Paper No. ____
`Date Filed: June 27, 2018
`
`Filed On Behalf Of:
`Novartis Pharmaceuticals Corporation
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BRECKENRIDGE PHARMACEUTICAL, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`
`Case IPR2017-01592
`Patent No. 8,410,131
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO
`EVIDENCE SUBMITTED BY PETITIONER WITH ITS REPLY
`
`
`Date Filed: June 27, 2018
`
`Filed On Behalf Of:
`Novartis Pharmaceuticals Corporation
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BRECKENRIDGE PHARMACEUTICAL, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`
`Case IPR2017-01592
`Patent No. 8,410,131
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO
`EVIDENCE SUBMITTED BY PETITIONER WITH ITS REPLY
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Novartis Pharmaceuticals
`
`Corporation (“Novartis”) objects to the following exhibits filed with Petitioner’s
`
`Breckenridge Pharmaceutical, Inc. (Petitioner) Reply on the grounds set forth
`
`below.
`
`In this paper, a reference to “F.R.E.” means the Federal Rules of Evidence, a
`
`reference to “C.F.R.” means the Code of Federal Regulations, and “the ’131
`
`Patent” means U.S. Patent No. 8,410,131. All objections under F.R.E. 802
`
`(hearsay) and 37 C.F.R § 42.61(c) (hearsay) apply to the extent Petitioner relies on
`
`the exhibits identified in connection with that objection for the truth of the matters
`
`asserted therein. Novartis’s objections to Petitioner’s exhibits are without prejudice
`
`to Novartis’s reliance on or discussion of those exhibits in Novartis’s papers in this
`
`proceeding.
`
`Novartis’s objections are as follows:
`
`1
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`1121
`
`Shrinkage
`table
`showing
`results of
`the
`Weckbecker
`in vivo
`assay
`
` F.R.E. 802 (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
` F.R.E. 106 (incomplete).
`
` F.R.E. 901 (authentication). Petitioner has not provided sufficient evidence that this exhibit
`
`is authentic or that the exhibit is self-authenticating under F.R.E. 902.
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
` F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases for expert opinion), as it is not relevant to any issue in this
`
`IPR proceeding, and is not the type of document upon which a person of ordinary skill in
`
`2
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`the art at the time of invention would rely.
`
` 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert testimony),
`
`and F.R.E. 703 (bases for expert opinion) as this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority date of the
`
`’131 Patent, or the February 18, 2002 application date of the ’131 Patent, and is not the type
`
`of document upon which a person of ordinary skill in the art at the time of invention would
`
`rely.
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`3
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`42.6(a)(3). See Ex. 1126 (Burris Deposition Transcript) at 25:23-27:5, 247:22-248:1.
`
` 37 C.F.R. § 42.104(b)(5) (failure to identify specific portions of evidence).
`
`1122
`
`O’Donnell
`
` F.R.E. 802 (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
` 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert testimony),
`
`and F.R.E. 703 (bases for expert opinion) as this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority date of the
`
`4
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`’131 Patent, or the February 18, 2002 application date of the ’131 Patent, and is not the type
`
`of document upon which a person of ordinary skill in the art at the time of invention would
`
`rely.
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3). See Ex. 1126 (Burris Deposition Transcript) at 247:22-248:1.
`
` 37 C.F.R. § 42.104(b)(5) (failure to identify specific portions of evidence).
`
`1123
`
`O’Reilly
`
` F.R.E. 802 (hearsay).
`
` F.R.E. 402 (relevance).
`
`5
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
` F.R.E. 403 (confusing, waste of time).
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
` 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert testimony),
`
`and F.R.E. 703 (bases for expert opinion) as this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority date of the
`
`’131 Patent, or the February 18, 2002 application date of the ’131 Patent, and is not the type
`
`of document upon which a person of ordinary skill in the art at the time of invention would
`
`rely.
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`6
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3). See Ex. 1126 (Burris Deposition Transcript) at 247:22-248:1.
`
` 37 C.F.R. § 42.104(b)(5) (failure to identify specific portions of evidence).
`
` Improper on the grounds that no questions or testimony was elicited with respect to this
`
`Exhibit. See Ex. 1126 (Burris Deposition Transcript) at 248:20-22.
`
`1124
`
`Pages from
`U.S. Patent
`6,432,973
`Zhu (pages
`from
`Exhibit
`1092
`marked as
`Burris
`
` F.R.E. 802 (hearsay).
`
` 37 C.F.R. 42.61(c) (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
`7
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`Depo. Ex.
