MPEP § 2145 — MPEP § 2145
Current through: 2022-07-01

2145-Consideration of Applicant’s Rebuttal Arguments and Evidence 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2100 

 Section 2145 
 

 
 
 
 
 
 2145 Consideration of Applicant’s Rebuttal Arguments and
 Evidence [R-01.2024]
 

 [Editor Note: This MPEP section is applicable regardless of whether an application
 is examined under the AIA or under pre-AIA law. For applications subject to the first
 inventor to file (FITF) provisions of the AIA, the relevant time is "before the
 effective filing date of the claimed invention". For applications subject to
 pre-AIA 35 U.S.C.
 102 , the relevant time is "at the time of the invention". See
 MPEP §
 2150 et seq. Many of the court decisions discussed in this
 section involved applications or patents subject to pre-AIA 35 U.S.C. 102 . These court
 decisions may be applicable to applications and patents subject to AIA 35 U.S.C.
 102 but the relevant time is before the effective filing date of
 the claimed invention and not at the time of the invention.] 

 If a prima facie case of obviousness is established,
 the burden shifts to the applicant to come forward with arguments and/or evidence to rebut
 the prima facie case. See, e.g., In re Dillon, 919
 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc). 
 Applicant may also present rebuttal evidence and arguments prior to an Office action in
 anticipation of possible prior art rejections. Examiners should consider all evidence of
 obviousness and nonobviousness of record before making a determination under
 35 U.S.C.
 103 . 
 

 Rebuttal evidence and arguments can be presented in the
 specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed.
 Cir. 1995), by way of an affidavit or declaration under 37 CFR 1.132 , e.g.,
 Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re
 Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984), or
 otherwise presented during prosecution. See, e.g., MPEP §§ 714 to 716 et seq. However, arguments presented by applicant cannot take the place
 of factually supported objective evidence. See, e.g., In re Schulze, 346
 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d
 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
 

 Office personnel should consider all rebuttal arguments and evidence
 presented by applicants. See, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at
 1687 (error not to consider evidence presented in the specification). C.f., In re
 Kao, 639 F.3d 1057, 1067, 98 USPQ2d 1799, 1807 (Fed. Cir. 2011) (“[W]hen
 secondary considerations are present, though they are not always dispositive, it is error
 not to consider them.”); In re Alton, 76 F.3d 1168, 37 USPQ2d 1578 (Fed.
 Cir. 1996) (error not to consider factual evidence submitted to counter a 35 U.S.C. 112 
 rejection); In re Beattie, 974 F.2d 1309, 1313, 24 USPQ2d 1040, 1042-43
 (Fed. Cir. 1992) (Office personnel should consider declarations from those skilled in the
 art praising the claimed invention and opining that the art teaches away from the
 invention.); Piasecki, 745 F.2d at 1472, 223 USPQ at 788 (“[Rebuttal
 evidence] may relate to any of the Graham factors including the
 so-called secondary considerations.”). The Federal Circuit has “emphasized that
 consideration of the objective indicia is part of the whole obviousness analysis, not just
 an afterthought.” Leo Pharm. Prod., Ltd. v. Rea, 726 F.3d 1346, 1357,
 107 USPQ2d 1943, 1952 (Fed. Cir. 2013) (emphasis in original). Even though court decisions
 “have used the ‘prima facie’ and ‘rebuttal’ language [the decisions have] generally have
 made clear that a fact finder must consider all evidence of obviousness
 and nonobviousness before reaching a determination.” In re Cyclobenzaprine
 Hydrochloride Extended- Release Capsule Patent Litig., 676 F.3d 1063, 1077,
 102 USPQ2d 1760, 1772 (Fed. Cir. 2012) (emphasis in the original).
 

 Rebuttal evidence may include evidence of “secondary considerations,” such
 as “commercial success, long felt but unsolved needs, [and] failure of others.”
 Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 4459, 467. See also,
 e.g., In re Piasecki, 745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir.
 1984) (commercial success). Rebuttal evidence may also include evidence that the claimed
 invention yields unexpectedly improved properties or properties not present in the prior
 art. Rebuttal evidence may consist of a showing that the claimed compound possesses
 unexpected properties. Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1901. A
 showing of unexpected results must be based on evidence, not argument or speculation.
 In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed.
 Cir. 1997) (conclusory statements regarding unusually low immune response or unexpected
 biological activity that were unsupported by comparative data held insufficient to overcome
 prima facie case of obviousness). Rebuttal evidence may include
 evidence that the claimed invention was copied by others. See, e.g., In re
 GPAC, 57 F.3d 1573, 1580, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995);
 Hybritech Inc. v. Monoclonal Antibodies, 802 F.2d 1367, 1380, 231 USPQ 81, 90 (Fed.
 Cir. 1986). It may also include evidence of the state of the art, the level of skill in the
 art, and the beliefs of those skilled in the art. See, e.g., In re Oelrich,
 579 F.2d 86, 91-92, 198 USPQ 210, 214 (CCPA 1978) (Expert opinions regarding the
 level of skill in the art were probative of the nonobviousness of the claimed invention.);
 Piasecki, 745 F.2d at 1471, 1473-74, 223 USPQ at 790 (Evidence of
 nontechnological nature is pertinent to the conclusion of obviousness. The declarations of
 those skilled in the art regarding the need for the invention and its reception by the art
 were improperly discounted by the Board.); Beattie, 974 F.2d at 1313, 24
 USPQ2d at 1042-43 (Seven declarations provided by music teachers opining that the art
 teaches away from the claimed invention must be considered, but were not probative because
 they did not contain facts and did not deal with the specific prior art that was the
 subject of the rejection.). For example, rebuttal evidence may include a showing that the
 prior art fails to disclose or render obvious a method for making the compound, which would
 preclude a conclusion of obviousness of the compound. A conclusion of obviousness requires
 that the reference(s) relied upon, together with the knowledge of a person skilled in the
 art, be enabling in that it put the public in possession of the claimed invention.
 In re Hoeksema, 399 F.2d 269, 273, 158 USPQ 596, 600 (CCPA 1968)
 (citing In re Le Grice, 301 F.2d 929, 936, 133 USPQ 365, 372 (CCPA
 1962)). The Hoeksema, court stated: 
 

 
 Thus, upon careful reconsideration it is our view that if the prior
 art of record fails to disclose or render obvious a method for making a claimed
 compound, at the time the invention was made, it may not be legally concluded that the
 compound itself is in the possession of the public. [footnote omitted.] In this context,
 we say that the absence of a known or obvious process for making the claimed compounds
 overcomes a presumption that the compounds are obvious, based on close relationships
 between their structures and those of prior art compounds.
 

 
 See Hoeksema , 399 F.2d at 274, 158 USPQ at 601. The
 Hoeksema court further noted that once a prima
 facie case of obviousness is made by the USPTO through citation of references,
 the burden is on the applicant to produce contrary evidence. In
 Hoeksema , the contrary evidence was that the applied reference did not
 disclose or render obvious a process for producing the claimed compounds.
 Id. at 274-75, 158 USPQ at 601. See also Ashland Oil, Inc.
 v. Delta Resins & Refractories, Inc., 776 F.2d 281, 295, 297, 227 USPQ
 657, 666, 667 (Fed. Cir. 1985) (citing Hoeksema for the proposition
 above); In re Grose, 592 F.2d 1161, 1168, 201 USPQ 57, 63-64 (CCPA 1979)
 ("One of the assumptions underlying a prima facie obviousness rejection based upon a
 structural relationship between compounds, such as adjacent homologs, is that a method
 disclosed for producing one would provide those skilled in the art with a method for
 producing the other... Failure of the prior art to disclose or render obvious a method for
 making any composition of matter, whether a compound or a mixture of compounds like a
 zeolite, precludes a conclusion that the composition would have been obvious.").
 

