Trials@uspto.gov
`571-272-7822
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` Paper No. 8
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` Entered: April 13, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COMPLEX INNOVATIONS, LLC,
`Petitioner,
`
`v.
`
`AMGEN INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00085
`Patent 7,829,595 B2
`____________
`
`
`
`Before LORA M. GREEN, JONI Y. CHANG, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`HARLOW, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`
` Paper No. 8
`
`
`
` Entered: April 13, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COMPLEX INNOVATIONS, LLC,
`Petitioner,
`
`v.
`
`AMGEN INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00085
`Patent 7,829,595 B2
`____________
`
`
`
`Before LORA M. GREEN, JONI Y. CHANG, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`HARLOW, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`IPR2016-00085
`Patent 7,829,595 B2
`
`
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`I.
`
`INTRODUCTION
`
`Petitioner, Complex Innovations, LLC (“CI”), filed a Petition
`
`requesting an inter partes review of claims 1–25 of U.S. Patent
`
`No. 7,829,595 B2 (Ex. 1001, “the ’595 patent”). Paper 2 (“Pet.”). Patent
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`Owner, Amgen, Inc. (“Amgen”), filed a Preliminary Response on
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`February 2, 2016. Paper 7 (“Prelim. Resp.”). We have jurisdiction under
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`35 U.S.C. § 314, which provides that an inter partes review may not be
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`instituted unless the information presented in the petition “shows that there
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`is a reasonable likelihood that the petitioner would prevail with respect to at
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`least 1 of the claims challenged in the petition.”
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`For the reasons set forth below, we deny the Petition.
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`A. Related Matters
`
`No related proceedings concerning the’595 patent have been
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`identified. Pet. 4; Paper 5, 2.
`
`B. The ’595 Patent
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`The ’595 patent, titled “Rapid Dissolution Formulation of a Calcium
`
`Receptor-Active Compound,” issued November 9, 2010, from U.S. Patent
`
`Application No. 10/937,870 (Ex. 1002), filed September 10, 2004.
`
`Ex. 1001, [54], [45], [21], [22]. The ’595 patent claims priority to
`
`U.S. Provisional Patent Application No. 60/502,219, filed September 12,
`
`2003. Id. at [60].
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`
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`2
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`IPR2016-00085
`Patent 7,829,595 B2
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`The ’595 patent describes a “pharmaceutical composition comprising
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`a therapeutically effective amount of a calcium receptor-active compound
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`and at least one pharmaceutically acceptable excipient, wherein the
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`composition has a controlled dissolution profile.” Id. at Abstract. The
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`’595 patent also describes methods for treating diseases, including
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`hyperparathyroidism, using the disclosed pharmaceutical composition. Id.
`
`at 4:17–22.
`
`The ’595 patent explains that although calcium receptor-active
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`compounds, such as cinacalcet, are known in the art, the low solubility of
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`these compounds in water limits pharmaceutical formulation and delivery
`
`options, and can result in low bioavailability for these compounds. Id. at
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`1:7–20. To address these limitations, the ’595 patent discloses a
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`pharmaceutical composition including cinacalcet and six excipients:
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`microcrystalline cellulose, povidone, starch, crospovidone, colloidal silicon
`
`dioxide, and magnesium stearate. Id. at 11:14–14:14. The ’595 patent also
`
`discloses a method for treating hyperparathyroidism, hyperphosphonia,
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`hypercalcemia, or elevated calcium phosphorus product, through the
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`administration of this composition. Id. at 4:17–22, 16:14–20.
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`
`
`
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`3
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`IPR2016-00085
`Patent 7,829,595 B2
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`C. Illustrative Claim
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`Of the challenged claims, claims 1 alone is independent. Claim 1,
`
`reproduced below, is illustrative of the claimed subject matter.
`
`1.
