Trials@uspto.gov
`571.272.7822
`
`
`
`
`
` Paper No. 11
`
` Entered: July 27, 2018
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`
`
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`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INITIATIVE FOR MEDICINES, ACCESS & KNOWLEDGE (I-MAK),
`INC.,
`Petitioner,
`
`v.
`
`GILEAD PHARMASSET LLC,
`Patent Owner.
`____________
`
`Case IPR2018-00125
`Patent 8,633,309 B2
`____________
`
`
`Before ERICA A. FRANKLIN, GRACE KARAFFA OBERMANN, and
`RICHARD J. SMITH, Administrative Patent Judges.
`
`SMITH, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
` Paper No. 11
`
` Entered: July 27, 2018
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INITIATIVE FOR MEDICINES, ACCESS & KNOWLEDGE (I-MAK),
`INC.,
`Petitioner,
`
`v.
`
`GILEAD PHARMASSET LLC,
`Patent Owner.
`____________
`
`Case IPR2018-00125
`Patent 8,633,309 B2
`____________
`
`
`Before ERICA A. FRANKLIN, GRACE KARAFFA OBERMANN, and
`RICHARD J. SMITH, Administrative Patent Judges.
`
`SMITH, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`
`
`IPR2018-00125
`Patent 8,633,309 B2
`
`
`
`
`
` INTRODUCTION
`Petitioner, Initiative for Medicines, Access & Knowledge (I-MAK),
`Inc., requests reconsideration of the Board’s decision (Paper 9, “Dec.”)
`denying institution of inter partes review of claims 1–12 of U.S. Patent No.
`8,633,309 B2 (Ex. 1001, “the ’309 patent”). Paper 10 (“Req. Reh’g). For
`the reasons discussed below, we deny the request for rehearing.
` DISCUSSION
`When rehearing a decision on a petition, the Board reviews the
`decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of
`discretion occurs when a “decision was 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., Inc., 840 F.2d 1565,
`1567 (Fed. Cir. 1988) (citations omitted). A request for rehearing “must
`specifically identify all matters the party believes the Board misapprehended
`or overlooked, and the place where each matter was previously addressed.”
`37 C.F.R. § 42.71(d).
`The Board did not overlook or misapprehend Petitioner’s arguments;
`the Board considered them, but was not persuaded by them. We briefly
`address Petitioner’s contentions below.
`Analysis
`Petitioner specifically requests rehearing of the Board’s denial of
`institution regarding the asserted ground of obviousness over Sofia ’6341
`and Congiatu.2 Req. Reh’g 1. The Board denied institution of that asserted
`
`
`1Sofia et al., WO 2008/121634 A2, published Oct. 9, 2008 (“Sofia ’634”).
`Ex. 1005.
`2 C. Congiatu et al., Novel Potential Anticancer Naphthyl Phosphoramidates
`of BVdU: Separation of Diastereoisomers and Assignment of the Absolute
`2
`
`
`
`
`
`
`
`IPR2018-00125
`Patent 8,633,309 B2
`ground under 35 U.S.C. § 325(d). Dec. 12–18. Petitioner argues that
`Congiatu and the Declaration of Dr. Fortunak (Ex. 1002) are not cumulative
`to the evidence of record during prosecution, and directly rebut the
`Examiner’s unsupported sole reason for allowance. Req. Reh’g 2–7.
`Congiatu
`
`Petitioner argues that “the Board overlooked several of Congiatu’s
`teachings that are not present in Sofia ‘634 and are thus materially additive
`over the evidence that was of record during prosecution.” See Req. Reh’g
`2–7. However, Petitioner’s request for rehearing fails to identify where in
`the Petition those additional teachings of Congiatu were addressed. See
`37 C.F.R. § 42.71(d). Moreover, Petitioner’s arguments regarding Congiatu,
`that it relied on in the Petition, were expressly noted in the Decision as
`similar to Petitioner’s arguments regarding Sofia ’634. Dec. 16–17.
`Dr. Fortunak’s Declaration
`Petitioner argues that “the Board also erroneously misapprehended
`and overlooked Dr. Fortunak’s expert testimony.” See Req. Reh’g 5–6. To
`the contrary, the Board considered Dr. Fortunak’s declaration and accorded
`it appropriate weight. First, contrary to Petitioner’s contention, the fact that
`the Decision pointed out that Dr. Fortunak’s statement regarding unexpected
`results (Ex. 1002 ¶ 124) was verbatim to Petitioner’s argument (Dec. 16–17)
`does not mean the Board ignored Dr. Fortunak’s statement. Second,
`contrary to Petitioner’s contention that the Board did not cite any evidence
`contradicting Dr. Fortunak’s opinions, the Board cited extensively to the
`prosecution history – including the Reasons for Allowance – of the ’309
`
`
`Configuration of the Phosphorus Center, J. MED. CHEM. 49, 452–55 (2006)
`(“Congiatu”). Ex. 1006.
`
`3
`
`
`
`
`
`
`
`IPR2018-00125
`Patent 8,633,309 B2
`patent. See Dec. 12–18. Finally, the fact that the Board noted that Dr.
`Fortunak’s statement regarding unexpected results (Ex. 1002 ¶ 124) was
`made “without citing evidentiary support” (Dec. 17) does not mean that the
`Board dismissed Dr. Fortunak’s opinions. See Req. Reh’g 5–6.
`Petitioner further contends that the Board dismissed “Dr. Fortunak’s
`unrebutted expert testimony” in citing Patent Owner’s “conclusory attorney
`argument” of unexpected results. Req. Reh’g 6. To the contrary, the Board
`considered Dr. Fortunak’s testimony and found it unpersuasive, and further
`found no sufficient basis to reconsider the Examiner’s allowance of the ’309
`patent. As we explained in the Decision, the Examiner’s reasons for
`allowance were based on test results disclosed in the specification of the
`’309 patent and not mere attorney argument. See Dec. 12–18.
`Notice of Allowance
`Petitioner contends that “the Board misapprehended the Examiner’s
`finding in the Notice of Allowance that, ‘Applicant has discovered that the
`Sp enantiomer of the claimed compound is unexpectedly more potent in
`inhibiting HCV replication.’” Req. Reh’g 6–7, citing Dec. 14. To the
`contrary, the Board carefully considered the prosecution history and the
`examiner’s reasons for allowance. Furthermore, the Board found that Dr.
`Fortunak’s declaration and Petitioner’s arguments regarding the Congiatu
`reference were not sufficiently persuasive to justify a reconsideration of the
`Examiner’s decision. See Dec. 12–18.
` CONCLUSION
`For the foregoing reasons, the Board did not abuse its discretion in
`denying institution on the basis of 35 U.S.C. § 325(d) as to the asserted
`
`4
`
`
`
`
`
`
`
`IPR2018-00125
`Patent 8,633,309 B2
`ground of obviousness over Sofia ’634 and Congiatu. Accordingly,
`Petitioner’s request for rehearing is denied.
`
`
`PETITIONER:
`
`Daniel Ravicher
`dan@ravicher.com
`
`PATENT OWNER:
`
`David Cavanaugh
`David.cavanaugh@wilmerhale.com
`
`
`Emily Whelan
`Emily.whelan@wilmerhale.com
`
`Dorothy Whelan
`whelan@fr.com
`PTABInbound@fr.com
`
`Mike Kane
`kane@fr.com
`
`Chad Shear
`shear@fr.com
`
`
`
`
`5
`
`
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