Filed: April 21, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
`v.
`NEURELIS, INC.,
`Patent Owner.
`
`_____________________________
`
`Case IPR2019-00451
`Patent 9,763,876
`_____________________________
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`37 C.F.R. §42.64
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
`v.
`NEURELIS, INC.,
`Patent Owner.
`
`_____________________________
`
`Case IPR2019-00451
`Patent 9,763,876
`_____________________________
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`37 C.F.R. §42.64
`
`
`
`I.
`
`INTRODUCTION
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`Pursuant to 37 C.F.R. §§ 42.62 and 42.64(c), Patent Owner respectfully
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`moves to exclude Petitioner’s reliance on EX1009, EX1013, EX1017, EX1021,
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`EX1022, EX1033, EX1036, EX1038, paragraphs 29-63, 167-168, 171-191, 264-
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`362, and Appendix A (pp. 197-224) of EX1041, EX1048, EX1050, EX1065,
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`EX1069, EX1080, EX1081, EX1122, portions of EX1149, EX1150.
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`The Federal Rules of Evidence apply to inter partes proceedings. 37 C.F.R.
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`§ 42.62. This Motion addresses issues in Patent Owner’s Objections to Evidence
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`(Paper 11, 23) and the cross-examination of the parties’ witnesses.
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`II.
`
`ARGUMENT
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`A.
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`EX1009, EX1017, EX1021, EX1022, EX1033, EX1036, EX1038,
`EX1048, and EX1065 Should Be Excluded Under F.R.E. 402-403.
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`EX1009, EX1017, EX1021, EX1022, EX1033, EX1036, EX1038, EX1048,
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`and EX1065 should be excluded under F.R.E. 402 and 403 because they are not
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`discussed in the Petition or Reply, cannot be relevant to the Petition, and
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`consequently would serve only to confuse and create prejudice through belated
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`surprise.
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`B.
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`EX1013 Should be Excluded Under F.R.E. 402-403.
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`EX1013 should be excluded under F.R.E. 402 and 403. EX1013 (Sonne)
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`was originally offered as the primary prior art reference for Ground 1 in Petition
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`IPR2019-00450 (Paper 2)—which was denied institution (Paper 8)—and is
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`repeatedly misidentified by Dr. Peppas (Petitioner’s original expert) as ground
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`reference EX1014 (Gwozdz). See e.g., EX1041, Section XVI-XVII (“Gwozdz
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`(Exhibit 1013)”); see also EX2011, 60:22-25 (“The important exhibits, Gwozdz
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`1013…”). Adding to the confusion is Dr. Peppas’ discussion of EX1013 as part of
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`the prosecution history and general background. See e.g., EX1041, IV.B.2 (“PO’s
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`Inaccurate and Misleading Statements Regarding Sonne Generally and Sonne
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`Example 11”); EX2011, 90:6-16, 93-97 (discussing opinions therein); see also id.,
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`¶¶126-127, 154 (citing EX1013 as background); id., ¶366 (citing EX1013 as
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`further support of disclosure in Meezan’962). Thus, EX1013 lacks relevance and
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`risks unfair prejudice and confusing the issues. Cf. LaserDynamics, Inc. v. Quanta
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`Computer, Inc., 694 F.3d 51, 78 (Fed. Cir. 2012) (abuse of discretion to admit
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`evidence with little relation to legal issue as probative value was greatly
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`outweighed by the risk of unfair prejudice and confusion of the issues); In re
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`Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (reversing for
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`reliance on reference not cited in ground).
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`C.
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`Paragraphs 29-63, 167-168, 171-191, 264-362, and Appendix A
`(pp. 197-224) of EX1041 Should be Excluded Under F.R.E. 402-
`403, 602, 701-702, and 1006.
`
`Paragraphs 171-191, 264-362, and Appendix A (pages 197-224) of EX1041
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`should be excluded under F.R.E. 402 and 403 because they relate to non-instituted
`
`Ground 1 of IPR2019-00450 and are not relevant to any contested issue in this
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`proceeding. Thus, they lack relevance and risk unfair prejudice and confusing the
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`issues. LaserDynamics, 694 F.3d at 78; Magnum Oil, 829 F.3d at 1381.
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`Paragraphs 29-63 and 167-168 of EX1041 should be excluded under F.R.E.
