Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`Paper 10
`Entered: May 16, 2017
`
`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 B1
`
`Before BRIAN P. MURPHY, CHRISTOPHER M. KAISER, and
`JEFFREY W. ABRAHAM, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`Paper 10
`Entered: May 16, 2017
`
`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 B1
`
`Before BRIAN P. MURPHY, CHRISTOPHER M. KAISER, and
`JEFFREY W. ABRAHAM, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-00203
`Patent 6,649,180 B1
`
`I.
`
`INTRODUCTION
`
`Mylan Pharmaceuticals Inc. (“Petitioner”) filed a Petition (Paper 1,
`“Pet.”) requesting inter partes review of claims 1 and 4 of U.S. Patent No.
`6,649,180 B1 (Ex. 1001, “the ’180 patent”). Qualicaps Co., Ltd. (“Patent
`Owner”) filed a Preliminary Response (Paper 9, “Prelim. Resp.”).1 We have
`statutory authority under 35 U.S.C. § 314(a), which provides that an inter
`partes review may not be instituted “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.”
`Based on the arguments and evidence presented in the Petition and
`the Preliminary Response, we determine there is a reasonable likelihood
`Petitioner would prevail with respect to claims 1 and 4 of the ’180 patent
`challenged in the Petition. Therefore, we institute an inter partes review.
`A. Related Matters
`Petitioner and Patent Owner identify the following as related district
`court proceedings in the Eastern District of Texas regarding the ’180 patent:
`Warner Chilcott (US), LLC v. Mylan Pharmaceuticals Inc., Case No. 2:15-
`cv-01740-JRG-RSP (consolidated for the purposes of claim construction and
`discovery with Case No. 2:15-cv-01471-JRG-RSP) (E.D. Tex.); Warner
`Chilcott (US), LLC v. Teva Pharmaceuticals USA, Inc., Case No. 2:15-cv-
`01471-JRG-RSP (consolidated with Case No. 2:15-cv-01740-JRG-RSP)
`
`
`1 Petitioner identifies Mylan Pharmaceuticals Inc., Mylan Laboratories
`Limited, Mylan Inc., and Mylan N.V. as real parties in interest to this
`proceeding. Pet. 1. Patent Owner identifies Qualicaps Co., Ltd., Mitsubishi
`Chemical Holdings Corporation, and Warner Chilcott Company LLC as real
`parties in interest to this proceeding. Paper No. 4, 1.
`
`2
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`IPR2017-00203
`Patent 6,649,180 B1
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`Challenged Claims
`1 and 4
`
`(E.D. Tex.); Warner Chilcott (US), LLC v. Zydus Pharmaceuticals (USA)
`Inc., Case No. 2:16-cv-00323-JRG-RSP (E.D. Tex.); and, in the District of
`Delaware, Warner Chilcott (US), LLC v. Teva Pharmaceuticals USA, Inc.,
`Case No. 1:15-cv-00761-GMS (D. Del.). Pet. 1–2; Paper 4, 1.
`B. The Asserted Grounds of Unpatentability
`Petitioner contends that claims 1 and 4 of the ’180 patent are
`unpatentable based on the following grounds:
`References
`Statutory Basis
`Yamamoto2 and
`§ 103
`Japanese
`Pharmacopoeia3
`Greminger4
`
`Pet. 13. Petitioner supports the Petition with the Declaration of Dr. Arthur
`Kibbe. Ex. 1011.
`C. The ’180 Patent
`The ’180 patent is directed to a hard capsule for use in the
`pharmaceutical and health food fields. Ex. 1001, 1:10–11. The capsule is
`formed of a cellulose ether film composition comprising “a cellulose ether as
`a base in which some of the hydrogen atoms of cellulosic hydroxyl groups
`are replaced by alkyl groups and/or hydroxyalkyl groups, a gelling agent,
`and a gelling aid.” Ex. 1001, Abstract. “The total content of alkoxyl and
`hydroxyalkoxyl groups in the cellulose ether is limited to 23–37.6% by
`
`§ 103
`
`1 and 4
`
`
`2 U.S. Patent No. 5,756,123 to Yamamoto et al., issued May 26, 1998
`(“Yamamoto”). Ex. 1004.