`
`A pharmaceutical composition comprising
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`(a) from about 10% to about 40% by weight of cinacalcet
`
`
`HCl;
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`(b) from about 40% to about 75% by weight of
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`microcrystalline cellulose;
`
`
`
`
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`(c) from about 1% to about 5% by weight of povidone;
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`(d) from about 5% to about 35% by weight of starch;
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`(e) from about 1%
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`crospovidone;
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`to about 10% by weight of
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`(f) from about 0.05% to about 1.5% by weight of colloidal
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`silicon dioxide; and
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`(g) from about 0.05% to about 1.5% by weight of
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`magnesium stearate;
`
`wherein the percentage by weight is relative to the total
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`weight of the composition.
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`Ex. 1001, 14:16–19:31.
`
`D. Prior Art Relied Upon
`
`
`
`CI relies upon the following prior art references (Pet. 4–6):
`
`Van Wagenen et al., US 6,211,244 B1, issued Apr. 3, 2001
`(“Van Wagenen”) (Ex. 1003); and
`
`Handbook of Pharmaceutical Excipients (Arthur H. Kibbe, ed., 3rd ed. 2000)
`(“HPE”) (Exs. 1012; Ex. 2005 (includes portions of reference not contained
`in Ex. 1012)).
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`4
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`IPR2016-00085
`Patent 7,829,595 B2
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`E. Asserted Grounds of Unpatentability
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`CI asserts the following grounds of unpatentability (Pet. 7):
`
`Claims
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`Basis
`
`Reference(s)
`
`1–25
`
`§ 103(a)
`
`Van Wagenen, HPE, and general knowledge of a
`person of ordinary skill in the art.
`
`II. ANALYSIS
`
`A. Claim Construction
`
`In an inter partes review, claim terms in an unexpired patent are given
`
`their broadest reasonable interpretation in light of the specification of the
`
`patent in which they appear. 37 C.F.R. § 42.100(b); see also In re Cuozzo
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`Speed Techs., LLC, 793 F.3d 1268, 1278–79 (Fed. Cir. 2015) (“Congress
`
`implicitly approved the broadest reasonable interpretation standard in
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`enacting the AIA,” and “the standard was properly adopted by PTO
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`regulation.”), cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee, 136
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`S. Ct. 890 (mem.) (2016). Under this standard, we may take into account
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`definitions or other explanations provided in the written description of the
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`specification. In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). Only
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`those terms that are in controversy need be construed, and only to the extent
`
`necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g,
`
`Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
`
`Neither party proposes any claim term for construction. Furthermore,
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`we determine that, for purposes of this decision, it is unnecessary to interpret
`
`any claim term recited in the challenged claims of the ’595 patent.
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`B. Principles of Law
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`A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
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`differences between the claimed subject matter and the prior art are such that
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`the subject matter, as a whole, would have been obvious at the time the
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`invention was made to a person having ordinary skill in the art to which said
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`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`
`(2007). The question of obviousness is resolved on the basis of underlying
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`factual determinations including: (1) the scope and content of the prior art;
`
`(2) any differences between the claimed subject matter and the prior art;
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`(3) the level of ordinary skill in the art; and (4) objective evidence of
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`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`
`When a work is available in one field of endeavor, design
`incentives and other market forces can prompt variations of it,
`either in the same field or a different one. If a person of
`ordinary skill can implement a predictable variation, § 103
`likely bars its patentability. For the same reason, if a technique
`has been used to improve one device, and a person of ordinary
`skill in the art would recognize that it would improve similar
`devices in the same way, using the technique is obvious unless
`its actual application is beyond his or her skill. Sakraida [v. Ag
`Pro, Inc., 425 U.S. 273 (1976)] and Anderson’s–Black Rock [v.
`Pavement Salvage Co., 396 U.S. 57 (1969)] are illustrative—a
`court must ask whether the improvement is more than the
`predictable use of prior art elements according to their
`established functions.
`
`KSR, 550 U.S. at 417. However, “a patent composed of several elements is
`
`not proved obvious merely by demonstrating that each of its elements was,
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`independently, known in the prior art.” Id. at 418. “[T]here must be some
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`articulated reasoning with some rational underpinning to support the legal
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`conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
`
`2006); see also KSR, 550 U.S. at 418.
`
`The level of ordinary skill in the art is reflected by the prior art of
`
`record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001);
`
`In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich,
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`579 F.2d 86, 91 (CCPA 1978).
