throbber
Paper No. 11
`Date Filed: September 1, 2016
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD, and ALKERMES CONTROLLED
`THERAPEUTICS, INC.,
`Patent Owners.
`____________
`Case IPR2016-01096
`Patent 6,667,061
`____________
`PATENT OWNERS’ PRELIMINARY RESPONSE PURSUANT TO
`37 C.F.R. § 42.107
`
`

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`Case IPR2016-1096
`U.S. Patent 6,667,061
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................1
`
`BACKGROUND OF THE INVENTION .....................................................4
`
`A.
`
`B.
`
`The Development of the ’061 Patent...................................................5
`
`The ’061 Prosecution History .............................................................7
`
`III.
`
`THE PERSON OF ORDINARY SKILL IN THE ART ................................9
`
`IV. CLAIM CONSTRUCTION..........................................................................9
`
`A.
`
`B.
`
`“Suspension” and “Fluid Phase of Said Suspension” ..........................9
`
`“Viscosity” .......................................................................................10
`
`V.
`
`VI.
`
`LEGAL STANDARDS ..............................................................................12
`
`PETITIONERS’ ALLEGED UNPATENTABILITY
`GROUNDS ARE FATALLY FLAWED ....................................................14
`
`A.
`
`None of Petitioners’ References Disclose or Teach
`Claimed Viscosity Limitation ...........................................................14
`
`1.
`
`2.
`
`3.
`
`The Teachings in Johnson and Gustafsson that
`Petitioners Rely On Do Not Relate to the Fluid
`Phase of a Suspension.............................................................15
`
`Neither Johnson nor Gustafsson Specify the
`Viscosity or the Temperature at which Viscosity
`Should be Measured................................................................16
`
`Petitioners’ Reliance on the Tracy Declaration is
`Flawed ....................................................................................19
`
`B.
`
`Gustafsson Does Not Disclose or Teach Claimed
`Microparticle Limitation...................................................................22
`
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`Case IPR2016-1096
`U.S. Patent 6,667,061
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`C.
`
`Petitioners Have Not Shown that a POSA Would Have
`Combined the Cited Art with a Reasonable Expectation
`of Success.........................................................................................23
`
`1.
`
`Petitioners Have Failed to Show a POSA Would
`Have Combined Johnson and Kino With a
`Reasonable Expectation of Success.........................................24
`
`a.
`
`b.
`
`c.
`
`Petitioners Offer Only Conclusory and
`Vague Statements About Motivation to
`Combine and Likelihood of Success .............................25
`
`A POSA Would Not Have Combined
`Johnson and Kino .........................................................28
`
`A POSA Would Not Have Had a
`Reasonable Expectation of Success at
`Arriving at the Claimed Invention by
`Combining Johnson and Kino.......................................31
`
`2.
`
`Petitioners Have Failed to Show a POSA Would
`Have Combined Gustafsson, Ramstack and the
`Handbook with a Reasonable Expectation of
`Success ...................................................................................32
`
`a.
`
`b.
`
`c.
