 224 USPQ 739, 747-48 (Fed. Cir.
	1985), commented on the significance of data from in vitro testing
	that showed pharmacological activity:




	>
	> We perceive no insurmountable difficulty, under appropriate
	> circumstances, in finding that the first link in the screening chain, *in
	> vitro* testing, may establish a practical utility for the compound in
	> question. Successful in vitro testing will marshal resources
	> and direct the expenditure of effort to further in vivo testing
	> of the most potent compounds, thereby providing an immediate benefit to the
	> public, analogous to the benefit provided by the showing of an *in
	> vivo* utility.
	>
	>
	>
	>


	The Federal Circuit has reiterated that therapeutic utility
	sufficient under the patent laws is not to be confused with the requirements of the
	FDA with regard to safety and efficacy of drugs to marketed in the United States.




	>
	> FDA approval, however, is not a prerequisite for finding a
	> compound useful within the meaning of the patent laws. Scott v.Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 [(Fed.Cir.
	> 1994)]. Usefulness in patent law, and in particular in the context of
	> pharmaceutical inventions, necessarily includes the expectation of further
	> research and development. The stage at which an invention in this field becomes
	> useful is well before it is ready to be administered to humans. Were we to require
	> Phase II testing in order to prove utility, the associated costs would prevent
	> many companies from obtaining patent protection on promising new inventions,
	> thereby eliminating an incentive to pursue, through research and development,
	> potential cures in many crucial areas such as the treatment of cancer.
	>
	>
	>
	>


	In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995).
	Accordingly, Office personnel should not construe [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376), under the logic of
	"practical" utility or otherwise, to require that an applicant demonstrate that a
	therapeutic agent based on a claimed invention is a safe or fully effective drug for
	humans. See, e.g., In re Sichert, 566 F.2d 1154, 196 USPQ 209
	(CCPA 1977); In re Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA 1962);
	In re Anthony, 414 F.2d 1383, 162 USPQ 594 (CCPA 1969);
	In re Watson, 517 F.2d 465, 186 USPQ 11 (CCPA 1975).



	These general principles are equally applicable to situations where
	an applicant has claimed a process for treating a human or animal disorder. In such
	cases, the asserted utility is usually clear — the invention is asserted to be useful
	in treating the particular disorder. If the asserted utility is
	credible, there is no basis to challenge such a claim on
	the basis that it lacks utility under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376).



	See [MPEP § 2107.03](s2107.html#d0e200058) for special considerations for asserted
	therapeutic or pharmacological utilities.


	IV. **RELATIONSHIP BETWEEN 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, FIRST
	PARAGRAPH, AND 35 U.S.C. 101 A deficiency under the utility prong of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**
	also creates a deficiency under [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824)*, first paragraph. See In re
	Brana,* 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995); *In re
	Jolles,* 628 F.2d 1322, 1326 n.10, 206 USPQ 885, 889 n.11 (CCPA 1980);
	In re Fouche, 439 F.2d 1237, 1243, 169 USPQ 429, 434 (CCPA
	1971) ("If such compositions are in fact useless, appellant’s specification cannot
	have taught how to use them."). Courts have also cast the **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)/[35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)** relationship such
	that **[35 U.S.C.
	112](mpep-9015-appx-l.html#d0e302824) presupposes compliance with [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**.
	See In re Ziegler, 992 F.2d 1197, 1200-1201, 26 USPQ2d 1600, 1603
	(Fed. Cir. 1993) ("The how to use prong of [section 112](mpep-9015-appx-l.html#d0e302824) incorporates as a
	matter of law the requirement of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) that the
	specification disclose as a matter of fact a practical utility for the invention. ...
	If the application fails as a matter of fact to satisfy **[35 U.S.C. §
	101](mpep-9015-appx-l.html#d0e302376)**, then the application also fails as a matter of law to enable
	one of ordinary skill in the art to use the invention under **[35 U.S.C. §
	112](mpep-9015-appx-l.html#d0e302824)*."); In re Kirk,* 376 F.2d 936, 942, 153 USPQ
	48, 53 (CCPA 1967) ("Necessarily, compliance with [§ 112](mpep-9015-appx-l.html#d0e302824) requires a description of
	how to use presently useful inventions, otherwise an applicant would anomalously be
	required to teach how to use a useless invention."). For example, the Federal Circuit
	noted, "[o]bviously, if a claimed invention does not have utility, the specification
	cannot enable one to use it." In re Brana, 51 F.3d 1560, 34 USPQ2d
	1436 (Fed. Cir. 1995). As such, a rejection properly imposed under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	for lack of utility should be accompanied with a rejection under **[35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph. It is equally clear that a rejection based on "lack of utility," whether
	grounded upon **[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376) or [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824912)**, first paragraph, rests on the same basis (i.e., the
	asserted utility is not credible). To avoid confusion, any lack of utility rejection
	that is imposed on the basis of [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) should be
	accompanied by a rejection based on [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824), first paragraph. The [35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, rejection should be set out as a separate rejection that incorporates by
	reference the factual basis and conclusions set forth in the [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	rejection. The [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or
	**[pre-AIA
	35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph, rejection should indicate that
	because the invention as claimed does not have utility, a person skilled in the art
	would not be able to use the invention as claimed, and as such, the claim is
	defective under [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824), first paragraph. A [35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, rejection based on lack of utility should not be imposed or maintained
	unless an appropriate basis exists for imposing a utility rejection under
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)**. In other words, Office personnel should not impose a
	**[35
	U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, rejection grounded on a "lack of utility" basis unless a [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	rejection is proper. In particular, the factual showing needed to impose a rejection
	under **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376) must be provided if a rejection under [35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, is to be imposed on "lack of utility" grounds.



