Case: 19-1871 Document: 146 Page: 1 Filed: 03/05/2024
`
`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`PFIZER INC.,
`Appellant
`
`v.
`
`SANOFI PASTEUR INC., SK CHEMICALS CO.,
`LTD.,
`Appellees
`
`KATHERINE K. VIDAL, UNDER SECRETARY OF
`COMMERCE FOR INTELLECTUAL PROPERTY
`AND DIRECTOR OF THE UNITED STATES
`PATENT AND TRADEMARK OFFICE,
`Intervenor
`______________________
`
`2019-1871, 2019-1873, 2019-1875, 2019-1876, 2019-2224
`______________________
`
`Appeals from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board
`in Nos.
`IPR2017-02131,
`IPR2017-02132,
`IPR2017-02136,
`IPR2017-02138, IPR2018-00187.
`______________________
`
`Decided: March 5, 2024
`______________________
`
`JOHN P. SCHEIBELER, White & Case LLP, New York,
`NY, argued for appellant. Also represented by DIMITRIOS
`T. DRIVAS, AMIT THAKORE; ELIZABETH K. CHANG, CATALIN
`
`

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`PFIZER INC. v. SANOFI PASTEUR INC.
`
`SEBASTIAN ZONTE, Los Angeles, CA; HENRY HUANG, Palo
`Alto, CA.
`
` SIEGMUND Y. GUTMAN, Proskauer Rose LLP, Los Ange-
`les, CA, argued for appellees. Also represented by JOHN E.
`ROBERTS, Boston, MA.
`
` MARY L. KELLY, Office of the Solicitor, United States
`Patent and Trademark Office, Alexandria, VA, argued for
`intervenor. Also represented by PETER J. AYERS, DANIEL
`KAZHDAN, FARHEENA YASMEEN RASHEED; SCOTT R. MCIN-
`TOSH, Appellate Staff, Civil Division, United States De-
`partment of Justice, Washington, DC.
`______________________
`
`Before LOURIE, BRYSON, and STARK, Circuit Judges.
`LOURIE, Circuit Judge.
`Pfizer Inc. appeals from five final written decisions of
`the U.S. Patent and Trademark Office Patent Trial and Ap-
`peal Board (“the Board”) concluding that claims 1–45 of
`U.S. Patent 9,492,559 (“the ’559 patent”) are unpatentable.
`Inc.,
`Merck Sharp & Dohme Corp.
`v. Pfizer
`No. IPR2017-02131, 2019 WL 1222935 (P.T.A.B. Mar. 13,
`2019) (holding claims 1–10, 16–19, and 38–45 unpatenta-
`ble) (“’131 Decision”), J.A. 1–81; Merck Sharp & Dohme
`Corp. v. Pfizer Inc., No. IPR2017-02132, 2019 WL 1220899
`(P.T.A.B. Mar. 13, 2019)
`(same)
`(“’132 Decision”),
`J.A. 82–160; Merck Sharp & Dohme Corp. v. Pfizer Inc.,
`No. IPR2017-02136, 2019 WL 1222965 (P.T.A.B. Mar. 13,
`2019) (holding claims 11–15 and 20–37 unpatentable)
`(“’136 Decision”), J.A. 161–216; Merck Sharp & Dohme
`Corp. v. Pfizer Inc., No. IPR2017-02138, 2019 WL 1220900
`(P.T.A.B. Mar. 13, 2019)
`(same)
`(“’138 Decision”),
`J.A. 217–71; Sanofi Pasteur
`Inc.,
`Inc. v. Pfizer
`No. IPR2018-00187, 2019 WL 2352182 (P.T.A.B. June 3,
`2019)
`(holding claims 1–45 unpatentable)
`(“Sanofi
`
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`PFIZER INC. v. SANOFI PASTEUR INC.
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`Decision”), J.A. 272–360.1 The Board also denied Pfizer’s
`contingent motions to amend the claims filed in three of the
`five IPRs, concluding that proposed claims 46–52, which
`Pfizer proposed to substitute for claims 1–4, 9, 41, and 42,
`respectively, were not independently patentable. Sanofi
`Decision at *27–37; ’131 Decision at *24–33; ’132 Decision
`at *23–32.
