`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`QUALICAPS CO., LTD,
`Patent Owner
`
`Case IPR2017-00203
`Patent 6,649,180
`
`PATENT OWNER PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.107
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`IPR2017-00203
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`LIST OF EXHIBITS
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`DESCRIPTION
`
`HARD CAPSULES (K. Ridgway ed., 1987)
`
`Toshihiro Ogura, Yoshihiro Furuya, & Seinosuke Matsuura, HPMC
`Capsules — An Alternative to Gelatin, 20(11) J. PHARM. TECH.
`EUROPE 32 (November 1998)
`
`THE HANDBOOK OF PHARMACEUTICAL EXCIPIENTS (“HPE”) Second
`Edition 229–32 (Ainley Wade and Paul J. Weller, eds., 1994)
`
`Jae-Hwang Lee, et al., Specific PCR assays to determine bovine,
`porcine, fish and plant origin of gelatin capsules of dietary
`supplements, 211 FOOD CHEMISTRY 253 (2016)
`
`Federal Standard No. 285A, Capsules (For Medicinal Purposes)
`(October 19, 1976)
`
`E. Bradbury & C. Martin, The effect of temperature of preparation
`on the mechanical properties and structure of gelatin films, 214
`PROC. R. SOC. LONDON SERIES A 183 (1952)
`
`EXHIBIT
`
`Ex. 2001
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`Ex. 2002
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`Ex. 2003
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`Ex. 2004
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`Ex. 2005
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`Ex. 2006
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`Ex. 2007
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`U.S. Pat. No. 2,526,683 (issued Oct. 24, 1950 to Murphy)
`
`Ex. 2008
`
`U.S. Pat. No. 2,810,659 (issued Oct. 22, 1957 to Greminger, et al.)
`
`Ex. 2009
`
`intentionally left blank
`
`Ex. 2010
`
`Ex. 2011
`
`J. C. Stone, Objective Visual Evaluation of the Relative Content of
`Major and Minor Defects in Tablets and Capsules, 59(9) J. PHARM.
`SCI. 1364 (1970)
`
`I. H. Coopes, Structure Formation in Gelatin Films,
`PHOTOGRAPHIC GELATIN II, PROCEEDINGS OF THE ROYAL
`PHOTOGRAPHIC SOCIETY SYMPOSIUM 121 (R. J. Cox, ed., 1974)
`
`Ex. 2012
`
`J. E. Jolley, The Microstructure of Photographic Gelatin Binders,
`14(3) PHOTOGR. SCI. ENG’G 169 (1970)
`
`- i -
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`
`
`EXHIBIT
`
`Ex. 2013
`
`Ex. 2014
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`IPR2017-00203
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`DESCRIPTION
`
`George A. Digenis, Thomas B. Gold, & Vinod P. Shah, Cross-
`Linking of Gelatin Capsules and Its Relevance to Their In Vitro-In
`Vivo Performance, 83(7) J. PHARM. SCI. 915 (1994)
`
`James Hogan, et al., Investigations into the Relationship Between
`Drug Properties, Filling, and the Release of Drugs from Hard
`Gelatin Capsules Using Multivariate Statistical Analysis, 13(6)
`PHARM. RES. 944 (1996)
`
`Ex. 2015
`
`THE UNITED STATES PHARMACOPOEIA, at 774– 76 (1994)
`
`Ex. 2016
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`Ex. 2017
`
`Ex. 2018
`
`Ex. 2019
`
`THE JAPANESE PHARMACOPOEIA, at i–vii; 750–51, 800–804 (13th
`ed. 1996)
`DOW METHOCEL CELLULOSE EITHERS HANDBOOK (1978)
`
`Jaime Curtis-Fisk, et al., Effect of Formulation Conditions on
`Hypromellose Performance Properties in Films Used for Capsules
`and Tablet Coatings, 13(4) AAPS PHARMSCITECH 1170 (December
`2012)
`
`Linda Felton, Film Coating of Oral Solid Dosage Forms, in
`ENCYCLOPEDIA OF PHARMACEUTICAL TECHNOLOGY, at 1729–47 (J.
`Swabrick ed., 3rd ed., 2007)
`
`Ex. 2020
`
`U.S. Pat. No. 4,001,211 (issued Jan. 4, 1977 to Sarkar)
`
`Ex. 2021
`
`Document comparison by Workshare Compare software:
`comparison of Petition and Declaration of Arthur H. Kibbe
`
`Ex. 2022
`
`U.S. Pat. No. 5,431,917 (issued Jul. 11, 1995 to Yamamoto, et al.)