	It is important to recognize that **[35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, addresses matters other than those related to the question of whether or
	not an invention lacks utility. These matters include whether the claims are fully
	supported by the disclosure (In re Vaeck, 947 F.2d 488, 495, 20
	USPQ2d 1438, 1444 (Fed. Cir. 1991)), whether the applicant has provided an enabling
	disclosure of the claimed subject matter (In re Wright, 999 F.2d
	1557, 1561-1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)), whether the applicant has
	provided an adequate written description of the invention and whether the applicant
	has disclosed the best mode of practicing the claimed invention *(Chemcast
	Corp.v.Arco Indus. Corp.,* 913 F.2d 923, 927-928, 16 USPQ2d 1033,
	1036-1037 (Fed. Cir. 1990)). See also Transco Products Inc.v. Performance Contracting Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed.
	Cir. 1994); Glaxo Inc.v.Novopharm Ltd., 52 F.3d 1043, 34 USPQ2d 1565 (Fed. Cir. 1995). The
	fact that an applicant has disclosed a specific utility for an invention and provided
	a credible basis supporting that specific utility does not provide a basis for
	concluding that the claims comply with all the requirements of **[35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph. For example, if an applicant has claimed a process of treating a certain
	disease condition with a certain compound and provided a credible basis for asserting
	that the compound is useful in that regard, but to actually practice the invention as
	claimed a person skilled in the relevant art would have to engage in an undue amount
	of experimentation, the claim may be defective under [35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824),
	but not **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)**. To avoid confusion during examination, any rejection under
	**[35
	U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, based on grounds other than "lack of utility" should be imposed separately
	from any rejection imposed due to "lack of utility" under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	and **[35
	U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph.



	,
	# 2107.02 Procedural Considerations Related to Rejections for Lack of
	Utility [R-10.2019]

	I. THE CLAIMED INVENTION IS THE FOCUS OF THE UTILITY REQUIREMENTThe claimed invention is the focus of the assessment of whether an
	applicant has satisfied the utility requirement. Each claim (i.e., each "invention"),
	therefore, must be evaluated on its own merits for compliance with all statutory
	requirements. Generally speaking, however, a dependent claim will define an invention
	that has utility if the independent claim from which the dependent claim depends is
	drawn to the same statutory class of invention as the dependent claim and the
	independent claim defines an invention having utility. An exception to this general
	rule is where the utility specified for the invention defined in a dependent claim
	differs from that indicated for the invention defined in the independent claim from
	which the dependent claim depends. Where an applicant has established utility for a
	species that falls within an identified genus of compounds, and presents a generic
	claim covering the genus, as a general matter, that claim should be treated as being
	sufficient under **[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**. Only where it can be established that other species
	clearly encompassed by the claim do not have utility should a rejection be imposed on
	the generic claim. In such cases, the applicant should be encouraged to amend the
	generic claim so as to exclude the species that lack utility.



	It is common and sensible for an applicant to identify several
	specific utilities for an invention, particularly where the invention is a product
	(e.g., a machine, an article of manufacture or a composition of matter). However,
	regardless of the category of invention that is claimed (e.g., product or process),
	an applicant need only make one credible assertion of specific utility for the
	claimed invention to satisfy [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) and
	**[35 U.S.C.
	112](mpep-9015-appx-l.html#d0e302824)**; additional statements of utility, even if not "credible,"
	do not render the claimed invention lacking in utility. See, e.g.,
	Raytheonv.Roper, 724 F.2d 951, 958, 220 USPQ 592, 598 (Fed. Cir. 1983),
	cert. denied, 469 U.S. 835 (1984) ("When a properly claimed
	invention meets at least one stated objective, utility under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	is clearly shown."); In re Gottlieb, 328 F.2d 1016, 1019, 140 USPQ
	665, 668 (CCPA 1964) ("Having found that the antibiotic is useful for some purpose,
	it becomes unnecessary to decide whether it is in fact useful for the other purposes
	‘indicated’ in the specification as possibly useful."); *In re
	Malachowski,* 530 F.2d 1402, 189 USPQ 432 (CCPA 1976);
	Hoffmanv.Klaus, 9 USPQ2d 1657 (Bd. Pat. App. & Inter. 1988). Thus, if
	applicant makes one credible assertion of utility, utility for the claimed invention
	as a whole is established.



	Statements made by the applicant in the specification or incident to
	prosecution of the application before the Office cannot, standing alone, be the basis
	for a lack of utility rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) or
	**[35 U.S.C.
	112](mpep-9015-appx-l.html#d0e302824)*. Tol-O-Matic, Inc.v.Proma Produkt-Und Mktg. Gesellschaft m.b.h.,* 945 F.2d 1546, 1553,
	20 USPQ2d 1332, 1338 (Fed. Cir. 1991) (It is not required that a particular
	characteristic set forth in the prosecution history be achieved in order to satisfy
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)**.). An applicant may include statements in the specification
	whose technical accuracy cannot be easily confirmed if those statements are not
	necessary to support the patentability of an invention with regard to any statutory
	basis. Thus, the Office should not require an applicant to strike nonessential
	statements relating to utility from a patent disclosure, regardless of the technical
	accuracy of the statement or assertion it presents. Office personnel should also be
	especially careful not to read into a claim unclaimed results, limitations or
	embodiments of an invention. See Carl Zeiss Stiftungv.Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991);
	In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Doing so
	can inappropriately change the relationship of an asserted utility to the claimed
	invention and raise issues not relevant to examination of that claim.


	II. **IS THERE AN ASSERTED OR WELL-ESTABLISHED UTILITY FOR THE CLAIMED
	INVENTION?**Upon initial examination, the examiner should review the
	specification to determine if there are any statements asserting that the claimed
	invention is useful for any particular purpose. A complete disclosure should include
	a statement which identifies a specific and substantial utility for the invention.


	*A.**An Asserted Utility Must Be Specific and Substantial*A statement of specific and substantial utility should fully and
	clearly explain why the applicant believes the invention is useful. Such
	statements will usually explain the purpose of or how the invention may be used
	(e.g., a compound is believed to be useful in the treatment of a particular
	disorder). Regardless of the form of statement of utility, it must enable one
	ordinarily skilled in the art to understand why the applicant believes the claimed
	invention is useful.



	Except where an invention has a well-established utility, the
	failure of an applicant to specifically identify why an invention is believed to
	be useful renders the claimed invention deficient under **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376) and [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph. In such cases, the applicant
	has failed to identify a "specific and substantial utility" for the claimed
	invention. For example, a statement that a composition has an unspecified
	"biological activity" or that does not explain why a composition with that
	activity is believed to be useful fails to set forth a "specific and substantial
	utility." Brennerv.Manson, 383 US 519, 148 USPQ 689 (1966) (general assertion of
	similarities to known compounds known to be useful without sufficient
	corresponding explanation why claimed compounds are believed to be similarly
	useful insufficient under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)); *In re
	Ziegler,* 992 F.2d 1197, 1201, 26 USPQ2d 1600, 1604 (Fed. Cir. 1993)
	(disclosure that composition is "plastic-like" and can form "films" not sufficient
	to identify specific and substantial utility for invention); *In re
	Kirk,* 376 F.2d 936, 153 USPQ 48 (CCPA 1967) (indication that compound
	is "biologically active" or has "biological properties" insufficient standing
	alone). See also In re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA
	1967); Kawaiv.Metlesics, 480 F.2d 880, 890, 178 USPQ 158, 165 (CCPA 1973)
	(contrasting description of invention as sedative which did suggest specific
	utility to general suggestion of "pharmacological effects on the central nervous
	system" which did not). In contrast, a disclosure that identifies a particular
	biological activity of a compound and explains how that activity can be utilized
	in a particular therapeutic application of the compound does contain an assertion
	of specific and substantial utility for the invention.



