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,
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`v.
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`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 SUR-REPLY
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`________________________
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________________
`
`
`DR. REDDY’S LABORATORIES S.A. AND
`DR. REDDY’S LABORATORIES, INC.
`Petitioners,
`
`v.
`
`INDIVIOR UK LIMITED.
`Patent Owner.
`
`________________________
`
`
`IPR2019-00329
`Patent 9,687,454
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`________________________
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`PATENT OWNER SUR-REPLY
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`IPR2019-00329
`Patent 9,687,454
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`Patent Owner Sur-Reply
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`2.
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`3.
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`B.
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`TABLE OF CONTENTS
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`INTRODUCTION .......................................................................................... 1
`I.
`II. ARGUMENT .................................................................................................. 4
`A.
`Petitioners have not shown the claimed polymer weight
`percentages lack written description support. ...................................... 4
`1.
`Petitioners’ concessions establish the invention
`encompasses polymer weight percentages and bounded
`ranges thereof. ............................................................................ 4
`There is written description support for “about 48.2 wt %
`to about 58.6 wt %” (claims 7 and 12). ................................... 12
`There is written description support for “about 40 wt %
`to about 60 wt %” (claim 1). .................................................... 16
`Petitioners have not shown the claimed buprenorphine:polymer/
`(b):(a) ratio range lacks written description support. ......................... 18
`1.
`The (b):(a) ratio is part of the invention. ................................. 18
`2.
`There is written description support for “about 1:3 to
`about 1:11.5” (claims 5 and 12). .............................................. 22
`III. CONCLUSION ............................................................................................. 24
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`Patent Owner Sur-Reply
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
`Ark. Game & Fish Comm’n v. United States,
`736 F.3d 1364 (Fed. Cir. 2013) ............................................................................ 3
`Ex Parte Bo L. Tran, et al.,
`Appeal No. 2014-008001, 2016 WL 4128591 (P.T.A.B. July 14,
`2016) ................................................................................................................... 12
`Dynamic Drinkware, LLC v. National Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) ........................................................................ 4, 8
`Ex Parte Mark Andrew Lomaga,
`Appeal No. 2016-003407, 2017 WL 657405 (P.T.A.B. Feb. 14,
`2017) ................................................................................................................... 21
`Ex Parte Michael Molenda, et al.,
`Appeal No. 2016-007717, 2017 WL 3620343 (P.T.A.B. Aug. 18,
`2017) ................................................................................................................... 16
`Nalpropion Pharm., Inc. v. Actavis Labs. FL, Inc.,
`934 F.3d 1344 (Fed. Cir. 2019) ...................................................................... 1, 15
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000) ........................................................................ 1, 6
`Rimfrost AS v. Aker Biomarine Antartic AS.,
`PGR2018-00033, 2018 WL 4183083 (P.T.A.B. Aug. 29, 2018) ....................... 14
`Ex Parte Siemens Energy, Inc.,
`Appeal No. 2010-012109, 2010 WL 5137101 (B.P.A.I. Dec. 15,
`2010) ................................................................................................................... 21
`Trading Techs. Int’l, Inc. v. eSpeed, Inc.,
`595 F.3d 1340 (Fed. Cir. 2010) ............................................................................ 3
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) .......................................................................... 20
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`iii
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`Vasudevan Software, Inc. v. MicroStrategy, Inc.,
`782 F.3d 671 (Fed. Cir. 2015) .............................................................................. 3
`In re Wertheim,
`541 F.2d 257 (C.C.P.A. 1976) .....................................................................passim
`Statutes
`35 U.S.C. § 316(e) ..................................................................................................... 4
`Rules
`Fed. R. Evid. 702 ....................................................................................................... 3
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`iv
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`I. INTRODUCTION
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`Petitioners’ reply brief shows their challenges rest on a misapprehension of
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`the written description standard and disregard how a POSA would have understood
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`the disclosures of the ’571 Application. Petitioners repeatedly argue that the
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`challenged claim limitations do not have support because the ’571 Application does
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`not recite them expressly. But claim limitations “do[] not have to be described in
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`ipsis verbis.” In re Wertheim, 541 F.2d 257, 265 (C.C.P.A. 1976). Instead, the
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`disclosure must “reasonably convey[] to [a POSA] that the inventor had possession
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`of the claimed subject matter,” and the inquiry focuses on what a POSA would have
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`“recognize[d]” or “immediately discern[ed]”
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`from a “flexible, sensible
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`interpretation” of the disclosure. Nalpropion Pharm., Inc. v. Actavis Labs. FL, Inc.,
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`934 F.3d 1344, 1350–51 (Fed. Cir. 2019); Purdue Pharma L.P. v. Faulding Inc., 230
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`F.3d 1320, 1323 (Fed. Cir. 2000).