`For the following reasons, we affirm the Board’s con-
`clusions that claims 1–45 are unpatentable. We further af-
`firm the Board’s denials of Pfizer’s motions to amend by
`adding proposed claims 46, 47, and 50–52. But we vacate
`those denials as to proposed claims 48 and 49, and remand
`to the Board for further consideration of those claims.
`BACKGROUND
`Pfizer owns the ’559 patent, which is directed to immu-
`nogenic compositions comprising conjugated Streptococcus
`pneumoniae capsular saccharide antigens (i.e., glycoconju-
`gates) for use in pneumococcal vaccines. See ’559 Patent at
`Abstract, J.A. 845. As the ’559 patent explains, S. pneu-
`moniae “is a Gram-positive encapsulated coccus, sur-
`rounded by a polysaccharide capsule.” Id. at col. 1,
`ll. 50–52, J.A. 863. There are over 91 different pneumococ-
`cus serotypes, some of which cause diseases such as pneu-
`monia, febrile bacteremia, and meningitis. See id. at col. 1,
`ll. 52–58, J.A. 863. Claim 1 is the only independent claim.
`It reads as follows:
`1. An immunogenic composition comprising a
`Streptococcus pneumoniae serotype 22F glycocon-
`jugate, wherein the glycoconjugate has a molecular
`weight of between 1000 kDa and 12,500 kDa and
`
`1 The final written decisions consolidated in this ap-
`peal share similar analyses of the issues relevant to the
`parties’ disputes. Unless otherwise indicated, we cite the
`Sanofi Decision as representative.
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`PFIZER INC. v. SANOFI PASTEUR INC.
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`comprises an isolated capsular polysaccharide from
`S. pneumoniae serotype 22F and a carrier protein,
`and wherein a ratio (w/w) of the polysaccharide to
`the carrier protein is between 0.4 and 2.
`Id. at col. 141, ll. 28–34, J.A. 933. As relevant here, de-
`pendent claims 3 and 4 recite that the composition further
`includes various additional glycoconjugates. Those claims
`read as follows:
`3. The immunogenic composition of claim 1,
`wherein the composition further comprises a
`S. pneumoniae serotype 15B glycoconjugate and a
`S. pneumoniae serotype 33F glycoconjugate.
`4. The immunogenic composition of claim 3,
`wherein the composition further comprises a
`S. pneumoniae serotype 12F glycoconjugate, a
`S. pneumoniae serotype 10A glycoconjugate, a
`S. pneumoniae serotype 11A glycoconjugate and a
`S. pneumoniae serotype 8 glycoconjugate.
`Id. at col. 141, ll. 38–46, J.A. 933.
`Across five IPR petitions, Merck Sharp & Dohme Corp.
`(“Merck”) and Sanofi Pasteur Inc. and SK Chemicals Co.,
`Ltd. (collectively, “Sanofi”) separately challenged all claims
`of the ’559 patent, arguing that they would have been obvi-
`ous over, inter alia, PCT Patent Application Publication
`2007/071711 (“GSK-711”) and U.S. Patent Application
`Publication 2011/0195086 (“Merck-086”).2 GSK-711 is
`
`
`2 Sanofi asserted that the claims would have been
`obvious over GSK-711 and Merck-086, while Merck as-
`serted that the claims would have been obvious over Inter-
`national Patent Application Publication 2011/100151
`(“Merck 2011”) and International Patent Application Pub-
`lication 2009/000825 (“GSK 2008”). Merck-086 is the U.S.
`counterpart to Merck 2011, while GSK-711 and GSK 2008
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`PFIZER INC. v. SANOFI PASTEUR INC.
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`directed to S. pneumoniae vaccines comprising “capsular
`saccharide antigens (preferably conjugated), wherein the
`saccharides are derived from at least ten serotypes of S.
`pneumoniae,” which may include an “S. pneumoniae sac-
`charide conjugate of 22F.” GSK-711 at p. 6, ll. 4, 24–26,
`J.A. 4578. Merck-086 is directed to “multivalent immuno-
`genic composition[s] having 15 distinct polysaccharide-pro-
`tein conjugates” in which an S. pneumoniae serotype,
`including 22F,
`is conjugated to a carrier protein.
