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`Paper No. ___
`Filed: November 8, 2017
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`ACRUX DDS PTY LTD. & ACRUX LIMITED
`Petitioners,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.
`Patent Owner and Licensee.
`
`
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`
`
`PATENT OWNER’S OBJECTIONS
`TO EVIDENCE SUBMITTED WITH PETITIONER’S REPLY
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
`
`
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`
`
`

`

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`Pursuant to 37 C.F.R. § 42.64(b)(1), Kaken Pharmaceutical Co., Ltd. and
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`Case: IPR2017-00190
`
`
`
`Valeant Pharmaceuticals International, Inc. (collectively “Patent Owner”) hereby
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`object to the admissibility of the following evidence submitted by Acrux DDS
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`PTY Ltd. and Acrux Limited (collectively “Petitioner”) with Petitioner’s Reply to
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`Patent Owner’s Response (Paper No. 37) (“PR”).
`
`
`
`In a clear end-run around the 5,600-word limit that 37 C.F.R. § 42.24 (c)(1)
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`imposes, Petitioner’s Reply uses three new declarations, totaling nearly 50,000
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`additional words, to present new arguments and introduce new evidence in an
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`improper attempt to cure deficiencies in the Petition. Petitioner’s efforts to
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`undermine the regulations are most readily evidenced by one of its new
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`declarations, Ex. 1510, which is from an entirely new expert declarant and attempts
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`to fill the void created by Petitioner’s original declarant, Dr. Walters. Petitioner’s
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`original declarant is clearly not one of skill in the art and is not qualified to opine
`
`on the claimed subject matter, as explained in Patent Owner’s Response.
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`
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`Not only does Petitioner present three new declarations in an attempt to
`
`avoid the word limit, but the substance of those declarations is barely captured by
`
`Petitioner’s Reply and is almost never explained with any particularity. For
`
`example, Petitioner’s Reply commonly cites to large blocks of Dr. Walters’ new
`
`20,000-word declaration without any specificity. See, e.g., PR at 9 (citing Ex.
`
`1509, §§ IV.C, XII-XIII (35 paragraphs)), 13 (citing Ex. 1509, §§ XIII-X (22
`
`
`
`2
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`

`

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`paragraphs)). In fact, only five out of 134 paragraphs are ever cited directly and
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`Case: IPR2017-00190
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`more than forty are never cited at all (i.e., §§ I-IV.A, XI, XIV, XV). Petitioner uses
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`this same inappropriate bulk citation strategy for the other two declarations,
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`Exhibits 1510 and 1511. See, e.g., PR at 20 (citing Ex. 1510, § X (twelve
`
`paragraphs)), 21-22 (citing Ex. 1511, ¶¶ 20-54). Petitioner never cites significant
`
`portions of these additional declarations at all. See generally PR (never citing Ex.
`
`1510 §§ I-V, VI.A, VI.C, VII-IX, XI; and never citing Ex. 1511 ¶¶ 1-19, 55-60,
`
`72-77).
`
`
`
`Petitioner’s improper efforts do not end there. Petitioner also cites more than
`
`150 new exhibits in its three new declarations, amounting to more than 5,000
`
`additional pages of material. Almost none of these new exhibits are even cited in
`
`the Reply, much less described with any reasonable specificity. In large part, the
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`new exhibits are also not actually relevant to any of the issues at bar. Tellingly,
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`Petitioner fails to even cite most of them in their Reply, demonstrating either that
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`they are trying to avoid the required word limit or that they have no bearing on the
`
`issues in this proceeding. In fact, Petitioner’s Reply manages to cite just ten of the
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`new exhibits. These exhibits are used to raise new arguments that could have been
`
`raised in the Petition or to introduce arguments that are not responsive to Patent
`
`Owner’s Response. Patent Owner is therefore prejudiced by Petitioner’s blatant
`
`attempt to avoid the limits set out in 37 C.F.R. § 42.24 (c)(1).
`
`
`
`3
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`