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`Crucially, Petitioners fail to respond to Dr. Cremer’s testimony regarding a
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`POSA’s perspective, which demonstrates the challenged claims are adequately
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`described. Dr. Cremer explained that a POSA “would have read the ’571
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`Application … with a focus on how to make a pharmaceutical film” and “would
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`have understood that the weight percentages and ratios of ingredients,” especially
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`“the required ingredients” such as the actives, polymer, and buffer, “are essential to
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`making pharmaceutical films.” Ex. 2008, ¶¶ 65–66. Petitioners do not respond to
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`this critical testimony. Instead, they provide only attorney argument in their Reply
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`Patent Owner Sur-Reply
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`and do not attempt to contest Dr. Cremer’s testimony through a reply expert
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`declaration.
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`Petitioners’ third error is their repeated assertion that Dr. Cremer should have
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`cited testing or scientific literature other than the ’571 Application. E.g., Reply 9–
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`11. However, the written description standard asks what a POSA would have
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`understood from the specification, not from independent testing or research. Dr.
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`Cremer’s advanced education and extensive experience with pharmaceutical films
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`qualify him to opine about that.1 Indeed, Petitioners do not challenge his
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`1 Dr. Cremer holds a “Ph.D. in Pharmaceutical Technology and Biopharmaceutics.”
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`Ex. 2008 ¶ 5. At LTS, he was “responsible for the development of oral film
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`formulations” and led a team that was “among the pioneers of thin film technology,”
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`and he has since worked as a “technology consultant” on projects including “oral
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`films.” Id. ¶¶ 5–7; Ex. 1030, 20:22–27:10. Dr. Cremer has also “published ten
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`articles … including on topics relating to mucoadhesive polymer films” and is “a
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`named inventor on twenty patents and patent applications,” including for
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`“pharmaceutical preparations for the oral release of buprenorphine.” Ex. 2008 ¶ 12.
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`Although Dr. Cremer is licensed as a European Patent Attorney, he stated that his
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`role here is “as an expert.” Id. ¶ 4. He explained that he “would have met (and
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`2
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`qualification as a POSA, nor could they. Dr. Cremer testified, moreover, that when
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`Patent Owner Sur-Reply
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`he offered an opinion about the ’571 Application without citing additional testing or
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`scientific literature, he “felt confident in coming to this opinion based on [his]
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`experience and qualification and in the light of the … ’571 application.” Ex. 1030,
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`105:17–106:19; see also id., 74:7–76:10, 152:7–22.
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`Furthermore, “experience alone” or “with other knowledge, skill, training or
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`education” may “provide a sufficient foundation for expert testimony.” Fed. R. Evid.
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`702, Advisory Committee Notes to 2000 Amendments; see also Ark. Game & Fish
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`Comm’n v. United States, 736 F.3d 1364, 1377–78 (Fed. Cir. 2013) (expert’s
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`testimony based on “his experience” rather than “data” or “scientific literature” was
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`admissible). This is especially so when an expert’s testimony regarding the
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`understanding of a POSA is undisputed. See Vasudevan Software, Inc. v.