`
`Petitioners Offer Only Conclusory and
`Vague Statements About Motivation to
`Combine and Likelihood of Success .............................33
`
`A POSA Would Not Have Combined
`Gustafsson, Ramstack and the Handbook .....................35
`
`A POSA Would Not Have Had a
`Reasonable Expectation of Success in
`Combining Gustafsson, Ramstack and the
`Handbook .....................................................................38
`
`VII. PETITIONERS FAIL TO REBUT THE OBJECTIVE
`EVIDENCE OF NONOBVIOUSNESS......................................................40
`
`VIII. CONCLUSION ..........................................................................................42
`
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`Case IPR2016-1096
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`TABLE OF AUTHORITIES
`
`Cases
`Abbott Labs. v. Sandoz, Inc.,
`544 F.3d 1341 (Fed. Cir. 2010).................................................................. 22
`
`Apple, Inc. v. Int’l Trade Comm’n,
`725 F.3d 1356 (Fed. Cir. 2013).................................................................. 41
`
`Aristocrat Techs. Australia Pty Ltd. v. Int’l Game Tech.,
`709 F.3d 1348 (Fed. Cir. 2013).................................................................. 11
`
`Continental Can Co. U.S.A. v. Monsanto Co.,
`948 F.2d 1264 (Fed. Cir. 1991).................................................................. 17
`
`Crocs v. U.S. Int’l Trade Comm’n,
`598 F.3d 1294 (Fed. Cir. 2010).............................................................31, 39
`
`In re GPAC Inc.,
`57 F.3d 1573, 1580 (Fed. Cir. 1995) .......................................................... 42
`
`In re Montgomery,
`677 F.3d 1375 (Fed. Cir. 2012).............................................................13, 18
`
`In re Soni,
`554 F.3d 746 (Fed. Cir. 1995).................................................................... 13
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007)........................................................................12, 13, 23
`
`Leo Pharm. Prods., Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013)............................................................passim
`
`Mformation Techs., Inc. v. Research in Motion Ltd.,
`764 F.3d 1392 (Fed. Cir. 2014).................................................................. 11
`
`Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc.,
`773 F.3d 1186 (Fed. Cir. 2014).................................................................. 13
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005).................................................................. 11
`
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`U.S. Patent 6,667,061
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`Procter & Gamble Co. v. Teva Pharms. USA, Inc.,
`566 F.3d 989 (Fed. Cir. 2009)...............................................................13, 23
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk
`Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012).................................................................. 41
`
`Statutes
`35 U.S.C. § 103 ..............................................................................................12, 14
`
`35 U.S.C. § 311(b)....................................................................................12, 20, 21
`
`35 U.S.C. § 314(a) ............................................................................................... 12
`
`35 C.F.R. § 42.65(a) ........................................................................................... 26
`
`P.T.A.B.
`Coalition for Affordable Drugs VII LLC v. Pozen Inc.,
`IPR No. 2015-01680, Paper 18 (P.T.A.B. Feb. 11, 2016)........................... 21
`
`Conopco v. Procter & Gamble,
`IPR No. 2013-00510, Paper 9 (P.T.A.B. Feb. 12, 2014)............................. 24
`
`E.I. du Pont de Nemours & Co. v. Monsanto Tech. LLC,
`IPR No. 2014-00333, Paper 14 (P.T.A.B. July 11, 2014)........................... 24
`
`Fontaine Engineered Prods., Inc. v. Raildecks, Inc., IPR No.
`2013-00361, Paper 8 (P.T.A.B. Dec. 13, 2013).....................................15, 24
`
`Johns Manville Corp. v. Knauf Insulation, Inc.,
`IPR No. 2015-01633, Paper 10 (P.T.A.B. Jan. 4, 2016) ........................26, 28
`
`Merial Ltd. v. Virbac,
`IPR No. 2014-01279, Paper 13 (P.T.A.B. Jan. 22, 2015) ........................... 41
`
`Oxford Nanopore Techs. Ltd. v. Univ. of Wash.,
`IPR No. 2014-00512, Paper 12 (P.T.A.B. Sept. 15, 2014) ...................passim
`
`Phigenix, Inc. v. Immunogen, Inc.,
`IPR No. 2014-00676, Paper 39 (P.T.A.B. Oct. 27, 2015)........................... 42
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`Case IPR2016-1096
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`Praxair Distr. Inc. v. INO Therapeutics, Inc.,
`IPR Nos. 2015-00522, 2015-00524, 2015-00525, 2015-
`00526 Paper 12 (P.T.A.B. July 29, 2015)................................................2, 40
`
`Zetec, Inc. v. Westinghouse Elec. Co., LLC,
`IPR No. 2014-00384, Paper 10 (P.T.A.B. July 23, 2014)........................... 15
`
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`Case IPR2016-1096
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`Alkermes Pharma Ireland Limited and Alkermes Controlled Therapeutics,
`
`Inc. (collectively “Patent Owners”) respectfully submit this Preliminary Response
`
`to the Petition of Luye Pharma Group Limited, Luye Pharma (USA) Limited,
`
`Shandong Luye Pharmaceutical Company, Limited and Nanjing Luye
`
`Pharmaceutical Co., Limited (collectively “Petitioners”) seeking inter partes
`
`review (“IPR”) of U.S. Patent No. 6,667,061 (“the ’061 patent”).1
`
`I.
