`571.272.7822
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`Paper 72
`Entered: November 5, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MERCK SHARP & DOHME CORP.,
`Petitioner,
`
`v.
`
`WYETH LLC,
`Patent Owner.
`_______________
`
`IPR2017-00380
`Patent 8,562,999 B2
`_______________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.1
`
`FRANKLIN, Administrative Patent Judge.
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`
`
`JUDGMENT
`Final Decision on Remand
`Determining Claims 1–6, 10, 11, 14, 17, 19, and 20 Unpatentable
`35 U.S.C. §§ 144, 318
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`
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`1 As explained in the Panel Change Order, Administrative Patent Judge
`Francisco C. Prats replaces Administrative Patent Judge Jacqueline T.
`Harlow, who is no longer with the Patent Trial and Appeal Board. See Paper
`63.
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`IPR2017-00380
`Patent 8,562,999 B2
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`I. INTRODUCTION
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`We address this case on remand after a decision by the U.S. Court of
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`Appeals for the Federal Circuit in Merck Sharp & Dohme Corp. v. Wyeth
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`LLC, 792 F. App’x 813 (Fed. Cir. 2019) (“Merck”).
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`As background, Merck Sharp & Dohme Corp. (“Petitioner”) filed a
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`Petition (Paper 1; “Pet.”) to institute an inter partes review of claims 1–6,
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`10, 11, 14, and 17–20 of U.S. Patent 8,562,999 B2 (Ex. 1001; “the ’999
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`patent”). Wyeth LLC (“Patent Owner”) filed a Patent Owner’s Preliminary
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`Response (Paper 6; “Prelim. Resp.”).
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`On June 13, 2017, we instituted an inter partes review of all
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`challenged claims. Paper 9 (“Dec. Inst.”). On September 13, 2017, Patent
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`Owner filed a Patent Owner Response to the Petition. Paper 16 (“PO
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`Resp.”). On December 13, 2017, Petitioner filed a Reply to the Patent
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`Owner Response. Paper 28 (“Reply”).
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`Petitioner and Patent Owner each filed a Motion to Exclude Evidence.
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`Papers 34 and 38. Each party filed an Opposition to the other party’s
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`motion. Papers 43 and 47. Each party filed also a Reply to the other party’s
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`Opposition. Papers 50 and 55.2 Patent Owner filed Motions for Observation
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`on Cross-Examination Testimony. Papers 39 and 40. Petitioner filed a
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`Response to each of Patent Owner’s Motions for Observation. Paper 44 and
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`45.
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`2 We authorized Patent Owner to file a Revised Reply to Petitioner’s
`Opposition to Patent Owner’s Motion to Exclude Evidence that complied
`with the page limit set forth in 37 C.F.R. § 42.24(c)(2). See Paper 54.
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`IPR2017-00380
`Patent 8,562,999 B2
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`On February 27, 2018, the parties presented arguments at an oral
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`hearing. The hearing transcript has been entered in the record. Paper 56
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`(“Tr.”). We issued a Final Written Decision, in accordance with 37 C.F.R.
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`§ 42.73, on June 8, 2018. Paper 59 (“FWD”). In the Final Written Decision,
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`we determined that Petitioner had shown by a preponderance of the evidence
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`that claims 1–6, 10, 11, 14, 17, 19, and 20 are unpatentable. See 35 U.S.C.
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`§ 316(e). Additionally, we determined that Petitioner had not shown by a
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`preponderance of the evidence that claim 18 is unpatentable. In the Final
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`Written Decision, we also addressed the parties’ Motions to Exclude
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`Evidence, as set forth below in Section III. FWD 37–40.
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`Neither party requested a rehearing of any matter decided in the Final
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`Written Decision. Petitioner, however, appealed the Final Written Decision
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`to the United States Court of Appeals for the Federal Circuit, challenging
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`only our determination that Petitioner had not shown by a preponderance of
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`the evidence that claim 18 is unpatentable.
