throbber
IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`Filed on behalf of Patent Owners Genentech, Inc. and City of Hope by:
`
`David L. Cavanaugh
`Reg. No. 36,476
`Heather M. Petruzzi
`Reg. No. 71,270
`Owen K. Allen
`Reg. No. 71,118
`Robert J. Gunther, Jr.
`Pro Hac Vice
`WilmerHale
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`
`
`Adam R. Brausa
`Reg. No. 60,287
`Daralyn J. Durie
`Pro Hac Vice
`David F. McGowan
`Pro Hac Vice
`Durie Tangri LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`Michael R. Fleming
`Reg. No. 67,933
`David I. Gindler
`Pro Hac Vice
`Joseph M. Lipner
`Pro Hac Vice
`Irell & Manella LLP
`1800 Avenue of the
`Stars, Suite 900 Los
`Angeles, CA 90067
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`MERCK SHARP & DOHME CORP.,
`Petitioner,
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners.
`____________________________________________
`
`Case IPR2016-007101
`U.S. Patent 6,331,415
`____________________________________________
`
`PATENT OWNERS’ SECOND OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`1 Case IPR2017-00047 has been joined with this proceeding.
`
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`
`Pursuant to 37 C.F.R. § 42.64, Patent Owners Genentech, Inc. and City of
`
`Hope serve the following objections to evidence served with the Petitioner’s Reply
`
`of Merck Sharp & Dohme Corp. (“Petitioner”).
`
`Genentech/City of Hope object to Exhibit 1090, Rebuttal Declaration of
`
`Roger D. Kornberg in Support of Petitioners’ Reply for Inter Partes Review of
`
`U.S. Patent No. 6,331,415. Genentech/City of Hope object to Exhibit 1090, as
`
`well as all new evidence cited in Exhibit 1090 (e.g., Ex. 1069, 1071-1073, 1075-
`
`1076, 1095-1112, 1120, 1147, and 1150) as irrelevant under FRE 401 because they
`
`do not respond to arguments raised in the Patent Owner Response, as required by
`
`37 C.F.R. § 42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope further object to Exhibit 1090 as being inconsistent with
`
`Petitioner Merck’s representations in its motion for joinder in IPR2017-00047
`
`(Paper 3) in which Merck stated that it would rely on and “not alter or otherwise
`
`seek to supplement the opinions” offered in the declaration of Kathryn Calame
`
`(Ex. 1059) or, if former Petitioner Mylan settled, it “would elect to rely on its own
`
`expert, Dr. Margaret H. Baron” (IPR2017-00047, Ex. 1006). See IPR2017-00047,
`
`Paper 3 at 7-8. Genentech/City of Hope also specifically object to ¶¶ 49-58 of
`
`Exhibit 1090 as irrelevant under FRE 401 because they were previously submitted
`
`in declaration by Dr. Kornberg to support Merck’s petition in IPR2016-01373,
`
`which challenged the same ʼ415 patent and was denied institution, and therefore do
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`
`not respond to arguments raised in the Patent Owner Response and should have
`
`been introduced with the petition. Genentech/City of Hope specifically object to
`
`¶¶ 44-46, 49, 53, 56, 58, 60, 63-65, 67, 69, 73, 88, 103-104, 106, 110-113, 123,
`
`131-132, 135-138, 145-146, 151, 153, 155, 157, 159, 162-163, and all paragraphs
`
`that rely on those paragraphs as inadmissible hearsay (FRE 802); and ¶¶ 42-47, 49-
`
`58, 60-63, 65-68, 70-77, 81-88, 93-96, 98-102, 104-105, 107, 109, 111, 114-115,
`
`117, 120-123, 125-128, 130, 132, 135-141, 143, 145-149, 151, 153, 155-157, 159-
`
`164, and all paragraphs that rely on those paragraphs as lacking a disclosed basis of
`
`sufficient facts or data (FRE 705; 37 C.F.R. § 42.65), not being based on sufficient
`
`facts or data, the product of reliable principles and methods, and/or a reliable
`
`application of the principles and methods to the facts (FRE 702, 703), and being
`
`misleading and/or confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1091, Declaration of Marc J.
