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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`____________________________________________
`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`____________________________________________
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE FILED AND SERVED
`WITH PETITIONER’S REPLY PURSUANT TO 37 C.F.R. § 42.64
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`IPR2023-00480
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
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`Pursuant to 37 C.F.R. § 42.64, Patent Owner submits the following
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`objections to evidence filed and served with Petitioner’s Reply (“Reply”). Patent
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`Owner’s objections apply equally to Petitioner’s reliance on these exhibits in any
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`subsequently filed documents. These objections are timely, having been filed
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`within five business days of service of evidence to which the objection is directed
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`(April 5, 2024).
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`Exhibit 1084 (Second Declaration of Aaron E. Miller, M.D.).
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`Patent Owner objects to Exhibit 1084 as misleading, incomplete, lacking
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`relevance, and because any probative value is substantially outweighed by the
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`danger of unfair prejudice, confusing the issues, misleading the fact finder, undue
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`delay, wasting time, and/or needlessly presenting cumulative evidence. See Fed.
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`R. Evid. 106 and 401-403. Patent Owner also objects to the extent the content of
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`the declaration is not discussed in the Reply and represents an improper
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`incorporation by reference to impermissibly expand the page limit for the Reply.
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`See 37 C.F.R. § 42.6(a)(3). In particular, Patent Owner objects to:
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` ¶¶ 10, 18, 27-35, 62, 93, and 124-125 as misleading, incomplete, and
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`irrelevant because they lack support for the contentions for which they are
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`cited and improperly characterize the teachings of the ’947 patent;
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` ¶¶ 7, 9, 12-14, 16, 21-35, 49-50, 53-55, 59, 61-64, 66-67, 69, 72-74, 76, 78,
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`80-83, 86, 89-91, 97, 99-102, 104-119, 121-130, and 132-133 as misleading,
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`IPR2023-00480
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
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`incomplete, and irrelevant because they lack support for the contentions for
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`which they are cited;
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` ¶¶ 8, 10-11, 15, 17-19, 51-52, 56-58, 60, 65, 68, 70-71, 75, 77, 79, 84-85,
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`87-88, 92-96, 98, 103, 120, and 131 as misleading, incomplete, and
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`irrelevant because they lack support for the contentions for which they are
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`cited and improperly characterize the teachings of Bodor and Stelmasiak;
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` ¶¶ 7-15, 17-19, 22-26, 29-31, 50-55, 57-58, 60, 62-97, 102, 104-115, 117,
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`119-127, and 129-133 as misleading, incomplete, and irrelevant because
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`they lack support for the contentions for which they are cited and/or
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`improperly characterize the testimony and opinions of Dr. Lublin;
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` ¶¶ 8, 15, 17, 58, 60, 63-65, 91, and 94 as misleading, incomplete, and
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`irrelevant because they lack support for the contentions for which they are
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`cited and/or improperly characterize the testimony and opinions of Dr.
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`Meibohm;
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` ¶¶ 8 and 58 as misleading, incomplete, and irrelevant because they lack
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`support for the contentions for which they are cited and/or improperly
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`characterize the testimony and opinions of Dr. Bodor; and
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` ¶¶ 16, 18, and 91-93 as irrelevant because these paragraphs refer to art not
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`relied upon in the Grounds at issue in this inter partes review. Further, any
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`probative value of these paragraphs is substantially outweighed by the
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`IPR2023-00480
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
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`danger of unfair prejudice, confusing the issues, misleading the fact finder,
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`undue delay, wasting time, and/or needlessly presenting cumulative
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`evidence.
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`Patent Owner further objects to ¶¶ 7-19, 21-35, and 49-133 as not being
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`based on sufficient facts or data, the product of reliable principles and methods,
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`and/or not reflecting a reliable application of the principles and methods to the
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`facts. See Fed. R. Evid. 702-703.
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`Patent Owner further objects to ¶¶ 9, 21, and 49, because these paragraphs
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`are not directly cited in the Reply and the relevance of these paragraphs is not
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`apparent. See Fed. R. Evid. 401-402. Petitioner includes two citations in the
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`Reply to all paragraphs in Exhibit 1084. See Reply, 18 (citing “EX1084, ¶¶1-133”
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`for the assertion that “Merck’s remaining arguments also fail”), 23 (citing
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`“EX1084, ¶¶1-133” for the assertion that “Merck’s other arguments” should be
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`rejected). This does not moot Patent Owner’s objection to ¶¶ 9, 21, and 49 because
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`Petitioner’s wholesale citation to every paragraph in Dr. Miller’s second
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`declaration amounts to improper incorporation by reference. See 37 C.F.R.
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`§42.6(a)(3); see also Instrumentation Lab. Co. v. HemoSonics LLC, IPR2017-
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`00855, Paper 55 at 22-23 (P.T.A.B. Feb. 13, 2019) (declining to consider
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`paragraphs of declaration “merely because they are cited in the Petition”).
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`IPR2023-00480
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
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`Patent Owner further objects to ¶ 23, n.1, which cites to an exhibit that is not
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`cited in the Reply, as irrelevant. See Fed. R. Evid. 402.
