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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`
`DR. REDDY’S LABORATORIES S.A. AND
`DR. REDDY’S LABORATORIES, INC.
`Petitioners,
`
`v.
`
`INDIVIOR UK LIMITED.
`Patent Owner.
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`________________________
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`IPR2019-00329
`Patent 9,687,454
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`________________________
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`PATENT OWNER RESPONSE
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`IPR2019-00329
`Patent 9,687,454
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`Patent Owner Response
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`TABLE OF CONTENTS
`INTRODUCTION .......................................................................................... 1
`I.
`PROSECUTION HISTORY OF THE ’454 PATENT ................................... 6
`II.
`III. LEGAL STANDARD .................................................................................... 7
`IV. PETITIONERS FAIL TO SHOW THAT THE CHALLENGED
`CLAIMS ARE ANTICIPATED BY MYERS. ............................................ 11
`A.
`The ’571 Application Provides Written Description Support for
`the Claimed Polymer Weight Percentages. ........................................ 11
`1.
`The Inventors Had Possession of the Claimed Polymer
`Weight Percentages. ................................................................. 11
`a.
`The ’571 Application Provides Written Description
`Support for the Polymer Weight Percentage of
`“about 48.2 wt %” Recited in Claim 8. ......................... 12
`The ’571 Application Provides Written Description
`Support for the Polymer Weight Percentage Range
`of “about 48.2 wt % to about 58.6 wt %” Recited in
`Claims 7 and 12. ............................................................ 14
`i.
`A POSA Would Have Understood that the
`Exemplary Formulations in Table 1 and Test
`Formulation 2 in Table 5 Pertain to the Same
`Invention and
`thus
`that
`the Inventors
`Possessed the Claimed Polymer Weight
`Percentage Range of “about 48.2 wt % to
`about 58.6 wt %.” ................................................ 17
`A POSA Would Have Understood from the
`Presence of Optional Ingredients that the
`Inventors Possessed the Claimed Polymer
`Weight Percentage Range of “about 48.2 wt
`% to about 58.6 wt %.” ....................................... 18
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`ii.
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`b.
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`iv.
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`c.
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`ii.
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`iii. A POSA Would Have Understood from the
`Disclosure of a Polymer Weight Percentage
`Range of 25% to About 58.6% that the
`Inventors Possessed the Claimed Polymer
`Weight Percentage Range of “about 48.2 wt
`% to about 58.6 wt %.” ....................................... 21
`In Similar Cases, Courts Have Found
`Adequate Written Description Support. .............. 22
`The ’571 Application Provides Written Description
`Support for the Polymer Weight Percentage Range
`of “about 40 wt % to about 60 wt %” Recited in
`Claim 1. .......................................................................... 29
`i.
`A POSA Would Have Understood from the
`Presence of Optional Ingredients that the
`Inventors Possessed the Claimed Polymer
`Weight Percentage Range of “about 40 wt %
`to about 60 wt %.” ............................................... 31
`A POSA Would Have Understood from the
`Disclosure of a Polymer Weight Percentage
`Range of 25% to About 60% that the
`Inventors Possessed the Claimed Polymer
`Weight Percentage Range of “about 40 wt %
`to about 60 wt %.” ............................................... 31
`Particular Polymer Weight Percentages and Bounded
`Polymer Weight Percentage Ranges Were an Aspect of the
`Inventive Films. ....................................................................... 33
`a.
`The
`’571 Application Expressly Discloses
`Particular Polymer Weight Percentages. ....................... 34
`The ’571 Application Discloses Bounded Polymer
`Weight Percentage Ranges. ........................................... 35
`The ’571 Application Discloses that the Polymer
`and Amount of Polymer Are Important to the
`Inventive Films. ............................................................. 39
`iii
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`2.
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`b.
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`c.
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`d.
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`e.
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`B.
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`2.