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`MicroStrategy, Inc., 782 F.3d 671, 681–83 (Fed. Cir. 2015); Trading Techs. Int’l,
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`Inc. v. eSpeed, Inc., 595 F.3d 1340, 1360–61 (Fed. Cir. 2010). Here, Dr. Das did not
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`offer a reply declaration to contest either the bases for or merits of Dr. Cremer’s
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`opinions, and Petitioners’ attorney argument cannot overcome Dr. Cremer’s expert
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`surpassed) the qualifications of a POSA in 2009,” and his analysis is “from the
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`perspective of a POSA.” Id. ¶ 22; see Ex. 1030, 48:10–49:17.
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`3
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`sound opinions regarding what a POSA would have understood from the ’571
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`Patent Owner Sur-Reply
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`Application.
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`Accordingly, Petitioners have failed to meet their burden under Dynamic
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`Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375 (Fed. Cir. 2015). The
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`POR and accompanying Cremer Declaration satisfied Patent Owner’s burden of
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`production to show the polymer weight percentage and (b):(a) ratio limitations have
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`support in the ’571 Application, and thus that Myers is not prior art to the ’454
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`patent. Id. at 1380. The burden of production shifted to Petitioners to show the
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`challenged claims are not supported, id., but Petitioners failed to meet this burden.
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`Petitioners thus have not met their “burden of persuasion to prove unpatentability by
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`a preponderance of the evidence.” Id. at 1379; see 35 U.S.C. § 316(e).
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`II. ARGUMENT
`A. Petitioners have not shown the claimed polymer weight percentages lack
`written description support.
`1. Petitioners’ concessions establish the invention encompasses
`polymer weight percentages and bounded ranges thereof.
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`Polymer weight percentages. There is no dispute that the invention
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`encompasses polymer weight percentages. As Dr. Das conceded, see Ex. 2009,
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`100:3–17, 101:5–12, the ’571 Application expressly discloses “at least 25%”
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`polymer. Ex. 1011, 1444 ¶ [0065], 1459 cl. 5; see also Ex. 2008 ¶ 53. Dr. Das also
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`conceded the ’571 Application discloses 48.2% and 58.6% polymer based on the
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`4
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`formulations in Table 1 and Test Formulation 2 in Table 5. Ex. 1003, ¶¶ 74, 77; Ex.
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`Patent Owner Sur-Reply
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`2009, 93:19–23, 107:7–16, 118:14–120:3; see also Pet. 26 n.8; Paper No. 21 at 19.
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`Thus, Petitioners do not contest the support for “about 48.2%” (claim 8). See Ex.
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`2009, 93:19–23, 118:14–120:3; Pet. 26 n.8, 38; see also Paper No. 21 at 22 (“[T]he
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`’571 application does provide written description support for the [48.2%]
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`limitation … because that limitation is disclosed in the ’571 application, as
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`acknowledged by Petitioners.”).
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`Dr. Das further conceded that a POSA would have understood polymer weight
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`percentages are important to the inventive films. For example, a POSA would have
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`understood a film’s polymer weight percentage “could potentially impact [its]
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`adhesive properties and drug release profile,” both of which “have relevance for a
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`pharmaceutical film.” Ex. 2009, 50:7–51:24, 57:17–25; see also id., 54:4–15, 76:20–
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`77:14, 113:24–114:9. In fact, if a POSA “var[ied] the [polymer] concentration,” she
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`would “expect an impact on all of the properties of [the] formulation.” Id. at 59:8–
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`12; see also id. at 30:18–33:21, 33:13–21, 53:2–54:15, 58:2–59:25; Ex. 2007 at 381,
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`386. Dr. Das’s testimony supports Dr. Cremer’s opinion that “[a] POSA would have
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`immediately discerned” that the polymer weight percentage is “important to the
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`invention” because “the amount of polymer would generally need to be selected in
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`light of the total weight of the film so that the polymer weight percentage was within
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`a range that enabled the polymer to function effectively as a carrier, provide a self-
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`5
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`supporting film, and achieve the desired mucoadhesion level and dissolution and/or
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`Patent Owner Sur-Reply
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`disintegration rates.” Ex. 2008 ¶ 62; see Purdue Pharma, 230 F.3d at 1323. Each of
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`these functions of the polymer is disclosed expressly in the ’571 Application. Ex.