`Merck-086 at Abstract, J.A. 4667.
`The Board instituted review based on each petition and
`issued final written decisions which, taken together, found
`all claims unpatentable. See, e.g., Sanofi Decision at *39.
`The Board also rejected Pfizer’s contingent motions to
`amend, finding that Merck and Sanofi had each demon-
`strated that the proposed substitute claims were unpatent-
`able. Id. at *27; ’131 Decision at *24; ’132 Decision at *23.
`Pfizer timely appealed. After a stay pending the Su-
`preme Court’s decision in United States v. Arthrex, Inc.,
`141 S. Ct. 1970 (2021), we remanded for the limited pur-
`pose of allowing Pfizer the opportunity to request Director
`Review of the Board’s decisions. See, e.g., Appeal
`2019-1871, ECF No. 82. The Director denied those re-
`quests on February 4, 2022, see id., ECF No. 85, so the
`Board’s final written decisions are now ripe for our review.
`We have jurisdiction under 28 U.S.C. § 1295(a)(4)(A) and
`35 U.S.C. § 141(c).
`
`DISCUSSION
`Pfizer raises four challenges on appeal. First, it argues
`that the Board erred in determining that GSK-711 and
`
`are related international applications with substantively
`identical disclosures. For clarity, we will refer only to the
`Sanofi-asserted references, GSK-711 and Merck-086, in
`this opinion.
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`PFIZER INC. v. SANOFI PASTEUR INC.
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`Merck-086 would have rendered obvious the claimed im-
`munogenic composition comprising a S. pneumoniae sero-
`type 22F glycoconjugate, wherein the glycoconjugate has a
`molecular weight of between 1000 kDa and 12,500 kDa.
`Second, it argues that the Board erred in finding that the
`compositions of claims 3 and 4, which comprise a total of
`three and seven distinct S. pneumoniae serotype glycocon-
`jugates, respectively, would have been obvious over GSK-
`711 and Merck-086. Third, it contends that the Board
`abused its discretion in denying its contingent motions to
`amend. And finally, it challenges the Patent and Trade-
`mark Office’s (“PTO’s”) Director Review procedure, arguing
`that it violates the Administrative Procedure Act (“APA”).
`We address each argument in turn.
`I
`Pfizer’s first two challenges relate to the Board’s obvi-
`ousness determinations. “Obviousness is a question of law
`that we review de novo, but the Board’s underlying find-
`ings of fact are reviewed for substantial evidence.” Liqwd,
`Inc. v. L’Oreal USA, Inc., 941 F.3d 1133, 1136 (Fed. Cir.
`2019). “An obviousness determination requires finding
`that a person of ordinary skill in the art would have been
`motivated to combine or modify the teachings in the prior
`art and would have had a reasonable expectation of success
`in doing so.” OSI Pharms., LLC v. Apotex Inc., 939 F.3d
`1375, 1382 (Fed. Cir. 2019) (quoting Regents of Univ. of
`Cal. v. Broad Inst., Inc., 903 F.3d 1286, 1291 (Fed. Cir.
`2018)). Whether or not a person of ordinary skill would
`have had the requisite motivation to combine references,
`and whether or not she would have had a reasonable ex-
`pectation of success in doing so, are questions of fact we
`review for substantial evidence. Id. A finding is supported
`by substantial evidence if a reasonable mind might accept
`the evidence as adequate to support the finding. Consol.
`Edison Co. v. NLRB, 305 U.S. 197, 229 (1938).
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`PFIZER INC. v. SANOFI PASTEUR INC.
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`A
`Claim 1 of the ’559 patent recites that the S. pneu-
`moniae serotype 22F glycoconjugate has a molecular
`weight of between 1000 kDa and 12,500 kDa. ’559 patent
`at col. 141, ll. 30–31, J.A. 933. As the Board recognized,
`and Sanofi concedes, neither GSK-711 nor Merck-086 dis-
`closes any molecular weight for a S. pneumoniae serotype
`22F glycoconjugate. See Sanofi Decision at *5; Sanofi Resp.