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`On November 26, 2019, the Federal Circuit issued a decision in
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`Merck vacating and remanding the Final Written Decision for further
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`proceedings. Merck, 792 F. App’x at 814. The Court entered the Mandate
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`on January 2, 2020. Mandate, Merck Sharp & Dohme Corp. v. Wyeth LLC,
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`No. 18-2133 (Fed. Cir. Jan. 2, 2020), ECF No. 71. The Court found that our
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`findings were insufficient to support a determination that Petitioner failed to
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`demonstrate a motivation or a reasonable expectation of success for
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`modifying the prior art to yield the subject matter of dependent claim 18.
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`Merck, 792 F. App’x at 817. In particular, the Federal Circuit explained that
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`the Board “did not address the evidence as to whether someone skilled in the
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`art would have been motivated to combine the 13 serotypes [disclosed in the
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`prior art and recited by claim 18] into a CRM197 conjugate or whether the
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`potential loss of immunogenicity would have dissuaded someone skilled in
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`the art from making such a combination.” Id. at 818.
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`On January 24, 2020, we held a conference call with the parties to
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`discuss their proposals for a procedure on remand, in view of the Board’s
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`Standard Operating Procedure 9 (“SOP 9”), App’x 2, “Guidance for Parties
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`Regarding Remand Procedures.” See Paper 66 (Conduct of the Proceeding
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`Order). As a result, we authorized each party to file a table highlighting
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`arguments and evidence of record previously asserted in this proceeding
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`regarding the challenge to claim 18. Paper 66, 4. We explained that
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`submission of the table was not an opportunity to incorporate by reference
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`any additional evidence or arguments to their previous submissions
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`regarding claim 18. Id. at 5. Thereafter, such briefing was completed. See
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`Paper 67 (Patent Owner’s Citation Table), Paper 68 (Petitioner’s Citation
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`Table).
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`Although the Federal Circuit vacated the Final Written Decision only
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`with respect to “the Board’s obviousness findings with respect to claim 18,”
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`this Decision on Remand includes: our previous, unappealed analysis on the
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`patentability of challenged claims 1–6, 10, 11, 14, 17, 19, and 20; 3 our
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`previous determination on the parties’ Motions to Exclude Evidence, with
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`3 Patent Owner’s appeal was limited to claim 18 and did not challenge the
`findings or conclusions regarding claims 1–6, 10, 11, 14, 17, 19, and 20.
`Our original analysis of claims 1–6, 10, 11, 14, 17, 19, and 20 is included in
`this Decision on Remand only for completeness and we have not revisited
`those claims here.
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`Patent 8,562,999 B2
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`revised remarks relating to Exhibit 1037; 4 and our further discussion
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`regarding the challenges to claim 18. In other words, in this Decision on
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`Remand, we revisit only the challenges to claim 18 and the Motion to
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`Exclude Exhibit with respect to 1037.
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`A. Related Proceedings
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`We issued Final Written Decisions in two additional inter partes
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`reviews challenging claims of the ’999 patent in IPR2017-00378 and
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`IPR2017-00390. Petitioner has appealed our Final Written Decision in
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`IPR2017-00378 and the Federal Circuit has vacated and remanded that
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`decision for the same reasons involved here. Merck, 792 F. App’x at 813–
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`819. The Decision on Remand in that case is issued concurrently with the
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`Decision on Remand in the instant case.
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`B. The ’999 patent
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`In some aspects, the ’999 patent relates to formulations comprising an
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`immunogen in the form of a polysaccharide-protein conjugate, a pH buffered
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`saline solution, and an aluminum salt. Ex. 1001, 2:62–64, 12:9–15. The
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`Specification defines the term “polysaccharide” as including “any antigenic
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`saccharide element (or antigenic unit) commonly used in the immunologic
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`and bacterial vaccine arts, including, but not limited to, a ‘saccharide’, an
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`‘oligosaccharide’, a ‘polysaccharide’, a ‘liposaccharide’, a ‘lipo-
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`oligosaccharide (LOS)’, a ‘lipopolysaccharide (LPS)’, a ‘glycosylate’, a
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`4 Petitioner submits Exhibit 1037 and identifies it as “Ireland EPA
`Memorandum regarding ‘Application for IPC licence from AHP
`Manufacturing B.V. Trading as Wyeth Medica Ireland for the Wyeth
`BioPharma Campus at Grange Castle Reg. No. 652’ (June
`11, 2003).” Pet. viii.; Ex. 1037 (“Ireland EPA Memo”).