`
`INTRODUCTION
`
`The ’061 patent “relates to injectable suspensions having improved
`
`injectability, and to methods for the preparation of such injectable suspensions.”
`
`(Exh. 1001 at 1:11-14.) Long-acting injectable dosage forms offer a number of
`
`advantages over oral medications, including improved patient compliance, reduced
`
`risk of overdose and more consistent bioavailability. Such benefits are especially
`
`important in treating diseases, such as schizophrenia, which have a lifelong course
`
`and are progressive in nature.
`
`However, injectable suspensions are among the “most difficult dosage forms
`
`to develop.” (Id. at 1:24-25; Exh. 1014 at 285; Exh. 1020 at 212; Exh. 2001 at
`
`173.) For instance, in order to be effective and pharmaceutically acceptable, a
`
`1 Petitioners have also filed another petition for IPR (IPR No. 2016-01095)
`
`challenging claims 1-13 and 17-23 of the ’061 patent.
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`suspension must achieve a certain level of injectability. (Exh. 1001 at 1:39-43.)
`
`“Injectability includes factors such as pressure or force required for injection,
`
`evenness of flow, aspiration qualities, and freedom from clogging.” (Id. at 1:62-
`
`64; Exh. 1014 at 299.) Injectability failures often manifest themselves in the form
`
`of a clog at the tip of the needle, and occur immediately or shortly after injection
`
`has been initiated. (Exh. 1001 at 4:52-55.) In view of this problem, conventional
`
`wisdom has been to keep viscosity of injectable suspensions low in order to make
`
`suspensions easier to inject. (Id. at 2:27-31, 2:37-40, 4:60-62; Exh. 1014 at 287,
`
`299.)
`
`The invention of the ’061 patent provided “injectable compositions … [that]
`
`overcome injectability problems, particularly injectability failures that occur upon
`
`injection into muscle or subcutaneous tissue.” (Id. at 4:47-50.) Surprisingly, the
`
`present invention addresses the problem by increasing viscosity of the fluid phase,
`
`contrary to conventional wisdom. This unexpected outcome was addressed in
`
`detail during prosecution, including through the submission of declaration
`
`evidence—making the Petitioners’ silence on the issue of unexpected results even
`
`more glaring. Praxair Distr. Inc. v. INO Therapeutics, Inc., IPR Nos. 2015-00522,
`
`2015-00524, 2015-00525, 2015-00526, Paper 12 at 16-17 (P.T.A.B. July 29, 2015)
`
`(denying institution where petitioner failed to address arguments made during
`
`prosecution, which the Examiner found persuasive).
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`Case IPR2016-1096
`U.S. Patent 6,667,061
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`Moreover, despite the importance of the claimed viscosity range described in
`
`the specification and highlighted during prosecution, Petitioners fail to identify any
`
`piece of prior art that teaches the claimed viscosity limitation. Specifically, the
`
`claims require a viscosity range of the fluid phase of a suspension at a particular
`
`temperature. However Petitioners’ asserted references are silent as to the viscosity
`
`of any formulation described therein. In their attempt to fill this gap in their
`
`asserted references, Petitioners inappropriately rely on a declaration which they
`
`have failed to show is prior art or a reflection of the knowledge a person of
`
`ordinary skill in the art (“POSA”) would have had as of the time of the invention.
`
`Petitioners also fail to identify any piece of prior art that teaches the claimed
`
`microparticle limitation. The microparticles disclosed in Gustafsson are
`
`completely different from those claimed in the ’061 patent. These deficiencies are
`
`fatal to the petition in its entirety. Oxford Nanopore Techs. Ltd. v. Univ. of Wash.,
`
`IPR No. 2014-00512, Paper 12 at 15 (P.T.A.B. Sept. 15, 2014) (denying institution
`
`where petition failed to explain why the prior art possessed a claimed structural
`
`attribute).
