Trials@uspto.gov
`571-272-7822
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`
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` Paper No. 10
`
`
` Entered: July 14, 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 Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`
` Paper No. 10
`
`
` Entered: July 14, 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 Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`IPR2016-00085
`Patent 7,829,595 B2
`
`
`
`Petitioner, Complex Innovations, LLC (“CI”), requests rehearing of
`the Board’s Decision (Paper 8) (“Decision”) denying inter partes review of
`claims 1–25 of U.S. Patent No. 7,829,595 B2 (Ex. 1001, “the ’595 patent”).
`Paper 9 (“Req. Reh’g.”). For the reasons that follow, CI’s request for
`rehearing is denied.
`
`ANALYSIS
`Pursuant to 37 C.F.R. § 42.71(d):
`A party dissatisfied with a decision may file a single request for
`rehearing without prior authorization from the Board. The
`burden of showing a decision should be modified lies with the
`party challenging the decision. The request must specifically
`identify all matters the party believes the Board misapprehended
`or overlooked, and the place where each matter was previously
`addressed in a motion, an opposition, or a reply.
`When reconsidering a decision on institution, we review the decision for an
`abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion exists
`where a “decision [i]s based on an erroneous conclusion of law or clearly
`erroneous factual findings, or . . . a clear error of judgment.” PPG Indus.
`Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed.
`Cir. 1988).
`CI seeks rehearing of our denial of inter partes review of claims 1–25
`as obvious under 35 U.S.C. § 103(a) in view of Van Wagenen (Ex. 1003),1
`the Handbook of Pharmaceutical Excipients (“HPE”) (Exs. 1012, 2005),2
`
`
`1 Van Wagenen et al., US 6,211,244 B1, issued Apr. 3, 2001.
`2 Handbook of Pharmaceutical Excipients (Arthur H. Kibbe, ed., 3rd ed.
`2
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`IPR2016-00085
`Patent 7,829,595 B2
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`and the general knowledge of a person of ordinary skill in the art. Req.
`Reh’g. 1; Decision 5, 16. In particular, CI contends that we abused our
`discretion by purportedly failing to recognize that “all of the elements of the
`claimed invention were known in the prior art.” Id. 2–3. CI also asserts that
`we misapprehended or overlooked the standard for obviousness set forth in
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), “by failing to consider
`that in certain chemical arts a POSITA’s practice of selection and routine
`formulation or experimentation is sufficient for an obviousness
`determination.” Req. Reh’g. 3–7.
`CI’s first argument, that we abused our discretion in allegedly failing
`to recognize that “all of the elements of the claimed invention were known
`in the prior art” (Req. Reh’g. 2–3), is inapt. Our Decision is not premised on
`a determination that cinacalcet was unknown in the prior art. See Decision
`9–12. Neither is it premised on CI’s failure to identify where Van Wagenen
`discloses cinacalcet. See id. Rather, it is based on the absence of any
`showing of a reasonable likelihood of success in establishing that it would
`have been obvious to use an amount of cinacalcet HCl within the range
`claimed in the ’595 patent. Id.
`For example, we explained that “CI does not identify any disclosure in
`the prior art that an amount by weight of cinacalcet HCl within the claimed
`range should be used” (Decision 10), and “Dr. Chambliss’ testimony is
`insufficient to establish that it would have been obvious to include from
`
`
`2000).
`
`3
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`IPR2016-00085
`Patent 7,829,595 B2
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`about 10% to about 40% by weight of cinacalcet HCl in a pharmaceutical
`composition” (id. at 11). We further determined that, in view of the
`evidence presented, including evidence of exemplary compositions having
`active agents present in amounts inconsistent with the claimed range of
`cinacalcet, Dr. Chambliss’ testimony was unpersuasive. Id. at 11–12 (citing
`Rohm and Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed.
`Cir. 1997)).
`CI’s second argument, that we misapprehended or overlooked the
`standard for obviousness set forth in KSR “by failing to consider that in
`certain chemical arts a POSITA’s practice of selection and routine
`formulation or experimentation is sufficient for an obviousness
`determination” (Req. Reh’g. 3–7), is likewise unavailing. In particular, CI
`asserts that “a POSITA seeking a cinacalcet formulation would be motivated
`to select each individual excipient based on its prior art properties listed in
`the Handbook of Pharmaceutical Excipients (‘HPE’), i.e., KSR’s ‘finite
`number of identified, predictable solutions.’” Id. at 4. CI further contends
`that “[a]fter selection of the known excipients for combination with
`cinacalcet, a POSITA would have arrived at the ’595’s claimed composition
`through routine formulation or experimentation, which is explained as
`commonly used by a POSITA in the pharmaceutical arts.” Id.