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`‘glycoconjugate’ and the like.” Id. at 16:32–38.
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`In certain embodiments, the compositions further comprise a
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`surfactant. Id. at 12:65–67. The Specification explains that a suitable
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`surfactant is one that “stabilizes and inhibits aggregation of an immunogenic
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`composition described herein.” Id. at 13:9–12. According to the
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`Specification, in one aspect, the “invention relates to the unexpected and
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`surprising results that formulating an immunogenic composition with a
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`surfactant such as TweenTM80 significantly enhances the stability and
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`inhibits precipitation of an immunogenic composition.” Id. at 10:35–39.
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`The container means includes, among other items, syringes and vials.
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`Id. at 3:2–8. The Specification explains that “silicone oil is a necessary
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`component of plastic syringes, as it serves to lubricate the rubber plunger
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`and facilitate transfer of the plunger down the syringe barrel.” Id. at 2:31–
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`34. Additionally, silicone oil is used as a coating for glass vials to minimize
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`protein adsorption, and as a lubricant. Id. at 2:37–41. According to the
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`Specification, “[i]t has been suggested in the art, that silicone oil, which
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`induces protein secondary and tertiary conformational changes, might be
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`responsible for the aggregation/precipitation seen in certain protein
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`pharmaceutical preparations.” Id. at 2:17–20 (citation omitted). To address
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`that issue, the Specification states that the invention “broadly relates to novel
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`formulations which stabilize and inhibit precipitation of immunogenic
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`compositions.” Id. at 2:53–55. More specifically, certain embodiments of
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`the invention relate to formulations that inhibit precipitation of immunogenic
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`compositions comprised in siliconized container means. Id. at 5:44–50.
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`C. Illustrative Claims
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`Independent claim 1 and dependent claim 18 of the ’999 patent are
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`illustrative and reproduced below:
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`1. A formulation comprising (i) a pH buffered saline
`solution, wherein the buffer has a pKa of about 3.5 to about 7.5,
`(ii) an aluminum salt and (iii) one or more polysaccharide-
`protein conjugates, wherein the formulation is comprised in a
`siliconized container means and inhibits aggregation induced by
`the siliconized container means.
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`18. The formulation of claim 1, wherein the one or more
`polysaccharide-protein conjugate comprises an S. pneumoniae
`serotype 4 polysaccharide conjugated to a CRM197 polypeptide,
`an S. pneumoniae serotype 6B polysaccharide conjugated to a
`CRM197 polypeptide, an S. pneumoniae serotype 9V
`polysaccharide conjugated to a CRM197 polypeptide, an S.
`pneumoniae serotype 14 polysaccharide conjugated to a
`CRM197 polypeptide, an S. pneumoniae serotype 18C
`polysaccharide conjugated to a CRM197 polypeptide, an S.
`pneumoniae serotype 19F polysaccharide conjugated to a
`CRM197 polypeptide, an S. pneumoniae serotype 23F
`polysaccharide conjugated to a CRM197 polypeptide, an S.
`pneumoniae serotype 1 polysaccharide conjugated to a CRM197
`polypeptide, an S. pneumoniae serotype 3 polysaccharide
`conjugated to a CRM197 polypeptide, an S. pneumoniae
`serotype 5 polysaccharide conjugated to a CRM197 polypeptide,
`an S. pneumoniae serotype 6A polysaccharide conjugated to a
`CRM197 polypeptide, an S. pneumoniae serotype 7F
`polysaccharide conjugated to a CRM197 polypeptide and an S.