`
`In addition, Petitioners fail to explain why or how a POSA would have
`
`combined the alleged teachings of certain prior art references in the manner recited
`
`by the ’061 patent claims with a reasonable expectation of successfully improving
`
`suspension injectability. More specifically, Petitioners make only vague and
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`nonspecific arguments as to why a POSA would have combined select teachings
`
`from distinct references. For instance, Petitioners argue that “[a] POSA would
`
`look to combine . . . sustained release microparticles, to improve the injectability of
`
`the suspension” (Petition at 30), without showing that a POSA would have
`
`reasonably expected any of the changes or combinations required to arrive at the
`
`claimed invention would advance that motivation. Indeed, a POSA would not
`
`have made the combinations relied upon by Petitioners, at least, because the prior
`
`art references are directed at diverse subject matter and, in fact, teach away from
`
`suspensions with a fluid phase of increased viscosity. This too is fatal to the
`
`petition. Oxford Nanopore Techs., Paper 12 at 17 (denying institution where
`
`petition did “not discuss, with any specificity, the teachings . . . that would have
`
`prompted an ordinary artisan to use” one prior art element in another prior art’s
`
`system).
`
`For at least these reasons, institution of IPR should be denied.
`
`II.
`
`BACKGROUND OF THE INVENTION
`
`The ’061 patent relates to injectable suspensions having improved
`
`injectability. (Exh. 1001 at 1:12-15.) A central concept of the patent is that the
`
`fluid phase of the suspension has a viscosity greater than about 20 centipoise (cp)
`
`and less than about 600 cp (when measured at 20°C) in order to achieve improved
`
`injectability.
`
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`U.S. Patent 6,667,061
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`Claim 1, the sole independent claim of the ’061 patent, recites:
`
`1. A composition suitable for injection through a needle into a host,
`comprising:
`microparticles comprising a polymeric binder; and
`
`an injection vehicle, wherein said microparticles are
`suspended in said injection vehicle at a
`concentration of greater than about 30 mg/ml to
`form a suspension, wherein a fluid phase of said
`suspension has a viscosity greater than about 20 cp
`and less than about 600 cp at 20º C., wherein the
`viscosity of said fluid phase of said suspension
`provides injectability of the composition through a
`needle ranging in diameter from 18-22 gauge.
`
`A.
`
`The Development of the ’061 Patent
`
`The invention of the ’061 patent overcomes injectability problems,
`
`particularly injectability failures that occur upon injection into muscle or
`
`subcutaneous tissues. (Exh. 1001 at 4:47-50.) The ’061 patent describes a series
`
`of tests directed at evaluating injectability. (Id. at Examples 2-4.) These tests
`
`revealed that “injectability is improved, and in vivo injectability failures
`
`significantly and unexpectedly reduced, by increasing the viscosity of the fluid
`
`phase of an injectable suspension.” (Id. at 4:47-60, Examples 1-4.) This is in
`
`direct contrast to “conventional teachings that an increase in the viscosity hinders
`
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`injectability.” (Id. at 4:60-62; see also Exh. 1014 at 33 (“Increases in the following
`
`characteristics tend to reduce syringeability or make material transfer through the
`
`needle more difficult: The viscosity of the vehicle . . . Probably the most important
`
`of these factors is viscosity.”), 287 (“However, most parenteral suspensions are
`
`usually dilute and have practical limitations for viscosity because of syringeability
`
`and injectability constraints.”), 297 (“However, the high viscosity and poor
`
`syringeability of such systems limit their use in parenteral suspensions.”), 299
`
`(“Increase in viscosity, density, particle size, and concentration of solids in
`
`suspension hinders the syringeability of suspension.”).)2 This discovery was all the
`
`more unexpected because it “contradicted” the in vitro studies conducted by the
`
`inventors. (Exh. 1001 at Example 1.) Their in vivo injectability studies, by
`
`contrast, showed “a dramatic improvement in injectability with increased injection
`
`vehicle viscosity.” (Id.; see also id. at Examples 2-3.)
