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+[
+# 2143 Examples of Basic Requirements of a *Prima Facie*
+ Case of Obviousness [R-10.2019]
+
+
+*[Editor Note: This MPEP section is **applicable** to applications subject
+ to the first inventor to file (FITF) provisions of the AIA except that the relevant date
+ is the "effective filing date" of the claimed invention instead of the "time of the
+ invention" or "time the invention was made," which are only applicable to applications
+ subject to **[pre-AIA 35
+ U.S.C. 102](mpep-9015-appx-l.html#d0e302383)**. See **[35 U.S.C. 100 (note)](mpep-9015-appx-l.html#al_d1d917_1bef1_2b)** and
+ **[MPEP §
+ 2150](s2150.html#ch2100_d2002f_22805_16e)** et seq.]*
+
+
+The Supreme Court in *KSR Int'l Co. v. Teleflex Inc.,*
+ 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to
+ support a conclusion of obviousness which are consistent with the proper "functional
+ approach" to the determination of obviousness as laid down in *Graham*.
+ The key to supporting any rejection under **[35 U.S.C. 103](mpep-9015-appx-l.html#d0e302450)** is the clear articulation
+ of the reason(s) why the claimed invention would have been obvious. The Supreme Court in
+ *KSR* noted that the analysis supporting a rejection under
+ **[35 U.S.C.
+ 103](mpep-9015-appx-l.html#d0e302450)** should be made explicit. In *Ball Aerosol v. Ltd.
+ Brands,* 555 F.3d 984, 89 USPQ2d 1870 (Fed. Cir. 2009), the Federal Circuit
+ offered additional instruction as to the need for an explicit analysis. The Federal Circuit
+ explained that the Supreme Court’s requirement for an explicit analysis does not require
+ record evidence of an explicit teaching of a motivation to combine in the prior art.
+ 
+
+
+ "[T]he analysis that "should be made explicit" refers not
+ to the teachings in the prior art of a motivation to combine, but to the court’s analysis.
+ . . . Under the flexible inquiry set forth by the Supreme Court, the district court
+ therefore erred by failing to take account of 'the inferences and creative steps,' or even
+ routine steps, that an inventor would employ and by failing to find a motivation to combine
+ related pieces from the prior art." *Ball Aerosol,* 555 F.3d at 993, 89
+ USPQ2d at 1877. 
+ 
+
+
+The Federal Circuit’s directive in *Ball
+ Aerosol* was addressed to a lower court, but it applies to Office personnel as
+ well. When setting forth a rejection, Office personnel are to continue to make appropriate
+ findings of fact as explained in **[MPEP § 2141](s2141.html#d0e208143)** and **[§ 2143](s2143.html#d0e209516)**, and must provide
+ a reasoned explanation as to why the invention as claimed would have been obvious to a
+ person of ordinary skill in the art at the time of the invention. This requirement for
+ explanation remains even in situations in which Office personnel may properly rely on
+ common sense or ordinary ingenuity. *In re Van Os,* 844 F.3d 1359, 1361,
+ 121 USPQ2d 1209, 1211 (Fed. Cir. 2017) ("Absent some articulated rationale, a finding that
+ a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different
+ than merely stating the combination ‘would have been obvious.’").
+ 
+
+**I.** **EXEMPLARY RATIONALES** Examples of rationales that may support a conclusion of obviousness
+ include:
+ 
+
+
+* (A) Combining prior art elements according to known methods to yield
+ predictable results;
+* (B) Simple substitution of one known element for another to obtain
+ predictable results;
+* (C) Use of known technique to improve similar devices (methods, or
+ products) in the same way;
+* (D) Applying a known technique to a known device (method, or product)
+ ready for improvement to yield predictable results;
+* (E) "Obvious to try" – choosing from a finite number of identified,
+ predictable solutions, with a reasonable expectation of success;
+* (F) Known work in one field of endeavor may prompt variations of it
+ for use in either the same field or a different one based on design incentives or
+ other market forces if the variations are predictable to one of ordinary skill in
+ the art;
+* (G) Some teaching, suggestion, or motivation in the prior art that
+ would have led one of ordinary skill to modify the prior art reference or to
+ combine prior art reference teachings to arrive at the claimed invention.
+
+
+Note that the list of rationales provided is not intended to be an
+ all-inclusive list. Other rationales to support a conclusion of obviousness may be
+ relied upon by Office personnel. Any rationale employed must provide a link between the
+ factual findings and the legal conclusion of obviousness.
+ 
+
+
+ It is important for Office personnel to recognize that
+ when they do choose to formulate an obviousness rejection using one of the rationales
+ suggested by the Supreme Court in *KSR* and discussed herein, they are
+ to adhere to the guidance provided regarding the necessary factual findings. It remains
+ Office policy that appropriate factual findings are required in order to apply the
+ enumerated rationales properly. 
+ 
+
+
+ The subsections below include discussions of each rationale along with
+ examples illustrating how the cited rationales may be used to support a finding of
+ obviousness. Some examples use the facts of pre-*KSR* cases to show how
+ the rationales suggested by the Court in *KSR* may be used to support a
+ finding of obviousness. The cases cited (from which the facts were derived) may not
+ necessarily stand for the proposition that the particular rationale is the basis for the
+ court’s holding of obviousness, but they do illustrate consistency of past decisions
+ with the lines of reasoning laid out in *KSR.* Other examples are
+ post-*KSR* decisions that show how the Federal Circuit has applied
+ the principles of *KSR.* Cases are included that illustrate findings of
+ obviousness as well as nonobviousness. Note that, in some instances, a single case is
+ used in different subsections to illustrate the use of more than one rationale to
+ support a finding of obviousness. It will often be the case that, once the
+ *Graham* inquiries have been satisfactorily resolved, a conclusion
+ of obviousness may be supported by more than one line of reasoning. 
+ 
+
+***A.******Combining Prior Art Elements According to Known Methods To Yield
+ Predictable Results*** To reject a claim based on this rationale, Office personnel must
+ resolve the *Graham* factual inquiries. Then, Office personnel must
+ articulate the following:
+ 
+
+
+* (1) a finding that the prior art included each element claimed,
+ although not necessarily in a single prior art reference, with the only
+ difference between the claimed invention and the prior art being the lack of
+ actual combination of the elements in a single prior art reference;
+* (2) a finding that one of ordinary skill in the art could have
+ combined the elements as claimed by known methods, and that in combination,
+ each element merely performs the same function as it does separately;
+* (3) a finding that one of ordinary skill in the art would have
+ recognized that the results of the combination were predictable; and
+* (4) whatever additional findings based on the
+ *Graham* factual inquiries may be necessary, in view of the
+ facts of the case under consideration, to explain a conclusion of obviousness.
+
+
+ The rationale to support a conclusion that the claim would have
+ been obvious is that all the claimed elements were known in the prior art and one
+ skilled in the art could have combined the elements as claimed by known methods with
+ no change in their respective functions, and the combination yielded nothing more
+ than predictable results to one of ordinary skill in the art. *KSR,*
+ 550 U.S. at 416, 82 USPQ2d at 1395; *Sakraida v. AG Pro, Inc.,* 425
+ U.S. 273, 282, 189 USPQ 449, 453 (1976); *Anderson’s-Black Rock, Inc. v.
+ Pavement Salvage Co.,* 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969);
+ *Great Atl. & P. Tea Co. v. Supermarket Equip. Corp.,* 340
+ U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason
+ that would have prompted a person of ordinary skill in the relevant field to combine
+ the elements in the way the claimed new invention does." *KSR,* 550
+ U.S. at 418, 82 USPQ2d at 1396. If any of these findings cannot be made, then this
+ rationale cannot be used to support a conclusion that the claim would have been
+ obvious to one of ordinary skill in the art.
+ 
+
+
+**Example 1:**The claimed invention in *Anderson’s-Black Rock, Inc. v.
+ Pavement Salvage Co.,* 396 U.S. 57, 163 USPQ 673 (1969) was a paving
+ machine which combined several well-known elements onto a single chassis. Standard
+ prior art paving machines typically combined equipment for spreading and shaping
+ asphalt onto a single chassis. The patent claim included the well-known element of
+ a radiant-heat burner attached to the side of the paver for the purpose of
+ preventing cold joints during continuous strip paving. The prior art used radiant
+ heat for softening the asphalt to make patches, but did not use radiant heat
+ burners to achieve continuous strip paving. All of the component parts were known
+ in the prior art. The only difference was the combination of the "old elements"
+ into a single device by mounting them on a single chassis. The Court found that
+ the operation of the heater was in no way dependent on the operation of the other
+ equipment, and that a separate heater could also be used in conjunction with a
+ standard paving machine to achieve the same results. The Court concluded that
+ "[t]he convenience of putting the burner together with the other elements in one
+ machine, though perhaps a matter of great convenience, did not produce a ‘new’ or
+ ‘different function’" and that to those skilled in the art the use of the old
+ elements in combination would have been obvious. *Id.* at 60, 163
+ USPQ at 674. 
+ 
+
+
+Note that combining known prior art elements is not sufficient to
+ render the claimed invention obvious if the results would not have been
+ predictable to one of ordinary skill in the art.  *United States v.
+ Adams,* 383 U.S. 39, 51-52, 148 USPQ 479, 483-84 (1966). In
+ *Adams,* the claimed invention was to a battery with one
+ magnesium electrode and one cuprous chloride electrode that could be stored dry
+ and activated by the addition of plain water or salt water. Although magnesium and
+ cuprous chloride were individually known battery components, the Court concluded
+ that the claimed battery was nonobvious. The Court stated that "[d]espite the fact
+ that each of the elements of the Adams battery was well known in the prior art, to
+ combine them as did Adams required that a person reasonably skilled in the prior
+ art must ignore" the teaching away of the prior art that such batteries were
+ impractical and that water-activated batteries were successful only when combined
+ with electrolytes detrimental to the use of magnesium electrodes.
+ *Id.* at 42-43, 50-52, 148 USPQ at 480, 483. "[w]hen the prior
+ art teaches away from combining certain known elements, discovery of successful
+ means of combining them is more likely to be nonobvious."*KSR,*
+ 550 U.S. at 416, 82 USPQ2d at 1395. 
+ 
+
+
+
+**Example 2:**The claimed invention in *Ruiz v. A.B. Chance
+ Co.,* 357 F.3d 1270, 69 USPQ2d 1686 (Fed. Cir. 2004) was directed to a
+ system which employs a screw anchor for underpinning
+ existing foundations and a metal bracket to transfer the
+ building load onto the screw anchor. The prior art (Fuller) used screw anchors for
+ underpinning existing structural foundations. Fuller used a concrete haunch to
+ transfer the load of the foundation to the screw anchor. The prior art (Gregory)
+ used a push pier for underpinning existing structural foundations. Gregory taught
+ a method of transferring load using a bracket, specifically: a metal bracket
+ transfers the foundation load to the push pier. The pier is driven into the ground
+ to support the load. Neither reference showed the two elements of the claimed
+ invention – screw anchor and metal bracket – used together. The court found that
+ "artisans knew that a foundation underpinning system requires a means of
+ connecting the foundation to the load-bearing member." *Id.* at
+ 1276, 69 USPQ2d at 1691.
+ 
+
+
+The nature of the problem to be solved – underpinning unstable
+ foundations – as well as the need to connect the member to the foundation to
+ accomplish this goal, would have led one of ordinary skill in the art to choose an
+ appropriate load bearing member and a compatible attachment. Therefore, it would
+ have been obvious to use a metal bracket (as shown in Gregory) in combination with
+ the screw anchor (as shown in Fuller) to underpin unstable foundations.
+ 
+
+
+
+**Example 3:** The case of *In re Omeprazole Patent
+ Litigation,* 536 F.3d 1361, 87 USPQ2d 1865 (Fed. Cir. 2008), is one in
+ which the claims in question were found to be nonobvious in the context of an
+ argument to combine prior art elements. The invention involved applying enteric
+ coatings to a drug in pill form for the purpose of ensuring that the drug did not
+ disintegrate before reaching its intended site of action. The drug at issue was
+ omeprazole, the generic name for gastric acid inhibitor marketed as Prilosec®. The
+ claimed formulation included two layers of coatings over the active ingredient. 
+ 
+
+
+The district court found that Astra’s patent in
+ suit was infringed by defendants Apotex and Impax. The district court rejected
+ Apotex’s defense that the patents were invalid for obviousness. Apotex had argued
+ that the claimed invention was obvious because coated omeprazole tablets were
+ known from a prior art reference, and because secondary subcoatings in
+ pharmaceutical preparations generally were also known. There was no evidence of
+ unpredictability associated with applying two different enteric coatings to
+ omeprazole. However, Astra’s reason for applying an intervening subcoating between
+ the prior art coating and omeprazole had been that the prior art coating was
+ actually interacting with omeprazole, thereby contributing to undesirable
+ degradation of the active ingredient. This degradation of omeprazole by
+ interaction with the prior art coating had not been recognized in the prior art.
+ Therefore, the district court reasoned that based on the evidence available, a
+ person of ordinary skill in the art would have had no reason to include a
+ subcoating in an omeprazole pill formulation. 
+ 
+
+
+The Federal Circuit affirmed the district court’s
+ decision that the claimed invention was not obvious. Even though subcoatings for
+ enteric drug formulation were known, and there was no evidence of undue technical
+ hurdles or lack of a reasonable expectation of success, the formulation was
+ nevertheless not obvious because the flaws in the prior art formulation that had
+ prompted the modification had not been recognized. Thus there would have been no
+ reason to modify the initial formulation, even though the modification could have
+ been done. Moreover, a person of skill in the art likely would have chosen a
+ different modification even if they had recognized the problem.
+ 
+
+
+ Office personnel should note that in this case the
+ modification of the prior art that had been presented as an argument for
+ obviousness was an extra process step that added an additional component to a
+ known, successfully marketed formulation. The proposed modification thus amounted
+ to extra work and greater expense for no apparent reason. This is not the same as
+ combining known prior art elements A and B when each would have been expected to
+ contribute its own known properties to the final product. In the
+ *Omeprazole* case, in view of the expectations of those of
+ ordinary skill in the art, adding the subcoating would not have been expected to
+ confer any particular desirable property on the final product. Rather, the final
+ product obtained according to the proposed modifications would merely have been
+ expected to have the same functional properties as the prior art product. 
+ 
+
+
+The *Omeprazole* case can also be
+ analyzed in view of the discovery of a previously unknown problem by the patentee.
+ If the adverse interaction between active agent and coating had been known, it
+ might well have been obvious to use a subcoating. However, since the problem had
+ not been previously known, there would have been no reason to incur additional
+ time and expense to add another layer, even though the addition would have been
+ technologically possible. This is true because the prior art of record failed to
+ mention any stability problem, despite the acknowledgment during testimony at
+ trial that there was a known theoretical reason that omeprazole might be subject
+ to degradation in the presence of the known coating material.
+ 
+
+
+
+**Example 4:**The case of *Crocs, Inc. v. U.S. Int'l
+ Trade Comm'n,* 598 F.3d 1294, 93 USPQ 1777 (Fed. Cir. 2010), is a
+ decision in which the claimed foam footwear was held by the Federal Circuit to be
+ nonobvious over a combination of prior art references. 
+ 
+
+
+The claims involved in the obviousness issue were
+ from Crocs’ U.S. Patent No. 6,993,858, and were drawn to footwear in which a
+ one-piece molded foam base section formed the top of the shoe (the upper) and the
+ sole. A strap also made of foam was attached to the foot opening of the upper,
+ such that the strap could provide support to the Achilles portion of the wearer’s
+ foot. The strap was attached via connectors that allowed it to be in contact with
+ the base section, and to pivot relative to the base section. Because both the base
+ portion and the strap were made of foam, friction between the strap and the base
+ section allowed the strap to maintain its position after pivoting. In other words,
+ the foam strap did not fall under the force of gravity to a position adjacent to
+ the heel of the base section. 
+ 
+
+
+The International Trade Commission (ITC) determined
+ that the claims were obvious over the combination of two pieces of prior art. The
+ first was the Aqua Clog, which was a shoe that corresponded to the base section of
+ the footwear of the ‘858 patent. The second was the Aguerre patent, which taught
+ heel straps made of elastic or another flexible material. In the ITC’s view, the
+ claimed invention was obvious because the prior art Aqua Clog differed from the
+ claimed invention only as to the presence of the strap, and a suitable strap was
+ taught by Aguerre. 
+ 
+
+
+The Federal Circuit disagreed. The Federal Circuit
+ stated that the prior art did not teach foam heel straps, or that a foam heel
+ strap should be placed in contact with a foam base. The Federal Circuit pointed
+ out that the prior art actually counseled against using foam as a material for the
+ heel strap of a shoe. 
+ 
+
+
+
+> 
+> The record shows that the prior art would
+>  actually discourage and teach away from the use of foam straps. An ordinary
+>  artisan in this field would not add a foam strap to the foam Aqua Clog because
+>  foam was likely to stretch and deform, in addition to causing discomfort for a
+>  wearer. The prior art depicts foam as unsuitable for straps.
+>  
+> 
+> 
+> 
+
+
+*Id.* at 1309, 93 USPQ2d at 1787-88. 
+ 
+
+
+The Federal Circuit continued, stating that even if
+ – contrary to fact – the claimed invention had been a combination of elements that
+ were known in the prior art, the claims still would have been nonobvious. There
+ was testimony in the record that the loose fit of the heel strap made the shoe
+ more comfortable for the wearer than prior art shoes in which the heel strap was
+ constantly in contact with the wearer’s foot. In the claimed footwear, the foam
+ heel strap contacted the wearer’s foot only when needed to help reposition the
+ foot properly in the shoe, thus reducing wearer discomfort that could arise from
+ constant contact. This desirable feature was a result of the friction between the
+ base section and the strap that kept the strap in place behind the Achilles
+ portion of the wearer’s foot. The Federal Circuit pointed out that this
+ combination "yielded more than predictable results." *Id.* at
+ 1310, 93 USPQ2d at 1788. Aguerre had taught that friction between the base section
+ and the strap was a problem rather than an advantage, and had suggested the use of
+ nylon washers to reduce friction. Thus the Federal Circuit stated that even if all
+ elements of the claimed invention had been taught by the prior art, the claims
+ would not have been obvious because the combination yielded more than predictable
+ results. 
+ 
+
+
+The Federal Circuit’s discussion in Crocs serves as
+ a reminder to Office personnel that merely pointing to the presence of all claim
+ elements in the prior art is not a complete statement of a rejection for
+ obviousness. In accordance with **[MPEP § 2143](s2143.html#d0e209516)**, subsection I.A.(3),
+ a proper rejection based on the rationale that the claimed invention is a
+ combination of prior art elements also includes a finding that results flowing
+ from the combination would have been predictable to a person of ordinary skill in
+ the art. **[MPEP §
+ 2143](s2143.html#d0e209516)**, subsection I.A.(3). If results would not have been
+ predictable, Office personnel should not enter an obviousness rejection using the
+ combination of prior art elements rationale, and should withdraw such a rejection
+ if it has been made. 
+ 
+
+
+
+**Example 5:***Sundance, Inc. v. DeMonte Fabricating Ltd.,* 550 F.3d 1356, 89
+ USPQ2d 1535 (Fed. Cir. 2008), involved a segmented and mechanized cover for
+ trucks, swimming pools, or other structures. The claim was found to be obvious
+ over the prior art applied.
+ 
+
+
+ A first prior art reference taught that a reason
+ for making a segmented cover was ease of repair, in that a single damaged segment
+ could be readily removed and replaced when necessary. A second prior art reference
+ taught the advantages of a mechanized cover for ease of opening. The Federal
+ Circuit noted that the segmentation aspect of the first reference and the
+ mechanization function of the second perform in the same way after combination as
+ they had before. The Federal Circuit further observed that a person of ordinary
+ skill in the art would have expected that adding replaceable segments as taught by
+ the first reference to the mechanized cover of the other would result in a cover
+ that maintained the advantageous properties of both of the prior art covers. 