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`The ’571 Application Discloses that the Inventors
`in Most Cases Kept the Polymer Weight Percentage
`of the Exemplary Films Constant. ................................. 41
`The Disclosed Testing’s Focus on pH Does Not
`Detract from the Disclosed Importance of Polymer
`Weight Percentages to the Inventive Films. .................. 44
`The ’571 Application Provides Written Description Support for
`the Claimed Buprenorphine:Polymer / (b):(a) Ratios. ....................... 46
`1.
`The
`Inventors
`Had
`Possession
`of
`the
`Buprenorphine:Polymer Ratio Range of “about 1:3 to
`about 1:11.5.” ........................................................................... 46
`Buprenorphine:Polymer Ratios Were an Aspect of the
`Inventive Films. ....................................................................... 48
`a.
`The ’571 Application Discloses that Buprenorphine
`Is an Important Component of the Inventive Films. ..... 49
`The ’571 Application Discloses that the Polymer Is
`an Important Component of the Inventive Films. ......... 50
`A POSA Would Have Noticed that the Inventors in
`Most Cases Kept the (b):(a) Ratio Consistent
`Across the Disclosed Formulations with Different
`Dosage Strengths. .......................................................... 51
`The ’571 Application Discloses that the Inventors
`Scaled Up from the Unit Formulas in Tables 1 and
`5. .................................................................................... 52
`A POSA Would Have Understood
`that
`the
`Buprenorphine: Polymer Ratio Is Important to the
`Inventive Films in Light of the Disclosed Functions
`of the Polymer. ............................................................... 53
`Petitioners’ Arguments Lack Merit. .............................. 54
`i.
`Purdue Is Inapposite. ........................................... 54
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`b.
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`c.
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`d.
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`e.
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`f.
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`ii.
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`iii.
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`iv.
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`A Claimed Ratio Need Not Be Recited
`Expressly in the Disclosure to Have Written
`Description Support. ............................................ 57
`The Express Disclosure of Other Ratios Does
`Not Detract from the Disclosed Importance
`of the Buprenorphine: Polymer Ratio. ................ 59
`Petitioners’ Argument
`that
`the
`’571
`Application Discloses Unlimited Amounts of
`Buprenorphine and Polymer Is Irrelevant and
`Incorrect. .............................................................. 60
`CONCLUSION ............................................................................................. 61
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`V.
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`Application of Eickmeyer, 602 F.2d 974 (C.C.P.A. 1979) ........................................ 8
`Application of Ruschig, 379 F.2d 990 (C.C.P.A. 1967) .......................................... 27
`Ariad Pharm., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) ............................................................ 7
`
`Crown Packaging Tech., Inc. v. Ball Metal Beverage Container
`Corp.,
`635 F.3d 1373 (Fed. Cir. 2011) .......................................................................... 34
`Dynamic Drinkware, LLC v. National Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) ........................................................................ 1, 2
`General Electric Co. v. University of Virginia Patent Foundation,
`IPR2016-00357, Paper 57, 2017 WL 2684573 (P.T.A.B. June 21,
`2017) ................................................................................................................... 57
`General Hospital Corp. v. Sienna Biopharmaceuticals, Inc.,
`888 F.3d 1368 (Fed. Cir. 2018) .................................................................... 25, 26
`Grunenthal Gmbh v. Antecip Bioventures II LLC,
`PGR2017–00008, Paper 43, 2018 WL 3105488 (P.T.A.B. June 22,
`2018) ............................................................................................................. 28, 29
`Kolmes v. World Fibers Corp.,
`107 F.3d 1534 (Fed. Cir. 1997) .......................................................................... 35
`Ex Parte Mark Andrew Lomaga, Appeal No. 2016-003407,
`Application No. 12/452,838, 2017 WL 657405 (P.T.A.B. Feb. 14,
`2017) ....................................................................................................... 57, 58, 59
`Ex Parte Michael Molenda, Martin Hoffmann, & Sabine Forster,
`Appeal No. 2016-007717, Application No. 12/187,648, 2017 WL
`3620343 (P.T.A.B. Aug. 18, 2017) ............................................................... 24, 25
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`Nalpropion Pharm., Inc. v. Actavis Labs. FL, Inc.,
`--- F.3d ----, No. 2018-1221, 2019 WL 3819335 (Fed. Cir. Aug.