 Consideration of rebuttal evidence and arguments requires Office personnel
 to weigh the proffered evidence and arguments. Id.; see also In
 re Alton, 76 F.3d 1168, 1174-75, 37 USPQ2d 1578, 1582-83 (Fed. Cir. 1996).
 Office personnel should avoid giving no weight to evidence submitted by applicant, except
 in rare circumstances. However, to be entitled to substantial weight, the applicant should
 establish a nexus between the rebuttal evidence and the claimed invention, i.e., objective
 evidence of nonobviousness must be attributable to the claimed invention. The Federal
 Circuit has acknowledged that applicant bears the burden of establishing nexus,
 stating:
 

 
 In the ex parte process of examining a patent
 application, however, the PTO lacks the means or resources to gather evidence which
 supports or refutes the applicant’s assertion that the sales constitute commercial
 success. C.f. Ex parte Remark, 15 USPQ2d 1498, 1503 ([BPAI] 1990)
 (evidentiary routine of shifting burdens in civil proceedings inappropriate in
 ex parte prosecution proceedings because examiner has no available
 means for adducing evidence). Consequently, the PTO must rely upon the applicant to
 provide hard evidence of commercial success.
 

 
 In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir.
 1996). See also GPAC, 57 F.3d at 1580, 35 USPQ2d at 1121; In re
 Paulsen, 30 F.3d 1475, 1482, 31 USPQ2d 1671, 1676 (Fed. Cir. 1994) (Evidence
 of commercial success of articles not covered by the claims subject to the
 35 U.S.C.
 103 rejection was not probative of nonobviousness.). Additionally,
 the evidence must be reasonably commensurate in scope with the claimed invention. See,
 e.g., In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed.
 Cir. 1990); In re Grasselli, 713 F.2d 731, 743, 218 USPQ 769, 777 (Fed.
 Cir. 1983). In re Soni, 54 F.3d 746, 34 USPQ2d 1684 (Fed. Cir. 1995)
 does not change this analysis. In Soni, the court declined to consider
 the Office’s argument that the evidence of nonobviousness was not commensurate in scope
 with the claim because it had not been raised by the examiner. Id. 54
 F.3d at 751, 34 USPQ2d at 1688. 
 

 In other words, in order for evidence of secondary
 considerations to be accorded substantial weight, there must be a nexus, i.e., a legally
 and factually sufficient connection or correspondence between the submitted evidence and
 the claimed invention. Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366,
 1373, 2019 USPQ2d 483355 (Fed. Cir. 2019), cert. denied, 141 S.Ct. 373 (2020). “A
 presumption of nexus requires both that the product embodies the invention and is
 coextensive with it.” Volvo Penta of the Americas, LLC v. Brunswick
 Corp., 81 F.4th 1202,1211-12, 2023 USPQ2d 1000 (Fed. Cir. 2023) (While Volvo
 Penta provided insufficient evidence to show a presumption of nexus, they did provide
 sufficient evidence to show nexus, independent of the presumption, through evidence of
 commercial success and copying due to the unique features of the claimed invention.). See
 MPEP §
 716.01(b) .
 

 When considering whether proffered evidence is commensurate in scope with
 the claimed invention, Office personnel should not require the applicant to show
 unexpected results over the entire range of properties possessed by a chemical compound or
 composition. See, e.g., In re Chupp, 816 F.2d 643, 646, 2 USPQ2d 1437,
 1439 (Fed. Cir. 1987). Evidence that the compound or composition possesses superior and
 unexpected properties in one of a spectrum of common properties can be sufficient to rebut
 a prima facie case of obviousness. Id. 

 For example, a showing of unexpected results for a single member of a
 claimed subgenus, or a narrow portion of a claimed range would be sufficient to rebut a
 prima facie case of obviousness if a skilled artisan “could ascertain
 a trend in the exemplified data that would allow him to reasonably extend the probative
 value thereof.” In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296
 (CCPA 1980) (Evidence of the nonobviousness of a broad range can be proven by a narrower
 range when one skilled in the art could ascertain a trend that would allow him to
 reasonably extend the probative value thereof.). But see, Grasselli, 713
 F.2d at 743, 218 USPQ at 778 (evidence of superior properties for sodium containing
 composition insufficient to establish the non-obviousness of broad claims for a catalyst
 with “an alkali metal” where it was well known in the catalyst art that different alkali
 metals were not interchangeable and applicant had shown unexpected results only for sodium
 containing materials); In re Greenfield, 571 F.2d 1185, 1189, 197 USPQ
 227, 230 (CCPA 1978) (evidence of superior properties in one species insufficient to
 establish the nonobviousness of a subgenus containing hundreds of compounds); In
 re Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972) (one test not
 sufficient where there was no adequate basis for concluding the other claimed compounds
 would behave the same way). However, an exemplary showing may be sufficient to establish a
 reasonable correlation between the showing and the entire scope of the claim, when viewed
 by a skilled artisan. See, e.g., Chupp, 816 F.2d at 646, 2 USPQ2d at
 1439; Clemens, 622 F.2d at 1036, 206 USPQ at 296. On the other hand,
 evidence of an unexpected property may not be sufficient regardless of the scope of the
 showing. Usually, a showing of unexpected results is sufficient to overcome a
 prima facie case of obviousness. See, e.g., In re
 Albrecht, 514 F.2d 1389, 1396, 185 USPQ 585, 590 (CCPA 1975). However, where
 the claims are not limited to a particular use, and where the prior art provides other
 motivation to select a particular species or subgenus, a showing of a new use alone may not
 be sufficient to confer patentability. See Dillon, 919 F.2d at 692, 16
 USPQ2d at 1900-01. Accordingly, each case should be evaluated individually based on the
 totality of the circumstances. 
 

 Evidence pertaining to secondary considerations must be taken into
 account whenever it has been properly presented; however, it does not necessarily control
 the obviousness conclusion. See, e.g., Pfizer, Inc. v. Apotex, Inc., 480
 F.3d 1348, 1372, 82 USPQ2d 1321, 1339 (Fed. Cir. 2007) (“the record establish[ed] such a
 strong case of obviousness” that allegedly unexpectedly superior results were ultimately
 insufficient to overcome obviousness conclusion); Leapfrog Enterprises Inc. v.
 Fisher-Price Inc., 485 F.3d 1157, 1162, 82 USPQ2d 1687, 1692 (Fed. Cir. 2007)
 (“given the strength of the prima facie obviousness showing, the
 evidence on secondary considerations was inadequate to overcome a final conclusion” of
 obviousness); and Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757,
 768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988). Office personnel should not evaluate rebuttal
 evidence for its “knockdown” value against the prima facie case,
 Piasecki, 745 F.2d at 1473, 223 USPQ at 788, or summarily dismiss it
 as not compelling or insufficient. Office personnel should weigh all relevant evidence of
 record in order to determine whether the claims would have been obvious based on a
 preponderance (more likely than not) standard, and then explain their conclusions. See
 MPEP §
 716 - § 716.10 for additional information
 pertaining to the evaluation of rebuttal evidence submitted under 37 CFR 1.132 .
 

 The following cases exemplify the continued application of
 the principle that when evidence has been presented to rebut an obviousness rejection, it
 should not be evaluated simply for its “knockdown” value. Rather, all evidence must be
 reweighed to determine whether the claims are nonobvious.
 

 Example 1: The claims at issue in PharmaStem Therapeutics,
 Inc. v. Viacell, Inc., 491 F.3d 1342, 83 USPQ2d 1289 (Fed. Cir. 2007), were
 directed to compositions comprising hematopoietic stem cells from umbilical cord or
 placental blood, and to methods of using such compositions for treatment of blood and
 immune system disorders. The composition claims required that the stem cells be present
 in an amount sufficient to effect hematopoietic reconstitution when administered to a
 human adult. The trial court had found that PharmaStem’s patents were infringed and not
 invalid on obviousness or other grounds. On appeal, the Federal Circuit reversed the
 district court, determining that the claims were invalid for obviousness. 
 

 The Federal Circuit discussed the evidence presented at
 trial. It pointed out that the patentee, PharmaStem, had not invented an entirely new
 procedure or new composition. Rather, PharmaStem’s own specification acknowledged that
 it was already known in the prior art that umbilical cord and placental blood-based
 compositions contained hematopoietic stem cells, and that hematopoietic stem cells were
 useful for the purpose of hematopoietic reconstitution. PharmaStem’s contribution was to
 provide experimental proof that umbilical cord and placental blood could be used to
 effect hematopoietic reconstitution in mice. By extrapolation, one of ordinary skill in
 the art would have expected this reconstitution method to work in humans as well. 
 