+ 
+
+
+Thus, the Sundance case points out that a hallmark
+ of a proper obviousness rejection based on combining known prior art elements is
+ that one of ordinary skill in the art would reasonably have expected the elements
+ to maintain their respective properties or functions after they have been
+ combined. 
+ 
+
+
+
+**Example 6:** In the case of *Ecolab, Inc. v. FMC
+ Corp.,* 569 F.3d 1335, 91 USPQ2d 1225 (Fed Cir. 2009), an "apparent
+ reason to combine" in conjunction with the technical ability to optimize led to
+ the conclusion that the claimed invention would have been obvious. 
+ 
+
+
+The invention in question was a method of treating
+ meat to reduce the incidence of pathogens, by spraying the meat with an
+ antibacterial solution under specified conditions. The parties did not dispute
+ that a single prior art reference had taught all of the elements of the claimed
+ invention, except for the pressure limitation of "at least 50 psi." 
+ 
+
+
+FMC had argued at the district court that the
+ claimed invention would have been obvious in view of the first prior art reference
+ mentioned above in view of a second reference that had taught the advantages of
+ spray-treating at pressures of 20 to 150 psi when treating meat with a different
+ antibacterial agent. The district court did not find FMC’s argument to be
+ convincing, and denied the motion for judgment as a matter of law that the claim
+ was obvious. 
+ 
+
+
+Disagreeing with the district court, the Federal
+ Circuit stated that "there was an apparent reason to combine these known elements
+ – namely to increase contact between the [antibacterial solution] and the bacteria
+ on the meat surface and to use the pressure to wash additional bacteria off the
+ meat surface." *Id.* at 1350, 91 USPQ2d at 1234. The Federal
+ Circuit explained that because the second reference had taught "using high
+ pressure to improve the effectiveness of an antimicrobial solution when sprayed
+ onto meat, and because an ordinarily skilled artisan would have recognized the
+ reasons for applying [the claimed antibacterial solution] using high pressure and
+ would have known how to do so, Ecolab’s claims combining high pressure with other
+ limitations disclosed in FMC’s patent are invalid as obvious."
+ *Id.*
+
+
+When considering the question of obviousness,
+ Office personnel should keep in mind the capabilities of a person of ordinary
+ skill. In *Ecolab,* the Federal Circuit stated: 
+ 
+
+
+
+> 
+> Ecolab’s expert admitted that one skilled in the
+>  art would know how to adjust application parameters to determine the optimum
+>  parameters for a particular solution. The question then is whether it would
+>  have been obvious to combine the high pressure parameter disclosed in the
+>  Bender patent with the PAA methods disclosed in FMC’s ’676 patent. The answer
+>  is yes. *Id.*
+> 
+> 
+> 
+
+
+ If optimization of the application parameters had
+ not been within the level of ordinary skill in the art, the outcome of the
+ *Ecolab* case may well have been different. 
+ 
+
+
+
+**Example 7:** In the case of *Wyers v. Master Lock
+ Co.,* 616 F.3d 1231, 95 USPQ2d 1525 (Fed. Cir. 2010), the Federal
+ Circuit held that the claimed barbell-shaped hitch pin locks used to secure
+ trailers to vehicles were obvious. 
+ 
+
+
+The court discussed two different sets of claims in
+ *Wyers,* both drawn to improvements over the prior art hitch
+ pin locks. The first improvement was a removable sleeve that could be placed over
+ the shank of the hitch pin lock so that the same lock could be used with towing
+ apertures of varying sizes. The second improvement was an external flat flange
+ seal adapted to protect the internal lock mechanism from contaminants. Wyers had
+ admitted that each of several prior art references taught every element of the
+ claimed inventions except for the removable sleeve and the external covering.
+ Master Lock had argued that these references, in combination with additional
+ references teaching the missing elements, would have rendered the claims obvious.
+ The court first addressed the question of whether the additional references relied
+ on by Master Lock were analogous prior art. As to the reference teaching the
+ sleeve improvement, the court concluded that it dealt specifically with using a
+ vehicle to tow a trailer, and was therefore in the same field of endeavor as
+ Wyers’ sleeve improvement. The reference teaching the sealing improvement dealt
+ with a padlock rather than a lock for a tow hitch. The court noted that Wyers’
+ specification had characterized the claimed invention as being in the field of
+ locking devices, thus at least suggesting that the sealed padlock reference was in
+ the same field of endeavor. However, the court also observed that even if sealed
+ padlocks were not in the same field of endeavor, they were nevertheless reasonably
+ pertinent to the problem of avoiding contamination of a locking mechanism for tow
+ hitches. The court explained that the Supreme Court’s decision in
+ *KSR* "directs [it] to construe the scope of analogous art
+ broadly." *Id.* at 1238, 95 USPQ2d at 1530. For these reasons,
+ the court found that Master Lock’s asserted references were analogous prior art,
+ and therefore relevant to the obviousness inquiry. 
+ 
+
+
+The court then turned to the question of whether
+ there would have been adequate motivation to combine the prior art elements as had
+ been urged by Master Lock. The court recalled the *Graham*
+ inquiries, and also emphasized the "expansive and flexible" post-KSR approach to
+ obviousness that must not "deny factfinders recourse to common sense."
+ *Id.* at 1238, 95 USPQ2d at 1530-31. (quoting
+ *KSR,* 550 U.S. at 415, 421, 82 USPQ2d at 1395, 1397). The
+ court stated: 
+ 
+
+
+
+> 
+> *KSR* and our later cases establish that the legal
+>  determination of obviousness may include recourse to logic, judgment, and
+>  common sense, in lieu of expert testimony. . . . Thus, in appropriate cases,
+>  the ultimate inference as to the existence of a motivation to combine
+>  references may boil down to a question of "common sense," appropriate for
+>  resolution on summary judgment or JMOL.
+>  
+> 
+> 
+> 
+
+
+*Id.* at 1240, 82 USPQ2d at 1531 (citing *Perfect Web
+ Techs., Inc. v. InfoUSA, Inc.,* 587 F.3d 1324, 1330, 92 USPQ2d, 1849,
+ 1854 (Fed. Cir. 2009); *Ball Aerosol,* 555 F.3d at 993, 89 USPQ2d
+ 1870, 1875 (Fed. Cir. 2009)). 
+ 
+
+
+After reviewing these principles, the court
+ proceeded to explain why adequate motivation to combine had been established in
+ this case. With regard to the sleeve improvement, it pointed out that the need for
+ different sizes of hitch pins was well known in the art, and that this was a known
+ source of inconvenience and expense for users. The court also mentioned the
+ marketplace aspect of the issue, noting that space on store shelves was at a
+ premium, and that removable sleeves addressed this economic concern. As to the
+ sealing improvement, the court pointed out that both internal and external seals
+ were well-known means to protect locks from contaminants. The court concluded that
+ the constituent elements were being employed in accordance with their recognized
+ functions, and would have predictably retained their respective functions when
+ combined as suggested by Master Lock. The court cited *In re
+ O’Farrell,* 853 F.2d 894, 904 (Fed. Cir. 1988) for the proposition
+ that a reasonable expectation of success is a requirement for a proper
+ determination of obviousness. 
+ 
+
+
+Office personnel should note that although the
+ Federal Circuit invoked the idea of common sense in support of a conclusion of
+ obviousness, it did not end its explanation there. Rather, the court explained why
+ a person of ordinary skill in the art at the time of the invention, in view of the
+ facts relevant to the case, would have found the claimed inventions to have been
+ obvious. The key to supporting any rejection under **[35 U.S.C.
+ 103](mpep-9015-appx-l.html#d0e302450)** is the clear articulation of the reason(s) why the
+ claimed invention would have been obvious. The Supreme Court in
+ *KSR* noted that the analysis supporting a rejection under
+ **[35 U.S.C.
+ 103](mpep-9015-appx-l.html#d0e302450)** should be made explicit. The Court quoting *In
+ re Kahn,* 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006),
+ stated that "[R]ejections on obviousness cannot be sustained by mere conclusory
+ statements; instead, there must be some articulated reasoning with some rational
+ underpinning to support the legal conclusion of obviousness." See
+ **[MPEP §
+ 2141](s2141.html#d0e208143)**, subsection III. Office personnel should continue
+ to provide a reasoned explanation for every obviousness rejection. 
+ 
+
+
+
+**Example 8:** The claim in *DePuy Spine, Inc. v.
+ Medtronic Sofamor Danek, Inc.,* 567 F.3d 1314, 90 USPQ2d 1865 (Fed.
+ Cir. 2009), was directed to a polyaxial pedicle screw used in spinal surgeries
+ that included a compression member for pressing a screw head against a receiver
+ member. A prior art reference (Puno) disclosed all of the elements of the claim
+ except for the compression member. Instead, the screw head in Puno was separated
+ from the receiver member to achieve a shock absorber effect, allowing some motion
+ between receiver member and the vertebrae. The missing compression member was
+ readily found in another prior art reference (Anderson), which disclosed an
+ external fracture immobilization splint for immobilizing long bones with a swivel
+ clamp capable of polyaxial movement until rigidly secured by a compression member.
+ It was asserted during trial that a person of ordinary skill would have recognized
+ that the addition of Anderson’s compression member to Puno’s device would have
+ achieved a rigidly locked polyaxial pedicle screw covered by the claim. 
+ 
+
+
+In conducting its analysis, the Federal Circuit
+ noted that the "predictable result" discussed in *KSR* refers not
+ only to the expectation that prior art elements are capable of being physically
+ combined, but also that the combination would have worked for its intended
+ purpose. In this case, it was successfully argued that Puno "teaches away" from a
+ rigid screw because Puno warned that rigidity increases the likelihood that the
+ screw will fail within the human body, rendering the device inoperative for its
+ intended purpose. In fact, the reference did not merely express a general
+ preference for pedicle screws having a "shock absorber" effect, but rather
+ expressed concern for failure and stated that the shock absorber feature
+ "decrease[s] the chance of failure of the screw of the bone-screw interface"
+ because "it prevent[s] direct transfer of load from the rod to the bone-screw
+ interface." Thus, the alleged reason to combine the prior art elements of Puno and
+ Anderson—increasing the rigidity of the screw—ran contrary to the prior art that
+ taught that increasing rigidity would result in a greater likelihood of failure.
+ In view of this teaching and the backdrop of collective teachings of the prior
+ art, the Federal Circuit determined that Puno teaches away from the proposed
+ combination such that a person of ordinary skill would have been deterred from
+ combining the references as proposed. Secondary considerations evaluated by the
+ Federal Circuit relating to failure by others and copying also supported the view
+ that the combination would not have been obvious at the time of the invention.
+ 
+ 
+
+
+***B.******Simple Substitution of One Known Element for Another To Obtain
+ Predictable Results*** To reject a claim based on this rationale, Office personnel must
+ resolve the *Graham* factual inquiries. Then, Office personnel must
+ articulate the following:
+ 
+
+
+* (1) a finding that the prior art contained a device (method,
+ product, etc.) which differed from the claimed device by the substitution of
+ some components (step, element, etc.) with other components;
+* (2) a finding that the substituted components and their functions
+ were known in the art;
+* (3) a finding that one of ordinary skill in the art could have
+ substituted one known element for another, and the results of the substitution
+ would have been predictable; and
+* (4) whatever additional findings based on the
+ *Graham* factual inquiries may be necessary, in view of the
+ facts of the case under consideration, to explain a conclusion of
+ obviousness.
+
+
+ The rationale to support a conclusion that the claim would have
+ been obvious is that the substitution of one known element for another yields
+ predictable results to one of ordinary skill in the art. If any of these findings
+ cannot be made, then this rationale cannot be used to support a conclusion that the
+ claim would have been obvious to one of ordinary skill in the art.
+ 
+
+
+**Example 1:**The claimed invention in *In re Fout,* 675 F.2d
+ 297, 213 USPQ 532 (CCPA 1982) was directed to a method for decaffeinating coffee
+ or tea. The prior art (Pagliaro) method produced a decaffeinated vegetable
+ material and trapped the caffeine in a fatty material (such as oil). The caffeine
+ was then removed from the fatty material by an aqueous extraction process.
+ Applicant (Fout) substituted an evaporative distillation step for the aqueous
+ extraction step. The prior art (Waterman) suspended coffee in oil and then
+ directly distilled the caffeine through the oil. The court found that "[b]ecause
+ both Pagliaro and Waterman teach a method for separating caffeine from oil, it
+ would have been *prima facie* obvious to substitute one method
+ for the other. Express suggestion to substitute one equivalent for another need
+ not be present to render such substitution obvious." *Id.* at
+ 301, 213 USPQ at 536.
+ 
+
+
+
+**Example 2:**The claimed invention in *In re O’Farrell,* 853
+ F.2d 894, 7 USPQ2d 1673 (Fed. Cir. 1988) was directed to a method for synthesizing
+ a protein in a transformed bacterial host species by substituting a heterologous
+ gene for a gene native to the host species. Generally speaking, protein synthesis
+ *in vivo* follows a path from DNA to mRNA. Although the prior
+ art Polisky article (authored by two of the three joint inventors of the
+ application) had explicitly suggested employing the method described for protein
+ synthesis, the inserted heterologous gene exemplified in the article was one that
+ normally did not proceed all the way to the protein production step, but instead
+ terminated with the mRNA. A second reference to Bahl had described a general
+ method of inserting chemically synthesized DNA into a plasmid. Thus, it would have
+ been obvious to one of ordinary skill in the art to replace the prior art gene
+ with another gene known to lead to protein production, because one of ordinary
+ skill in the art would have been able to carry out such a substitution, and the
+ results were reasonably predictable. 
+ 
+
+
+In response to applicant’s argument that there had been
+ significant unpredictability in the field of molecular biology at the time of the
+ invention, the court stated that the level of skill was quite high and that the
+ teachings of Polisky, even taken alone, contained detailed enabling methodology
+ and included the suggestion that the modification would be successful for
+ synthesis of proteins. 
+ 
+
+
+This is not a situation where the rejection is a statement that
+ it would have been "obvious to try" without more. Here there was a reasonable
+ expectation of success. "Obviousness does not require absolute predictability of
+ success." *Id.* at 903, 7 USPQ2d at 1681.
+ 
+
+
+
+**Example 3:**The fact pattern in *Ruiz v. AB Chance Co.,* 357
+ F.3d 1270, 69 USPQ2d 1686 (Fed. Cir. 2004) is set forth above in Example 2 in
+ subsection I.A., above.
+ 
+
+
+The prior art showed differing load-bearing members and differing
+ means of attaching the foundation to the member. Therefore, it would have been
+ obvious to one of ordinary skill in the art to substitute the metal bracket taught
+ in Gregory for Fuller’s concrete haunch for the predictable result of transferring
+ the load.
+ 
+
+
+
+**Example 4:**The claimed invention in *Ex parte Smith,* 83
+ USPQ2d 1509 (Bd. Pat. App. & Int. 2007), was a pocket insert for a bound book
+ made by gluing a base sheet and a pocket sheet of paper together to form a
+ continuous two-ply seam defining a closed pocket. The prior art (Wyant) disclosed
+ at least one pocket formed by folding a single sheet and securing the folder
+ portions along the inside margins using any convenient bonding method. The prior
+ art (Wyant) did not disclose bonding the sheets to form a continuous two-ply seam.
+ The prior art (Dick) disclosed a pocket that is made by stitching or otherwise
+ securing two sheets along three of its four edges to define a closed pocket with
+ an opening along its fourth edge.
+ 
+
+
+ In considering the teachings of Wyant and Dick, the Board "found
+ that (1) each of the claimed elements is found within the scope and content of the
+ prior art; (2) one of ordinary skill in the art could have combined the elements
+ as claimed by methods known at the time the invention was made; and (3) one of
+ ordinary skill in the art would have recognized at the time the invention was made
+ that the capabilities or functions of the combination were predictable." Citing
+ *KSR,* the Board concluded that "[t]he substitution of the
+ continuous, two-ply seam of Dick for the folded seam of Wyant thus is no more than
+ the simple substitution of one known element for another or the mere application
+ of a known technique to a piece of prior art ready for improvement.
+ 
+
+
+
+**Example 5:** The claimed invention in *In re ICON Health
+ & Fitness, Inc.,* 496 F.3d 1374, 83 USPQ2d 1746 (Fed. Cir. 2007),
+ was directed to a treadmill with a folding tread base that swivels into an upright
+ storage position, including a gas spring connected between the tread base and the
+ upright structure to assist in stably retaining the tread base in the storage
+ position. On reexamination, the examiner rejected the claims as obvious based on a
+ combination of references including an advertisement (Damark) for a folding
+ treadmill demonstrating all of the claim elements other than the gas spring, and a
+ patent (Teague) with a gas spring. Teague was directed to a bed that folds into a
+ cabinet using a novel dual-action spring that reverses force as the mechanism
+ passes a neutral position, rather than a single-action spring that would provide a
+ force pushing the bed closed at all times. The dual-action spring reduced the
+ force required to open the bed from the closed position, while reducing the force
+ required to lift the bed from the open position. 
+ 
+
+
+The Federal Circuit addressed the propriety of
+ making the combination since Teague was in a different field than the application.
+ Teague was found to be reasonably pertinent to the problem addressed in the
+ application because the folding mechanism did not require any particular focus on
+ treadmills, but rather generally addressed problems of supporting the weight of
+ such a mechanism and providing a stable resting position. 
+ 
+
+
+The court also considered whether one skilled in the
+ art would have been led to combine the teachings of Damark and Teague. Appellant
+ argued that Teague teaches away from the invention because it directs one skilled
+ in the art not to use single-action springs and does not satisfy the claim
+ limitations as the dual-action springs would render the invention inoperable. The
+ Federal Circuit considered these arguments and found that, while Teague at most
+ teaches away from using single-action springs to decrease the opening force, it
+ actually instructed that single-action springs provide the result desired by the
+ inventors, which was to increase the opening force provided by gravity. As to
+ inoperability, the claims were not limited to single-action springs and were so
+ broad as to encompass anything that assists in stably retaining the tread base,
+ which is the function that Teague accomplished. Additionally, the fact that the
+ counterweight mechanism from Teague used a large spring, which appellant argued
+ would overpower the treadmill mechanism, ignores the modifications that one
+ skilled in the art would make to a device borrowed from the prior art. One skilled
+ in the art would size the components from Teague appropriately for the
+ application.
+ 
+
+
+ *ICON* is another useful example for understanding the scope of
+ analogous art. The art applied concerned retaining mechanisms for folding beds,
+ not treadmills. When determining whether a reference may properly be applied to an
+ invention in a different field of endeavor, it is necessary to consider the
+ problem to be solved. It is certainly possible that a reference may be drawn in
+ such a way that its usefulness as a teaching is narrowly restricted. However,
+ in *ICON,* the problem to be solved was not limited to the
+ teaching of the "treadmill" concept. The Teague reference was analogous art
+ because "Teague and the current application both address the need to stably retain
+ a folding mechanism," and because "nothing about ICON’s folding mechanism requires
+ any particular focus on treadmills," *Id.* at 1378, 1380, 83
+ USPQ2d at 1749-50. 
+ 
+
+
+*ICON* is also informative as to the relationship between the
+ problem to be solved and existence of a reason to combine. "Indeed, while perhaps
+ not dispositive of the issue, the finding that Teague, by addressing a similar
+ problem, provides analogous art to ICON’s application goes a long way towards
+ demonstrating a reason to combine the two references. Because ICON’s broad claims
+ read on embodiments addressing that problem as described by Teague, the prior art
+ here indicates a reason to incorporate its teachings." *Id.* at
+ 1380-81, 83 USPQ2d at 1751. 
+ 
+
+
+The Federal Circuit’s discussion in
+ *ICON* also makes clear that if the reference does not teach
+ that a combination is undesirable, then it cannot be said to teach away. An
+ assessment of whether a combination would render the device inoperable must not
+ "ignore the modifications that one skilled in the art would make to a device
+ borrowed from the prior art." *Id.* at 1382, 83 USPQ2d at
+ 1752.