`Br. at 26. The Board nevertheless concluded that, based
`on the evidence of record, glycoconjugate molecular weight
`is a result-effective variable that a person of ordinary skill
`in the art would have been motivated to optimize to provide
`a conjugate having improved stability and good immune re-
`sponse. Sanofi Decision at *13. The Board therefore con-
`cluded that claim 1 would have been obvious over the
`references.
`Pfizer first contends that the Board erred in applying
`the “result-effective variable doctrine,” arguing that it is
`only appropriate in circumstances where there is actual
`overlap between a range in the prior art and a claimed
`range. See Pfizer Br. at 27. In Pfizer’s view, because it is
`undisputed that the prior art does not disclose any molec-
`ular weight for the claimed serotype 22F glycoconjugate,
`there could be no presumption of obviousness, and it was
`error for the Board to consider whether that variable was
`result-effective. Id. We disagree.
`We begin by stating that the determination whether or
`not a claimed parameter is a result-effective variable is
`merely one aspect of a broader routine optimization analy-
`sis. That analysis is rooted in the decades-old legal princi-
`ple that “where the general conditions of a claim are
`disclosed in the prior art, it is not inventive to discover the
`optimum or workable ranges by routine experimentation.”
`In re Aller, 220 F.2d 454, 456 (CCPA 1955); see E.I. DuPont
`de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006
`(Fed. Cir. 2018) (collecting cases). In the context of claimed
`
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`PFIZER INC. v. SANOFI PASTEUR INC.
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`numerical ranges, such as the molecular weight here, we
`have explained that an overlap between a claimed range
`and a prior art range creates a presumption of obviousness
`that can be rebutted with evidence that the given parame-
`ter was not recognized as result-effective. See Genentech,
`Inc. v. Hospira, Inc., 946 F.3d 1333, 1341 (Fed. Cir. 2020)
`(citing E.I. DuPont, 904 F.3d at 1006); In re Applied Mate-
`rials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012). That does
`not mean, however, that the determination whether or not
`a variable is result-effective is only appropriate when there
`is such an overlap. A routine optimization analysis gener-
`ally requires consideration whether a person of ordinary
`skill in the art would have been motivated, with a reason-
`able expectation of success, to bridge any gaps in the prior
`art to arrive at a claimed invention. Where that gap in-
`cludes a parameter not necessarily disclosed in the prior
`art, it is not improper to consider whether or not it would
`have been recognized as result-effective. If so, then the op-
`timization of that parameter is “normally obvious.” In re
`Antonie, 559 F.2d 618, 620 (CCPA 1977). The Board there-
`fore did not err in considering, as part of its obviousness
`analysis, whether or not the claimed molecular weight of a
`S. pneumoniae serotype 22F glycoconjugate was a result-
`effective variable.
`Substantial evidence supports the Board’s conclusion
`that the molecular weight recited in claim 1 would have
`been obvious over the references. Although it is undis-
`puted that no reference teaches a molecular weight for the
`particularly claimed serotype 22F glycoconjugate, it is sim-
`ilarly undisputed that GSK-711 discloses both a serotype
`22F glycoconjugate and the molecular weights for fourteen
`other S. pneumoniae serotype glycoconjugates. As the
`Board observed, those molecular weights, ranging from
`1303 kDa to 9572 kDa, overlap with the claimed range (i.e.,
`1000 kDa to 12,500 kDa). Sanofi Decision at *5; GSK-711
`at Table 2, J.A. 25056. The Board further explained that
`GSK-711 discloses that “saccharide conjugate vaccines
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`retaining a larger size of saccharide can provide a good im-
`mune response against pneumococcal disease,” and that
`both GSK-711 and Merck-086 disclose that known methods
`and techniques could be used to isolate the polysaccharide
`from the bacteria and to couple it to a carrier protein.
`Sanofi Decision at *9–10. For example, both GSK-711 and
`Merck-086 disclose methods for preparing S. pneumoniae
`glycoconjugates and teach that the polysaccharides can be
`sized to improve the filterability of the conjugated product.