`
`Ex. 2023
`
`U.S. Pat. No. 6,326,026 (issued Dec. 4, 2001 to Parekh, et al.)
`
`Ex. 2024
`
`U.S. Pat. No. 6,228,416 (issued May 8, 2001 to Reibert, et al.)
`
`Ex. 2025
`
`U.S. Pat. No. 4,365,060 (issued Dec. 21, 1982 to Onda, et al.)
`
`- ii -
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`IPR2017-00203
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`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES .................................................................................... v
`
`I.
`
`II.
`
`INTRODUCTION .......................................................................................... 1
`
`THE INVENTORS DISCOVERED, AND UNEXPECTEDLY
`SOLVED, THE PROBLEM OF GELLING AID PRECIPITATION
`IN HPMC CAPSULE TECHNOLOGY. ....................................................... 2
`
`A.
`
`B.
`
`Background of the technology. ............................................................ 2
`
`The specification and file history of the ’180 patent establish
`the inventors’ unexpected discovery. ................................................... 4
`
`III. THE BOARD SHOULD DENY INSTITUTION OF BOTH
`GROUNDS UNDER 35 U.S.C. § 325(d) BECAUSE THE PETITION
`FAILS TO ADDRESS PATENT OWNER’S UNEXPECTED
`RESULTS EVIDENCE. ................................................................................. 9
`
`A.
`
`B.
`
`Petitioner’s asserted art does not “inherently” disclose the
`claimed HPMC capsules. ................................................................... 11
`
`Petitioner’s asserted art does not discuss the problem of gelling
`aid precipitation, or its relationship to HPO/MO content. ................. 13
`
`IV. THE BOARD SHOULD DENY INSTITUTION OF BOTH
`GROUNDS UNDER 35 U.S.C. § 325(d) BECAUSE THE OFFICE
`ALREADY DETERMINED THAT THE ’180 PATENT CLAIMS
`ARE PATENTABLE IN VIEW OF THE SAME HPMC
`TEACHINGS ASSERTED IN GROUNDS 1 AND 2. ............................... 17
`
`A.
`
`B.
`
`The teachings of Petitioner’s asserted references do not differ
`materially from those already considered during prosecution. .......... 18
`
`Petitioner cites no new reason why the asserted references
`would motivate a POSA to develop the claimed invention. .............. 20
`
`1.
`
`Petitioner fails to explain why Yamomoto would give a
`POSA reason to develop the inventors’ claimed HPMC
`substitution ranges.................................................................... 22
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`- iii -
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`IPR2017-00203
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`2.
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`Petitioner fails to explain why Greminger would give a
`POSA reason to develop the inventors’ claimed HPMC
`substitution ranges.................................................................... 23
`
`V.
`
`CONCLUSION ............................................................................................. 26
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`- iv -
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`
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`TABLE OF AUTHORITIES
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`IPR2017-00203
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` Page(s)
`
`Cases
`Allergan, Inc. v. Sandoz Inc.,
`796 F.3d 1293 (Fed. Cir. 2015) .......................................................................... 13
`
`Cardiac Pacemakers, Inc. v. St. Jude Med., Inc.,
`381 F.3d 1371 (Fed. Cir. 2004) ............................................................................ 7
`
`Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche, Inc.,
`IPR2015-01792, Paper 14 (March 11, 2016) ....................................................... 9
`
`Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc.,
`655 F.3d 1291 (Fed. Cir. 2011) .......................................................................... 13
`
`Kingbright Elecs. Co. Ltd., et. al. v. Cree, Inc.,
`IPR2015-00744, Paper 8 (Sept. 9, 2015) ...................................................... 20, 24
`
`Leo Pharm. Prods., Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) ............................................................................ 6
`
`Lower Drug Prices for Consumers, LLC v. Forest Labs. Holdings
`Ltd.,
`IPR2016-00379, Paper 14 (July 1, 2016) ............................................................. 9
`
`In re McLaughlin,
`443 F.2d 1392, 1395 (C.C.P.A. 1971) ................................................................ 13
`
`Merial Ltd. v. Virbac,
`IPR2014-01279, Paper 13 (January 22, 2015) ................................................... 10
`
`In re Nuvasive, Inc.,
`842 F.3d 1376 (Fed. Cir. 2016) .......................................................................... 14
`
`PAR Pharm., Inc. v. TWI Pharm., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) .......................................................................... 11
`
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003) .......................................................................... 13
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`IPR2017-00203
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`Procter & Gamble v. Teva Pharm.,
`566 F.3d 989 (Fed. Cir. 2009) ............................................................................ 20
`
`In re Rijckaert,
`9 F.3d 1531 (Fed. Cir. 1993) .............................................................................. 11
`
`Statutes
`
`35 U.S.C. § 103(a) ............................................................................................. 24, 25
`
`35 U.S.C. § 325(d) ............................................................................................passim
`
`Other Authorities
`
`37 C.F.R. § 42.65(a) ................................................................................................. 11
`
`37 C.F.R. § 42.104(b) .............................................................................................. 23
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`37 C.F.R. § 42.104(b)(2) .......................................................................................... 24
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`37 C.F.R. § 42.104(b)(4) ........................................................................ 13, 14, 20, 25
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`37 C.F.R. § 42.104(b)(5) .................................................................................... 13, 14
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`37 C.F.R § 42.108(c) ................................................................................................ 10
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`- vi -
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`IPR2017-00203
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`I.