`
`C. Obviousness Grounds of Unpatentability
`Based on Van Wagenen, HPE, and the Knowledge of
`a Person of Ordinary Skill in the Art
`
`CI asserts that claims 1–25 are unpatentable under § 103(a) as obvious
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`in view of Van Wagenen, HPE, and the general knowledge of a person of
`
`ordinary skill in the art. Pet. 14–32. Claims 2–25 depend, directly or
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`indirectly, from claim 1. CI relies on a Declaration of Dr. Walter Chambliss
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`(Ex. 1021) to support its position.
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`Amgen contends that CI’s reliance on the general knowledge of an
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`ordinarily skilled artisan to establish that the claimed weight range of
`
`cinacalcet was known in the art is improper. Prelim. Resp. 20. Amgen
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`further asserts that CI fails to demonstrate a reason for, or expectation of
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`success in, combining the cited references to arrive at the claimed
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`composition. Id. at 21–22. In particular, Amgen argues that CI fails to
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`identify a reason to select cinacalcet as an active agent in view of its low
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`solubility, fails to articulate a reason to select the six claimed excipients over
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`other possible excipient combinations, and fails to establish a reason for
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`7
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`selecting the claimed weight ranges for cinacalcet and the recited excipients.
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`Id. at 23–31. Amgen additionally contends that CI is incorrect in its
`
`assertion that Amgen bears the burden of proving that the claimed ingredient
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`weight ranges set forth in the ’595 patent are non-obvious. Id. at 33–34.
`
`Van Wagenen
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`Van Wagenen describes compounds that “can mimic or block the
`
`effect of extracellular calcium on a cell surface calcium receptor.” Ex. 1003,
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`2:1–3. Van Wagenen discloses that “[i]n a preferred embodiment, the
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`compound is a calcimimetic acting on a parathyroid cell calcium receptor
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`and reduces the level of parathyroid hormone in the serum of the patient.”
`
`Id. at 6:48–51; see also id. at 11:30–53. Van Wagenen also states that
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`“[s]uitable dosage ranges, formulations, and dosage forms for other
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`compounds described herein can also be determined by one skilled in art
`
`based on the teachings provided in the application.” Id. at 44:42–45.
`
`HPE
`
`HPE is a reference text that discloses “essential data on the physical
`
`properties of excipients such as: boiling point, bulk and tap density,
`
`compression characteristics, hygroscopicity, flowability, melting point,
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`moisture content, moisture-absorption isotherms, particle size distribution,
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`rheology, specific surface area, and solubility.” Ex. 2005, xv. HPE lists
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`properties for 210 excipients, including microcrystalline cellulose, povidone,
`
`starch, crospovidone, colloidal silicon dioxide, and magnesium stearate. Id.
`
`at v–vi; see also Ex. 1012, 3–28.
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`8
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`In describing the properties of the disclosed excipients, HPE identifies
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`“related substance(s) to help the formulator develop a list of possible
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`materials for use in a new dosage form or product.” Ex. 2005, xv. HPE
`
`cautions, however, that “[r]elated substances are not directly substitutable
`
`for each other but are excipients that have been used for similar purposes in
`
`various dosage forms.” Id.
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`from about 10% to about 40% by weight of cinacalcet HCl
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`CI contends that “Van Wagenen discloses pharmaceutical
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`compositions containing cinacalcet hydrochloride.” Pet. 14. CI points to the
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`’595 patent, not Van Wagenen itself, to support this contention. Id. CI
`
`further asserts that “the ranges of the cinacalcet hydrochloride and excipients
`
`disclosed in Claim 1 are common ranges known to a POSITA.” Id. In
`
`support of this position, Dr. Chambliss testifies that “[t]he percentage by
`
`weight of [active pharmaceutical ingredient (“API”)] in a pharmaceutical
`
`composition such as a tablet is determined through routine experimentation.
`
`Based on my experience, pharmaceutical compositions containing from
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`about 10% to about 40% by weight of an API are common.” Ex. 1021 ¶ 76.
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`Dr. Chambliss also testifies that “as pointed out by Van Wagenen, ‘suitable
`
`dosage ranges, formulations, and dosage forms’ can be ‘determined by one
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`skilled in the art.’” Id. at ¶ 77.