+ 
+
+
+
+**Example 6:***Agrizap, Inc. v. Woodstream Corp.,* 520 F.3d 1337, 86 USPQ2d
+ 1110 (Fed. Cir. 2008), involved a stationary pest control device for electrocution
+ of pests such as rats and gophers, in which the device is set in an area where the
+ pest is likely to encounter it. The only difference between the claimed device and
+ the prior art stationary pest control device was that the claimed device employed
+ a resistive electrical switch, while the prior art device used a mechanical
+ pressure switch. A resistive electrical switch was taught in two prior art
+ patents, in the contexts of a hand-held pest control device and a cattle prod. 
+ 
+
+
+In determining that the claimed invention was
+ obvious, the Federal Circuit noted that "[t]he asserted claims simply substitute a
+ resistive electrical switch for the mechanical pressure switch" employed in the
+ prior art device. *Id.* at 1344, 86 USPQ2d at 1115. In this case,
+ the prior art concerning the hand-held devices revealed that the function of the
+ substituted resistive electrical switch was well known and predictable, and that
+ it could be used in a pest control device. According to the Federal Circuit, the
+ references that taught the hand-held devices showed that "the use of an animal
+ body as a resistive switch to complete a circuit for the generation of an electric
+ charge was already well known in the prior art." *Id.* Finally,
+ the Federal Circuit noted that the problem solved by using the resistive
+ electrical switch in the prior art hand-held devices – malfunction of mechanical
+ switches due to dirt and dampness – also pertained to the prior art stationary
+ pest control device. 
+ 
+
+
+The Federal Circuit recognized*Agrizap* as "a textbook case of when the asserted claims involve a
+ combination of familiar elements according to known methods that does no more than
+ yield predictable results." *Id.**Agrizap* exemplifies a strong case of obviousness based on
+ simple substitution that was not overcome by the objective evidence of
+ nonobviousness offered. It also demonstrates that analogous art is not limited to
+ the field of applicant’s endeavor, in that one of the references that used an
+ animal body as a resistive switch to complete a circuit for the generation of an
+ electric charge was not in the field of pest control.
+ 
+
+
+
+**Example 7:** The invention at issue in *Muniauction,
+ Inc. v. Thomson Corp.,* 532 F.3d 1318, 87 USPQ2d1350 (Fed. Cir. 2008),
+ was a method for auctioning municipal bonds over the Internet. A municipality
+ could offer a package of bond instruments of varying principal amounts and
+ maturity dates, and an interested buyer would then submit a bid comprising a price
+ and interest rate for each maturity date. It was also possible for the interested
+ buyer to bid on a portion of the offering. The claimed invention considered all of
+ the noted parameters to determine the best bid. It operated on conventional Web
+ browsers and allowed participants to monitor the course of the auction. 
+ 
+
+
+The only difference between the prior art bidding
+ system and the claimed invention was the use of a conventional Web browser. At
+ trial, the district court had determined that Muniauction’s claims were not
+ obvious. Thomson argued that the claimed invention amounted to incorporating a Web
+ browser into a prior art auction system, and was therefore obvious in light of
+ *KSR.* Muniauction rebutted the argument by offering evidence
+ of skepticism by experts, copying, praise, and commercial success. Although the
+ district court found the evidence to be persuasive of nonobviousness, the Federal
+ Circuit disagreed. It noted that a nexus between the claimed invention and the
+ proffered evidence was lacking because the evidence was not coextensive with the
+ claims at issue. For this reason, the Federal Circuit determined that
+ Muniauction’s evidence of secondary considerations was not entitled to substantial
+ weight. 
+ 
+
+
+ The Federal Circuit analogized this case to
+ *Leapfrog Enters., Inc. v. Fisher-Price, Inc.,* 485 F.3d 1157,
+ 82 USPQ2d 1687 (Fed. Cir. 2007). The *Leapfrog* case involved a
+ determination of obviousness based on application of modern electronics to a prior
+ art mechanical children’s learning device. In *Leapfrog,* the
+ court noted that market pressures would have prompted a person of ordinary skill
+ to use modern electronics in the prior art device. Similarly in
+ *Muniauction,* market pressures would have prompted a person
+ of ordinary skill to use a conventional Web browser in a method of auctioning
+ municipal bonds. 
+ 
+
+
+
+**Example 8:** In *Aventis Pharma Deutschland v. Lupin
+ Ltd.,* 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007), the claims were
+ drawn to the 5(S) stereoisomer of the blood pressure drug ramipril in
+ stereochemically pure form, and to compositions and methods requiring 5(S)
+ ramipril. The 5(S) stereoisomer is one in which all five stereocenters in the
+ ramipril molecule are in the S rather than the R configuration. A mixture of
+ various stereoisomers including 5(S) ramipril had been taught by the prior art.
+ The question before the court was whether the purified single stereoisomer would
+ have been obvious over the known mixture of stereoisomers. 
+ 
+
+
+The record showed that the presence of multiple S
+ stereocenters in drugs similar to ramipril was known to be associated with
+ enhanced therapeutic efficacy. For example, when all of the stereocenters were in
+ the S form in the related drug enalapril (SSS enalapril) as compared with only two
+ stereocenters in the S form (SSR enalapril), the therapeutic potency was 700 times
+ as great. There was also evidence to indicate that conventional methods could be
+ used to separate the various stereoisomers of ramipril. 
+ 
+
+
+The district court saw the issue as a close case,
+ because, in its view, there was no clear motivation in the prior art to isolate
+ 5(S) ramipril. However, the Federal Circuit disagreed, and found that the claims
+ would have been obvious. The Federal Circuit cautioned that requiring such a
+ clearly stated motivation in the prior art to isolate 5(S) ramipril ran counter to
+ the Supreme Court’s decision in KSR, and the court stated:
+ 
+
+
+
+> 
+>  Requiring an explicit teaching to purify the
+>  5(S) stereoisomer from a mixture in which it is the active ingredient is
+>  precisely the sort of rigid application of the TSM test that was criticized in
+>  *KSR.*
+> 
+> 
+> 
+
+
+*Id.* at 1301, 84 USPQ2d at 1204. The *Aventis*
+ court also relied on the settled principle that in chemical cases, structural
+ similarity can provide the necessary reason to modify prior art teachings. The
+ Federal Circuit also addressed the kind of teaching that would be sufficient in
+ the absence of an explicitly stated prior art-based motivation, explaining that an
+ expectation of similar properties in light of the prior art can be sufficient,
+ even without an explicit teaching that the compound will have a particular
+ utility. 
+ 
+
+
+In the chemical arts, the cases involving so-called
+ "lead compounds" form an important subgroup of the obviousness cases that are
+ based on substitution. The Federal Circuit has had a number of opportunities since
+ the *KSR* decision to discuss the circumstances under which it
+ would have been obvious to modify a known compound to arrive at a claimed
+ compound. The following cases explore the selection of a lead compound, the need
+ to provide a reason for any proposed modification, and the predictability of the
+ result. 
+ 
+
+
+
+**Example 9:***Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd.,* 533 F.3d 1353, 87
+ USPQ2d 1452 (Fed. Cir. 2008), concerns the pharmaceutical compound rabeprazole.
+ Rabeprazole is a proton pump inhibitor for treating stomach ulcers and related
+ disorders. The Federal Circuit affirmed the district court’s summary judgment of
+ nonobviousness, stating that no reason had been advanced to modify the prior art
+ compound in a way that would destroy an advantageous property. 
+ 
+
+
+Co-defendant Teva based its obviousness argument on
+ the structural similarity between rabeprazole and lansoprazole. The compounds were
+ recognized as sharing a common core, and the Federal Circuit characterized
+ lansoprazole as a "lead compound." The prior art compound lansoprazole was useful
+ for the same indications as rabeprazole, and differed from rabeprazole only in
+ that lansoprazole has a trifluoroethoxy substituent at the 4-position of the
+ pyridine ring, while rabeprazole has a methoxypropoxy substituent. The trifluoro
+ substituent of lansoprazole was known to be a beneficial feature because it
+ conferred lipophilicity to the compound. The ability of a person of ordinary skill
+ to carry out the modification to introduce the methoxypropoxy substituent, and the
+ predictability of the result were not addressed. 
+ 
+
+
+Despite the significant similarity between the
+ structures, the Federal Circuit did not find any reason to modify the lead
+ compound. According to the Federal Circuit: 
+ 
+
+
+
+> 
+> Obviousness based on structural similarity thus
+>  can be proved by identification of some motivation that would have led one of
+>  ordinary skill in the art to select and then modify a known compound (i.e. a
+>  lead compound) in a particular way to achieve the claimed compound. . . . In
+>  keeping with the flexible nature of the obviousness inquiry, the requisite
+>  motivation can come from any number of sources and need not necessarily be
+>  explicit in the art. Rather "it is sufficient to show that the claimed and
+>  prior art compounds possess a ‘sufficiently close relationship . . . to create
+>  an expectation,’ in light of the totality of the prior art, that the new
+>  compound will have ‘similar properties’ to the old." *Id.* at
+>  1357, 87 USPQ2d at 1455. (citations omitted)
+>  
+> 
+> 
+> 
+
+
+The prior art taught that introducing a fluorinated
+ substituent was known to increase lipophilicity, so a skilled artisan would have
+ expected that replacing the trifluoroethoxy substituent with a methoxypropoxy
+ substituent would have reduced the lipophilicity of the compound. Thus, the prior
+ art created the expectation that rabeprazole would be less useful than
+ lansoprazole as a drug for treating stomach ulcers and related disorders because
+ the proposed modification would have destroyed an advantageous property of the
+ prior art compound. The compound was not obvious as argued by Teva because, upon
+ consideration of all of the facts of the case, a person of ordinary skill in the
+ art at the time of the invention would not have had a reason to modify
+ lansoprazole so as to form rabeprazole. 
+ 
+
+
+Office personnel are cautioned that the term "lead
+ compound" in a particular opinion can have a contextual meaning that may vary from
+ the way a pharmaceutical chemist might use the term. In the field of
+ pharmaceutical chemistry, the term "lead compound" has been defined variously as
+ "a chemical compound that has pharmacological or biological activity and whose
+ chemical structure is used as a starting point for chemical modifications in order
+ to improve potency, selectivity, or pharmacokinetic parameters;" "[a] compound
+ that exhibits pharmacological properties which suggest its development;" and "a
+ potential drug being tested for safety and efficacy." See, e.g.,
+ http://en.wikipedia.org/wiki/Lead\_compound, accessed January 13, 2010;
+ www.combichemistry.com/glossary\_k.html, accessed January 13, 2010; and
+ www.buildingbiotechnology.com/glossary4.php, accessed January 13, 2010. 
+ 
+
+
+The Federal Circuit in *Eisai*
+ makes it clear that from the perspective of the law of obviousness, any known
+ compound might possibly serve as a lead compound: "Obviousness based on structural
+ similarity thus can be proved by identification of some motivation that would have
+ led one of ordinary skill in the art to select and then modify a known compound
+ (i.e. a lead compound) in a particular way to achieve the claimed compound."
+ *Eisai,* 533 F.3d at 1357, 87 USPQ2d at 1455. Thus, Office
+ personnel should recognize that a proper obviousness rejection of a claimed
+ compound that is useful as a drug might be made beginning with an inactive
+ compound, if, for example, the reasons for modifying a prior art compound to
+ arrive at the claimed compound have nothing to do with pharmaceutical activity.
+ The inactive compound would not be considered to be a lead compound by
+ pharmaceutical chemists, but could potentially be used as such when considering
+ obviousness. Office personnel might also base an obviousness rejection on a known
+ compound that pharmaceutical chemists would not select as a lead compound due to
+ expense, handling issues, or other business considerations. However, there must be
+ some reason for starting with that particular lead compound other than the mere
+ fact that the "lead compound" exists. See *Altana Pharma AG v. Teva Pharm.
+ USA, Inc.,* 566 F.3d 999, 1007, 91 USPQ2d 1018, 1024 (Fed. Cir. 2009)
+ (holding that there must be some reason "to select and modify a known compound");
+ *Ortho-McNeil Pharm., Inc. v. Mylan Labs, Inc.,* 520 F.3d
+ 1358, 1364, 86 USPQ2d 1196, 1201 (Fed. Cir. 2008). 
+ 
+
+
+
+**Example 10:** The claimed chemical compound was also found to be
+ nonobvious in *Procter & Gamble Co. v. Teva Pharm. USA,
+ Inc.,* 566 F.3d 989, 90 USPQ2d 1947 (Fed. Cir. 2009). The compound at
+ issue was risedronate – the active ingredient of Procter & Gamble’s
+ osteoporosis drug Actonel®. Risedronate is an example
+ of a bisphosphonate, which is a class of compounds known to inhibit bone
+ resorption. 
+ 
+
+
+When Procter & Gamble sued Teva for
+ infringement, Teva defended by arguing invalidity for obviousness over one of
+ Procter & Gamble’s earlier patents. The prior art patent did not teach
+ risedronate, but instead taught thirty-six other similar compounds including 2-pyr
+ EHDP that were potentially useful with regard to osteoporosis. Teva argued
+ obviousness on the basis of structural similarity to 2-pyr EHDP, which is a
+ positional isomer of risedronate. 
+ 
+
+
+The district court found no reason to select 2-pyr
+ EHDP as a lead compound in light of the unpredictable nature of the art, and no
+ reason to modify it so as to obtain risedronate. In addition, there were
+ unexpected results as to potency and toxicity. Therefore the district court found
+ that Teva had not made a *prima facie* case, and even if it had,
+ it was rebutted by evidence of unexpected results. 
+ 
+
+
+The Federal Circuit affirmed the district court’s
+ decision. The Federal Circuit did not deem it necessary in this case to consider
+ the question of whether 2-pyr EHDP had been appropriately selected as a lead
+ compound. Rather, the Federal Circuit reasoned that, if 2-pyr EHDP is presumed to
+ be an appropriate lead compound, there must be both a reason to modify it so as to
+ make risedronate and a reasonable expectation of success. Here, there was no
+ evidence that the necessary modifications would have been routine, so there would
+ have been no reasonable expectation of success. 
+ 
+
+
+*Procter & Gamble* is also informative in its discussion of
+ the treatment of secondary considerations of non-obviousness. Although the court
+ found that no *prima facie* case of obviousness had been
+ presented, it proceeded to analyze Procter & Gamble’s proffered evidence
+ countering the alleged *prima facie* case in some detail, thus
+ shedding light on the proper treatment of such evidence. 
+ 
+
+
+The Federal Circuit noted in dicta that even if a
+ *prima facie* case of obviousness had been established,
+ sufficient evidence of unexpected results was introduced to rebut such a showing.
+ At trial, the witnesses consistently testified that the properties of risedronate
+ were not expected, offering evidence that researchers did not predict either the
+ potency or the low dose at which the compound was effective. Tests comparing
+ risedronate to a compound in the prior art reference showed that risedronate
+ outperformed the other compound by a substantial margin, could be administered in
+ a greater amount without an observable toxic effect, and was not lethal at the
+ same levels as the other compound. The weight of the evidence and the credibility
+ of the witnesses were sufficient to show unexpected results that would have
+ rebutted an obviousness determination. Thus, nonobviousness can be shown when a
+ claimed invention is shown to have unexpectedly superior properties when compared
+ to the prior art. 
+ 
+
+
+The court then addressed the evidence of commercial
+ success of risedronate and the evidence that risedronate met a long felt need. The
+ court pointed out that little weight was to be afforded to the commercial success
+ because the competing product was also assigned to Procter & Gamble. However,
+ the Federal Circuit affirmed the district court’s conclusion that risedronate met
+ a long-felt, but unsatisfied need. The court rejected Teva’s contention that
+ because the competing drug was available before
+ Actonel®, there was no unmet need that the invention
+ satisfied. The court emphasized that whether there was a long-felt but unsatisfied
+ need is to be evaluated based on the circumstances as of the filing date of the
+ challenged invention – not as of the date that the invention is brought to market. 
+ 
+
+
+It should be noted that the lead compound cases do
+ not stand for the proposition that identification of a single lead compound is
+ necessary in every obviousness rejection of a chemical compound. For example, one
+ might envision a suggestion in the prior art to formulate a compound having
+ certain structurally defined moieties, or moieties with certain properties. If a
+ person of ordinary skill would have known how to synthesize such a compound, and
+ the structural and/or functional result could reasonably have been predicted, then
+ a *prima facie* case of obviousness of the claimed chemical
+ compound might exist even without identification a particular lead compound. As a
+ second example, it could be possible to view a claimed compound as consisting of
+ two known compounds attached via a chemical linker. The claimed compound might
+ properly be found to have been obvious if there would have been a reason to link
+ the two, if one of ordinary skill would have known how to do so, and if the
+ resulting compound would have been the predictable result of the linkage
+ procedure. Thus, Office personnel should recognize that in certain situations, it
+ may be proper to reject a claimed chemical compound as obvious even without
+ identifying a single lead compound. 
+ 
+
+
+
+**Example 11:**The decision reached by the Federal Circuit
+ in *Altana Pharma AG v. Teva Pharm. USA, Inc.,* 566 F.3d 999,
+ 91 USPQ2d 1018 (Fed. Cir. 2009), as discussed below, involved a motion for
+ preliminary injunction and did not include a final determination of obviousness.
+ However, the case is instructive as to the issue of selecting a lead compound. 
+ 
+
+
+The technology involved in
+ *Altana* was the compound pantoprazole, which is the active
+ ingredient in Altana’s antiulcer drug Protonix®.
+ Pantoprazole belongs to a class of compounds known as proton pump inhibitors that
+ are used to treat gastric acid disorders in the stomach. 
+ 
+
+
+Altana accused Teva of infringement. The district
+ court denied Altana’s motion for preliminary injunction for failure to establish a
+ likelihood of success on the merits, determining that Teva had demonstrated a
+ substantial question of invalidity for obviousness in light of one of Altana’s
+ prior patents. Altana’s patent discussed a compound referred to as compound 12,
+ which was one of eighteen compounds disclosed. The claimed compound pantoprazole
+ was structurally similar to compound 12. The district court found that one of
+ ordinary skill in the art would have selected compound 12 as a lead compound for
+ modification, and the Federal Circuit affirmed. 
+ 
+
+
+Obviousness of a chemical compound in view of its
+ structural similarity to a prior art compound may be shown by identifying some
+ line of reasoning that would have led one of ordinary skill in the art to select
+ and modify the prior art compound in a particular way to produce the claimed
+ compound. The necessary line of reasoning can be drawn from any number of sources
+ and need not necessarily be explicitly found in the prior art of record. The
+ Federal Circuit determined that ample evidence supported the district court’s
+ finding that compound 12 was a natural choice for further development. For
+ example, Altana’s prior art patent claimed that its compounds, including compound
+ 12, were improvements over the prior art; compound 12 was disclosed as one of the
+ more potent of the eighteen compounds disclosed; the patent examiner had
+ considered the compounds of Altana’s prior art patent to be relevant during the
+ prosecution of the patent in suit; and experts had opined that one of ordinary
+ skill in the art would have selected the eighteen compounds to pursue further
+ investigation into their potential as proton pump inhibitors. 
+ 
+
+
+In response to Altana’s argument that the prior art
+ must point to only a single lead compound for further development, the Federal
+ Circuit stated that a "restrictive view of the lead compound test would present a
+ rigid test similar to the teaching-suggestion-motivation test that the Supreme
+ Court explicitly rejected in *KSR* . . . . The district court in
+ this case employed a flexible approach – one that was admittedly preliminary – and
+ found that the defendants had raised a substantial question that one of skill in
+ the art would have used the more potent compounds of [Altana’s prior art] patent,
+ including compound 12, as a starting point from which to pursue further
+ development efforts. That finding was not clearly erroneous."