`3 The Japanese Pharmacopoeia (The Society of Japanese Pharmacopoeia),
`13th ed. 1996 (“Japanese Pharmacopoeia”). Ex. 1005.
`4 U.S. Patent No. 3,493,407 to Greminger et al., issued February 3, 1970
`(“Greminger”). Ex. 1006.
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`IPR2017-00203
`Patent 6,649,180 B1
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`weight, which is effective for preventing the gelling aid from precipitating
`out and maintaining a favorable outer appearance during long-term storage.”
`Id.
`The ’180 patent describes how gelatin capsules may lose water
`content when filled with hygroscopic material. Id. at 1:26–34. As a result,
`cellulose ether capsules made from hydroxypropylmethylcellulose
`(“HPMC”), a gelling agent, and a gelling aid were developed “and used in
`practice” to maintain sufficient capsule strength at relatively low water
`content, while maintaining dissolution properties equivalent to gelatin
`capsules. Id. at 1:38–51. The ’180 patent describes a problem with using a
`gelling aid, such as water-soluble potassium or calcium chloride salts, that
`“will precipitate out on the film surface during long-term storage,” thereby
`providing an unwanted visual appearance such as cloud spots on an
`otherwise clear, colorless capsule. Id. at 1:52–55; see also id. at 1:56–2:6.
`The ’180 patent describes solving the gelling aid precipitation problem by
`limiting the total content of alkoxyl and hydroxyalkoxyl groups in the
`cellulose ether “up to 37.6% by weight” of the HPMC. Id. at 2:16–32, 41–
`43.
`
`The ’180 patent provides examples of compositions comprising
`HPMC mixed with carrageenan (gelling agent) and potassium chloride
`(gelling aid) in dipping solutions used to form capsules. Id. at 5:50–58.
`HPMC 2910 and HPMC 2808, as specified in the Japanese Pharmacopoeia
`and available from Shin-Etsu Chemical Co., Ltd. (“Shin-Etsu”), were mixed
`in different proportions, stored at 40 °C for one month, and visually
`inspected for potassium chloride precipitates. Id. at 5:28–49, 5:60–63. The
`
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`results are reported in Table 1 of the ’180 patent, reproduced below. Id. at
`5:63–6:15.
`
`
`
`
`
`In Table 1, above, the Comparison composition contains 100%
`HPMC 2910 having a total methoxyl (“MO”) plus hydroxypropoxyl
`(“HPO”) content of 38.1% by weight and shows precipitates on the capsule
`surface. Id. Examples 1–3 represent different blends of HPMC 2910 and
`HPMC 2808 having a combined MO/HPO content ranging from 35.5%–
`37.6% by weight. Id. Examples 1–3 show either “few precipitates” deemed
`acceptable in appearance or “no precipitates.” Id. Example 4 contains
`100% HPMC 2808 having a combined MO/HPO content of 29.4% by
`weight and shows “no precipitates.” Id. The ’180 patent states that the data
`in Table 1 indicates that controlling the MO/HPO content “to 37.6% by
`weight or lower is effective for preventing the gelling aid . . . from
`precipitating on the film surface.” Id. at 6:16–20.
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`D. Claims 1 and 4
`Claims 1 and 4 of the ’180 patent are reproduced below. Id. at 6:38–
`45, 6:55–58.
`1. A hard capsule formed of a film composition comprising
`a hydroxypropyl methyl cellulose as a base, a gelling
`agent, and a gelling aid, wherein said hydroxypropyl
`methyl cellulose has a content of hydroxypropoxyl groups
`of at least 4% by weight of the hydroxypropyl methyl
`cellulose and a content of methoxyl groups and
`hydroxypropoxyl groups combined of 23 to 37.6% by
`weight of the hydroxypropyl methyl cellulose.
`
`
`
`4. The hard capsule formed of a film of claim 1, wherein the
`content of methoxyl and hydroxypropoxyl groups
`combined is 29 to 37% by weight of the hydroxypropyl
`methyl cellulose.
