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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
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`Moderna Therapeutics, Inc.
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`Petitioner
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`v.
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`Protiva Biotherapeutics, Inc.
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`Patent Owner
`___________
`
`
`Case No. IPR2018-00739
`U.S. Patent No. 9,364,435
`
`
`___________
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`
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`PETITIONER’S OBJECTIONS TO EVIDENCE SUBMITTED IN PATENT
`OWNER’S SUR-REPLY PURSUANT TO 37 C.F.R. § 42.64(b)
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`Mail Stop: PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`10670073
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`
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`IPR Case No. IPR2018-00739
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`
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`
`
` U.S. Patent No. 9,364,435
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Moderna Therapeutics, Inc.
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`(“Moderna” or “Petitioner”), submits the following objections to evidence
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`accompanying the Patent Owner’s Sur-Reply. Petitioner’s objections are timely
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`under 37 C.F.R. § 42.64(b)(1) because they are being filed within five (5) business
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`days of service of the Patent Owner’s Sur-Reply.
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`Petitioner reserves the right to present further objections to these or
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`additional Exhibits submitted by Patent Owner, as allowed by the applicable rules
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`or other authority.
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`Evidence
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`Description
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`Objection(s)
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`Exhibit 2046
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`Alleged “Listing of
`Example Formulations
`Falling within the
`Scope of the ’435
`Patent Claims”
`
`
`FRE 401, 402, 403 – Petitioner objects
`to the Exhibit as containing mere
`attorney argument without a
`sponsoring expert witness and
`mischaracterizations of the cited
`patents and cited art. Accordingly, the
`document is not relevant to any issue in
`the proceeding and/or any probative
`value is substantially outweighed by
`the danger of unfair prejudice.
`
`FRE 701, 702, 703 – Petitioner objects
`to the Exhibit including the title and the
`titles of the columns of this Exhibit as
`containing without a sponsoring expert
`witness and mischaracterizations of the
`cited patents and cited art which are not
`based on sufficient facts or data and are
`not based on a reliable foundation,
`and/or constitute conclusory opinion
`without sufficient support. See also
`Daubert v. Merrell Dow Pharms, Inc.,
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`- 1 -
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`IPR Case No. IPR2018-00739
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` U.S. Patent No. 9,364,435
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`509 U.S. 579 (1993). Moreover,
`Petitioner objects to this Exhibit as
`improper opinion testimony by a lay
`witness (FRE 701) and Petitioner
`objects to this Exhibit to the extent it is
`being offered as opinion testimony
`(FRE 702). An unknown author of the
`chart does not qualify as an expert in
`patent law by knowledge, skill,
`experience, training or education.
`
`FRE 801/802 –Petitioner objects to
`this Exhibit as inadmissible hearsay to
`the extent Patent Owner relies on it for
`the truth of the matter asserted therein.
`
`FRE 401, 402, 403 – Petitioner objects
`to the entry of EX2047 as untimely.
`Further, this Exhibit is offered in
`support of mere attorney argument
`without a sponsoring expert witness
`that mischaracterizes the cited
`reference. As a result, this reference is
`not relevant to this proceeding.
`
`To the extent this exhibit is deemed
`relevant, admission of the exhibit
`would be unduly prejudicial given its
`untimeliness and lack of supporting
`expert testimony.
`
`FRE 401, 402, 403 – Petitioner objects
`to the entry of EX2048 as untimely.
`Further, this Exhibit is offered in
`support of mere attorney argument
`without a sponsoring expert witness
`that mischaracterizes the cited
`reference. As a result, this reference is
`not relevant to this proceeding.
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`
`Exhibit 2047 WO 2010/088537
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`Exhibit 2048 Sedic 2017 Article
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`- 2 -
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`IPR Case No. IPR2018-00739
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` U.S. Patent No. 9,364,435
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`Exhibit 2049 WO 2013/090648
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`Exhibit 2050 Bahl 2017 Article
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`To the extent this exhibit is deemed
`relevant, admission of the exhibit
`would be unduly prejudicial given its
`untimeliness and lack of supporting
`expert testimony.