+ *Id.* at 1008, 91 USPQ2d at 1025. 
+ 
+
+
+***C.******Use of Known Technique To Improve Similar Devices (Methods, or Products)
+ in the Same Way***To reject a claim based on this rationale, Office personnel must
+ resolve the *Graham* factual inquiries. Then, Office personnel must
+ articulate the following:
+ 
+
+
+* (1) a finding that the prior art contained a "base" device
+ (method, or product) upon which the claimed invention can be seen as an
+ "improvement;"
+* (2) a finding that the prior art contained a 
+ "comparable"
+ 
+ 
+ device (method, or product
+ that is not the same as the base device) that has been improved in the same way
+ as the claimed invention;
+* (3) a finding that one of ordinary skill in the art could have
+ applied the known "improvement" technique in the same way to the "base" device
+ (method, or product) and the results would have been predictable to one of
+ ordinary skill in the art; and
+* (4) whatever additional findings based on the
+ *Graham* factual inquiries may be necessary, in view of the
+ facts of the case under consideration, to explain a conclusion of obviousness.
+
+
+ The rationale to support a conclusion that the claim would have
+ been obvious is that a method of enhancing a particular class of devices (methods, or
+ products) has been made part of the ordinary capabilities of one skilled in the art
+ based upon the teaching of such improvement in other situations. One of ordinary
+ skill in the art would have been capable of applying this known method of enhancement
+ to a "base" device (method, or product) in the prior art and the results would have
+ been predictable to one of ordinary skill in the art. The Supreme Court in
+ *KSR* noted that if the actual application of the technique would
+ have been beyond the skill of one of ordinary skill in the art, then using the
+ technique would not have been obvious. *KSR,* 550 U.S. at 417, 82
+ USPQ2d at 1396. If any of these findings cannot be made, then this rationale cannot
+ be used to support a conclusion that the claim would have been obvious to one of
+ ordinary skill in the art. 
+ 
+
+
+**Example 1:**The claimed invention in *In re Nilssen,* 851
+ F.2d 1401, 7 USPQ2d 1500 (Fed. Cir. 1988) was directed to a "means by which the
+ self-oscillating inverter in a power-line-operated inverter-type fluorescent lamp
+ ballast is disabled in case the output current from the inverter exceeds some
+ pre-established threshold level for more than a very brief period."
+ *Id.* at 1402, 7 USPQ2d at 1501 That is, the current output
+ was monitored, and if the current output exceeded some threshold for a specified
+ short time, an actuation signal was sent and the inverter was disabled to protect
+ it from damage.
+ 
+
+
+The prior art (a USSR certificate) described a device for
+ protecting an inverter circuit in an undisclosed manner via a control means. The
+ device indicated the high-load condition by way of the control means, but did not
+ indicate the specific manner of overload protection. The prior art (Kammiller)
+ disclosed disabling the inverter in the event of a high-load current condition in
+ order to protect the inverter circuit. That is, the overload protection was
+ achieved by disabling the inverter by means of a cutoff switch.
+ 
+
+
+The court found "it would have been obvious to one of ordinary
+ skill in the art to use the threshold signal produced in the USSR device to
+ actuate a cutoff switch to render the inverter inoperative as taught by
+ Kammiller." *Id.* at 1403, 7 USPQ2d at 1502. That is, using the
+ known technique of a cutoff switch for protecting a circuit to provide the
+ protection desired in the inverter circuit of the USSR document would have been
+ obvious to one of ordinary skill.
+ 
+
+
+
+**Example 2:**The fact pattern in *Ruiz v. AB Chance Co.,* 357
+ F.3d 1270, 69 USPQ2d 1686 (Fed. Cir. 2004) is set forth above in Example 2 in
+ subsection I.A.
+ 
+
+
+The nature of the problem to be solved may lead inventors to look
+ at references relating to possible solutions to that problem.
+ *Id.* at 1277, 69 USPQ2d at 1691. Therefore, it would have
+ been obvious to use a metal bracket (as shown in Gregory) with the screw anchor
+ (as shown in Fuller) to underpin unstable foundations.
+ 
+
+
+***D.******Applying a Known Technique to a Known Device (Method, or Product) Ready
+ for Improvement To Yield Predictable Results***To reject a claim based on this rationale, Office personnel must
+ resolve the *Graham* factual inquiries. Then, Office personnel must
+ articulate the following:
+ 
+
+
+* (1) a finding that the prior art contained a "base" device
+ (method, or product) upon which the claimed invention can be seen as an
+ "improvement;"
+* (2) a finding that the prior art contained a known technique that
+ is applicable to the base device (method, or product);
+* (3) a finding that one of ordinary skill in the art would have
+ recognized that applying the known technique would have yielded predictable
+ results and resulted in an improved system; and
+* (4) whatever additional findings based on the
+ *Graham* factual inquiries may be necessary, in view of the
+ facts of the case under consideration, to explain a conclusion of obviousness.
+
+
+ The rationale to support a conclusion that the claim would have
+ been obvious is that a particular known technique was recognized as part of the
+ ordinary capabilities of one skilled in the art. One of ordinary skill in the art
+ would have been capable of applying this known technique to a known device (method,
+ or product) that was ready for improvement and the results would have been
+ predictable to one of ordinary skill in the art. If any of these findings cannot be
+ made, then this rationale cannot be used to support a conclusion that the claim would
+ have been obvious to one of ordinary skill in the art.
+ 
+
+
+**Example 1:**The claimed invention in *Dann v. Johnston,* 425
+ U.S. 219, 189 USPQ 257 (1976) was directed towards a system (i.e., computer) for
+ automatic record keeping of bank checks and deposits. In this system, a customer
+ would put a numerical category code on each check or deposit slip. The check
+ processing system would record these on the check in magnetic ink, just as it does
+ for amount and account information. With this system in place, the bank can
+ provide statements to customers that are broken down to give subtotals for each
+ category. The claimed system also allowed the bank to print reports according to a
+ style requested by the customer. As characterized by the Court, "[u]nder
+ respondent’s invention, then, a general purpose computer is programmed to provide
+ bank customers with an individualized and categorized breakdown of their
+ transactions during the period in question." *Id.* at 222, 189
+ USPQ at 259. 
+ 
+
+
+ BASE SYSTEM - The nature of the use of data processing equipment
+ and computer software in the banking industry was that banks routinely did much of
+ the record-keeping automatically. In routine check processing, the system read any
+ magnetic ink characters identifying the account and routing. The system also read
+ the amount of the check and then printed that value in a designated area of the
+ check. The check was then sent through a further data processing step which used
+ the magnetic ink information to generate the appropriate records for transactions
+ and for posting to the appropriate accounts. These systems included generating
+ periodic statements for each account, such as the monthly statement sent to
+ checking account customers.
+ 
+
+
+ IMPROVED SYSTEM - The claimed invention supplemented this system
+ by recording a category code which could be used to track expenditures by
+ category. Again, the category code will be a number recorded on the check (or
+ deposit slip) which will be read, converted into a magnetic ink imprint, and then
+ processed in the data system to include the category code. This enabled reporting
+ of data by category as opposed to only allowing reporting by account number. 
+ 
+
+
+ KNOWN TECHNIQUE - This is an application of a technique from the
+ prior art – the use of account numbers (generally used to track an individual's
+ total transactions) to solve the problem of how to track categories of
+ expenditures to more finely account for a budget. That is, account numbers
+ (identifying data capable of processing in the automatic data processing system)
+ were used to distinguish between different customers. Furthermore, banks have long
+ segregated debits attributable to service charges within any given separate
+ account and have rendered their customers subtotals for those charges. Previously,
+ one would have needed to set up separate accounts for each category and thus
+ receive separate reports. Supplementing the account information with additional
+ digits (the category codes) solved the problem by effectively creating a single
+ account that can be treated as distinct accounts for tracking and reporting
+ services. That is, the category code merely allowed what might previously have
+ been separate accounts to be handled as a single account, but with a number of
+ sub-accounts indicated in the report. 
+ 
+
+
+The basic technique of putting indicia on data to enable standard
+ sorting, searching, and reporting yielded no more than the predictable outcome
+ which one of ordinary skill would have expected to achieve with this common tool
+ of the trade and was therefore an obvious expedient. The Court held that "[t]he
+ gap between the prior art and respondent’s system is simply not so great as to
+ render the system nonobvious to one reasonably skilled in the art."
+ *Id.* at 230, 189 USPQ at 261. 
+ 
+
+
+
+**Example 2:**The fact pattern in *In re Nilssen,* 851 F.2d
+ 1401, 7 USPQ2d 1500 (Fed. Cir. 1988) is set forth above in Example 1 in subsection
+ C.
+ 
+
+
+The court found "it would have been obvious to one of ordinary
+ skill in the art to use the threshold signal produced in the USSR device to
+ actuate a cutoff switch to render the inverter inoperative as taught by
+ Kammiller." *Id.* at 1403, 7 USPQ2d at 1502. The known
+ technique of using a cutoff switch would have predictably resulted in protecting
+ the inverter circuit. Therefore, it would have been within the skill of the
+ ordinary artisan to use a cutoff switch in response to the actuation signal to
+ protect the inverter.
+ 
+
+
+
+**Example 3:**The claimed invention in *In re
+ Urbanski,* 809 F.3d 1237, 1244, 117 USPQ2d 1499, 1504 (Fed. Cir. 2016)
+ was directed to a method of enzymatic hydrolysis of soy fiber to reduce water
+ holding capacity, requiring reacting the soy fiber and enzyme in water for about
+ 60-120 minutes. The claims were rejected over two references, wherein the primary
+ reference, Gross, taught using a reaction time of 5 to 72 hours and the secondary
+ reference, Wong, taught using a reaction time of 100 to 240 minutes, preferably
+ 120 minutes. The applicant argued that modifying the primary reference in the
+ manner suggested by the secondary reference would forego the benefits taught by
+ the primary reference, thereby teaching away from the combination. The court found
+ there was sufficient motivation to combine because both references recognized
+ reaction time and degree of hydrolysis as result-effective variables, which can be
+ varied to have a predictable effect on the final product; and the primary
+ reference does not contain an express teaching away from the proposed
+ modification. "Substantial evidence thus supports the Board’s finding that a
+ person of ordinary skill would have been motivated to modify the Gross process by
+ using a shorter reaction time, in order to obtain the favorable properties
+ disclosed in Wong." 
+ 
+
+
+***E.******"Obvious To Try" – Choosing From a Finite Number of Identified,
+ Predictable Solutions, With a Reasonable Expectation of Success*** To reject a claim based on this rationale, Office personnel must
+ resolve the *Graham* factual inquiries. Then, Office personnel must
+ articulate the following:
+ 
+
+
+* (1) a finding that at the time of the invention, there had been a
+ recognized problem or need in the art, which may include a design need or
+ market pressure to solve a problem;
+* (2) a finding that there had been a finite number of identified,
+ predictable potential solutions to the recognized need or problem;
+* (3) a finding that one of ordinary skill in the art could have
+ pursued the known potential solutions with a reasonable expectation of success;
+ and
+* (4) whatever additional findings based on the
+ *Graham* factual inquiries may be necessary, in view of the
+ facts of the case under consideration, to explain a conclusion of obviousness.
+
+
+ The rationale to support a conclusion that the claim would have
+ been obvious is that "a person of ordinary skill has good reason to pursue the known
+ options within his or her technical grasp. If this leads to the anticipated success,
+ it is likely that product [was] not of innovation but of ordinary skill and common
+ sense. In that instance the fact that a combination was obvious to try might show
+ that it was obvious under **[§ 103](mpep-9015-appx-l.html#d0e302450)**."*KSR,*
+ 550 U.S. at 421, 82 USPQ2d at 1397. If any of these findings cannot be made, then
+ this rationale cannot be used to support a conclusion that the claim would have been
+ obvious to one of ordinary skill in the art.
+ 
+
+
+The question of whether a claimed invention can be
+ shown to be obvious based on an "obvious to try" line of reasoning has been explored
+ extensively by the Federal Circuit in several cases since the *KSR*
+ decision. The case law in this area is developing quickly in the chemical arts,
+ although the rationale has been applied in other art areas as well. 
+ 
+
+
+Some commentators on the *KSR*
+ decision have expressed a concern that because inventive activities are always
+ carried out in the context of what has come before and not in a vacuum, few
+ inventions will survive scrutiny under an obvious to try standard. The cases decided
+ since KSR have proved this fear to have been unfounded. Courts appear to be applying
+ the KSR requirement for "a finite number of identified predictable solutions" in a
+ manner that places particular emphasis on predictability and the reasonable
+ expectations of those of ordinary skill in the art. 
+ 
+
+
+The Federal Circuit pointed out the challenging nature
+ of the task faced by the courts – and likewise by Office personnel – when considering
+ the viability of an obvious to try argument: "The evaluation of the choices made by a
+ skilled scientist, when such choices lead to the desired result, is a challenge to
+ judicial understanding of how technical advance is achieved in the particular field
+ of science or technology." *Abbott Labs. v. Sandoz, Inc.,* 544 F.3d
+ 1341, 1352, 89 USPQ2d 1161, 1171 (Fed. Cir. 2008). The Federal Circuit cautioned that
+ an obviousness inquiry based on an obvious to try rationale must always be undertaken
+ in the context of the subject matter in question, "including the characteristics of
+ the science or technology, its state of advance, the nature of the known choices, the
+ specificity or generality of the prior art, and the predictability of results in the
+ area of interest." *Id.*
+
+
+**Example 1:**The claimed invention in *Pfizer, Inc. v. Apotex,
+ Inc.,* 480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007), was directed to
+ the amlodipine besylate drug product, which was sold in tablet form in the United
+ States under the trademark Norvasc®. Amlodipine and the
+ use of besylate anions were both known at the time of the invention. Amlodipine
+ was known to have the same therapeutic properties as were being claimed for the
+ amlodipine besylate, but Pfizer discovered that the besylate form had better
+ manufacturing properties (e.g., reduced "stickiness").
+ 
+
+
+Pfizer argued that the results of forming amlodipine besylate
+ would have been unpredictable and therefore nonobvious. The court rejected the
+ notion that unpredictability could be equated with nonobviousness here, because
+ there were only a finite number (53) of ***pharmaceutically acceptable*** salts to be tested for improved properties.
+ 
+
+
+The court found that one of ordinary skill in the art having
+ problems with the machinability of amlodipine would have looked to forming a salt
+ of the compound and would have been able to narrow the group of potential
+ salt-formers to a group of 53 anions known to form pharmaceutically acceptable
+ salts, which would be an acceptable number to form "a reasonable expectation of
+ success." 
+ 
+
+
+
+**Example 2:**The claimed invention in *Alza Corp. v. Mylan Labs.,
+ Inc.,* 464 F.3d 1286, 80 USPQ2d 1001 (Fed. Cir. 2006) was drawn to
+ sustained-release formulations of the drug oxybutynin in which the drug is
+ released at a specified rate over a 24-hour period. Oxybutynin was known to be
+ highly water-soluble, and the specification had pointed out that development of
+ sustained-release formulations of such drugs presented particular problems. 
+ 
+
+
+A prior art patent to Morella had taught sustained-release
+ compositions of highly water-soluble drugs, as exemplified by a sustained-release
+ formulation of morphine. Morella had also identified oxybutynin as belonging to
+ the class of highly water-soluble drugs. The Baichwal prior art patent had taught
+ a sustained-release formulation of oxybutynin that had a different release rate
+ than the claimed invention. Finally, the Wong prior art patent had taught a
+ generally applicable method for delivery of drugs over a 24-hour period. Although
+ Wong mentioned applicability of the disclosed method to several categories of
+ drugs to which oxybutynin belonged, Wong did not specifically mention its
+ applicability to oxybutynin. 
+ 
+
+
+The court found that because the absorption properties of
+ oxybutynin would have been reasonably predictable at the time of the invention,
+ there would have been a reasonable expectation of successful development of a
+ sustained-release formulation of oxybutynin as claimed. The prior art, as
+ evidenced by the specification, had recognized the obstacles to be overcome in
+ development of sustained-release formulations of highly water-soluble drugs, and
+ had suggested a finite number of ways to overcome these obstacles. The claims were
+ obvious because it would have been obvious to try the known methods for
+ formulating sustained-release compositions, with a reasonable expectation of
+ success. The court was not swayed by arguments of a lack of absolute
+ predictability.
+ 
+
+
+
+**Example 3:** The Federal Circuit’s decision in *In re
+ Kubin,* 561 F.3d 1351, 90 USPQ2d 1417 (Fed. Cir. 2009), affirmed the
+ Office’s determination in *Ex parte Kubin,* 83 USPQ2d 1410 (Bd.
+ Pat. App. & Int. 2007) that the claims in question, directed to an isolated
+ nucleic acid molecule, would have been obvious over the prior art applied. The
+ claim stated that the nucleic acid encoded a particular polypeptide. The encoded
+ polypeptide was identified in the claim by its partially specified sequence, and
+ by its ability to bind to a specified protein. 
+ 
+
+
+ A prior art patent to Valiante taught the polypeptide encoded by
+ the claimed nucleic acid, but did not disclose either the sequence of the
+ polypeptide, or the claimed isolated nucleic acid molecule. However, Valiante did
+ disclose that by employing conventional methods such as those disclosed by a prior
+ art laboratory manual by Sambrook, the sequence of the polypeptide could be
+ determined, and the nucleic acid molecule could be isolated. In view of Valiante’s
+ disclosure of the polypeptide, and of routine prior art methods for sequencing the
+ polypeptide and isolating the nucleic acid molecule, the Board found that a person
+ of ordinary skill in the art would have had a reasonable expectation that a
+ nucleic acid molecule within the claimed scope could have been successfully
+ obtained. 
+ 
+
+
+ Relying on *In re Deuel,* 51 F.3d 1552, 34
+ USPQ2d 1210 (Fed. Cir. 1995), appellant argued that it was improper for the Office
+ to use the polypeptide of the Valiante patent together with the methods described
+ in Sambrook to reject a claim drawn to a specific nucleic acid molecule without
+ providing a reference showing or suggesting a structurally similar nucleic acid
+ molecule. Citing *KSR,* the Board stated that 
+ "when there is motivation to solve a problem and there are a
+ finite number of identified, predictable solutions, a person of ordinary skill
+ has good reason to pursue the known options within his or her technical grasp.
+ If this leads to anticipated success, it is likely the product not of
+ innovation but of ordinary skill and common sense."
+ 
+ 
+ The
+ Board noted that the problem facing those in the art was to isolate a specific
+ nucleic acid, and there were a limited number of methods available to do so. The
+ Board concluded that the skilled artisan would have had reason to try these
+ methods with the reasonable expectation that at least one would be successful.
+ Thus, isolating the specific nucleic acid molecule claimed was "the product not of
+ innovation but of ordinary skill and common sense."
+ 
+
+
+The Board’s reasoning was substantially adopted by
+ the Federal Circuit. However, it is important to note that in the
+ *Kubin* decision, the Federal Circuit held that "the Supreme
+ Court in *KSR* unambiguously discredited" the Federal Circuit’s
+ decision in *Deuel,* insofar as it "implies the obviousness
+ inquiry cannot consider that the combination of the claim’s constituent elements
+ was ‘obvious to try.’" *Kubin,* 561 F.3d at 1358, 90 USPQ2d at
+ 1422. Instead, *Kubin* stated that *KSR*
+ "resurrects" the Federal Circuit’s own wisdom in *O’Farrell,* in
+ which "to differentiate between proper and improper applications of ‘obvious to
+ try,’" the Federal Circuit "outlined two classes of situations where ‘obvious to
+ try’ is erroneously equated with obviousness under **[§ 103](mpep-9015-appx-l.html#d0e302450)**."