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`602 and 701-702 because they relate to statements and decisions made by the
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`applicant during prosecution and Dr. Peppas testifies outside the scope of his
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`expertise in analyzing what happened during the prosecution of the patent-at-issue.
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`Indeed, Dr. Peppas admitted that he was not an expert on this subject matter. See
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`EX2011, 70:13-89:6 (“I agree with you I did express on a matter that I was not an
`
`expert on.”). Paragraphs 29-63 and 167-168 are otherwise conclusory and
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`unreliable as Dr. Peppas does not disclose the underlying facts or any basis in
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`support of his opinions—including, e.g., “the USPTO Examiner rejected the claims
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`because (s)he believed that the rejected claims were very similar” and Applicants
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`“admitt[ed] that the claims of the ’876 Patent ‘are not patentably distinct…’” or
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`that “the ’439 application [] was ultimately abandoned because Applicants could
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`not overcome the prior art…”. EX1041, ¶¶32, 36. Accordingly, paragraphs 29-63
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`and 167-168 are inadmissible under F.R.E. 602 and 701-702.
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`Paragraphs 186-191 and 264-362 of EX1041 should also be excluded for
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`additional grounds under F.R.E. 701-702 and 1006 as they include conclusory and
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`unreliable statements and otherwise rely on EX1050, which itself is an improper
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`summary and chart with underlying documents not made available. Paragraphs
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`186-191 and 264-362 include Dr. Peppas’s opinions as to how a POSA would
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`adjust Sonne’s (EX1013) Example 11 to meet the claim limitations of the patent-
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`at-issue without providing sufficient facts or data as to how he reached his
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`conclusions. Dr. Peppas does not set forth the principles used nor does he
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`demonstrate the methods or calculations used in generating the combinations set
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`forth in paragraphs 186-191 and 264-362 (or in EX1050). Accordingly, paragraphs
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`186-191 and 264-362 are inadmissible under F.R.E. 701-702 and 1006.
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`D.
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`EX1050 Should be Excluded Under F.R.E. 402-403 and 1006.
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`EX1050 should be excluded under F.R.E. 402-403 because it relates to non-
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`instituted Ground 1 of IPR2019-00450—specifically, EX1013—and is thus not
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`relevant to any contested issue in this proceeding. See Section II.C. Thus, it lacks
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`relevance and risks confusing the issues.
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`EX1050 should also be excluded under F.R.E. 1006 as it is an improper
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`summary and chart with underlying documents not made available. See Section
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`II.C. EX1050 is titled “Table of Various Diazepam Solutions Described in or
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`Modified From Sonne’s Example 11 (DS11)” and includes Dr. Peppas’s
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`unsubstantiated opinions as to various “DS11” diazepam solutions available by
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`way of Sonne’s (EX1013) Example 11. EX1050 fails to include any facts or data
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`showing how Dr. Peppas reached his combinations and otherwise does not set forth
`
`the principles used or demonstrate the methods or calculations used in generating
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`the combinations set forth therein. Accordingly, EX1050 is inadmissible under
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`F.R.E. 701-702 and 1006.
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`E.
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`EX1069 Should be Excluded Under F.R.E. 402-403, 802, and 901.
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`EX1069 should be excluded under F.R.E. 402-403 as it was not discussed in
`
`the Petition, cannot be relevant to it, and consequently serves only to confuse and
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`create prejudice through belated surprise. EX1069—titled “Florida Regional
`
`Common EMS Protocols Field Guide”—is first cited in Petitioner’s Reply and in
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`Dr. Wermeling’s (Petitioner’s new expert) declaration (EX1150). The new exhibit
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`violates Board rules and the procedural order in these proceedings. 37 C.F.R.
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`42.23(b) (reply may only respond to arguments raised in the corresponding paper);
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`see also Paper 26. Petitioner is not permitted to introduce new evidence and
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`arguments with its Reply in order to resolve the deficient arguments and
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`evidentiary shortcomings of its Petition. Belden Inc. v. Berk-Tek LLC, 805 F.3d
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`1064, 1081 (Fed. Cir. 2015) (“a party may move to exclude evidence, whether as
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`improper under the response-only regulation, under the Trial Practice Guide’s
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`advice, or on other grounds.”). Specifically, Petitioner and Dr. Wermeling rely
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`heavily on EX1069 to support new obviousness arguments—including a new
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`“ternary co-solvent system” argument and a new theory on motivation and
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`miscibility—that should have been presented with the Petition. See Paper 26, 2-3.1
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`By relying on EX1069, Petitioner attempts to circumvent Board rules and insulate
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`the newly relied on disclosure from reasoned expert analysis. Thus, EX1069 lacks
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`relevance, is unfairly prejudicial and risks confusing the issues.