`
`In response, Amgen observes that CI relies on the general knowledge
`
`of a relevant skilled artisan, rather than the teachings of the prior, as
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`disclosing the claimed range of cinacalcet. Prelim. Resp. 20. Amgen asserts
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`that “[a]s a legal matter, deficiencies in the prior art references cannot be
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`9
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`remedied by citation to the General Knowledge” of a skilled artisan. Id. at
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`21 (citing Eizo Corp. v. Barco N.V., Case IPR2014-00358, slip op. at 16
`
`(PTAB July 23, 2014) (Paper 11) (“Although basic knowledge available to a
`
`person with ordinary skill in the art may provide a reason to combine
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`elements in a prior art, it does not establish the presence of the element
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`itself.”)).
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`The evidence presented by CI in this record is insufficient to persuade
`
`us that there is a reasonable likelihood that CI will prevail in showing that
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`claims 1–25 are unpatentable under § 103(a) as obvious in view of Van
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`Wagenen, HPE, and the general knowledge of a person of ordinary skill in
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`the art. Each challenged claim recites a pharmaceutical composition
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`comprising “from about 10% to about 40% by weight of cinacalcet HCl,”
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`(Ex. 1001, 14:16–19:31), however, CI does not identify any disclosure in the
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`prior art that an amount by weight of cinacalcet HCl within the claimed
`
`range should be used. Indeed, CI fails to identify any disclosure of
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`cinacalcet in the prior art at all, much less an amount of cinacalcet for
`
`inclusion in a pharmaceutical composition. Rather, CI relies exclusively on
`
`the Specification of the ’595 patent to support a finding that Van Wagenen
`
`discloses cinacalcet. Pet. 14; see also Ex. 1021 ¶ 75; Ex. 1001, 2:18–28
`
`(“The calcimimetic compounds and calcilytic compounds useful in the
`
`present invention include those disclosed in, for example . . . U.S. Pat. No[.]
`
`. . . 6,211,244 . . .”).
`
`Moreover, Dr. Chambliss does not offer testimony that the claimed
`
`range of cinacalcet would have been obvious based on the cited prior art.
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`10
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`See, e.g., Ex. 1021 ¶ 73–96. Rather, Dr. Chambliss testifies that “[t]he
`
`percentage by weight of API in a pharmaceutical composition such as a
`
`tablet is determined through routine experimentation. Based on my
`
`experience, pharmaceutical compositions containing from about 10% to
`
`about 40% by weight of an API are common.” Id. at ¶ 76. Dr. Chambliss’
`
`testimony is insufficient to establish that it would have been obvious to
`
`include from about 10% to about 40% by weight of cinacalcet HCl in a
`
`pharmaceutical composition.
`
`Dr. Chambliss fails to articulate any reason why a skilled artisan
`
`would choose an amount from about 10% to about 40% by weight for
`
`cinacalcet. First, the exemplary pharmaceutical compositions Dr. Chambliss
`
`identifies as supporting his testimony that “pharmaceutical compositions
`
`containing from about 10% to about 40% by weight of an API are common”
`
`do not include cinacalcet.1 Id. And Dr. Chambliss does not identify any
`
`reason that the amount of active agent included in the exemplary compounds
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`would suggest the amount of cinacalcet that should be included in a
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`pharmaceutical composition. Id.
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`Second, Dr. Chambliss’ exemplary compositions contain as little as
`
`0.14% active agent, to as much as 60% active agent. Id. Out of the 13
`
`
`
`1 Dr. Chambliss cites to 11 references (Exs. 1004–1015) as corroborating
`prior art to establish what would have been general knowledge to one skilled
`in the art at the time of invention. Ex. 1021 ¶¶ 49–73. CI does not
`otherwise rely on these references as part of the asserted grounds of
`unpatentability. See Pet. 14, note 1.
`
`11
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`exemplary compositions identified by Dr. Chambliss as supporting a finding
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`that it would have been obvious to include from about 10% to about 40% by
`
`weight of cinacalcet in the claimed composition, 5 disclose amounts of
`
`active agent that do not overlap with this claimed range at all. Id. Third,
`
`Dr. Chambliss acknowledges that “[t]he amount of the same API in a
`
`particular pharmaceutical composition is known to vary as well.” Id.