	Situations where an applicant either fails to indicate why an
	invention is considered useful, or where the applicant inaccurately describes the
	utility should rarely arise. One reason for this is that applicants are required
	to disclose the best mode known to them of practicing the invention at the time
	they file their application. An applicant who omits a description of the specific
	and substantial utility of the invention, or who incompletely describes that
	utility, may encounter problems with respect to the best mode requirement of
	**[35
	U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph.


	*B.****No Statement of Utility for the Claimed Invention in the Specification
	Does Not Per Se Negate Utility***Occasionally, an applicant will not explicitly state in the
	specification or otherwise assert a specific and substantial utility for the
	claimed invention. If no statements can be found asserting a specific and
	substantial utility for the claimed invention in the specification, Office
	personnel should determine if the claimed invention has a well-established
	utility. An invention has a well-established utility if (i) a person of ordinary
	skill in the art would immediately appreciate why the invention is useful based on
	the characteristics of the invention (e.g., properties or applications of a
	product or process), and (ii) the utility is specific, substantial, and credible.
	If an invention has a well- established utility, rejections under
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376) and [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph, based on lack of utility should
	not be imposed. In re Folkers, 344 F.2d 970, 145 USPQ 390 (CCPA
	1965). For example, if an application teaches the cloning and characterization of
	the nucleotide sequence of a well-known protein such as insulin, and those skilled
	in the art at the time of filing knew that insulin had a well-established use, it
	would be improper to reject the claimed invention as lacking utility solely
	because of the omitted statement of specific and substantial utility.



	If a person of ordinary skill would not immediately recognize a
	specific and substantial utility for the claimed invention (i.e., why it would be
	useful) based on the characteristics of the invention or statements made by the
	applicant, the examiner should reject the application under **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376) and under [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** or
	**[pre-AIA 35
	U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph, as failing to identify a
	specific and substantial utility for the claimed invention. The rejection should
	clearly indicate that the basis of the rejection is that the application fails to
	identify a specific and substantial utility for the invention. The rejection
	should also specify that the applicant must reply by indicating why the invention
	is believed useful and where support for any subsequently asserted utility can be
	found in the specification as filed. See [MPEP § 2701](s2701.html#d0e271945).



	If the applicant subsequently indicates why the invention is
	useful, Office personnel should review that assertion according to the standards
	articulated below for review of the credibility of an asserted utility.


	III. EVALUATING THE CREDIBILITY OF AN ASSERTED UTILITY*

	*A.**An Asserted Utility Creates a Presumption of Utility*In most cases, an applicant’s assertion of utility creates a
	presumption of utility that will be sufficient to satisfy the utility requirement
	of **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)*. See, e.g., In re Jolles,* 628 F.2d
	1322, 206 USPQ 885 (CCPA 1980); In re Irons, 340 F.2d 974, 144
	USPQ 351 (CCPA 1965); In re Langer, 503 F.2d 1380, 183 USPQ 288
	(CCPA 1974); In re Sichert, 566 F.2d 1154, 1159, 196 USPQ 209,
	212-13 (CCPA 1977). As the Court of Customs and Patent Appeals stated in
	In re Langer:




	>
	> As a matter of Patent Office practice, a specification which
	> contains a disclosure of utility which corresponds in scope to the subject
	> matter sought to be patented must be taken as sufficient
	> to satisfy the utility requirement of [§ 101](mpep-9015-appx-l.html#d0e302376) for the entire
	> claimed subject matter unless there is a reason for one
	> skilled in the art to question the objective truth of the statement of utility
	> or its scope.
	>
	>
	>
	>


	In re Langer, 503 F.2d at 1391, 183 USPQ at 297 (emphasis in
	original). The "Langer" test for utility has been used by both the Federal Circuit
	and the Court of Customs and Patent Appeals in evaluation of rejections under
	**[35
	U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, where the rejection is based on a deficiency under **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)*. In In re Brana,* 51 F.3d 1560, 34
	USPQ2d 1436 (Fed. Cir. 1995), the Federal Circuit explicitly adopted the Court of
	Customs and Patent Appeals formulation of the "Langer" standard for
	**[35
	U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph rejections, as it was expressed in a slightly reworded format in
	In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA
	1971), namely:




	>
	> [A] specification disclosure which contains a teaching of the
	> manner and process of making and using the invention in terms which correspond
	> in scope to those used in describing and defining the subject matter sought to
	> be patented must be taken as in compliance with the
	> enabling requirement of the first paragraph of [§ 112](mpep-9015-appx-l.html#d0e302824)
	> unless there is reason to doubt the objective truth of the statements contained
	> therein which must be relied on for enabling support. (emphasis added).
	>
	>
	>
	>


	Thus, Langer and subsequent cases direct the
	Office to presume that a statement of utility made by an applicant is true. See
	In re Langer, 503 F.2d at 1391, 183 USPQ at 297; *In
	re Malachowski,* 530 F.2d 1402, 1404, 189 USPQ 432, 435 (CCPA 1976);
	In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995).
	For obvious reasons of efficiency and in deference to an applicant’s understanding
	of the invention, when a statement of utility is evaluated, Office personnel
	should not begin by questioning the truth of the statement of utility. Instead,
	any inquiry must start by asking if there is any reason to question the truth of
	the statement of utility. This can be done by simply evaluating the logic of the
	statements made, taking into consideration any evidence cited by the applicant. If
	the asserted utility is credible (i.e., believable based on the record or the
	nature of the invention), a rejection based on "lack of utility" is not
	appropriate. Clearly, Office personnel should not begin an evaluation of utility
	by assuming that an asserted utility is likely to be false, based on the technical
	field of the invention or for other general reasons.