`
`
`INTRODUCTION
`
`The Petition should be rejected because it offers no evidence addressing
`
`Patent Owner’s unexpected results of record. The Petition instead covers the same
`
`ground Patent Owner already covered during prosecution of the ’180 patent, during
`
`which Patent Owner showed that the inventors unexpectedly overcame a problem,
`
`known as “gelling aid precipitation,” that they encountered during their work of
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`making hydroxypropyl methyl cellulose (“HPMC”) capsules. The inventors
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`discovered the problem itself, and then solved it by synthesizing an HPMC capsule
`
`having a narrow and novel range of hydroxypropyl (HPO) and methoxyl (MO)
`
`group content. The ’180 patent sets forth experimental data establishing this
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`unexpected result, and Patent Owner supplemented these data with a declaration
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`during prosecution.
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`
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`The Petition addresses none of these data, and the Board should decline
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`institution for this reason alone, as it has in other instances where a Petition fails to
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`address unexpected results evidence that served as the basis for allowance.
`
`Because the Petition cites no evidence countering Patent Owner’s record of
`
`unexpected results, and the evidence in the Petition is the only source Petitioner
`
`may rely on to make this point in its case-in-chief, the Petitioner cannot succeed
`
`here, and Patent Owner should not be put through a necessarily futile trial
`
`proceeding. (See infra Section III.)
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`
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`–1–
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`IPR2017-00203
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`For these reasons, and others set forth below, the Board should deny
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`institution.
`
`II. THE INVENTORS DISCOVERED, AND UNEXPECTEDLY
`SOLVED, THE PROBLEM OF GELLING AID PRECIPITATION
`IN HPMC CAPSULE TECHNOLOGY.
`A. Background of the technology.
`Petitioner provides no reference recognizing the problem of gelling aid
`
`
`
`precipitation in HPMC capsules, let alone the relationship between gelling aid
`
`precipitation and HPO/MO group content. This is because no such teaching existed
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`at the time of the invention. For about 170 years up to the priority date of the ’180
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`patent, pharmaceutical capsules were usually manufactured from gelatin. (Ridgway
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`at 1–10 (Ex. 2001); Ogura at 32 (Ex. 2002).) Despite gelatin’s virtually universal
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`use as a capsule base for over a century and a half, gelatin capsules were known to
`
`pose problems. Gelatin is a known medium for bacterial growth; prone to reacting
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`with certain types of filler; susceptible to degradation when exposed to hot and
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`humid environments; and animal-derived, raising humanitarian and dietary
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`concerns. (Ridgway at 57–58 (Ex. 2001); Ogura at 32, 40–42 (Ex. 2002); Lee at
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`253 (Ex. 2004).)
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`–2–
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`IPR2017-00203
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`By 1999, cellulose ethers, such as HPMC, had long been considered a
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`potentially attractive alternative to gelatin as a base material for capsules.1
`
`Cellulose ethers are polymers made by reacting cellulose in the presence of
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`chemical reagents. (Dow Methocel Cellulose Ethers at 10 (Ex. 2017).) Cellulose
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`ethers were thought to have the potential to improve upon gelatin because of their
`
`low susceptibility to moisture and bacterial growth. (See Ogura at 32–34, 42 (Ex.