`

`
`Accordingly, Petitioner’s Reply and the evidence submitted therewith
`
`Case: IPR2017-00190
`
`
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`represent a flagrant effort to avoid the practice rules clearly limiting the scope of
`
`Petitioner’s Reply.
`
`Evidence
`Submitted by
`Petitioner
`1500-1503
`
`1504
`
`1505
`
`1506-1508
`
`1509
`
`
`
`Patent Owner’s Objection(s)
`
`Exhibits were marked during the cross-examination of Dr. Boni
`Elewski, Patent Owner’s declarant in this proceeding. Patent
`Owner’s objections are already of record in the transcript.
`
`Exhibit was marked during the cross-examination of Dr. Boni
`Elewski, Patent Owner’s declarant in this proceeding. Patent
`Owner’s objections are already of record in the transcript.
`
`Patent Owner notes that the pagination of Exhibit 1504 indicates
`that the document is incomplete (FRE 106). Specifically, pages
`2, 24, and 25, are missing, as are all of attachment 1 and page 2
`of attachment 2.
`
`Exhibit was marked during the cross-examination of Dr. Boni
`Elewski, Patent Owner’s declarant in this proceeding. Patent
`Owner’s objections are already of record in the transcript.
`
`Exhibit is inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because it is used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. See also, 37 C.F.R. § 42.23(b).
`
`Exhibits are copies of the trial transcripts of the cross-
`examination of Yoshiyuki Tatsumi, Vincent Alexander Thomas,
`and Boni E. Elewski, Patent Owner’s declarants in this
`proceeding. Patent Owner objections are already of record in the
`transcripts.
`
`Exhibit is inadmissible as lacking foundation, assuming facts
`not in evidence, conclusory, unsupported by sufficient facts or
`4
`
`

`

`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`data, and containing testimony concerning several exhibits for
`which authentication is lacking.
`
`Exhibit is inadmissible under Rules 401/402 (lack of relevance)
`and Rule 403 (misleading, confusing, unfair prejudice, waste of
`time, needlessly cumulative) for providing opinions that
`Petitioner elected not to rely on in the Reply brief.
`
`Exhibit is inadmissible for reliance on hearsay documents (FRE
`801, 802, 803, 805) to the extent the relied-upon documents are
`used to prove the truth of the matters asserted therein. Neither
`the Exhibit nor the underlying documents themselves qualify for
`any hearsay exception, including use by an expert.
`
`¶¶ 80,81, 86-90, 92-93, and 120-122 include conclusory
`statements and lack explanation for the bases of the stated
`opinions. There is inadequate information establishing that these
`statements / opinions rely on sufficient facts or data, that they
`are the product of reliable principles and methods, and/or that
`they reliably apply those principles and methods to the facts.
`FRE 702 and 703.
`
`¶¶ 24, 26, 65, 66, 69, 71, 73, 91, 98, and 115 provide improper
`opinions by raising new arguments and relying on exhibits in
`ways that do not appear in the Petition or Ex. 1005 and are not
`responsive to any positions raised in Patent Owner’s Response.
`Thus, they are untimely and irrelevant to any issue in this IPR
`and are also inadmissible as unfairly prejudicial. They are used
`in Petitioner’s Reply brief to raise new arguments that could
`have been raised in the Petition and/or to introduce arguments
`that are not responsive to Patent Owner’s Response. Any future
`reliance on these opinions would be, among other things, unduly
`prejudicial, misleading, and a waste of the Board’s time. FRE
`401, 402, 403; 37 C.F.R. § 42.23(b); see, e.g., In re NuVasive,
`Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibit is inadmissible as lacking foundation, assuming facts
`5
`
`Evidence
`Submitted by
`Petitioner
`
`1510
`
`
`
`