`pneumoniae serotype 19A polysaccharide conjugated to a
`CRM197 polypeptide.
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`Ex. 1001, 31:7–12, 32:24–44.
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`In addition to claim 18, claims 26, 10, 14, 17, and 19 depend directly
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`from claim 1. Claim 11 depends from claim 10. Claim 20 depends from
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`claim 19.
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`D. The Asserted Grounds of Unpatentability
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`Petitioner challenges the patentability of the claims as follows:
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`Claim(s) Challenged
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`35 U.S.C. §
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`References
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`16, 10, 11, 14, 17–20
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`103(a)
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`Prevenar5, Chiron6
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`18
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`103(a)
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`Prevenar, Chiron, Peña7
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`Petitioner also relies on the Declarations of Dennis L. Kasper, M.D.
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`(Ex. 1007), Devendra Kalonia, Ph.D. (Ex. 1009), Christopher Jones, Ph.D.
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`(Ex. 1119), and Harm HogenEsch, D.V.M., Ph.D. (Ex. 1122). Patent Owner
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`relies on the Declarations of Paul Dalby Ph.D. (Ex. 2116), Ali Fattom, Ph.D.
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`(Ex. 2118), Lakshmi Khandke, Ph.D. (Ex. 2119), Garry Morefield, Ph.D.
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`(Ex. 2121), and James W. Thomson, Ph.D. (Ex. 2124).
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`II. ANALYSIS
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`A. Claim Construction
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`For petitions filed before November 13, 2018—as here—the Board
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`interprets claim terms in an unexpired patent according to the broadest
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`reasonable construction in light of the specification of the patent in which
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`they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136
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`S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable
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`construction standard to inter partes review proceedings). Under that
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`5 Summary of Product Characteristics for Prevenar Suspension for injection:
`Pneumococcal saccharide conjugated vaccine, adsorbed, Annex 1:1–15
`(2005). Ex. 1017 (“Prevenar”).
`6 Patent Application Publication No. WO 2003/009869 A1 by Mario
`Contorni et al., published February 6, 2003. Ex. 1011 (“Chiron”).
`7 de la Peña et al., Present and future of the pneumonia vaccination, 24(4)
`PEDIATRIKA 47–55(2004) (English Translation). Ex. 1015 (“Peña”).
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`standard, and absent any special definitions, we give claim terms their
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`ordinary and customary meaning, as would be understood by one of ordinary
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`skill in the art at the time of the invention. In re Translogic Tech., Inc., 504
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`F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms
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`must be set forth with reasonable clarity, deliberateness, and precision. In re
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`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
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`Petitioner and Patent Owner propose constructions for certain claims
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`terms. Pet. 33–38; PO Resp. 12–21. As relevant to this Decision, we
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`address the following claim terms:
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`1. “polysaccharide” and “polysaccharide-protein conjugates”
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`Petitioner asserts that the broadest reasonable interpretation of the
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`claim term “polysaccharide” is set forth in the Specification. Pet. 33–35. In
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`particular, the Specification defines “polysaccharide” as including “any
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`antigenic saccharide element (or antigenic unit) commonly used in the
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`immunologic and bacterial vaccine arts, including, but not limited to, a
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`‘saccharide’, an ‘oligosaccharide’, a ‘polysaccharide’, a ‘liposaccharide’, a
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`‘lipo-oligosaccharide (LOS)’, a ‘lipopolysaccharide (LPS)’, a ‘glycosylate’,
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`a ‘glycoconjugate’ and the like.” Ex. 1001, 16:32–38. Patent Owner
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`similarly acknowledges that the term “polysaccharide” is expressly defined
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`in the Specification. PO Resp. 12.