`
`The inventors’ work further revealed that (1) “[v]iscosities of at least about
`
`20 cp are necessary for successful and medically acceptable injectability rates” but
`
`2 Petitioners’ declarant, Dr. Patrick DeLuca, relies on Exh. 1014 (see, e.g., Exh.
`
`1002 at ¶¶ 17-19, 21-24) but fails to address that Exh. 1014 specifically teaches
`
`away from the invention by disclosing that increasing viscosity tends to decrease
`
`syringeability.
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`that viscosities of up to about 600 cp could be used in the invention (id. at
`
`Examples 3-4, 10:64-65) and (2) the inclusion of density enhancing agents results
`
`in fewer injectability failures (id. at Examples 3-4).
`
`B.
`
`The ’061 Prosecution History
`
`U.S. Pat. Appl. No. 09/577,875 (“the ’875 application”) was filed on May
`
`25, 2000, and issued as U.S. Patent No. 6,495,164 on December 17, 2002. The
`
`’875 application is the parent to U.S. Pat. Appl. No. 10/259,949 (“the ’949
`
`application”), which was filed on September 30, 2002 as a continuation of the ’875
`
`application and issued as the ’061 patent on December 23, 2003. (Exh. 1001.)
`
`During prosecution, the Examiner considered prior art including the Kino
`
`reference relied upon by Petitioners. (See, e.g., Exh. 1001 at References Cited;
`
`Exh. 1016 at 3-4; Exh. 1017 at 2-4; Exh. 1018.) Despite Petitioners’ claims
`
`otherwise (Petition at 38), the Examiner also considered Ramstack during
`
`prosecution. It, as well as its U.S. counterpart (U.S. Patent No. 5,650,173), are
`
`clearly cited on the face of the patent. (Exh. 1001 at References Cited.)
`
`Initially, the Examiner rejected the claims of the ’949 application,
`
`concluding that “absent unexpected results regarding the criticality of the viscosity,
`
`Kino discloses all the limitations of the instant claims.” (Exh. 1016 at 4.) The
`
`Examiner explained that “Kino discloses a sustained release microsphere
`
`preparation, which is produced by including a hydrophobic antipsychotic drug”
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`and that the drug may be risperidone, a leading treatment for schizophrenia, which
`
`is injected intramuscularly. (Id. at 3-4.) In response, the applicants argued that
`
`“none of the cited documents or other documents of record discloses or suggests
`
`the relationship between increased viscosity and improved injectability.” (Exh.
`
`1017 at 2.) This argument was further supported by the Declaration of Mark A.
`
`Tracy, Ph.D., which was originally filed during prosecution of the parent ’875
`
`application. (Exh. 1018 at ¶ 3.) Consistent with the teachings in the art at the time,
`
`Dr. Tracy also established that, assuming measurement at 20ºC, the viscosity of the
`
`compositions disclosed in Kino fell far below the claimed range. (Id. at ¶¶ 4-5.) In
`
`Examples 1, 3 and 4 of Kino, the viscosity would be approximately 1 cp, if
`
`measured at 20ºC and in Example 2 the viscosity would be less than 7 cp if
`
`measured at 20ºC. (Id.) Kino thus taught a low viscosity for injections of
`
`antipsychotic drugs, including risperidone.
`
`By contrast, the claimed range requires a viscosity of greater than about
`
`20 cp and less than about 600 cp at 20ºC. The applicants also pointed to portions
`
`of the specification of the ’949 application, which establish the criticality of
`
`viscosity to improved injectability, and explained that such criticality was
`
`unexpected given the “conventional teachings that an increase in the viscosity
`
`hinders injectability and syringeability.” (Exh. 1017 at 3-4.)
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`Upon consideration of these arguments and this evidence, the Examiner
`
`withdrew all rejections and allowed the instant claims. (Exh. 1019.)
`
`III. THE PERSON OF ORDINARY SKILL IN THE ART
`
`Patent Owners disagree with Petitioners’ proposed definition of a POSA and
`
`reserve the right to offer a correct definition. At this point, however, given the
`
`deficiencies in the petition, institution should be denied under any definition of a
`
`POSA.