`
`
`
`
`
`II. ANALYSIS
`
`
`A. Claim Construction
`
`In an inter partes review, we construe claim terms in an unexpired
`patent according to their broadest reasonable construction in light of the
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b); see
`Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 2131, 2144 (2016) (upholding
`the use of the broadest reasonable interpretation standard). Claim terms
`generally are given their ordinary and customary meaning, as would be
`understood by one of ordinary skill in the art in the context of the entire
`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). Any special definition for a claim term must be set forth in the
`specification with reasonable clarity, deliberateness, and precision. In re
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`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Only terms that are in
`controversy need be construed, and only to the extent necessary to resolve
`the controversy. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d
`1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed to the
`extent necessary to resolve the controversy.”) (internal citation omitted).
`We determine that none of the claim terms require express
`construction for purposes of this Decision.
`
`B. Asserted Obviousness of Claims 1 and 4 over Yamamoto and the
`Japanese Pharmacopoeia
`Petitioner argues that the subject matter of claims 1 and 4 would have
`been obvious to a person of ordinary skill in the art (hereafter “POSA”) in
`view of Yamamoto and the Japanese Pharmacopoeia.5 Pet. 21–41. Patent
`Owner opposes, emphasizing asserted unexpected results from solving the
`problem of gelling aid precipitation, which were considered by the Examiner
`during prosecution of the ’180 patent application. Prelim. Resp. 1–20. We
`address the parties’ arguments below.
`1. Yamamoto
`Yamamoto discloses an HPMC capsule shell “comprising 79.6–98.7%
`by weight of a [HPMC], 0.03–0.5% by weight of carrageenan, and 0.14–
`3.19% by weight of a potassium ion and/or a calcium [ion].” Ex. 1004,
`Abstract. Yamamoto teaches control over the amount of HPMC mixed with
`
`
`5 Petitioner asserts, and Patent Owner does not contest in its Preliminary
`Response, that a POSA at the time of the earliest priority date of the ’180
`patent would have had at least an undergraduate degree in chemistry,
`chemical engineering, material engineering, pharmacy or the equivalent
`technical degree and at least two years of experience in pharmaceutical
`formulation. Pet. 15 (citing Ex. 1011 ¶ 41); Prelim. Resp. 5–6. We adopt
`and apply Petitioner’s definition of a POSA in this Decision.
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`carrageenan gelling agent and potassium ion co-gelling agent (a “gelling
`aid” in the language of the ’180 patent) in a dipping solution used to form
`hard capsule shells. Id. at 2:54–3:9, 4:31–47. By controlling the relative
`proportions of the components as taught in Yamamoto, hard capsule shells
`are produced that maintain “satisfactory disintegration ability even in the
`presence of calcium ions and exert[] performance equivalent to conventional
`gelatin capsules.” Id. at 3:1–6. Yamamoto goes on to teach that HPMC,
`designated TC-5M and TC-5E, is commercially available from Shin-Etsu
`and may be used alone or blended with other HPMC products “to form a
`mixture having an optimum viscosity.”6 Id. at 3:63–4:6. Yamamoto also
`references the Japanese Pharmacopoeia in the context of complying with test
`procedures described therein. Id. at 3:27–34, 7:29–31, 7:44–46, 8:13–15,
`8:23–26, 8:44–47.
`2. The Japanese Pharmacopoeia
`The Japanese Pharmacopoeia is an Official Monograph of
`pharmaceutical components promulgated by the Ministry of Health and
`Welfare of Japan. Ex. 1005, 2, 47; Ex. 1011 ¶ 96. The Japanese
`Pharmacopoeia discloses three types of HPMC:
`• HPMC type 2208 contains 19 to 24% by weight of MO groups and 4
`to 12% by weight of HPO groups for a combined MO/HPO content ranging
`from 23 to 36% by weight of HPMC (Ex. 1005, 5 (Col. 2));
`
`
`6 Petitioner submits evidence that Shin-Etsu TC-5E and TC-5M are forms of
`HPMC “substitution type” 2910, each having a different viscosity. Ex.
`1012, 2.
`7 Citations are to the exhibit page numbers rather than to the internal
`pagination of the reference itself.
`
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`• HPMC type 2906 contains 27 to 30% by weight of MO groups and 4
`to 7.5% of HPO groups for a combined MO/HPO content ranging from 31 to
`37.5% by weight of HPMC (id. at 7 (Col. 1)); and
`• HPMC type 2910 contains 28 to 30% by weight of MO groups and 7
`to 12% by weight of HPO groups for a combined MO/HPO content ranging
`from 35 to 42% by weight of HPMC (id. at 8 (Col. 2)).
