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` Paper 10
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` Date: April 30, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`APOTEX INC. and APOTEX CORP.,
`Petitioner,
`
`v.
`
`CELGENE CORPORATION,
`Patent Owner.
`
`
`IPR2018-00685
`Patent 8,741,929 B2
`
`
`
`Before TONI R. SCHEINER, GRACE KARAFFA OBERMANN, and
`TINA E. HULSE, