`Patent Owner’s Motion to Strike
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`Adam R. Brausa (Reg No. 60,287)
`Daralyn J. Durie (Pro Hac Vice)
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
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`Filed on behalf of Patent Owner Genentech, Inc. by:
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`David L. Cavanaugh (Reg. No. 36,476)
`Lauren V. Blakely (Reg. No. 70,247)
`Robert J. Gunther, Jr. (Pro Hac Vice)
`Lisa J. Pirozzolo (Pro Hac Vice)
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`Kevin S. Prussia (Pro Hac Vice)
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`Andrew J. Danford (Pro Hac Vice)
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`WILMER CUTLER PICKERING
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` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
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`Washington, DC 20006
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`PFIZER, INC. AND
`SAMSUNG BIOEPIS CO., LTD.;
`Petitioners,
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`v.
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`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`Case IPR2017-014881
`U.S. Patent No. 6,407,213
`____________________________________________
`PATENT OWNER’S MOTION TO STRIKE
`PURSUANT TO PAPER NO. 60
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`1 Case IPR2017-02139 has been joined with this proceeding.
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`IPR2017-01488
`Patent Owner’s Motion to Strike
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`TABLE OF CONTENTS
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`I.
`II.
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`2.
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`C.
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`Page
`PETITIONERS’ EVOLVING INVALIDITY THEORY ............................... 1
`PETITIONERS’ NEW ARGUMENTS ARE FORECLOSED BY
`FEDERAL CIRCUIT PRECEDENT, STATUTE, AND THE
`BOARD’S REGULATIONS ........................................................................... 2
`A. Applicable Law ..................................................................................... 2
`B.
`Petitioners’ Reliance on Foote 1989 is Improper .................................. 4
`1.
`Petitioners’ arguments and testimony regarding Foote 1989
`present a new theory of unpatentability ...................................... 4
`The prejudice to Patent Owner outweighs any marginal
`relevance of Foote 1989 to unexpected results ........................... 6
`Petitioners’ Arguments as to the Kurrle Reference Are
`Improper ................................................................................................ 9
`III. CONCLUSION .............................................................................................. 10
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`Apple Inc. v. e-Watch Inc.,
`IPR2015-00412, Paper 50 (PTAB May 6, 2016) ................................................. 3
`Coherus Biosciences Inc. v. AbbVie Biotech. Ltd.,
`IPR2016-00188, Paper 54 (PTAB Jun. 9, 2017) .................................................. 5
`Cox Comms., Inc. v. AT&T Intellectual Prop. II, L.P,
`IPR2015-01187, Paper 59 (PTAB Nov. 15, 2016) ............................................... 6
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litigation,
`676 F.3d 1063 (Fed. Cir. 2012) ............................................................................ 7
`Dexcom, Inc. v. Waveform Techs, Inc.,
`IPR2016-01679, Paper 53 (PTAB Feb. 28, 2018) ................................................ 3
`Intelligent-BioSystems, Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ........................................................................ 3, 8
`Mylan Pharm. Inc. v. UCB Pharma GmbH,
`IPR2016-00517, Paper 37 (PTAB Jul. 19, 2017) ............................................... 10
`Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc.,
`853 F.3d 1272 (Fed. Cir. 2017) .............................................................. 3, 5, 8, 10
`Federal Statutes
`35 U.S.C. § 312(a) ..................................................................................................... 3
`35 U.S.C. § 325(d) ..................................................................................................... 8
`Regulations
`37 C.F.R. § 42.23 (b) ............................................................................................. 2, 3
`Patent Trial Practice Guide, 77 Fed. Reg. 48,612, 48,620 (Aug. 14,
`2012) ..................................................................................................................... 2
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`IPR2017-01488
`Patent Owner’s Motion to Strike
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`Pursuant to Paper No. 60, Patent Owner files this motion to strike new
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`evidence and argument presented in Petitioners’ Reply (Paper 57) pertaining to the
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`alleged disclosure of a “consensus” sequence in the prior art. First, Petitioners
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`argue that a new exhibit, Foote 1989 (Ex. 1193), teaches that a “consensus”
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`sequence was used by Petitioners’ expert to generate the humanized antibody in
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`Riechmann 1988 (Ex. 1069). Neither Foote 1989 nor Riechmann 1988 were cited
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`or discussed in the Petition. Second, Petitioners present a new argument that
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`Kurrle (Ex. 1071) discloses a humanized antibody with a “consensus” sequence.