 The court rejected PharmaStem’s expert testimony that
 hematopoietic stem cells had not been proved to exist in cord blood prior to the
 experiments described in PharmaStem’s patents. The court explained that the expert
 testimony was contrary to the inventors’ admissions in the specification, as well as
 prior art teachings that disclosed stem cells in cord blood. In this case, PharmaStem’s
 evidence of nonobviousness was outweighed by contradictory evidence. 
 

 Despite PharmaStem’s useful experimental validation of
 hematopoietic reconstitution using hematopoietic stem cells from umbilical cord and
 placental blood, the Federal Circuit found that the claims at issue would have been
 obvious. There had been ample suggestion in the prior art that the claimed method would
 have worked. Absolute predictability is not a necessary prerequisite to a case of
 obviousness. Rather, a degree of predictability that one of ordinary skill would have
 found to be reasonable is sufficient. The Federal Circuit concluded that “[g]ood science
 and useful contributions do not necessarily result in patentability.”
 Id. at 1364, 83 USPQ2d at 1304.
 

 

 Example 2: It was found to be an error in In re
 Sullivan, 498 F.3d 1345, 84 USPQ2d 1034 (Fed. Cir. 2007), for the Board to
 fail to consider evidence submitted to rebut a prima facie case of
 obviousness. 
 

 The claimed invention was directed to an antivenom
 composition comprising F(ab) fragments used to treat venomous rattlesnake bites. The
 composition was created from antibody molecules that include three fragments, F(ab)2,
 F(ab) and F(c), which have separate properties and utilities. There had been
 commercially available antivenom products that consisted of whole antibodies and F(ab)2
 fragments, but researchers had not experimented with antivenoms containing only F(ab)
 fragments because it was believed that their unique properties would prevent them from
 decreasing the toxicity of snake venom. The inventor, Sullivan, discovered that F(ab)
 fragments are effective at neutralizing the lethality of rattlesnake venom, while
 reducing the occurrence of adverse immune reactions in humans. On appeal of the
 examiner’s rejection, the Board held that the claim was obvious because all the elements
 of the claimed composition were accounted for in the prior art, and that the composition
 taught by that prior art would have been expected by a person of ordinary skill in the
 art at the time the invention was made (the case was examined under pre-AIA 35 U.S.C.
 103 ) to neutralize the lethality of the venom of a rattlesnake. 
 

 Rebuttal evidence had not been considered by the Board
 because it considered the evidence to relate to the intended use of the claimed
 composition as an antivenom, rather than the composition itself. Appellant successfully
 argued that even if the Board had shown a prima facie case of
 obviousness, the extensive rebuttal evidence must be considered. The evidence included
 three expert declarations submitted to show that the prior art taught away from the
 claimed invention, an unexpected property or result from the use of F(ab) fragment
 antivenom, and why those having ordinary skill in the art expected antivenoms comprising
 F(ab) fragments to fail. The declarations related to more than the use of the claimed
 composition. While a statement of intended use may not render a known composition
 patentable, the claimed composition was not known, and whether it would have been
 obvious depends upon consideration of the rebuttal evidence. Appellant did not concede
 that the only distinguishing factor of its composition is the statement of intended use
 and extensively argued that its claimed composition exhibits the unexpected property of
 neutralizing the lethality of rattlesnake venom while reducing the occurrence of adverse
 immune reactions in humans. The Federal Circuit found that such a use and unexpected
 property cannot be ignored – the unexpected property is relevant and thus the
 declarations describing it should have been considered. 
 

 Nonobviousness can be shown when a person of ordinary
 skill in the art would not have reasonably predicted the claimed invention based on the
 prior art, and the resulting invention would not have been expected. All evidence must
 be considered when properly presented. 
 

 

 Example 3: The case of Hearing Components, Inc. v. Shure
 Inc., 600 F.3d 1357, 94 USPQ2d 1385 (Fed. Cir. 2010), involved a disposable
 protective covering for the portion of a hearing aid that is inserted into the ear
 canal. The covering was such that it could be readily replaced by a user as needed. 
 

 At the district court, Shure had argued that Hearing
 Components’ patents were obvious over one or more of three different combinations of
 prior art references. The jury disagreed, and determined that the claims were
 nonobvious. The district court upheld the jury verdict, stating that in view of the
 conflicting evidence presented by the parties as to the teachings of the references,
 motivation to combine, and secondary considerations, the nonobviousness verdict was
 sufficiently grounded in the evidence. 
 

 Shure appealed to the Federal Circuit, but the Federal
 Circuit agreed with the district court that the jury’s nonobviousness verdict had been
 supported by substantial evidence. Although Shure had argued before the jury that the
 Carlisle reference taught an ear piece positioned inside the ear canal, Hearing
 Components’ credible witness countered that only the molded duct and not the ear piece
 itself was taught by Carlisle as being inside the ear canal. On the issue of combining
 references, Shure’s witness had given testimony described as “rather sparse, and lacking
 in specific details.” Id. at 1364, 94 USPQ2d at 1397. In
 contradistinction, Hearing Components’ witness “described particular reasons why one
 skilled in the art would not have been motivated to combine the references.”
 Id. Finally, as to secondary considerations, the Federal Circuit
 determined that Hearing Components had shown a nexus between the commercial success of
 its product and the patent by providing evidence that “the licensing fee for a covered
 product was more than cut in half immediately upon expiration” of the patent. 
 

 Although the Hearing Components case
 involves substantial evidence of nonobviousness in a jury verdict, it is nevertheless
 instructive for Office personnel on the matter of weighing evidence. Office personnel
 routinely must consider evidence in the form of prior art references, statements in the
 specification, or declarations under 37 CFR 1.130 (for cases examined
 under the AIA
 35 U.S.C. 102 and 103 ), 37 CFR 1.131 
 (for cases examined under pre-AIA 35 U.S.C. 102 and
 103 ), or 1.132 (for cases examined either
 under the AIA or under pre-AIA law). Other forms of evidence may also be presented
 during prosecution. Office personnel are reminded that evidence that has been presented
 in a timely manner should not be ignored, but rather should be considered on the record.
 However, not all evidence need be accorded the same weight. In determining the relative
 weight to accord to rebuttal evidence, considerations such as whether a nexus exists
 between the claimed invention and the proffered evidence, and whether the evidence is
 commensurate in scope with the claimed invention, are appropriate. The mere presence of
 some credible rebuttal evidence does not dictate that an obviousness rejection must
 always be withdrawn. See MPEP § 2145 . Office personnel must consider the appropriate
 weight to be accorded to each piece of evidence. An obviousness rejection should be made
 or maintained only if evidence of obviousness outweighs evidence of nonobviousness. See
 MPEP §
 706 , subsection I. (“The standard to be applied in all cases
 is the ‘preponderance of the evidence’ test. In other words, an examiner should reject a
 claim if, in view of the prior art and evidence of record, it is more likely than not
 that the claim is unpatentable.”). MPEP § 716.01(d) provides further
 guidance on weighing evidence in making a determination of patentability. 
 

 

 Example 4: Yita LLC, v MacNeil IP LLC, 69 F.4th
 1356, 2023 USPQ2d 667 (Fed. Cir. 2023) involved consideration of Yita’s challenge to
 MacNeil’s patent in two inter partes reviews (IPRs). In
 IPR2020-01139, the Board found the patent claims nonobvious due to MacNeil’s “evidence
 of secondary considerations [which was] compelling and indicative of non-obviousness.”
 On appeal, the Federal Circuit reversed the Board’s final written decision.
 

 MacNeil’s patent claims were directed to a vehicle floor
 tray “closely conforming” to certain walls of the vehicle foot well, a feature that the
 Board recognized was disclosed in one of the asserted prior art references (Rabbe). The
 Board had found that MacNeil was entitled to a presumption of nexus because its marketed
 vehicle trays embodied the claimed invention and were coextensive with the claims. 
 