+ *Kubin,* 561 F.3d at 1359, 90 USPQ2d at 1423. These two
+ classes of situations are: (1) when what would have been "obvious to try" would
+ have been to vary all parameters or try each of numerous possible choices until
+ one possibly arrived at a successful result, where the prior art gave either no
+ indication of which parameters were critical or no direction as to which of many
+ possible choices is likely to be successful; and (2) when what was "obvious to
+ try" was to explore a new technology or general approach that seemed to be a
+ promising field of experimentation, where the prior art gave only general guidance
+ as to the particular form of the claimed invention or how to achieve it.
+ *Id.* (citing *In re O’Farrell,* 853 F.2d
+ 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir.)). 
+ 
+
+
+
+**Example 4:***Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd.,* 492 F.3d
+ 1350, 83 USPQ2d 1169 (Fed. Cir. 2007), is an example of a chemical case in which
+ the Federal Circuit found that the claimed invention was not obvious. The claimed
+ compound was pioglitazone, a member of a class of drugs known as
+ thiazolidinediones (TZDs) marketed by Takeda as a treatment for Type 2 diabetes.
+ The *Takeda* case brings together the concept of a "lead
+ compound" and the obvious-to-try argument. 
+ 
+
+
+Alphapharm had filed an Abbreviated New Drug
+ Application with the Food and Drug Administration, which was a technical act of
+ infringement of Takeda’s patent. When Takeda brought suit, Alphapharm’s defense
+ was that Takeda’s patent was invalid due to obviousness. Alphapharm argued that a
+ two-step modification – involving homologation and ring-walking – of a known
+ compound identified as "compound b" would have produced pioglitazone, and that it
+ was therefore obvious. 
+ 
+
+
+The district court found that there would have been
+ no reason to select compound b as a lead compound. There were a large number of
+ similar prior art TZD compounds; fifty-four were specifically identified in
+ Takeda’s prior patent, and the district court observed that "hundreds of millions"
+ were more generally disclosed. Although the parties agreed that compound b
+ represented the closest prior art, one reference taught certain disadvantageous
+ properties associated with compound b, which according to the district court would
+ have taught the skilled artisan not to select that compound as a lead compound.
+ The district court found no *prima facie* case of obviousness,
+ and stated that even if a *prima facie* case had been
+ established, it would have been overcome in this case in view of the unexpected
+ lack of toxicity of pioglitazone. 
+ 
+
+
+The Federal Circuit affirmed the decision of the
+ district court, citing the need for a reason to modify a prior art compound. The
+ Federal Circuit quoted *KSR,* stating: 
+ 
+
+
+
+> 
+> The *KSR* Court recognized that
+>  "[w]hen there is a design need or market pressure to solve a problem and there
+>  are a finite number of identified, predictable solutions, a person of ordinary
+>  skill has good reason to pursue the known options within his or her technical
+>  grasp." *KSR,* 550 U.S. at 421, 82 USPQ2d at 1397. In such
+>  circumstances, "the fact that a combination was obvious to try might show that
+>  it was obvious under **[§ 103](mpep-9015-appx-l.html#d0e302450)**."
+>  *Id.* That is not the case here. Rather than identify
+>  predictable solutions for antidiabetic treatment, the prior art disclosed a
+>  broad selection of compounds any one of which could have been selected as a
+>  lead compound for further investigation. Significantly, the closest prior art
+>  compound (compound b, the 6-methyl) exhibited negative properties that would
+>  have directed one of ordinary skill in the art away from that compound. Thus,
+>  this case fails to present the type of situation contemplated by the Court when
+>  it stated that an invention may be deemed obvious if it was "obvious to try."
+>  The evidence showed that it was not obvious to try.
+>  
+> 
+> 
+> 
+
+
+*Takeda,* 492 F.3d at 1359, 83 USPQ2d at 1176. 
+ 
+
+
+Accordingly, Office personnel should recognize that
+ the obvious to try rationale does not apply when the appropriate factual findings
+ cannot be made. In *Takeda,* there was a recognized need for
+ treatment of diabetes. However, there was no finite number of identified,
+ predictable solutions to the recognized need, and no reasonable expectation of
+ success. There were numerous known TZD compounds, and although one clearly
+ represented the closest prior art, its known disadvantages rendered it unsuitable
+ as a starting point for further research, and taught the skilled artisan away from
+ its use. Furthermore, even if there had been reason to select compound b, there
+ had been no reasonable expectation of success associated with the particular
+ modifications necessary to transform compound b into the claimed compound
+ pioglitazone. Thus, an obviousness rejection based on an obvious to try rationale
+ was not appropriate in this situation. 
+ 
+
+
+
+**Example 5:** The case of *Ortho-McNeil Pharm., Inc. v.
+ Mylan Labs, Inc.,* 520 F.3d 1358, 86 USPQ2d 1196 (Fed. Cir. 2008),
+ provides another example in which a chemical compound was determined not to be
+ obvious. The claimed subject matter was topiramate, which is used as an
+ anti-convulsant. 
+ 
+
+
+In the course of working toward a new anti-diabetic
+ drug, Ortho-McNeil’s scientist had unexpectedly discovered that a reaction
+ intermediate had anti-convulsant properties. Mylan’s defense of invalidity due to
+ obviousness rested on an obvious to try argument. However, Mylan did not explain
+ why it would have been obvious to begin with an anti-diabetic drug precursor,
+ especially the specific one that led to topiramate, if one had been seeking an
+ anti-convulsant drug. The district court ruled on summary judgment that
+ Ortho-McNeil’s patent was not invalid for obviousness. 
+ 
+
+
+The Federal Circuit affirmed. The Federal Circuit
+ pointed out that there was no apparent reason a person of ordinary skill would
+ have chosen the particular starting compound or the particular synthetic pathway
+ that led to topiramate as an intermediate. Furthermore, there would have been no
+ reason to test that intermediate for anticonvulsant properties if treating
+ diabetes had been the goal. The Federal Circuit recognized an element of
+ serendipity in this case, which runs counter to the requirement for
+ predictability. Summarizing their conclusion with regard to Mylan’s obvious to try
+ argument, the Federal Circuit stated: 
+ 
+
+
+
+> 
+> [T]his invention, contrary to Mylan’s
+>  characterization, does not present a finite (and small in the context of the
+>  art) number of options easily traversed to show obviousness. . . .
+>  *KSR* posits a situation with a finite, and in the context
+>  of the art, small or easily traversed, number of options that would convince an
+>  ordinarily skilled artisan of obviousness. . . . [T]his clearly is not the
+>  easily traversed, small and finite number of alternatives that
+>  *KSR* suggested might support an inference of obviousness.
+>  *Id.* at 1364, 86 USPQ2d at 1201. 
+>  
+> 
+> 
+> 
+
+
+Thus, *Ortho-McNeil* helps to
+ clarify the Supreme Court’s requirement in KSR for "a finite number" of
+ predictable solutions when an obvious to try rationale is applied: under the
+ Federal Circuit’s case law "finite" means "small or easily traversed" in the
+ context of the art in question. As taught in *Abbott,* discussed
+ above, it is essential that the inquiry be placed in the context of the subject
+ matter at issue, and each case must be decided on its own facts. 
+ 
+
+
+
+**Example 6:** In *Bayer Schering Pharma A.G. v. Barr
+ Labs., Inc.,* 575 F.3d 1341, 91 USPQ2d 1569 (Fed. Cir. 2009), the
+ claimed invention was an oral contraceptive containing micronized drospirenone
+ marketed as Yasmin®. The prior art compound
+ drospirenone was known to be a poorly water-soluble, acid-sensitive compound with
+ contraceptive effects. It was also known in the art that micronization improves
+ the solubility of poorly water soluble drugs.
+ 
+
+
+ Based on the known acid sensitivity, Bayer had
+ studied how effectively an enteric-coated drospirenone tablet delivered a
+ formulation as compared to an intravenous injection of the same formulation to
+ measure the "absolute bioavailability" of the drug. Bayer added an unprotected
+ (normal) drospirenone tablet and compared its bioavailability to that of the
+ enteric-coated formulation and the intravenous delivery. Bayer expected to find
+ that the enteric-coated tablet would produce a lower bioavailability than an
+ intravenous injection, while the normal pill would produce an even lower
+ bioavailability than the enteric-coated tablet. However, they found that despite
+ observations that drospirenone would quickly isomerize in a highly acidic
+ environment (supporting the belief that an enteric coating would be necessary to
+ preserve bioavailability), the normal pill and the enteric-coated pill resulted in
+ the same bioavailability. Following this study, Bayer developed micronized
+ drospirenone in a normal pill, the basis for the disputed patent. 
+ 
+
+
+The district court found that a person having
+ ordinary skill in the art would have considered the prior art result that a
+ structurally related compound, spirorenone, though acid-sensitive, would
+ nevertheless absorb *in vivo,* would have suggested the same
+ result for drospirenone. It also found that while another reference taught that
+ drospirenone isomerizes *in vitro* when exposed to acid
+ simulating the human stomach, a person of ordinary skill would have been aware of
+ the study’s shortcomings, and would have verified the findings as suggested by a
+ treatise on the science of dosage form design, which would have then showed that
+ no enteric coating was necessary. 
+ 
+
+
+The Federal Circuit held that the patent was invalid
+ because the claimed formulation was obvious. The Federal Circuit reasoned that the
+ prior art would have funneled the formulator toward two options. Thus, the
+ formulator would not have been required to try all possibilities in a field
+ unreduced by the prior art. The prior art was not vague in pointing toward a
+ general approach or area of exploration, but rather guided the formulator
+ precisely to the use of either a normal pill or an enteric-coated pill. 
+ 
+
+
+It is important for Office personnel to recognize
+ that the mere existence of a large number of options does not in and of itself
+ lead to a conclusion of nonobviousness. Where the prior art teachings lead one of
+ ordinary skill in the art to a narrower set of options, then that reduced set is
+ the appropriate one to consider when determining obviousness using an obvious to
+ try rationale. 
+ 
+
+
+
+**Example 7:** The case of *Sanofi-Synthelabo v. Apotex,
+ Inc.,* 550 F.3d 1075, 89 USPQ2d 1370 (Fed. Cir. 2008), also sheds
+ light on the obvious to try line of reasoning. The claimed compound was
+ clopidogrel, which is the dextrorotatory isomer of methyl alpha-
+ 5(4,5,6,7-tetrahydro(3,2-c)thienopyridyl)(2-chlorophenyl)-acetate. Clopidogrel is
+ an anti-thrombotic compound used to treat or prevent heart attack or stroke. The
+ racemate, or mixture of dextrorotatory and levorotatory (D- and L-) isomers of the
+ compound, was known in the prior art. The two forms had not previously been
+ separated, and although the mixture was known to have anti-thrombotic properties,
+ the extent to which each of the individual isomers contributed to the observed
+ properties of the racemate was not known and was not predictable. 
+ 
+
+
+The district court assumed that in the absence of
+ any additional information, the D-isomer would have been *prima
+ facie* obvious over the known racemate. However, in view of the
+ evidence of unpredicted therapeutic advantages of the D-isomer presented in the
+ case, the district court found that any *prima facie* case of
+ obviousness had been overcome. At trial, the experts for both parties testified
+ that persons of ordinary skill in the art could not have predicted the degree to
+ which the isomers would have exhibited different levels of therapeutic activity
+ and toxicity. Both parties’ experts also agreed that the isomer with greater
+ therapeutic activity would most likely have had greater toxicity. Sanofi witnesses
+ testified that Sanofi’s own researchers had believed that the separation of the
+ isomers was unlikely to have been productive, and experts for both parties agreed
+ that it was difficult to separate isomers at the time of the invention.
+ Nevertheless, when Sanofi ultimately undertook the task of separating the isomers,
+ it found that they had the "rare characteristic of ‘absolute stereoselectivity,’"
+ whereby the D-isomer provided all of the favorable therapeutic activity but no
+ significant toxicity, while the L-isomer produced no therapeutic activity but
+ virtually all of the toxicity. Based on this record, the district court concluded
+ that Apotex had not met its burden of proving by clear and convincing evidence
+ that Sanofi’s patent was invalid for obviousness. The Federal Circuit affirmed the
+ district court’s conclusion. 
+ 
+
+
+Office personnel should recognize that even when
+ only a small number of possible choices exist, the obvious to try line of
+ reasoning is not appropriate when, upon consideration of all of the evidence, the
+ outcome would not have been reasonably predictable and the inventor would not have
+ had a reasonable expectation of success. In *Bayer,* there were
+ art-based reasons to expect that both the normal pill and the enteric-coated pill
+ would be therapeutically suitable, even though not all prior art studies were in
+ complete agreement. Thus, the result obtained was not unexpected. In
+ *Sanofi,* on the other hand, there was strong evidence that
+ persons of ordinary skill in the art, prior to the separation of the isomers,
+ would have had no reason to expect that the D-isomer would have such strong
+ therapeutic advantages as compared with the L-isomer. In other words, the result
+ in *Sanofi* was unexpected. 
+ 
+
+
+
+**Example 8:** In *Rolls-Royce, PLC v. United Tech.
+ Corp.,* 603 F.3d 1325, 95 USPQ2d 1097 (Fed. Cir. 2010), the Federal
+ Circuit addressed the obvious to try rationale in the context of a fan blade for
+ jet engines. The case had arisen out of an interference proceeding. Finding that
+ the district court had correctly determined that there was no interference-in-fact
+ because Rolls-Royce’s claims would not have been obvious in light of United’s
+ application, the Federal Circuit affirmed. 
+ 
+
+
+The Federal Circuit described the fan blade of the
+ count as follows: 
+ 
+
+
+
+> 
+> Each fan blade has three regions – an inner, an
+>  intermediate, and an outer region. The area closest to the axis of rotation at
+>  the hub is the inner region. The area farthest from the center of the engine
+>  and closest to the casing surrounding the engine is the outer region. The
+>  intermediate region falls in between. The count defines a fan blade with a
+>  swept-forward inner region, a swept-rearward intermediate region, and
+>  forward-leaning outer region. 
+>  
+> 
+> 
+> 
+
+
+*Id.* at 1328, 95 USPQ2d at 1099. 
+ 
+
+
+United had argued that it would have been obvious
+ for a person of ordinary skill in the art to try a fan blade design in which the
+ sweep angle in the outer region was reversed as compared with prior art fan blades
+ from rearward to forward sweep, in order to reduce endwall shock. The Federal
+ Circuit disagreed with United’s assessment that the claimed fan blade would have
+ been obvious based on an obvious to try rationale. The Federal Circuit pointed out
+ that in a proper obvious to try approach to obviousness, the possible options for
+ solving a problem must have been "known and finite." *Id.* at
+ 1339, 95 USPQ2d at 1107 (citing *Abbott,* 544 F.3d at 1351, 89
+ USPQ2d at 1171). In this case, nothing in the prior art would have suggested that
+ changing the sweep angle as Rolls-Royce had done would have addressed the issue of
+ endwall shock. Thus, the Federal Circuit concluded that changing the sweep angle
+ "would not have presented itself as an option at all, let alone an option that
+ would have been obvious to try." *Id.* The decision in
+ *Rolls-Royce* is a reminder to Office personnel that the
+ obvious to try rationale can properly be used to support a conclusion of
+ obviousness only when the claimed solution would have been selected from a finite
+ number of potential solutions known to persons of ordinary skill in the art. 
+ 
+
+
+
+**Example 9:** The case of *Perfect Web Tech., Inc. v.
+ InfoUSA, Inc.,* 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed.
+ Cir. 2009), provides an example in which the Federal Circuit held that a claimed
+ method for managing bulk email distribution was obvious on the basis of an obvious
+ to try argument. In *Perfect Web,* the method required selecting
+ the intended recipients, transmitting the emails, determining how many of the
+ emails had been successfully received, and repeating the first three steps if a
+ pre-determined minimum number of intended recipients had not received the email. 
+ 
+
+
+The Federal Circuit affirmed the district court’s
+ determination on summary judgment that the claimed invention would have been
+ obvious. Failure to meet a desired quota of email recipients was a recognized
+ problem in the field of email marketing. The prior art had also recognized three
+ potential solutions: increasing the size of the initial recipient list; resending
+ emails to recipients who did not receive them on the first attempt; and selecting
+ a new recipient list and sending emails to them. The last option corresponded to
+ the fourth step of the invention as claimed. 
+ 
+
+
+The Federal Circuit noted that based on "simple
+ logic," selecting a new list of recipients was more likely to result in the
+ desired outcome than resending to those who had not received the email on the
+ first attempt. There had been no evidence of any unexpected result associated with
+ selecting a new recipient list, and no evidence that the method would not have had
+ a reasonable likelihood of success. Thus, the Federal Circuit concluded that, as
+ required by KSR, there were a "finite number of identified, predictable
+ solutions," and that the obvious to try inquiry properly led to the legal
+ conclusion of obviousness. 
+ 
+
+
+The Federal Circuit in *Perfect
+ Web* also discussed the role of common sense in the determination of
+ obviousness. The district court had cited *KSR* for the
+ proposition that "[a] person of ordinary skill is also a person of ordinary
+ creativity, not an automaton," and found that "the final step [of the claimed
+ invention] is merely the logical result of common sense application of the maxim
+ ‘try, try again.’" In affirming the district court, the Federal Circuit undertook
+ an extended discussion of common sense as it has been applied to the obviousness
+ inquiry, both before and since the *KSR* decision. 
+ 
+
+
+The Federal Circuit pointed out that application of
+ common sense is not really an innovation in the law of obviousness when it stated,
+ "Common sense has long been recognized to inform the analysis of obviousness if
+ explained with sufficient reasoning." *Perfect Web,* 587 F.3d at
+ 1328, 92 USPQ2d at 1853 (emphasis added). The Federal Circuit then provided a
+ review of a number of precedential cases that inform the understanding of common
+ sense, including *In re Bozek,* 416 F.2d 1385, 1390, 163 USPQ
+ 545, 549 (CCPA 1969) (explaining that a patent examiner may rely on "common
+ knowledge and common sense of the person of ordinary skill in the art without any
+ specific hint or suggestion in a particular reference") and *In re
+ Zurko,* 258 F.3d 1379, 1383, 1385, 59 USPQ2d 1693 at 1695, 1697 (Fed.
+ Cir. 2001) (clarifying that a factual foundation is needed in order for an
+ examiner to invoke "good common sense" in a case in which "basic knowledge and
+ common sense was not based on any evidence in the record"). The Federal Circuit
+ implicitly acknowledged in *Perfect Web* that the kind of strict
+ evidence-based teaching, suggestion, or motivation required in *In re
+ Lee,* 277 F.3d 1338, 1344, 61 USPQ2d 1430, 1434 (Fed. Cir. 2002), is
+ not an absolute requirement for an obviousness rejection in light of the teachings
+ of *KSR.* The Federal Circuit explained that "[a]t the time [of
+ the Lee decision], we required the PTO to identify record evidence of a teaching,
+ suggestion, or motivation to combine references." However, *Perfect
+ Web* went on to state that even under *Lee,* common
+ sense could properly be applied when analyzing evidence relevant to obviousness.
+ Citing *DyStar Textilfarben GmbH v. C.H. Patrick Co.,* 464 F.3d
+ 1356, 80 USPQ2d 1641 (Fed. Cir. 2006), and *In re Kahn,* 441 F.3d
+ 977, 78 USPQ2d 1329 (Fed. Cir. 2006), two cases decided shortly before the Supreme
+ Court’s decision in *KSR,* the Federal Circuit noted that
+ although "a reasoned explanation that avoids conclusory generalizations" is
+ required to use common sense, identification of a "specific hint or suggestion in
+ a particular reference" is not. See also *Arendi v. Apple,* 832
+ F.3d 1355, 119 USPQ2d 1822 (Fed. Cir. 2016) (finding that the Board had not
+ provided a reasoned analysis, supported by the evidence of record, for why "common
+ sense" taught the missing process step). 