`3. Analysis
`A party who 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) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d
`1348, 1361 (Fed. Cir. 2007)). We assess Petitioner’s evidence and argument
`according to this standard.
`
`a. Limitation 1.1: hard capsule composition “comprising a
`[HPMC] as a base, a gelling agent, and a gelling aid”
`Petitioner relies on Yamamoto for teaching a hard capsule
`composition comprising HPMC, a gelling agent, and a gelling aid
`(“limitation 1.1”). Pet. 22–23 (citing Ex. 1004, 3:10–24, 4:12–20, 5:34–43;
`Ex. 1011 ¶¶ 55–59). Petitioner further relies on Yamamoto for disclosing
`that low viscosity HPMC, such as TC-5M and TC-5E (HPMC type 2910),
`was commercially available from Shin-Etsu. Id. at 24 (citing Ex. 1004,
`3:47–67, 7:19–25, Table 4 (Note, Col. 9–10); Ex. 1011 ¶ 60); Ex. 1012
`(Shin-Etsu HPMC data sheet). Patent Owner does not respond directly to
`Petitioner’s evidence regarding limitation 1.1. Prelim. Resp. 9–26. We
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`determine Petitioner has provided sufficient evidence to support the
`disclosure of limitation 1.1 in Yamamoto.
`
`b. Combined MO/HPO content ranging from “23 to 37.6%”
`(limitation 1.2) and from “29 to 37%” (limitation 4.1)
`Petitioner relies on the combination of Yamamoto and the Japanese
`Pharmacopoeia for teaching HPMC having (i) HPO “of at least 4% by
`weight” of the HPMC and (ii) combined MO/HPO content ranging from
`“23 to 37.6% by weight” (together, “limitation 1.2”). Pet. 24–32 (citing,
`inter alia, Ex. 1005, 5, 7, 8; Ex. 1011 ¶¶ 60–86). Petitioner further relies on
`the combination of Yamamoto and the Japanese Pharmacopoeia for teaching
`HPMC having a combined MO/HPO content ranging from “29 to 37% by
`weight” (“limitation 4.1”). Id. at 33–41 (citing, inter alia, Ex. 1005, 5, 7, 8;
`Ex. 1011 ¶¶ 87–111). Patent Owner does not respond directly to Petitioner’s
`evidence regarding the first portion of limitation 1.2 that recites HPMC
`having HPO “of at least 4% by weight” of the HPMC. Prelim. Resp. 9–26.
`We determine Petitioner has provided sufficient evidence to support its
`argument that the combination of Yamamoto and the Japanese
`Pharmacopoeia teach hard capsules containing HPMC having HPO “of at
`least 4% by weight” of the HPMC.
`The parties’ dispute focuses on whether the teachings of Yamamoto
`and the Japanese Pharmacopoeia would have rendered the combined
`MO/HPO ranges recited in limitation 1.2 (“23 to 37.6% by weight”) and
`limitation 4.1 (“29 to 37% by weight”) obvious to a POSA, particularly in
`view of Patent Owner’s evidence of asserted unexpected results.
`Petitioner notes, in particular, that the ’180 patent (i) recognizes the
`Japanese Pharmacopoeia as prescribing appropriate HPMC content, (ii)
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`reproduces the MO and HPO group content for the three types of HPMC
`disclosed in the Japanese Pharmacopoeia, and (iii) recognizes that HPMC
`types 2208 and 2910 were commercially available from Shin-Etsu. Pet. 24
`(citing Ex. 1001, 3:33–54, 5:26–38). Petitioner argues that a POSA would
`have recognized the combined MO/HPO content of the HPMC hard capsules
`in Yamamoto “would range between 23 and 42% by weight of the HPMC”
`and “would have been motivated to use the standard types and percentage
`contents of HPMC disclosed in The Japanese Pharmacopoeia to ensure that
`a capsule was commercially acceptable” in Japan. Id. at 26–27 (citing Ex.