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`2008 ¶ 61 (citing Ex. 1011, 1432 ¶ [0023], 1435 ¶ [0030], 1444 ¶ [0065], 1459 cl.
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`1).
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`Petitioners assert that “[t]he ’571 application provides no direction” to “sum[]
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`the concentrations of each of the individual polymer weights [of the exemplary
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`formulations] and calculat[e] the [polymer weight] percentage.” Reply 3–4. As
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`discussed above, however, Dr. Das conceded the ’571 Application discloses polymer
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`weight percentages and that a POSA would have understood their importance to the
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`inventive films (because of functions expressly disclosed in the ’571 Application).
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`Similarly, the ’571 Application did not need to expressly “link[] the amount of
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`polymer with … inventive characteristics of the film,” Reply 7, because as Dr. Das
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`conceded, a POSA would have understood the polymer weight percentage was
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`important to the invention.
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`Moreover, Petitioners have not attempted to rebut Dr. Cremer’s opinion that
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`a POSA would “have read the ’571 Application while keeping in mind that the
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`[polymer] weight percentages … are especially important to achieving the aim of
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`the ’571 Application to create a pharmaceutical film.” Ex. 2008, ¶¶ 65–66. With this
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`perspective, and the Application’s disclosures indicating the importance of polymer
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`weight percentages, a POSA “would have focused on the polymer weight
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`Patent Owner Sur-Reply
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`percentages” and “been led to calculate” them for the “desirable representative
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`formulations” in Tables 1 and 5. Ex. 2008 ¶¶ 54, 68; Ex. 1030, 92:3–19; see also Ex.
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`2009, 85:11–86:6 (conceding a POSA may “immediately” discern an element even
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`if she must perform calculations).
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`At his deposition, Dr. Cremer confirmed a POSA would have “recognize[d]
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`that there are [polymer] weight percentages” in Table 1 because the POSA would
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`have understood that the polymer weight percentage is “important to constructing
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`the [inventive] films,” and thus the POSA’s “natural reaction” is “to look at these
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`[polymer weight] figures [in Table 1] and to see them together.” Ex. 1030, 59:13–
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`60:22, 63:10–66:2. The POSA would “look at the important … ingredients of the
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`film, including the polymer; and would want to understand their quantitative
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`relationship and the quantitative relationship with respect to the total film, which is
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`the polymer weight percentage.” Id. There is no need for “an express indication” to
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`“sum up these [polymer weight] figures.” Id.
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`Bounded ranges of polymer weight percentages. When asked whether
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`pharmaceutical films include “other ingredients … besides the polymer and the
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`active,” Dr. Das testified that they “[m]ay or may not”—“[i]t’s a choice of the
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`researcher.” Ex. 2009, 39:19–24. This testimony is consistent with the ’571
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`7
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`Application’s express disclosure that, for example, the flavor and sweetener are
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`Patent Owner Sur-Reply
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`optional. Ex. 2008 ¶¶ 39–40 (citing Ex. 1011, 1436–37 ¶¶ [0034]–[0035]).
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`To support Patent Owner’s showing under Dynamic Drinkware that the
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`claimed polymer weight percentage ranges have written description support, Dr.
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`Cremer explained in his POR declaration and at his deposition why the disclosure of
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`optional ingredients reasonably conveys to a POSA that the invention includes
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`polymer weight percentage ranges. As Dr. Cremer explained, “[a] POSA would have
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`understood from the ’571 Application that … varying the amount of the flavor and
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`sweetener in the disclosed films by a reasonable degree … would result in a film
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`pertaining to the same invention with generally the same properties.” Ex. 2008 ¶ 40;
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`see Ex. 1030, 72:3–12. For example, a POSA would have understood that, if she
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`“left out the [sweetener] Ace-K,” the film would still be “an example of the
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`invent[ive] films.” Ex. 1030, 66:12–22, 80:18–82:2.