`
`2002); see Ridgway at 57–58 (Ex. 2001).)
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`
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`The industry had tried to use various cellulose ethers for capsule
`
`manufacturing. (See, e.g., U.S. Pat. No. 4,001,211 at col. 4, ll. 7–15
`
`(hydroxypropyl cellulose; hydroxyethyl cellulose) (Ex. 2020); U.S. Pat. No.
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`2,526,683 at col. 1, ll. 46– 49 (methyl cellulose) (Ex. 2007).) By the time of the
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`invention, one such cellulose ether, HPMC, had been used in an extensive array of
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`non-capsule applications. (HPE at 229 (Ex. 2003); Ex. 1009 at 139–140; Dow
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`Methocel Cellulose Ethers at 16 (Ex. 2017).) In fact, most of what was known
`
`about HPMC and its properties was documented in literature unrelated to its use in
`
`capsules. For example, Petitioner cites as purportedly relevant a reference that is
`
`
`1 See, e.g. U.S. Pat. No. 2,526,683 at col. 1, ll. 1–20 (Ex. 2007); U.S. Pat. No.
`
`2,810,659 at col. 3, ll. 5–36 (Ex. 2008); see also Ridgway (Ex. 2001) at 56–57
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`(detailing earlier failed efforts to develop commercially viable HPMC capsules).
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`–3–
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`IPR2017-00203
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`directed to food applications of HPMC, which describes HPMC uses from
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`“[b]akery products” to “[w]hipped toppings.” (See Ex. 1013 at 317.)
`
`
`
`
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`The industry’s lack of understanding of HPMC capsules is evident from the
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`difficulties skilled artisans encountered in developing workable HPMC and
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`cellulose ether capsule formulations. (See Ridgway at 56–57, 58 (Ex. 2001)
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`(“Despite the numerous patents, there have been no products successfully marketed
`
`in synthetic polymer capsules[.]”).) For example, it took skilled artisans decades to
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`simply develop an HPMC capsule that could actually dissolve within the body.
`
`(See id. at 56–57.)
`
`
`
`In attempting to overcome challenges with cellulose ether capsule
`
`formulations, researchers had investigated a diverse range of solutions, from the
`
`addition of a variety of plasticizers, modifiers, and solvents, to the outright
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`redesign of the capsule manufacturing process. (Id. at 56–57.) But, confirming the
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`nascent stage of HPMC capsule technology, Petitioner provides no reference
`
`showing there were any HPMC capsules on the market prior to the date of the
`
`invention.
`
`B.
`
`The specification and file history of the ’180 patent establish the
`inventors’ unexpected discovery.
`
`
`
`By 1999, gelatin capsules were often made by creating a gel, dipping pins
`
`into the gel, extracting the pins, and drying the gel adhered to the pins to form
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`capsules. (Ridgway at 68 (Ex. 2001).) In the course of investigating whether
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`–4–
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`IPR2017-00203
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`HPMC capsules could be made in a similar manner, see ’180 patent at col. 1, ll.
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`50–52 (Ex. 1001), the inventors of the ’180 patent discovered a significant problem.
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`They found that “the gelling aid used in these capsules of cellulose ether film
`
`precipitates out on the film surface during long-term storage.” (File History at 47
`
`(Ex. 1010).) The precipitates, in turn, caused noticeable spotting on the surface of
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`the capsules that made the capsules “less aesthetically pleasing to the consumer.”
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`(Id.)
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`
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`Petitioner fails to point to any evidence that a person of ordinary skill in the
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`art (“POSA”) would have recognized that the properties of the HPMC base could
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`be responsible for gelling aid precipitation—let alone that a POSA would
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`understand that HPO/MO content was responsible for that problem. More
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`generally, the prior art lacked any teaching that would have been helpful in
`
`diagnosing and solving that problem. Very few prior art references discussed the
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`physical appearance of HPMC capsules at all, and even then the HPMC capsules
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`were merely compared to gelatin capsules. (See, e.g., Ogura at 36, 40 (Ex. 2002).)
`
`For example, one reference indicates that “HPMC does not contain reactive groups,
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`thereby minimizing discolouration problems [like those observed in gelatin
`
`capsules] that occur as a result of interactions between the drug and capsule shell.”