`

`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`not in evidence, conclusory, unsupported by sufficient facts or
`data, and containing testimony concerning several exhibits for
`which authentication is lacking.
`
`Exhibit is inadmissible under Rules 401/402 (lack of relevance)
`and Rule 403 (misleading, confusing, unfair prejudice, waste of
`time, needlessly cumulative) for providing opinions that
`Petitioner elected not to rely on in the Reply brief.
`
`Exhibit is inadmissible for reliance on hearsay documents (FRE
`801, 802, 803, 805) to the extent the relied-upon documents are
`used to prove the truth of the matters asserted therein. Neither
`the Exhibit nor the underlying documents themselves qualify for
`any hearsay exception, including use by an expert.
`
`Exhibit is inadmissible as duplicative of the testimony in Ex.
`1509 and for providing evidence and arguments allegedly
`remedying deficiencies with Petitioner’s case-in-chief, including
`statements regarding the meaning of the terms “nail” and
`“onychomycosis,” the activity and prior testing of
`efinaconazole, and the alleged availability of other topical
`treatments. The arguments are therefore untimely and
`prejudicial. FRE 401, 402, 403; 37 C.F.R. § 42.23(b); see, e.g.,
`In re NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`¶¶ 47, 52, 60, and 69 include conclusory statements and lack
`explanation for the bases of the stated opinions. There is
`inadequate information establishing that these statements /
`opinions rely on sufficient facts or data, that they are the product
`of reliable principles and methods, and/or that they reliably
`apply those principles and methods to the facts. FRE 702 and
`703.
`
`¶¶ 25, 57, 58, 63-66, 68, and 72 provide improper opinions by
`raising new arguments and relying on exhibits in ways that do
`not appear in the Petition or Ex. 1005 and are not responsive to
`any positions raised in Patent Owner’s Response. Thus, they are
`6
`
`Evidence
`Submitted by
`Petitioner
`
`
`
`

`

`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`untimely and irrelevant to any issue in this IPR and are also
`inadmissible as unfairly prejudicial. They are used in
`Petitioner’s Reply brief to raise new arguments that could have
`been raised in the Petition and/or to introduce arguments that are
`not responsive to Patent Owner’s Response. Any future reliance
`on these opinions would be, among other things, unduly
`prejudicial, misleading, and a waste of the Board’s time. FRE
`401, 402, 403; 37 C.F.R. § 42.23(b); see, e.g., In re NuVasive,
`Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibit is inadmissible as lacking foundation, assuming facts
`not in evidence, conclusory, unsupported by sufficient facts or
`data, and containing testimony concerning several exhibits for
`which authentication is lacking.
`
`Exhibit is inadmissible under Rules 401/402 (lack of relevance)
`and Rule 403 (misleading, confusing, unfair prejudice, waste of
`time, needlessly cumulative) for providing opinions that
`Petitioner elected not to rely on in the Reply brief.
`
`Exhibit is inadmissible for reliance on hearsay documents (FRE
`801, 802, 803, 805) to the extent the relied-upon documents are
`used to prove the truth of the matters asserted therein. Neither
`the Exhibit nor the underlying documents themselves qualify for
`any hearsay exception, including use by an expert.
`
`¶¶ 12-17 provide an extended discussion of insurance
`procedures that are, among other things, unduly prejudicial,
`misleading, and a waste of the Board’s time because they have
`no bearing on the purported opinions regarding commercial
`success. FRE 401 and 403. Further, the Declarant has not stated
`that he is an expert in insurance procedures and, thus, is not
`qualified to opine on them as an expert or a lay witness. FRE
`701-703
`
`¶¶ 18, 21, 55, 72 in particular represent improper expert
`testimony as they purport to provide legal opinions by a non-
`7
`
`Evidence
`Submitted by
`Petitioner
`
`1511
`
`
`
`

`

`Evidence
`Submitted by
`Petitioner
`
`1538, 1542,
`1551, 1566,
`1599, 1605,
`1609, 1613,
`1617, 1626-
`1628, 1631,
`1636, 1638-1645
`
`1530, 1543,
`1544, 1547, 1596
`
`
`
`Case: IPR2017-00190
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`Patent Owner’s Objection(s)
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`attorney declarant. FRE 701-703.
`
`¶¶ 7 and 57 are inadmissible for raising new arguments and
`relying on exhibits in ways that do not appear in the Petition or
`Ex. 1005 and are not responsive to any positions raised in Patent
`Owner’s Response. FRE 401, 402, 403; 37 C.F.R. § 42.23(b);
`see, e.g., In re NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir.
`2016).
`
`Exhibits are inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because they are used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response.
`
`Exhibits are inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the documents are used
`to prove the truth of the matters asserted therein. The documents
`do not provide the necessary information to establish eligibility
`for any hearsay exception.
`
`Exhibits are inadmissible as lacking authentication (FRE 901) as
`there are no indications of sources accompanying the document,
`no witness testimony is offered to indicate sources, and the
`exhibits are not self-authenticating (FRE 902).
`
`Exhibits are inadmissible as incomplete (FRE 106) because, for
`example, they fail to include website address or web location
`information.
`
`Exhibits are inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because they are used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`
`
`
`8
`
`