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`For the reasons set forth below, the Board should strike:
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` Exhibit 1193 submitted with Petitioners’ Reply and the associated arguments
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`and testimony that rely on this exhibit, including the first full paragraph of
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`Page 27 of the Reply; Ex. 1202, ¶¶ 12, 41-43, 79, 82, 119, 162, and 187; Ex.
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`1197, 176:25-178:23; Ex. 2039, 327:12-331:11.
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` The last paragraph of page 16 and the graphic on page 17 of the Reply and
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`the testimony relying on Petitioners’ new theory including: Ex. 1202, ¶¶7,
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`12, 82, 104-106, 119, 160-162, 187; Ex. 1197, 2258:3-263:21; 264:9-
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`267:18; 267:24-268:12; Ex. 2039, 313:7-320:11.
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`I.
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`PETITIONERS’ EVOLVING INVALIDITY THEORY
` Claims 4, 33, 62, 64, and 69 require the use of “consensus” sequence. The
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`’213 patent provides a specific definition of the claimed human “consensus”
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`1
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`sequence, “which comprises the most frequently occurring amino acid residues at
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`each location in all human immunoglobulins of any particular subclass or subunit
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`structure.” (Ex 1001, 11:32-38; see also Paper 27 at 8.) The Petition argued that
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`the “consensus” limitation was met by Queen 1990’s (Ex. 1050) disclosure of
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`“us[ing] a consensus framework from many human antibodies.” (See, e.g., Paper 1
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`at 36-37, 39, 45-47, 50.) Petitioners did not argue in the Petition that Foote 1989,
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`Riechmann 1988, or Kurrle anticipate, render obvious, or otherwise disclose a
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`“consensus” sequence as claimed in the ’213 patent.
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`Consistent with the arguments in the Petition, Patent Owner’s Response
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`focused on showing that Queen 1990 does not teach the “consensus” sequence
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`limitations of claims 4, 33, 62, 64, and 69. (See, e.g., Paper 45 at 48-49.) For the
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`first time in their Reply, Petitioners pivot from relying solely on Queen 1990 with
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`respect to the “consensus” sequence limitations, and now invite the Board to find
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`those limitations in a new reference, Foote 1989, as well as in Kurrle.
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`II.
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`PETITIONERS’ NEW ARGUMENTS ARE FORECLOSED BY
`FEDERAL CIRCUIT PRECEDENT, STATUTE, AND THE BOARD’S
`REGULATIONS.
`A. Applicable Law
`Evidence introduced in a reply “must be responsive and not merely new
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`evidence that could have been presented earlier” to support the petition. Patent
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`Trial Practice Guide, 77 Fed. Reg. 48,612, 48,620 (Aug. 14, 2012); see also 37
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`C.F.R. § 42.23 (b) (“A reply may only respond to arguments raised in the … patent
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`owner response.”). But “‘[r]espond,’ in the context of 37 C.F.R. § 42.23(b), does
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`not mean embark in a new direction with a new approach as compared to the
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`position originally taken in the Petition.” Apple Inc. v. e-Watch Inc., IPR2015-
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`00412, Paper 50 at 44 (PTAB May 6, 2016).
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`When a reply strays from “explaining how [the] original petition was
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`correct” and begins arguing new theories of unpatentability or relying on
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`references not disclosed in the petition, this amounts to a shifting of arguments that
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`is “foreclosed by statute, our precedent, and Board Guidelines.” Wasica Fin.
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`GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286–87 (Fed. Cir. 2017); see also
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`Dexcom, Inc. v. Waveform Techs, Inc., IPR2016-01679, Paper 53 at 50 (PTAB
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`Feb. 28, 2018) (evidence necessary to make out a prima facie case of
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`unpatentability may not be introduced for the first time in the reply brief); 35
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`U.S.C. § 312(a) (petition must identify “with particularity” the evidence supporting
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`the grounds). Thus, “[i]t is of the utmost importance that petitioners in the IPR
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`proceedings adhere to the requirement that the initial petition identify with
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`particularity the evidence that supports the grounds for the challenge to each claim
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`….” Intelligent-BioSystems, Inc. v. Illumina Cambridge, Ltd., 821 F.3d 1359,
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`1369-70 (Fed. Cir. 2016); id. at 1370 (“[T]he expedited nature of IPRs bring with it
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`an obligation for petitioners to make their case in their petition to institute.”).
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`B.
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`Petitioners’ Reliance on Foote 1989 is Improper.