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`EX1069 should also be excluded under F.R.E. 802 because it is hearsay
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`without an exception. EX1069 is hearsay because it is an out-of-court statement
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`offered to prove the truth of the matter asserted, namely—as Petitioner states—
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`related to Petitioner’s argument for a motivation to combine alcohols and rebuttal
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`to Patent Owner’s showing of long-felt need. See Paper 26; see generally Paper 21;
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`EX1150. Petitioner has not argued that any hearsay exception applies.
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`Lastly, EX1069 should be excluded under F.R.E. 901 because Petitioner has
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`failed to produce any evidence to support a finding that EX1069 is in fact what
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`Petitioner claims that it is, and it thus lacks authentication. Petitioner has also not
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`1 Petitioner otherwise provides that EX069 was submitted in response to Patent
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`Owner’s discussion of secondary considerations. Paper 26, 4-5 (Petitioner’s
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`Response) (“Rebuts PO’s long felt need arguments”). Yet, Dr. Peppas addressed
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`the “need” in the industry with the filing of the Petition and EX1069 should thus
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`have been brought forth with the Petition. See e.g., EX1041, ¶¶102-104, 173, 242-
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`244.
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`asserted that EX1069 is self-authenticating under F.R.E. 902. Nor has Petitioner
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`presented that Dr. Wermeling, or any other witness, has first-hand knowledge of
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`EX1069. Indeed, during his cross-examination, Dr. Wermeling admitted that
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`EX1069 did not come from his files and testified that it was provided by the law
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`firm representing Petitioner. EX2031, 109-111. Thus, EX1069 should be excluded
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`for the additional reason that Petitioner fails to establish its authenticity.
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`F.
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`EX1080 Should be Excluded Under F.R.E. 802 and 901.
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`EX1080 should be excluded under F.R.E. 802 and 901 because it is hearsay
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`with no applicable hearsay exception and because it lacks authentication. EX1080
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`appears to be a Valium® label. EX1080 is hearsay because it is an out-of-court
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`statement offered to prove the truth of the matter asserted—purportedly, related to
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`Dr. Wermeling’s argument that diazepam is 100% bioavailable. See EX1150, ¶¶55,
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`188. Petitioner has not argued that any hearsay exception applies.
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`Petitioner also fails to authenticate EX1080 under F.R.E. 901 and has
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`otherwise not asserted that EX1080 is self-authenticating under F.R.E. 902.
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`EX1080 bears no publication date—listing only a “Revised” date of January 2008.
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`See EX1080, 0012. Petitioner has not produced any evidence showing who
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`authored EX1080 or that EX1080 is what it purports to be. Nor has Petitioner
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`presented that Dr. Wermeling, or any other witness, has first-hand knowledge of
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`EX1080. Thus, EX1080 should be excluded for the additional reason that
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`Petitioner fails to establish its authenticity.
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`G.
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`EX1081 Should be Excluded Under F.R.E. 802 and 901.
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`EX1081 should be excluded under F.R.E. 802 and 901 because it is hearsay
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`with no applicable hearsay exception and because it lacks authentication. EX1081
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`appears to be a webpage showing “Diazepam Prices and Coupons.” EX1081 is
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`hearsay because it is an out-of-court statement offered to prove the truth of the
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`matter asserted—purportedly, related to Dr. Wermeling’s argument of lack of
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`secondary considerations and commercial success. See EX1150, ¶¶67, 116.
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`Petitioner has not argued that any hearsay exception applies.
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`Petitioner also fails to authenticate EX1081 under F.R.E. 901 and has
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`otherwise not asserted that EX1081 is self-authenticating under F.R.E. 902.
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`EX1080 bears no publication date and includes only a stamp of 1/24/2020—twelve
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`years after the priority date of the ’876 patent. Petitioner has not produced any
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`evidence showing who authored EX1081 or that EX1081 is what it purports to be.
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`Nor has Petitioner presented that Dr. Wermeling, or any other witness, has first-
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`hand knowledge of EX1081. Thus, EX1081 should be excluded for the additional
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`reason that Petitioner fails to establish its authenticity.