 On appeal, the Federal Circuit determined that the
 finding of nexus rested on two legal errors: (1) the finding that Rabbe’s disclosure
 needed to but did not establish that close conformance was well-known; and (2) the
 misapplication of WBIP, LLC v. Kohler Co., 829 F.3d 1317, 119 USPQ2d
 1301 (Fed. Cir. 2016), which did not speak to the present situation where the secondary
 consideration evidence is linked to an individual element of the claimed invention,
 specifically the close-conformity element taught by Rabbe.
 

 As to the first error, the court determined that their
 previous case law made clear that “objective evidence of nonobviousness lacks a nexus if
 it exclusively relates to a feature that was ‘known in the prior art’—not necessarily
 well-known.” Rambus Inc. v. Rea, 731 F.3d 1248, 1257, 108 USPQ2d 1400
 (Fed. Cir. 2013) (emphasis in the original) (quoting Ormco Corp. v. Align
 Technology, Inc., 463 F.3d 1299, 1312, 79 USPQ2d 1931 (Fed. Cir. 2006))
 (internal quotation marks omitted). Additionally, the court noted that the finding of
 coextensiveness is only relevant to the presumption of nexus and it alone does not
 decide the overall nexus question. 
 

 As to the second error, the court determined the
 secondary consideration evidence was related solely to the individual element of
 close-conformance disclosed in the prior art to Rabbe. This circumstance was different
 than the one present in WBIP in which no single feature (but only the
 combination) was responsible for the secondary consideration evidence. 
 

 The secondary consideration evidence was the only
 Graham factor that the Board deemed to weigh in favor of
 nonobviousness. Because the Board determined that an artisan of ordinary skill would
 have been motivated to combine the teachings of the prior art references to arrive at
 the claimed invention with a reasonable expectation of success, the court reversed the
 final written decision.
 

 MPEP § 716.01(b) provides further
 guidance on the nexus requirement and evidence of nonobviousness.
 

 See MPEP § 2155 regarding affidavits or
 declarations under 37
 CFR 1.130 to overcome prior art rejections. 
 

 See MPEP §§ 715 et seq. and
 2136.05(a) regarding affidavits or declarations under
 37 CFR
 1.131 to overcome prior art rejections. 
 

 See MPEP §§ 716 et seq. and
 2136.05(b) regarding affidavits or declarations under
 37 CFR
 1.132 to overcome prior art rejections. 
 

 
 I. ARGUMENT DOES NOT REPLACE EVIDENCE WHERE EVIDENCE IS NECESSARY An argument by the applicant is not evidence unless it is an admission,
 in which case, an examiner may use the admission in making a rejection. See
 MPEP §
 2129 and § 2144.03 for a discussion of
 admissions as prior art. 
 

 Arguments presented by applicant cannot take the place of evidence in
 the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196
 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965);
 In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An
 assertion of what seems to follow from common experience is just attorney argument and
 not the kind of factual evidence that is required to rebut a prima
 facie case of obviousness.”). See MPEP § 716.01(c) for examples of
 applicant statements which are not evidence and which must be supported by an
 appropriate affidavit or declaration.
 

 II. ARGUING ADDITIONAL ADVANTAGES OR LATENT PROPERTIES 
 

 Prima Facie Obviousness Is Not Rebutted by Merely Recognizing Additional
 Advantages or Latent Properties Present But Not Recognized in the Prior
 Art Mere recognition of latent properties in the prior art does not
 render nonobvious an otherwise known invention. In re Wiseman, 596
 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc
 brakes wherein the grooves were provided to vent steam or vapor during a braking
 action. A prior art reference taught noncarbon disc brakes which were grooved for the
 purpose of cooling the faces of the braking members and eliminating dust. The court
 held the prior art references when combined would overcome the problems of dust and
 overheating solved by the prior art and would inherently overcome the steam or vapor
 cause of the problem relied upon for patentability by applicants. Granting a patent
 on the discovery of an unknown but inherent function (here venting steam or vapor)
 “would remove from the public that which is in the public domain by virtue of its
 inclusion in, or obviousness from, the prior art.” 596 F.2d at 1022, 201 USPQ at
 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281
 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a
 blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any
 prima facie showing of obviousness. However, the closest prior
 art utilizing a DEHP plasticized blood collection bag inherently achieved same
 result, although this fact was unknown in the prior art.).
 

 “The fact that appellant has recognized another advantage which
 would flow naturally from following the suggestion of the prior art cannot be the
 basis for patentability when the differences would otherwise be obvious.” Ex
 parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The
 prior art taught combustion fluid analyzers which used labyrinth heaters to maintain
 the samples at a uniform temperature. Although appellant showed that an unexpectedly
 shorter response time was obtained when a labyrinth heater was employed, the Board
 held this advantage would flow naturally from following the suggestion of the prior
 art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077
 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished
 — not citable as precedent) (“The recitation of an additional advantage associated
 with doing what the prior art suggests does not lend patentability to an otherwise
 unpatentable invention.”).
 

 In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) and
 In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990)
 discussed in MPEP
 § 2144 are also pertinent to this issue.
 

 See MPEP § 716.02 - § 716.02(g) for a discussion of
 declaratory evidence alleging unexpected results.
 

 III. ARGUING THAT PRIOR ART DEVICES ARE NOT PHYSICALLY COMBINABLE “It is well-established that a determination of obviousness based on
 teachings from multiple references does not require an actual, physical substitution of
 elements.” In re Mouttet, 686 F.3d 1322, 1332, 103 USPQ2d 1219, 1226
 (Fed. Cir. 2012) (citing In re Etter, 756 F.2d 852, 859, 225 USPQ 1,
 6 (Fed. Cir. 1985) ( en banc )) (“Etter's assertions that Azure cannot
 be incorporated in Ambrosio are basically irrelevant, the criterion being not whether
 the references could be physically combined but whether the claimed inventions are
 rendered obvious by the teachings of the prior art as a whole.”). See also In
 re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981) (“The test for
 obviousness is not whether the features of a secondary reference may be bodily
 incorporated into the structure of the primary reference.... Rather, the test is what
 the combined teachings of those references would have suggested to those of ordinary
 skill in the art.”); In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385,
 389 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the references be
 physically combinable to render obvious the invention under review.”); and In
 re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) (“Combining the
 teachings of references does not involve an ability to combine
 their specific structures.”).
 

 However, the claimed combination cannot change the principle of
 operation of the primary reference or render the reference inoperable for its intended
 purpose. See MPEP
 § 2143.01 , subsection VI. 
 

 IV. ARGUING AGAINST REFERENCES INDIVIDUALLY One cannot show nonobviousness by attacking references individually where the
 rejections are based on combinations of references . In re
 Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck &
 Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection
 of a claim is based on two or more references, a reply that is limited to what a subset
 of the applied references teaches or fails to teach, or that fails to address the
 combined teaching of the applied references may be considered to be an argument that
 attacks the reference(s) individually. Where an applicant’s reply establishes that each
 of the applied references fails to teach a limitation and addresses the combined
 teachings and/or suggestions of the applied prior art, the reply as a whole does not
 attack the references individually as the phrase is used in Keller 
 and reliance on Keller would not be appropriate. This is because
 “[T]he test for obviousness is what the combined teachings of the references would have
 suggested to [a PHOSITA].” In re Mouttet, 686 F.3d 1322, 1333, 103
 USPQ2d 1219, 1226 (Fed. Cir. 2012).
 

 V. ARGUING ABOUT THE NUMBER OF REFERENCES COMBINED Reliance on a large number of references in a rejection does not,
 without more, weigh against the obviousness of the claimed invention. In re
 Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991) (Court affirmed a
 rejection of a detailed claim to a candy sucker shaped like a thumb on a stick based on
 thirteen prior art references.).
 