`1.
`Petitioners’ arguments and testimony regarding Foote 1989
`present a new theory of unpatentability.
`Petitioners invite the Board to find the “consensus” sequence in a reference
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`other than Queen 1990—in the form of Exhibit 1193, a publication titled
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`“Humanized Antibodies” and authored by Petitioners’ expert, Jefferson Foote.
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`Petitioners argue that Foote 1989 supports the conclusion that the work described
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`in Riechmann 1988 was performed using a consensus sequence. (Reply at 27.)
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`However, neither of these references was disclosed or discussed in the Petition.
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`Although Petitioners’ discussion of Foote 1989 in the Reply is in a section
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`addressing secondary considerations, Petitioners’ reliance on Foote 1989 is not
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`limited to rebuttal on secondary considerations. Dr. Foote’s Reply Declaration
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`cites to Foote 1989 throughout his analysis, including when addressing Petitioners’
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`affirmative evidence of obviousness. (Ex. 1202, ¶¶ 12, 41, 61, 79, 82, 119, 162,
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`187.) For example, in addressing the “consensus” limitations of the challenged
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`claims, Dr. Foote cites to Ex. 1193 to argue “[t]he skilled artisan would know that
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`a consensus sequence had been used previously.” (Ex. 1202, ¶162; see also id.,
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`¶12 (arguing he “used a consensus sequence derived from Kabat (1983) to
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`humanize the light chain of an anti-lysozyme antibody starting in 1986” and that
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`Dr. Riechmann used that light chain to generate a humanized antibody prior to
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`Queen 1990); ¶79 (“[S]killed artisans, including myself, had used the same
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`‘consensus sequence approach’ in humanizing antibodies before the ’213 patent.”),
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`¶119 (“I used an earlier edition of Kabat [1987] to identify the consensus sequence
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`I used for my anti-lysozyme light chain….”).)
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`Petitioners’ reliance on Foote 1989 goes far beyond “explaining how [the]
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`original petition was correct” and instead encourages the Board to rely on evidence
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`outside the instituted grounds to find the challenged claims unpatentable. See
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`Wasica, 853 F.3d at 1286-87; see also Coherus Biosciences Inc. v. AbbVie Biotech.
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`Ltd., IPR2016-00188, Paper 54 at 22-23, (PTAB Jun. 9, 2017) (a shift in argument
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`from “half-life alone” as a motivation to combine, to reliance on “half-life as a
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`factor” improper under Wasica). The only attempted connection to the Petition is
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`a citation by Dr. Foote in his Reply Declaration back to ¶103 of his initial
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`declaration where he discussed the work of Dr. Riechmann as part of the
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`“background” of the patent. (Ex. 1202, ¶42; Ex. 1003, ¶103.) But a single
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`paragraph in Dr. Foote’s original declaration, cited in the Petition only as part of a
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`string citation (Paper 1 at 11), is insufficient to put Patent Owner on notice that
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`Petitioners would rely on additional publications to argue that substantive elements
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`of the claims were known in the prior art.2
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`2 Dr. Foote’s original declaration spans 354 paragraphs over 194 pages and
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`Moreover, even if Petitioners were correct that Foote 1989 shows the use of
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`a “consensus” sequence, that cannot cure the deficiencies in the Petition’s
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`arguments that the claims are anticipated by Queen 1990 (Ground 2). Nor does it
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`speak to whether it would have been obvious for a skilled artisan to combine
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`Queen 1990 with Kurrle (Ground 3) or Hudziak (Ground 8) to derive the claimed
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`invention. See Cox Comms., Inc. v. AT&T Intellectual Prop. II, L.P, IPR2015-
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`01187, Paper 59 at 16-17 (PTAB Nov. 15, 2016) (declining to consider
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`obviousness combination where a “background reference” would be substituted for
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`part of instituted reference, finding the assertion comprised a “new argument of
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`unpatentability,” and “trial was not instituted on this ground”).
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`2.
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`The prejudice to Patent Owner outweighs any marginal
`relevance of Foote 1989 to unexpected results.
`Petitioners’ citation to Foote 1989 under the heading of “[n]o unexpected
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`results” does not nullify Petitioners use of new evidence to argue that core claim
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`elements were disclosed in the prior art. Using Foote 1989 to rebut unexpected
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`results makes little practical sense. If Petitioners are correct that Queen 1990
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`discloses using a consensus sequence (it does not), then the addition of another
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`reference showing that the prior art disclosed the same thing adds nothing to
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`includes pages of discussion pertaining to grounds not asserted in the Petition.