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`H.
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`EX1122 Should be Excluded Under F.R.E. 402-403.
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`EX1122 should be excluded under F.R.E. 402-403 as it was not discussed in
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`the Petition, cannot be relevant to it, and consequently serves only to confuse and
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`create prejudice through belated surprise. EX1122—titled “A Multiple-Dose Phase
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`I Study of Intranasal Hydromorphone Hydrochloride in Healthy Volunteers”—is
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`first cited in Dr. Wermeling’s declaration (EX1150) as part of Petitioner’s Reply.
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`The new exhibit violates Board rules and the procedural order in these
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`proceedings. See supra, Section II.E. Dr. Wermeling relies on EX1122 purportedly
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`to undermine Patent Owner’s discussion of secondary considerations. See EX1150,
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`¶68. Dr. Wermeling specifically relies on EX1122 for the statement that “beyond
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`just removing the needle from delivery, intranasal products are designed for rapid
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`action, such as those products designed to treat migraine headache [] or pain in
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`general [].” EX1150, ¶68. EX1122 relates to hydromorphone—an unrelated
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`drug—and therefore is not relevant to any ground of unpatentability upon which
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`trial was instituted. Petitioner attempts to circumvent Board rules and insulate the
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`newly relied on disclosure from reasoned expert analysis. Thus, EX1122 lacks
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`relevance, is unfairly prejudicial and risks confusing the issues.
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`I.
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`EX1150 Should be Excluded
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`1. EX1150 Should be Excluded in its Entirety Under F.R.E. 402-
`403
`EX1150 should be excluded under F.R.E. 402-403 as it sets forth arguments
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`that were not presented in the Petition, cannot be relevant to it, and consequently
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`serves only to confuse and create unfair prejudice through belated surprise.
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`Petitioner presents a new expert and expert declaration with EX1150. As set forth
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`in the Parties’ Joint Submission of Patent Owner’s Identification of New
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`Arguments and Petitioner’s Responses Thereto (Paper 26), EX1150 includes at
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`least the following issues not presented in the petition: (1) claim construction of
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`“ethanol” and “consisting of”; (2) claim construction of “solution”; (3) POSA
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`definition including transmembrane experience; (4) “ternary co-solvent system”
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`argument (relying on new EX1069); (5) motivation and miscibility argument; (6)
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`unexpected results and criticality argument; (7) IV solutions argument relying on
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`new references and new theory; (8) commercialization argument; (9) attack on
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`SIGMA Catalog (EX2006) and priority; (10) FDA and commercialization theory;
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`and (11) “Background in the Intranasal Art”. See Paper 26. The new exhibit
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`violates Board rules and the procedural order in these proceedings. See Section
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`II.E. Petitioner attempts to circumvent Board rules and insulate the newly relied on
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`disclosure from reasoned expert analysis. Thus, EX1150 lacks relevance, is
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`unfairly prejudicial and risks confusing the issues.
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`2. In the Alternative, Paragraphs 23-30, 59-89, 90-126, 146, 171-
`177, 191-194, and 208 of EX1150 Should be Excluded Under
`F.R.E. 402-403, 602, 701-702, 805, and 1006
`Paragraphs 23-30, 59-89, 90-126, 146, 171-177, and 208 of EX1150 should
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`be excluded under F.R.E. 402 and 403 for the same reasons as set forth in Section
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`II.I(1)—specifically, as setting forth the following arguments not presented in the
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`petition: (1) claim construction of “ethanol” and “consisting of”; (2) FDA and
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`commercialization theory; (3) “ternary co-solvent system” argument; and (4) attack
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`on SIGMA Catalog (EX2006) and priority.
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`Paragraphs 59-89 and 90-126 of EX1150 should be excluded under F.R.E.
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`602 because Dr. Wermeling testifies outside the scope of his expertise in analyzing
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`regulatory approval and commercialization of drug products. Indeed, Dr.
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`Wermeling admitted that he was not an expert on this subject matter (EX2031, 8-
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`112) and that he relies on others for expertise in these matters (id., 79-803).
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`Accordingly, paragraphs 59-89 and 90-126 of EX1150 are inadmissible under
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`F.R.E. 602.