`

`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`Exhibits are inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the documents are used
`to prove the truth of the matters asserted therein. The documents
`do not provide the necessary information to establish eligibility
`for any hearsay exception.
`
`Exhibits are inadmissible as lacking authentication (FRE 901) as
`there are no indications of sources accompanying the
`documents, no witness testimony is offered to indicate sources,
`and the exhibits are not self-authenticating (FRE 902).
`
`Exhibit is inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because it is used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibit is inadmissible as lacking authentication (FRE 901) as
`there is no indication of source accompanying the document, no
`witness testimony is offered to indicate its source and is not
`self-authenticating (FRE 902).
`
`Exhibits are inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because they are used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Inadmissible under Rules 401/402 (lack of relevance) and Rule
`403 (misleading, confusing, unfair prejudice, waste of time,
`needlessly cumulative) for introducing arguments that Petitioner
`elected not to rely on in its Reply.
`
`Exhibits are inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the documents are used
`9
`
`Evidence
`Submitted by
`Petitioner
`
`1523
`
`1525, 1527,
`1528, 1531-
`1534, 1537,
`1539-1541,
`1545, 1546,
`1548, 1549,
`1555, 1557-
`1560, 1581,
`1594, 1607,
`1621, 1632-1634
`
`
`
`

`

`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`to prove the truth of the matters asserted therein. The documents
`do not provide the necessary information to establish eligibility
`for any hearsay exception.
`
`Exhibits are inadmissible as lacking authentication (FRE 901) as
`there is no indication of sources accompanying the documents,
`no witness testimony is offered to indicate sources, and the
`exhibits are not self-authenticating (FRE 902).
`
`Exhibit is inadmissible as incomplete (FRE 106) because page 1
`is missing (the document starts with the line “continued from
`page 1”).
`
`Exhibit is inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because it is used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibit is inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the document is used to
`prove the truth of the matters asserted therein. The document
`does not provide the necessary information to establish
`eligibility for any hearsay exception.
`
`Exhibit is inadmissible as lacking authentication (FRE 901) as
`there is no indication of source accompanying the document, no
`witness testimony is offered to indicate its source and is not
`self-authenticating (FRE 902).
`
`Exhibits are inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because they are used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`10
`
`Evidence
`Submitted by
`Petitioner
`
`1580
`
`1565, 1606
`
`
`
`

`

`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`
`Exhibits are inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the documents are used
`to prove the truth of the matters asserted therein. The documents
`do not provide the necessary information to establish eligibility
`for any hearsay exception.
`
`Exhibits are inadmissible as lacking authentication (FRE 901) as
`there are no indications of sources accompanying the
`documents, no witness testimony is offered to indicate the
`sources, and the exhibits are not self-authenticating (FRE 902)
`
`Exhibit is inadmissible as incomplete (FRE 106) because it does
`not indicate the source of the document.
`
`Exhibit is inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because it is used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibit is inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the document is used to
`prove the truth of the matters asserted therein. The document
`does not provide the necessary information to establish
`eligibility for any hearsay exception.
`
`Exhibit is inadmissible as lacking authentication (FRE 901) as
`there is no indication of source accompanying the document, no
`witness testimony is offered to indicate its source and is not
`self-authenticating (FRE 902).
`
`Exhibit is inadmissible as incomplete (FRE 106) because this
`document includes only sections of the document, including
`incomplete sections or chapters. Exhibit shows that other pages
`are marked or tabbed but those pages are not produced.
`11
`
`Evidence
`Submitted by
`Petitioner
`
`1561
`
`1564
`
`
`
`