 VI. ARGUING LIMITATIONS WHICH ARE NOT CLAIMED Although the claims are interpreted in light of the specification,
 limitations from the specification are not read into the claims. In re Van
 Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (Claims to a
 superconducting magnet which generates a “uniform magnetic field” were not limited to
 the degree of magnetic field uniformity required for Nuclear Magnetic Resonance (NMR)
 imaging. Although the specification disclosed that the claimed magnet may be used in an
 NMR apparatus, the claims were not so limited.); Constant v. Advanced
 Micro-Devices, Inc., 848 F.2d 1560, 1571-72, 7 USPQ2d 1057, 1064-1065 (Fed.
 Cir.), cert. denied, 488 U.S. 892 (1988) (Various limitations on
 which appellant relied were not stated in the claims; the specification did not provide
 evidence indicating these limitations must be read into the claims to give meaning to
 the disputed terms.); Ex parte McCullough, 7 USPQ2d 1889, 1891 (Bd.
 Pat. App. & Inter. 1987) (Claimed electrode was rejected as obvious despite
 assertions that electrode functions differently than would be expected when used in
 nonaqueous battery since “although the demonstrated results may be germane to the
 patentability of a battery containing appellant’s electrode, they are not germane to the
 patentability of the invention claimed on appeal.”).
 

 See MPEP
 § 2111 - § 2116.01 , for additional case law
 relevant to claim interpretation.
 

 VII. ARGUING ECONOMIC INFEASIBILITY The fact that a "combination would not be made by businessmen for
 economic reasons" does not mean that a person of ordinary skill in the art would not
 make the combination because of some technological incompatibility. In re
 Farrenkopf, 713 F.2d 714, 718, 219 USPQ 1, 4 (Fed. Cir. 1983) (Prior art
 reference taught that addition of inhibitors to radioimmunoassay is the most convenient,
 but costliest solution to stability problem. The court held that the additional expense
 associated with the addition of inhibitors would not discourage one of ordinary skill in
 the art from seeking the convenience expected therefrom.).
 

 VIII. ARGUING ABOUT THE AGE OF REFERENCES “The mere age of the references is not persuasive of the unobviousness
 of the combination of their teachings, absent evidence that, notwithstanding knowledge
 of the references, the art tried and failed to solve the problem.” In re
 Wright, 569 F.2d 1124, 1127, 193 USPQ 332, 335 (CCPA 1977) (100 year old
 patent was properly relied upon in a rejection based on a combination of references.).
 See also Ex parte Meyer, 6 USPQ2d 1966 (Bd. Pat. App. & Inter.
 1988) (length of time between the issuance of prior art patents relied upon (1920 and
 1976) was not persuasive of nonobviousness).
 

 IX. ARGUING THAT PRIOR ART IS NONANALOGOUS See MPEP
 § 2141.01(a) for case law pertaining to analogous art.
 

 X. ARGUING IMPROPER RATIONALES FOR COMBINING REFERENCES 
 

 A. Impermissible Hindsight Applicants may argue that the examiner’s conclusion of obviousness
 is based on improper hindsight reasoning. However, “[a]ny judgment on obviousness is
 in a sense necessarily a reconstruction based on hindsight reasoning, but so long as
 it takes into account only knowledge which was within the level of ordinary skill in
 the art at the time the claimed invention was made and does not include knowledge
 gleaned only from applicant’s disclosure, such a reconstruction is proper.”
 In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA
 1971). “A factfinder should be aware, of course, of the distortion caused by
 hindsight bias and must be cautious of arguments reliant upon ex post reasoning. . .
 . Rigid preventative rules that deny factfinders recourse to common sense, however,
 are neither necessary under our case law nor consistent with it.” KSR Int'l
 Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007)
 (internal quotations omitted). Applicants may also argue that the combination of two
 or more references is “hindsight” because “express” motivation to combine the
 references is lacking. However, there is no requirement that an “express, written
 motivation to combine must appear in prior art references before a finding of
 obviousness.” Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69
 USPQ2d 1686, 1690 (Fed. Cir. 2004). See KSR, 550 U.S. at 402, 82
 USPQ2d at 1389 (“The diversity of inventive pursuits and of modern technology
 counsels against confining the obviousness analysis by a formalistic conception of
 the words teaching, suggestion, and motivation, or by overemphasizing the importance
 of published articles and the explicit content of issued patents.”) See also
 Uber Techs., Inc. v. X One, Inc., 957 F.3d 1334, 1339-40, 2020
 USPQ2d 10476 (Fed. Cir. 2020) (“[W]e hold that the Board erred when it determined
 that a person of ordinary skill in the art would not have been motivated to combine
 the teachings of Okubo with Konishi's server-side plotting to render obvious the
 limitation ‘software ... to transmit the map with plotted locations to the first
 individual.’ This combination does not represent ‘impermissible hindsight’…. Rather,
 because Okubo's terminal-side plotting and Konishi's server-side plotting were both
 well known in the art, and were the only two identified, predictable solutions for
 transmitting a map and plotting locations, it would have been obvious to substitute
 server-side plotting for terminal-side plotting in a combination of Okubo and
 Konishi.”). 
 

 See MPEP § 2141 and
 §
 2143 for guidance regarding establishment of a
 prima facie case of obviousness.
 

 B. Obvious To Try Rationale An applicant may argue the examiner is applying an improper “obvious
 to try” rationale in support of an obviousness rejection. 
 

 An “obvious to try” rationale may support a conclusion that a claim
 would have been obvious where one skilled in the art is choosing from a finite number
 of identified, predictable solutions, with a reasonable expectation of success. “ [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 .” KSR Int'l Co. v. Teleflex Inc., 550
 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007).
 

 “The admonition that ‘obvious to try’ is not the standard under
 §
 103 has been directed mainly at two kinds of error. In some
 cases, 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.... In others, 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.” In re O’Farrell, 853 F.2d 894,
 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988) (citations omitted) (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.). 
 

 C. Lack of Suggestion To Combine References A teaching, suggestion, or motivation to combine references that is
 found in the prior art is an appropriate rationale for determining obviousness.
 KSR, 550 U.S. at 418, 82 USPQ2d at 1396. However, it is just
 one of a number of valid rationales for doing so. The Court in KSR 
 identified several exemplary 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. KSR, 550 U.S. at 415-21, 82 USPQ2d at 1395-97. See
 MPEP §
 2141 and § 2143 .
 

 D. References Teach Away from the Invention or Render Prior Art
 Unsatisfactory for Intended Purpose In addition to the material below, see MPEP § 2141.02 
 (prior art must be considered in its entirety, including disclosures that teach away
 from the claims) and MPEP § 2143.01 , subsection VI (proposed modification
 cannot render the prior art unsatisfactory for its intended purpose or change the
 principle of operation of a reference).
 

 1. The Nature of the Teaching Is Highly
 Relevant A prior art reference that “teaches away” from the claimed
 invention is a significant factor to be considered in determining obviousness.
 However, “the nature of the teaching is highly relevant and must be weighed in
 substance. A known or obvious composition does not become patentable simply
 because it has been described as somewhat inferior to some other product for the
 same use.” In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)
 (Claims were directed to an epoxy resin based printed circuit material. A prior
 art reference disclosed a polyester-imide resin based printed circuit material,
 and taught that although epoxy resin based materials have acceptable stability and
 some degree of flexibility, they are inferior to polyester-imide resin based
 materials. The court held the claims would have been obvious over the prior art
 because the reference taught epoxy resin based material was useful for the
 inventor’s purpose, applicant did not distinguish the claimed epoxy from the prior
 art epoxy, and applicant asserted no discovery beyond what was known to the
 art.).
 

 Furthermore, “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….” In re Fulton, 391 F.3d 1195, 1201, 73
 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs,
 UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) (“a
 reference does not teach away if it merely expresses a general preference for an
 alternative invention but does not criticize, discredit or otherwise discourage
 investigation into the invention claimed.”) (internal quotations omitted) (quoting
 DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d
 1314, 1327 (Fed. Cir. 2009)); and Schwendimann v. Neenah, Inc., 
 82 F.4th 1371, 1381, 2023 USPQ2d 1173 (Fed. Cir. 2023) (“Although Oez [the prior
 art] used a white pigment with a cross-linking polymer, it does not discourage a
 skilled artisan from using the white pigment without a cross-linking polymer or
 lead the skilled artisan in a direction divergent from the path taken in the
 Appealed Patents. Thus, Oez's disclosure is substantial evidence that supports the
 Board's finding that Oez does not teach away from the proposed combination.”).
 