`1011 ¶¶ 64–69). Petitioner further argues that HPMC types 2208 and 2906
`disclose “a virtually exact range” as recited in claim 1 (id. at 26), and that
`the combined MO/HPO ranges disclosed in the Japanese Pharmacopoeia
`overlap the claimed ranges, thereby rendering the subject matter of claims 1
`and 4 obvious to a POSA. Id. at 26–29 (citing Ex. 1011 ¶¶ 64–77; In re
`Peterson, 315 F.3d 1325, 1329–1330 (Fed. Cir. 2003) (“Selecting a narrow
`range from within a somewhat broader range disclosed in a prior art
`reference is no less obvious than identifying a range that simply overlaps a
`disclosed range.”); In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997); In re
`Malagari, 499 F.2d 1297, 1303 (CCPA 1974)); see also id. at 34–37.
`Patent Owner emphasizes asserted unexpected results derived from
`selecting particular ranges for combined MO/HPO content, as recited in
`claims 1 and 4, to solve the problem of gelling aid precipitation. Prelim.
`Resp. 1–17 (citing, inter alia, Ex. 1001, Col. 6 (Table 1); Ex. 1010, 105–108
`(Tanjoh Declaration)). Patent Owner argues that discovering the gelling aid
`precipitation problem itself is evidence of nonobviousness. Id. at 6–7 (citing
`Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1353–57 (Fed. Cir. 2013)).
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`Patent Owner also argues that Petitioner’s response to the unexpected results
`data, that solving the gelling agent precipitation problem was an inherent
`result of using the HPMC types disclosed in Yamamoto and the Japanese
`Pharmacopoeia, is not in accord with PAR Pharm., Inc. v. TWI Pharm., Inc.,
`773 F.3d 1186, 1195 (Fed. Cir. 2014), because avoiding gelling aid
`precipitation is not the “natural result” of all the prior art MO/HPO ranges
`up to 42%. Id. at 11–12.
`On the present record, we determine Petitioner has provided sufficient
`evidence to support its obviousness assertion regarding claims 1 and 4 based
`on Yamamoto and the Japanese Pharmacopoeia. We note the combined
`MO/HPO content of HPMC type 2208 disclosed in the Japanese
`Pharmacopoeia, ranging from 23–36% by weight, nearly matches and falls
`entirely within the range of combined MO/HPO content recited in limitation
`1.2 of the ’180 patent (“23 to 37.6%”). HPMC type 2906 contains a
`combined MO/HPO content ranging from 31 to 37.5% by weight, entirely
`within and nearly matching the upper portion of the range recited in
`limitation 1.2, and substantially overlapping the range recited in limitation
`4.1 (“29 to 37%”). HPMC type 2910 (combined MO/HPO content 31 to
`42%) also overlaps the upper portion of the ranges recited in claims 1 and 4.
`Contrary to Patent Owner’s argument (Prelim. Resp. 11–13), avoiding
`gelling aid precipitation is not a limitation of the claims; the ranges of
`combined MO/HPO content are the limitations at issue in claims 1 and 4.
`Avoiding gelling aid precipitation, moreover, is not necessarily the
`only motivation for why a POSA would have selected a type of HPMC
`having a combined MO/HPO content either within or overlapping the
`claimed ranges, when preparing HPMC hard capsules as taught by
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`Yamamoto. Pet. 24–29 (citing Ex. 1011 ¶¶ 60–74), 33–37 (citing Ex. 1011
`¶¶ 86–100). For example, Petitioner argues that a POSA “would have been
`motivated to use standard types and percentage contents of HPMC disclosed
`in The Japanese Pharmacopoeia to ensure that a capsule was commercially
`acceptable” in Japan. Id. at 27–28. This articulated reasoning has rational
`underpinnings supported by the cited evidence.
`Based on the current record, we are persuaded that a POSA would
`have had sufficient motivation to select HPMC types 2808, 2906, and 2910
`for use in Yamamoto’s hard capsule shell composition that would have
`satisfied the combined MO/HPO content ranges recited in limitations 1.2
`and 4.1. See In re Peterson, 315 F.3d at 1329 (“even a slight overlap in
`range establishes a prima facie case of obviousness”) (citations omitted); see
`also In re Geisler, 116 F.3d at 1469–1470; In re Malagari, 499 F.2d at 1303.