+ 
+
+
+***F.******Known Work in One Field of Endeavor May Prompt Variations of It for Use
+ in Either the Same Field or a Different One Based on Design Incentives or Other
+ Market Forces if the Variations Are Predictable to One of Ordinary Skill in the
+ Art***To reject a claim based on this rationale, Office personnel must
+ resolve the *Graham* factual inquiries. Then, Office personnel must
+ articulate the following:
+ 
+
+
+* (1) a finding that the scope and content of the prior art, whether
+ in the same field of endeavor as that of the applicant’s invention or a
+ different field of endeavor, included a similar or analogous device (method, or
+ product);
+* (2) a finding that there were design incentives or market forces
+ which would have prompted adaptation of the known device (method, or product);
+* (3) a finding that the differences between the claimed invention
+ and the prior art were encompassed in known variations or in a principle known
+ in the prior art;
+* (4) a finding that one of ordinary skill in the art, in view of
+ the identified design incentives or other market forces, could have implemented
+ the claimed variation of the prior art, and the claimed variation would have
+ been predictable to one of ordinary skill in the art; and
+* (5) whatever additional findings based on the
+ *Graham* factual inquiries may be necessary, in view of the
+ facts of the case under consideration, to explain a conclusion of obviousness.
+
+
+ The rationale to support a conclusion that the claimed invention
+ would have been obvious is that design incentives or other market forces could have
+ prompted one of ordinary skill in the art to vary the prior art in a predictable
+ manner to result in the claimed invention. If any of these findings cannot be made,
+ then this rationale cannot be used to support a conclusion that the claim would have
+ been obvious to one of ordinary skill in the art.
+ 
+
+
+**Example 1:**The fact pattern in *Dann v. Johnston,* 425 U.S.
+ 219, 189 USPQ 257 (1976) is set forth above in Example 1 in subsection D. 
+ 
+
+
+The Court found that the problem addressed by applicant – the
+ need to give more detailed breakdown by a category of transactions – was closely
+ analogous to the task of keeping track of the transaction files of individual
+ business units. *Id.* at 229, 189 USPQ at 261. Thus, an artisan
+ in the data processing area would have recognized the similar class of problem and
+ the known solutions of the prior art and it would have been well within the
+ ordinary skill level to implement the system in the different environment. The
+ Court held that "[t]he gap between the prior art and respondent’s system is simply
+ not so great as to render the system nonobvious to one reasonably skilled in the
+ art."  *Id.* at 230, 189 USPQ at 261.
+ 
+
+
+
+**Example 2:**The claimed invention in *Leapfrog Enterprises, Inc. v.
+ Fisher-Price, Inc.,* 485 F.3d 1157, 82 USPQ2d 1687 (Fed. Cir. 2007)
+ was directed to a learning device to help young children read phonetically. The
+ claim read as follows:
+ 
+
+
+An interactive learning device, comprising:
+
+
+a housing including a plurality of switches;
+
+
+a sound production device in communication with the switches and
+ including a processor and a memory;
+ 
+
+
+at least one depiction of a sequence of letters, each letter
+ being associable with a switch; and
+ 
+
+
+a reader configured to communicate the identity of the depiction
+ to the processor,
+ 
+
+
+wherein selection of a depicted letter activates an associated
+ switch to communicate with the processor, causing the sound production device to
+ generate a signal corresponding to a sound associated with the selected letter,
+ the sound being determined by a position of the letter in the sequence of
+ letter.
+ 
+
+
+The court concluded that the claimed invention would have been
+ obvious in view of the combination of two pieces of prior art, (1) Bevan (which
+ showed an electro-mechanical toy for phonetic learning), (2) the Super Speak &
+ Read device (SSR) (an electronic reading toy), and the knowledge of one of
+ ordinary skill in the art. 
+ 
+
+
+The court made clear that there was no technological advance
+ beyond the skill shown in the SSR device. The court stated that "one of ordinary
+ skill in the art of children’s learning toys would have found it obvious to
+ combine the Bevan device with the SSR to update it using modern electronic
+ components in order to gain the commonly understood benefits of such adaptation,
+ such as decreased size, increased reliability, simplified operation, and reduced
+ cost. While the SSR only permits generation of a sound corresponding to the first
+ letter of a word, it does so using electronic means. The combination is thus the
+ adaptation of an old idea or invention (Bevan) using newer technology that is
+ commonly available and understood in the art (the SSR)."
+ 
+
+
+The court found that the claimed invention was but a variation on
+ already known children’s toys. This variation presented no nonobvious advance over
+ other toys. The court made clear that there was no technological advance beyond
+ the skill shown in the SSR device. The court found that "[a]ccommodating a prior
+ art mechanical device that accomplishes that goal to modern electronics would have
+ been reasonably obvious to one of ordinary skill in designing children’s learning
+ devices. Applying modern electronics to older mechanical devices has been
+ commonplace in recent years." 
+ 
+
+
+
+**Example 3:**The claimed invention in *KSR Int'l Co. v.
+ Teleflex**Inc.,* 550 U.S. 398, 82 USPQ2d 1385 (2007), was an adjustable
+ pedal assembly with a fixed pivot point and an electronic pedal-position sensor
+ attached to the assembly support. The fixed pivot point meant that the pivot was
+ not changed as the pedal was adjusted. The placement of the sensor on the assembly
+ support kept the sensor fixed while the pedal was adjusted. 
+ 
+
+
+Conventional gas pedals operated by a mechanical link which
+ adjusted the throttle based on the travel of the pedal from a set position. The
+ throttle controlled the combustion process and the available power generated by
+ the engine. Newer cars used computer controlled throttles in which a sensor
+ detected the motion of the pedal and sent signals to the engine to adjust the
+ throttle accordingly. At the time of the invention, the marketplace provided a
+ strong incentive to convert mechanical pedals to electronic pedals, and the prior
+ art taught a number of methods for doing so. The prior art (Asano) taught an
+ adjustable pedal with a fixed pivot point with mechanical throttle control. The
+ prior art (‘936 patent to Byler) taught an electronic pedal sensor which was
+ placed on a pivot point in the pedal assembly and that it was preferable to detect
+ the pedal’s position in the pedal mechanism rather than in the engine. The prior
+ art (Smith) taught that to prevent the wires connecting the sensor to the computer
+ from chafing and wearing out, the sensor should be put on a fixed part of the
+ pedal assembly rather than in or on the pedal’s footpad. The prior art (Rixon)
+ taught an adjustable pedal assembly (sensor in the footpad) with an electronic
+ sensor for throttle control. There was no prior art electronic throttle control
+ that was combined with a pedal assembly which kept the pivot point fixed when
+ adjusting the pedal.
+ 
+
+
+The Court stated that "[t]he proper question to have asked was
+ whether a pedal designer of ordinary skill, facing the wide range of needs created
+ by developments in the field of endeavor, would have seen a benefit to upgrading
+ Asano with a sensor." *Id.* at 424, 82 USPQ2d at 1399. The Court
+ found that technological developments in the automotive design would have prompted
+ a designer to upgrade Asano with an electronic sensor. The next question was where
+ to attach the sensor. Based on the prior art, a designer would have known to place
+ the sensor on a nonmoving part of the pedal structure and the most obvious
+ nonmoving point on the structure from which a sensor can easily detect the pedal’s
+ position was a pivot point. The Court concluded that it would have been obvious to
+ upgrade Asano’s fixed pivot point adjustable pedal by replacing the mechanical
+ assembly for throttle control with an electronic throttle control and to mount the
+ electronic sensor on the pedal support structure.
+ 
+
+
+
+**Example 4:**The claimed invention in *Ex parte Catan,* 83
+ USPQ2d 1569 (Bd. Pat. App. & Int. 2007), was a consumer electronics device
+ using bioauthentication to authorize sub-users of an authorized credit account to
+ place orders over a communication network up to a pre-set maximum sub-credit
+ limit.
+ 
+
+
+The prior art (Nakano) disclosed a consumer electronics device
+ like the claimed invention, except that security was provided by a password
+ authentication device rather than a bioauthentication device. The prior art
+ (Harada) disclosed that the use of a bioauthentication device (fingerprint sensor)
+ on a consumer electronics device (remote control) to provide bioauthentication
+ information (fingerprint) was known in the prior art at the time of the invention.
+ The prior art (Dethloff) also disclosed that it was known in the art at the time
+ of the invention to substitute bioauthentication for PIN authentication to enable
+ a user to access credit via a consumer electronics device.
+ 
+
+
+The Board found that the prior art "shows that one of ordinary
+ skill in the consumer electronic device art at the time of the invention would
+ have been familiar with using bioauthentication information interchangeably with
+ or in lieu of PINs to authenticate users." The Board concluded that one of
+ ordinary skill in the art of consumer electronic devices would have found it
+ obvious to update the prior art password device with the modern bioauthentication
+ component and thereby gain, predictably, the commonly understood benefits of such
+ adaptation, that is, a secure and reliable authentication procedure.
+ 
+
+
+***G.******Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have
+ Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior
+ Art Reference Teachings To Arrive at the Claimed Invention*** To reject a claim based on this rationale, Office personnel must
+ resolve the *Graham* factual inquiries. Then, Office personnel must
+ articulate the following:
+ 
+
+
+* (1) a finding that there was some teaching, suggestion, or
+ motivation, either in the references themselves or in the knowledge generally
+ available to one of ordinary skill in the art, to modify the reference or to
+ combine reference teachings;
+* (2) a finding that there was reasonable expectation of success;
+ and
+* (3) whatever additional findings based on the
+ *Graham* factual inquiries may be necessary, in view of the
+ facts of the case under consideration, to explain a conclusion of obviousness.
+
+
+ The rationale to support a conclusion that the claim would have
+ been obvious is that "a person of ordinary skill in the art would have been motivated
+ to combine the prior art to achieve the claimed invention and whether there would
+ have been a reasonable expectation of success in doing so."  *DyStar
+ Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co.,* 464 F.3d
+ 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). If any of these findings cannot be
+ made, then this rationale cannot be used to support a conclusion that the claim would
+ have been obvious to one of ordinary skill in the art. 
+ 
+
+
+ The courts have made clear that the teaching, suggestion, or
+ motivation test is flexible and an explicit suggestion to combine the prior art is
+ not necessary. The motivation to combine may be implicit and may be found in the
+ knowledge of one of ordinary skill in the art, or, in some cases, from the nature of
+ the problem to be solved. *Id.* at 1366, 80 USPQ2d at 1649. "[A]n
+ implicit motivation to combine exists not only when a suggestion may be gleaned from
+ the prior art as a whole, but when the ‘improvement’ is technology-independent and
+ the combination of references results in a product or process that is more desirable,
+ for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more
+ durable, or more efficient. Because the desire to enhance commercial opportunities by
+ improving a product or process is universal-and even common-sensical-we have held
+ that there exists in these situations a motivation to combine prior art references
+ even absent any hint of suggestion in the references themselves. In such situations,
+ the proper question is whether the ordinary artisan possesses knowledge and skills
+ rendering him *capable* of combining the prior art references."
+  *Id.* at 1368, 80 USPQ2d at 1651.
+ 
+
+
+
+# 2143.01 Suggestion or Motivation To Modify the References [R-10.2019]
+
+
+Obviousness can be established by combining or modifying the teachings
+ of the prior art to produce the claimed invention where there is some teaching,
+ suggestion, or motivation to do so. *In re Kahn,* 441 F.3d 977, 986, 78
+ USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
+ motivation-suggestion-teaching test as a guard against using hindsight in an obviousness
+ analysis). A "motivation to combine may be found explicitly or implicitly in market
+ forces; design incentives; the ‘interrelated teachings of multiple patents’; ‘any need
+ or problem known in the field of endeavor at the time of invention and addressed by the
+ patent’; and the background knowledge, creativity, and common sense of the person of
+ ordinary skill." *Zup v. Nash Mfg.,* 896 F.3d 1365, 1371, 127 USPQ2d
+ 1423, 1427 (Fed. Cir. 2018) (quoting *Plantronics, Inc. v. Aliph,
+ Inc.,* 724 F.3d 1343, 1354 [107 USPQ2d 1706] (Fed. Cir. 2013)
+ (*citing**Perfect Web Techs., Inc. v. InfoUSA, Inc.,* 587 F.3d 1324, 1328 [92
+ USPQ2d 1849] (Fed. Cir. 2009) (*quoting* *KSR,* 550
+ U.S. at 418-21)) . See **[MPEP § 2143](s2143.html#d0e209516)** regarding the need to provide a reasoned
+ explanation even in situations involving common sense or ordinary ingenuity. See also
+ **[MPEP §
+ 2144.05](s2144.html#d0e211255)**, subsection II, B.
+ 
+
+**I.** **PRIOR ART SUGGESTION OF THE CLAIMED INVENTION NOT NECESSARILY NEGATED BY
+ DESIRABLE ALTERNATIVES**The disclosure of desirable alternatives does not necessarily negate
+ a suggestion for modifying the prior art to arrive at the claimed invention. In
+ *In re Fulton,* 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. 2004),
+ the claims of a utility patent application were directed to a shoe sole with
+ increased traction having hexagonal projections in a "facing orientation." 391 F.3d
+ at 1196-97, 73 USPQ2d at 1142. The Board combined a design patent having hexagonal
+ projections in a facing orientation with a utility patent having other limitations of
+ the independent claim. 391 F.3d at 1199, 73 USPQ2d at 1144. Applicant argued that the
+ combination was improper because (1) the prior art did not suggest having the
+ hexagonal projections in a facing (as opposed to a "pointing") orientation was the
+ "most desirable" configuration for the projections, and (2) the prior art "taught
+ away" by showing desirability of the "pointing orientation." 391 F.3d at 1200-01, 73
+ USPQ2d at 1145-46. The court stated that "the prior art’s mere disclosure of more
+ than one alternative does not constitute a teaching away from any of these
+ alternatives because such disclosure does not criticize, discredit, or otherwise
+ discourage the solution claimed…." *Id.* In affirming the Board’s
+ obviousness rejection, the court held that the prior art as a whole suggested the
+ desirability of the combination of shoe sole limitations claimed, thus providing a
+ motivation to combine, which need not be supported by a finding that the prior art
+ suggested that the combination claimed by the applicant was the preferred, or most
+ desirable combination over the other alternatives. *Id.* See also
+ *In re Urbanski,* 809 F.3d 1237, 1244, 117 USPQ2d 1499, 1504
+ (Fed. Cir. 2016). 
+ 
+
+
+In *Ruiz v. A.B. Chance Co.,* 357 F.3d 1270,
+ 69 USPQ2d 1686 (Fed. Cir. 2004), the patent claimed underpinning a slumping building
+ foundation using a screw anchor attached to the foundation by a metal bracket. One
+ prior art reference taught a screw anchor with a concrete bracket, and a second prior
+ art reference disclosed a pier anchor with a metal bracket. The court found
+ motivation to combine the references to arrive at the claimed invention in the
+ "nature of the problem to be solved" because each reference was directed "to
+ precisely the same problem of underpinning slumping foundations."
+ *Id.* at 1276, 69 USPQ2d at 1690. The court also
+ *rejected* the notion that "an express written motivation to
+ combine must appear in prior art references…." *Id.* at 1276, 69
+ USPQ2d at 1690.
+ 
+
+**II.** **WHERE THE TEACHINGS OF THE PRIOR ART CONFLICT, THE EXAMINER MUST WEIGH THE
+ SUGGESTIVE POWER OF EACH REFERENCE**The test for obviousness is what the combined teachings of the
+ references would have suggested to one of ordinary skill in the art, and all
+ teachings in the prior art must be considered to the extent that they are in
+ analogous arts. Where the teachings of two or more prior art references conflict, the
+ examiner must weigh the power of each reference to suggest solutions to one of
+ ordinary skill in the art, considering the degree to which one reference might
+ accurately discredit another. *In re Young,* 927 F.2d 588, 18 USPQ2d
+ 1089 (Fed. Cir. 1991) (Prior art patent to Carlisle disclosed controlling and
+ minimizing bubble oscillation for chemical explosives used in marine seismic
+ exploration by spacing seismic sources close enough to allow the bubbles to intersect
+ before reaching their maximum radius so the secondary pressure pulse was reduced. An
+ article published several years later by Knudsen opined that the Carlisle technique
+ does not yield appreciable improvement in bubble oscillation suppression. However,
+ the article did not test the Carlisle technique under comparable conditions because
+ Knudsen did not use Carlisle’s spacing or seismic source. Furthermore, where the
+ Knudsen model most closely approximated the patent technique there was a 30%
+ reduction of the secondary pressure pulse. On these facts, the court found that the
+ Knudsen article would not have deterred one of ordinary skill in the art from using
+ the Carlisle patent teachings.).
+ 
+
+**III.** **FACT THAT REFERENCES CAN BE COMBINED OR MODIFIED MAY NOT BE SUFFICIENT TO
+ ESTABLISH *PRIMA FACIE* OBVIOUSNESS**The mere fact that references can be combined
+ or modified does not render the resultant combination obvious unless the results
+ would have been predictable to one of ordinary skill in the art. *KSR Int'l
+ Co. v. Teleflex Inc.,* 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)
+ ("If a person of ordinary skill can implement a predictable variation,
+ **[§
+ 103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)** likely bars its patentability. For the same reason, if a
+ technique has been used to improve one device, and a person of ordinary skill in the
+ art would recognize that it would improve similar devices in the same way, using the
+ technique is obvious unless its actual application is beyond his or her skill.").
+ 
+
+**IV.** **MERE STATEMENT THAT THE CLAIMED INVENTION IS WITHIN THE CAPABILITIES OF ONE OF
+ ORDINARY SKILL IN THE ART IS NOT SUFFICIENT BY ITSELF TO ESTABLISH *PRIMA
+ FACIE* OBVIOUSNESS**A statement that modifications of the prior art to meet the claimed
+ invention would have been "‘well within the ordinary skill of the
+ art at the time the claimed invention was made’" because the
+ references relied upon teach that all aspects of the claimed invention were
+ individually known in the art is not sufficient to establish a *prima
+ facie* case of obviousness without some objective reason to combine the
+ teachings of the references. *Ex parte Levengood,* 28 USPQ2d 1300
+ (Bd. Pat. App. & Inter. 1993). ‘‘‘[R]ejections on obviousness cannot be sustained
+ by mere conclusory statements; instead, there must be some articulated reasoning with
+ some rational underpinning to support the legal conclusion of obviousness.’"
+ *KSR,* 550 U.S. at 418, 82 USPQ2d at 1396 (quoting *In re
+ Kahn,* 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)).
+ 
+
+**V.** **THE PROPOSED MODIFICATION CANNOT RENDER THE PRIOR ART UNSATISFACTORY FOR ITS
+ INTENDED PURPOSE**If a proposed modification would render the prior art invention
+ being modified unsatisfactory for its intended purpose, then there is no suggestion
+ or motivation to make the proposed modification. *In re Gordon,* 733
+ F.2d 900, 221 USPQ 1125 (Fed. Cir. 1984) (Claimed device was a blood filter assembly
+ for use during medical procedures wherein both the inlet and outlet for the blood
+ were located at the bottom end of the filter assembly, and wherein a gas vent was
+ present at the top of the filter assembly. The prior art reference taught a liquid
+ strainer for removing dirt and water from gasoline and other light oils wherein the
+ inlet and outlet were at the top of the device, and wherein a pet-cock (stopcock) was
+ located at the bottom of the device for periodically removing the collected dirt and
+ water. The reference further taught that the separation is assisted by gravity. The
+ Board concluded the claims were *prima facie* obvious, reasoning
+ that it would have been obvious to turn the reference device upside down. The court
+ reversed, finding that if the prior art device were turned upside down it would be
+ inoperable for its intended purpose because the gasoline to be filtered would be
+ trapped at the top, the water and heavier oils sought to be separated would flow out
+ of the outlet instead of the purified gasoline, and the screen would become
+ clogged.). But see *In re Urbanski,* 809 F.3d 1237, 1244, 117 USPQ2d
+ 1499, 1504 (Fed. Cir. 2016) (The patent claims were directed to a method of enzymatic
+ hydrolysis of soy fiber to reduce water holding capacity, requiring reacting the soy
+ fiber and enzyme in water for about 60-120 minutes. The claims were rejected over two
+ prior art references, wherein the primary reference taught using a longer reaction
+ time of 5 to 72 hours and the secondary taught using a reaction time of 100 to 240
+ minutes, preferably 120 minutes. The applicant argued that modifying the primary
+ reference in the manner suggested by the secondary reference would forego the
+ benefits taught by the primary reference, thereby teaching away from the combination.
