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`Paper 26
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`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
`____________________
`
`
`
`
`PARTIES’ JOINT SUBMISSION OF
`PATENT OWNER’S IDENTIFICATION OF NEW ARGUMENTS
`AND PETITIONER’S RESPONSES THERETO
`
`
`
`
`
`
`
`New Arguments Raised in Petitioner’s
`Reply
`
`New claim construction of “ethanol” and
`
`Petitioner’s Responses to Patent Owner’s
`(PO’s) Identification of Alleged “New”
`Arguments in Petitioner’s Reply
`(1) Rebuts PO’s new claim construction.
`
`“consisting of”. Reply, 11, 20-21; EX1150,
`
`POR, 12-13.
`
`¶¶28-29.
`
`- PO argued the challenged claims exclude
`
`- New argument for a new theory that
`
`water and a POSA would therefore not be
`
`should have appeared, if anywhere, in
`
`motivated to use Meezan’s alkyl glycosides.
`
`the original petition and EX1041
`
`POR, 38, see also 25. Claims recite
`
`[Peppas]; contradicts Peppas
`
`“ethanol” and “dehydrated ethanol” and the
`
`testimony without explanation EX2011,
`
`plain and ordinary meaning of “ethanol” is
`
`138:16-139:23 (Dr. Peppas: “Yes, it’s
`
`“ethanol USP” which requires the presence of
`
`not – water is not there.”). Shows
`
`water. Wermeling Dec. Ex. 1150, ¶¶ 23-30.
`
`Wermeling is NOT adopting Peppas
`
`Dr. Peppas was given a definition of
`
`positions.
`
`“consisting of” at his deposition which
`
`excluded ingredients not specified, and
`
`correctly stated “water is not there”. Peppas
`
`Dep. Ex. 2011, 139:11-23.
`
`New claim construction of “solution”. Reply,
`
`(2) Rebuts PO’s argument that Gwozdz’s
`
`11 (Sec. B).
`
`solution does not disclose particulate
`
`- New argument in support of new
`
`formulations and a POSA therefore would not
`
`theory, not appearing in petition or in
`
`consider Cartt ‘784, Ex. 1015 in connection
`
`1
`
`
`
`EX1041 [Peppas]. Contradicts Peppas
`
`with Gwozdz Ex. 1014 and the ‘876 Patent’s
`
`testimony demonstrating Wermeling is
`
`solution claims. POR 24, 26-27, 39.
`
`NOT adopting Peppas positions.
`
`- Relies on Gwozdz Ex. 1014, 5:17-25
`
`EX2011, 145:13:17 (Dr. Peppas: “No.
`
`(“particulates of therapeutic agent may be
`
`Solution and particulates don’t go
`
`present in the pharmaceutical solution”), see
`
`together. Solution means total
`
`also 14:1-4, 25-30, and ‘876 Patent’s history
`
`molecular dissolution of the active in
`
`(Ex. 1002, claims 1 & 2, p. 98). Dr. Peppas
`
`the solvent.”).
`
`was testifying as to the ordinary meaning of
`
`“solution” for Cartt ‘784’s solutions.
`
`New POSA definition including
`
`(3) Rebuts POR, pp. 4, n.2, 15-17 and
`
`transmembrane experience. Reply, 12;
`
`Gizurarson Dec. Exhibit 2012, ¶ 32.
`
`EX1150, ¶¶20-22.
`
`- Consistent with Petition’s and Dr. Peppas’
`
`- No basis in petition or EX1041.
`
`POSA definition which included experience
`
`Contradicts use of Peppas, confirming
`
`in transmembrane/transmucosal, e.g.,
`
`this is not supplementation of his
`
`intranasal, rectal, buccal development. See
`
`testimony. Reply, 1.
`
`Petition 4, Peppas Dec. 1041, ¶ 74.
`
`New “ternary co-solvent system” argument
`
`(4) Rebuts PO’s solubility arguments (POR
`
`used to slip in new references. Reply, 14, 16,
`
`29; Gizurarson Dec. Ex. 2012, ¶¶ 82-83) with
`
`20 and 21
`
`solubility effect of three solvents (Reply 14;
`
`- This theory does not appear in the
`
`Wermeling Dec. Ex.1150, ¶¶ 129-145).
`
`petition or in EX1041 [Peppas].
`
`- “Ternary co-solvent system” is a term of art
`
`2
`
`
`
`Instead, Petition, 23, cites Gwozdz
`
`and describes co-solvent systems with three
`
`[EX1014], 4:24-26, for a different,
`
`solvents such as tocopherol+ ethanol+benzyl
`
`broader teaching. Wermeling uses
`
`alcohol.” Wermeling Dec. Ex. 1150, ¶ 131.
`
`(e.g., EX1150, ¶112) to introduce new
`
`- Petition 27 (“varying the relative amounts
`
`references, e.g., EX1069, to provide
`
`of tocopherols, ethanol, and benzyl alcohol”);
`
`new teachings.