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`(Id. at 36.) Nor did any reference teach that water loss—identified by the inventors
`
`as possibly associated with gelling aid precipitation—may be prevented by the
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`–5–
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`IPR2017-00203
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`selection of the proper amount of HPO/MO group content in HPMC capsules.
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`(See ’180 pat. at col. 2, ll. 33–49 (Ex. 1001).)
`
`
`
` Even if a POSA had attempted to investigate spotting problems in HPMC
`
`capsules, most guidance available to a POSA would have been from the literature
`
`regarding gelatin capsule quality control. Yet none of this literature pertained to
`
`the problem of gelling aid precipitation. Instead, the gelatin capsule literature
`
`identified a wide assortment of quite different problems causing capsule
`
`appearance issues, including: i) quality of the raw material ingredients; ii)
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`manufacturing conditions, including the nature of the gelling, dipping, or drying
`
`conditions; and iii) chemical reactions and capsule degradation resulting from, for
`
`example, reactions with filler material or excipients, or the storage temperature,
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`humidity, or light exposure.2
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`
`
`Petitioner does not appear to dispute that the inventors of the ’180 patent
`
`discovered and were the first to disclose the problem of gelling aid precipitation.
`
`Discovering a problem, by itself, can support nonobviousness. See, e.g., Leo
`
`
`2 See Fed. Std. No. 285A at 6 (Ex. 2005); Ridgway at 68–72 (Ex. 2001); Stone at
`
`1364 (Ex. 2010); Bradbury at 187–89 (Ex. 2006); Coopes at 121–24 (Ex. 2011);
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`Jolley at 173–74 (Ex. 2012); Digenis at 915–21 (Ex. 2013); Hogan at 944 (Ex.
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`2014); Ogura at 36–42 (Ex. 2002).
`
`–6–
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`IPR2017-00203
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`Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1353–57 (Fed. Cir. 2013) (reversing
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`PTAB ruling that claims were obvious, since “[t]he problem was not known, the
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`possible approaches to solving the problem were not known or finite, and the
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`solution was not predictable”); see also Cardiac Pacemakers, Inc. v. St. Jude Med.,
`
`Inc., 381 F.3d 1371, 1377 (Fed. Cir. 2004) (holding that identification of a problem
`
`can, in some circumstances, itself constitute the invention). As the patent notes, the
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`inventors identified the problem, and proposed that the evaporation of water
`
`trapped in the HPMC capsule film during long-term storage was a possible cause,
`
`because the evaporation left behind the gelling aid that was once dissolved in the
`
`water. (’180 pat. at col. 2, ll. 33–49 (Ex. 1001).) Prior to their discovery, water
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`evaporation in HPMC capsules had not been recognized in the art; the literature
`
`stated without qualification that HPMC capsules were preferable to gelatin because,
`
`in contrast to gelatin capsules, they retain water. (See Ogura at 32, 34 (Ex. 2002).)
`
`
`
`The inventors also discovered that HPMC having a critical range of HPO
`
`and MO—a range not previously synthesized—unexpectedly eliminated the
`
`gelling aid precipitation problem. (’180 pat. at col. 2, ll. 9–32; col. 6, ll. 1–28 (Ex.
`
`1001).) At the time of the invention, HPMC raw material was sold in at least four
`
`different grades, each grade having a different amount of hydroxypropyl or methyl
`
`substitution (the “degree of substitution” or “degree of HPO/MO substitution”).
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`–7–
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`IPR2017-00203
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`(See The United States Pharmacopoeia at 775 (col. 1, table) (Ex. 2015); The
`
`Japanese Pharmacopoeia 800–04 (Ex. 2016); HPE at 229 (Ex. 2003))
`
`
`
`The inventors discovered—and documented in the ’180 patent—that it was
`
`possible to control gelling aid precipitation by synthesizing capsules with HPMC
`
`having less than 37.6% HPO/MO substitution. (’180 pat. at col. 3., ll. 8–19 (Ex.
`
`1001).) Specifically, they discovered that, the lower the degree of HPO/MO
`
`substitution, “the better becomes the effect of preventing precipitation of the
`
`gelling aid.” (Id. at col. 3., ll. 20–32; col. 6, ll. 1–20; see also File History at 105–
`
`08 (Ex. 1010) (inventor declaration).) The ’180 patent documents this critical
`
`threshold in the experimental results in Table 1. (’180 pat. at col. 6, ll. 1–14 (Ex.