`15, 2019) ......................................................................................................passim
`Orexigen Therapeutics, Inc. v. Actavis Labs. FL, Inc.,
`282 F. Supp. 3d 793 (D. Del. 2017) .................................................................... 28
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000) ...................................................................passim
`Rimfrost AS v. Aker Biomarine Antartic AS.,
`PGR2018-00033, Paper 9, 2018 WL 4183083 (P.T.A.B. Aug. 29,
`2018) ................................................................................................................... 36
`Scriptpro, LLC v. Innovation Assocs., Inc.,
`762 F.3d 1355 (Fed. Cir. 2014) .......................................................................... 10
`ScriptPro LLC v. Innovation Assocs., Inc.,
`833 F.3d 1336 (Fed. Cir. 2016) .......................................................................... 34
`Ex Parte Siemens Energy, Inc., Appeal No. 2010-012109,
`Reexamination Control No. 90/007,359, 2010 WL 5137101
`(B.P.A.I. Dec. 15, 2010) ..................................................................................... 58
`Star Scientific, Inc. v. R.J. Reynolds Tobacco Co.,
`655 F.3d 1364 (Fed. Cir. 2011) ............................................................................ 8
`Ex Parte Bo L. Tran, Joseph M. Hamnik, & Stephen J. Blubaugh,
`Appeal No. 2014-008001, Application No. 11/524,815, 2016 WL
`4128591 (P.T.A.B. July 14, 2016) ........................................................................ 9
`Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd.,
`887 F.3d 1117 (Fed. Cir. 2018) ............................................................................ 9
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) .................................................................... 45, 46
`In re Wertheim,
`541 F.2d 257 (C.C.P.A. 1976) .....................................................................passim
`Statutes
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`IPR2019-00329
`IPR2019-00329
`Patent 9,687,454
`Patent 9,687,454
`35 U.S.C. § 316(e)…………………………………………………………………..1
`35 U.S.C. § 316(6) ............................................................................. 1
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`Patent Owner Response
`Patent Owner Response
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`Indivior UK Limited (“Indivior”) submits this Patent Owner Response
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`(“POR”) to the petition filed by Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s
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`Laboratories, Inc. (“Petitioners”) requesting inter partes review of claims 1–5 and
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`7–14 of U.S. Patent No. 9,687,454 (“the ’454 Patent”).
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`I. INTRODUCTION
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`The patentability of claims 1–5 and 7–14 of the ’454 Patent should be
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`confirmed. Petitioners’ sole challenge to these claims alleges anticipation by U.S.
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`Patent Publication No. 2011/0033541 (“Myers”) (Ex. 1010), the publication of U.S.
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`Patent Application No. 12/537,571 (“the ’571 Application”), to which the ’454
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`Patent claims priority. However, the challenged claims are entitled to priority to the
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`filing date of the ’571 Application, August 7, 2009, as the ’571 Application provides
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`ample written description support for those claims. Thus, Myers, published in 2011,
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`is not prior art to, and does not anticipate, the challenged claims.1
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`1 Under Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375 (Fed.
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`Cir. 2015), Petitioners “ha[ve] the burden of persuasion to prove unpatentability by
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`a preponderance of the evidence, and this burden never shift[s].” Id. at 1379; see 35
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`U.S.C. § 316(e). At this stage, Patent Owner has the burden of production to show
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`Myers “is not prior art because the [challenged] claims in the ′[454] patent are
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`IPR2019-00329
`Patent 9,687,454
`For independent claim 1 and dependent claims 2–4, 7–11, and 13–14,
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`Patent Owner Response
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`Petitioners challenge only the written description support for the limitations directed
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`to the percent by weight of the total amount of polymer2 in the film composition.
