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`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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`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
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`v.
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`QUALICAPS CO., LTD,
`Patent Owner
`
`____________
`
`IPR2017-00203
`Patent 6,649,180 B1
`____________
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`PATENT OWNER RESPONSE
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` DC: 6475280-2
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`
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`IPR2017-00203
`Patent 6,649,180 B1
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`Patent Owner Response
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`I.
`II.
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`III.
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`TABLE OF CONTENTS
`INTRODUCTION ................................................................................ 1
`LEVEL OF SKILL AND CLAIM CONSTRUCTION ....................... 1
`A.
`Claim Construction..................................................................... 1
`B.
`Person of Ordinary Skill in the Art ............................................ 1
`1.
`Petitioner’s definition of the level of skill ....................... 1
`2.
`The person of ordinary skill, by the Petitioner’s
`definition, would have lacked the skill to make the
`claimed invention ............................................................. 2
`PETITIONER HAS NOT PROVED THAT CLAIMS 1
`AND 4 ARE OBVIOUS OVER THE COMBINATION OF
`YAMAMOTO AND JP ........................................................................ 7
`A.
`Petitioner failed to show that one of ordinary skill would
`have had reason to modify the prior art and thereby reach the
`claimed invention ....................................................................... 7
`1.
`Petitioner infected its argument with hindsight by
`using outdated and incomplete prior art .......................... 8
`One of ordinary skill would have understood
`Yamamoto as disclosing only one HPMC type ............. 12
`One of ordinary skill in the art would have regarded
`HPMC types 2208 and 2906 as unsuitable for making
`capsules .......................................................................... 17
`Petitioner failed to show that one of ordinary skill would
`have had a reasonable expectation of success .......................... 24
`1.
`HPMC 2910 was assigned that number to indicate
`about 29% MO and about 10% HPO, leading one of
`ordinary skill to expect about 39% ................................ 25
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`2.
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`3.
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`B.
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`2.
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`Patent Owner Response
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`Petitioner cites no evidence that HPMC 2910 within
`the claimed range ever existed ....................................... 26
`Petitioner cites no evidence that the invention resulted
`from routine testing ........................................................ 27
`Petitioner failed to rebut Patent Owner’s evidence of
`unexpected results .................................................................... 28
`1.
`The person of ordinary skill would have expected
`HPMC capsules to have similar properties throughout
`the pharmacopeia substitution percentage range ........... 29
`The inventors discovered a surprising problem and
`invented an unexpected solution .................................... 31
`The evidence has nexus with the claims ........................ 37
`Petitioner failed to address this evidence in its case-in-
`chief and may not do so in its Reply .............................. 37
`D. Dr. Kibbe’s testimony has been repeatedly discredited in
`multiple IPR proceedings ......................................................... 40
`IV. THE CONSTITUTIONALITY OF THE IPR PROCESS
`HAS BEEN CHALLENGED ............................................................. 43
`CONCLUSION ................................................................................... 44
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`C.
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`3.
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`2.
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`3.
`4.
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`V.
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
`Allergan, Inc. v. Sandoz, Inc.,
`796 F.3d 1293 (Fed. Cir. 2015) ............................................................... 37
`Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc.,
`807 F.2d 955 (Fed. Cir. 1986) ................................................................. 10
`Dastar Corp. v. Twentieth Century Fox Film Corp.,
`539 U.S. 23 (2003)................................................................................... 41
`Dr. Reddy’s Labs., Inc. v. Pozen, Inc.,
`IPR2015-00802 ........................................................................................ 42
`Genzyme Therapeutic Prods. L.P. v. Biomarin Pharm. Inc.,
`825 F.3d 1360 (Fed. Cir. 2016) ............................................................... 40
`Gray Square Pharm., LLC v. Pozen, Inc.,
`IPR2016-00191 ........................................................................................ 42
`IBS, Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ............................................................... 38
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) ......................................................... 29, 36
`Leo Pharm. Prods, Ltd. v. Rea,
`726 F.3d 1346 .......................................................................................... 33
`In re NuVasive, Inc.,
`841 F.3d 966 (Fed. Cir. 2016) ................................................................. 40
`Oil States Energy Services, LLC v. Greene’s Energy Group,
`LLC,
`No. 16-712 (U.S. cert. granted June 12, 2017) ........................................ 43
`Otsuka Pharm. Co., Ltd. v. Sandoz, Inc.,
`678 F.3d 1280 (Fed. Cir. 2012) ............................................................... 11
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`Parker v. Frilette,
`462 F.2d 544 (C.C.P.A. 1972) ................................................................. 28
`Rowe v. Dror,
`112 F.3d 473 (Fed. Cir. 1997) ................................................................. 15
`Teva Pharm. Indus. Ltd. v. AstraZeneca Pharm. LP,
`661 F.3d 1378 (Fed. Cir. 2011) ............................................................... 28
`Torrent Pharm. Ltd. v. Novartis AG,
`IPR2014-00784 ........................................................................................ 41
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ................................................... 29, 37, 39
`Other Authorities
`37 C.F.R. § 42.23(b) ..................................................................................... 37
`37 C.F.R. § 42.65(a) ..................................................................................... 10
`77 Fed. Reg. 48,756 (Aug. 14, 2012) ........................................................... 37
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`I.