`Id. at *6, *10. Expert testimony further supported the no-
`tion that, at the time of the invention, conjugation tech-
`niques and conditions were routine such that a person of
`ordinary skill in the art would have understood the claimed
`molecular weight to be “typical of immunogenic conju-
`gates.” Id. at *11. That evidence therefore supports the
`Board’s conclusion that “conjugate size is a result[-]effec-
`tive variable associated with improved stability of conju-
`gates and good immune response, limited only by filter
`size, thereby rendering ‘optimization within the grasp of
`one of ordinary skill in the art.’” Sanofi Decision at *13
`(quoting Applied Materials, 692 F.3d at 1295).
`We are unpersuaded by Pfizer’s argument that the
`Board disregarded contrary evidence showing that gly-
`coconjugate molecular weight would have been unpredict-
`able because it required “case-by-case experimentation” or
`“individualized design and testing.” See Pfizer Br. at 36.
`Not only does Pfizer’s argument call on us to reweigh evi-
`dence presented to the Board—which is not the role of this
`court, see In re NTP, Inc., 654 F.3d 1279, 1292 (Fed. Cir.
`2011)—but it relies on the faulty premise that where opti-
`mization requires case-specific considerations, then the re-
`sults must be unexpected. Although that could be the case
`under some circumstances, it is not the case here where the
`methods and conditions for creating the glycoconjugates of
`the invention were generally recognized as routine. As
`Pfizer’s own expert explained, “[c]hemists have all kind of
`tricks to control . . . to come up with the desired product,”
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`PFIZER INC. v. SANOFI PASTEUR INC.
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`such that conjugation conditions could be easily controlled.
`Sanofi Decision at *11; see J.A. 30375–78.
`Accordingly, we conclude that the Board’s determina-
`tion that claim 1 would have been obvious over the refer-
`ences was supported by substantial evidence.
`B
`Claims 3 and 4 of the ’559 patent depend from claim 1
`and recite that the claimed immunogenic composition fur-
`ther comprises glycoconjugates from S. pneumoniae sero-
`types 15B, 33F, 12F, 10A, 11A, and 8. ’559 patent at
`col. 141, ll. 38–46, J.A. 933. As with claim 1, the Board
`concluded that the compositions of those claims would have
`been obvious over the combination of GSK-711 and
`Merck-086. Specifically, the Board concluded that, because
`GSK-711 expressly discloses multivalent immunogenic
`S. pneumoniae glycoconjugate compositions that can in-
`clude serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A,
`12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F, it
`would have been obvious to incorporate the claimed gly-
`coconjugates into an immunogenic composition containing
`an S. pneumoniae serotype 22F glycoconjugate to arrive at
`the claimed invention. Sanofi Decision at *21–22.
`Pfizer argues that the Board’s conclusion was not sup-
`ported by substantial evidence because the record does not
`support a finding that “there would have been a reasonable
`expectation of success in formulating immunogenic conju-
`gates for the claimed serotypes.” Pfizer Br. at 40. In
`Pfizer’s view, because none of the prior art discloses that
`any of the claimed glycoconjugates were actually made or
`tested, there was insufficient evidence to support the
`Board’s finding that the glycoconjugates would have each
`been expected to “elicit functional antibody,” as the term
`“immunogenic” was construed to mean. Id. at 42–43; see
`Sanofi Decision at *3–4. Pfizer argues that, because the
`unpredictability of the art is high, without examples show-
`ing that the claimed glycoconjugates would have each been
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`immunogenic, there would have been no reasonable expec-
`tation of success. We disagree.
`As an initial matter, Pfizer’s position that the claims
`could not have been obvious because no prior art reference
`exemplifies each of the claimed serotype glycoconjugates is
`unavailing. That argument was considered, and rejected,
`by the Board. The Board correctly explained that a prior
`art reference is not limited to its specific working examples.
`Sanofi Decision at *21 (citing In re Mills, 470 F.2d 649, 651
`(CCPA 1972)). And the fact that the art of pneumococcal
`glycoconjugate vaccines is unpredictable does not affect our
`analysis. We have previously explained that “a rule of law
`equating unpredictability to patentability . . . . cannot be
`the proper standard since the expectation of success need
`only be reasonable, not absolute.” Pfizer, Inc. v. Apotex,
`Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) (collecting cases
`and explaining that “obviousness cannot be avoided simply
`by a showing of some degree of unpredictability in the art
`so long as there was a reasonable probability of success”).