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`However, the ’571 Application reasonably conveys to a POSA that the inventors
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`entitled to the benefit of a filing date (constructive or otherwise) prior to the filing
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`date of [Myers].” Dynamic Drinkware, 800 F.3d at 1380. As described herein, Patent
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`Owner has discharged this burden through this Response and the accompanying
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`Declaration of Karsten Cremer, Ph.D. (Ex. 2008). The burden of production next
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`shifts to Petitioners to show the challenged claims are not adequately supported by
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`the ’571 Application and thus do not antedate Myers. See Dynamic Drinkware, 800
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`F.3d at 1380. For the reasons discussed in this Response and the accompanying
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`declaration, Petitioners cannot satisfy this burden of production or their ultimate
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`“burden of persuasion to prove unpatentability by a preponderance of the evidence.”
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`Id. at 1379.
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`2 The polymer matrix in the inventive films may include one or more polymers. Ex.
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`1011, 1433 ¶ [0024]. Here, the term “polymer” likewise will be used to refer to one
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`or more polymers.
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`2
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`possessed the claimed polymer weight percentages. For example, Tables 1 and 5
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`Patent Owner Response
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`disclose polymer weight percentages of 48.2% and 58.6% in films also containing
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`optional ingredients whose amounts can be varied without changing the invention,
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`directly supporting the claimed polymer weight percentages of “about 48.2 wt %”
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`(claim 8); “about 48.2 wt % to about 58.6 wt %” (claims 7, 12); and “about 40 wt %
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`to about 60 wt %” (claim 1).3 A POSA would have recognized, for instance, that
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`adding more sweetener or flavor (optional ingredients) to the film formulations
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`disclosed in those Tables would yield lower weight percentages of polymer, but
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`without altering the film properties.
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`Contrary to Petitioners’ assertion that particular polymer weight percentages
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`and weight percentage ranges were not within the scope of the invention, the ’571
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`Application discloses (1) particular polymer weight percentages, (2) bounded ranges
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`of polymer weight percentages, (3) the importance of the polymer and amount of
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`polymer, and (4) that the inventors in most cases kept the polymer weight percentage
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`3 Unless the context indicates otherwise, both “%” and “wt %” will be used here to
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`refer to a weight percentage.
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`of the exemplary films constant.4 At her deposition, Dr. Das conceded that “any
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`Patent Owner Response
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`formulator” reading the ’571 Application “would be very geared to see the numbers
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`[in the disclosed exemplary formulations] and how they move,” Das Depo. Tr. (Ex.
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`2009) at 117:7–118:13, which confirms that a POSA would have noticed that the
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`inventors in most cases kept the polymer weight percentage of the exemplary films
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`constant. Moreover, Dr. Das testified that a POSA would already have understood
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`that a film’s polymer weight percentage is important because, for instance, it “could
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`potentially impact the [film’s] adhesive properties and drug release profile,” both of
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`4 Four of the five formulations disclosed in the ’571 Application—the exemplary
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`formulations with buprenorphine:naloxone ratios of 16/4, 12/3, and 8/2 in Table 1
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`as well as Test Formulation 2 in Table 5—had a polymer weight percentage of
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`48.2%. The fifth disclosed formulation—the exemplary formulation with a
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`buprenorphine:naloxone ratio of 2/0.5 in Table 1—had a polymer weight percentage
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`of 58.6%. Ex. 2008 ¶¶ 32–33. Test Formulations 1 and 3 in Table 5 are not addressed
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`here because they were not substantially bioequivalent to the Suboxone one dose
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`tablet and were not identified as embodiments of the invention. See infra note 8.
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`4
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`which “have relevance for a pharmaceutical film.” Id. at 50:7–51:24, 57:17–25; see
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`Patent Owner Response
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`also id. at 54:4–15, 76:20–77:14, 113:24–114:9.