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`INTRODUCTION
`The patentability of claims 1 and 4 should be confirmed because (a)
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`Patent Owner Response
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`Petitioner failed to prove that one of ordinary skill would have had reason to
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`modify the prior art to reach the claimed invention; (b) Petitioner failed to
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`show that one of ordinary skill would have had a reasonable expectation of
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`success; and (c) Petitioner failed to rebut Patent Owner’s evidence of
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`unexpected results.
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`II. LEVEL OF SKILL AND CLAIM CONSTRUCTION
`A. Claim Construction
`Patent Owner does not acquiesce in Petitioner’s proposed constructions
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`(Pet. 17–18) and agrees with the Board, for purposes of this proceeding, that
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`no claim terms require express construction. Paper 10, 7.
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`B.
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`Person of Ordinary Skill in the Art
`1. Petitioner’s definition of the level of skill
`Petitioner asserts that “[o]ne of ordinary skill in the art at time of the
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`earliest effective filing date of the ’180 Patent would have been someone with
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`at least a bachelor’s degree in chemistry, chemical engineering, material
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`engineering, pharmacy, or the equivalent technical degree, and at least two
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`years of industry experience in pharmaceutical formulation.” Pet. 15 (citing
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`Ex. 1011 ¶ 41). For purposes of this proceeding, Patent Owner’s expert
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`1
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`Dr. McConville (background and qualifications, Ex. 2028 ¶¶ 1–16), adopts
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`Dr. Kibbe’s definition. Id. ¶¶ 17–19.
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`2. The person of ordinary skill, by the Petitioner’s
`definition, would have lacked the skill to make the
`claimed invention
`A person having a bachelor’s degree and two years’ industry experience
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`is a technician, not an investigator. Ex. 2028 ¶ 20. This level of training
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`familiarizes one with the existing body of knowledge and the ability to
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`perform work following instructions of others. Id. ¶¶ 20–21. It does not
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`qualify one to undertake independent research or design programs in
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`pharmaceutics, and activity that typically is reserved for those with doctoral-
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`level training. Id. ¶ 21.
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`Petitioner’s person of ordinary skill would go “by the book,” i.e., would
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`have used conventional materials for known purposes. Id. Dr. McConville,
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`who by 1999 had a bachelor’s degree in chemistry and had been working for
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`a few years as a research technician in pharmaceutics, explains that he carried
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`out experiments at that time under the direction of a principal investigator,
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`using materials he was told to use, to prepare and test various formulations.
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`Id. ¶ 5. He used pharmaceutical-grade excipients in his work, relying on con-
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`tainer labels to ensure he had the correct materials. Id. He did not make new
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`combinations of materials or propose the use of existing materials for pur-
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`poses previously not described for them. Id. In Dr. McConville’s opinion,
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`others having his level of skill at the time similarly would have worked under
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`supervision, carrying out assigned tasks using conventional materials.
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`Id. ¶ 21.
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`Dr. McConville explains that the person of ordinary skill, having a
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`bachelor’s degree and two years’ industry experience, would have been
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`unlikely to have any familiarity with, or understanding of, the effect of
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`changing hydroxypropoxyl (“HPO”) and methoxyl (“MO”) percentage on the
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`properties of HPMC, because in 1999 this was an area of doctoral-level peer-
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`reviewed research. Id. ¶ 44; see also ¶¶ 27–28. According to Dr. McConville,
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`the person of ordinary skill, at most, would have been familiar with the types
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`of HPMC available (1828, 2208, 2906, and 2910) and the various viscosity
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`grades for each. Id. ¶ 46.