	Compliance with [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) is a question of
	fact. Raytheonv.Roper, 724 F.2d 951, 956, 220 USPQ 592, 596 (Fed. Cir. 1983)
	cert. denied, 469 U.S. 835 (1984). Thus, to overcome the
	presumption of truth that an assertion of utility by the applicant enjoys, Office
	personnel must establish that it is more likely than not that one of ordinary
	skill in the art would doubt (i.e., "question") the truth of the statement of
	utility. The evidentiary standard to be used throughout *ex
	parte* examination in setting forth a rejection is a preponderance of
	the totality of the evidence under consideration. *In re
	Oetiker,* 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992)
	("After evidence or argument is submitted by the applicant in response,
	patentability is determined on the totality of the record, by a preponderance of
	evidence with due consideration to persuasiveness of argument."); *In re
	Corkill,* 771 F.2d 1496, 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). A
	preponderance of the evidence exists when it suggests that it is more likely than
	not that the assertion in question is true. Hermanv.Huddleston, 459 U.S. 375, 390 (1983). To do this, Office
	personnel must provide evidence sufficient to show that the statement of asserted
	utility would be considered "false" by a person of ordinary skill in the art. Of
	course, a person of ordinary skill must have the benefit of both facts and
	reasoning in order to assess the truth of a statement. This means that if the
	applicant has presented facts that support the reasoning used in asserting a
	utility, Office personnel must present countervailing facts and reasoning
	sufficient to establish that a person of ordinary skill would not believe the
	applicant’s assertion of utility. In re Brana, 51 F.3d 1560, 34
	USPQ2d 1436 (Fed. Cir. 1995). The initial evidentiary standard used during
	evaluation of this question is a preponderance of the evidence (i.e., the totality
	of facts and reasoning suggest that it is more likely than not that the statement
	of the applicant is false).


	*B.**When Is an Asserted Utility Not Credible?*Where an applicant has specifically asserted that an invention
	has a particular utility, that assertion cannot simply be dismissed by Office
	personnel as being "wrong," even when there may be reason to believe that the
	assertion is not entirely accurate. Rather, Office personnel must determine if the
	assertion of utility is credible (i.e., whether the
	assertion of utility is believable to a person of ordinary skill in the art based
	on the totality of evidence and reasoning provided). An assertion is credible
	unless (A) the logic underlying the assertion is seriously flawed, or (B) the
	facts upon which the assertion is based are inconsistent with the logic underlying
	the assertion. Credibility as used in this context refers to the reliability of
	the statement based on the logic and facts that are offered by the applicant to
	support the assertion of utility.



	One situation where an assertion of utility would not be
	considered credible is where a person of ordinary skill would consider the
	assertion to be "incredible in view of contemporary knowledge" and where nothing
	offered by the applicant would counter what contemporary knowledge might otherwise
	suggest. Office personnel should be careful, however, not to label certain types
	of inventions as "incredible" or "speculative" as such labels do not provide the
	correct focus for the evaluation of an assertion of utility. "Incredible utility"
	is a conclusion, not a starting point for analysis under **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)**. A conclusion that an asserted utility is incredible can
	be reached only after the Office has evaluated both the assertion of the applicant
	regarding utility and any evidentiary basis of that
	assertion. The Office should be particularly careful not to start with a
	presumption that an asserted utility is, per se, "incredible"
	and then proceed to base a rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) on that
	presumption.



	Rejections under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) based on a lack
	of credible utility have been sustained by federal courts when, for example, the
	applicant failed to disclose any utility for the invention or asserted a utility
	that could only be true if it violated a scientific principle, such as the second
	law of thermodynamics, or a law of nature, or was wholly
	inconsistent with contemporary knowledge in the art. *In re
	Gazave,* 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967). Special care
	should be taken when assessing the credibility of an asserted therapeutic utility
	for a claimed invention. In such cases, a previous lack of success in treating a
	disease or condition, or the absence of a proven animal model for testing the
	effectiveness of drugs for treating a disorder in humans, should not, standing
	alone, serve as a basis for challenging the asserted utility under
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376). See [MPEP § 2107.03](s2107.html#d0e200058)** for additional
	guidance with regard to therapeutic or pharmacological utilities.


	IV. *INITIAL BURDEN IS ON THE OFFICE TO ESTABLISH A PRIMA FACIE*
	CASE AND PROVIDE EVIDENTIARY SUPPORT THEREOFTo properly reject a claimed invention under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**,
	the Office must (A) make a prima facie showing that the claimed
	invention lacks utility, and (B) provide a sufficient evidentiary basis for factual
	assumptions relied upon in establishing the prima facie showing.
	In re Gaubert, 524 F.2d 1222, 1224, 187 USPQ 664, 666 (CCPA
	1975) "Accordingly, the PTO must do more than merely question operability - it must
	set forth factual reasons which would lead one skilled in the art to question the
	objective truth of the statement of operability." If the Office cannot develop a
	proper prima facie case and provide evidentiary support for a
	rejection under **[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**, a rejection on this ground should not be imposed.
	See, e.g., In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443,
	1444 (Fed. Cir. 1992) ("[T]he examiner bears the initial burden, on review of the
	prior art or on any other ground, of presenting a prima facie case
	of unpatentability. If that burden is met, the burden of coming forward with evidence
	or argument shifts to the applicant.... If examination at the initial stage does not
	produce a prima facie case of unpatentability, then without more
	the applicant is entitled to grant of the patent."). See also
	Fregeauv.Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985)
	(applying prima facie case law to [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376));
	In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984).



	The prima facie showing must be set forth in a
	well-reasoned statement. Any rejection based on lack of utility should include a
	detailed explanation why the claimed invention has no specific and substantial
	credible utility. Whenever possible, the examiner should provide documentary evidence
	regardless of publication date (e.g., scientific or technical journals, excerpts from
	treatises or books, or U.S. or foreign patents) to support the factual basis for the
	prima facie showing of no specific and substantial credible
	utility. If documentary evidence is not available, the examiner should specifically
	explain the scientific basis for the examiner's factual conclusions.



	Where the asserted utility is not specific or substantial, a
	prima facie showing must establish that it is more likely than
	not that a person of ordinary skill in the art would not consider that any utility
	asserted by the applicant would be specific and substantial. The *prima
	facie* showing must contain the following elements:



	* (A) An explanation that clearly sets forth the reasoning used in
	concluding that the asserted utility for the claimed invention is neither both
	specific and substantial nor well-established;
	* (B) Support for factual findings relied upon in reaching this
	conclusion; and
	* (C) An evaluation of all relevant evidence of record, including
	utilities taught in the closest prior art.