 2. References Cannot Be Combined Where Reference Teaches Away from Their
 Combination It is improper to combine references where the references teach
 away from their combination. In re Grasselli, 713 F.2d 731,
 743, 218 USPQ 769, 779 (Fed. Cir. 1983) (The claimed catalyst which contained both
 iron and an alkali metal was not suggested by the combination of a reference which
 taught the interchangeability of antimony and alkali metal with the same
 beneficial result, combined with a reference expressly excluding antimony from,
 and adding iron to, a catalyst.). 
 

 3. Proceeding Contrary to Accepted Wisdom Is Evidence of Nonobviousness The totality of the prior art must be considered, and proceeding
 contrary to accepted wisdom in the art is evidence of nonobviousness. In
 re Hedges, 783 F.2d 1038, 228 USPQ 685 (Fed. Cir. 1986) (Applicant’s
 claimed process for sulfonating diphenyl sulfone at a temperature above 127ºC was
 contrary to accepted wisdom because the prior art as a whole suggested using lower
 temperatures for optimum results as evidenced by charring, decomposition, or
 reduced yields at higher temperatures.).
 

 Furthermore, “[k]nown disadvantages in old devices which would
 naturally discourage search for new inventions may be taken into account in
 determining obviousness.” United States v. Adams, 383 U.S. 39,
 52, 148 USPQ 479, 484 (1966).
 

 E. Applicability of KSR to All Technologies At the time the KSR decision was
 handed down, some observers questioned whether the principles discussed were intended
 by the Supreme Court to apply to all fields of inventive endeavor. Arguments were
 made that because the technology at issue in KSR involved the
 relatively well-developed and predictable field of vehicle pedal assemblies, the
 decision was relevant only to such fields. The Federal Circuit has soundly repudiated
 such a notion, stating that KSR applies across technologies:
 

 
 This court also declines to cabin KSR to the
 “predictable arts” (as opposed to the “unpredictable art” of biotechnology). In
 fact, this record shows that one of skill in this advanced art would find these
 claimed “results” profoundly “predictable.” 
 

 
 In re Kubin, 561 F.3d 1351, 1360, 90 USPQ2d 1417, 1424 (Fed. Cir.
 2009). Thus, Office personnel should not withdraw any rejection solely on the basis
 that the invention lies in a technological area ordinarily considered to be
 unpredictable. See also MPEP § 2143.02 .
 

 XI. FORM PARAGRAPHS See MPEP
 § 707.07(f) for form paragraphs 7.37 through 7.38 which may be used where applicant’s
 arguments are not persuasive or are moot.
 

 [top] 

 

 

 
 

 
 

 

 

 

 
 
 
 2101-2102-[Reserved] 

 2103-Patent Examination Process 

 2104-Requirements of 35 U.S.C. 101 
 2104.01-Barred by Atomic Energy Act 

 
 

 2105-Patent Eligible Subject Matter — Living Subject Matter 

 2106-Patent Subject Matter Eligibility 
 2106.01-[Reserved] 

 2106.02-[Reserved] 

 2106.03-Eligibility Step 1: The Four Categories of Statutory Subject Matter 

 2106.04-Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception 
 2106.04(a)-Abstract Ideas 
 2106.04(a)(1)-Examples of Claims That Do Not Recite Abstract Ideas 

 2106.04(a)(2)-Abstract Idea Groupings 

 2106.04(a)(3)-Tentative Abstract Ideas 

 
 

 2106.04(b)-Laws of Nature, Natural Phenomena & Products of Nature 

 2106.04(c)-The Markedly Different Characteristics Analysis 

 2106.04(d)-Integration of a Judicial Exception Into A Practical Application 
 2106.04(d)(1)-Evaluating Improvements in the Functioning of a Computer, or an Improvement to Any Other Technology or Technical Field in
 Step 2A Prong Two 

 2106.04(d)(2)-Particular Treatment and Prophylaxis in Step 2A Prong Two 

 
 

 
 

 2106.05-Eligibility Step 2B: Whether a Claim Amounts to Significantly More 
 2106.05(a)-Improvements to the Functioning of a Computer or To Any Other Technology or Technical Field 

 2106.05(b)-Particular Machine 

 2106.05(c)-Particular Transformation 

 2106.05(d)-Well-Understood, Routine, Conventional Activity 

 2106.05(e)-Other Meaningful Limitations 

 2106.05(f)-Mere Instructions To Apply An Exception 

 2106.05(g)-Insignificant Extra-Solution Activity 

 2106.05(h)-Field of Use and Technological Environment 

 
 

 2106.06-Streamlined Analysis 
 2106.06(a)-Eligibility is Self Evident 

 2106.06(b)-Clear Improvement to a Technology or to Computer Functionality 

 
 

 2106.07-Formulating and Supporting Rejections For Lack Of Subject Matter Eligibility 
 2106.07(a)-Formulating a Rejection For Lack of Subject Matter Eligibility 
 2106.07(a)(1)-Form Paragraphs for use in Lack of Subject Matter Eligibility Rejections 

 
 

 2106.07(b)-Evaluating Applicant’s Response 

 2106.07(c)-Clarifying the Record 

 
 

 
 

 2107-Guidelines for Examination of Applications for Compliance with the Utility Requirement 
 2107.01-General Principles Governing Utility Rejections 

 2107.02-Procedural Considerations Related to Rejections for Lack of Utility 

 2107.03-Special Considerations for Asserted Therapeutic or Pharmacological Utilities 

 
 

 2108-[Reserved] 

 2109-Inventorship 

 2109.01-Joint Inventorship 

 2110-[Reserved] 

 2111-Claim Interpretation; Broadest Reasonable Interpretation 
 2111.01-Plain Meaning 

 2111.02-Effect of Preamble 

 2111.03-Transitional Phrases 

 2111.04-“Adapted to,” “Adapted for,” “Wherein,” “Whereby,” and Contingent Clauses 

 2111.05-Functional and Nonfunctional Descriptive Material 

 
 

 2112-Requirements of Rejection Based on Inherency; Burden of Proof 
 2112.01-Composition, Product, and Apparatus Claims 

 2112.02-Process Claims 

 
 

 2113-Product-by-Process Claims 

 2114-Apparatus and Article Claims — Functional Language 

 2115-Material or Article Worked Upon by Apparatus 

 2116-Novel, Nonobvious Starting Material or End Product 
 2116.01-Novel, Nonobvious Starting Material or End Product 

 
 

 2117-Markush Claims 

 2118-2119-[Reserved] 

 2120-Rejection on Prior Art 
 2120.01-Rejections Under 35 U.S.C. 102(a)(1) and (a)(2) and Pre-AIA 35 U.S.C. 102(a), (b), or (e): Printed Publication or Patent 

 2120.02-Rejections Under 35 U.S.C. 102(a)(1) or Pre-AIA 35 U.S.C. 102(a) or (b): Knowledge by Others, or Public Use, or On Sale 

 
 

 2121-Prior Art; General Level of Operability Required to Make a Prima Facie Case 
 2121.01-Use of Prior Art in Rejections Where Operability is in Question 

 2121.02-Compounds and Compositions — What Constitutes Enabling Prior Art 

 2121.03-Plant Genetics — What Constitutes Enabling Prior Art 

 2121.04-Apparatus and Articles — What Constitutes Enabling Prior Art 

 
 

 2122-Discussion of Utility in the Prior Art 

 2123-Rejection Over Prior Art’s Broad Disclosure Instead of Preferred Embodiments 

 2124-Exception to the Rule That the Reference Must be Prior Art 
 2124.01-Tax Strategies Deemed Within the Prior Art 

 
 

 2125-Drawings as Prior Art 

 2126-Availability of a Document as a “Patent” for Purposes of Rejection Under 35 U.S.C. 102(a) or Pre-AIA 35 U.S.C. 102(a), (b),
 and (d) 
 2126.01-Date of Availability of a Patent as a Reference 

 2126.02-Scope of Reference’s Disclosure Which Can Be Used to Reject Claims When the Reference Is a “Patent” but Not a “Publication” 

 
 

 2127-Domestic and Foreign Patent Applications as Prior Art 

 2128-“Printed Publications” as Prior Art 
 2128.01-Level of Public Accessibility Required 