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`In Dr. McConville’s opinion, a person working as a research technician
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`in 1999 and using HPMC to make capsules would not have questioned the
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`degree of HPO+MO substitution, because nothing in Yamamoto, or in Japa-
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`nese Pharmacopoeia (“JP”), or in any other evidence Petitioner cites, indicates
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`that anyone appreciated in 1999 that the substitution percentage would affect
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`the suitability of HPMC 2910 for making capsules, or even films. Id. ¶ 45.
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`Indeed, the very fact that JP (as well as U.S. Pharmacopeia and the
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`Handbook of Pharmaceutical Excipients)
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`lists ranges of HPO+MO
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`substitution percentages for materials that qualify as pharmaceutical grade
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`would have indicated to the technician that the degree of HPO+MO
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`substitution was irrelevant to the suitability of the material. Id. ¶ 46. That is
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`to say, the technician would have understood the substitution ranges listed in
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`any of the pharmacopeiae of record to be tolerances—ranges of acceptable
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`values— for what materials would qualify as a particular type of HPMC.
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`Id. ¶ 89. HPMC of a given substitution type could not be made with a precise
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`substitution percentage because the chemical reactions carried out to make the
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`substitutions occur randomly; i.e., the HPO and MO substitutions are made
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`by two chemical reactions carried out simultaneously, and these reactions
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`compete with one another for modification sites. Therefore, the degree of
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`substitution can be controlled only to a certain extent. Id. ¶¶ 37–39.
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`Consequently, pharmaceutical-grade HPMC of a given type (say, 2910) was
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`marketed by pharmacopeial percentage range. Id. ¶ 40. One of ordinary skill
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`in the art would have consulted the label to determine the HPMC substitution
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`type but otherwise would not have cared what the substitution percentage of
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`a given batch was, because the pharmacopeiae gave no reason to care about
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`it. Id. ¶ 43.
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`The point here is that the details of the substitution percentage would
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`simply have gone over the technician’s head. Id. ¶¶ 44–45, 89–93. As long
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`as the material was identified as being pharmaceutical grade, the technician
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`would have had no further concern about the particular substitution
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`percentage, because nothing in Yamamoto or JP (or the other pharmacopeiae)
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`indicated that the particular substitution percentage mattered for anything.
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`Id. ¶¶ 87–90. Even to the extent the person of ordinary skill might have been
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`aware of properties specific to a particular substitution type, it would have
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`been clear that the relationship between substitution type and at least some
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`properties was unpredictable. Ex. 2028 ¶ 44, 74–76; Ex. 2043, 8-11
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`(reporting that the least elastic substitution type inexplicably had the fastest
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`matrix erosion and drug release rates).
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`Thus, to a person of ordinary skill in the art (remember: the bachelor’s
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`graduate with 2 years’ experience, according to Petitioner), 2910 is 2910 is
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`2910, whatever its substitution percentage within the pharmacopeial range.
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`The person of ordinary skill would rely on the label to know that it was the
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`correct material. Once secure in the knowledge that the material was of the
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`correct type, the person of ordinary skill would then have used it for its
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`intended purpose without further consideration of the substitution percentage.
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`Id. ¶¶ 44–45, 89–93.
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`The challenged claims require, however, specific limitations on
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`substitution percentage of the HPMC used to make the hard capsules. The
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`inventors observed cloud spots develop in capsules stored for long periods.
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`Ex. 1001, 1:62–2:6. The inventors surmised that the cloud spots resulted from
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`salt precipitation. Id. The inventive insight came from their recognition that
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`the HPMC substitution percentage could be manipulated to alleviate the
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`problem. Id. at 2:16–25. The solution the inventors found was to impose a
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`particular limit on substitution percentage, a limit distinct from the ranges
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`listed in the pharmacopeiae. Id.
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`This solution was out of reach of the person of ordinary skill in the art,
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`because an understanding of the relevance of substitution percentage was not
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`in this person’s fund of knowledge. Ex. 2028 ¶¶ 44–46. To the extent the
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`person of ordinary skill even was aware of substitution percentage, it was only
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`as a numerical parameter to be found in the pharmacopeial definition of the
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`various HPMC grades. Id. ¶¶ 45–46. Its significance, such as its influence on
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`HPMC properties, was described nowhere in the literature Petitioner has cited.