`1124)
`
` 37 C.F.R. §§ 42.6(a)(3) (combined documents), 42.63 (form of evidence) as this exhibit
`
`appears to be a compilation of more than one document.
`
` F.R.E. 901 (authentication). Petitioner has not provided sufficient evidence that this exhibit
`
`is authentic or that the exhibit is self-authenticating under F.R.E. 902.
`
` F.R.E. 106 (incomplete).
`
` 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert testimony),
`
`and F.R.E. 703 (bases for expert opinion) as this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority date of the
`
`’131 Patent, or the February 18, 2002 application date of the ’131 Patent, and is not the type
`
`of document upon which a person of ordinary skill in the art at the time of invention would
`
`rely.
`
`8
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3). See Ex. 1126 (Burris Deposition Transcript) at 247:22-248:1.
`
` 37 C.F.R. § 42.104(b)(5) (failure to identify specific portions of evidence).
`
` Ex. 1124 is an excerpt from Exhibit 1092, so Patent Owner objects to Ex. 1124 to the same
`
`extent and on the same grounds that Patent Owner objected to Exhibit 1092 in Patent
`
`9
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`Owner’s Objections dated January 18, 2018. See Ex. 1126 (Burris Deposition Transcript) at
`
`1125
`
`Pages from
`Zhu ‘973
`patent
`provisional
`application
`(pages from
`Exhibit
`1092
`marked as
`Burris
`Depo. Ex.
`1125)
`
`248:23-249:3.
`
` F.R.E. 802 (hearsay)
`
` 37 C.F.R. 42.61(c) (hearsay)
`
` F.R.E. 402 (relevance)
`
` F.R.E. 403 (confusing, waste of time)
`
` 37 C.F.R. §§ 42.6(a)(3) (combined documents), 42.63 (form of evidence) as this exhibit
`
`appears to be a compilation of more than one document.
`
` F.R.E. 901 (authentication). Petitioner has not provided sufficient evidence that this exhibit
`
`is authentic or that the exhibit is self-authenticating under F.R.E. 902.
`
` F.R.E. 106 (incomplete)
`
` 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402
`
`10
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert testimony),
`
`and F.R.E. 703 (bases for expert opinion) as this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority date of the
`
`’131 Patent, or the February 18, 2002 application date of the ’131 Patent, and is not the type
`
`of document upon which a person of ordinary skill in the art at the time of invention would
`
`rely.
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`11
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3). See Ex. 1126 (Burris Deposition Transcript) at 247:22-248:1.
`
` 37 C.F.R. § 42.104(b)(5) (failure to identify specific portions of evidence).
`
` Ex. 1125 is an excerpt from Exhibit 1092, so Patent Owner objects to Ex. 1125 to the same
`
`extent and on the same grounds that Patent Owner objected to Exhibit 1092 in Patent
`
`Owner’s Objections dated January 18, 2018. See Ex. 1126 (Burris Deposition Transcript)
`
`at 248:23-249:3.
`
`1126
`
`Burris Tr.
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time) and F.R.E. 106 (completeness); Petitioner’s Reply p.
`
`12 includes argument citing misleading or incomplete excerpts of Dr. Burris’s deposition
`
`testimony. Ex. 1159 (Second Declaration of Allan J. Pantuck, M.D. in support of Inter
`
`Partes Review of U.S. Patent 8,410,131) ¶¶ 4, 83, 84, 108, 110, 111, 114, 134, 135, 141,
`
`12
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`304, 347 include expert opinion based on misleading or incomplete excerpts of Dr. Burris’s
`
`deposition testimony, and omit portions of answers or follow up questions that in fairness
`
`ought to be considered in connection with Exhibit 1126, including for Petitioner’s Reply p.
`
`12, Dep. Tr. 85:10-86:22, 88:8-89:10, 89:20-90:3, 97:1-98:1; for Ex. 1159 ¶110, Dep. Tr.
`
`85:10-86:22, 88:8-89:10, 89:20-90:3, 97:1-98.1; for Ex. 1159 ¶ 111, Dep. Tr. 254:6-255:8;
`
`for Ex. 1159 ¶ 134, Dep. Tr. 57:22-58:3; for Ex. 1159 ¶ 135, Dep. Tr. 31:10-32:18; for Ex.
`
`1159 ¶ 304, Dep. Tr. 239:6-240:7, 246:5-17; for Ex. 1159 ¶ 347, Dep. Tr. 31:10-32:18.