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`Petitioner does not propose a separate construction for the claim
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`phrase “polysaccharide-protein conjugates.” Patent Owner, however, asserts
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`that the broadest reasonable interpretation of that claim phrase is:
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`a conjugate resulting from reacting any antigenic saccharide
`element (or antigenic unit) commonly used in the immunologic
`and bacterial vaccine arts, including but not limited to, a
`saccharide,
`an
`oligosaccharide,
`a
`polysaccharide,
`a
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`liposaccharide, a
`lipooligosaccharide, a
`liposaccharide, a
`glycosylate, a glycoconjugate, and the like with a carrier protein,
`that is amenable to standard conjugation procedures, wherein the
`antigenic
`saccharide element
`retains antigenicity after
`conjugation.
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`PO Resp. 13 (underlining removed). Patent Owner notes that its proposed
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`construction is “rooted in the preliminary construction adopted by the
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`Board,” but adds the requirement that the antigenic saccharide element
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`retains antigenicity after conjugation. Id.
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`Patent Owner asserts that “a purpose of the invention is to provide
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`formulations that preserve the antigenicity of immunogenic formulations.”
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`Id. at 14. According to Patent Owner, the “inhibition of aggregation/
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`precipitation” described in the Specification is a “proxy for whether there is
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`a loss of antigenicity in the formulation.” Id. Patent Owner asserts that it
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`would be “improper to ignore the properties (i.e., antigenicity) of the
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`conjugate” when construing the claim. Id. at 13–14 In support of its
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`proposed construction, Patent Owner identifies various instances in the
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`Specification wherein the polysaccharide-protein conjugate is referred to as
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`an “immunogen” or “immunogenic” composition. Id. at 14 (citing, e.g., Ex.
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`1001, 14:19–23) (“the immunogen (i.e., a polysaccharide-protein
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`conjugate . . .)”).
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`Patent Owner draws our attention to the Specification discussion in
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`the “Background of the Invention” section that “the immunogenic
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`composition must be active throughout its ‘expected’ shelf life, wherein any
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`breakdown of the immunogenic composition to an inactive or otherwise
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`undesired form (e.g., an aggregate) lowers the total concentration of the
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`product.” Id. (quoting Ex. 1001, 1:41–46). According to Patent Owner and
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`its declarant, Dr. Thomson, a person of skill in the art would have
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`understood an active polysaccharide-protein conjugate composition to mean
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`an active immunogenic composition. Id. (citing Ex. 2124 ¶ 39). Patent
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`Owner asserts that “[f]or an immunogen to be capable of inducing an
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`immune response in a body, the immunogen must be antigenic.” Id. Patent
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`Owner asserts that “[a]ntigenicity is a prerequisite for immunogenicity.” Id.
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`at 15. According to Patent Owner, although immunogenicity is not recited
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`in the claims, it is related to a property recited in the claims, i.e., that the
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`formulation “inhibits aggregation induced by the siliconized container
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`means.” Id. Patent Owner asserts that “silicone-induced aggregation is
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`assessed by measuring antigenicity to determine the extent of the loss of
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`antigenicity due to silicone-induced aggregation.” Id. (citing Ex. 1001,
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`Example 4).
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`Petitioner asserts that the “Board should reject Patent Owner’s
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`proposed ‘antigenicity’ limitation for the same reasons it rejected the
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`importation of an ‘immunogenicity’ requirement” in the Institution Decision,
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`because Patent Owner refers to “antigenicity” as a “prerequisite for
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`immunogenicity.” Reply 5–6 (citing PO Resp. 15).
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`Based on the record as a whole, we determine that the Specification
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`sets forth with reasonable clarity, deliberateness, and precision the definition
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`of the term “polysaccharide,” as accurately represented by Petitioner, and
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`acknowledged by Patent Owner. With respect to the phrase
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`“polysaccharide-protein conjugates,” the Specification does not provide a
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`similarly precise definition. However, the Specification generally describes
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`such conjugates in a manner that is consistent with the plain and ordinary
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`meaning of the phrase. For example, the Specification explains that
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`polysaccharides are “chemically activated (e.g., via reductive amination) to
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`make the saccharides capable of reacting with the carrier protein.” Ex. 1001,
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`17:35–37. The Specification also explains that “[c]arrier proteins should be
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`amenable to standard conjugation procedures.” Id. at 17:47–50. In
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`particular, the Specification states, “[t]he chemical activation of the
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`polysaccharides and subsequent conjugation to the carrier protein (i.e., a
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`polysaccharide-protein conjugate) are achieved by conventional means.” Id.