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`FRE 801/802 –Petitioner objects to
`this Exhibit as inadmissible hearsay to
`the extent Patent Owner relies on it for
`the truth of the matter asserted therein.
`
`FRE 401, 402, 403 – Petitioner objects
`to the entry of EX2049 as untimely.
`Further, this Exhibit is offered in
`support of mere attorney argument
`without a sponsoring expert witness
`that mischaracterizes the cited
`reference. As a result, this reference is
`not relevant to this proceeding.
`
`To the extent this exhibit is deemed
`relevant, admission of the exhibit
`would be unduly prejudicial given its
`untimeliness and lack of supporting
`expert testimony.
`
`FRE 401, 402, 403 – Petitioner objects
`to the entry of EX2050 as untimely.
`Further, this Exhibit is offered in
`support of mere attorney argument
`without a sponsoring expert witness
`that mischaracterizes the cited
`reference. As a result, this reference is
`not relevant to this proceeding.
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`To the extent this exhibit is deemed
`relevant, admission of the exhibit
`would be unduly prejudicial given its
`untimeliness and lack of supporting
`expert testimony.
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`
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`- 3 -
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`IPR Case No. IPR2018-00739
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` U.S. Patent No. 9,364,435
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`FRE 801/802 –Petitioner objects to
`this Exhibit as inadmissible hearsay to
`the extent Patent Owner relies on it for
`the truth of the matter asserted therein.
`
`FRE 401, 402, 403 – Petitioner objects
`to the entry of EX2051 as untimely.
`Further, this Exhibit is offered in
`support of mere attorney argument
`without a sponsoring expert witness
`that mischaracterizes the cited
`reference. As a result, this reference is
`not relevant to this proceeding.
`
`To the extent this exhibit is deemed
`relevant, admission of the exhibit
`would be unduly prejudicial given its
`untimeliness and lack of supporting
`expert testimony.
`
`FRE 401, 402, 403 – Petitioner objects
`to the entry of EX2047 as untimely.
`Further, this Exhibit is offered in
`support of mere attorney argument
`without a sponsoring expert witness
`that mischaracterizes the cited
`reference. As a result, this reference is
`not relevant to this proceeding.
`
`To the extent this exhibit is deemed
`relevant, admission of the exhibit
`would be unduly prejudicial given its
`untimeliness and lack of supporting
`expert testimony.
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`- 4 -
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`Exhibit 2051 WO 2017/223135
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`Exhibit 2052 WO 2018/232357
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`IPR Case No. IPR2018-00739
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`Dated: April 24, 2019
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`
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`
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` U.S. Patent No. 9,364,435
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`Respectfully submitted,
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`By: Michael R. Fleming
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`Michael R. Fleming (Reg. No. 67,933)
`C. Maclain Wells (Reg. No. 48,991)
`IRELL & MANELLA LLP
`1800 Avenue of the Stars, Suite 900
`Los Angeles, California 90067-4276
`Attorneys for Petitioner
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`- 5 -
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`IPR Case No. IPR2018-00739
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` U.S. Patent No. 9,364,435
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`CERTIFICATE OF SERVICE
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`I hereby certify, pursuant to 37 C.F.R. section 42.6, that on April 24, 2019, a
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`complete copy of the PETITIONER’S OBJECTIONS TO EVIDENCE
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`SUBMITTED IN PATENT OWNER’S SUR-REPLY PURSUANT TO 37
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`C.F.R. § 42.64(b) is being served via electronic mail upon the following:
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`Michael T. Rosato, Reg. No. 52,182
`mrosato@wsgr.com
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`Steven W. Parmelee, Reg. No. 31,990
`sparmelee@wsgr.com
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`Sonja R. Gerrard, Reg. No. 72,802
`sgerrard@wsgr.com
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`Edward R. Reines
`Edward.reines@weil.com
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`Derek C. Walter
`Derek.walter@weil.com
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`Susan M. Langworthy
`Susan M. Langworthy
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`
`
`
`
`
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