`
` 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert testimony),
`
`and F.R.E. 703 (bases for expert opinion) as this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority date of the
`
`’131 Patent, or the February 18, 2002 application date of the ’131 Patent, and is not the type
`
`of document upon which a person of ordinary skill in the art at the time of invention would
`
`13
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`rely.
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 to the
`
`extent that this document is not cited in the Reply, and therefore any attempt by Petitioner
`
`to rely on the remainder of this Exhibit to establish unpatentability (either directly by citing
`
`this Exhibit, or indirectly by citing paragraphs of Petitioner’s expert declaration that
`
`discusses this Exhibit) is improper and untimely and will constitute an improper
`
`incorporation by reference under 37 C.F.R. § 42.6(a)(3).
`
`1127
`
`Komanduri
`Tr.
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time) and F.R.E. 106 (completeness); Petitioner’s Reply p.
`
`14
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`20-21 includes argument citing misleading or incomplete excerpts of Dr. Komanduri’s
`
`deposition testimony. Ex. 1159 (Second Declaration of Allan J. Pantuck, M.D. in support
`
`of Inter Partes Review of U.S. Patent 8,410,131) ¶¶ 299, 307, 308, 312, 313, 317, 318, 321,
`
`324 include expert opinion based on misleading or incomplete excerpts of Dr. Komanduri’s
`
`deposition testimony, and omit portions of answers or follow up questions that in fairness
`
`ought to be considered in connection with Exhibit 1127, including for Petitioner’s Reply p.
`
`20, Dep. Tr. 12:8-15, 74:7-17, 77:5-78:21, 79:18-80:22, 81:10-82:23, 87:4-9, 87:22-88:6;
`
`for Ex. 1159 ¶ 299, Dep Tr. 59:12-61:24; for Ex. 1159 ¶ 307/308, Dep. Tr. 28:7-19; for Ex.
`
`1159 ¶ 312, Dep Tr. 37:3-38:5; for Ex. 1159 ¶ 313, Dep. Tr. 12:8-15; for Ex. 1159 ¶ 318,
`
`Dep. Tr. 74:7-17, 97:23-98:18; for Ex. 1159 ¶ 321, Dep. Tr. 74:7-17, 77:5-78:21, 79:18-
`
`80:22, 81:10-82:23, 87:4-9, 87:22-88:6.
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`15
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 to the
`
`extent that this document is not cited in the Reply, and therefore any attempt by Petitioner
`
`to rely on the remainder of this Exhibit to establish unpatentability (either directly by citing
`
`this Exhibit, or indirectly by citing paragraphs of Petitioner’s expert declaration that
`
`discusses this Exhibit) is improper and untimely and will constitute an improper
`
`incorporation by reference under 37 C.F.R. § 42.6(a)(3).
`
` 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert testimony),
`
`and F.R.E. 703 (bases for expert opinion) as this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority date of the
`
`’131 Patent, or the February 18, 2002 application date of the ’131 Patent, and is not the type
`
`of document upon which a person of ordinary skill in the art at the time of invention would
`
`16
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`rely.
`
`1128
`
`Burris First
`Trial
`Demonstrati
`ves
`
` F.R.E. 802 (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3).
`
` 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert testimony),
`
`17
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`and F.R.E. 703 (bases for expert opinion) as this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority date of the
`
`’131 Patent, or the February 18, 2002 application date of the ’131 Patent, and is not the type
`
`of document upon which a person of ordinary skill in the art at the time of invention would
`
`rely.
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
`1129
`
`Burris First
`Trial
`Testimony
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time) and F.R.E. 106 (completeness); Ex. 1159 (Second
`
`Declaration of Allan J. Pantuck, M.D. in support of Inter Partes Review of U.S. Patent
`
`8,410,131) ¶ 4 includes expert opinion based on misleading or incomplete excerpts of Dr.
`
`18
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`Burris’s previous trial testimony.
`
` 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert testimony),
`
`and F.R.E. 703 (bases for expert opinion) as this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority date of the
`
`’131 Patent, or the February 18, 2002 application date of the ’131 Patent, and is not the type
`
`of document upon which a person of ordinary skill in the art at the time of invention would
`
`rely.
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`19
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`1130
`
`Burris
`Second
`Trial
`Testimony
`
`42.6(a)(3).
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time) and F.R.E. 106 (completeness); Petitioner’s Reply p.