`
`Shulman in Support of Petitioners’ Reply for Inter Partes Review of U.S. Patent
`
`No. 6,331,415. Genentech/City of Hope object to Exhibit 1091, as well as all new
`
`evidence cited in Exhibit 1091 (e.g., Ex. 1119, 1120, and 1148), as irrelevant under
`
`FRE 401 because they do not respond to arguments raised in the Patent Owner
`
`Response, as required by 37 C.F.R. § 42.23(b), and should have been introduced
`
`with the petition; Exhibit 1091 contains new testimony pertaining to the
`
`“prevailing mindset” argument, which Merck originally raised in its petition.
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`
`Genentech/City of Hope specifically object to ¶ 15, and all paragraphs that rely on
`
`that paragraphs as inadmissible hearsay (FRE 802); and ¶¶ 23-25, 30-33, 35, and
`
`all paragraphs that rely on those paragraphs as lacking a disclosed basis of
`
`sufficient facts or data (FRE 705; 37 C.F.R. § 42.65), not being based on sufficient
`
`facts or data, the product of reliable principles and methods, and/or a reliable
`
`application of the principles and methods to the facts (FRE 702, 703), and being
`
`misleading and/or confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1092, Declaration of Louis G.
`
`Dudney, CPA, CFF. Genentech/City of Hope specifically object to ¶¶ 29-31, 36
`
`38-39, 44, 45, 47-48, and all paragraphs that rely on those paragraphs as
`
`inadmissible hearsay (FRE 802); and ¶¶ 22, 24-31, 33-36, 38-48, and all
`
`paragraphs that rely on those paragraphs as lacking a disclosed basis of sufficient
`
`facts or data (FRE 705; 37 C.F.R. § 42.65), not being based on sufficient facts or
`
`data, the product of reliable principles and methods, and/or a reliable application of
`
`the principles and methods to the facts (FRE 702, 703), and being misleading
`
`and/or confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1093, Declaration of Atsuo Ochi
`
`in Support of Merck’s Reply to Patent Owner’s Response for Inter Partes Review
`
`of U.S. Patent No. 6,331,415. Genentech/City of Hope object to Exhibit 1093, as
`
`well as all new evidence cited in Exhibit 1093 (e.g., Ex. 1137, 1138, and 1146), as
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`
`irrelevant under FRE 401 because they do not respond to arguments raised in the
`
`Patent Owner Response, as required by 37 C.F.R. § 42.23(b), and should have been
`
`introduced with the petition; Exhibit 1093 contains new testimony pertaining to the
`
`“prevailing mindset” argument, which Merck originally raised in its petition.
`
`Genentech/City of Hope specifically object to ¶ 17-19, and all paragraphs that rely
`
`on that paragraph as lacking a disclosed basis of sufficient facts or data (FRE 705;
`
`37 C.F.R. § 42.65), not being based on sufficient facts or data, the product of
`
`reliable principles and methods, and/or a reliable application of the principles and
`
`methods to the facts (FRE 702, 703), and being misleading and/or confusing (FRE
`
`403).
`
`Genentech/City of Hope object to Exhibit 1094, Declaration of Nobumichi
`
`Hozumi, as well as all new evidence cited in Exhibit 1094 (e.g., Ex. 1140), as
`
`irrelevant under FRE 401 because they do not respond to arguments raised in the
`
`Patent Owner Response, as required by 37 C.F.R. § 42.23(b), and should have been
`
`introduced with the petition; Exhibit 1094 contains new testimony pertaining to the
`
`“prevailing mindset” argument, which Merck originally raised in its petition.
`
`Genentech/City of Hope object to Exhibit 1069, Berg, Dissections and
`
`Reconstructions of Genes and Chromosomes, Science, 213:296-303 (1981), as
`
`irrelevant under FRE 401 because it does not respond to arguments raised in the
`
`
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`

`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`Patent Owner Response, as required by 37 C.F.R. § 42.23(b), and should have been
`
`
`
`introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1071, Stenesh, Dictionary of
`
`Biochemistry, 203, 205, 220, 256 (1975), as irrelevant under FRE 401 because it
`
`does not respond to arguments raised in the Patent Owner Response, as required by
`
`37 C.F.R. § 42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1072, Pauza et al., “Genes
`
`Encoding Escherichia Coli Aspartate Transcarbamoylase: The pyrB-pyrI Operon,”
`
`Proc. Nat. Acad. Sci. 79:4020-24 (July 1982), under FRE 401 as being irrelevant
`
`because it represents subject matter which is beyond the scope of this IPR.2
`
`Genentech/City of Hope also object to Exhibit 1072 as irrelevant under FRE 401
`
`because it does not respond to arguments raised in the Patent Owner Response, as
`
`required by 37 C.F.R. § 42.23(b), and should have been introduced with the
`
`petition.