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`For dependent claims 5 and 12, Petitioners also challenge the written
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`description support for the limitation stating a buprenorphine:polymer (or “(b):(a)”)
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`ratio range of about 1:3 to about 1:11.5 (i.e., the ratio of the weight of the
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`buprenorphine in a film to the total weight of the polymer in the film). However,
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`Tables 1 and 5 disclose (b):(a) ratios of 1:2.8 and 1:10.9, which provide direct
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`support for the claims. Moreover, a POSA reading the ’571 Application would have
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`been attuned to the buprenorphine:polymer ratio and recognized it as an aspect of
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`the inventive films because (1) buprenorphine is important to the inventive films;
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`(2) the polymer is important to the inventive films; (3) the inventors in most cases
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`kept the (b):(a) ratio constant across their disclosed formulations5; (4) the inventors
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`5 Four of the five formulations disclosed in the ’571 Application—the exemplary
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`formulations with buprenorphine:naloxone ratios of 16/4, 12/3, and 8/2 in Table 1
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`as well as Test Formulation 2 in Table 5—had a buprenorphine:polymer ratio of
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`1:2.8. The fifth disclosed formulation—the exemplary formulation with a
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`5
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`Patent 9,687,454
`scaled up from the unit formulas disclosed in Tables 1 and 5, which generally entails
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`Patent Owner Response
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`keeping the (b):(a) ratio constant; and (5) with the disclosed functions of the
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`polymer, the (b):(a) ratio would have been understood to be important to the
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`inventive films.
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`For these reasons, Petitioners fall short of their burden of proving that the ’454
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`Patent is not entitled to priority to the filing date of the ’571 Application. The
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`patentability of claims 1–5 and 7–14 of the ’454 Patent should be confirmed.6
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`II. PROSECUTION HISTORY OF THE ’454 PATENT
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`The application that issued as the ’454 patent—Application No. 14/989,669
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`(“the ’669 Application”)—was filed on January 6, 2016. Ex. 1002, 667–712. On
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`September 9, 2016, the applicants amended the claims of the ’669 Application to
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`add the terms relating to polymer weight percentages and buprenorphine:polymer
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`ratios challenged here. Id., 615–22.
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`buprenorphine:naloxone ratio of 2/0.5 in Table 1—had a buprenorphine:polymer
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`ratio of 1:10.9. Ex. 2008 ¶ 71.
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`6 Based in part on the Institution Decision, Patent Owner does not further argue the
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`real party in interest issue in this Response.
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`6
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`During the subsequent prosecution of the ’669 Application, the Examiner
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`Patent Owner Response
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`considered the patentability of the pending claims, including through two office
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`actions and one telephonic interview, but never questioned whether the claims had
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`written description support, either in the ’669 Application or the ’571 Application to
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`which it claimed priority. See id., 173–80 (September 23, 2016 Office Action); id.,
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`77–83 (January 3, 2017 Office Action); id., 65–66 (March 29, 2017 telephonic
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`interview). The ’454 Patent issued on June 27, 2017. Ex. 1001.
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`III.
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`LEGAL STANDARD
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`A disclosure satisfies the written description requirement if it “clearly allow[s]
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`persons of ordinary skill in the art to recognize that [the inventor] invented what is
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`claimed.” Nalpropion Pharm., Inc. v. Actavis Labs. FL, Inc., --- F.3d ----, No. 2018-
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`1221, 2019 WL 3819335, at *5 (Fed. Cir. Aug. 15, 2019) (quoting Ariad Pharm.,
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`Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc)) (internal
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`quotation marks omitted). “In other words, the test for sufficiency is whether the
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`disclosure of the application relied upon reasonably conveys to those skilled in the
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`art that the inventor had possession of the claimed subject matter as of the filing
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`date.” Id. (quoting Ariad, 598 F.3d at 1351) (internal quotation marks omitted). The
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`Federal Circuit has emphasized that “[i]t is not necessary that the exact terms of a
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`claim be used in haec verba in the specification” and “[r]igidity should yield to
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`flexible, sensible interpretation” of the disclosure in assessing written description
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`Patent Owner Response
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`support.7 Id. at *5–*6.
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`An inventor may claim patent protection for a subset of the invention—the
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`inventor “need not claim all that he is entitled to claim and need have support only
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`for what he does claim.” Application of Eickmeyer, 602 F.2d 974, 981 (C.C.P.A.