	Where the asserted specific and substantial utility is not credible,
	a prima facie showing of no specific and substantial credible
	utility must establish that it is more likely than not that a person skilled in the
	art would not consider credible any specific and substantial utility asserted by the
	applicant for the claimed invention. The prima facie showing must
	contain the following elements:



	* (A) An explanation that clearly sets forth the reasoning used in
	concluding that the asserted specific and substantial utility is not
	credible;
	* (B) Support for factual findings relied upon in reaching this
	conclusion; and
	* (C) An evaluation of all relevant evidence of record, including
	utilities taught in the closest prior art.


	Where no specific and substantial utility is disclosed or is
	well-established, a prima facie showing of no specific and
	substantial utility need only establish that applicant has not asserted a utility and
	that, on the record before the examiner, there is no known well-established
	utility.



	It is imperative that Office personnel use specificity in setting
	forth and initial rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) and support any
	factual conclusions made in the prima facie showing.



	By using specificity, the applicant will be able to identify the
	assumptions made by the Office in setting forth the rejection and will be able to
	address those assumptions properly.



	Use form paragraphs [7.04.01](#fp7.04.01) and
	[7.05.02](#fp7.05.02)
	through [7.05.04](#fp.7.05.04) to reject claims under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	for failure to satisfy the utility requirement.



	# ¶ 7.05.02 Rejection, 35 U.S.C. 101, Utility Lacking


	the claimed invention lacks patentable utility. [1]


	### Examiner Note:


	In bracket 1, provide explanation of lack of utility. See
	[MPEP §§ 2105](s2105.html#d0e197008) - [2107.03](s2107.html#d0e200058).




	# ¶ 7.05.03 Rejection, 35 U.S.C. 101, Inoperative


	the disclosed invention is inoperative and therefore lacks utility. [1]


	### Examiner Note:


	In bracket 1, explain why invention is inoperative.



	# ¶ 7.05.04 Utility Rejections Under 35 U.S.C. 101 and 35 U.S.C. 112(a) or 35
	U.S.C. 112 (pre-AIA), First Paragraph


	Claim [1] rejected under
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** because the claimed invention is not supported by either a
	[2] asserted utility or a well established utility.



	[3]


	Claim [4] also rejected
	under **[35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first paragraph.
	Specifically, because the claimed invention is not supported by either a [5]
	asserted utility or a well established utility for the reasons set forth above, one skilled in
	the art clearly would not know how to use the claimed invention.



	### Examiner Note:

	* 1. Where the specification would not enable one skilled in the art to
	make the claimed invention, or where alternative reasons support the enablement
	rejection, a separate rejection under [35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or **[pre-AIA 35 U.S.C.
	112](mpep-9015-appx-l.html#d0e302824)**, first paragraph, enablement should be made using the factors
	set forth in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir.
	1988) and an undue experimentation analysis. See [MPEP §§ 2164](s2164.html#d0e215224) - [2164.08(c)](s2164.html#d0e216899).
	* 2. Use Format A, B, or C below as
	appropriate.
	+ Format A:- (a) Insert the same claim numbers in
	brackets 1 and 4.
	- (b) Insert --specific and substantial--
	in inserts 2 and 5.
	- (c) In bracket 3, insert the explanation
	as to why the claimed invention is not supported by either a specific and
	substantial asserted utility or a well established
	utility.
	- (d) Format A is to be used when there is
	no asserted utility and when there is an asserted utility but that
	utility is not specific and substantial.
	+ Format B:- (a) Insert the same claim numbers in
	brackets 1 and 4.
	- (b) Insert --credible-- in inserts 2 and
	5.
	- (c) In bracket 3, insert the explanation
	as to why the claimed invention is not supported by either a credible
	asserted utility or a well established utility.
	+ Format C:- For claims that have multiple utilities, some of which
	are not specific and substantial, some of which are not credible, but none of
	which are specific, substantial and credible:
	* (a) Insert the same claim numbers in brackets 1 and
	4.
	* (b) Insert --specific and substantial asserted
	utility, a credible-- in inserts 2 and 5.
	* (c) In bracket 3, insert the explanation as to why the
	claimed invention is not supported by either a specific and substantial
	asserted utility, a credible asserted utility or a well established
	utility. Each utility should be addressed.


	V. EVIDENTIARY REQUESTS BY AN EXAMINER TO SUPPORT AN ASSERTED UTILITYIn appropriate situations the Office may require an applicant to
	substantiate an asserted utility for a claimed invention. See *In re
	Pottier,* 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) ("When the
	operativeness of any process would be deemed unlikely by one of ordinary skill in the
	art, it is not improper for the examiner to call for evidence of operativeness.").
	See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890
	(CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963);
	In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962).
	In In re Citron, the court held that when an "alleged utility
	appears to be incredible in the light of the knowledge of the art, or factually
	misleading, applicant must establish the asserted utility by acceptable proof." 325
	F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which
	affirmed the rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376) "in view
	of the art knowledge of the lack of a cure for cancer and the absence of any
	clinical data to substantiate the allegation." 325 F.2d at 252, 139
	USPQ at 519 (emphasis in original). The court thus established a higher burden on the
	applicant where the statement of use is incredible or misleading. In such a case, the
	examiner should challenge the use and require sufficient evidence of operativeness.
	The purpose of this authority is to enable an applicant to cure an otherwise
	defective factual basis for the operability of an invention. Because this is a
	curative authority (e.g., evidence is requested to enable an applicant to support an
	assertion that is inconsistent with the facts of record in the application), Office
	personnel should indicate not only why the factual record is defective in relation to
	the assertions of the applicant, but also, where appropriate, what type of
	evidentiary showing can be provided by the applicant to remedy the problem.