`
`Peppas Dec. Ex. 1041, ¶ 54 (“a co-solvent
`
`system including tocopherol, ethanol, and
`
`benzyl alcohol. . .”). Ex. 1069, see infra, (8).
`
`New arguments and evidence for new theory
`
`(5) Rebuts PO’s arguments regarding
`
`on motivation and miscibility, improperly
`
`motivation to combine and mixing alcohols.
`
`incorporated by reference from EX1150,
`
`POR 23-44; Gizurarson Dec. Ex. 2012, ¶¶
`
`¶¶41-45, 127-170, 212-214. Reply, 22.
`
`76-117. Elaborates on arguments made in
`
`- New motivation theory based on new
`
`Petition and advanced by Dr. Peppas. See,
`
`evidence, e.g., Wermeling at ¶146
`
`e.g., Petition 33-35; Peppas Dec. Ex. 1041, ¶¶
`
`(citing to EX1069).
`
`257-262. Ex. 1069, see infra, (8).
`
`New unexpected results/criticality argument.
`
`(6) Responds to Decision 18-19, 20-21, 25-
`
`Reply, 23-24 (Secs. A & B); EX1150, ¶¶178-
`
`27 and elaborates on why there was no
`
`207.
`
`demonstration of criticality or unexpected
`
`- The reply does not identify anything in
`
`results based on the data in Figs. 1–3, Tables
`
`the opposition to which this responds—
`
`4-1, 11-1, 11-2, and 11-3 relied on by the
`
`classic improper bolstering.
`
`Decision and the Opposition. Id., 19. Peppas
`
`3
`
`
`
`Dec. Ex. 1041, ¶56; Wermeling Dec. Ex.
`
`1150, ¶¶ 178-207; Petition 24, 40, 44, 48, 79.
`
`New bioavailability argument. Reply, 26-27
`
`(7) Responds to Decision 18-19, 27-31, 30
`
`(Sec. G).
`
`and statements of skepticism regarding
`
`- The reply does not identify anything in
`
`bioavailability, elaborates on why a POSA
`
`the opposition to which this responds—
`
`would have expected a high bioavailability -
`
`classic improper bolstering.
`
`especially for diazepam. POSA motivated to
`
`avoid high first-pass metabolism to increase
`
`bioavailability. Peppas Dec. Ex. 1041, ¶109,
`
`n.10; Wermeling Dec. Ex. 1150, ¶¶149-150.
`
`Nas-oral Diazepam is 100% bio-available –
`
`no first pass. Id., ¶¶188-190, 203.
`
`New IV solutions argument, introducing new
`
`(8) Rebuts PO’s long felt need arguments.
`
`references and new theory. Reply, 28-29
`
`POR 1, 2, 40-44, Gizurarson Dec. Ex. 2012,
`
`(Sec. A); EX1150, ¶¶46-58, 67, 75, 88, 111-
`
`¶¶ 51, 78, 110-116. Ex 1069 rebuts, inter
`
`112.
`
`alia, PO’s arguments that: (i) intranasal use
`
`- No such history or evidence in the
`
`of a diazepam solution was not publicly
`
`petition or EX1041.
`
`known/available and (ii) that intranasal use of
`
`ethanol and benzyl alcohol not recommended.
`
`New commercialization argument,
`
`(9) Rebuts PO’s long felt need arguments.
`
`introducing new references and new theory.
`
`POR 1, 2, 40-44, Gizurarson Dec. Ex. 2012,
`
`4
`
`
`
`Reply, 28-30 (Secs. B & C); EX1150 ¶¶46-
`
`¶¶ 51, 78, 110-116. See (8), supra, regarding
`
`126.
`
`Ex. 1069.
`
`- No such history or evidence in the
`
`petition or EX1041.
`
`Alkyl Glycosides argument. Reply, 4 – 9.
`
`(10) Petitioner has consistently argued that
`
`- New theory of the case, which should
`
`Gwozdz was a proper reference because alkyl
`
`have appeared, if at all, in the petition.
`
`glycosides were not disclosed, described, or
`
`Relies on new facts, which should have
`
`enabled by ‘558 Provisional. Petition 19-20.
`
`appeared, if at all, in the Peppas
`
`As such, Petitioner met its burden and is
`
`Declaration (EX1041). Reply, 3,
`
`rebutting POR 17-23 and POPR 25-27. See
`
`miscites Petition, 18-20, as presenting
`
`also Decision 7-10. In rebuttal of POR 10-
`
`this new theory. Aquestive uses new
`
`12, 22-23, Dr. Wermeling testifies, arguing
`
`theory as an improper burden shift
`
`arguendo, why, even if incorporated, the
`
`because Aquestive did not make the
`
`SIGMA Catalog does not disclose alkyl
`
`argument in the petition and thus
`
`glycosides. Wermeling Dec. Ex. 1150, ¶¶
`
`cannot have met its facial burden.
`
`175-177.