`
`IV. CLAIM CONSTRUCTION
`
`Petitioners advance proposed constructions for a number of claim terms in
`
`the ’061 patent. Patent Owners reserve the right to fully respond to each of
`
`Petitioners’ proposed constructions. At this stage, however, Patent Owners focus
`
`on several highly erroneous constructions proposed by Petitioners, which may
`
`impact the Board’s institution analysis.
`
`A.
`
`“Suspension” and “Fluid Phase of Said Suspension”
`
`Petitioners contend that “suspension” means “a mixture of microparticles
`
`dispersed throughout an injection vehicle” (Petition at 21) while “fluid phase of
`
`said suspension” means “the reconstituted product in a two-phase product
`
`formulation” (id.). While Petitioners’ proposed construction for “suspension” is
`
`reasonable in light of the patent claims and specification (see, e.g., Exh. 1001 at
`
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`1:17-19, 5:8-13, 6:20-27, 11:55-13:61, claim 1), their proposed construction for
`
`“fluid phase of said suspension” is not.
`
`Petitioners have improperly limited their proposed construction of “fluid
`
`phase of said suspension” to only reconstituted suspensions. This limitation is
`
`clearly at odds with the patent specification, which makes clear that “injectable
`
`suspensions [of the invention] may be formulated as a ready-to-use injection or
`
`require a reconstitution step prior to use.” (Exh. 1001 at 1:30-32.)
`
`Therefore, consistent with the patent specification and claims, Patent
`
`Owners propose that “fluid phase of said suspension” be given its broadest
`
`reasonable construction, which includes ready-to-use injections and those that
`
`require a reconstitution step prior to use.
`
`B.
`
`“Viscosity”
`
`Petitioners also contend that “viscosity” should be construed to include the
`
`requirement that “[u]nless otherwise specified, viscosity is typically measured at
`
`20 or 25ºC.” (Petition at 22.) Petitioners’ proposed construction ignores that claim
`
`1 expressly specifies the particular temperature (20ºC) that corresponds to the
`
`claimed viscosity range. Thus, Petitioners’ proposed definition of viscosity
`
`improperly seeks to re-write the claim language which expressly specifies the
`
`temperature at which viscosity should be measured. It is also contradicted by the
`
`teachings of Petitioners’ own cited references.
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`There is no reason to construe the viscosity term of the ’061 patent to
`
`implicitly include a temperature at which viscosity is presumed to be measured
`
`when claim 1 expressly recites elsewhere that the claimed viscosity range
`
`corresponds to a measurement at 20ºC. See, e.g., Mformation Techs., Inc. v.
`
`Research in Motion Ltd., 764 F.3d 1392, 1399 (Fed. Cir. 2014) (favoring a
`
`construction that does not render another limitation “superfluous”); Aristocrat
`
`Techs. Australia Pty Ltd. v. Int’l Game Tech., 709 F.3d 1348, 1356-57 (Fed. Cir.
`
`2013) (declining to adopt proposed construction that would render another
`
`limitation “superfluous”); Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir.
`
`2005) (finding claim term “baffles” does not inherently mean objects made of steel
`
`where claim also referred to “steel baffles”).
`
`Petitioners’ construction seems to be an attempt to circumvent the prior art
`
`that teaches that temperatures for viscosity measurements can range from 20ºC to
`
`121ºC. (See, e.g., Exh. 1006 at 1840.) Furthermore, Petitioners’ construction
`
`seems to be an attempt to use claim construction to overcome the failure of the
`
`asserted prior art to actually specify a temperature that corresponds to the alleged
`
`viscosity disclosures.
`
`Moreover, Petitioners’ construction attempts to include a temperature option
`
`higher than the one required by the claims. Such an attempt is improper in view of
`
`Petitioners’ own evidence, which states that “[t]he specifying of temperature is
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`important because viscosity changes with temperature” and even “small
`
`temperature changes may lead to marked changes in viscosity.” (Exh. 1006 at
`
`1840.)
`
`Patent Owners propose that “viscosity” be given its broadest reasonable
`
`construction, consistent with the specification’s teaching that “viscosity describes
`
`the resistance that a liquid system offers to flow when it is subjected to an applied
`
`shear stress.” (Exh. 1001 at 2:14-15.)
