Paper 41
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________
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`AQUESTIVE THERAPEUTICS, INC.
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`Petitioner
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`v.
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`NEURELIS, INC.
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`Patent Owner
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`_______________________
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`Case: IPR2019-00451
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`U.S. Patent No. 9,763,876
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`______________________
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`PETITIONER’S REPLY IN SUPPORT OF ITS
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`MOTION TO EXCLUDE EVIDENCE
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`
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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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`AQUESTIVE THERAPEUTICS, INC.
`
`
`Petitioner
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`v.
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`NEURELIS, INC.
`
`Patent Owner
`
`_______________________
`
`Case: IPR2019-00451
`
`U.S. Patent No. 9,763,876
`
`______________________
`
`
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`PETITIONER’S REPLY IN SUPPORT OF ITS
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`MOTION TO EXCLUDE EVIDENCE
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`IPR2019-00451
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`I.
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`INTRODUCTION
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`U.S. Patent No. 9,763,876
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`In its Opposition to Petitioner’s Motion to Exclude (Paper 39, “PO’s Opp.”),
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`Patent Owner’s (“PO’s”) arguments attempting to support admissibility can be
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`divided into three main categories: (a) exhibits that are not being relied on for the
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`truth of the matter, but rather for what those exhibits allegedly describe to one
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`skilled in the art; (b) exhibits that purportedly satisfy the “residual exception”
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`because they are cited by PO’s expert; and (c) arguments relating to excerpts of
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`testimony proffered in the declaration of PO’s expert (Exhibit 2012).
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`A. Exhibits 2001-2004, 2013, 2018, 2023-2024
`Patent Owner urges that each of these exhibits is admissible because they are
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`“not relied on for the truth of the matter asserted but rather for what [the exhibit]
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`described to an ordinary artisan.” See, e.g., PO’s Opp., 2-4, 10-12, 14. In making
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`its arguments in support of the admissibility of these exhibits, PO conveniently
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`loses sight of the effective filing date of the ‘876 patent (i.e., March 27, 2009), and
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`that each of these exhibits was published after that date. In fact, some of these
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`exhibits (i.e., Exhibits 2001, 2018, 2021 and 2023-2024) are even dated after the
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`‘876 patent issued in 2017. Based on an effective filing date of March 27, 2009,
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`what each of these post-critical date exhibits purportedly describe to a POSITA or
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`the exhibits’ effect on a POSA’s state of mind is simply not relevant. Exhibits
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`2001-2004, 2013, 2018, 2021 and 2023-2024 are hearsay and should be excluded.
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`1
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`IPR2019-00451
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`U.S. Patent No. 9,763,876
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`Exhibits 2007-2010, 2013-2024
`B.
`PO argues that Exhibits 2007-2010 and 2013-2024 is not hearsay and “meet
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`the ‘residual exception’ under FRE 807” because PO’s expert cites them in his
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`declaration. PO’s Opp., pp. 6-7, 13. PO also asserts that Exhibits 2015, 2018,
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`2021 and 2023-2024 are “not relied on for the truth of the matter asserted but
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`rather for what [it exhibit] described to an ordinary artisan,” and are therefore
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`admissible.1
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`While an expert may rely on hearsay, that does not make the underlying
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`exhibit and evidence admissible. Even if PO’s expert could rely on such hearsay to
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`form his opinions, PO cannot itself directly rely on them. Committee Note to 2000
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`Amendment to Rule 703 (“[W]hen an expert reasonably relies on inadmissible
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`information to form an opinion or inference, the underlying information is not
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`admissible simply because the opinion or inference is admitted.”); Malletier v.
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`Dooney & Bourke, Inc., 525 F. Supp. 2d 558, 666 (S.D.N.Y. 2007) (“[A]party
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`cannot call an expert simply as a conduit for introducing hearsay under the guise
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`that the testifying expert used the hearsay. . .”).
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`Additionally, the residual exception of Federal Rule of Evidence 807(a) was
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`“meant to be reserved for exceptional cases [and was] not intended to confer ‘a
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`broad license’” to admit hearsay. Conoco Inc. v. Dept. of Energy, 99 F.3d 387,
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`1 These post-critical date publications are inadmissible. See supra, p. 1.
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`2
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`IPR2019-00451
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`392 (Fed. Cir. 1996). PO’s hearsay exhibits present no such “exceptional case.”
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`U.S. Patent No. 9,763,876
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`Also, for hearsay statement not to be excluded, PO must satisfy several criteria,
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`including, that the exhibit is “more probative on the point for which it is offered
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`than any other evidence that the proponent can obtain through reasonable efforts.”
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`Fed. R. Evid. 807(a)(2); see Committee Note to 2019 Amendments (“proponent
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`must show that the hearsay statement is more probative then any other evidence the
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`proponent can obtain”). PO failed to meet the requirements needed to satisfy the
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`“residual exception.” Exhibits 2007-2010 and 2013-2024 should be excluded.
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`C. Exhibit 2012
`Relevance
`1.
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`Contrary to PO’s assertion, the narratives provided by PO’s expert in
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`paragraphs 2, 5, 7 and 67 of his declaration is not relevant to the subject recited in
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`the challenged claims of the ‘876 patent.
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`2.