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`1979); see also In re Wertheim, 541 F.2d 257, 263 (C.C.P.A. 1976) (“That what
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`appellants claim as patentable to them is less than what they describe as their
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`invention is not conclusive if their specification also reasonably describes that which
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`they do claim.”). When inventors “claim a range within [a] described broad range,”
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`the narrower claimed range has adequate support unless the party challenging
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`written description “has presented sufficient reason to doubt that the broader
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`described range also describes the somewhat narrower claimed range.” Wertheim,
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`7 Recent Federal Circuit decisions illustrate the “flexible, sensible” standard for
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`written description. For instance, in Star Scientific, Inc. v. R.J. Reynolds Tobacco
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`Co., 655 F.3d 1364 (Fed. Cir. 2011), the court held the disclosure of minimum air
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`flow of “about 28,000 CFM” and “minimum flow of air may vary according to
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`conditions” supported the example of “air flow of approximately 25,000 CFM,” id.
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`at 1371–72.
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`541 F.2d at 264; see also Ex Parte Bo L. Tran, Joseph M. Hamnik, & Stephen J.
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`Patent Owner Response
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`Blubaugh, Appeal No. 2014-008001, Application No. 11/524,815, Decision at 4,
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`2016 WL 4128591, at *2 (P.T.A.B. July 14, 2016).
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`In Wertheim, the court found adequate written description for a claimed range
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`within a broader disclosed range because “there is no evidence … [of] any
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`distinction, in terms of the operability of appellants’ process or of the achieving of
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`any desired result, between the claimed lower limit of solids content and that
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`disclosed in the Swiss application.” Wertheim, 541 F.2d at 264. Furthermore, the
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`PTO had not shown that “the broad described range pertains to a different invention
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`than the narrower (and subsumed) claimed range.” Id. at 265. The court expressly
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`rejected the argument that a “lack of literal support” for the claims establishes a lack
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`of written description, holding that was “not enough” to defeat written description.
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`Id.
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`Similarly, in Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d
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`1117 (Fed. Cir. 2018), the court held that disclosure of a poor metabolizer “reduced
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`dosage of 18, 12, or 6 mg per day” provided “adequate written description for the
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`claimed ‘12 mg/day or less’ dosage range for poor metabolizers.” Id. at 1136–37.
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`The court noted that “[t]he disclosure of a dose outside of the claimed range does
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`not compel a finding that the asserted claims lack adequate written description.” Id.
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`at 1137 (“It is common, and often permissible, for particular claims to pick out a
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`subset of the full range of described features, omitting others.” (quoting Scriptpro,
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`Patent Owner Response
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`LLC v. Innovation Assocs., Inc., 762 F.3d 1355, 1359 (Fed. Cir. 2014) (internal
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`quotation marks omitted)).
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`Petitioners assert that Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320
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`(Fed. Cir. 2000), supports their argument that the challenged claims are not
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`supported by the ’571 Application. Pet. 19, 26–27. Purdue held that the district court
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`did not clearly err in finding that the specification did not provide an adequate
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`description of a pharmacokinetic parameter (“a maximum plasma concentration
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`(Cmax) which is more than twice the plasma level of said opioid at about 24 hours
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`after administration of the dosage form”) that was not discussed or called out in the
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`specification, which could only be derived by focusing on certain examples while
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`ignoring others, and whose role could not even be determined to be part of the
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`invention. 230 F.3d at 1323; see also id. at 1323–28. Purdue has little if any
`
`relevance here: the ’571 Application provides polymer weight percentages,
`
`information about ranges for both polymer weight percentages and (b):(a) ratios, and
`
`examples of the inventive films that support the claimed ranges. There also can be
`
`no doubt that the inventors regarded both limitations as important to their
`
`invention—which was not the case in Purdue. Id. at 1327–28. For these and other
`
`reasons discussed below in section IV.B.2.f.i, Purdue is inapposite.