`
`Genentech/City of Hope object to Exhibit 1073, Wild et al., “A Mutation in
`
`the Catalytic Cistron of Aspartate Carbamoyltransferase Affecting Catalysis,
`
`Regulatory Response and Holoenzyme Assembly,” Nature, 292:373-375 (1981),
`
`
`2 Patent Owners initially objected to Exhibit 1072 during the deposition of Dr. John
`
`Fiddes. See Fiddes Tr. at 225:7-17, 23-24 (Ex. 1113).
`
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`
`under FRE 401 as being irrelevant because it represents subject matter which is
`
`beyond the scope of this IPR.3 Genentech/City of Hope also object to Exhibit
`
`1073 as irrelevant under FRE 401 because it does not respond to arguments raised
`
`in the Patent Owner Response, as required by 37 C.F.R. § 42.23(b), and should
`
`have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1075, Roof et al., “The
`
`Organization and Regulation of the pyrBI Operon in E. Coli Includes a Rho-
`
`Independent Attenuator Sequence,” Molecular and General Genetics, 187:391-400
`
`(1982), under FRE 401 as being irrelevant because it represents matter which is
`
`beyond the scope of this IPR. 4 Genentech/City of Hope also object to Exhibit
`
`1075 as irrelevant under FRE 401 because it does not respond to arguments raised
`
`in the Patent Owner Response, as required by 37 C.F.R. § 42.23(b), and should
`
`have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1076, Navre and Schachman,
`
`“Synthesis of Aspartate Transcarbamoylase in Escherichia Coli: Transcriptional
`
`
`3 Patent Owners initially objected to Exhibit 1073 during the deposition of Dr. John
`
`Fiddes. See Fiddes Tr. at 234:21-235:8 (Ex. 1113).
`
`4 Patent Owners initially objected to Exhibit 1075 during the deposition of Dr. John
`
`Fiddes. See Fiddes Tr. at 239:14-240:15 (Ex. 1113).
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`
`Regulation of the pyrB-pyrI Operon,” Proc. Natl. Acad. Sci. USA, 80:1207-1211
`
`(1983), under FRE 401 as being irrelevant because it represents matter which is
`
`beyond the scope of this IPR. 5 Genentech/City of Hope also object to Exhibit
`
`1076 as irrelevant under FRE 401 because it does not respond to arguments raised
`
`in the Patent Owner Response, as required by 37 C.F.R. § 42.23(b), and should
`
`have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1095, Maniatis, Molecular
`
`Cloning: A Laboratory Manual, Cold Spring Harbor Laboratory (1982), as
`
`irrelevant under FRE 401 because it does not respond to arguments raised in the
`
`Patent Owner Response, as required by 37 C.F.R. § 42.23(b), and should have been
`
`introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1096, Wigler et al., “Transfer of
`
`purified herpes virus thymidine kinase gene to cultured mouse cells,” Cell
`
`11(1):223-32 (1977), as irrelevant under FRE 401 because it does not respond to
`
`arguments raised in the Patent Owner Response, as required by 37 C.F.R. §
`
`42.23(b), and should have been introduced with the petition.
`
`
`5 Patent Owners initially objected to Exhibit 1076 during the deposition of Dr. John
`
`Fiddes. See Fiddes Tr. at 239:14-240:15 (Ex. 1113).
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`
`Genentech/City of Hope object to Exhibit 1097, Wigler et al.,
`
`“Transformation of mammalian cells with genes from procaryotes and eucaryotes,”
`
`Cell 16(4):777-85 (1979), as irrelevant under FRE 401 because it does not respond
`
`to arguments raised in the Patent Owner Response, as required by 37 C.F.R. §
`
`42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1098, Walter L. Miller, “Use of
`
`Recombinant DNA Technology for the Production of Polypeptides,” Adv. Exp.
`
`Med. Biol., 118: 153-174 (1979), as irrelevant under FRE 401 because it does not
`
`respond to arguments raised in the Patent Owner Response, as required by 37
`
`C.F.R. § 42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1099, Turnbough et al.,
`
`“Attenuation Control of pyrBI Operon Expression in Escherichia coli K-12,” Proc.