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`Personal Knowledge
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`In a failed attempt to support admissibility, PO proclaims that paragraphs 2-
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`3, 5, 28-33, 36, 44, 48 and 50-51 “are replete with citations” to supporting printed
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`publications. PO’s Opp., 8. However, PO’s expert does not cite any documentary
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`evidence in paragraphs 2-3, 28-33, 36, 48 and 50-51. Nor does he otherwise
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`provide the underlying basis for the statements contained in those paragraphs.
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`Additionally, PO’s lack of personal knowledge regarding the statements in
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`IPR2019-00451
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`paragraphs 2, 28-33, 36, 48 and 50-51 is germane in evaluating his credibility.
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`U.S. Patent No. 9,763,876
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`Fed. R. Evid. 702. For example, PO’s expert opines, with insufficient personal
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`knowledge, regarding the appropriate level of skill possessed by a POSA as of the
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`invention date of the subject matter recited in the ’876 patent (e.g., ¶¶ 28-33), and
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`the alleged secondary considerations PO attempts points to in an attempt to support
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`patentability (e.g., ¶¶ 36, 48, 50-51). Paragraphs 2-3, 5, 28-33, 36, 44, 48 and 50-
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`51 should be excluded.
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`3.
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`Expert Testimony
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`Paragraphs 35, 77-80, 100-109, and 115-116 offers improper testimony on
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`the ultimate legal conclusion of obviousness. 37 C.F.R § 42.65(a) (prohibiting
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`expert testimony on patent law or patent examination practice).
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`PO’s expert, in paragraphs 34, 68-70, 75 and 114, offers his views on an
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`ultimate question of law -- what constitutes sufficient incorporation by reference.
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`This is impermissible and the paragraphs should be excluded. 37 C.F.R § 42.65(a);
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`see Advanced Display v. Kent State Univ., 212 F.3d 1272, 1283 (Fed. Cir. 2000).
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`Paragraphs 16-26, 28, 31, 34-36, 41-43, 48, 68-70, 75, 77-79, 85, 87, 89, 95,
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`100-109 and 111-116 contain nothing more than improper attorney argument and
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`testimony regarding United States patent law shrouded in an expert report, and
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`constitutes improper and unqualified expert testimony. See 37 C.F.R § 42.65(a).
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`PO’s expert failed to provide information relating to his methodology and
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`4
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`IPR2019-00451
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`the factual assumptions underlying his analysis and opinions offered in paragraphs
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`U.S. Patent No. 9,763,876
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`49-52, 54, 56, 58, 60-61, 67 and 82-84, and these paragraphs should be excluded.
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`PO’s experts fails to provide sufficient explanation regarding his comments
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`regarding secondary considerations in paragraphs 36, 48, 50-51, and 111-116.
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`4. Hearsay
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`Paragraphs 28-33 are inadmissible hearsay, as the statements in these
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`paragraphs are predicated on information that an expert in his field would not
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`reasonably rely on. PO has failed to show an expert would rely on the legal
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`analysis provided by PO counsel.
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`5.
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`Summary to Prove Content
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`PO and its expert failed not make the originals available, as required by Fed.
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`R. Evid. 1006 to support the opinions in paragraphs 36, 56, 58, 60, 79, and 89.
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`II. CONCLUSION
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`For the foregoing reasons, Petitioner’s Motion to Exclude (Paper 34) should
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`be granted and Exhibits 2001-2010, 2013-2024 and paragraphs 2-3, 5, 7, 6-26, 28-
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`36, 41-44, 48-52, 54, 56, 58, 60-61, 67-70, 75, 77-79, 82-85, 87, 89, 95, 100-109
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`and 111-116 of Exhibit 2012 should be excluded from the record.
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`Dated: May 5, 2020
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`/Michael I. Chakansky/
`Michael I. Chakansky (Reg. No. 31,600)
`Hoffmann & Baron, LLP
`4 Century Drive
`Parsippany, N.J. 07054
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`mchakansky@hbiplaw.com
`Tel: 973.331.1700
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`First Backup Counsel for
`Petitioner Aquestive Therapeutics, Inc.
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`6
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`IPR2019-00451
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`U.S. Patent No. 9,763,876
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`CERTIFICATE OF SERVICE
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`I hereby certify that on this the 5th day of May 2020, the foregoing
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`PETITIONER’S REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE was
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`served in its entirety on the following counsel of record by electronic service by
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`email at the email addresses as set forth below.
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` Jeffrey Guise
`Richard Torczon
`Lorelei Westin
`Lee Johnson
`Nathaniel Leachman
`Alina L. Litoshyk
`Wendy Devine
`WILSON SONSINI GOODRICH & ROSATI
`jguise@wsgr.com
`rtorczon@wsgr.com
`lwestin@wsgr.com
`ljohnson@wsgr.com
`nleachman@wsgr.com
`alitoshyk@wsgr.com
`wdevine@wsgr.com
`35401.652.palib1@matters.wsgr.com
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`By:
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`/Michael I. Chakansky/
`Michael I. Chakansky (Reg. No. 31,600)
`Hoffmann & Baron, LLP
`4 Century Drive
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`Parsippany, N.J. 07054
`mchakansky@hbiplaw.com
`Tel: 973.331.1700
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`7
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