`
`1001); see also infra Section III.A.) Table 1 shows that HPMC capsules with
`
`HPO/MO content just over 37.6%—at 38.1%—did not work. (’180 pat. at col. 6, ll.
`
`1–14 (Ex. 1001).) Only capsules at 37.6% or below worked to prevent the gelling
`
`aid precipitation that causes an unsuitable capsule appearance. (Id.)
`
`
`
`Further confirming the unexpected results of this claimed critical HPO/MO
`
`threshold, Patent Owner submitted a declaration by inventor Masaru Tanjoh
`
`documenting experiments that demonstrate how the degree of HPO/MO
`
`substitution in HPMC affects gelling aid precipitation in HPMC capsules. (File
`
`History at 105–08 (Ex. 1010).) The declaration verified that, when the degree of
`
`HPO/MO substitution of the HPMC used to form a capsule was controlled at
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`–8–
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`IPR2017-00203
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`37.6% by weight, the capsule did not suffer from gelling aid precipitation. (Id.; see
`
`also supra instant Section II.B.) Based on the unexpected results of record, the
`
`Office determined the claims were patentable. (File History at 116 (Ex. 1010); see
`
`infra Section IV.A.)
`
`III. THE BOARD SHOULD DENY INSTITUTION OF BOTH GROUNDS
`UNDER 35 U.S.C. § 325(d) BECAUSE THE PETITION FAILS TO
`ADDRESS PATENT OWNER’S UNEXPECTED RESULTS
`EVIDENCE.
`This Board may properly exercise its discretion to deny inter partes review
`
`
`
`when, as here, a petition fails to address unexpected results cited by the patent
`
`Examiner as the basis for patentability. See Lower Drug Prices for Consumers,
`
`LLC v. Forest Labs. Holdings Ltd., IPR2016-00379, Paper 14 at 3–4 (July 1,
`
`2016); r’hng denied at Lower Drug Prices for Consumers, LLC v. Forest Labs.
`
`Holdings Ltd., IPR2016-00379, Paper 16 (October 19, 2016); see also Coalition
`
`for Affordable Drugs V LLC v. Hoffman-LaRoche, Inc., IPR2015-01792, Paper 14
`
`at 17 (March 11, 2016) (denying the Petition in part because it “[did] not address
`
`adequately the objective indicia of non-obviousness presented to the Office during
`
`the prosecution[.]”).
`
`
`
`Petitioner has not addressed the unexpected results found by the Office to
`
`warrant patentability. Instead, Petitioner devotes the majority of its 55-page
`
`Petition to attempting to demonstrate that the asserted art contains HPO and MO
`
`ranges exceeding Patent Owner’s unexpected threshold. (Pet. at 22–50.) The Office
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`–9–
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`IPR2017-00203
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`has already considered ranges in the art that exceed this unexpected threshold. (See
`
`infra Section IV.A.) But even if Petitioner’s asserted art does establish a rationale
`
`to use the art’s ranges of HPO/MO content, this showing would not justify
`
`institution of inter partes review in this case. Because the Examiner here has
`
`already found that the subject matter of the challenged claims possesses
`
`unexpected results sufficient to overcome an alleged prima facie case of
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`obviousness, the Petition fails to “demonstrate that there is a reasonable likelihood
`
`that at least one of the claims challenged in the petition is unpatentable.” 37 C.F.R
`
`§ 42.108(c). To institute inter partes review when the Petition does not
`
`substantively address an Examiner’s finding of unexpected results would be
`
`improper because it would be “unfair to impose upon [the patent holder] in the first
`
`instance the burden of establishing unexpected results at trial.” Merial Ltd. v.
`
`Virbac, IPR2014-01279, Paper 13 at 26–27 (January 22, 2015) (denying
`
`institution when petitioner “was aware of the unexpected results showing which
`
`the Examiner found persuasive . . . in view of substantially the same prior art
`
`combination”).
`
`
`
`Imposing a trial on Patent Owner would be particularly unfair when the
`
`single expert declaration accompanying the Petition is virtually identical to the
`
`Petition. (See Ex. 2021 (software comparison of the Petition and Declaration of
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`Arthur H. Kibbe (Ex. 1011)).) Because it adds nothing to what is already in the
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`–10–
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`IPR2017-00203
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`Petition, the declaration by Petitioner’s expert Dr. Kibbe is nothing more than an
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`expertized version of the Petition. (See id.) The assertions in the declaration are
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`therefore entitled to no weight under 37 C.F.R. § 42.65(a).