`
`Natl. Acad. Sci. USA, 80:368-372 (January 1983), as irrelevant under FRE 401
`
`because it does not respond to arguments raised in the Patent Owner Response, as
`
`required by 37 C.F.R. § 42.23(b), and should have been introduced with the
`
`petition.
`
`Genentech/City of Hope object to Exhibit 1100, Baptist, et al.,
`
`“Identification of the Salmonella typhimurium cysB Gene Product by Two-
`
`Dimensional Protein Electrophoresis,” J. Bacter. 151:495-499 (July 1982), as
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`irrelevant under FRE 401 because it does not respond to arguments raised in the
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`Patent Owner Response, as required by 37 C.F.R. § 42.23(b), and should have been
`
`
`
`introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1101, Mosher, et al., “Synthesis
`
`and Secretion of Thrombospondin by Cultured Human Endothelial Cells,” J. Cell
`
`Biol. 93:343-348 (May 1982), as irrelevant under FRE 401 because it does not
`
`respond to arguments raised in the Patent Owner Response, as required by 37
`
`C.F.R. § 42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1102, Kornberg, “Chromatin
`
`Structure: Oligomers of the Histones,” Science 184:865 (1974), as irrelevant under
`
`FRE 401 because it does not respond to arguments raised in the Patent Owner
`
`Response, as required by 37 C.F.R. § 42.23(b), and should have been introduced
`
`with the petition.
`
`Genentech/City of Hope object to Exhibit 1103, Kornberg, “Chromatin
`
`Structure: A Repeating Unit of Histones and DNA,” Science 184:868 (1974), as
`
`irrelevant under FRE 401 because it does not respond to arguments raised in the
`
`Patent Owner Response, as required by 37 C.F.R. § 42.23(b), and should have been
`
`introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1104, Thomas & Kornberg, “An
`
`octamer of histones in chromatin and free in solution,” Proc. Nat’l Acad. Sci. USA
`
`72:2626 (1975), Science 184:868 (1974), as irrelevant under FRE 401 because it
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`does not respond to arguments raised in the Patent Owner Response, as required by
`
`
`
`37 C.F.R. § 42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1105, Henderson’s Dictionary of
`
`Biological Terms at 274 (9th ed. 1979), as irrelevant under FRE 401 because it
`
`does not respond to arguments raised in the Patent Owner Response, as required by
`
`37 C.F.R. § 42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1106, Stenesh, Dictionary of
`
`Biochemistry and Molecular Biology at 312, 333 (2nd ed. 1989), as irrelevant
`
`under FRE 401 because it does not respond to arguments raised in the Patent
`
`Owner Response, as required by 37 C.F.R. § 42.23(b), and should have been
`
`introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1107, Dorland’s Illustrated
`
`Medical Dictionary at 1206 (31st ed. 1990), as irrelevant under FRE 401 because it
`
`does not respond to arguments raised in the Patent Owner Response, as required by
`
`37 C.F.R. § 42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1108, Tirri, et al., Elsevier’s
`
`Dictionary of Biology at 443 (1st ed. 1998), as irrelevant under FRE 401 because it
`
`does not respond to arguments raised in the Patent Owner Response, as required by
`
`37 C.F.R. § 42.23(b), and should have been introduced with the petition.
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`
`Genentech/City of Hope object to Exhibit 1109, Kahl, The Dictionary of
`
`Gene Technology Terms at 305 (2001), as irrelevant under FRE 401 because it
`
`does not respond to arguments raised in the Patent Owner Response, as required by
`
`37 C.F.R. § 42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1110, King, et al, Dictionary of
`
`Genetics at 288 (7th ed. 2006), as irrelevant under FRE 401 because it does not
`
`respond to arguments raised in the Patent Owner Response, as required by 37
`
`C.F.R. § 42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1111, ’715 (Morrison) File
`
`History, 1/3/92 Response and Oi & Morrison Declarations, as lacking relevance
`
`(FRE 401) and being misleading or confusing (FRE 403). Genentech/City of Hope
`
`also object to Exhibit 1111 as irrelevant under FRE 401 because it does not
`
`respond to arguments raised in the Patent Owner Response, as required by 37
`
`C.F.R. § 42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1112, ’715 (Morrison) File
`
`History, 8/23/93 Response and Herzenberg Declarations, as lacking relevance
`
`(FRE 401) and being misleading or confusing (FRE 403). Genentech/City of Hope
`
`also object to Exhibit 1112 as irrelevant under FRE 401 because it does not
`
`respond to arguments raised in the Patent Owner Response, as required by 37
`
`C.F.R. § 42.23(b), and should have been introduced with the petition.