	Requests for additional evidence should be imposed rarely, and only
	if necessary to support the scientific credibility of the asserted utility (e.g., if
	the asserted utility is not consistent with the evidence of record and current
	scientific knowledge). As the Federal Circuit recently noted, "[o]nly after the PTO
	provides evidence showing that one of ordinary skill in the art would reasonably
	doubt the asserted utility does the burden shift to the applicant to provide rebuttal
	evidence sufficient to convince such a person of the invention’s asserted utility."
	In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995)
	(citing In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA
	1981)). In Brana, the court pointed out that the purpose of
	treating cancer with chemical compounds does not
	suggest, per se, an incredible utility. Where the prior
	art disclosed "structurally similar compounds to those claimed by applicants which
	have been proven in vivo to be effective as chemotherapeutic
	agents against various tumor models . . ., one skilled in the art would be without
	basis to reasonably doubt applicants’ asserted utility on its face." 51 F.3d at 1566,
	34 USPQ2d at 1441. As courts have stated, "it is clearly improper for the examiner to
	make a demand for further test data, which as evidence would be essentially redundant
	and would seem to serve for nothing except perhaps to unduly burden the applicant."
	In re Isaacs, 347 F.2d 887, 890, 146 USPQ 193, 196 (CCPA
	1965).


	VI. *CONSIDERATION OF A REPLY TO A PRIMA FACIE* REJECTION FOR
	LACK OF UTILITYIf a rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** has been properly
	imposed, along with a corresponding rejection under **[35 U.S.C.
	112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5) or [pre-AIA 35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, first
	paragraph, the burden shifts to the applicant to rebut the *prima
	facie* showing. In re Oetiker, 977 F.2d 1443, 1445, 24
	USPQ2d 1443, 1444 (Fed. Cir. 1992) ("The examiner bears the initial burden, on review
	of the prior art or on any other ground, of presenting a *prima
	facie* case of unpatentability. If that burden is met, the burden of
	coming forward with evidence or argument shifts to the applicant. . . After evidence
	or argument is submitted by the applicant in response, patentability is determined on
	the totality of the record, by a preponderance of evidence with due consideration to
	persuasiveness of argument."). An applicant can do this using any combination of the
	following: amendments to the claims, arguments or reasoning, or new evidence
	submitted in an affidavit or declaration under [37 CFR 1.132](mpep-9020-appx-r.html#d0e323552), or in a printed
	publication. New evidence provided by an applicant must be relevant to the issues
	raised in the rejection. For example, declarations in which conclusions are set forth
	without establishing a nexus between those conclusions and the supporting evidence,
	or which merely express opinions, may be of limited probative value with regard to
	rebutting a prima facie case. In re Grunwell,
	609 F.2d 486, 203 USPQ 1055 (CCPA 1979); In re Buchner, 929 F.2d
	660, 18 USPQ2d 1331 (Fed. Cir. 1991). See [MPEP § 716.01(a)](s716.html#d0e92557) through
	**[MPEP
	§ 716.01(c)](s716.html#d0e92659)**.



	If the applicant responds to the prima facie
	rejection, Office personnel should review the original disclosure, any evidence
	relied upon in establishing the prima facie showing, any claim
	amendments, and any new reasoning or evidence provided by the applicant in support of
	an asserted specific and substantial credible utility. It is essential for Office
	personnel to recognize, fully consider and respond to each substantive element of any
	response to a rejection based on lack of utility. Only where the totality of the
	record continues to show that the asserted utility is not specific, substantial, and
	credible should a rejection based on lack of utility be maintained. If the record as
	a whole would make it more likely than not that the asserted utility for the claimed
	invention would be considered credible by a person of ordinary skill in the art, the
	Office cannot maintain the rejection. In re Rinehart, 531 F.2d
	1048, 1052, 189 USPQ 143, 147 (CCPA 1976).


	VII. EVALUATION OF EVIDENCE RELATED TO UTILITYThere is no predetermined amount or character of evidence that must
	be provided by an applicant to support an asserted utility, therapeutic or otherwise.
	Rather, the character and amount of evidence needed to support an asserted utility
	will vary depending on what is claimed (Ex parte Ferguson, 117
	USPQ 229 (Bd. App. 1957)), and whether the asserted utility appears to contravene
	established scientific principles and beliefs. In re Gazave, 379
	F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967); In re Chilowsky,
	229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). Furthermore, the applicant does not
	have to provide evidence sufficient to establish that an asserted utility is true
	"beyond a reasonable doubt." In re Irons, 340 F.2d 974, 978, 144
	USPQ 351, 354 (CCPA 1965). Nor must an applicant provide evidence such that it
	establishes an asserted utility as a matter of statistical certainty.
	Nelsonv.Bowler, 626 F.2d 853, 856-57, 206 USPQ 881, 883-84 (CCPA 1980)
	(reversing the Board and rejecting Bowler’s arguments that the evidence of utility
	was statistically insignificant. The court pointed out that a rigorous correlation is
	not necessary when the test is reasonably predictive of the response). See also
	Rey-Belletv.Englehardt, 493 F.2d 1380, 181 USPQ 453 (CCPA 1974) (data from
	animal testing is relevant to asserted human therapeutic utility if there is a
	"satisfactory correlation between the effect on the animal and that ultimately
	observed in human beings"). Instead, evidence will be sufficient if, considered as a
	whole, it leads a person of ordinary skill in the art to conclude that the asserted
	utility is more likely than not true.



	,
	# 2107.03 Special Considerations for Asserted Therapeutic or
	Pharmacological Utilities [R-08.2012]


	The federal courts have consistently reversed rejections by the Office
	asserting a lack of utility for inventions claiming a pharmacological or therapeutic
	utility where an applicant has provided evidence that reasonably supports such a
	utility. In view of this, Office personnel should be particularly careful in their
	review of evidence provided in support of an asserted therapeutic or pharmacological
	utility.


	I. **A REASONABLE CORRELATION BETWEEN THE EVIDENCE AND THE ASSERTED UTILITY IS
	SUFFICIENT**As a general matter, evidence of pharmacological or other biological
	activity of a compound will be relevant to an asserted therapeutic use if there is a
	reasonable correlation between the activity in question and
	the asserted utility. Crossv. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985);
	In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980);
	Nelsonv.Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980). An applicant can
	establish this reasonable correlation by relying on statistically relevant data
	documenting the activity of a compound or composition, arguments or reasoning,
	documentary evidence (e.g., articles in scientific journals), or any combination
	thereof. The applicant does not have to prove that a correlation exists between a
	particular activity and an asserted therapeutic use of a compound as a matter of
	statistical certainty, nor does he or she have to provide actual evidence of success
	in treating humans where such a utility is asserted. Instead, as the courts have
	repeatedly held, all that is required is a reasonable correlation between the
	activity and the asserted use. Nelsonv.Bowler, 626 F.2d 853, 857, 206 USPQ 881, 884 (CCPA 1980).