`As we explain next, the Board’s conclusion that a person of
`ordinary skill in the art would have had a reasonable ex-
`pectation of success in arriving at the immunogenic compo-
`sitions of claims 3 and 4 was supported by substantial
`evidence.
`The Board found that GSK-711 teaches the incorpora-
`tion of glycoconjugates of the claimed serotypes, specifi-
`cally 15B, 33F, 12F, 10A, 11A, and 8, into a pneumococcal
`vaccine. Sanofi Decision at *21–22. The Board also ob-
`served that, like the ’559 patent, GSK-711 refers to its com-
`positions as “immunogenic.” Id. The Board therefore
`concluded that each of the glycoconjugates of GSK-711
`must be taken to be immunogenic (i.e., elicit functional an-
`tibody) because “otherwise there would be no need to in-
`clude a serotype unable to induce such a response.” Id. at
`*21. That conclusion is not unreasonable, particularly
`where the specifically claimed serotypes have long been
`recognized as immunogenic.
` Since 1983, free (i.e.,
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`unconjugated) polysaccharides from the claimed S. pneu-
`moniae serotypes have been formulated into a commercial
`pneumococcal vaccine, PNEUMOVAX® 23. Id. And, as the
`’559 patent itself explains, at the time of the invention,
`there were three other commercial pneumococcal vaccines
`that incorporated glycoconjugates of other, unclaimed S.
`pneumoniae serotypes. See id. at *1. The Board therefore
`accepted Sanofi’s expert’s testimony that, because the
`claimed serotypes had already been included in commercial
`multivalent vaccines (albeit in “free,” not “conjugated,”
`form), and because multivalent glycoconjugate vaccines
`were generally known to be effective, the person of ordinary
`skill in the art would have reasonably expected that the
`claimed glycoconjugates could be incorporated into a vac-
`cine “while maintaining the immunogenicity to all sero-
`types in the composition.” Id. at *22. Substantial evidence
`therefore supports the Board’s conclusion that the subject
`matter of claims 3 and 4 “would have been obvious in order
`to increase the coverage of serotypes of pneumococcal vac-
`cines.” Id.
`Because all of the remaining claims of the ’559 patent
`depend from claim 1, they are subject to the obviousness
`reasoning that we have affirmed. Pfizer has not argued
`otherwise.
`
`II
`Pfizer next challenges the Board’s denials of its mo-
`tions to amend, which Pfizer filed in three of the five IPRs.
`We review the Board’s decision to deny a motion to amend
`under the APA and must set aside the Board’s action if it
`is “arbitrary, capricious, an abuse of discretion, or other-
`wise not in accordance with law.” 5 U.S.C. § 706(2)(A);
`Fleming v. Cirrus Design Corp., 28 F.4th 1214, 1225 (Fed.
`Cir. 2022). We will uphold a decision of less than ideal clar-
`ity if the agency’s path can reasonably be discerned, but
`“we may not supply a reasoned basis for the agency’s action
`that the agency itself has not given.” Bowman Transp.,
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`Inc. v. Ark.-Best Freight Sys., Inc., 419 U.S. 281, 285–86
`(1974); see also SEC v. Chenery Corp., 318 U.S. 80, 94
`(1943). Accordingly, “the Board must, as to issues made
`material by the governing law, set forth a sufficiently de-
`tailed explanation of its determinations both to enable
`meaningful judicial review and to prevent judicial intru-
`sion on agency authority.” Rovalma, S.A. v. Bohler-Edel-
`stahl GmbH & Co. KG, 856 F.3d 1019, 1024 (Fed. Cir. 2017)
`(collecting cases).
`In each of IPR2017-02131, IPR2017-02132, and
`IPR2018-00187, Pfizer submitted, pursuant to 35 U.S.C.