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`Patent Owner further objects to paragraphs that cite to Exhibit 1080 for the
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`same reasons Patent Owner objects to Exhibit 1080 as discussed below.
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`
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`Exhibit 1080 (Declaration of Rodolfo Pinal, Ph.D.).
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`Patent Owner objects to Exhibit 1080 as misleading, incomplete, lacking
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`relevance, and because any probative value is substantially outweighed by the
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`danger of unfair prejudice, confusing the issues, misleading the fact finder, undue
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`delay, wasting time, and/or needlessly presenting cumulative evidence. See Fed.
`
`R. Evid. 106 and 401-403. Patent Owner also objects to the extent the content of
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`the declaration is not discussed in the Reply and represents an improper
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`incorporation by reference to impermissibly expand the page limit for the Reply.
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`See 37 C.F.R. § 42.6(a)(3). In particular, Patent Owner objects to:
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` ¶¶ 14-15, 20, 22, 27-44, 46-49, 51-52, 55, 59, 62-63, 66-68, 70, 74-75, 78-
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`79, 82-83 as misleading, incomplete, and irrelevant because they lack
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`support for the contentions for which they are cited;
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` ¶¶ 16-19, 45, 50, 53-54, 56-58, 60-61, 64-65, 69, 71-73, 76-77, and 80-81 as
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`misleading, incomplete, and irrelevant because they lack support for the
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`contentions for which they are cited and improperly characterize the
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`teachings of Bodor and Stelmasiak;
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`IPR2023-00480
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
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` ¶¶ 17-18, 67-69, and 78 as misleading, incomplete, and irrelevant because
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`they lack support for the contentions for which they are cited and/or
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`improperly characterize the testimony and opinions of Dr. Lublin;
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` ¶¶ 15, 17-18, 32-34, 41, 43, 67-69, 72-73, and 78 as misleading, incomplete,
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`and irrelevant because they lack support for the contentions for which they
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`are cited and/or improperly characterize the testimony and opinions of Dr.
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`Meibohm;
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` ¶¶ 15-16, 31, 34, 38, 41-42, 54, 60, and 63 as misleading, incomplete, and
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`irrelevant because they lack support for the contentions for which they are
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`cited and/or improperly characterize the testimony and opinions of Dr.
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`Bodor;
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` ¶¶ 45, 54, and 62 as misleading, incomplete, and irrelevant because they lack
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`support for the contentions for which they are cited and/or improperly
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`characterize the testimony and opinions of Dr. Munafo;
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` ¶¶ 38, 41, and 63 as misleading, incomplete, and irrelevant because they lack
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`support for the contentions for which they are cited and/or improperly
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`characterize the testimony and opinions of Dr. Dandiker; and
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` ¶¶ 19, 79, and 82 as irrelevant because these paragraphs refer to art not
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`relied upon in the Grounds at issue in this inter partes review. Further, any
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`probative value of these paragraphs is substantially outweighed by the
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`IPR2023-00480
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
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`danger of unfair prejudice, confusing the issues, misleading the fact finder,
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`undue delay, wasting time, and/or needlessly presenting cumulative
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`evidence.
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`Patent Owner further objects to ¶¶ 14-20, 22, and 27-83 as not being based
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`on sufficient facts or data, the product of reliable principles and methods, and/or
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`not reflecting a reliable application of the principles and methods to the facts. See
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`Fed. R. Evid. 702-703.
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`Patent Owner further objects to ¶¶ 14 and 19-20 because these paragraphs
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`are not directly cited in the Petition and the relevance of these paragraphs is not
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`apparent. See Fed. R. Evid. 401-402. Petitioner includes two citations in the
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`Reply to all paragraphs in Exhibit 1080. See Reply, 23 (citing “EX1080, ¶¶1-83”
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`for the assertion that “Merck’s other arguments” should be rejected). This does not
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`moot Patent Owner’s objection to ¶¶ 14 and 19-20 because Petitioner’s wholesale
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`citation to every paragraph in Dr. Pinal’s declaration amounts to improper
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`incorporation by reference. See 37 C.F.R. §42.6(a)(3); see also Instrumentation
`
`Lab. Co. v. HemoSonics LLC, IPR2017-00855, Paper 55 at 22-23 (P.T.A.B. Feb.
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`13, 2019) (declining to consider paragraphs of declaration “merely because they
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`are cited in the Petition”).
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`Patent Owner further objects to ¶¶ 4, 31, 33, 44, 46, 61, and 77, which cite to
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`exhibits that are not cited in the Reply, as irrelevant. See Fed. R. Evid. 402.
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`IPR2023-00480
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
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`Patent Owner further objects to paragraphs that cite Exhibit 1084 for the
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`same reasons Patent Owner objects to Exhibit 1084 as discussed above.
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`Exhibits 1068, 1070-1071, 1073, 1075, 1079, 1081, 1083.
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`Patent Owner objects to Exhibits 1068, 1070-1071, 1073, 1075, 1079, 1081,
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`and 1083 under Fed. R. Evid. 401-403 as lacking relevance and because their
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`probative value is substantially outweighed by the danger of unfair prejudice,
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`confusing the issues, misleading the fact finder, undue delay, and/or wasting time.