	II. STRUCTURAL SIMILARITY TO COMPOUNDS WITH ESTABLISHED UTILITYCourts have routinely found evidence of structural similarity to a
	compound known to have a particular therapeutic or pharmacological utility as being
	supportive of an assertion of therapeutic utility for a new compound. In *In
	re Jolles,* 628 F.2d 1322, 206 USPQ 885 (CCPA 1980), the claimed
	compounds were found to have utility based on a finding of a close structural
	relationship to daunorubicin and doxorubicin and shared pharmacological activity with
	those compounds, both of which were known to be useful in cancer chemotherapy. The
	evidence of close structural similarity with the known compounds was presented in
	conjunction with evidence demonstrating substantial activity of the claimed
	compounds in animals customarily employed for screening anticancer agents. Such
	evidence should be given appropriate weight in determining whether one skilled in the
	art would find the asserted utility credible. Office personnel should evaluate not
	only the existence of the structural relationship, but also the reasoning used by the
	applicant or a declarant to explain why that structural similarity is believed to be
	relevant to the applicant's assertion of utility.


	III. *DATA FROM IN VITRO* OR ANIMAL TESTING IS GENERALLY
	SUFFICIENT TO SUPPORT THERAPEUTIC UTILITY**If reasonably correlated to the particular therapeutic or
	pharmacological utility, data generated using in vitro assays, or
	from testing in an animal model or a combination thereof almost invariably will be
	sufficient to establish therapeutic or pharmacological utility for a compound,
	composition or process. A cursory review of cases involving therapeutic inventions
	where **[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** was the dispositive issue illustrates the fact that the
	federal courts are not particularly receptive to rejections under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)
	based on inoperability. Most striking is the fact that in those cases where an
	applicant supplied a reasonable evidentiary showing supporting an asserted
	therapeutic utility, almost uniformly the [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)-based rejection was
	reversed. See, e.g., In re Brana, 51 F.3d 1560, 34 USPQ 1436 (Fed.
	Cir. 1995); Crossv. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985);
	In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980);
	Nelsonv.Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980);
	In re Malachowski, 530 F.2d 1402, 189 USPQ 432 (CCPA 1976);
	In re Gaubert, 530 F.2d 1402, 189 USPQ 432 (CCPA 1975);
	In re Gazave, 379 F.2d 973, 154 USPQ 92 (CCPA 1967);
	In re Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA 1962);
	In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Only in
	those cases where the applicant was unable to come forward with any relevant evidence
	to rebut a finding by the Office that the claimed invention was inoperative was a
	**[35 U.S.C.
	101](mpep-9015-appx-l.html#d0e302376)** rejection affirmed by the court. *In re
	Citron,* 325 F.2d 248, 253, 139 USPQ 516, 520 (CCPA 1963) (therapeutic
	utility for an uncharacterized biological extract not supported or scientifically
	credible); In re Buting, 418 F.2d 540, 543, 163 USPQ 689, 690
	(CCPA 1969) (record did not establish a credible basis for the assertion that the
	single class of compounds in question would be useful in treating disparate types of
	cancers); In re Novak, 306 F.2d 924, 134 USPQ 335 (CCPA 1962)
	(claimed compounds did not have capacity to effect physiological activity upon which
	utility claim based). Contrast, however, In re Buting to
	In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973),
	reh'g denied, 480 F.2d 879 (CCPA 1973), in which the court held
	that utility for a genus was found to be supported through a showing of utility for
	one species. In no case has a federal court required an applicant to support an
	asserted utility with data from human clinical trials.



	If an applicant provides data, whether from *in
	vitro* assays or animal tests or both, to support an asserted utility,
	and an explanation of why that data supports the asserted utility, the Office will
	determine if the data and the explanation would be viewed by one skilled in the art
	as being reasonably predictive of the asserted utility. See, e.g., *Ex parte
	Maas,* 9 USPQ2d 1746 (Bd. Pat. App. & Inter. 1987); *Ex parte
	Balzarini,* 21 USPQ2d 1892 (Bd. Pat. App. & Inter. 1991). Office
	personnel must be careful to evaluate all factors that might influence the
	conclusions of a person of ordinary skill in the art as to this question, including
	the test parameters, choice of animal, relationship of the activity to the particular
	disorder to be treated, characteristics of the compound or composition, relative
	significance of the data provided and, most importantly, the explanation offered by
	the applicant as to why the information provided is believed to support the asserted
	utility. If the data supplied is consistent with the asserted utility, the Office
	cannot maintain a rejection under [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376).



	Evidence does not have to be in the form of data from an
	art-recognized animal model for the particular disease or disease condition to which
	the asserted utility relates. Data from any test that the applicant reasonably
	correlates to the asserted utility should be evaluated substantively. Thus, an
	applicant may provide data generated using a particular animal model with an
	appropriate explanation as to why that data supports the asserted utility. The
	absence of a certification that the test in question is an industry-accepted model is
	not dispositive of whether data from an animal model is in fact relevant to the
	asserted utility. Thus, if one skilled in the art would accept the animal tests as
	being reasonably predictive of utility in humans, evidence
	from those tests should be considered sufficient to support the credibility of the
	asserted utility. In re Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA
	1962); In re Krimmel, 292 F.2d 948, 953, 130 USPQ 215, 219 (CCPA
	1961); Ex parte Krepelka, 231 USPQ 746 (Bd. Pat. App. & Inter.
	1986). Office personnel should be careful not to find evidence unpersuasive simply
	because no animal model for the human disease condition had been established prior to
	the filing of the application. See In re Chilowsky, 229 F.2d 457,
	461, 108 USPQ 321, 325 (CCPA 1956) ("The mere fact that something has not previously
	been done clearly is not, in itself, a sufficient basis for rejecting all
	applications purporting to disclose how to do it."); In re Wooddy,
	331 F.2d 636, 639, 141 USPQ 518, 520 (CCPA 1964) ("It appears that no one on earth is
	certain as of the present whether the process claimed will operate in the manner
	claimed. Yet absolute certainty is not required by the law. The mere fact that
	something has not previously been done clearly is not, in itself, a sufficient basis
	for rejecting all applications purporting to disclose how to do it.").