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`For these reasons, the person of ordinary skill in the art, as defined by
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`Petitioner and adopted by the Board, would have lacked the skill necessary to
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`make the prior-art modifications necessary to reach the claimed invention.
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`III. PETITIONER HAS NOT PROVED THAT CLAIMS 1 AND 4
`ARE OBVIOUS OVER THE COMBINATION OF
`YAMAMOTO AND JP
`Petitioner failed to show that one of ordinary skill would
`A.
`have had reason to modify the prior art and thereby reach
`the claimed invention
`Petitioner argues that Yamamoto discloses the use of HPMC to make
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`capsules and that one of ordinary skill would have known from JP that the
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`types of HPMC listed there have HPO+MO substitution percentages within
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`or overlapping the claimed range and, taken together, fully cover and only
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`slightly exceed the claimed range, so that confining the HPO+MO percentage
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`to the claimed range would have been an obvious modification. Pet. 25–32.
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`Petitioner’s rationale for making the modification suffers from three
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`flaws: (1) Petitioner mischaracterizes the state of the art by using obsolete
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`prior art references; (2) Petitioner offers no evidence that one of ordinary skill
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`in the art would have understood Yamamoto as teaching anything other than
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`what it discloses, namely, a single HPMC type, not all types; and (3) the
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`evidence of the state of the art, both Petitioner’s and Patent Owner’s, shows
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`that one of ordinary skill in the art would not have regarded HPMC types 2906
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`and 2208 as suitable for making films, let alone capsules. Ex. 2028 ¶ 110.
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`Patent Owner Response
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`1. Petitioner infected its argument with hindsight by
`using outdated and incomplete prior art
`Petitioner does not contest that the ’180 patent is entitled to a priority
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`date of April 14, 1999. Pet. 13–14; Ex. 1011 ¶ 37; Ex. 2029, 31:6–12; accord
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`Ex. 2028 ¶ 31. But Petitioner’s challenge relies on hindsight bias because it
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`inaccurately portrays the state of the art as of that date. Petitioner argues that
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`one of ordinary skill would have been motivated to rely on the 1996 Japanese
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`Pharmacopeia (“JP,” Ex. 1005) to create an HPMC base with an HPO+MO
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`substitution of between 23 and 42% by weight. Pet. 28. Petitioner reaches
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`the percentage range by combining the substitution ranges disclosed in JP for
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`the three listed HPMC types: 2208, 2906, and 2910. See Pet. 25 (summarizing
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`percentage ranges from JP). Petitioner also states that the U.S. Pharmacopeia
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`(“USP”) similarly lists these three types of HPMC, and cites the 1986
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`Handbook of Pharmaceutical Excipients (“HPE”) as evidence of this. Pet. 25.
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`n.4 (citing Ex. 1009, 139).1 Thus Petitioner’s case amounts to an argument
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` Petitioner mistakenly cites to Ex. 1010, but it is clear from the context of the
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`citation that Ex. 1009 was intended.
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`that one of ordinary skill would have landed within or overlapping the claimed
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`Patent Owner Response
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`subject matter regardless of which pharmacopeia-listed HPMC was chosen.
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`Id. at 27.
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`But Petitioner’s argument is flawed because it relies on obsolete prior
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`art. The 1986 HPE was outdated in 1999 because it had been replaced in 1994
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`by a Second Edition (a fact Petitioner’s expert Dr. Kibbe knew or should have
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`known given that he was a contributing author and later editor of the
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`Handbook, Ex. 2029, 98:17–22). Ex. 2003, 1; Ex. 2028 ¶ 46. The HPE
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`Second Edition (“HPE2”) listed four types of HPMC, including the three from
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`JP plus HPMC 1828, which has an HPO+MO fraction of 39.5 to 52.0%,
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`entirely outside the ranges recited in the challenged claims. Ex. 2003, 3;
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`Ex. 2028 ¶ 41. The 1995 U.S. Pharmacopeia, which was still current in April
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`1999 (and which Petitioner’s expert Dr. Kibbe acknowledges is the “go to”
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`reference for U.S. artisans, Ex. 2029, 70:24–25; 122:13–14) also listed those
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`same four HPMC types and percentage ranges. Ex. 2015, 4; Ex. 2028 ¶ 40.
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`The Dow Methocel Technical Handbooks also list the four HPMC types by
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`Dow’s trade names: 2910 is Methocel E, 2906 is Methocel F, 2208 is
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`Methocel K, and 1828 is Methocel J. Ex. 2028 ¶ 47 (citing Exs. 2017, 2035).