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`
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`For the reasons explained below, the Board should exercise its discretion to
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`deny the petition under 35 U.S.C. § 325(d).
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`A.
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`Petitioner’s asserted art does not “inherently” disclose the
`claimed HPMC capsules.
`
`
`
`Rather than addressing Patent Owner’s unexpected results evidence,
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`Petitioner asserts that the properties of the claimed capsule shell “are inherent and
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`foreseeable,” relying on Dr. Kibbe’s declaration. (Pet at 52 (citing Ex. 1011 at
`
`¶ 148); see also id. at 52–55 (citing Ex. 1011 at ¶¶ 149–160).) As demonstrated
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`below, the ability to avoid gelling aid precipitation is not an “inherent” property of
`
`the prior art that can support an obviousness determination.
`
`
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`A feature “inherently” disclosed in the prior art is relevant to the
`
`obviousness analysis only if the feature is present in every embodiment of the prior
`
`art. PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014)
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`(property inherent in the prior art only supports an obviousness determination if
`
`that property “is the ‘natural result’ of the combination of prior art elements.”); see
`
`also In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993). Here, Petitioner never
`
`argues that avoidance of gelling aid precipitation is the “natural result” of the
`
`combinations of prior art relied on as part of either Ground. And Petitioner cannot
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`–11–
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`IPR2017-00203
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`do so. As Table 1 of the ’180 patent illustrates, and as the patentee demonstrated
`
`during prosecution, gelling aid precipitation is avoided by controlling HPMC
`
`capsule base HPO/MO content at 37.6% or less:
`
`
`
`(’180 pat. at col. 6, ll. 1–14 (Ex. 1001).) Petitioner and Petitioner’s expert
`
`themselves argue that the asserted references disclose capsules made from HPMC
`
`having more than 37.6% HPO/MO content. (See Pet. at 26, 35, 46, 49 (arguing that
`
`the asserted references disclose capsules made from HPMC having up to 42%
`
`HPO/MO content); see also Ex. 1011 at ¶¶ 64–65; 90–91; 124–125 (same).) Thus,
`
`by their own admission, avoidance of gelling aid precipitation is not a feature of
`
`every embodiment of Petitioner’s prior art references.
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`–12–
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`IPR2017-00203
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`
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`As noted above, Petitioner does not address the unexpected results, much
`
`less allege that avoidance of gelling aid precipitation was inherent and foreseeable.
`
`Instead, Petitioner claims, without explanation, that the “properties of the capsule
`
`shell that prevent precipitation” would have been inherent and foreseeable. (Pet at
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`52.) Because Petitioner does not explain what these properties are, and why they
`
`are expected, Petitioner’s arguments based on inherency are entitled to no weight.
`
`See 37 C.F.R. § 42.104(b)(4–5).
`
`B.
`
`Petitioner’s asserted art does not discuss the problem of gelling
`aid precipitation, or its relationship to HPO/MO content.
`
`
`
`When a patentee demonstrates that a claimed range “achieves unexpected
`
`results relative to the prior art,” the claimed range is patentable even if a broader
`
`range is established in the asserted art. In re Peterson, 315 F.3d 1325, 1330 (Fed.
`
`Cir. 2003). Unexpected results support a finding of non-obviousness when they are
`
`different in kind from what one would expect based on the disclosures of the prior
`
`art. Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1307 (Fed. Cir. 2015); see also
`
`Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc., 655 F.3d 1291,
`
`1306 (Fed. Cir. 2011).
`
`
`
`Here, Petitioner asserts that “the properties of the capsule shell that prevent
`
`precipitation are not an ‘unexpected benefit.’” (Pet. at 52; see also id. at 51–55.)
`
`But Petitioner improperly bases this argument on citations to the invention itself.
`
`(Pet. at 51–52 (quoting Ex. 1001).); see also In re McLaughlin, 443 F.2d 1392,
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`–13–
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`
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`IPR2017-00203
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`1395 (C.C.P.A. 1971) (explaining that obviousness determination may not be
`
`based on information “gleaned only from applicant's disclosure”). Petitioner also
`
`misses the mark because of its focus on capsule “properties” rather than the actual
`
`problem discovered and solved by the inventors—gelling aid precipitation. In fact,
`
`Petitioner does not even allege that the problem of gelling aid precipitation was
`
`known in the art. Instead, Petitioner and its expert Dr. Kibbe claim that the asserted
`
`art addresses capsule “performance and stability” or “clarity and stability,” and that
`
`these properties somehow relate to the discussions in the ’180 patent and
`
`prosecution history reply paper about avoiding gelling aid precipitation. (Pet. at
`
`51–53, 55; Ex. 1011 at ¶¶ 145–48, 151–52, 60.) Dr. Kibbe’s arguments are entitled
`
`to no weight, because he cites no evidence to support these claims. See 37 C.F.R.