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`at 17:43–45. Moreover, as Patent Owner asserts, the Specification describes
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`the polysaccharide-protein conjugates as an example of an “immunogenic
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`composition.” Ex. 1001, 1:29–30.
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`In light of those Specification descriptions, we determine that the
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`broadest reasonable construction of the claim phrase “polysaccharide-protein
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`conjugates” refers to an immunogenic composition resulting from reacting
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`any antigenic saccharide element (or antigenic unit) commonly used in the
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`immunologic and bacterial vaccine arts, including, but not limited to, a
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`saccharide, an oligosaccharide, a polysaccharide, a liposaccharide, a lipo-
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`oligosaccharide, a lipopolysaccharide, a glycosylate, a glycoconjugate, and
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`the like with a carrier protein that is amenable to standard conjugation
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`procedures.
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`Although we recognize that the claimed invention is directed toward
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`an immunogenic composition, we also note that the claims do not recite any
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`specific level of immunogenicity for the composition. The Specification
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`explains that the invention “broadly relates to novel formulations which
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`stabilize and inhibit precipitation of immunogenic compositions.” Ex. 1001,
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`2:53–55. The Specification describes aggregation as an indicator of
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`physical/thermal stability of the immunogenic composition. Id. at 2:7–8.
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`Breakdown of the composition to an undesired form (e.g., an aggregate)
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`lowers the total concentration of the product. Id. at 1:43–46.
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`Insofar as Patent Owner asserts that the claims require “measuring
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`antigenicity to determine the extent of the loss of antigenicity due to
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`silicone-induced aggregation,” as in Example 4 of the Specification, PO
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`Resp. 15, we disagree. Although Example 4 discusses total antigenicity (and
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`loss), the claims do not require the formulation to retain a particular degree
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`of immunogenicity. Instead, the claims are directed to a formulation
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`comprising a polysaccharide-protein conjugate, i.e., an “immunogen,” see,
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`e.g., Ex. 1001, 14:19–23, wherein the formulation inhibits aggregation8
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`induced by the siliconized container means. The presence of a
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`polysaccharide-protein conjugate confers the immunogenic element of the
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`claim. While performing an immunoassay to measure loss of antigenicity,
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`as in Example 4, may provide information regarding whether silicone-
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`induced aggregation has occurred, such an assay is not required to meet the
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`“protein-polysaccharide conjugate” element of the claim. Moreover, as
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`explained in each example described in the Specification, the occurrence of
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`aggregation/precipitation may be detected upon visual inspection. See, e.g.,
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`Ex. 1001, 27:6–11 (discussing visual inspection for precipitation).
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`2. “the formulation . . . inhibits aggregation induced by the
` siliconized container means”
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`Petitioner asserts this claim phrase “recites a property of the
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`formulation as a whole, without attributing inhibitory effect to any specific
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`ingredient recited in the claim.” Pet. 37 (citing Ex. 1009 ¶ 95). For
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`8 See Ex. 1001, 12:38–40 (describing interchangeable use of the terms
`“precipitation” and “aggregation”).
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`example, Petitioner asserts that the plain language of the claim does not
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`require that the aluminum salt inhibits silicone-induced aggregation. Id. at
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`37–38 (citing Ex. 1009 ¶ 96). According to Petitioner, because independent
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`claim 1 recites a “formulation” followed by an open-ended term,
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`“comprising,” any element(s) comprised in the formulation may contribute
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`the required inhibition, so long as the formulation as a whole “inhibits
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`aggregation induced by the siliconized container means.” Id.