`

`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`
`Exhibit is inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 403) because it is used in the Reply brief to raise new
`arguments that could have been raised in the Petition and/or to
`introduce arguments that are not responsive to Patent Owner’s
`Response. 37 C.F.R. § 42.23(b); see, e.g., In re NuVasive, Inc.,
`841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`
`Exhibit is inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the document is used to
`prove the truth of the matters asserted therein. The document
`does not provide the necessary information to establish
`eligibility for any hearsay exception.
`
`Exhibit is inadmissible as lacking authentication (FRE 901) as
`there is no indication of source accompanying the document, no
`witness testimony is offered to indicate its source and is not
`self-authenticating (FRE 902).
`
`Exhibits are inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because they are used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibits are inadmissible as lacking authentication (FRE 901) as
`there is no witness testimony offered to indicate their sources
`and the exhibits are not self-authenticating (FRE 902).
`
`Exhibit is inadmissible as incomplete (FRE 106) because pages
`31, 32, 41, 58, 64, 70, 88, 90, and 101 are redacted.
`
`Exhibit is inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because it is used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`12
`
`Evidence
`Submitted by
`Petitioner
`
`1526, 1529,
`1569-1574,
`1576, 1578,
`1579, 1582-
`1586, 1591-
`1593, 1598,
`1600, 1608,
`1610-1612,
`1618, 1658-1660
`
`1575
`
`
`
`

`

`Evidence
`Submitted by
`Petitioner
`
`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`1552, 1556
`
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibit is inadmissible as lacking authentication (FRE 901) as
`there is no witness testimony offered to indicate its source and
`the exhibit is not self-authenticating (FRE 902).
`1590, 1646-1651 Exhibits are inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because they are used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibits are inadmissible as lacking authentication (FRE 901) as
`there is no witness testimony offered to indicate its source and is
`not self-authenticating (FRE 902).
`
`Exhibits are inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because they are used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibits are inadmissible for lack of authentication (FRE 901)
`as there is no witness testimony offered to indicate their sources
`and the documents are not self-authenticating (FRE 902).
`
`1602, 1652-1657 Exhibits are inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because they are used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or they are not responsive to Patent Owner’s Response. 37
`C.F.R. § 42.23(b); see, e.g., In re NuVasive, Inc., 841 F.3d 966,
`972-3 (Fed. Cir. 2016).
`
`Exhibits are inadmissible as incomplete (FRE 106) because
`these documents include only sections of larger materials.
`13
`
`
`
`

`

`Evidence
`Submitted by
`Petitioner
`
`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`1553, 1554,
`1563, 1568,
`1587, 1588,
`1597, 1603,
`1604, 1614, 1630
`
`
`Exhibits are inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the documents are used
`to prove the truth of the matters asserted therein. The documents
`do not provide the necessary information to establish eligibility
`for any hearsay exception.
`
`Exhibits are inadmissible as lacking authentication (FRE 901) as
`there is no indication of sources accompanying the documents,
`no witness testimony is offered to indicate sources, and the
`exhibits are not self-authenticating (FRE 902).
`
`Exhibits are inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because they are used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibits are inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the documents are used
`to prove the truth of the matters asserted therein. The documents
`do not provide the necessary information to establish eligibility
`for any hearsay exception.
`
`Exhibits are inadmissible for lack of authentication (FRE 901)
`as there is no indication of sources accompanying the
`documents, no witness testimony is offered to indicate sources,
`and the exhibits are not self-authenticating (FRE 902).
`
`1515-1517, 1550 Exhibits are inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because they are used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`
`
`
`14
`
`