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`It would also be “apparent to a POSA” that varying the optional ingredient
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`amounts “would change the polymer weight percentage.” Ex. 2008 ¶ 39; Ex. 1030,
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`122:17–124:21. Thus, “the polymer weight percentages … could be decreased … or
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`increased … while staying within the scope of the disclosed invention.” Ex. 2008
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`¶ 42. For example, “a POSA would have immediately discerned that the inventors
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`possessed not only the polymer weight percentage of 48.2%, but also a range of
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`8
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`polymer weight percentages that encompasses that value.” Id. ¶ 39; see also id.
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`Patent Owner Sur-Reply
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`¶¶ 41–42.
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`Although Petitioners attempt to criticize Dr. Cremer for not defining the outer
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`bounds of reasonable variation in flavor and sweetener amounts, there was no reason
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`or need to do so because he provided examples of such variation in his Examples 1–
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`5, discussed in paragraph 41 of his POR declaration. Examples 1–3 removed all
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`flavor and sweetener from the formulations in Table 1 and Test Formulation 2 in
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`Table 5, and Examples 4–5 added sweetener to the Table 1 formulations to match
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`the sweetener weight percentage of Test Formulation 2, based on a POSA’s
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`understanding that all these formulations pertained to the same invention.2 Ex. 2008
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`¶¶ 38, 41. “[T]hese examples illustrate” that, for instance, “the polymer weight
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`percentages … could be decreased by at least 7.2% … or increased by at least 12.8%
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`of the total weight of the films while staying within the scope of the disclosed
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`invention.” Id. ¶ 42. Thus, “a POSA would have immediately discerned that,” in
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`addition to 48.2%, the inventors possessed, “for example, a range from 7.2% below
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`to 12.8% above 48.2%.” Id. ¶ 39. Whatever the outer bounds of reasonable variation,
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`it includes at least the variation in Examples 1–5. Furthermore, Dr. Cremer testified
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`2 The variation in Examples 1–5 was therefore not selected “at random.” Reply 13.
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`that the extent of reasonable variation would have been “clear” to a POSA from “the
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`Patent Owner Sur-Reply
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`application as a whole.” Ex. 1030, 72:14–74:6.
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`Moreover, the outer bounds of reasonable variation are immaterial to Dr.
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`Cremer’s testimony that the invention encompasses variation in optional ingredient
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`amounts and polymer weight percentages, and thus includes ranges of polymer
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`weight percentages around the disclosed embodiments of 48.2% and 58.6%. As Dr.
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`Cremer testified, “the gist of [his] examples” is that, in light of permissible variation
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`in optional ingredient amounts, it would be “apparent to the POSA” that the
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`inventors possessed not only the disclosed embodiments, but also “a margin or a
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`range that encompasses” them. Ex. 1030, 123:14–124:21.
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`Petitioners argue that Dr. Cremer provided “no testing or other basis to say”
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`that the flavor and sweetener are optional or that varying their amounts by a
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`reasonable degree would result in a film pertaining to the same invention. Reply 9–
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`11. However, given the disclosed formulations in Tables 1 and 5 and the express
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`disclosure that the flavor and sweetener are optional, Ex. 2008 ¶¶ 39–40 (citing Ex.
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`1011, 1436–37 ¶¶ [0034]–[0035]), there was no reason or need for Dr. Cremer to
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`cite testing or additional scientific literature. Moreover, the written description
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`requirement asks what a POSA would have understood from the ’571 Application,
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`not from independent testing or research, and Dr. Cremer is qualified to opine on
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`Patent Owner Sur-Reply
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`that.3 See supra pp. 2–4.
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`Petitioners wrongly allege that Dr. Cremer “could not explain” his decision
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`not to consider whether maltitol was optional. Reply 9–10. To the contrary, Dr.
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`Cremer testified that he “did not need to analyze” maltitol in his analysis of varying
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`the amounts of flavor and sweetener as exemplary optional ingredients and that,
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`because maltitol can perform several functions and “we don’t know for sure [its]
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`predominant” function in the inventive films, he decided to “work[] with other
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`ingredients” whose functions are unambiguous. Ex. 1030, 70:4–7, 77:6–21.