`The weight to be given Patent Owner’s asserted discovery of the gelling aid
`precipitation problem and unexpected results data, including whether the
`avoidance of gelling aid precipitation would have been an inherent result of
`selecting the HPMC types disclosed in the Japanese Pharmacopoeia, will be
`determined during trial. As explained in Peterson, “unexpected results must
`be commensurate in scope with the claimed range.” 315 F.3d at 1330–31
`(citations omitted).
`4. Patent Owner’s § 325(d) argument
`Patent Owner argues that we should deny the Petition pursuant to 35
`U.S.C. § 325(d), because the Examiner considered the same contested issue,
`comparable prior art, and unexpected results data before allowing the
`challenged claims to issue. Prelim. Resp. 17–20 (citing Ex. 1010, 38–39, 51,
`90–91, 116; Ex. 2024 (“Reibert”), 2:25–32 (21–42%, preferably 25–35%
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`MO content), 3:7–11 (32% or less, preferably 3–12% HPO content)
`(combined content range 21–74%); Ex. 2023 (“Parekh”), 5:18–23
`(combined content range 23–42%, preferably 35–42%)). First, neither
`Patent Owner nor Petitioner cite to evidence that the Examiner considered
`the Japanese Pharmacopoeia’s disclosure of HPMC types and combined
`MO/HPO content. Id. at 17–20; Pet. 22; see Ex. 1001, (56); Ex. 1010. We
`have found none. Second, the ranges of combined MO/HPO content
`disclosed in Reibert and Parekh are not directly comparable to those
`disclosed in the Japanese Pharmacopoeia. Reibert discloses a very large
`range from 21 to 74%. Ex. 1010, 51; Ex. 2024, 2:25–32, 3:7–11. Parekh
`discloses a narrower range from 23–42%, but the ranges for HPMC types
`2208 (23–36%), 2906 (31–37.5%), and 2910 (35–42%) disclosed in the
`Japanese Pharmacopoeia are each narrower and different from the range
`disclosed in Parekh. Third, the arguments in the Petition are not
`substantially the same arguments that were addressed during prosecution.
`For example, neither party has cited evidence that the Examiner considered
`(i) the combined MO/HPO content of HPMC types 2208, 2906, and 2910
`disclosed in the Japanese Pharmacopoeia, or (ii) Petitioner’s asserted
`motivation for why a POSA would have selected the HPMC types disclosed
`in the Japanese Pharmacopoeia when making HPMC hard capsules as taught
`by Yamamoto. Therefore, we decline to exercise our discretion to deny the
`Petition under § 325(d), because substantially the same prior art and
`arguments were not previously presented to the Office.
`5. Conclusion
`For the reasons given above, we determine Petitioner has provided
`sufficient argument and evidence to support a reasonable likelihood of
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`prevailing on its assertion that the subject matter of claims 1 and 4 would
`have been obvious to a POSA over the combination of Yamamoto and the
`Japanese Pharmacopoeia.
`
`C. Asserted Obviousness of Claims 1 and 4 over Greminger
`Petitioner argues that claims 1 and 4 would have been obvious to a
`POSA in view of Greminger. Pet. 41–51. Petitioner acknowledges that
`Greminger is directed to capsule shells prepared from “a solution containing
`about 10–30 weight percent” of HPMC having an operational viscosity of
`about 1,000–12,000 cps. Id. at 41–42 (citing Ex. 1006, 1:15–19, 1:51–61,
`and 2:7–16). Greminger does not disclose a capsule composition that
`contains a gelling agent or gelling aid (limitation 1.1), but Petitioner argues
`that “Greminger also discloses that the medicinal capsules can include
`additional additives such as plasticizers, non-toxic pigment dies, and filler.”
`Id. at 42–43 (citing Ex. 1006, 3:35–44). Based on the cited disclosure,
`Petitioner makes the conclusory argument that a POSA would have
`understood that plasticizers such as glycerine, propylene glycol or
`hydroxypropylglycerine “can function as gelling agents or gelling aids.” Id.
`at 43 (citing Ex. 1011 ¶ 116).