	IV. HUMAN CLINICAL DATAOffice personnel should not impose on applicants the unnecessary
	burden of providing evidence from human clinical trials. There is no decisional law
	that requires an applicant to provide data from human clinical trials to establish
	utility for an invention related to treatment of human disorders (see *In re
	Isaacs,* 347 F.2d 889, 146 USPQ 193 (CCPA 1963); *In re
	Langer,* 503 F.2d 1380, 183 USPQ 288 (CCPA 1974)), even with respect to
	situations where no art-recognized animal models existed for the human disease
	encompassed by the claims. Ex parte Balzarini, 21 USPQ2d 1892 (Bd.
	Pat. App. & Inter. 1991) (human clinical data is not required to demonstrate the
	utility of the claimed invention, even though those skilled in the art might not
	accept other evidence to establish the efficacy of the claimed therapeutic
	compositions and the operativeness of the claimed methods of treating humans). Before
	a drug can enter human clinical trials, the sponsor, often the
	applicant, must provide a convincing rationale to those
	especially skilled in the art (e.g., the Food and Drug
	Administration (FDA)) that the investigation may be successful. Such a rationale
	would provide a basis for the sponsor’s expectation that the investigation may be
	successful. In order to determine a protocol for phase I testing, the first phase of
	clinical investigation, some credible rationale of how the drug might be effective or
	could be effective would be necessary. Thus, as a general rule, if an
	applicant has initiated human clinical trials for a therapeutic product or
	process, Office personnel should presume that the applicant has established that
	the subject matter of that trial is reasonably predictive of having the asserted
	therapeutic utility.

	V. SAFETY AND EFFICACY CONSIDERATIONSThe Office must confine its review of patent applications to the
	statutory requirements of the patent law. Other agencies of the government have been
	assigned the responsibility of ensuring conformance to standards established by
	statute for the advertisement, use, sale or distribution of drugs. The FDA pursues a
	two-prong test to provide approval for testing. Under that test, a sponsor must show
	that the investigation does not pose an unreasonable and significant risk of illness
	or injury and that there is an acceptable rationale for the study. As a review
	matter, there must be a rationale for believing that the compound could be effective.
	If the use reviewed by the FDA is not set forth in the specification, FDA review may
	not satisfy **[35
	U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**. However, if the reviewed use is one set forth in
	the specification, Office personnel must be extremely hesitant to challenge utility.
	In such a situation, experts at the FDA have assessed the rationale for the drug or
	research study upon which an asserted utility is based and found it satisfactory.
	Thus, in challenging utility, Office personnel must be able to carry their burden
	that there is no sound rationale for the asserted utility even though experts
	designated by Congress to decide the issue have come to an opposite conclusion. "FDA
	approval, however, is not a prerequisite for finding a compound useful within the
	meaning of the patent laws." In re Brana, 51 F.3d 1560, 34 USPQ2d
	1436 (Fed. Cir. 1995) (citing Scottv.Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 (Fed. Cir.
	1994)).



	Thus, while an applicant may on occasion need to provide evidence to
	show that an invention will work as claimed, it is improper for Office personnel to
	request evidence of safety in the treatment of humans, or regarding the
	degree of effectiveness. See *In re
	Sichert,* 566 F.2d 1154, 196 USPQ 209 (CCPA 1977); *In re
	Hartop,* 311 F.2d 249, 135 USPQ 419 (CCPA 1962); *In re
	Anthony,* 414 F.2d 1383, 162 USPQ 594 (CCPA 1969); *In re
	Watson,* 517 F.2d 465, 186 USPQ 11 (CCPA 1975); *In re
	Krimmel,* 292 F.2d 948, 130 USPQ 215 (CCPA 1961); *Ex parte
	Jovanovics,* 211 USPQ 907 (Bd. Pat. App. & Inter. 1981).


	VI. TREATMENT OF SPECIFIC DISEASE CONDITIONSClaims directed to a method of treating or curing a disease for
	which there have been no previously successful treatments or cures warrant careful
	review for compliance with [35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376). The credibility of
	an asserted utility for treating a human disorder may be more difficult to establish
	where current scientific understanding suggests that such a task would be impossible.
	Such a determination has always required a good understanding of the state of the art
	as of the time that the invention was made. For example, prior to the 1980’s, there
	were a number of cases where an asserted use in treating cancer in humans was viewed
	as "incredible." In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA
	1980); In re Buting, 418 F.2d 540, 163 USPQ 689 (CCPA 1969);
	Ex parte Stevens, 16 USPQ2d 1379 (Bd. Pat. App. & Inter.
	1990); Ex parte Busse, 1 USPQ2d 1908 (Bd. Pat. App. & Inter.
	1986); Ex parte Krepelka, 231 USPQ 746 (Bd. Pat. App. & Inter.
	1986); Ex parte Jovanovics, 211 USPQ 907 (Bd. Pat. App. &
	Inter. 1981). The fact that there is no known cure for a disease, however, cannot
	serve as the basis for a conclusion that such an invention lacks utility. Rather,
	Office personnel must determine if the asserted utility for the invention is credible
	based on the information disclosed in the application. Only those claims for which an
	asserted utility is not credible should be rejected. In such
	cases, the Office should carefully review what is being claimed by the applicant. An
	assertion that the claimed invention is useful in treating a symptom of an incurable
	disease may be considered credible by a person of ordinary skill in the art on the
	basis of a fairly modest amount of evidence or support. In contrast, an assertion
	that the claimed invention will be useful in "curing" the disease may require a
	significantly greater amount of evidentiary support to be considered credible by a
	person of ordinary skill in the art. In re Sichert, 566 F.2d 1154,
	196 USPQ 209 (CCPA 1977); In re Jolles, 628 F.2d 1322, 206 USPQ
	885 (CCPA 1980). See also Ex parte Ferguson, 117 USPQ 229 (Bd.
	Pat. App. & Inter. 1957).



	In these cases, it is important to note that the Food and Drug
	Administration has promulgated regulations that enable a party to conduct clinical
	trials for drugs used to treat life threatening and severely-debilitating illnesses,
	even where no alternative therapy exists. See 21 CFR 312.80-88 (1994). Implicit in
	these regulations is the recognition that experts qualified to evaluate the
	effectiveness of therapeutics can and often do find a sufficient basis to conduct
	clinical trials of drugs for incurable or previously untreatable illnesses. Thus,
	affidavit evidence from experts in the art indicating that there is a reasonable
	expectation of success, supported by sound reasoning, usually should be sufficient to
	establish that such a utility is credible.



	]