+ The court held that both prior art references "suggest[ed] that hydrolysis time may
+ be adjusted to achieve *different* fiber properties. Nothing in the
+ prior art teaches that the proposed modification would have resulted in an
+ ‘inoperable’ process or a dietary fiber product with undesirable properties."
+ (emphasis in original). 
+ 
+
+
+"Although statements limiting the function or capability of a prior
+ art device require fair consideration, simplicity of the prior art is rarely a
+ characteristic that weighs against obviousness of a more complicated device with
+ added function." *In re Dance,* 160 F.3d 1339, 1344, 48 USPQ2d 1635,
+ 1638 (Fed. Cir. 1998) (Court held that claimed catheter for removing obstruction in
+ blood vessels would have been obvious in view of a first reference which taught all
+ of the claimed elements except for a "means for recovering fluid and debris" in
+ combination with a second reference describing a catheter including that means. The
+ court agreed that the first reference, which stressed simplicity of structure and
+ taught emulsification of the debris, did not teach away from the addition of a
+ channel for the recovery of the debris.). Similarly, in *Allied Erecting v.
+ Genesis Attachments,* 825 F.3d 1373, 1381, 119 USPQ2d 1132, 1138 (Fed.
+ Cir. 2016), the court stated "[a]lthough modification of the movable blades may
+ impede the quick change functionality disclosed by Caterpillar, ‘[a] given course of
+ action often has simultaneous advantages and disadvantages, and this does not
+ necessarily obviate motivation to combine’" (quoting *Medichem, S.A. v.
+ Rolabo, S.L.,* 437 F.3d 1157, 1165, 77 USPQ2d 1865, 1870 (Fed Cir. 2006)
+ (citation omitted)).
+ 
+
+**VI.** **THE PROPOSED MODIFICATION CANNOT CHANGE THE PRINCIPLE OF OPERATION OF A
+ REFERENCE**If the proposed modification or combination of the prior art would
+ change the principle of operation of the prior art invention being modified, then the
+ teachings of the references are not sufficient to render the claims *prima
+ facie* obvious. *In re Ratti,* 270 F.2d 810, 813, 123
+ USPQ 349, 352 (CCPA 1959) (Claims were directed to an oil seal comprising a bore
+ engaging portion with outwardly biased resilient spring fingers inserted in a
+ resilient sealing member. The primary reference relied upon in a rejection based on a
+ combination of references disclosed an oil seal wherein the bore engaging portion was
+ reinforced by a cylindrical sheet metal casing. The seal construction taught in the
+ primary reference required rigidity for operation, whereas the seal in the claimed
+ invention required resiliency. The court reversed the rejection holding the
+ "suggested combination of references would require a substantial reconstruction and
+ redesign of the elements shown in [the primary reference] as well as a change in the
+ basic principle under which the [primary reference] construction was designed to
+ operate.").
+ 
+
+
+
+
+# 2143.02 Reasonable Expectation of Success Is Required [R-10.2019]
+
+
+*[Editor Note: This MPEP section is **applicable** to applications
+ subject to the first inventor to file (FITF) provisions of the AIA except that the
+ relevant date is the "effective filing date" of the claimed invention instead of the
+ "time the invention was made," which is only applicable to applications subject to
+ **[pre-AIA 35
+ U.S.C. 102](mpep-9015-appx-l.html#d0e302383)**. See **[35 U.S.C. 100 (note)](mpep-9015-appx-l.html#al_d1d917_1bef1_2b)** and
+ **[MPEP
+ § 2150](s2150.html#ch2100_d2002f_22805_16e)** et seq.]*
+
+
+ A rationale to support a conclusion that a claim would have been
+ obvious is that all the claimed elements were known in the prior art and one skilled in
+ the art could have combined the elements as claimed by known methods with no change in
+ their respective functions, and the combination would have yielded nothing more than
+ predictable results to one of ordinary skill in the art.  *KSR Int'l Co. v.
+ Teleflex Inc.,* 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007);
+ *Sakraida v. AG Pro, Inc.,* 425 U.S. 273, 282, 189 USPQ 449, 453
+ (1976); *Anderson’s-Black Rock, Inc. v. Pavement Salvage Co.,* 396 U.S.
+ 57, 62-63, 163 USPQ 673, 675 (1969); *Great Atlantic & P. Tea Co. v.
+ Supermarket Equip. Corp.,* 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
+ 
+
+**I.** **OBVIOUSNESS REQUIRES A REASONABLE EXPECTATION OF SUCCESS** Where there is a reason to modify or combine the prior art to
+ achieve the claimed invention, the claims may be rejected as *prima
+ facie* obvious provided there is also a reasonable expectation of
+ success. *In re Merck & Co., Inc.,* 800 F.2d 1091, 231 USPQ 375
+ (Fed. Cir. 1986) (Claims directed to a method of treating depression with
+ amitriptyline (or nontoxic salts thereof) were rejected as *prima
+ facie* obvious over prior art disclosures that amitriptyline is a
+ compound known to possess psychotropic properties and that imipramine is a
+ structurally similar psychotropic compound known to possess antidepressive
+ properties, in view of prior art suggesting the aforementioned compounds would be
+ expected to have similar activity because the structural difference between the
+ compounds involves a known bioisosteric replacement and because a research paper
+ comparing the pharmacological properties of these two compounds suggested clinical
+ testing of amitriptyline as an antidepressant. The court sustained the rejection,
+ finding that the teachings of the prior art provide a sufficient basis for a
+ reasonable expectation of success.); *Ex parte Blanc,* 13 USPQ2d
+ 1383 (Bd. Pat. App. & Inter. 1989) (Claims were directed to a process of
+ sterilizing a polyolefinic composition with high-energy radiation in the presence
+ of a phenolic polyester antioxidant to inhibit discoloration or degradation of the
+ polyolefin. Appellant argued that it is unpredictable whether a particular
+ antioxidant will solve the problem of discoloration or degradation. However, the
+ Board found that because the prior art taught that appellant’s preferred antioxidant
+ is very efficient and provides better results compared with other prior art
+ antioxidants, there would have been a reasonable expectation of success.). 
+ 
+
+
+Conclusive proof of efficacy is not required to show
+ a reasonable expectation of success. *Acorda Therapeutics, Inc. v. Roxane
+ Lab., Inc.,* 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018)
+ ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for
+ obviousness." (citing to *Hoffmann-La Roche Inc. v. Apotex Inc.,*
+ 748 F.3d 1326, 1331 (Fed. Cir. 2014); *PharmaStem Therapeutics, Inc. v.
+ ViaCell, Inc.,* 491 F.3d 1342, 1364 (Fed. Cir. 2007); *Pfizer,
+ Inc. v. Apotex, Inc.,* 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007)
+ (reasoning that "the expectation of success need only be reasonable, not
+ absolute")).
+ 
+
+**II.** **AT LEAST SOME DEGREE OF PREDICTABILITY IS REQUIRED; APPLICANTS MAY PRESENT
+ EVIDENCE SHOWING THERE WAS NO REASONABLE EXPECTATION OF SUCCESS**Obviousness does not require absolute predictability, however, at
+ least some degree of predictability is required. Evidence showing there was no
+ reasonable expectation of success may support a conclusion of nonobviousness.
+ *In re Rinehart,* 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (Claims
+ directed to a method for the commercial scale production of polyesters in the
+ presence of a solvent at superatmospheric pressure were rejected as obvious over a
+ reference which taught the claimed method at atmospheric pressure in view of a
+ reference which taught the claimed process except for the presence of a solvent. The
+ court reversed, finding there was no reasonable expectation that a process combining
+ the prior art steps could be successfully scaled up in view of unchallenged evidence
+ showing that the prior art processes individually could not be commercially scaled up
+ successfully.). See also *Amgen, Inc. v. Chugai Pharm. Co.,* 927
+ F.2d 1200, 1207-08, 18 USPQ2d 1016, 1022-23 (Fed. Cir.), *cert.
+ denied,* 502 U.S. 856 (1991) (In the context of a biotechnology case,
+ testimony supported the conclusion that the references did not show that there was a
+ reasonable expectation of success.); *In re O’Farrell,* 853 F.2d
+ 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988) (The court held the claimed method
+ would have been obvious over the prior art relied upon because one reference
+ contained a detailed enabling methodology, a suggestion to modify the prior art to
+ produce the claimed invention, and evidence suggesting the modification would be
+ successful.).
+ 
+
+**III.** **PREDICTABILITY IS DETERMINED AT THE TIME THE INVENTION WAS MADE**Whether an art is predictable or whether the proposed modification
+ or combination of the prior art has a reasonable expectation of success is determined
+ at the time the invention was made. *Ex parte Erlich,* 3 USPQ2d
+ 1011, 1016 (Bd. Pat. App. & Inter. 1986) (Although an earlier case reversed a
+ rejection because of unpredictability in the field of monoclonal antibodies, the
+ court found "in this case at the time
+ this invention was made, one of ordinary skill in the art
+ would have been motivated to produce monoclonal antibodies specific for human
+ fibroplast interferon using the method of [the prior art] with a reasonable
+ expectation of success.") (emphasis in original).
+ 
+
+
+
+
+# 2143.03 All Claim Limitations Must Be Considered [R-10.2019]
+
+
+ "All words in a claim must be considered in judging the patentability
+ of that claim against the prior art." *In re Wilson,* 424 F.2d 1382,
+ 1385, 165 USPQ 494, 496 (CCPA 1970). 
+ 
+
+
+Examiners must consider all claim limitations when
+ determining patentability of an invention over the prior art. *In re
+ Gulack,* 703 F.2d 1381, 1385, 217 USPQ 401, 403-04 (Fed. Cir. 1983). The
+ subject matter of a properly construed claim is defined by the terms that limit the
+ scope of the claim when given their broadest reasonable interpretation. See
+ **[MPEP §
+ 2111](s2111.html#d0e200352)***et seq.* It is this subject matter that must be examined. The
+ determination of whether particular language is a limitation in a claim depends on the
+ specific facts of the case. See, e.g., *Griffin v. Bertina,* 285 F.3d
+ 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002).
+ 
+
+
+As a general matter, the grammar and ordinary meaning of
+ terms as understood by one having ordinary skill in the art used in a claim will dictate
+ whether, and to what extent, the language limits the claim scope. Language that suggests
+ or makes a feature or step optional but does not require that feature or step does not
+ limit the scope of a claim under the broadest reasonable claim interpretation. In
+ addition, when a claim requires selection of an element from a list of alternatives, the
+ prior art teaches the element if one of the alternatives is taught by the prior art.
+ See, e.g., *Fresenius USA, Inc. v. Baxter Int’l, Inc.,* 582 F.3d 1288,
+ 1298 (Fed. Cir. 2009). 
+ 
+
+
+The following types of claim language may raise a
+ question as to its limiting effect (this list is not exhaustive): 
+ 
+
+
+* • preamble (**[MPEP § 2111.02](s2111.html#d0e200689)**);
+* • clauses such as "adapted to," adapted for,"
+ "wherein," and "whereby" (**[MPEP § 2111.04](s2111.html#d0e201000)**, subsection I);
+* • contingent limitations (**[MPEP § 2111.04](s2111.html#d0e201000)**,
+ subsection II);
+* • printed matter (**[MPEP §
+ 2111.05](s2111.html#ch2100_d1b148_1ea0c_2c0)**); and
+* • functional language associated with a claim term
+ (**[MPEP §
+ 2181](s2181.html#d0e219279)**).
+
+
+If an independent claim is nonobvious under
+ **[35 U.S.C.
+ 103](mpep-9015-appx-l.html#d0e302450)**, then any claim depending therefrom is nonobvious. *In
+ re Fine,* 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988). However, this
+ conclusion of the *Fine* court may not apply if a claim is not properly
+ dependent. See **[MPEP §
+ 608.01(n)](s608.html#d0e45256)** for a discussion of dependent claims. 
+ 
+
+**I.** **INDEFINITE LIMITATIONS MUST BE CONSIDERED**A claim limitation which is considered indefinite cannot be
+ disregarded. If a claim is subject to more than one interpretation, at least one of
+ which would render the claim unpatentable over the prior art, the examiner should
+ reject the claim as indefinite under **[35 U.S.C. 112(b)](mpep-9015-appx-l.html#al_d1d85b_2ae65_215)** or
+ **[pre-AIA 35
+ U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, second paragraph (see **[MPEP §
+ 2175](s2175.html#ch2100_d2c184_13a97_15)**) and should reject the claim
+ over the prior art based on the interpretation of the claim that renders the prior
+ art applicable. *Ex parte Ionescu,* 222 USPQ 537 (Bd. Pat. App.
+ & Inter. 1984) (Claims on appeal were rejected on indefiniteness grounds only;
+ the rejection was reversed and the case remanded to the examiner for consideration of
+ pertinent prior art.). Making both rejections, when appropriate, avoids piecemeal
+ appellate review. See *Ionescu,* 222 USPQ at 540 n.9 (citing CCPA
+ and Federal Circuit cases.). See also *In re Wilson,* 424 F.2d 1382,
+ 165 USPQ 494 (CCPA 1970) (The Board erred because it ignored claim language that it
+ considered to be indefinite, and reached a conclusion that the claim would have been
+ obvious based only on the rest of the claim.). However, an examiner should not simply
+ speculate about the meaning of the claim language and then enter an obviousness
+ rejection in view of that speculative interpretation. *In re
+ Steele,* 305 F.2d 859,134 USPQ 292 (CCPA 1962) (The "considerable
+ speculation" by the examiner and the Board as to the scope of the claims did not
+ provide a proper basis for an obviousness rejection.). A claim should not be rejected
+ over prior art just because it is indefinite. *Ionescu,* 222 USPQ at
+ 540 (citing *Steele*). Although a claim that is indefinite because
+ it is susceptible to more than one interpretation may be rejected over prior art, an
+ examiner should not base a prior art rejection on a claim interpretation that is not
+ reasonable; see **[MPEP §
+ 2111](s2111.html#d0e200352)** regarding proper claim interpretation. 
+ 
+
+**II.** **LIMITATIONS WHICH DO NOT FIND SUPPORT IN THE ORIGINAL SPECIFICATION MUST BE
+ CONSIDERED**When evaluating claims for obviousness under **[35 U.S.C. 103](mpep-9015-appx-l.html#d0e302450)**,
+ all the limitations of the claims must be considered and given weight, including
+ limitations which do not find support in the specification as originally filed (i.e.,
+ new matter). *Ex parte Grasselli,* 231 USPQ 393 (Bd. App. 1983)
+ *aff’d mem.* 738 F.2d 453 (Fed. Cir. 1984) (Claim to a catalyst
+ expressly excluded the presence of sulfur, halogen, uranium, and a combination of
+ vanadium and phosphorous. Although the negative limitations excluding these elements
+ did not appear in the specification as filed, it was error to disregard these
+ limitations when determining whether the claimed invention would have been obvious in
+ view of the prior art.).
+ 
+
+
+
+[[top]](#top)
+
+
+, 
+# 2143.01 Suggestion or Motivation To Modify the References [R-10.2019]
+
+
+Obviousness can be established by combining or modifying the teachings
+ of the prior art to produce the claimed invention where there is some teaching,
+ suggestion, or motivation to do so. *In re Kahn,* 441 F.3d 977, 986, 78
+ USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
+ motivation-suggestion-teaching test as a guard against using hindsight in an obviousness
+ analysis). A "motivation to combine may be found explicitly or implicitly in market
+ forces; design incentives; the ‘interrelated teachings of multiple patents’; ‘any need
+ or problem known in the field of endeavor at the time of invention and addressed by the
+ patent’; and the background knowledge, creativity, and common sense of the person of
+ ordinary skill." *Zup v. Nash Mfg.,* 896 F.3d 1365, 1371, 127 USPQ2d
+ 1423, 1427 (Fed. Cir. 2018) (quoting *Plantronics, Inc. v. Aliph,
+ Inc.,* 724 F.3d 1343, 1354 [107 USPQ2d 1706] (Fed. Cir. 2013)
+ (*citing**Perfect Web Techs., Inc. v. InfoUSA, Inc.,* 587 F.3d 1324, 1328 [92
+ USPQ2d 1849] (Fed. Cir. 2009) (*quoting* *KSR,* 550
+ U.S. at 418-21)) . See **[MPEP § 2143](s2143.html#d0e209516)** regarding the need to provide a reasoned
+ explanation even in situations involving common sense or ordinary ingenuity. See also
+ **[MPEP §
+ 2144.05](s2144.html#d0e211255)**, subsection II, B.
+ 
+
+**I.** **PRIOR ART SUGGESTION OF THE CLAIMED INVENTION NOT NECESSARILY NEGATED BY
+ DESIRABLE ALTERNATIVES**The disclosure of desirable alternatives does not necessarily negate
+ a suggestion for modifying the prior art to arrive at the claimed invention. In
+ *In re Fulton,* 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. 2004),
+ the claims of a utility patent application were directed to a shoe sole with
+ increased traction having hexagonal projections in a "facing orientation." 391 F.3d
+ at 1196-97, 73 USPQ2d at 1142. The Board combined a design patent having hexagonal
+ projections in a facing orientation with a utility patent having other limitations of
+ the independent claim. 391 F.3d at 1199, 73 USPQ2d at 1144. Applicant argued that the
+ combination was improper because (1) the prior art did not suggest having the
+ hexagonal projections in a facing (as opposed to a "pointing") orientation was the
+ "most desirable" configuration for the projections, and (2) the prior art "taught
+ away" by showing desirability of the "pointing orientation." 391 F.3d at 1200-01, 73
+ USPQ2d at 1145-46. The court stated that "the prior art’s mere disclosure of more
+ than one alternative does not constitute a teaching away from any of these
+ alternatives because such disclosure does not criticize, discredit, or otherwise
+ discourage the solution claimed…." *Id.* In affirming the Board’s
+ obviousness rejection, the court held that the prior art as a whole suggested the
+ desirability of the combination of shoe sole limitations claimed, thus providing a
+ motivation to combine, which need not be supported by a finding that the prior art
+ suggested that the combination claimed by the applicant was the preferred, or most
+ desirable combination over the other alternatives. *Id.* See also
+ *In re Urbanski,* 809 F.3d 1237, 1244, 117 USPQ2d 1499, 1504
+ (Fed. Cir. 2016). 
+ 
+
+
+In *Ruiz v. A.B. Chance Co.,* 357 F.3d 1270,
+ 69 USPQ2d 1686 (Fed. Cir. 2004), the patent claimed underpinning a slumping building
+ foundation using a screw anchor attached to the foundation by a metal bracket. One
+ prior art reference taught a screw anchor with a concrete bracket, and a second prior
+ art reference disclosed a pier anchor with a metal bracket. The court found
+ motivation to combine the references to arrive at the claimed invention in the
+ "nature of the problem to be solved" because each reference was directed "to
+ precisely the same problem of underpinning slumping foundations."
+ *Id.* at 1276, 69 USPQ2d at 1690. The court also
+ *rejected* the notion that "an express written motivation to
+ combine must appear in prior art references…." *Id.* at 1276, 69
+ USPQ2d at 1690.