`

`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`Exhibits are inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the documents are used
`to prove the truth of the matters asserted therein. The documents
`do not provide the necessary information to establish eligibility
`for any hearsay exception.
`
`Exhibits are inadmissible as lacking authentication (FRE 901) as
`there is no indication of sources accompanying the documents,
`no witness testimony is offered to indicate sources, and the
`articles retrieved from the internet are not self-authenticating
`under FRE 902.
`
`Exhibit is inadmissible as incomplete (FRE 106) because
`pagination is inconsistent and it is not clear that all pages are
`included.
`
`Exhibit is inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because it is used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibit is inadmissible as lacking authentication (FRE 901) as
`there is no indication of source accompanying the document, no
`witness testimony is offered to indicate its source, and it is not
`clearly self-authenticating under FRE 902 based on the
`unconfirmed cover page.
`
`Exhibit is inadmissible as incomplete (FRE 106) because
`pagination is inconsistent and it is not clear that all pages are
`included.
`
`Exhibit is inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the document is used to
`prove the truth of the matters asserted therein. The document
`does not provide the necessary information to establish
`15
`
`Evidence
`Submitted by
`Petitioner
`
`1521
`
`1519
`
`
`
`

`

`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`eligibility for any hearsay exception
`
`Exhibit is inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because it is used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibit is inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because it is used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibit is inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the document is used to
`prove the truth of the matters asserted therein. The document
`does not provide the necessary information to establish
`eligibility for any hearsay exception.
`
`Exhibit is inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because it is used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibit is inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the document is used to
`prove the truth of the matters asserted therein. The document
`does not provide the necessary information to establish
`eligibility for any hearsay exception.
`
`Exhibit is inadmissible as lacking authentication (FRE 901) as
`there is no indication of source accompanying the document, no
`16
`
`Evidence
`Submitted by
`Petitioner
`
`1520
`
`1513
`
`
`
`

`

`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`witness testimony is offered to indicate its source, and journals
`are not self-authenticating (FRE 902).
`.
`Exhibit is inadmissible as incomplete (FRE 106) because
`sections of the document are not complete, including pages
`ending mid-sentence.
`
`Exhibit is inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because it is used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibit is inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the document is used to
`prove the truth of the matters asserted therein. The document
`does not provide the necessary information to establish
`eligibility for any hearsay exception.
`
`Exhibit is inadmissible as lacking authentication (FRE 901) as
`there is no indication of source accompanying the document, no
`witness testimony is offered to indicate its source, and journals
`are not self-authenticating (FRE 902).
`
`Exhibits are inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because they are used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response. 37 C.F.R. § 42.23(b); see, e.g., In re
`NuVasive, Inc., 841 F.3d 966, 972-3 (Fed. Cir. 2016).
`
`Exhibits are inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the documents are used
`to prove the truth of the matters asserted therein. The documents
`do not provide the necessary information to establish eligibility
`for any hearsay exception.
`17
`
`Evidence
`Submitted by
`Petitioner
`
`1514
`
`1512, 1518,
`1524, 1562,
`1567, 1623,
`1625, 1637
`
`
`
`

`

`
`
`Case: IPR2017-00190
`
`Patent Owner’s Objection(s)
`
`
`Exhibits are inadmissible as lacking authentication (FRE 901) as
`there is no indication of sources accompanying the documents
`and no witness testimony is offered to indicate sources.
`
`Exhibits are inadmissible as not relevant and unfairly prejudicial
`(FRE 401, 402, 403) because they are used in the Reply brief to
`raise new arguments that could have been raised in the Petition
`and/or to introduce arguments that are not responsive to Patent
`Owner’s Response.
`37 C.F.R. § 42.23(b); see, e.g., In re NuVasive, Inc., 841 F.3d
`966, 972-3 (Fed. Cir. 2016). Indeed, Petitioner admits to lack of
`relevance for Ex. 1522 by providing a Bates stamp on the
`exhibit for a different IPR proceeding.
`
`Exhibits are inadmissible as hearsay and hearsay within hearsay
`(FRE 801, 802, 803, 805) to the extent the documents are used
`to prove the truth of the matters asserted therein. The documents
`do not provide the necessary information to establish eligibility
`for any hearsay exception.
`
`Exhibits are inadmissible as lacking authentication (FRE 901) as
`there is no indication of sources accompanying the documents,
`no witness testimony is offered to indicate sources, and the
`exhibits are not