`
`V.
`
`LEGAL STANDARDS
`
`In challenging the patentability of an issued patent through IPR, petitioners
`
`are limited to relying on prior art patents and printed publications.
`
`35 U.S.C. § 311(b). To institute an IPR, Petitioners must show a reasonable
`
`likelihood of prevailing on unpatentability. See 35 U.S.C. § 314(a).
`
`For a claim to be unpatentable under 35 U.S.C. § 103, the differences
`
`between the claimed subject matter and the prior art must be such that the subject
`
`matter as a whole would have been obvious at the time the invention was made to a
`
`POSA in the art to which the subject matter pertains. KSR Int’l Co. v. Teleflex Inc.,
`
`550 U.S. 398, 406 (2007). While a party asserting obviousness may rely on
`
`inherency, it must “meet a high standard in order to rely on inherency to establish
`
`the existence of a claim limitation in the prior art in an obviousness analysis—the
`
`limitation at issue necessarily must be present, or the natural result of the
`- 12 -
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`

`
`Case IPR2016-1096
`U.S. Patent 6,667,061
`
`combination of elements explicitly disclosed by the prior art.” Par
`
`Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., 773 F.3d 1186, 1195-96 (Fed.
`
`Cir. 2014) (emphasis added). “The keystone of the inherency doctrine is
`
`inevitability . . . Absent inevitability, inherency does not follow even from a very
`
`high likelihood that a prior art method will result in the claimed invention.” In re
`
`Montgomery, 677 F.3d 1375, 1384 (Fed. Cir. 2012).
`
`Furthermore, “a patent composed of several elements is not proved obvious
`
`merely by demonstrating that each of its elements was, independently, known in
`
`the prior art.” KSR, 550 U.S. at 418. A party that petitions the Board for a
`
`determination of obviousness must show that “a skilled artisan would have been
`
`motivated to combine the teachings of the prior art references to achieve the
`
`claimed invention, and that the skilled artisan would have had a reasonable
`
`expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharms. USA,
`
`Inc., 566 F.3d 989, 994 (Fed. Cir. 2009). Additionally, a showing of obviousness
`
`may be overcome with objective evidence of secondary considerations such as
`
`unexpected results. In re Soni, 554 F.3d 746, 750 (Fed. Cir. 1995) (“[W]hen an
`
`applicant demonstrates substantially improved results . . . and states that the results
`
`were unexpected, this should suffice to establish unexpected results in the absence
`
`of evidence to the contrary.”) (emphasis in original); see also Procter & Gamble
`
`Co., 566 F.3d at 994 (“If a patent challenger makes a prima facie showing of
`
`- 13 -
`
`

`
`Case IPR2016-1096
`U.S. Patent 6,667,061
`
`obviousness, the owner may rebut based on ‘unexpected results’ by demonstrating
`
`‘that the claimed invention exhibits some superior property or advantage that a
`
`person of ordinary skill in the relevant art would have found surprising or
`
`unexpected.’”).
`
`VI. PETITIONERS’ ALLEGED UNPATENTABILITY GROUNDS ARE
`FATALLY FLAWED
`
`Petitioners advance two grounds challenging claims 1-13 and 17-23 of the
`
`’061 patent. In Ground 1, Petitioners argue that these claims are obvious under 35
`
`U.S.C. § 103 over Johnson in view of Kino. In Ground 2, Petitioners challenge the
`
`same claims as obvious under 35 U.S.C. § 103 over Gustafsson in view of
`
`Ramstack and the Handbook of Pharmaceutical Excipients. As detailed below,
`
`Petitioners have failed to show there is a reasonable likelihood they will prevail in
`
`rendering unpatentable even one claim of the ’061 patent based on any of their
`
`asserted grounds.
`
`A.