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`6
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`Petitioners’ response to “unexpected results”; Petitioners could simply rely on
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`Queen 1990. And, in any event, Petitioners raised unexpected results in the
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`Petition (see, e.g., Paper 1 at 65) and did not argue that any prior art antibodies
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`embody the consensus sequence limitation.
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`The substantial prejudice caused by Petitioners’ reliance on a new piece of
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`evidence to teach missing claim elements—even if in context of secondary
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`considerations—greatly outweighs any marginal relevance of Foote 1989 to the
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`secondary considerations debate. The Federal Circuit has required that all
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`evidence—including objective indicia of non-obviousness—must be considered
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`together before finding a patent invalid as obviousness. In re Cyclobenzaprine
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`Hydrochloride Extended-Release Capsule Patent Litigation, 676 F.3d 1063, 1079-
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`80 (Fed. Cir. 2012). Here, it is clear that Petitioners are attempting to use Foote
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`1989 to fill the gaps in Petitioners’ prima facie case. (See supra pp. 4-7.)
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`Moreover, Petitioners should have been aware of Foote 1989 before filing
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`the Petition at least because, as Petitioners note in Reply, Foote 1989 is
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`substantively discussed in the prosecution history. (See, e.g., Reply at 27.)3 More
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`3 Whether Patent Owner was on notice of the existence of Foote 1989 is a separate
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`question from whether Patent Owner was on notice of Petitioners’ reliance on
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`Foote 1989 to teach the “consensus” sequence limitations of the ’213 patent.
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`fundamentally, Foote 1989 was authored by and describes the work of Petitioners’
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`IPR2017-01488
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`own expert, Dr. Jefferson Foote. If Petitioners’ are correct that it teaches a key
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`component of the claims—the use of a consensus sequence—Dr. Foote should
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`have included this information when he was drafting his initial declaration, and
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`Petitioners should have included that information in its grounds for institution.
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`Lastly, the prejudice to Patent Owner is not mitigated by the introduction of
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`Foote 1989 during the redirect testimony (elicited by Petitioners) of Dr. Foote
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`during his first deposition prior to the submission of Patent Owner’s Response.
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`The Federal Circuit has been clear, where a party relies on a reference to disclose a
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`substantive element of the claims, the reference and accompanying argument must
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`have been made in the Petition. See, e.g., Wasica, 853 F.3d at 1286-87; Intelligent-
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`BioSystems, 821 F.3d at 1369-70. Moreover, had Foote 1989 been raised in the
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`Petition, Patent Owner would have responded to the Petition differently, including,
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`for example, by presenting argument that the Petition should have been denied
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`under 35 U.S.C. § 325(d) because the challenged claims were allowed over Foote
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`1989. (See, e.g., Ex. 1002 at 2500 (discussing Foote 1989); id. at 4462-71 (Notice
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`of Allowability); Ex. 1001 at 4 (listing Foote 1989).)
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`Accordingly, the Board should strike Ex. 1193 and the testimony that relies
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`on it, including the portions of Dr. Foote’s Reply Declaration and deposition
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`testimony that discuss Ex. 1193, and the portions of Dr. Wilson’s testimony that
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`were elicited from questioning related to Ex. 1193.
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`C.
` Petitioners’ Arguments as to the Kurrle Reference Are Improper.
`In Reply, Petitioners argue for the first time that Kurrle describes an
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`antibody with a consensus human variable domain. (Reply at 16-17.) Petitioners
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`argue that Kurrle discloses a method of humanizing an antibody using a “best fit”
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`approach as a first step, followed by comparing the results to a consensus sequence
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`to identify any differences, such that the remaining framework residues are all
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`“consensus” human residues. (Id.; see also Ex. 1202, ¶105.)
