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.

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.

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.

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.

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.

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.).

“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.”).

“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.”).

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).

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).

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).

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.).

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.).

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.).

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.).

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, “[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).

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).

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.

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).

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:

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:

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.

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.

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.

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.

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.

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.

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.

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.

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.).

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.).

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.

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 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:

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.

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.

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.

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.

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.

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.

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.

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

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:

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:

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:

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:

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:

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:

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:

“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.”).

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.

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.

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.

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.

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

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 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).

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.).

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.

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.

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.

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.

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.

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.

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.

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.”).

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.”).

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.”).

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.”).

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.”).

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:

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:

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:

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:

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 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.

“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.).

“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.).

“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.).

“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.).

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.”).

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.”).

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.”).

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.”).

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.”).

[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.]

[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.]

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.

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.

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:

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 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 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.

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:

“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.”).

“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.”).

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.

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.

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.

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.).

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.).

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).

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).

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).

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).

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.

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.

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.

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.

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.”).

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.”).

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).

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.

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).

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).

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).

[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.]

[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.]

[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.]

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).

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).

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).

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).

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).

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 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 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.

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.”).

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.”).

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).

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:

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.

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 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.

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.

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.

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.).

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.”).

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.”).

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.”).

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.