`
`§ 42.104(b)(4–5); see also In re Nuvasive, Inc., 842 F.3d 1376, 1382–83 (Fed. Cir.
`
`2016).
`
`
`
`In any event, the art recognized that performance, stability, and clarity were
`
`distinct attributes of capsules—not synonyms for gelling aid precipitation. (See,
`
`e.g., Fed. Std. 285A at 8–12 (Ex. 2005) (standardizing the following separate
`
`“Characteristics of Capsules”: “Appearance [includes] transparency;” “Stability;”
`
`and performance attributes such as “Disintegration and solubility”); Ridgway at
`
`65–66 (Ex. 2001) (explaining that standards for hard capsules include appearance;
`
`stability and strength; and performance attributes including the timing and extent
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`–14–
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`IPR2017-00203
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`of dissolution).) Moreover, Petitioner and Dr. Kibbe cite no art teaching that any
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`one of “performance,” “stability,” or “clarity” refers to the presence or absence of
`
`gelling aid precipitation. (See Pet. at 51–55; Ex. 1011 at ¶¶ 145–160.) Simply put,
`
`Petitioner nowhere alleges that gelling aid precipitation, much less any relationship
`
`to HPO/MO substitution, was known in the art. (See Pet. at 51–55.)
`
`
`
`A review of Petitioner’s asserted references confirms that they do not teach
`
`or suggest the relationship between gelling aid precipitation and the narrow range
`
`of HPO/MO substitution claimed by the ’180 patent.
`
`
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`Yamamoto (Ex. 1004): The purported “performance and stability discussed
`
`in Yamamoto” relates to capsules’ more rapid disintegration, not to gelling aid
`
`precipitation. (Pet. at 52.) Neither Petitioner nor Dr. Kibbe states that these
`
`properties are associated with a lack of gelling aid precipitation. (Pet. at 52–53.)
`
`Instead, Dr. Kibbe claims that “one of ordinary skill in the art would understand
`
`that a desirable capsule shell would necessarily include the properties of clarity and
`
`stability that are the purported objects of the invention of the ’180 patent.” (Ex.
`
`1011 at ¶ 152.) He does not, however, explain how a POSA would have known
`
`that the capsules claimed in Yamamoto achieve even these properties.
`
`
`
`Greminger (Ex. 1006): Likewise, although Greminger discusses several
`
`properties of capsule appearance, it does not address the problem of gelling aid
`
`precipitation. Greminger discloses HPMC capsules having “enhanced clarity”
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`–15–
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`IPR2017-00203
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`compared to the prior art. (Ex. 1006 at col. 1, ll. 67–col. 2, ll. 1.) To demonstrate
`
`this aspect of the disclosed capsules, Greminger rates various embodiments of the
`
`disclosure based on their appearance, considering whether the capsules display
`
`“haze,” noticeable “gels of fibers,” or “orange peel effect.” (Ex. 1006 at col. 4, ll.
`
`70–col. 5, ll. 66.) Although these attributes describe the appearance of HPMC
`
`capsules, Greminger itself makes clear that none of these attributes describes
`
`gelling aid precipitation: it specifies that any flaws observed in capsule appearance
`
`appeared rapidly after an HPMC film was prepared. (Id. at col. 5, ll. 34–36.)
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`Gelling aid precipitation, however, is evident only after long-term storage.
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`(Compare Ex. 1006 at col. 5, ll. 34–52 (stating that flaws were observed
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`“rapid[ly]” after preparing HPMC films); with ’180 pat. at col. 1, ll. 53–56
`
`(explaining that gelling aid precipitation occurs later, during “long term storage”)
`
`(Ex. 1001).) Moreover, the art in 1999 indicated that each of these flaws refers to a
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`problem other than gelling aid precipitation. (See Curtis-Fisk at 1170–71
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`(describing “haze” as a “lack of clarity” of HPMC film resul
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