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`Paragraphs 23-30, 59-89, 95-100, 114-118, and 171-177 of EX1150 should
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`be excluded under F.R.E. 701-702. Dr. Wermeling’s opinions therein—
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`specifically, related to claim construction of “ethanol” and “consisting of”;
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`regulatory approval and commercialization of drug products; development of the
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`formulation-at-issue; and disclosure of the SIGMA Catalog (EX2006)—are
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`conclusory and unreliable as Dr. Wermeling does not disclose the underlying facts
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`2 Testifying that he (1) only completed two “pre-pharmacy” courses in economics
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`(macro- and microeconomics); and (2) has not completed and courses or
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`certifications in FDA regulatory issues.
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`3 Testifying that it is “a team” effort and decision.
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`or any basis in support of his opinions. Dr. Wermeling further does not set forth the
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`principles or methods used in reaching the conclusions set forth in these
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`paragraphs. As an illustrative example, Dr. Wermeling’s conclusions as to a
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`POSA’s consideration of regulatory approval and commercialization of drug
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`products in paragraphs 95-100 lack any supporting evidence. Of particular concern
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`is Dr. Wermeling’s unsubstantiated statement that “[t]he 505(b)(2) pathway for
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`converting diazepam injection formulation or Disastat® formulation into a
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`diazepam nasal spray is very logical and a reason why the ‘discovery’ is not an
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`invention”—especially, in light of Dr. Wermeling’s admission that he is not an
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`expert in this field. Accordingly, paragraphs 23-30, 59-89, 95-100, 114-118, and
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`171-177 are inadmissible under F.R.E. 701-702.4
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`4 Petitioner’s Reply only adds to the conclusive nature of Dr. Wermeling’s
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`opinions in these paragraphs as Petitioner block-cites paragraphs 46-126 of
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`EX1150 for the proposition that “many non-formulation issues contributed to lack
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`of commercialization” without any further analysis or discussion. See Paper 21, 29-
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`30. Petitioner’s reliance on paragraphs 46-126 amounts to improper incorporation
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`by reference and does not save these opinions from exclusion under F.R.E. 702-
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`703. See Cisco Systems, Inc. v. C-Cation Tech., LLC, IPR2014-00454, Paper 12, 7-
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`Paragraphs 191-194 of EX1150 should be excluded under F.R.E. 805 as it is
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`hearsay within hearsay. Specifically, Dr. Wermeling opines on EX1025 (an article
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`published by Patent Owner’s expert-Dr. Gizurarson)—wherein EX1025 is subject
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`to F.R.E. 802 as it is hearsay with no applicable hearsay exception. EX1025 is an
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`out-of-court statement used to prove the truth of the matter asserted—purportedly,
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`the bioavailability of diazepam. See EX1150, ¶¶191-194. Petitioner has not argued
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`that any hearsay exception applies to EX1025. Petitioner otherwise did not
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`question the author of EX1025, Dr. Gizurarson, about the statements made therein
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`during his cross-examination. Accordingly, paragraphs 191-194 should be
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`excluded under F.R.E. 805.
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`Paragraphs 102-104 of EX1150 should also be excluded under F.R.E. 1006
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`as including an improper summary and chart with underlying documents not made
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`available. Paragraphs 102-104 include Dr. Wermeling’s opinions as to “options”
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`that a POSA would have for intranasal formulation candidates without providing
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`sufficient facts or data as to how he reached these conclusions. Dr. Wermeling
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`does not set forth the principles used nor does he demonstrate the methods or
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`10 (finding improper incorporation by reference of block cites to expert declaration
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`without sufficient explanation of those portions).
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`calculations used in generating the options set forth in paragraphs 102-104.
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`Accordingly, paragraphs 102-104 are inadmissible under F.R.E. 1006.
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`J.
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`Portions of EX1149 Should be Excluded Under F.R.E. 402-403.
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`The line of questioning on pages 0024-0027 discussing EX1069 and 0086-
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`0088 discussing EX1065 of EX1149 (January 14, 2020 Cross-Examination of Dr.
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`Gizurarson) should be excluded under F.R.E. 402 and 403. Neither EX1065 nor
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`EX1069 were discussed in the Petition, cannot be relevant to it, and consequently
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`serve only to confuse and create prejudice through belated surprise. Timely
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`objections as to the improper scope of this line of questioning were made during
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`the cross-examination.
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`K.
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`Limiting Request Under F.R.E. 105.