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`Needless to say, one of ordinary skill in 1999 would have consulted the
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`most current versions of the prior art, because the most current versions are
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`the most pertinent ones. Ex. 2028 ¶ 46; see, e.g., Custom Accessories, Inc. v.
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`Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (“The person of
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`ordinary skill is a hypothetical person who is presumed to be aware of all the
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`pertinent prior art”). Thus, Petitioner’s sole reliance on JP, which lists only
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`three types of HPMC, is misplaced and presents an incomplete view of the
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`pertinent prior art in 1999. Ex. 2028 ¶¶ 58, 68.
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`Because HPMC 1828 has a substitution range entirely outside the
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`recited limit, one of ordinary skill would not have just blindly stumbled into
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`the claimed subject matter regardless of which HPMC was selected; rather, a
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`person of ordinary skill would have to make a conscious choice about which
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`type of HPMC to select. Ex. 2028 ¶ 68. Petitioner has identified nothing in
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`the prior art, however, that would have informed that choice. Instead,
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`Petitioner presents attorney argument, unsupported by anything other than
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`verbatim statements by its expert, Dr. Kibbe, to justify its case for
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`obviousness. Dr. Kibbe’s testimony, being simply an exact replica of the
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`petition (Ex. 2021, text comparison), is entitled to little or no weight because
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`it does not disclose the underlying facts on which Dr. Kibbe’s opinions are
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`based. See 37 C.F.R. § 42.65(a).
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`Despite Dr. Kibbe’s awareness of (Ex. 2029, 98:6–20) and access to
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`(id. at 13:9–13) HPE2, Petitioner chose to rely on obsolete versions of the
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`prior art. The effect of this choice is clear: Petitioner has painted an
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`incomplete picture of the state of the art. See Ex. 2028 ¶¶ 58, 68.
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`Petitioner’s argument that one of skill in the art could choose
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`indiscriminately among any pharmacopeia-listed HPMC types and still be
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`within or overlapping the claim scope rests on a deceptive mischaracterization
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`of the state of the art. When taking HPMC 1828 into account by consulting
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`evidence that more fully describes the state of the prior art than does
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`Petitioner’s, one of ordinary skill had to have had some reason to select 2208,
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`2906, or 2910 in preference to 1828. But Petitioner offers no rationale for
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`why one of ordinary skill in 1999 would have selected any particular HPMC
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`over any other.
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`Rather, Petitioner impermissibly cites to the rationale in the ’180 patent
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`itself, which identifies a specific benefit achieved by employing HPMC with
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`a substitution percentage in the claimed range. The Federal Circuit has
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`described such reliance on the inventors’ own work a “poster child for
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`impermissible hindsight.” Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d
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`1280, 1296 (Fed. Cir. 2012). Without the benefit of the ’180 patent’s
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`disclosure—to which the Petition cites no less than ten times with respect to
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`this limitation of claim 1 (Pet. 24-29)—the choice of HPMC substitution
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`percentage would have been arbitrary. Petitioner has not explained why one
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`of ordinary skill in the art would have chosen any particular HPMC over any
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`other. Thus Petitioner’s challenge is based on hindsight and should not
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`prevail.
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`2. One of ordinary skill would have understood
`Yamamoto as disclosing only one HPMC type
`Yamamoto confines its entire disclosure to only one type of HPMC:
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`TC-5, available from Shin-Etsu in several viscosity grades identified by
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`various letter suffixes. Ex. 1004, 3:63–65, 7:19–25; Ex. 2028 ¶ 50.
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`Yamamoto describes this HPMC type in some detail, Ex. 1004, 3:46–4:6, and
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`describes numerous examples of capsules made using various blends of the
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`TC-5 viscosity grades. Id. 7:1–9:46; Ex. 2028 ¶¶ 52–57.