`
`
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`10
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`

`IPR2019-00329
`Patent 9,687,454
`IV.
`PETITIONERS FAIL TO SHOW THAT THE CHALLENGED
`CLAIMS ARE ANTICIPATED BY MYERS.
`
`Patent Owner Response
`
`
`
`Petitioners’ contention that Myers anticipates claims 1–5 and 7–14 has no
`
`merit. Myers is not prior art to the ’454 Patent because the ’571 Application provides
`
`written description support for the challenged claims, which are therefore entitled to
`
`a priority date in 2009 and predate Myers’ publication in 2011.
`
`A. The ’571 Application Provides Written Description Support for the
`Claimed Polymer Weight Percentages.
`
`The polymer weight percentages recited in the challenged claims have written
`
`description support in the ’571 Application. Contrary to Petitioners’ argument,
`
`moreover, particular polymer weight percentages and weight percentage ranges were
`
`an aspect of the inventive films.
`
`1. The Inventors Had Possession of the Claimed Polymer Weight
`Percentages.
`
`A POSA would have understood that the inventors possessed the polymer
`
`weight percentages recited in challenged claims 1, 7, 8, and 12: (1) “about 48.2
`
`wt %,” Ex. 1001, cl. 8; (2) “about 48.2 wt % to about 58.6 wt %,” id., cls. 7, 12; and
`
`(3) “about 40 wt % to about 60 wt %,” id., cl. 1.
`
`
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`11
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`

`

`IPR2019-00329
`Patent 9,687,454
`a. The ’571 Application Provides Written Description Support for
`the Polymer Weight Percentage of “about 48.2 wt %” Recited
`in Claim 8.
`
`Patent Owner Response
`
`
`
`Claim 8 recites a polymer weight percentage of “about 48.2 wt %.” As
`
`summarized in Figure 1 in the Declaration of Karsten Cremer, Ph.D. (Ex. 2008),
`
`reproduced below, this limitation is directly supported by the 48.2 wt % polymer
`
`amount in the 16/4, 12/3, and 8/2 formulations in Table 1 as well as Test Formulation
`
`2 in Table 5:
`
`Claim Term
`“wherein the film
`comprises about 48.2 wt
`% of the water soluble
`polymeric matrix” (cl. 8)
`
`Written Description Support
`Table 1
`•
`The 16/4, 12/3, and 8/2 formulations
`each contain 48.2 wt % polymer.
`
`Table 5
`•
`Test Formulation 2 contains 48.2 wt %
`polymer.
`
`Detailed Description of the Preferred Embodiments
`•
`“In one embodiment, the film
`composition contains a film forming polymer
`in an amount of at least 25% by weight of the
`composition.” Ex. 1011, 1444 ¶ [0065]
`(emphasis added), 1459 cl. 5.
`
`
`
`
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`12
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`

`

`IPR2019-00329
`Patent 9,687,454
`Ex. 2008 ¶ 34. Test Formulation 2 was identified as a preferred embodiment because
`
`Patent Owner Response
`
`
`
`it was “substantially bioequivalent to … the Suboxone® one dose tablet.”8 Ex. 1011,
`
`1457 ¶ [00101]; see also id., 1432 ¶ [0022]; Ex. 2009 at 120:4–121:7 (conceding
`
`Test Formulation 2 “is substantially bioequivalent to the Suboxone one-dose tablet”
`
`and “achieving this bioequivalence was one of the objectives” of the ’571
`
`Application)
`
`Dr. Das conceded at her deposition that a POSA would have understood that
`
`the inventors possessed films having a polymer weight percentage of about 48.2
`
`wt %. Ex. 2009 at 118:14–119:2, 119:22–120:3. The claimed polymer weight
`
`percentage of about 48.2% is also within the disclosed polymer weight percentage
`
`range of “at least 25%.” Ex. 1011, 1444 ¶ [0065], 1459 cl. 5; Ex. 2008 ¶ 34; Ex.