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`Patent Owner asserts that this claim phrase means that “the
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`formulation inhibits antigenicity loss of the polysaccharide component of the
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`polysaccharide-protein conjugate that can occur as a result of aggregation
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`induced by the siliconized container.” PO Resp. 16. In support of that
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`construction, Patent Owner relies again upon the antigenicity assessment
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`described in Example 4 of the Specification. Id. at 16–19. According to
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`Patent Owner, although visual inspection is used in the Specification
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`examples to observe particulates, such inspection did not indicate whether
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`the polysaccharide components of the vaccine maintained or lost antigenicity
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`as a result of aggregation. Id. at 18.
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`Further, Patent Owner asserts that the “broadest reasonable
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`interpretation of claim 1 should go no further than to read on embodiments
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`that contain the three recited ingredients in a formulation that meets the
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`functional property limitation.” Id. at 21. According to Patent Owner, the
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`functional requirement of inhibiting aggregation induced by the siliconized
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`container means must be satisfied by “a formulation of the three specifically
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`recited ingredients [buffered saline solution, aluminum salt, and
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`polysaccharide-protein conjugate], without any un-recited ingredient(s).” Id.
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`at 20.
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`Having considered the arguments and evidence, we agree with
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`Petitioner’s rationale that claim 1 “recites a property of the formulation as a
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`whole, without attributing inhibitory effect to any specific ingredient recited
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`in the claim.” Pet. 37. Further, we agree with Patent Owner that the claim
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`element “the formulation . . . inhibits aggregation induced by the siliconized
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`container means” may be interpreted to include an embodiment wherein the
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`three specific ingredients recited in the claim, i.e., buffered saline solution,
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`aluminum salt, and polysaccharide-protein conjugate, cause inhibition of
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`aggregation induced by the siliconized container means. See PO Resp. 19–
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`20. However, we do not agree with Patent Owner that the broadest
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`reasonable interpretation ends there. Rather, we determine that by reciting
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`the formulation using the open-ended term “comprising,” along with
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`attributing the aggregation inhibition property to “the formulation,” the
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`broadest reasonable construction also includes formulations comprising
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`additional, unrecited ingredients, and such additional ingredient(s) may
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`contribute to the required aggregation inhibition by the formulation. See In
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`re Baxter, 656 F.2d 679, 686 (CCPA 1981) (use of the term “comprising” in
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`a preamble of a claim permits inclusion of elements in addition to those
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`specified in the claims); CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d
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`1356, 1360 (Fed. Cir. 2007) (“In the patent claim context the term
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`‘comprising’ is well understood to mean ‘including but not limited to.’”).
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`Further, we do not determine that the claim phrase requires
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`maintaining any specific level of antigenicity of the conjugate, as asserted by
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`Patent Owner, PO Resp. 16–18, for the same reasons discussed above, with
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`respect to Patent Owner’s similar argument raised in connection with its
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`proposed construction of the “polysaccharide-protein conjugate” term.
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`In view of our analysis, we determine that no additional claim terms
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`require construction for the purpose of this Decision. See Vivid Techs., Inc.
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`v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only terms
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`which are in controversy need to be construed, and only to the extent
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`necessary to resolve the controversy).
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`B. Level of Ordinary Skill in the Art
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`The level of skill in the art is a factual determination that provides a
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`primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v.
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`VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham v. John
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`Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-Star, Inc., 950
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`F.2d 714, 718 (Fed. Cir. 1991)).
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`Petitioner asserts that a person of ordinary skill in the art at the time of
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`the invention would have had either (a) “a Ph.D. degree in the
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`pharmaceutical sciences, physical chemistry or protein chemistry, at least 2
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`years of work experience formulating protein-based compositions, and
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`would have had familiarity or experience with the general components of
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`bacterial vaccines,” or (b) “a Master’s degree in the pharmaceutical sciences,
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`physical chemistry or protein chemistry, at least 4 years of work experience
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`formulating protein-based compositions, and would have had familiarity or
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`experience with the general components of bacterial vaccines.” Pet. 32
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`(citing Ex. 1009 ¶ 80).