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`Petitioners’ argument that there is no “direction from the specification” to
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`perform the exact calculations in Dr. Cremer’s Examples 1–5, Reply 11–14, is
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`inapposite. Examples 1–5 “are just examples,” Ex. 1030, 82:20–84:4, which
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`“illustrate” that films “would remain within the scope of the disclosed invention even
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`3 For the same reasons, and contrary to Petitioners’ argument, e.g., Reply 7, 16–17,
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`Dr. Cremer’s education and experience provide ample support for his opinion that
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`the formulations in Table 1 and Test Formulation 2 in Table 5 all pertain to the same
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`invention, as well as his other opinions that certain ranges pertain to the same
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`invention.
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`11
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`if the flavor and sweetener were … varied in amount by a reasonable degree.” Ex.
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`2008 ¶¶ 40–41.
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`Finally, Petitioners posit a conflict in Dr. Cremer’s testimony that the 61.0%
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`polymer weight percentage from his Example 3 is both “about 58.6%” and “about
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`60%.” Reply 13–14. Not so: Dr. Cremer’s testimony simply reflects his judgment
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`that a POSA would have understood “about 58.6%” and “about 60%” to overlap in
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`the context of the invention. Furthermore, a disclosure may support several claim
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`limitations. See Ex Parte Bo L. Tran, et al., Appeal No. 2014-008001, 2016 WL
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`4128591, at *1–2 (P.T.A.B. July 14, 2016) (disclosed range of “about 40 to about
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`99” percent supported claimed ranges of “90 to 99 percent” and “90 to 95 percent”).
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`2. There is written description support for “about 48.2 wt % to about
`58.6 wt %” (claims 7 and 12).
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`a. The formulations in Tables 1 and 5, which pertain to the same
`invention, disclose a range of about 48.2% to about 58.6%.
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`As discussed above, Dr. Das conceded the ’571 Application discloses 48.2%
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`and 58.6% polymer based on the formulations in Table 1 and Test Formulation 2 in
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`Table 5. Ex. 1003, ¶¶ 74, 77; Ex. 2009, 93:19–23, 107:7–16, 118:14–120:3; see also
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`Pet. 26 n.8; Paper No. 21 at 19. Dr. Cremer explained, moreover, that “a POSA
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`would have understood that the[se] exemplary formulations … all pertained to the
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`same invention.” Ex. 2008 ¶ 38. Thus, a POSA would have understood that the
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`inventors possessed not only the embodiments of 48.2% and 58.6%, but also the
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`Patent Owner Sur-Reply
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`range between them. Id.
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`b. The ’571 Application discloses a range of 25% to 58.6%, which
`pertains to the same invention as the claimed range of about 48.2%
`to about 58.6%.
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`Although the range of 25% to 58.6% is not “explicitly discussed on the face
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`of the ’571 application,” Reply 5, a POSA “would have understood that the inventors
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`possessed” this range based on the disclosed range of “at least 25%” and the
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`disclosure of 58.6% as “an example of the amount of polymer that could be included
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`in the inventive films in light of the constraints imposed by the presence of other
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`ingredients.” Ex. 2008 ¶¶ 43–45, 55–60; Ex. 1030, 122:1–8 (58.6% “is one upper
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`bound that is derivable” from Table 1). Dr. Cremer explained, moreover, that the
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`described range of 25% to about 58.6% “pertain[s] to the same invention” as the
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`narrower, claimed range of about 48.2% to about 58.6%. Ex. 2008 ¶ 45. Petitioners
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`have not met their burden to rebut that. Wertheim, 541 F.2d at 264.