`§ 316(d) and 37 C.F.R. § 42.121, a motion to amend that
`proposed to substitute claims 46–52 for claims 1–4, 9, 41,
`and 42, respectively, should those claims be deemed un-
`patentable. See Sanofi Decision at *27; ’131 Decision at
`*24; ’132 Decision at *23. Relevant here, proposed claims
`46, 48, and 49 recite:
`46. An immunogenic composition comprising:
`a Streptococcus pneumoniae serotype 22F gly-
`coconjugate, wherein the 22F glycoconjugate has a
`molecular weight of between 1000 kDa and 12,500
`kDa and comprises an isolated capsular polysac-
`charide from S. pneumoniae serotype 22F and a
`CRM197 carrier protein, and wherein a ratio (w/w)
`of the polysaccharide to the carrier protein is be-
`tween 0.4 and 2;
`glycoconjugates from S. pneumoniae serotypes
`1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and
`23F all individually conjugated to CRM197;
`an aluminum salt adjuvant; and
`wherein the composition exhibits more than a
`2-log increase above baseline in serum IgG levels
`in New Zealand White Rabbits across all serotypes
`in the composition following administration of two
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`14
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`PFIZER INC. v. SANOFI PASTEUR INC.
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`equal doses of the composition in the form of an in-
`itial dose and a booster dose.
`48. The immunogenic composition of claim 1 46,
`wherein the composition further comprises a
`S. pneumoniae serotype 15B glycoconjugate and a
`serotype 33F glycoconjugate,
`S. pneumoniae
`wherein said serotypes 15B and 33F are all individ-
`ually conjugated to CRM197.
`49. The immunogenic composition of claim 3 48,
`wherein the composition further comprises a
`S. pneumoniae serotype 12F glycoconjugate, a
`S. pneumoniae serotype 10A glycoconjugate, a
`S. pneumoniae serotype 11A glycoconjugate and a
`S. pneumoniae serotype 8 glycoconjugate, wherein
`said serotypes 12F, 10A, 11A and 8 are all individ-
`ually conjugated to CRM197.
`E.g., J.A. 28091–92 (additions underlined and deletions
`struck through).3
`The Board denied each of Pfizer’s motions to amend on
`the basis that the claimed subject matter would have been
`obvious over a combination of various references, including
`U.S. Patent Application Publication 2012/0237542
`(“Hausdorff”), Merck-086, GSK-711, and the knowledge of
`a person of ordinary skill in the art. See Sanofi Decision at
`*31.
`
`A
`We begin with the Board’s treatment of proposed claim
`46. As amended, that claim recites, in part, a 14-valent
`
`3 Pfizer has not independently challenged on appeal
`the Board’s treatment of proposed claims 47 and 50–52, so
`any challenge as to those claims is waived. SmithKline
`Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1319 (Fed.
`Cir. 2006).
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`15
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`immunogenic composition that exhibits a 2-log (i.e., 100-
`fold) increase above baseline in serum IgG levels across all
`serotypes according to a particular dosing regimen. The
`Board’s conclusion that, based on the prior art, it would
`have been obvious to arrive at the claimed composition
`with a reasonable expectation of success in obtaining a
`2-log increase above baseline in serum IgG levels across all
`serotypes was supported by substantial evidence.
`As the Board observed, each of Merck-086 and
`GSK-711 provides specific reasons why a person of ordi-
`nary skill in the art would have been motivated to incorpo-
`rate a serotype 22F glycoconjugate into a multivalent
`vaccine; for example, to provide “expand[ed] coverage of
`pneumococcal serotypes not covered by existing pneumo-
`coccal vaccines.”
` Sanofi Decision at *34 (quoting
`Merck-086 at ¶ 15, J.A. 4672). Merck-086 further shows
`that, in two of four studies, a multivalent pneumococcal
`vaccine comprising a serotype 22F glycoconjugate exhib-
`ited a greater than 2-log increase above baseline serum IgG
`levels as to the 22F serotype. Id. at *32 (citing Merck-086
`at ¶ 117, Table 4, J.A. 4680). Moreover, the Board observed
`that Hausdorff discloses a 13-valent glycoconjugate vaccine
`comprising the same thirteen serotypes added in proposed
`claim 46. See Sanofi Decision at *31, *34. That multiva-
`lent vaccine showed a greater than 2-log increase above
`baseline in serum IgG levels “for every single serotype
`tested.” Id. at *31 (citing Hausdorff at Table 3, J.A. 28170).