`
`Attack on SIGMA Catalog. Reply, 6;
`
`(11) There is no misstatement. Alkyl
`
`EX1150, ¶¶175-177; also Reply, 6-9.
`
`glycosides are not disclosed, described, or
`
`- This argument is improper new
`
`enabled by ‘558 Provisional. Petition 19-20;
`
`argument because the petition
`
`Peppas Dec. Ex. 1041, ¶ 68; Wermeling Dec.
`
`misstated the support in the ’558
`
`Ex. 1150, ¶¶ 175-177.
`
`5
`
`
`
`Provisional and failed to address the
`
`
`
`SIGMA Catalog at all. Compare Pet.,
`
`20 (asserting no support) and EX1007,
`
`31 ¶152 (cited in the Petition)
`
`(expressly pointing to the SIGMA
`
`Catalog as support).
`
`New argument misstating law. Reply, 9 (Sec.
`
`(12) Rebuts POR 10-12, 21-23 and
`
`C); EX1150, ¶¶171-177.
`
`arguments regarding the SIGMA Catalog’s
`
`- As cornerstone legal theory, should
`
`teachings and disclosure. Elaborates on why
`
`have appeared in the original petition.
`
`the SIGMA Catalog should not be
`
`considered. Dr. Wermeling testifies why
`
`even if SIGMA Catalog incorporated its does
`
`not disclose alkyl glycosides. Wermeling
`
`Dec. Ex. 1150, ¶¶ 171-177. See (10) supra.
`
`
`Petitioner’s Responses to Patent Owner’s
`Identification of Alleged “New”
`Arguments in Dr. Wermeling’s
`Declaration (Exhibit 1150)
`
`(13) No disparagement of FDA. Rebuts
`
`
`New Arguments Raised in Wermeling
`Declaration (EX1150)
`
`New theory disparaging FDA. EX1150, ¶45.
`
`- Not responsive to any argument in the
`
`PO’s claims of “secondary considerations” of
`
`opposition. No reason provided for
`
`patentability. POR 1, 2, 40-44; Gizurarson
`
`Ex. 2012, ¶¶ 51-52, 110-113, 116.
`
`6
`
`
`
`failure to disparage agency in petition
`
`or in EX1041 [Peppas]. .
`
`New arguments regarding formulations and
`
`(14) Rebuts arguments made in POR and by
`
`commercial success. EX1150, ¶¶65-81, 92-
`
`PO’s expert, Dr. Gizurarson regarding
`
`109.
`
`alleged commercial success and purported
`
`- No explanation why these factors and
`
`problems with formulating intranasal
`
`references were not in EX1041
`
`solutions. See, e.g., POR 6-8, 41-44;
`
`[Peppas]. Classic improper
`
`Gizurarson Ex. 2012, ¶¶ 47-60, 110-113, 116.
`
`bolstering.
`
`New arguments regarding benzodiazepine
`
`(15) Rebuts arguments made in POR and
`
`insolubility. EX1150, ¶¶90-91.
`
`PO’s expert, Dr. Gizurarson regarding
`
`- No explanation why these arguments
`
`alleged problems obtaining solutions for
`
`were not in EX1041 [Peppas]. Classic
`
`administering benzodiazepines intra-nasally.
`
`improper bolstering.
`
`See, e.g., POR 6-8, 41-44; Gizurarson Ex.
`
`2012, ¶¶47-60, 110-113.
`
`“Background In The Intranasal Art”
`
`(16) Rebuts PO’s long felt need arguments
`
`EX1150, ¶¶110-126.
`
`and assertions that problems in formulating
`
`- No explanation why this “background”
`
`an intranasal formulation was the reason for
`
`was not in EX1041 [Peppas]. Classic
`
`time needed to get an FDA approved product
`
`improper bolstering.
`
`to market. POR 1, 2, 40, 44; Gizurarson Dec.
`
`
`
`Ex. 2012, ¶ 78, 110-113.
`
`7
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`Respectfully submitted,
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`Dated: February 25, 2020.
`
`/Michael I. Chakansky/
`Michael I. Chakansky (Reg. No. 31,600)
`Hoffmann & Baron, LLP
`4 Century Drive
`
`Parsippany, N.J. 07054
`mchakansky@hbiplaw.com
`Tel: 973.331.1700
`
`
`
`First Back Up Counsel for Petitioner
`Aquestive Therapeutics, Inc.
`
`
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`8
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`CERTIFICATE OF SERVICE
`
`I hereby certify that on this the 25th day of February 2020, the foregoing PARTIES’
`
`JOINT SUBMISSION OF PATENT OWNER’S IDENTIFICATION OF NEW ARGUMENTS
`
`AND PETITIONER’S RESPONSES THERETO was served in its entirety on the following
`
`counsel of record by electronic service by 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
`
`Parsippany, N.J. 07054
`mchakansky@hbiplaw.com
`Tel: 973.331.1700
`
`
`
`9
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`
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