 2128.02-Date Publication Is Available as a Reference 

 
 

 2129-Admissions as Prior Art 

 2130-[Reserved] 

 2131-Anticipation — Application of 35 U.S.C. 102 
 2131.01-Multiple Reference 35 U.S.C. 102 Rejections 

 2131.02-Genus-Species Situations 

 2131.03-Anticipation of Ranges 

 2131.04-Secondary Considerations 

 2131.05-Nonanalogous or Disparaging Prior Art 

 
 

 2132-Pre-AIA 35 U.S.C. 102(a) 
 2132.01-Overcoming a Pre-AIA 35 U.S.C. 102(a) Rejection based on a Printed Publication or Patent 

 
 

 2133-Pre-AIA 35 U.S.C. 102(b) 
 2133.01-Rejections of Continuation-In-Part (CIP) Applications 

 2133.02-Rejections Based on Publications and Patents 
 2133.02(a)-Overcoming a Pre-AIA 35 U.S.C. 102(b) Rejection Based on a Printed Publication or Patent 

 
 

 2133.03-Rejections Based on “Public Use” or “On Sale” 
 2133.03(a)-“Public Use” 

 2133.03(b)-“On Sale” 

 2133.03(c)-The “Invention” 

 2133.03(d)-“In This Country” 

 2133.03(e)-Permitted Activity; Experimental Use 
 2133.03(e)(1)-Commercial Exploitation 

 2133.03(e)(2)-Intent 

 2133.03(e)(3)-“Completeness” of the Invention 

 2133.03(e)(4)-Factors Indicative of an Experimental Purpose 

 2133.03(e)(5)-Experimentation and Degree of Supervision and Control 

 2133.03(e)(6)-Permitted Experimental Activity and Testing 

 2133.03(e)(7)-Activity of an Independent Third Party Inventor 

 
 

 
 

 
 

 2134-Pre-AIA 35 U.S.C. 102(c) 

 2135-Pre-AIA 35 U.S.C. 102(d) 
 2135.01-The Four Requirements of Pre-AIA 35 U.S.C. 102(d) 

 
 

 2136-Pre-AIA 35 U.S.C. 102(e) 
 2136.01-Status of Unpublished or Published as Redacted U.S. Application as a Reference Under Pre-AIA 35 U.S.C. 102(e) 

 2136.02-Content of the Prior Art Available Against the Claims 

 2136.03-Critical Reference Date 

 2136.04-Different Inventive Entity; Meaning of “By Another” 

 2136.05-Overcoming a Rejection Under Pre-AIA 35 U.S.C. 102(e) 
 2136.05(a)-Antedating a Pre-AIA 35 U.S.C. 102(e) Reference 

 2136.05(b)-Showing The Reference Is Describing An Inventor's Or At Least One Joint Inventor's Own Work 

 
 

 
 

 2137-Pre-AIA 35 U.S.C. 102(f) 
 2137.01-[Reserved] 

 2137.02-[Reserved] 

 
 

 2138-Pre-AIA 35 U.S.C. 102(g) 
 2138.01-Interference Practice 

 2138.02-“The Invention Was Made in This Country” 

 2138.03-“By Another Who Has Not Abandoned, Suppressed, or Concealed It” 

 2138.04-“Conception” 

 2138.05-“Reduction to Practice” 

 2138.06-“Reasonable Diligence” 

 
 

 2139-Rejections Under Pre-AIA 35 U.S.C. 102 
 2139.01-Effective Filing Date of a Claimed Invention Under Pre-AIA 35 U.S.C. 102 

 2139.02-Determining Whether To Apply Pre-AIA 35 U.S.C. 102(a), (b), or (e) 

 2139.03-Form Paragraphs for Use in Rejections Under Pre-AIA 35 U.S.C. 102 

 
 

 2140-[Reserved] 

 2141-Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103 
 2141.01-Scope and Content of the Prior Art 
 2141.01(a)-Analogous and Nonanalogous Art 

 
 

 2141.02-Differences Between Prior Art and Claimed Invention 

 2141.03-Level of Ordinary Skill in the Art 

 
 

 2142-Legal Concept of Prima Facie Obviousness 

 2143-Examples of Basic Requirements of a Prima Facie Case of Obviousness 
 2143.01-Suggestion or Motivation To Modify the References 

 2143.02-Reasonable Expectation of Success Is Required 

 2143.03-All Claim Limitations Must Be Considered 

 
 

 2144-Supporting a Rejection Under 35 U.S.C. 103 
 2144.01-Implicit Disclosure 

 2144.02-Reliance on Scientific Theory 

 2144.03-Reliance on Common Knowledge in the Art or “Well Known” Prior Art 

 2144.04-Legal Precedent as Source of Supporting Rationale 

 2144.05-Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions 

 2144.06-Art Recognized Equivalence for the Same Purpose 

 2144.07-Art Recognized Suitability for an Intended Purpose 

 2144.08-Obviousness of Species When Prior Art Teaches Genus 

 2144.09-Close Structural Similarity Between Chemical Compounds (Homologs, Analogues, Isomers) 

 
 

 2145-Consideration of Applicant’s Rebuttal Arguments and Evidence 

 2146-Pre-AIA 35 U.S.C. 103(c) 
 2146.01-Prior Art Disqualification Under Pre-AIA 35 U.S.C. 103(c) 

 2146.02-Establishing Common Ownership or Joint Research Agreement Under Pre-AIA 35 U.S.C. 103(c) 

 2146.03-Examination Procedure With Respect to Pre-AIA 35 U.S.C. 103(c) 
 2146.03(a)-Provisional Rejection (Obviousness) Under 35 U.S.C. 103(a) Using Provisional Prior Art Under Pre-AIA 35 U.S.C. 102(e) 

 
 

 
 

 2147-Biotechnology Process Applications; Pre-AIA 35 U.S.C. 103(b) 

 2148-Form Paragraphs for Use in Rejections Under Pre-AIA 35 U.S.C. 103 

 2149-[Reserved] 

 2150-Examination Guidelines for 35 U.S.C. 102 and 103 as Amended by the First Inventor To File Provisions of the Leahy-Smith America
 Invents Act 

 2151-Overview of the Changes to 35 U.S.C. 102 and 103 in the AIA 

 2152-Detailed Discussion of AIA 35 U.S.C. 102(a) and (b) 
 2152.01-Effective Filing Date of the Claimed Invention 

 2152.02-Prior Art Under AIA 35 U.S.C. 102(a)(1) (Patented, Described in a Printed Publication, or in Public Use, on Sale, or Otherwise
 Available to the Public) 
 2152.02(a)-Patented 

 2152.02(b)-Described in a Printed Publication 

 2152.02(c)-In Public Use 

 2152.02(d)-On Sale 

 2152.02(e)-Otherwise Available to the Public 

 2152.02(f)-No Requirement of “By Others” 

 
 

 2152.03-Admissions 

 2152.04-The Meaning of “Disclosure” 

 2152.05-Determining Whether To Apply 35 U.S.C. 102(a)(1) or 102(a)(2) 

 2152.06-Overcoming a 35 U.S.C. 102(a)(1) or 102(a)(2) Rejection 

 2152.07-Form Paragraphs for Use in Rejections Under AIA 35 U.S.C. 102 

 
 

 2153-Prior Art Exceptions Under 35 U.S.C. 102(b)(1) to AIA 35 U.S.C. 102(a)(1) 
 2153.01-Prior Art Exception Under AIA 35 U.S.C. 102(b)(1)(A) To AIA 35 U.S.C. 102(a)(1) (Grace Period Inventor-Originated Disclosure
 Exception) 
 2153.01(a)-Grace Period Inventor-Originated Disclosure Exception 

 2153.01(b)-[Reserved] 

 
 

 2153.02-Prior Art Exception Under AIA 35 U.S.C. 102(b)(1)(B) to AIA 35 U.S.C. 102(a)(1) (Inventor-Originated Prior Public Disclosure
 Exception) 

 
 

 2154-Provisions Pertaining to Subject Matter in a U.S. Patent or Application Effectively Filed Before the Effective Filing Date
 of the Claimed Invention 
 2154.01-Prior Art Under AIA 35 U.S.C. 102(a)(2) “U.S. Patent Documents” 
 2154.01(a)-WIPO Published Applications 