`Dr. Kibbe’s cited Declaration testimony is identical to the conclusory
`argument made in the Petition. Dr. Kibbe does not explain why a POSA,
`reading Greminger, would have been motivated to formulate HPMC
`capsules using a gelling agent and gelling aid. Ex. 1011 ¶¶ 116, 120.
`Knowing that a plasticizer “can function” as a gelling agent or aid, without
`more, falls short of a suggestion or motivation to use plasticizers to
`accomplish such a function. All of the capsule composition examples
`
`15
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`IPR2017-00203
`Patent 6,649,180 B1
`
`disclosed in Greminger contain HPMC in various solvent systems, but none
`contain any identified plasticizers or gelling agents. Ex. 1006, 3:56–5:33.
`We also agree with Patent Owner that, although Greminger teaches
`HPMC capsules having “enhanced clarity” (id. at 1:67–2:1), Greminger rates
`capsule clarity based on different solvent systems, not based on MO/HPO
`content or gelling aid precipitation effects. Id. at 5:34–65; Prelim. Resp. 15–
`16. Petitioner also provides insufficient evidence and explanation as to why
`a POSA, reading Greminger, would have had a reasonable expectation of
`successfully arriving at the HPMC composition recited in limitation 1.1.
`Pet. 41–44. As the Federal Circuit has explained, “obviousness concerns
`whether a skilled artisan not only could have made but would have been
`motivated to make the combinations or modifications of prior art to arrive at
`the claimed invention.” Belden Inc. v. Berk–Tek LLC, 805 F.3d 1064, 1073
`(Fed. Cir. 2015); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
`(2007) (it is “important to identify a reason that would have prompted a
`person of ordinary skill in the relevant field to combine the elements in the
`way the claimed new invention does”); In re Kahn, 441 F.3d 977, 988 (Fed.
`Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by
`mere conclusory statements; instead, there must be some articulated
`reasoning with some rational underpinning to support the legal conclusion of
`obviousness.”) (quoted with approval in KSR Int’l Co. v. Teleflex Inc., 550
`U.S. 398, 418 (2007)). In short, Greminger’s brief disclosure of optional
`plasticizers, without more, is not a sufficient reason or motivation for a
`POSA to have derived the compositions recited in claims 1 and 4 of the ’180
`patent.
`
`16
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`IPR2017-00203
`Patent 6,649,180 B1
`
`For the reasons given above, we determine Petitioner has not
`established a reasonable likelihood of prevailing in showing the obviousness
`of claims 1 and 4 in view of Greminger. Therefore, we deny institution with
`respect to Petitioner’s second ground of challenge.
`
`
`III. CONCLUSION
`
`
`Petitioner has demonstrated a reasonable likelihood of prevailing with
`respect to claims 1 and 4 of the ’180 patent challenged in the Petition. At
`this stage of the proceeding, the Board has not made a final determination as
`to the patentability of the instituted claims. Our Final Decision will be based
`on the full record developed during trial.
`
`
`IV. ORDER
`
`
`Accordingly it is
`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
`review of the ’180 patent is instituted on the following ground:
`Claims 1 and 4 as obvious over Yamamoto and the Japanese
`Pharmacopoeia under 35 U.S.C. § 103;
`FURTHER ORDERED that inter partes review is commenced on the
`entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
`§ 42.4, notice is hereby given of the institution of trial; and
`FURTHER ORDERED that the inter partes review is limited to the
`grounds of unpatentability listed above, and no other grounds of
`unpatentability are authorized for inter partes review.
`
`
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`IPR2017-00203
`Patent 6,649,180 B1
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`
`
`FOR PETITIONER:
`
`Mitchell Stockwell
`Clay Holloway
`Miranda Rogers
`KILPATRICK TOWNSEND & STOCKTON LLP
`mstockwell@kilpatricktownsend.com
`cholloway@kilpatricktownsend.com
`mrogers@kilpatricktownsend.com
`
`
`
`FOR PATENT OWNER:
`
`Jessica Parezo
`Andrea Reister
`COVINGTON & BURLING LLP
`jparezo@cov.com
`areister@cov.com
`
`Maryanne Armstrong
`Lynde Herzbach
`BIRCH, STEWART, KOLASCH & BIRCH, LLP
`maa@bskb.com
`lynde.herzbach@bskb.com
`
`
`
`18
`
`
`
`
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