`
`Given the evidence before us, we do not find Dr. Chambliss’
`
`testimony persuasive, as the evidence he relies upon does not support his
`
`conclusion. See Rohm and Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092
`
`(Fed. Cir. 1997) (nothing requires a fact finder to credit the inadequately
`
`explained testimony of an expert).
`
`Accordingly, CI has not shown a reasonable likelihood of prevailing
`
`in showing that it would have been obvious to include from about 10% to
`
`about 40% by weight of cinacalcet HCl in a pharmaceutical composition.
`
`Rationale to Combine
`
`We also observe that CI has not established a reason to combine
`
`cinacalcet, microcrystalline cellulose, povidone, starch, crospovidone,
`
`colloidal silicon dioxide, and magnesium stearate to arrive at the claimed
`
`composition.
`
`As set forth above, CI asserts, without identifying where, that
`
`Van Wagenen discloses cinacalcet, and that it would be within the general
`
`knowledge of a skilled artisan to use from about 10% to about 40% by
`
`weight of cinacalcet in a pharmaceutical composition. Pet. 14; Ex. 1021
`
`¶¶ 75–76. CI further contends that “the ranges of the cinacalcet
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`hydrochloride and excipients disclosed in Claim 1 are common ranges
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`known to a POSITA,” and thus, a skilled artisan “would have been
`
`motivated to formulate cinacalcet hydrochloride with well-known excipients
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`and in the ranges disclosed with a reasonable expectation of success.”
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`Pet. 14–15; see also Ex. 1021 ¶¶ 75–77.
`
`In support of this conclusion, CI notes that “the HPE contains all of
`
`the claimed excipients and teaches their use in various percentage weight
`
`ranges.” Pet. 15. CI also relies on Dr. Chambliss’s testimony that a relevant
`
`skilled artisan “reading the HPE would know that microcrystalline cellulose,
`
`povidone, starch, crospovidone, colloidal silicon dioxide, and magnesium
`
`stearate may be used with cinacalcet hydrochloride in a manner that would
`
`yield an expected result without interfering with the therapeutic effect of the
`
`cinacalcet hydrochloride.” Ex. 1021 ¶ 95.
`
`In addition, CI argues that “market pressure to select [the] claimed
`
`excipients arose from the need to manufacture a commercial product. The
`
`HPE explains what each excipient is and why a POSITA should be
`
`encouraged to use it.” Pet. 16. Dr. Chambliss testifies that:
`
`Given the fact that excipients are typically included in
`pharmaceutical compositions, it would be obvious to include
`excipients in the claimed composition. It also would be obvious
`to include them in the claimed ranges. A POSITA would be
`motivated to combine the teachings of these references to
`formulate a cinacalcet hydrochloride tablet with commonly used
`excipients without undue experimentation. This combination
`would be the natural result of routine formulation development.
`In particular, a POSITA reading Van Wagenen with these other
`references would be motivated to prepare the disclosed
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`13
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`formulation. (Van Wagenen, col. 44, lines 39–45 (“Suitable
`dosage ranges, formulations, and dosage forms for other
`compounds described herein can also be determined by one
`skilled
`in art based on
`the
`teachings provided
`in
`the
`application.”)).
`
`Ex. 1021 ¶ 94.
`
`Amgen counters that CI fails to provide a reason why a relevant
`
`skilled artisan would have selected cinacalcet as an active ingredient, or
`
`combined it with the six claimed excipients. Prelim. Resp. 23–24. In
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`addition, Amgen observes that HPE discloses 210 excipients, many of which
`
`have similar properties to the claimed excipients. Id. at 26; see also
`
`Ex. 2005, v–vi. Amgen asserts that CI’s failure to explain why a relevant
`
`skilled artisan would have selected each claimed excipient over other
`
`excipients with the same properties is fatal to CI’s obviousness argument.
`
`Prelim. Resp. 26–27. Amgen argues also that Dr. Chambliss “does not even
`
`attempt to assert that there had been a motivation to select the claimed
`
`combination of components over other possibilities.” Prelim. Resp. 27.