`
`
`8 In contrast, the two other formulations in Table 5, Test Formulations 1 and 3, were
`
`neither substantially bioequivalent to the Suboxone® one dose tablet nor identified
`
`as embodiments of the invention. Ex. 1011, 1454 ¶ [0092], 1455 ¶ [0095]. They have
`
`not been included in the analysis for these reasons. However, consideration of these
`
`other formulations would support a finding of written description: the polymer
`
`weight percentages of Test Formulations 1 and 3 are 50.6% and 48.2%, respectively.
`
`Ex. 2008 ¶ 34 n.1.
`
`
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`13
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`

`IPR2019-00329
`Patent 9,687,454
`2009 at 100:3–17, 101:5–12 (conceding the inventors possessed the polymer weight
`
`Patent Owner Response
`
`
`
`percentage range of “at least 25%”).
`
`In its Institution Decision, the Board determined that the ’571 application
`
`provides support for claim 8’s limitation that the film comprises about 48.2 wt % of
`
`the water-soluble polymeric matrix. Paper No. 21 at 22 (citing Ex. 1001, 24:60–61;
`
`Pet. 26 n.8). And Petitioners themselves acknowledge that Table 1 “discloses
`
`polymer weight percentages of 48.2% and 58.6%,” Pet. 26 n.8; see also Ex. 2009 at
`
`93:19–23, further demonstrating that a POSA would have understood that the
`
`inventors possessed films with a polymer weight percentage of about 48.2%. See Ex.
`
`2009 at 118:14–120:3 (conceding inventors possessed formulations with a polymer
`
`weight percentage of 48.2%); Pet. 38 (arguing claimed polymer weight percentage
`
`of about 48.2% “is anticipated by the polymer weight percentage in three
`
`formulations in Table 1” of Myers, which discloses the same formulations as Table
`
`1 of the ’571 Application).
`
`b. The ’571 Application Provides Written Description Support for
`the Polymer Weight Percentage Range of “about 48.2 wt % to
`about 58.6 wt %” Recited in Claims 7 and 12.
`
`The ’571 Application also reasonably conveys to a POSA that the inventors
`
`possessed the polymer weight percentage range of “about 48.2 wt % to about 58.6
`
`wt %” recited in Claims 7 and 12. Ex. 2008 ¶¶ 36–45. As summarized in Figure 2 of
`
`the Cremer Declaration, reproduced below, this range is not only within the
`14
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`

`

`IPR2019-00329
`Patent 9,687,454
`disclosed range of “at least 25%,” Ex. 1011, 1444 ¶ [0065], 1459 cl. 5, but each
`
`Patent Owner Response
`
`
`
`endpoint is also directly supported by the 48.2% and 58.6% polymer weight
`
`percentages disclosed in the exemplary film formulations provided in Tables 1 and
`
`5:
`
`Claim Term
`“wherein the film
`comprises about
`48.2 wt % to
`about 58.6 wt %
`of the water
`soluble polymeric
`matrix” (cls. 7,
`12)
`
`Written Description Support
`Table 1
`•
`The 16/4, 12/3, and 8/2 formulations each
`contain 48.2 wt % polymer.
`•
`The 2/0.5 formulation contains 58.6 wt %
`polymer.
`•
`These formulations also each contain 6.0%
`flavor and 3.0% acesulfame potassium (sweetener),
`disclosed as optional ingredients.9
`
`Table 5
`
`
`9 As discussed below in section VI.A.1.b.2, optional ingredients, like a sweetener,
`
`could be removed, added, or varied in amount, thereby changing the polymer weight
`
`percentage of the film, while staying within the invention. This reasonably conveys
`
`to a POSA that the inventors possessed not only the particular polymer weight
`
`percentages of 48.2 wt % and 58.6 wt %, but also ranges of polymer weight
`
`percentages encompassing those values.
`
`15
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`

`

`IPR2019-00329
`Patent 9,687,454
`
`
`
`Patent Owner Response
`
`•
`Test Formulation 2 contains 48.2 wt %
`polymer.
`•
`Test Formulation 2 als