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`Patent Owner relies upon its definition of the level of ordinary skill in
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`the art set forth in the Patent Owner Preliminary Response. PO Resp. 21. In
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`that filing, Patent Owner disagreed with Petitioner’s definition insofar as it
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`suggests the field of invention involved protein-based formulations. Prelim.
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`Resp. 10. According to Patent Owner, a person of ordinary skill in the art at
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`the time of the invention would have had either (a) “a Ph.D. degree in the
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`pharmaceutical sciences, physical chemistry or protein chemistry, at least
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`two years of work experience formulating polysaccharide-protein conjugate
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`immunogenic compositions, and would have had familiarity or experience
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`with the general components and formulation of bacterial vaccines,” or (b)
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`“a Master’s degree in the pharmaceutical sciences, physical chemistry or
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`protein chemistry, at least four years of work experience formulating
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`polysaccharide-protein conjugate immunogenic compositions, and would
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`have had familiarity or experience with the general components and
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`formulation of bacterial vaccines.” Id. at 10–11.
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`In the Institution Decision, we adopted Patent Owner’s description of
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`the level of ordinary skill at that stage in the proceeding because it included
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`a requirement for experience relating to polysaccharide-protein conjugates.
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`Dec. Inst. 13. Based on the record as a whole, we determine that a declarant
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`having significant experience relating to protein-silicone oil interactions also
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`offers useful information relating to the subject matter of the challenged
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`claims. Thus, we also recognize those having ordinary skill in the art
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`relating to silicone-induced interactions/aggregation in pharmaceuticals.
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`Thus, we adopt Patent Owner’s description of one having ordinary
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`skill in the art of formulating polysaccharide-protein conjugate
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`immunogenic compositions. Further, we describe one having ordinary skill
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`in the art of silicone-induced interactions/aggregation in pharmaceuticals as
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`either (a) a Ph.D. degree in the pharmaceutical sciences, physical chemistry
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`or protein chemistry, at least two years of work experience involving
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`researching silicone-induced interactions/aggregation in pharmaceuticals, or
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`(b) a Master’s degree in the pharmaceutical sciences, physical chemistry or
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`protein chemistry, at least four years of work experience involving
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`researching silicone-induced interactions/aggregation in pharmaceuticals.
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`We also note that the applied prior art reflects the appropriate level of
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`skill at the time of the claimed invention. See Okajima v. Bourdeau, 261
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`F.3d 1350, 1355 (Fed. Cir. 2001). We recognize each of Petitioner’s and
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`Patent Owner’s declarants as qualified to provide the offered opinions on the
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`level of skill and the knowledge of a person of ordinary skill in the art at the
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`time of the invention with respect to formulating polysaccharide-protein
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`conjugates and/or silicone-induced interactions/aggregation in
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`pharmaceuticals. The relative weight that we assign such testimony,
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`however, is subject to additional factors. See, e.g., Office Patent Trial
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`Practice Guide, 77 Fed. Reg. 48,756, 48,763 (Aug. 14, 2012) (“Opinions
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`expressed without disclosing the underlying facts or data may be given little
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`or no weight.”).
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`Petitioner does not challenge the expertise of any of Patent Owner’s
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`declarants. Patent Owner, however, asserts that Petitioner’s declarants,
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`Drs. Kalonia and Kasper, lack “experience in developing polysaccharide-
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`protein conjugate formulations, and certainly not on a commercial scale.”
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`PO Resp. 21–22. Regarding Dr. Kalonia, Patent Owner asserts that his
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`experience is “limited to the aggregation of proteins in formulations on a
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`laboratory scale.” Id. at 20. However, as described in Dr. Kalonia’s
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`declaration, such experience involves “significant research experience in
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`protein-interface, protein-protein, and protein-excipient interactions,
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`including interactions among protein, silicone oil