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
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`Genentech/City of Hope object to Exhibit 1119, Hawley et al., “N. Mutant
`
`immunoglobulin genes have repetitive DNA elements inserted into their
`
`intervening sequences,” Proc. Natl. Acad. Sci. USA 79:7425-7429 (1982), as
`
`lacking relevance under FRE 401 because it does not respond to arguments raised
`
`in the Patent Owner Response, as required by 37 C.F.R. § 42.23(b), and should
`
`have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1120, Mulligan and Berg,
`
`“Expression of a bacterial gene in mammalian cells,” Science 209:1422-1427
`
`(1980), as lacking relevance under FRE 401 because it does not respond to
`
`arguments raised in the Patent Owner Response, as required by 37 C.F.R. §
`
`42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1122, Battersby and Grimes,
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`“2008 Licensing Update” at 99-100 (2008), as incomplete (FRE 106) and as
`
`lacking relevance (FRE 401) and being misleading or confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1123, Swiss Pharma International
`
`AG v. Biogen Idec, IPR2016-00916, Patent Owner’s Preliminary Response, Paper
`
`6, as lacking relevance (FRE 401) and being misleading or confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1124, Boehringer Ingelheim
`
`International GmbH et al., Genentech, Inc. et al., IPR2015-00415, Patent Owner's
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
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`Preliminary Response, Paper 10, as lacking relevance (FRE 401) and being
`
`misleading or confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1125, Boehringer Ingelheim
`
`International GmbH et al., Genentech, Inc. et al., IPR2015-00417, Patent Owner’s
`
`Preliminary Response, Paper 9, as lacking relevance (FRE 401) and being
`
`misleading or confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1126, Mylan Pharmaceuticals,
`
`Inc. v. Genentech, Inc., IPR2016-01693, Patent Owner's Preliminary Response,
`
`Paper 11, as lacking relevance (FRE 401) and being misleading or confusing (FRE
`
`403).
`
`Genentech/City of Hope object to Exhibit 1127, Mylan Pharmaceuticals,
`
`Inc. v. Genentech, Inc., IPR2016-01694, Patent Owner's Preliminary Response,
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`Paper 9, as lacking relevance (FRE 401) and being misleading or confusing (FRE
`
`403).
`
`Genentech/City of Hope object to Exhibit 1128, Application For Patent
`
`Term Extension for U.S. Patent No. 5,670,373, as lacking relevance (FRE 401) and
`
`being misleading or confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1129, Application For Patent
`
`Term Extension for U.S. Patent No. 6,602,684, as lacking relevance (FRE 401) and
`
`being misleading or confusing (FRE 403).
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
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`Genentech/City of Hope object to Exhibit 1130, Application For Patent
`
`Term Extension for U.S. Patent No. 7,097,840, as lacking relevance (FRE 401) and
`
`being misleading or confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1131, Coherus Biosciences Inc. v.
`
`AbbVie Biotechnology Ltd., IPR2016-00188, Patent Owner’s Preliminary
`
`Response, Paper 7, as lacking relevance (FRE 401) and being misleading or
`
`confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1132, Swiss Pharma International
`
`AG v. Biogen Idec, IPR2016-00915, Patent Owner’s Preliminary Response, Paper
`
`6, as lacking relevance (FRE 401) and being misleading or confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1133, Application For Patent
`
`Term Extension for U.S. Patent No. 6,355,245, as lacking relevance (FRE 401) and
`
`being misleading or confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1134, Application For Patent
`
`Term Extension for U.S. Patent No. 7,166,285, as lacking relevance (FRE 401) and
`
`being misleading or confusing (FRE 403).
`
`Genentech/City of Hope object to Exhibit 1135, Application For Patent
`
`Term Extension for U.S. Patent No. 6,984,720, as lacking relevance (FRE 401) and
`
`being misleading or confusing (FRE 403).
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`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
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`Genentech/City of Hope object to Exhibit 1136, Schorsch, Kristen, “How
`
`AbbVie has won the Humira fight – so far,” Crain’s Chicago Business (November
`
`5, 2016), as lacking relevance (FRE 401), being misleading or confusing (FRE
`
`403) and lacking appropriate authentication (FRE 901).