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`Petitioners assert that the ’571 Application does not disclose “any upper
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`endpoint for the polymer weight range.” Reply 3. But in their narrow focus on the
`
`’571 Application’s express disclosure, Petitioners ignore Dr. Cremer’s explanation
`
`of why a POSA “would have understood that there is an upper bound to the polymer
`
`weight percentages of the inventive films” when considering the ’571 Application
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`“as a whole.” Ex. 2008 ¶ 56 (emphasis added); Ex. 1030, 52:22–54:12. Petitioners
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`13
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`have no response to Dr. Cremer’s testimony that a POSA would have focused on
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`Patent Owner Sur-Reply
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`polymer weight percentages and “would have understood that the required presence
`
`of active ingredients and a buffer, optionally together with other ingredients such as
`
`a flavor and sweetener, would constrain the possible polymer weight percentage in
`
`the disclosed film.” Ex. 2008 ¶¶ 56, 66; see also Ex. 2009, 109:21–110:12
`
`(conceding that the presence of “other ingredients besides the polymer” means the
`
`polymer weight percentage “has to be less than 100%”).4 For example, although
`
`Petitioners cite Dr. Cremer’s acknowledgement that “Claim 5 does not expressly
`
`provide … a numerical upper limit” to the recited range of at least 25%, Reply 3–4,
`
`they omit his testimony that the claimed film also includes “other components” such
`
`as buprenorphine, naloxone, and a buffer, and that a POSA would account for these
`
`components in considering the film’s polymer weight percentage. Ex. 1030, 55:12–
`
`
`4 Petitioners ignore the pertinent finding of Rimfrost: that a claimed range with no
`
`express upper bound was construed to have an “upper boundary [that] is not infinity,
`
`but rather is bound by the nature of the starting material used to make the krill oil
`
`and the extraction processes utilized … . The breadth of the claims extends to a range
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`that a POS[A] would consider reasonable based on the admitted data in the
`
`specification … .” Rimfrost AS v. Aker Biomarine Antartic AS., PGR2018-00033,
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`2018 WL 4183083, at *7 (P.T.A.B. Aug. 29, 2018).
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`14
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`Patent 9,687,454
`56:9. Dr. Cremer further explained—and Petitioners do not rebut—that a POSA
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`Patent Owner Sur-Reply
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`
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`would have understood that the inventors possessed not only the idea of an upper
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`bound to the disclosed range of “at least 25%, but also the embodiment of 58.6%,
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`which a POSA would have understood as “an example of the amount of polymer
`
`that could be included in the inventive films in light of the constraints imposed by
`
`the presence of other ingredients.” Ex. 2008 ¶¶ 43–45.
`
`Petitioners cannot distinguish Nalpropion and Wertheim. In Nalpropion, the
`
`disclosure of 39% and 67% supported the claimed range of “between 39% and 70%,”
`
`and the disclosure of 62% and 85% supported the claimed range of “between 62%
`
`and 90%.” 934 F.3d at 1349. In Wertheim, the disclosed “range of 25–60%” and
`
`“embodiments of 36% and 50%” supported the claimed range of “35–60%.” 541
`
`F.2d at 265. Petitioners argue that the written description support was stronger in
`
`Nalpropion and Wertheim than here, Reply 8, but the support is stronger here
`
`because a POSA would have understood the ’571 Application discloses the precise
`
`claimed endpoints of 48.2% and 58.6%, and the range between them. Ex. 2008
`
`¶¶ 36–45. Furthermore, a POSA would have understood that the ’571 Application
`
`discloses a range of 25% to about 58.6%, id. ¶¶ 43–45, which “describes the
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`15
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`IPR2019-00329
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`somewhat narrower claimed range” of about 48.2% to about 58.6%, especially given
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`Patent Owner Sur-Reply
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`
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`the disclosure of 48.2%. Wertheim, 541 F.2d at 264.5
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`3. There is written description support for “about 40 wt % to about
`60 wt %” (claim 1).
`
`Dr. Cremer explained that the ’571 Application reasonably conveys to a
`
`POSA that the inventors possessed the range of 25% to about 58.6% and, because
`
`about 58.6% is “about 60%,” the range of 25% to about 60%. Ex. 2008 ¶ 49.
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`Moreover, the ranges of 25% to 58.6% and 25% to 60% “pertain to the same
`
`invention.” Id.; see also Paper No. 21 at 21 (“58.6% may well be a disclosure of
`
`‘about 60%’”). Dr. Cremer further explained that the range of 25% to 60%
`
`“pertain[s] to the same invention” as the somewhat narrower range of 40% to 60%.