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`Petitioner has cited no prior-art evidence demonstrating to which
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`numerical HPMC type TC-5 corresponds. The only evidence of record is
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`Ex. 1012, but that evidence is faulty for a number of reasons. First, it is
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`unauthenticated. There is no evidence that the web pages Ex. 1012 purports
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`to reproduce existed prior to September 27, 2016, which is the apparent date
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`Petitioner’s counsel printed them from a web browser. Second, the earliest
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`date anywhere in the document is in the copyright notice (“Copyright (c)
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`2001-2013 Shin-Etsu Chemical Co., Ltd.”), but there is no indication of which
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`parts of the page existed at which times. In any event, even 2001 is years after
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`the ’180 patent’s uncontested priority date. So even if this document were
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`cured of all its admissibility problems, on its own terms it is not prior art.2
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`Thus Petitioners have failed to prove with any documentary evidence
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`that the “TC-5” HPMC disclosed by Yamamoto in any way corresponds to
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`the types of HPMC disclosed in JP. This is a technical failure of proof by
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`Petitioner, which Patent Owner raised in the Preliminary Response (Paper 9,
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`22 n.3), and which is sufficient basis to defeat Petitioner’s entire case.
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`Without admitting the truth of same or waiving its objection to Exhibit
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`1012, Patent Owner assumes for the sake of the present argument that TC-5
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`was known in 1999 to be HPMC type 2910.
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`Yamamoto discloses the use of low viscosity HPMC as an alternative
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`to gelatin and cellulose ether for making capsules. Ex. 1004, 1:44–53, 2:3–8;
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` 2
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` Patent Owner objected to this exhibit. Paper 17, 5–6. Petitioner did not
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`submit any supplemental evidence in response to the objection and hence has
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`waived its right to do so.
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`2:37-42; Ex. 2028 ¶¶ 48, 51–57, 70. Cellulose ethers had emerged as
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`alternatives to gelatin, Ex. 2028 ¶¶ 32–33, but HPMC had eluded adoption.
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`Id. ¶¶ 33–35. Yamamoto explains that HPMC offers several advantages over
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`gelatin but has its own problems, such as impaired disintegration with certain
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`foods. Ex. 1004, 2:18–34; Ex. 2028 ¶ 48. Yamamoto solved this problem by
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`optimizing the viscosity of the HPMC to be within the range of 2.4 to 5.2
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`centistokes,3 which helped ensure that HPMC capsules retained both their
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`desirable properties as well as a good disintegration profile. Ex. 1004, Abstr.;
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`Ex. 2028 ¶¶ 49, 69.
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`Yamamoto identifies, describes, and uses a family of HPMC products
`
`termed “TC-5.” Ex. 1004, 3:63–65, 7:19–25; Ex. 2028 ¶ 50. Each member
`
`of the family has a letter suffix that corresponds to a particular viscosity grade.
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`Ex. 1004, 3:63–65, 7:19–25; Ex. 2028 ¶ 50. For example, TC-5E has a
`
`viscosity of 3.0 centistokes, TC-5M 4.5 centistokes, and TC-5R 6.0
`
`centistokes. Ex. 1004, 3:63–66, 7:21. Yamamoto discloses using TC-5E and
`
`M alone or in a blend to achieve the preferred viscosity. Id. at 3:67–4:2. As
`
`
`
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` 3
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` Viscosities are expressed for a standard 2% solution at 20°C throughout the
`
`literature of record. E.g., Ex. 1004, 3:51–54.
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`an alternative, Yamamoto discloses blending “with another HPMC product
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`Patent Owner Response
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`having higher or lower viscosity (by itself outside the scope of the invention).”
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`Id. at 4:2–5; Ex. 2028 ¶ 71. Yamamoto does not give an example of “another
`
`HPMC” at this point in the Specification but does so later in the
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`exemplification, when TC-5R (viscosity 6.0, outside Yamamoto’s viscosity
`
`range) is used. Id. at 7:1–25.
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`Yamamoto nowhere discloses or suggests to the person of ordinary skill
`
`in the art (remember, the bachelor’s graduate with 2 years’ experience) that
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`any HPMC other than the ones it specifically identifies are suitable for use in
`
`making capsules. Ex. 2028 ¶¶ 59–60. Instead, Yamamoto confines its
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`disclosure to the various viscosity grades of that one HPMC type. Id. ¶ 62.
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`Although Yamamoto does not expressly exclude or criticize other HPMC
`
`types, such absence does not amount to a suggestion to use them. See Rowe
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`v. Dror, 112 F.3d 473, 480 (Fed. Cir. 1997) (a “negative pregnant” is not
`
`sufficient to disclose a limitation).
`
`Petitioner’s person of ordinary skill would have had no reason to
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`venture beyond Yamamoto’s disclosure of 2910, which describes numerous
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`examples of capsules made with a variety of blended and unblended 2910
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`viscosity grades and provides detailed guidance for these formulations.