`
`None of Petitioners’ References Disclose or Teach Claimed
`Viscosity Limitation
`
`Claim 1, the only independent claim of the ’061 patent, requires that the
`
`“fluid phase of said suspension has a viscosity greater than about 20 cp and less
`
`than about 600 cp at 20º C . . .” (Exh. 1001 at claim 1.) As explained below,
`
`Petitioners have failed to show that any piece of prior art teaches this limitation,
`
`thus precluding institution. Oxford Nanopore Techs. Ltd. v. Univ. of Wash., IPR
`
`- 14 -
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`

`
`Case IPR2016-1096
`U.S. Patent 6,667,061
`
`No. 2014-00512, Paper 12 at 15 (P.T.A.B. Sept. 15, 2014) (denying institution
`
`where petition failed to explain why the prior art possesses a claimed structural
`
`attribute); Zetec, Inc. v. Westinghouse Elec. Co., LLC, IPR No. 2014-00384, Paper
`
`10 at 14 (P.T.A.B. July 23, 2014) (denying institution where petition failed to
`
`explain where each element of the claim was found in the prior art references);
`
`Fontaine Engineered Prods., Inc. v. Raildecks, Inc., IPR No. 2013-00361, Paper 8
`
`at 21 (P.T.A.B. Dec. 13, 2013) (denying institution where petition failed to show
`
`that the prior art disclosed or taught a particular limitation).
`
`1.
`
`The Teachings in Johnson and Gustafsson that Petitioners
`Rely On Do Not Relate to the Fluid Phase of a Suspension
`
`The viscosity limitation of the claims of the ’061 patent is directed to the
`
`fluid phase of the suspension. Petitioners admit that a suspension is formed only
`
`after a solid phase is dispersed in a liquid phase. (Petition at 21.) In contrast, both
`
`Johnson (relied upon by Petitioners for its alleged disclosure of the claimed
`
`viscosity limitation in Ground 1) and Gustafsson (relied upon by Petitioners for its
`
`alleged disclosure of the claimed viscosity limitation in Ground 2) describe the
`
`composition of the injection vehicles used therein. (Exh. 1009 at 12:42-45; Exh.
`
`1011 at 18:19-24.) According to Petitioners, a POSA would have understood an
`
`injection vehicle to be “the aqueous or non-aqueous fluid medium prior to the
`
`addition of microparticles to form a suspension.” (Petition at 20-21.) Petitioners
`
`- 15 -
`
`

`
`Case IPR2016-1096
`U.S. Patent 6,667,061
`
`have failed to explain how a POSA would have determined the viscosity of the
`
`fluid phase of the suspensions of Johnson and Gustafsson from disclosures related
`
`to the compositions of their injection vehicles prior to formation of a suspension or
`
`to show that the viscosity of the injection vehicles of Johnson and Gustafsson
`
`would be the same as that of the fluid phase of their suspensions. Indeed,
`
`Petitioners have failed to account for any impact the addition of the active
`
`ingredient containing microspheres of Johnson or Gustafsson may have on
`
`viscosity of the fluid phase of the suspension. As explained by the Examiner, as
`
`well as taught by Petitioners’ own cited reference, “[t]he presence of particles [in a
`
`suspension] contributes to the viscosity of the suspension.” (Exh. 1016 at 4; see
`
`also Exh. 1014 at 301 (“The suspension viscosity can change due to concentration
`
`of active ingredient(s), particle shape, size and distribution.”).)
`
`2.
`
`Neither Johnson nor Gustafsson Specify the Viscosity or the
`Temperature at which Viscosity Should be Measured
`
`The ’061 patent specifically claims viscosity measurement at 20ºC. Indeed,
`
`as Petitioners’ own reference, the U.S. Pharmacopeia, provides, “[t]he specifying
`
`of temperature is important because viscosity changes with temperature” and even
`
`“small temperature changes may lead to marked changes in viscosity.” (Exh. 1006
`
`at 1840.) However, Petitioners have not shown that a POSA would have
`
`understood what the viscosity of the Johnson or Gustafsson formulations would be
`
`- 16 -
`
`

`
`Case IPR2016-1096
`U.S. Patent 6,667,061
`
`if measured at 20ºC or that the viscosity of the Johnson or Gustafsson formulations
`
`should be measured at 20ºC. To the contrary, Petitioners’ own reference, the U.S.
`
`Pharmacop

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