+ 
+
+**II.** **WHERE THE TEACHINGS OF THE PRIOR ART CONFLICT, THE EXAMINER MUST WEIGH THE
+ SUGGESTIVE POWER OF EACH REFERENCE**The test for obviousness is what the combined teachings of the
+ references would have suggested to one of ordinary skill in the art, and all
+ teachings in the prior art must be considered to the extent that they are in
+ analogous arts. Where the teachings of two or more prior art references conflict, the
+ examiner must weigh the power of each reference to suggest solutions to one of
+ ordinary skill in the art, considering the degree to which one reference might
+ accurately discredit another. *In re Young,* 927 F.2d 588, 18 USPQ2d
+ 1089 (Fed. Cir. 1991) (Prior art patent to Carlisle disclosed controlling and
+ minimizing bubble oscillation for chemical explosives used in marine seismic
+ exploration by spacing seismic sources close enough to allow the bubbles to intersect
+ before reaching their maximum radius so the secondary pressure pulse was reduced. An
+ article published several years later by Knudsen opined that the Carlisle technique
+ does not yield appreciable improvement in bubble oscillation suppression. However,
+ the article did not test the Carlisle technique under comparable conditions because
+ Knudsen did not use Carlisle’s spacing or seismic source. Furthermore, where the
+ Knudsen model most closely approximated the patent technique there was a 30%
+ reduction of the secondary pressure pulse. On these facts, the court found that the
+ Knudsen article would not have deterred one of ordinary skill in the art from using
+ the Carlisle patent teachings.).
+ 
+
+**III.** **FACT THAT REFERENCES CAN BE COMBINED OR MODIFIED MAY NOT BE SUFFICIENT TO
+ ESTABLISH *PRIMA FACIE* OBVIOUSNESS**The mere fact that references can be combined
+ or modified does not render the resultant combination obvious unless the results
+ would have been predictable to one of ordinary skill in the art. *KSR Int'l
+ Co. v. Teleflex Inc.,* 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)
+ ("If a person of ordinary skill can implement a predictable variation,
+ **[§
+ 103](mpep-9015-appx-l.html#al_d1fbe1_19797_b0)** likely bars its patentability. For the same reason, if a
+ technique has been used to improve one device, and a person of ordinary skill in the
+ art would recognize that it would improve similar devices in the same way, using the
+ technique is obvious unless its actual application is beyond his or her skill.").
+ 
+
+**IV.** **MERE STATEMENT THAT THE CLAIMED INVENTION IS WITHIN THE CAPABILITIES OF ONE OF
+ ORDINARY SKILL IN THE ART IS NOT SUFFICIENT BY ITSELF TO ESTABLISH *PRIMA
+ FACIE* OBVIOUSNESS**A statement that modifications of the prior art to meet the claimed
+ invention would have been "‘well within the ordinary skill of the
+ art at the time the claimed invention was made’" because the
+ references relied upon teach that all aspects of the claimed invention were
+ individually known in the art is not sufficient to establish a *prima
+ facie* case of obviousness without some objective reason to combine the
+ teachings of the references. *Ex parte Levengood,* 28 USPQ2d 1300
+ (Bd. Pat. App. & Inter. 1993). ‘‘‘[R]ejections on obviousness cannot be sustained
+ by mere conclusory statements; instead, there must be some articulated reasoning with
+ some rational underpinning to support the legal conclusion of obviousness.’"
+ *KSR,* 550 U.S. at 418, 82 USPQ2d at 1396 (quoting *In re
+ Kahn,* 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)).
+ 
+
+**V.** **THE PROPOSED MODIFICATION CANNOT RENDER THE PRIOR ART UNSATISFACTORY FOR ITS
+ INTENDED PURPOSE**If a proposed modification would render the prior art invention
+ being modified unsatisfactory for its intended purpose, then there is no suggestion
+ or motivation to make the proposed modification. *In re Gordon,* 733
+ F.2d 900, 221 USPQ 1125 (Fed. Cir. 1984) (Claimed device was a blood filter assembly
+ for use during medical procedures wherein both the inlet and outlet for the blood
+ were located at the bottom end of the filter assembly, and wherein a gas vent was
+ present at the top of the filter assembly. The prior art reference taught a liquid
+ strainer for removing dirt and water from gasoline and other light oils wherein the
+ inlet and outlet were at the top of the device, and wherein a pet-cock (stopcock) was
+ located at the bottom of the device for periodically removing the collected dirt and
+ water. The reference further taught that the separation is assisted by gravity. The
+ Board concluded the claims were *prima facie* obvious, reasoning
+ that it would have been obvious to turn the reference device upside down. The court
+ reversed, finding that if the prior art device were turned upside down it would be
+ inoperable for its intended purpose because the gasoline to be filtered would be
+ trapped at the top, the water and heavier oils sought to be separated would flow out
+ of the outlet instead of the purified gasoline, and the screen would become
+ clogged.). But see *In re Urbanski,* 809 F.3d 1237, 1244, 117 USPQ2d
+ 1499, 1504 (Fed. Cir. 2016) (The patent claims were directed to a method of enzymatic
+ hydrolysis of soy fiber to reduce water holding capacity, requiring reacting the soy
+ fiber and enzyme in water for about 60-120 minutes. The claims were rejected over two
+ prior art references, wherein the primary reference taught using a longer reaction
+ time of 5 to 72 hours and the secondary taught using a reaction time of 100 to 240
+ minutes, preferably 120 minutes. The applicant argued that modifying the primary
+ reference in the manner suggested by the secondary reference would forego the
+ benefits taught by the primary reference, thereby teaching away from the combination.
+ The court held that both prior art references "suggest[ed] that hydrolysis time may
+ be adjusted to achieve *different* fiber properties. Nothing in the
+ prior art teaches that the proposed modification would have resulted in an
+ ‘inoperable’ process or a dietary fiber product with undesirable properties."
+ (emphasis in original). 
+ 
+
+
+"Although statements limiting the function or capability of a prior
+ art device require fair consideration, simplicity of the prior art is rarely a
+ characteristic that weighs against obviousness of a more complicated device with
+ added function." *In re Dance,* 160 F.3d 1339, 1344, 48 USPQ2d 1635,
+ 1638 (Fed. Cir. 1998) (Court held that claimed catheter for removing obstruction in
+ blood vessels would have been obvious in view of a first reference which taught all
+ of the claimed elements except for a "means for recovering fluid and debris" in
+ combination with a second reference describing a catheter including that means. The
+ court agreed that the first reference, which stressed simplicity of structure and
+ taught emulsification of the debris, did not teach away from the addition of a
+ channel for the recovery of the debris.). Similarly, in *Allied Erecting v.
+ Genesis Attachments,* 825 F.3d 1373, 1381, 119 USPQ2d 1132, 1138 (Fed.
+ Cir. 2016), the court stated "[a]lthough modification of the movable blades may
+ impede the quick change functionality disclosed by Caterpillar, ‘[a] given course of
+ action often has simultaneous advantages and disadvantages, and this does not
+ necessarily obviate motivation to combine’" (quoting *Medichem, S.A. v.
+ Rolabo, S.L.,* 437 F.3d 1157, 1165, 77 USPQ2d 1865, 1870 (Fed Cir. 2006)
+ (citation omitted)).
+ 
+
+**VI.** **THE PROPOSED MODIFICATION CANNOT CHANGE THE PRINCIPLE OF OPERATION OF A
+ REFERENCE**If the proposed modification or combination of the prior art would
+ change the principle of operation of the prior art invention being modified, then the
+ teachings of the references are not sufficient to render the claims *prima
+ facie* obvious. *In re Ratti,* 270 F.2d 810, 813, 123
+ USPQ 349, 352 (CCPA 1959) (Claims were directed to an oil seal comprising a bore
+ engaging portion with outwardly biased resilient spring fingers inserted in a
+ resilient sealing member. The primary reference relied upon in a rejection based on a
+ combination of references disclosed an oil seal wherein the bore engaging portion was
+ reinforced by a cylindrical sheet metal casing. The seal construction taught in the
+ primary reference required rigidity for operation, whereas the seal in the claimed
+ invention required resiliency. The court reversed the rejection holding the
+ "suggested combination of references would require a substantial reconstruction and
+ redesign of the elements shown in [the primary reference] as well as a change in the
+ basic principle under which the [primary reference] construction was designed to
+ operate.").
+ 
+
+
+, 
+# 2143.02 Reasonable Expectation of Success Is Required [R-10.2019]
+
+
+*[Editor Note: This MPEP section is **applicable** to applications
+ subject to the first inventor to file (FITF) provisions of the AIA except that the
+ relevant date is the "effective filing date" of the claimed invention instead of the
+ "time the invention was made," which is only applicable to applications subject to
+ **[pre-AIA 35
+ U.S.C. 102](mpep-9015-appx-l.html#d0e302383)**. See **[35 U.S.C. 100 (note)](mpep-9015-appx-l.html#al_d1d917_1bef1_2b)** and
+ **[MPEP
+ § 2150](s2150.html#ch2100_d2002f_22805_16e)** et seq.]*
+
+
+ A rationale to support a conclusion that a claim would have been
+ obvious is that all the claimed elements were known in the prior art and one skilled in
+ the art could have combined the elements as claimed by known methods with no change in
+ their respective functions, and the combination would have yielded nothing more than
+ predictable results to one of ordinary skill in the art.  *KSR Int'l Co. v.
+ Teleflex Inc.,* 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007);
+ *Sakraida v. AG Pro, Inc.,* 425 U.S. 273, 282, 189 USPQ 449, 453
+ (1976); *Anderson’s-Black Rock, Inc. v. Pavement Salvage Co.,* 396 U.S.
+ 57, 62-63, 163 USPQ 673, 675 (1969); *Great Atlantic & P. Tea Co. v.
+ Supermarket Equip. Corp.,* 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
+ 
+
+**I.** **OBVIOUSNESS REQUIRES A REASONABLE EXPECTATION OF SUCCESS** Where there is a reason to modify or combine the prior art to
+ achieve the claimed invention, the claims may be rejected as *prima
+ facie* obvious provided there is also a reasonable expectation of
+ success. *In re Merck & Co., Inc.,* 800 F.2d 1091, 231 USPQ 375
+ (Fed. Cir. 1986) (Claims directed to a method of treating depression with
+ amitriptyline (or nontoxic salts thereof) were rejected as *prima
+ facie* obvious over prior art disclosures that amitriptyline is a
+ compound known to possess psychotropic properties and that imipramine is a
+ structurally similar psychotropic compound known to possess antidepressive
+ properties, in view of prior art suggesting the aforementioned compounds would be
+ expected to have similar activity because the structural difference between the
+ compounds involves a known bioisosteric replacement and because a research paper
+ comparing the pharmacological properties of these two compounds suggested clinical
+ testing of amitriptyline as an antidepressant. The court sustained the rejection,
+ finding that the teachings of the prior art provide a sufficient basis for a
+ reasonable expectation of success.); *Ex parte Blanc,* 13 USPQ2d
+ 1383 (Bd. Pat. App. & Inter. 1989) (Claims were directed to a process of
+ sterilizing a polyolefinic composition with high-energy radiation in the presence
+ of a phenolic polyester antioxidant to inhibit discoloration or degradation of the
+ polyolefin. Appellant argued that it is unpredictable whether a particular
+ antioxidant will solve the problem of discoloration or degradation. However, the
+ Board found that because the prior art taught that appellant’s preferred antioxidant
+ is very efficient and provides better results compared with other prior art
+ antioxidants, there would have been a reasonable expectation of success.). 
+ 
+
+
+Conclusive proof of efficacy is not required to show
+ a reasonable expectation of success. *Acorda Therapeutics, Inc. v. Roxane
+ Lab., Inc.,* 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018)
+ ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for
+ obviousness." (citing to *Hoffmann-La Roche Inc. v. Apotex Inc.,*
+ 748 F.3d 1326, 1331 (Fed. Cir. 2014); *PharmaStem Therapeutics, Inc. v.
+ ViaCell, Inc.,* 491 F.3d 1342, 1364 (Fed. Cir. 2007); *Pfizer,
+ Inc. v. Apotex, Inc.,* 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007)
+ (reasoning that "the expectation of success need only be reasonable, not
+ absolute")).
+ 
+
+**II.** **AT LEAST SOME DEGREE OF PREDICTABILITY IS REQUIRED; APPLICANTS MAY PRESENT
+ EVIDENCE SHOWING THERE WAS NO REASONABLE EXPECTATION OF SUCCESS**Obviousness does not require absolute predictability, however, at
+ least some degree of predictability is required. Evidence showing there was no
+ reasonable expectation of success may support a conclusion of nonobviousness.
+ *In re Rinehart,* 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (Claims
+ directed to a method for the commercial scale production of polyesters in the
+ presence of a solvent at superatmospheric pressure were rejected as obvious over a
+ reference which taught the claimed method at atmospheric pressure in view of a
+ reference which taught the claimed process except for the presence of a solvent. The
+ court reversed, finding there was no reasonable expectation that a process combining
+ the prior art steps could be successfully scaled up in view of unchallenged evidence
+ showing that the prior art processes individually could not be commercially scaled up
+ successfully.). See also *Amgen, Inc. v. Chugai Pharm. Co.,* 927
+ F.2d 1200, 1207-08, 18 USPQ2d 1016, 1022-23 (Fed. Cir.), *cert.
+ denied,* 502 U.S. 856 (1991) (In the context of a biotechnology case,
+ testimony supported the conclusion that the references did not show that there was a
+ reasonable expectation of success.); *In re O’Farrell,* 853 F.2d
+ 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988) (The court held the claimed method
+ would have been obvious over the prior art relied upon because one reference
+ contained a detailed enabling methodology, a suggestion to modify the prior art to
+ produce the claimed invention, and evidence suggesting the modification would be
+ successful.).
+ 
+
+**III.** **PREDICTABILITY IS DETERMINED AT THE TIME THE INVENTION WAS MADE**Whether an art is predictable or whether the proposed modification
+ or combination of the prior art has a reasonable expectation of success is determined
+ at the time the invention was made. *Ex parte Erlich,* 3 USPQ2d
+ 1011, 1016 (Bd. Pat. App. & Inter. 1986) (Although an earlier case reversed a
+ rejection because of unpredictability in the field of monoclonal antibodies, the
+ court found "in this case at the time
+ this invention was made, one of ordinary skill in the art
+ would have been motivated to produce monoclonal antibodies specific for human
+ fibroplast interferon using the method of [the prior art] with a reasonable
+ expectation of success.") (emphasis in original).
+ 
+
+
+, 
+# 2143.03 All Claim Limitations Must Be Considered [R-10.2019]
+
+
+ "All words in a claim must be considered in judging the patentability
+ of that claim against the prior art." *In re Wilson,* 424 F.2d 1382,
+ 1385, 165 USPQ 494, 496 (CCPA 1970). 
+ 
+
+
+Examiners must consider all claim limitations when
+ determining patentability of an invention over the prior art. *In re
+ Gulack,* 703 F.2d 1381, 1385, 217 USPQ 401, 403-04 (Fed. Cir. 1983). The
+ subject matter of a properly construed claim is defined by the terms that limit the
+ scope of the claim when given their broadest reasonable interpretation. See
+ **[MPEP §
+ 2111](s2111.html#d0e200352)***et seq.* It is this subject matter that must be examined. The
+ determination of whether particular language is a limitation in a claim depends on the
+ specific facts of the case. See, e.g., *Griffin v. Bertina,* 285 F.3d
+ 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002).
+ 
+
+
+As a general matter, the grammar and ordinary meaning of
+ terms as understood by one having ordinary skill in the art used in a claim will dictate
+ whether, and to what extent, the language limits the claim scope. Language that suggests
+ or makes a feature or step optional but does not require that feature or step does not
+ limit the scope of a claim under the broadest reasonable claim interpretation. In
+ addition, when a claim requires selection of an element from a list of alternatives, the
+ prior art teaches the element if one of the alternatives is taught by the prior art.
+ See, e.g., *Fresenius USA, Inc. v. Baxter Int’l, Inc.,* 582 F.3d 1288,
+ 1298 (Fed. Cir. 2009). 
+ 
+
+
+The following types of claim language may raise a
+ question as to its limiting effect (this list is not exhaustive): 
+ 
+
+
+* • preamble (**[MPEP § 2111.02](s2111.html#d0e200689)**);
+* • clauses such as "adapted to," adapted for,"
+ "wherein," and "whereby" (**[MPEP § 2111.04](s2111.html#d0e201000)**, subsection I);
+* • contingent limitations (**[MPEP § 2111.04](s2111.html#d0e201000)**,
+ subsection II);
+* • printed matter (**[MPEP §
+ 2111.05](s2111.html#ch2100_d1b148_1ea0c_2c0)**); and
+* • functional language associated with a claim term
+ (**[MPEP §
+ 2181](s2181.html#d0e219279)**).
+
+
+If an independent claim is nonobvious under
+ **[35 U.S.C.
+ 103](mpep-9015-appx-l.html#d0e302450)**, then any claim depending therefrom is nonobvious. *In
+ re Fine,* 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988). However, this
+ conclusion of the *Fine* court may not apply if a claim is not properly
+ dependent. See **[MPEP §
+ 608.01(n)](s608.html#d0e45256)** for a discussion of dependent claims. 
+ 
+
+**I.** **INDEFINITE LIMITATIONS MUST BE CONSIDERED**A claim limitation which is considered indefinite cannot be
+ disregarded. If a claim is subject to more than one interpretation, at least one of
+ which would render the claim unpatentable over the prior art, the examiner should
+ reject the claim as indefinite under **[35 U.S.C. 112(b)](mpep-9015-appx-l.html#al_d1d85b_2ae65_215)** or
+ **[pre-AIA 35
+ U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**, second paragraph (see **[MPEP §
+ 2175](s2175.html#ch2100_d2c184_13a97_15)**) and should reject the claim
+ over the prior art based on the interpretation of the claim that renders the prior
+ art applicable. *Ex parte Ionescu,* 222 USPQ 537 (Bd. Pat. App.
+ & Inter. 1984) (Claims on appeal were rejected on indefiniteness grounds only;
+ the rejection was reversed and the case remanded to the examiner for consideration of
+ pertinent prior art.). Making both rejections, when appropriate, avoids piecemeal
+ appellate review. See *Ionescu,* 222 USPQ at 540 n.9 (citing CCPA
+ and Federal Circuit cases.). See also *In re Wilson,* 424 F.2d 1382,
+ 165 USPQ 494 (CCPA 1970) (The Board erred because it ignored claim language that it
+ considered to be indefinite, and reached a conclusion that the claim would have been
+ obvious based only on the rest of the claim.). However, an examiner should not simply
+ speculate about the meaning of the claim language and then enter an obviousness
+ rejection in view of that speculative interpretation. *In re
+ Steele,* 305 F.2d 859,134 USPQ 292 (CCPA 1962) (The "considerable
+ speculation" by the examiner and the Board as to the scope of the claims did not
+ provide a proper basis for an obviousness rejection.). A claim should not be rejected
+ over prior art just because it is indefinite. *Ionescu,* 222 USPQ at
+ 540 (citing *Steele*). Although a claim that is indefinite because
+ it is susceptible to more than one interpretation may be rejected over prior art, an
+ examiner should not base a prior art rejection on a claim interpretation that is not
+ reasonable; see **[MPEP §
+ 2111](s2111.html#d0e200352)** regarding proper claim interpretation. 
+ 
+
+**II.** **LIMITATIONS WHICH DO NOT FIND SUPPORT IN THE ORIGINAL SPECIFICATION MUST BE
+ CONSIDERED**When evaluating claims for obviousness under **[35 U.S.C. 103](mpep-9015-appx-l.html#d0e302450)**,
+ all the limitations of the claims must be considered and given weight, including
+ limitations which do not find support in the specification as originally filed (i.e.,
+ new matter). *Ex parte Grasselli,* 231 USPQ 393 (Bd. App. 1983)
+ *aff’d mem.* 738 F.2d 453 (Fed. Cir. 1984) (Claim to a catalyst
+ expressly excluded the presence of sulfur, halogen, uranium, and a combination of
+ vanadium and phosphorous. Although the negative limitations excluding these elements
+ did not appear in the specification as filed, it was error to disregard these
+ limitations when determining whether the claimed invention would have been obvious in
+ view of the prior art.).
+ 
+
+
+]
\ No newline at end of file