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`Ex. 2028 ¶¶ 70–71. Yamamoto provides no guidance for other HPMC types,
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`Patent Owner Response
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`nor does it indicate whether suitable viscosity grades of the other HPMC types
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`exist. Id. Neither does JP. Id. ¶¶ 35, 73. In fact, Petitioner has cited no
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`evidence that HPMC types 2208 or 2906 (or 1828, for that matter) were
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`known at the suitable low viscosities taught by Yamamoto.4
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`The only blends Yamamoto discloses are between different viscosity
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`grades of type TC-5. This is consistent with other evidence that HPMC was
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`only blended between viscosity grades within a substitution type. E.g.,
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`Ex. 2035, 23 (“METHOCEL products of the same substitution type but
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`different viscosity grades can be blended to obtain an intermediate viscosity
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`grade.”). There is no disclosure in any evidence of record of blends of
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` 4
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` Petitioner elicited redirect testimony from Dr. Kibbe that Ex. 1012 discloses
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`HPMC type 2208 with a viscosity in Yamamoto’s “low range.” Ex. 2029,
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`124:3–17. This testimony is inadmissible as irrelevant, or should be given no
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`weight, because Ex. 1012 is not prior art, as discussed above. Whether
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`“SB-4” was known to be HPMC 2208 in 1999 has not been proved, and
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`whether low-viscosity SB-4 was available in 2001 or later is irrelevant to
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`whether it was available in 1999.
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`different substitution types. As Dr. McConville notes, whatever properties
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`Patent Owner Response
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`result from such blends would have been difficult to predict, even for a
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`doctoral-level scientist, given uncertainties about the molecular interaction
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`among polymer chains with different substitution percentages. Ex. 2028 ¶¶
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`27–28, 74–76.
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`Faced with Yamamoto’s detailed description of 2910 viscosity blends
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`suitable for making capsules, and confronted with essentially no information
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`about the availability, behavior, or suitability of the other HPMC types in
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`making capsules, the person of ordinary skill would have had no reason to
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`consider any type of HPMC other than 2910. Ex. 2028 ¶ 59.
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`3. One of ordinary skill in the art would have regarded
`HPMC types 2208 and 2906 as unsuitable for making
`capsules
`Not only does Petitioner’s evidence fail to show any indication that the
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`suitability of 2208 or 2906 for making capsules was appreciated in the prior
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`art, but additional evidence suggests that the person of ordinary skill would
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`have considered them to be unsuitable. In particular, the prior art (a)
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`discussed several HPMC types but called out only 2910 for its film-forming
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`properties, which is a prerequisite for capsule-making, and (b) showed that
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`2208 and 2906 had materials properties that rendered them unsuitable for
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`capsule-making.
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`Patent Owner Response
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`a. Prior-art documents discussing 2208, 2906, and
`2910 identify only 2910 as a film former
`The Ridgway treatise explains that one essential quality of a material
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`for making capsules is that “it must be a good film former.” Ex. 2001, 71 (page
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`56); Ex. 2028 ¶ 61. Ridgway also names several other necessary qualities,
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`and it does not follow simply from having film-forming ability that a given
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`material is suitable for making capsules. Id.; Ex. 2028 ¶¶ 77–86.
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`No prior art of record identifies any type of HPMC other than 2910 as
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`being suitable for making capsules. JP is entirely silent about use of any
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`HPMC for making capsules. Yamamoto refers only to 2910, as described
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`above. Other references show that 2208 and 2906 were not regarded as
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`suitable even for making films, let alone capsules. A Dow HPMC catalog, for
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`example, describes dozens of uses for all types of HPMC it marketed
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`(Ex. 2017, 18–23), but lists only Methocel E (which is 2910, as can be seen
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`from the substitution percentages on page 28) as suitable for making tablet
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`film coats. Id. at 21, 28; Ex. 2028 ¶ 62.
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`HPE2 also shows that only HPMC 2910 was considered suitable for
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`making films. HPE2 cites a number of papers describing various uses of
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`HPMC. Ex. 2003, 3 (top of right column). References 2-7 are cited as
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`disclosing film-coating applications. Id. at 3, 5; Ex. 2028 ¶ 63. Those six
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`Patent Owner Response
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`references are submitted herewith as Exhibits 2036–2041, respectively. Of
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`them, references 2, 3, and 4 specify that 2910 was used to make film c
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