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`Patent Owner further objects to these exhibits under Fed. R. Evid. 401-402 because
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`the exhibits are not cited in the Reply.
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`Exhibits 1055-1056, 1064-1079, 1081, and 1083.
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`Patent Owner objects to Exhibits 1055-1056, 1064-1079, 1081, and 1083
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`under Fed. R. Evid. 401-403 as lacking relevance and because their probative value
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`is substantially outweighed by the danger of unfair prejudice, confusing the issues,
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`misleading the fact finder, undue delay, and/or wasting time.
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`Patent Owner objects to Exhibits 1064-1074, 1076-1079, 1081, and 1083 as
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`inadmissible hearsay, to the extent they are being offered to prove the truth of the
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`matter asserted.
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`Patent Owner further objects to Exhibits 1064-1074, 1076-1079, and 1083
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`under Fed. R. Evid. 901 because the documents lack authentication.
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`IPR2023-00480
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
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`Patent Owner further objects to any paragraph of Exhibits 1080 and 1084 to
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`the extent they rely on Exhibits 1064-1074, 1076-1079, 1081, and 1083, for at least
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`the reasons identified here.
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`Exhibits 1059-1063.
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`
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`Patent Owner objects to Exhibit 1059 under Fed. R. Evid. 106 as an
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`incomplete and/or inaccurate transcript of the February 15, 2024 Deposition of Dr.
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`Nicholas Bodor because the transcript does not include the accompanying errata
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`sheet, as served by Planet Depos on March 13, 2024. The submitted errata sheet
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`must in fairness be considered at the same time as the exhibit.
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`Patent Owner objects to Exhibit 1060 under Fed. R. Evid. 106 as an
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`incomplete and/or inaccurate transcript of the February 16, 2024 Deposition of Dr.
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`Yogesh Dandiker because the transcript does not include the accompanying errata
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`sheet, as served by Planet Depos on March 20, 2024. The submitted errata sheet
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`must in fairness be considered at the same time as the exhibit.
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`Patent Owner objects to Exhibit 1061 under Fed. R. Evid. 106 as an
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`incomplete and/or inaccurate transcript of the March 5, 2024 Deposition of Dr.
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`Fred Lublin because the transcript does not include the accompanying errata sheet,
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`as served by Planet Depos on April 1, 2024. The submitted errata sheet must in
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`fairness be considered at the same time as the exhibit.
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`IPR2023-00480
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
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`Patent Owner objects to Exhibit 1062 under Fed. R. Evid. 106 as an
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`
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`incomplete and/or inaccurate transcript of the March 6, 2024 Deposition of Dr.
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`Bernd Meibohm because the transcript does not include the accompanying errata
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`sheet, as served by Planet Depos on April 4, 2024. The submitted errata sheet
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`must in fairness be considered at the same time as the exhibit.
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`Patent Owner objects to Exhibit 1063 under Fed. R. Evid. 106 as an
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`incomplete and/or inaccurate transcript of the March 27, 2024 Deposition of Dr.
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`Alain Munafo because the transcript does not include the accompanying errata
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`sheet, as served by Planet Depos on April 5, 2024. The submitted errata sheet
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`must in fairness be considered at the same time as the exhibit.
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`Patent Owner further objects to Exhibits 1059-1063 for the same reasons as
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`the objections stated in those transcripts.
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`Patent Owner further objects to any paragraph of Exhibits 1080 and 1084 to
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`the extent they rely on Exhibits 1059-1063, for at least the reasons identified here.
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`IPR2023-00480
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
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`Respectfully submitted,
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`Date: April 12, 2024
`
`By: /Emily R. Whelan/
`Emily R. Whelan (Reg. No. 50,391)
`Wilmer Cutler Pickering Hale and Dorr LLP
`60 State Street
`Boston, MA 02109
`Tel. (617) 526-6567
`Email: Emily.Whelan@wilmerhale.com
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`
`
`Counsel for Patent Owner
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`IPR2023-00480
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
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`CERTIFICATE OF SERVICE
`I hereby certify that, on April 12, 2024, I caused a true and correct copy of
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`the following document:
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`
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`Patent Owner’s Objections to Evidence Pursuant to 37 C.F.R. § 42.64
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`to be served via e-mail, as consented to by Petitioner, on the following attorneys of
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`record:
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`
`
`
`
`eellison-PTAB@sternekessler.com
`opartington-PTAB@sternekessler.com
`cvira-PTAB@sternekessler.com
`jcrozendaal-PTAB@sternekessler.com
`cdashe-PTAB@sternekessler.com
`pkhanduri-PTAB@sternekessler.com
`tliu-PTAB@sternekessler.com
`mbond-PTAB@sternekessler.com
`PTAB@sternekessler.com
`
`By: /Cindy Kan/
`Cindy Kan (Reg. No. 76,385)
`Wilmer Cutler Pickering Hale and Dorr LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`Tel: 212-295-6470
`Email: cindy.kan@wilmerhale.com
`
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