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`We agree with Amgen that CI has not provided sufficient evidence to
`
`support the determination that a relevant skilled artisan would have
`
`combined cinacalcet with the six recited excipients to arrive at the claimed
`
`composition. As explained above, CI does not articulate a reason why a
`
`relevant skilled artisan would have selected cinacalcet for inclusion in a
`
`pharmaceutical composition, or even identify where in Van Wagenen
`
`cinacalcet is disclosed as a useful calcimimetic compound. Additionally,
`
`neither CI nor Dr. Chambliss identifies a reason a relevant skilled artisan
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`would have selected the claimed combination of excipients from among the
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`210 options presented by HPE.
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`Dr. Chambliss’ testimony that a skilled artisan “would know that [the
`
`claimed excipients] may be used with cinacalcet hydrochloride in a manner
`
`that would yield an expected result without interfering with the therapeutic
`
`effect of the cinacalcet hydrochloride,” (Ex. 1021 ¶ 95 (emphasis added)), is
`
`insufficient to establish that a skilled artisan “would have combined
`
`elements from specific references in the way the claimed invention does,”
`
`ActiveVideo Networks, Inc. v. Verizon Communications, Inc., 694 F.3d 1312,
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`1328 (Fed. Cir. 2012) (emphasis omitted). “[T]here must be some
`
`articulated reasoning with some rational underpinning to support the legal
`
`conclusion of obviousness.” Kahn, 441 F.3d at 988.
`
`Similarly, Dr. Chambliss’ testimony that “it would be obvious to
`
`include excipients in the claimed composition” and that a skilled artisan
`
`“would be motivated to combine the teachings of these references to
`
`formulate a cinacalcet hydrochloride tablet with commonly used excipients
`
`without undue experimentation” as a matter of “routine formulation
`
`development” (Ex. 1021 ¶ 94), is improperly conclusory, and insufficient to
`
`establish that a skilled artisan would have combined the claimed compounds
`
`as set forth in the ’595 patent. See 37 C.F.R. § 42.65(a); Office Patent Trial
`
`Practice Guide, 77 Fed. Reg. at 48,763 (“Affidavits expressing an opinion of
`
`an expert must disclose the underlying facts or data upon which the opinion
`
`is based.”); ActiveVideo Networks, 694 F.3d at 1328.
`
`15
`
`
`
`IPR2016-00085
`Patent 7,829,595 B2
`
`
`
`Moreover, contrary to Dr. Chambliss’ intimation (Ex. 1021 ¶ 94), the
`
`generic statement in Van Wagenen that “[s]uitable dosage ranges,
`
`formulations, and dosage forms for other compounds described herein can
`
`also be determined by one skilled in the art based on the teachings provided
`
`in the application” (Ex. 1003, 44:39–45), does not render the claimed
`
`cinacalcet formulation obvious. See Innogenetics, N.V. v. Abbott Labs., 512
`
`F.3d 1363, 1373 (Fed. Cir. 2008) (“[K]nowledge of a problem and
`
`motivation to solve it are entirely different from motivation to combine
`
`particular references to reach the particular claimed method.”).
`
`Conclusion
`
`For the foregoing reasons, we determine that the information
`
`presented in the Petition fails to establish a reasonable likelihood that CI
`
`would prevail in challenging claims 1–25 of the ’595 patent.
`
`In consideration of the foregoing, it is
`
`III. ORDER
`
`ORDERED that the Petition is DENIED and no trial is instituted.
`
`
`
`
`
`16
`
`
`
`IPR2016-00085
`Patent 7,829,595 B2
`
`
`PETITIONER:
`
`Vivek Ganti
`Sharad Bijanki
`HILL, KERTSCHER, & WHARTON, LLP
`vg@hkw-law.com
`sb@hkw-law.com
`
`
`PATENT OWNER:
`
`John D. Murnane
`Alicia A. Russo
`Justin J. Oliver
`FITZPATRICK, CELLA, HARPER & SCINTO
`Amgen595IPR@fchs.com
`
`17
`
`
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