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`Except for EX1149, to the extent that any of these exhibits or portion of an
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`exhibit is not excluded, use of the exhibit should be restricted to the use for which
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`it was originally submitted.
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`III. CONCLUSION
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`For the foregoing reasons, Patent Owner requests that this Motion to
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`Exclude be granted.
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`Dated: April 21, 2020
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`Respectfully submitted,
`
`/Jeffrey W. Guise/
` Jeffrey W. Guise, Lead Counsel
` Reg. No. 34,613
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`LIST OF EXHIBITS
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`Description
`
`Cartt et al., WO 2009/121039, Administration Of Benzodiazepine
`Compositions, published October 1, 2009, International Filing Date
`March 27, 2009 (PCT/US2009/038696) (Cartt ‘039)
`
`Sonne, U.S. Patent No. 6,193,985, Tocopherol Compositions For
`Delivery Of Biologically Active Agents, issued February 27, 2001
`(Sonne)
`
`Exhibit
`No.
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`EX1009
`
`EX1013
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`EX1017
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`Cartt et al., WO 2008/137960, Nasal Administration Of
`Benzodiazepines, published November 13, 2008, International filing
`date May 7, 2008 (PCT/US2008/062961) (Cartt ‘960)
`EX1021 Merkus, U.S. Patent Application Publication No. US 2005/0153956,
`Serial No. 11/034,474, published July 14, 2005 (Merkus)
`
`EX1022
`
`Liversidge et al., U.S. Patent Application Publication No. US
`2006/0198896, Serial No. 11/354,249, published September 7, 2006
`(Liversidge)
`
`EX1033
`
`French et al., Pharmacopeial Standards and Specifications for Bulk
`Drugs and Solid Oral Dosage Forms, Journal of Pharmaceutical
`Sciences, December 1967, Vol. 56(12):1622-1641 (French)
`EX1036 Deshmukh et al., Lorazepam in the Treatment of Refractory Neonatal
`Seizures, Am J Dis Child. 1986;140(10):1042-1044 (Deshmukh)
`EX1038 Bara, U.S. Patent Application Publication No. US 2006/0178290, Serial
`No. 10/563,967, published August 10, 2006 (Bara)
`
`EX1041 Declaration of Dr. Nicholas A. Peppas
`
`EX1048
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`Kagatani, et al., U.S. Patent No. 4,690,952, Pharmaceutical
`Compositions for Nasal administration Comprising Calcitonin and an
`Absorption-Promoting Substance, issued September 1, 1987 (Kagatani)
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`EX1050 Table of Various Diazepam Solutions Described in or Modified From
`Sonne’s Example 11 (“DS11”)
`
`EX1065 Maggio, Provisional Patent Appl’n Serial No. 60632038
`EX1069 Florida Regional Common EMS Protocols Field Guide, Jones and
`Barlett Publishers, MA (2005)
`
`EX1080 Valium® Tablet Label, Roche, January 2008
`
`EX1081 Drug Prices from Internet
`
`EX1122
`
`Rudy AC, Coda BA, Archer SM, Wermeling DP. A multiple dose phase
`1 study of intranasal hydromorphone hydrochloride in healthy
`volunteers. Anesth Analg 2004; 99: 1379-1386
`
`EX1149 Transcript of the January 14, 2020 deposition of Dr. Gizararson
`
`EX1150 Declaration of Daniel P. Wermeling, Pharm.D.
`
`-16-
`
`IPR2019-00451
`
`
`
`CERTIFICATE OF SERVICE
`This is to certify that I caused to be served true and correct copies of the
`
`foregoing Patent Owner’s Motion to Exclude on this 21st day of April, 2020, on the
`
`Petitioner at the correspondence address of the Patent Owner as follows:
`
`
`
`Daniel A. Scola, Jr.
`Michael I. Chakansky
`James F. Harrington
`Matthew J. Solow
`John T. Gallagher
`HOFFMANN & BARON, LLP
`
`dscola@hbiplaw.com
`mchakansky@hbiplaw.com
`jharrington@hbiplaw.com
`msolow@hbiplaw.com
`jgallagher@hbiplaw.com
`876IPR@hbiplaw.com
`
`Dated: April 21, 2020
`
`Respectfully submitted,
`
`/Jeffrey W. Guise/
` Jeffrey W. Guise, Lead Counsel
` Reg. No. 34,613
`
`-17-
`
`IPR2019-00451
`
`
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