`As an initial matter, we observe that the view of KSR advanced by CI
`is incomplete. KSR makes plain that “a patent composed of several elements
`is not proved obvious merely by demonstrating that each of its elements was,
`independently, known in the prior art.” 550 U.S. at 418. Rather, “there
`
`4
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`IPR2016-00085
`Patent 7,829,595 B2
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`must be some articulated reasoning with some rational underpinning to
`support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988
`(Fed. Cir. 2006); see also KSR, 550 U.S. at 418 (“To facilitate review, this
`analysis should be made explicit.”).
`Moreover, and critically, CI never explains why a relevant skilled
`artisan would have selected cinacalcet for inclusion in a pharmaceutical
`composition in the first place. See Decision 14. Instead, CI’s analysis starts
`from the premise that “a POSITA seeking a cinacalcet formulation would be
`motivated to select each individual excipient based on its prior art properties
`listed in the Handbook of Pharmaceutical Excipients.” Req. Reh’g. 4
`(emphasis added). The absence of any showing that we overlooked
`argument in the Petition as to why a relevant skilled artisan would have
`wanted to include cinacalcet in a pharmaceutical composition is fatal to CI’s
`rehearing request.
`CI similarly fails to identify “a reason a relevant skilled artisan would
`have selected the claimed combination of excipients from among the 210
`options presented by HPE.” Decision 14–15. For example, CI offers no
`explanation why a relevant skilled artisan would have chosen to include six
`excipients in a cinacalcet composition, rather than five, or perhaps seven.
`Nor does CI explain why that artisan would have selected the particular
`excipients claimed in the ’595 patent, in lieu of other excipients with similar
`properties disclosed by HPE. Id. at 14–15.
`CI nevertheless contends that we erred in determining that
`Dr. Chambliss’ testimony concerning the rationale to combine cinacalcet
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`Patent 7,829,595 B2
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`and the six claimed excipients was conclusory. Req. Reh’g 6.
`Dr. Chambliss testified, in pertinent part:
`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.
`Ex. 1021 ¶ 94. This testimony, unencumbered by any disclosure of the
`underlying facts or data that form the basis for the stated opinions, is
`unambiguously conclusory. 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, Inc. v. Verizon Commc’ns, Inc., 694 F3d.
`1312, 1328 (Fed. Cir. 2012).
`CI also asserts that our Decision is inconsistent with prior decisions in
`which the Board has “determined that [] selection and routine formulation or
`experimentation was sufficient for obviousness.” Req. Reh’g. 5.
`The decisions to which CI refers, however, plainly do not stand for the
`proposition that it would be obvious to select seven distinct compounds for
`inclusion in a composition, absent any articulated reason or rational
`underpinning for choosing those specific compounds, merely because each
`one was known in the prior art. See Conopco, Inc. DBA Unilever v. The
`Procter & Gamble Co., Case IPR2013-00505, slip op. 10–12 (PTAB Feb.
`12, 2014) (Paper 9) (instituting inter partes review for obviousness in view
`6
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`IPR2016-00085
`Patent 7,829,595 B2
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`of an exemplary prior art composition “comprising the components required
`by the claims, in amounts that fall within the specified weight-percent
`ranges,” where only routine optimization of known properties would be
`required to satisfy additional claim elements); Endo Pharm., Inc. v.
`Depomed, Inc., Case IPR2014-00652, slip op. 15–16 (PTAB Sept. 29, 2014)
`(Paper 12) (instituting inter partes review for obviousness in view of a prior
`art reference identifying both components of the recited monolithic matrix as
`“particularly preferred” compounds on an already “short list” of viable
`compounds that could be combined to form a polymeric matrix); Amneal
`Pharm., LLC v. Supernus Pharm., Inc., Case IPR2013-00368, slip op. 14
`(PTAB Dec. 9, 2014) (Paper 94) (“Put another way, Amneal has failed to
`persuade us that the prior art it cites for disclosure of IR:DR ratios actually
`discloses such ratios. Without evidence that the claimed IR:DR ratio was
`known or could have been reached through routine experimentation,
`Amneal’s challenge fails.”).
`
`CONCLUSION
`For the reasons given, CI has not demonstrated that we abused our
`discretion in denying institution, nor that we misapprehended or overlooked
`matters raised in the Petition in our Decision.
`
`ORDER
`
`Accordingly, it is
`ORDERED that CI’s Request for Rehearing is denied.
`
`
`
`7
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`
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`IPR2016-00085
`Patent 7,829,595 B2
`
`
`PETITIONER:
`
`Vivek Ganti
`Sharad Bijanki
`Steven G. Hill
`John L. North
`Jennifer L. Calvert
`HILL, KERTSCHER, & WHARTON, LLP
`vg@hkw-law.com
`sb@hkw-law.com
`sgh@hkw-law.com
`jln@hkw-law.com
`jc@hkw-law.com
`
`PATENT OWNER:
`
`John D. Murnane
`Alicia A. Russo
`Justin J. Oliver
`FITZPATRICK, CELLA, HARPER & SCINTO
`Amgen595IPR@fchs.com
`
`8
`
`
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