`
`11 includes argument citing misleading or incomplete excerpts of Dr. Burris’s previous
`
`trial testimony. Ex. 1159 (Second Declaration of Allan J. Pantuck, M.D. in support of Inter
`
`Partes Review of U.S. Patent 8,410,131) ¶¶ 4, 79, 107 n. 15, 185 n. 31, 344, and 345
`
`include expert opinion based on misleading or incomplete excerpts of Dr. Burris’s previous
`
`trial testimony, and omit portions of answers or follow up questions that in fairness ought to
`
`be considered in connection with Exhibit 1130, including for Petitioner’s Reply p. 11 and
`
`20
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`Ex. 1159 ¶¶ 79, 107, 185, 344, and 345, Trial. Tr. 520:4-531:9
`
` 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert testimony),
`
`and F.R.E. 703 (bases for expert opinion) as this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority date of the
`
`’131 Patent, or the February 18, 2002 application date of the ’131 Patent, and is not the type
`
`of document upon which a person of ordinary skill in the art at the time of invention would
`
`rely.
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
`1131
`
`Alexandre
`AACR
`Abstract
`
` F.R.E. 802 (hearsay).
`
`21
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
` 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), and 42.105, 35. U.S.C. §311(b), F.R.E.
`
`402 (relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert
`
`testimony) and F.R.E. 703 (bases for expert opinion) as Petitioner has not provided
`
`evidence to prove that this document was published before the October 17, 2001 priority
`
`date of the ’131 Patent or the February 18, 2002 application date of the ’131 Patent and this
`
`exhibit is not the type of document upon which a person of ordinary skill in the art at the
`
`time of invention would rely.
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`22
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3).
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
`1132
`
`Alley
`
` F.R.E. 802 (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`23
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3).
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
`1133
`
`Beirer
`
` F.R.E. 802 (hearsay).
`
` 37 C.F.R. 42.61(c) (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
` 37 C.F.R. §§ 42.6(a)(3) (combined documents), 42.63 (form of evidence) as this exhibit
`
`appears to be a compilation of more than one document.
`
`24
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
` F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases for expert opinion), as it is not relevant to any issue in this
`
`IPR proceeding, and is not the type of document upon which a person of ordinary skill in
`
`the art at the time of invention would rely.
`
` 37 C.F.R. § 42.104(b)(5) (failure to identify specific portions of evidence).
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
`1134
`
`Boyd
`
` F.R.E. 802 (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`25
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3).
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
`1135
`
`Fairlamb
`
` F.R.E. 802 (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
` 37 C.F.R. § 42.104(b)(5) (failure to identify specific portions of evidence).
`
`26
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3).
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
`1136
`
`Fiebig
`
` F.R.E. 802 (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
`27
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3).
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
`1137
`
`Gonzalez-
`Angulo
`
` F.R.E. 802 (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
`28
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
` 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert testimony),
`
`and F.R.E. 703 (bases for expert opinion) as this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority date of the
`
`’131 Patent, or the February 18, 2002 application date of the ’131 Patent, and is not the type
`
`of document upon which a person of ordinary skill in the art at the time of invention would
`
`rely.
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3).
`
`29
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
`1138
`
`Miller EP
`
` F.R.E. 802 (hearsay).
`
`’960
`
` 37 C.F.R. 42.61(c) (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
` 37 C.F.R. §§ 42.6(a)(3) (combined documents), 42.63 (form of evidence) as this exhibit
`
`appears to be a compilation of more than one document.
`
` 37 C.F.R. § 42.104(b)(5) (failure to identify specific portions of evidence).
`
` F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases for expert opinion), as it is not relevant to any issue in this
`
`30
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`IPR proceeding, and is not the type of document upon which a person of ordinary skill in
`
`the art at the time of invention would rely because it is not pertinent to the entire problem
`
`solved by the ’131 Patent.
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3).
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
`31
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`1139
`
`Monks
`
` F.R.E. 802 (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confusing, waste of time).
`
` 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this
`
`document is not cited in the Reply, and therefore any attempt by Petitioner to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of Petitioner’s expert declaration that discusses this Exhibit) is improper
`
`and untimely and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3).
`
` Improper and untimely to the extent they are cited in support of Petitioner’s prima facie
`
`case as they should have been included in the evidence served with Breckenridge’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b), and 42.105.
`
`32
`
`
`
`Ex. No. Description
`
`Patent Owner’s Objections
`
`1140
`
`Pantuck
`2007
`
` F.R.E. 802 (hearsay).
`
` F.R.E. 402 (relevance).
`
` F.R.E. 403 (confus
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