`
`Genentech/City of Hope object to Exhibit 1137, Ochi, “Binder: DNA, RNA
`
`Works,” June 1982, as incomplete (FRE 106), being misleading or confusing (FRE
`
`403), and lacking relevance under FRE 401 because it does not respond to
`
`arguments raised in the Patent Owner Response, as required by 37 C.F.R. §
`
`42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1138, Ochi, “Binder: Gene
`
`Transfer, B cell hybridomas,” Jan. 1983, as incomplete (FRE 106), being
`
`misleading or confusing (FRE 403), and lacking relevance under FRE 401 because
`
`it does not respond to arguments raised in the Patent Owner Response, as required
`
`by 37 C.F.R. § 42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1140, Hozumi et al., Abstract
`
`“Expression of Cloned Immunoglobulin Genes in Heterologous Cells,” submitted
`
`to the Fifth International Congress of Immunology in Kyoto, as being misleading
`
`or confusing (FRE 403), lacking appropriate authentication (FRE 901), and lacking
`
`relevance under FRE 401 because it does not respond to arguments raised in the
`
`
`
`
`- 15 -
`
`

`

`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`Patent Owner Response, as required by 37 C.F.R. § 42.23(b), and should have been
`
`
`
`introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1146, Ochi, “Binder: Gene
`
`Transfer, B cell hybridomas,” Jul. 1982, as incomplete (FRE 106), being
`
`misleading or confusing (FRE 403), and lacking relevance under FRE 401 because
`
`it does not respond to arguments raised in the Patent Owner Response, as required
`
`by 37 C.F.R. § 42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1147, ’715 (Morrison) File
`
`History, 11/1/94 Office Action, as incomplete (FRE 106), lacking relevance (FRE
`
`401), and being misleading or confusing (FRE 403). Genentech/City of Hope also
`
`object to Exhibit 1147 as irrelevant under FRE 401 because it does not respond to
`
`arguments raised in the Patent Owner Response, as required by 37 C.F.R. §
`
`42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1148, Boulianne, G., Hozumi, N.,
`
`Shulman, M., “Production of functional mouse/human antibody,” Nature 312:643-
`
`46 (1984), as lacking relevance under FRE 401 because it does not respond to
`
`arguments raised in the Patent Owner Response, as required by 37 C.F.R. §
`
`42.23(b), and should have been introduced with the petition.
`
`Genentech/City of Hope object to Exhibit 1150, U.S. Patent No. 5,807,715,
`
`as irrelevant under FRE 401 because it does not respond to arguments raised in the
`- 16 -
`
`
`
`
`

`

`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`Patent Owner Response, as required by 37 C.F.R. § 42.23(b), and should have been
`
`
`
`introduced with the petition.
`
`
`
`
`
`Date: April 14, 2017
`
`
`
`Respectfully submitted,
`
`/David L. Cavanaugh/
`David L. Cavanaugh
`Registration No. 36,476
`Counsel for Patent Owners
`
`
`WILMER CUTLER PICKERING HALE AND DORR LLP
`1875 PENNSYLVANIA AVENUE NW
`WASHINGTON, DC 20006
`TEL: 650-600-5036
`FAX: 650-858-6100
`EMAIL: david.cavanaugh@wilmerhale.com
`
`
`
`
`- 17 -
`
`

`

`
`
`IPR2016-00710
`Patent Owners’ Second Objections to Evidence
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that, on April 14, 2017, I caused a true and correct copy of
`the foregoing materials:
`
`
`• Patent Owners’ Second Objections to Evidence Pursuant to 37
`C.F.R. § 42.64
`
`to be served via electronic mail on the following attorneys of record:
`
`Raymond N. Nimrod
`Matthew A. Traupman
`Quinn Emanuel Urquhart & Sullivan LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`raynimrod@quinnemanuel.com
`matthewtraupman@quinnemanuel.com
`
`Amanda K. Antons
`Quinn Emanuel Urquhart & Sullivan LLP
`500 West Madison Avenue, Suite 2450
`Chicago, IL 60661
`amandaantons@quinnemanuel.com
`
`Katherine A. Helm
`Simpson Thatcher & Bartlett LLP
`425 Lexington Avenue
`New York, NY 10017
`khelm@stblaw.com
`
`/Heather M. Petruzzi /
`Heather M. Petruzzi
`Reg. No. 71,270
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Avenue., NW
`Washington, DC 20006
`(202) 663-6000
`
`- 18 -
`
`
`
`
`

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