`The Board therefore concluded that it would have been ob-
`vious to incorporate the serotype 22F glycoconjugate as
`rendered obvious by Merck-086 and GSK-711 “into a pneu-
`mococcal vaccine with the 13 serotypes . . . disclosed by
`Hausdorff with a reasonable expectation of success in ob-
`taining a 2-log increase above baseline in serum IgG levels
`as required by claim 46.” Sanofi Decision at *34.
`On appeal, Pfizer argues that the Board’s conclusion
`was error because the data in Merck-086 provide “clear ev-
`idence that the claimed 2-log increase across all serotypes
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`PFIZER INC. v. SANOFI PASTEUR INC.
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`would not have been obvious, notwithstanding the immu-
`nogenicity data in Hausdorff.” Pfizer Reply Br. at 24.
`Pfizer argues that “where the prior art contains evidence
`directly showing that others failed to achieve the claimed
`invention (as here), there can be no finding of obviousness.”
`Id. at 25 (citing Univ. of Strathclyde v. Clear-Vu Lighting
`LLC, 17 F.4th 155, 165–66 (Fed. Cir. 2021)). We disagree
`that that is the case here. As explained, Merck-086 dis-
`closes the claimed 2-log IgG increase for a 22F glycoconju-
`gate within a multivalent vaccine, and Hausdorff discloses
`that result for the remaining thirteen claimed glycoconju-
`gates. While neither Merck-086 nor Hausdorff discloses
`the claimed result across all fourteen claimed serotypes, a
`finding of obviousness does not require a guarantee of suc-
`cess. As we have already noted, an expectation of success
`need only be reasonable, not absolute. Pfizer, 480 F.3d at
`1364; Univ. of Strathclyde, 17 F.4th at 165.
`Pfizer’s reliance on Merck-086, alone, ignores other ev-
`idence in the record that suggests that achieving a 2-log
`IgG increase would have been reasonably expected. More-
`over, unlike in University of Strathclyde, the prior art here
`does not evidence “only failures to achieve that at which
`the inventors succeeded.” 17 F.4th at 165 (emphasis
`added). Indeed, each of Merck-086 and Hausdorff clearly
`demonstrated that the claimed 2-log IgG increase could be
`achieved across various serotypes in a multivalent compo-
`sition, which is consistent with the disclosure in the prior
`art that new glycoconjugates could be added to multivalent
`compositions without negatively affecting the components
`already within the vaccine. Id. at *36.
`Accordingly, substantial evidence supports the Board’s
`conclusion that a person of ordinary skill in the art would
`have had a reasonable expectation of success in arriving at
`the composition claimed in proposed claim 46. Therefore,
`the Board did not abuse its discretion in denying Pfizer’s
`motions to amend as to that claim.
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`PFIZER INC. v. SANOFI PASTEUR INC.
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`B
`We now turn to the Board’s treatment of proposed
`claims 48 and 49. Those claims mirror claims 3 and 4 but
`further require the limitation from proposed claim 46 that
`the compositions exhibit more than a 2-log increase above
`baseline in serum IgG levels across all serotypes within the
`claimed composition. That is, proposed claims 48 and 49
`require that, in addition to the 2-log IgG increase across all
`14 serotypes of claim 46, the composition must also exhibit
`that increase with respect to serotypes 15B and 33F for
`claim 48 and with respect to 15B, 33F, 12F, 10A, 11A and
`8 for claim 49.
`The Sanofi Decision is silent as to why proposed claims
`48 and 49 would have been obvious over the references.
`The only mention of those claims in that decision is a con-
`clusory statement, prior to any analysis, that the Board de-
`termined that “claims 46 and 48–52 would have been
`obvious over the combination of Hausdorff, Merck-086,
`GSK-711, and the knowledge of the skilled artisan.” Sanofi
`Decision at *31. The ensuing analysis, however, focuses
`only on the elements of claim 46, and fails to consider
`whether the incorporation of the glycoconjugates recited in
`proposed claims 48 and 49 would have been expected to ex-
`hibit the claimed 2-log IgG increa