`
`
`5 For the same reasons, and contrary to Petitioners’ argument, Reply 8, the written
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`description support is stronger here than in Ex Parte Molenda, which found support
`
`for “about 5%” because it fell within “broader disclosed ranges,” even though it was
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`“not expressly disclose[d].” Ex Parte Michael Molenda, et al., Appeal No. 2016-
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`007717, 2017 WL 3620343, at *7 (P.T.A.B. Aug. 18, 2017).
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`16
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`Id. ¶ 50. Under Wertheim, it was Petitioners’ burden to rebut that, 541 F.2d at 264,
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`Patent Owner Sur-Reply
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`
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`but they failed to meet their burden.6
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`Petitioners criticize Dr. Cremer’s testimony that “[a]s the polymer weight
`
`percentage of a film increased from 25% towards [the preferred embodiment of]
`
`48.2%, a POSA would have increasing confidence that [it] was in the inventors’
`
`possession,” and that because “about 40% is much closer to 48.2% than to 25% …
`
`a POSA would have a high degree of confidence that the inventors possessed” it. Ex.
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`2001 ¶ 42. Petitioners argue that this logic would extend written description support
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`to “any percentage value between 25% and 48.2%” that is “‘closer to’ 48.2% than
`
`25%.” Reply 5–6. However, Dr. Cremer did not say that being “closer to” 48.2%
`
`than 25% would itself be sufficient for written description support, but rather that
`
`this is one consideration that, together with the other facts discussed in his
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`declarations, reasonably conveys to a POSA that the inventors possessed the range
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`of about 40% to about 60%.
`
`Petitioners also attempt to fault Dr. Cremer for declining to offer opinions in
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`the first instance at his deposition regarding “whether 41%, 42%, etc. could have
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`6 Petitioners also did not rebut that the range of 41.0% to 61.0%, based on the
`
`reasonable variation encompassed by the invention, “pertain[s] to the same
`
`invention” as the range of 40% to 60%. Ex. 2008 ¶ 48.
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`17
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`also been claimed as the lower endpoint” of the claimed range. Reply 6. Petitioners
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`Patent Owner Sur-Reply
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`strain to assert that this shows that Dr. Cremer “attempt[ed] to find support for the
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`lower [claimed] endpoint of 40% in the specification, rather than relying on ‘blaze
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`marks’ in the specification” showing the inventors possessed that endpoint. Id. To
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`the contrary, Dr. Cremer appropriately focused his analysis on the challenged claim
`
`limitations, not other hypothetical limitations not found in any claim. Dr. Cremer
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`recited the correct written description standard, Ex. 2008 ¶¶ 20, 39, and consistently
`
`applied it in his analysis, e.g., id. ¶ 46.7
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`B. Petitioners have not shown the claimed buprenorphine:polymer/
`(b):(a) ratio range lacks written description support.
`1. The (b):(a) ratio is part of the invention.
`
`Contrary to Petitioners’ argument that “Patent Owner has not shown any
`
`reason for a POSA to calculate the (b):(a) ratio in the ’571 application,” Reply 15,
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`Dr. Cremer explained that a POSA reading the ’571 Application “would have been
`
`focused on the ratios between the necessary ingredients—the active ingredients,
`
`buffer, and polymer—because such ratios are
`
`important
`
`to constructing
`
`pharmaceutical films.” Ex. 2008 ¶ 74; see also id. ¶ 79; Ex. 2009, 106:20–107:6
`
`
`7 Likewise, Petitioners’ criticism of Dr. Cremer for considering the written
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`description support for only the challenged (b):(a) ratios, Reply 17–18, is unavailing.
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`18
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`(calculating (b):(a) ratio is within capability of POSA). Petitioners have not
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`Patent Owner Sur-Reply
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`
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`responded to this critical testimony.
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`Dr. Cremer further explained why a POSA would have understood the (b):(a)
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`ratio is particularly important to the invention. Dr. Cremer did not rely on “[t]he
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`relative weights of the [buprenorphine and polyme
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