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`The Board need only look to the proposed grounds for institution listed in
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`the Petition to determine that Petitioners’ new argument concerning Kurrle is
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`improper. Petitioners assert in Ground 1 that certain claims are anticipated by
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`Kurrle. (Paper 1 at 6.) Notably absent from the list of claims purportedly
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`anticipated by Kurrle are those claims that recite the “consensus” sequence
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`limitation. (Compare, e.g., Paper 1 at 6, with, Ex. 1001, claim 4, 33, 62, 64, 69.) It
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`is only in combination with Queen 1990 that Petitioners argue the “consensus”
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`limitation is met, and Petitioners rely only on Queen 1990 for that disclosure—for
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`example, in Ground 3. To be sure, the Petition’s description of Kurrle notes that
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`“[e]xisting human framework residues could be switched to a consensus human
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`residue” at certain positions. (See, e.g., Paper 1 at 20.) But a single sentence in a
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`generalized description of the reference outside the context of the particular claim
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`limitations or the proposed grounds does not permit Petitioners to morph that
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`discussion into a reason why the prior art discloses the “consensus” sequence
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`limitation. See e.g., Mylan Pharm. Inc. v. UCB Pharma GmbH, IPR2016-00517,
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`Paper 37 at 23-24 (PTAB Jul. 19, 2017) (change in argument presented in footnote
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`of Petition improper). Relying on different portions of a reference than those cited
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`in the Petition to support an obviousness case is “foreclosed by statute, [Federal
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`Circuit] precedent, and Board guidelines.” Wasica, 853 F.3d at 1286.
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`Accordingly, the Board should strike Petitioners’ new argument with respect
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`to Kurrle, including the portions of Dr. Foote’s Reply Declaration and deposition
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`testimony that discuss it, and the portions of Dr. Wilson’s testimony that were
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`elicited from questioning pertaining to this new argument.
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`III. CONCLUSION
`The Board should strike (1) Exhibit 1193 and the associated arguments and
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`testimony that rely on this exhibit, including the first full paragraph of Page 27; Ex.
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`1202, ¶¶ 12, 41-43, 79, 82, 119, 162, and 187; Ex. 1197, 176:25-178:23; Ex. 2039,
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`327:12-331:11; and (2) the last paragraph of page 16 and the graphic on page 17 of
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`the Reply and the testimony relying on Petitioners’ new theory including: Ex.
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`1202, ¶¶7, 12, 82, 104-106, 119, 160-162, 187; Ex. 1197, 258:3-263:21; 264:9-
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`267:18, 267:24-268:12; Ex. 2039, 313:7-320:11.
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`Date: June 22, 2018
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`IPR2017-01488
`Patent Owner’s Motion to Strike
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`Respectfully submitted,
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`/David L. Cavanaugh/
`By:
`David L. Cavanaugh
`Reg. No. 36,476
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Avenue NW
`Washington, DC 20006
`202-663-6025
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`IPR2017-01488
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`CERTIFICATE OF SERVICE
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`I hereby certify that, on June 22, 2018, I caused a true and correct
`copy of the following materials:
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` Patent Owner’s Motion to Strike
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`to be served via electronic mail on the following attorneys of record:
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`Amanda Hollis
`KIRKLAND & ELLIS LLP
`amanda.hollis@kirkland.com
`300 North LaSalle, Chicago, IL 60654
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`Stefan M. Miller, Ph.D.
`stefan.miller@kirkland.com
`601 Lexington Avenue, New York, NY 10022
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`Karen Younkins
`karen.younkins@kirkland.com
`333 South Hope Street, Los Angeles, CA 90071
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`Benjamin A. Lasky
`benjamin.lasky@kirkland.com
`601 Lexington Avenue, New York, NY 10022
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`Sarah K. Tsou
`sarah.tsou@kirkland.com
`601 Lexington Avenue, New York, NY 10022
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`Mark C. McLennan
`mark.mclennan@kirkland.com
`601 Lexington Avenue, New York, NY 10022
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`Christopher J. Citro
`christopher.citro@kirkland.com
`601 Lexington Avenue, New York, NY 10022
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`IPR2017-01488
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`Pfizer_Genentech_IPRs@kirkland.com
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`Dimitrios T. Drivas
`White & Case LLP
`ddrivas@whitecase.com
`1221 Avenues of the Americas, New York, NY 10020
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`Scott T. Weingaertner
`White & Case LLP
`scott.weingaertner@whitecase.com
`1221 Avenues of the Americas, New York, NY 10020
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`Amit H. Thakore
`White & Case LLP
`athakore@whitecase.com
`1221 Avenue of the Americas, New York, NY 10020
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`Eric Majchrzak
`White & Case LLP
`eric.majchrzak@whitecase.com
`1221 Avenue of the Americas, New York, NY 10020
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`/Lauren V. Blakely/
`Lauren V. Blakely
`Reg. No. 70,247
`Wilmer Cutler Pickering Hale and Dorr LLP
`950 Page Mill Road
`Palo Alto, CA 94304
`(650) 600-5039
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