 2154.01(b)-Determining When Subject Matter Was Effectively Filed Under AIA 35 U.S.C. 102(d) 

 2154.01(c)-Requirement Of “Names Another Inventor” 

 2154.01(d)-Provisional Rejections Under 35 U.S.C. 102(a)(2); Reference Is a Copending U.S. Patent Application 

 
 

 2154.02-Prior Art Exceptions Under 35 U.S.C. 102(b)(2) to AIA 35 U.S.C. 102(a)(2) 
 2154.02(a)-Prior Art Exception Under AIA 35 U.S.C. 102(b)(2)(A) to AIA 35 U.S.C. 102(a)(2) (Inventor-Originated Disclosure Exception) 

 2154.02(b)-Prior Art Exception Under AIA 35 U.S.C. 102(b)(2)(B) to AIA 35 U.S.C. 102(a)(2) (Inventor-Originated Prior Public Disclosure
 Exception) 

 2154.02(c)-Prior Art Exception Under AIA 35 U.S.C. 102(b)(2)(C) to AIA 35 U.S.C. 102(a)(2) (Common Ownership or Obligation of Assignment) 

 
 

 
 

 2155-Use of Affidavits or Declarations Under 37 CFR 1.130 To Overcome Prior Art Rejections 
 2155.01-Showing That the Disclosure Was Made by the Inventor or a Joint Inventor 

 2155.02-Showing That the Subject Matter Disclosed Had Been Previously Publicly Disclosed by the Inventor or a Joint Inventor 

 2155.03-Showing That the Disclosure was Made, or That Subject Matter had Been Previously Publicly Disclosed, by Another Who Obtained
 the Subject Matter Disclosed Directly or Indirectly From the Inventor or a Joint Inventor 

 2155.04-Enablement 

 2155.05-Who May File an Affidavit or Declaration Under 37 CFR 1.130 

 2155.06-Situations in Which an Affidavit or Declaration Is Not Available 

 
 

 2156-Joint Research Agreements 

 2157-Improper Naming of Inventors 

 2158-AIA 35 U.S.C. 103 
 2158.01-Form Paragraphs for Use in Rejections Under AIA 35 U.S.C. 103 

 
 

 2159-Applicability Date Provisions and Determining Whether an Application Is Subject to the First Inventor To File Provisions of
 the AIA 
 2159.01-Applications Filed Before March 16, 2013 

 2159.02-Applications Filed on or After March 16, 2013 

 2159.03-Applications Subject to the AIA but Also Containing a Claimed Invention Having an Effective Filing Date Before March 16, 2013 

 2159.04-Applicant Statement in Transition Applications Containing a Claimed Invention Having an Effective Filing Date on or After
 March 16, 2013 

 
 

 2160-[Reserved] 

 2161-Three Separate Requirements for Specification Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 
 2161.01-Computer Programming, Computer Implemented Inventions, and 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 

 
 

 2162-Policy Underlying 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 

 2163-Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph,
 “Written Description” Requirement 
 2163.01-Support for the Claimed Subject Matter in Disclosure 

 2163.02-Standard for Determining Compliance With the Written Description Requirement 

 2163.03-Typical Circumstances Where Adequate Written Description Issue Arises 

 2163.04-Burden on the Examiner with Regard to the Written Description Requirement 

 2163.05-Changes to the Scope of Claims 

 2163.06-Relationship of Written Description Requirement to New Matter 

 2163.07-Amendments to Application Which Are Supported in the Original Description 
 2163.07(a)-Inherent Function, Theory, or Advantage 

 2163.07(b)-Incorporation by Reference 

 
 

 
 

 2164-The Enablement Requirement 
 2164.01-Test of Enablement 
 2164.01(a)-Undue Experimentation Factors 

 2164.01(b)-How to Make the Claimed Invention 

 2164.01(c)-How to Use the Claimed Invention 

 
 

 2164.02-Working and Prophetic Examples 

 2164.03-Relationship of Predictability of the Art and the Enablement Requirement 

 2164.04-Burden on the Examiner Under the Enablement Requirement 

 2164.05-Determination of Enablement Based on Evidence as a Whole 
 2164.05(a)-Specification Must Be Enabling as of the Filing Date 

 2164.05(b)-Specification Must Be Enabling to Persons Skilled in the Art 

 
 

 2164.06-Quantity of Experimentation 
 2164.06(a)-Examples of Enablement Issues-Missing Information 

 2164.06(b)-Examples of Enablement Issues — Biological and Chemical Cases 

 2164.06(c)-Examples of Enablement Issues – Computer Programming Cases 

 
 

 2164.07-Relationship of Enablement Requirement to Utility Requirement of 35 U.S.C. 101 

 2164.08-Enablement Commensurate in Scope With the Claims 
 2164.08(a)-Single Means Claim 

 2164.08(b)-Inoperative Subject Matter 

 2164.08(c)-Critical Feature Not Claimed 

 
 

 
 

 2165-The Best Mode Requirement 
 2165.01-Considerations Relevant to Best Mode 

 2165.02-Best Mode Requirement Compared to Enablement Requirement 

 2165.03-Requirements for Rejection for Lack of Best Mode 

 2165.04-Examples of Evidence of Concealment 

 
 

 2166-Rejections Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 

 2167-2170-[Reserved] 

 2171-Two Separate Requirements for Claims Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph 

 2172-Subject Matter Which the Inventor or a Joint Inventor Regards as The Invention 
 2172.01-Unclaimed Essential Subject Matter 

 
 

 2173-Claims Must Particularly Point Out and Distinctly Claim the Invention 
 2173.01-Interpreting the Claims 

 2173.02-Determining Whether Claim Language is Definite 

 2173.03-Correspondence Between Specification and Claims 

 2173.04-Breadth Is Not Indefiniteness 

 2173.05-Specific Topics Related to Issues Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph 
 2173.05(a)-New Terminology 

 2173.05(b)-Relative Terminology 

 2173.05(c)-Numerical Ranges and Amounts Limitations 

 2173.05(d)-Exemplary Claim Language (“for example,” “such as”) 

 2173.05(e)-Lack of Antecedent Basis 

 2173.05(f)-Reference to Limitations in Another Claim 

 2173.05(g)-Functional Limitations 

 2173.05(h)-Alternative Limitations 

 2173.05(i)-Negative Limitations 

 2173.05(j)-Old Combination 

 2173.05(k)-Aggregation 

 2173.05(l)-[Reserved] 

 2173.05(m)-Prolix 

 2173.05(n)-Multiplicity 

 2173.05(o)-Double Inclusion 

 2173.05(p)-Claim Directed to Product-By- Process or Product and Process 

 2173.05(q)-“Use” Claims 

 2173.05(r)-Omnibus Claim 

 2173.05(s)-Reference to Figures or Tables 

 2173.05(t)-Chemical Formula 

 2173.05(u)-Trademarks or Trade Names in a Claim 

 2173.05(v)-Mere Function of Machine 

 
 

 2173.06-Practice Compact Prosecution 

 
 

 2174-Relationship Between the Requirements of 35 U.S.C. 112(a) and (b) or Pre-AIA 35 U.S.C. 112, First and Second Paragraphs 

 2175-Form Paragraphs for Use in Rejections Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph 

 2176-2180-[Reserved] 

 2181-Identifying and Interpreting a 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112, Sixth Paragraph Limitation 

 2182-Search and Identification of the Prior Art 

 2183-Making a Prima Facie Case of Equivalence 

 2184-Determining Whether an Applicant Has Met the Burden of Proving Nonequivalence After a Prima Facie Case Is Made 

 2185-Related Issues Under 35 U.S.C. 112(a) or (b) and Pre-AIA 35 U.S.C. 112, First or Second Paragraphs 

 2186-Relationship to the Doctrine of Equivalents 

 2187-Form Paragraphs for Use Relating to 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112, Sixth Paragraph 

 2188-2189-[Reserved] 

 2190-Prosecution Laches and Res Judicata 

 

 

 
 

 
 
 

 
 

 

 
 
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 03/09/2026 20:49:32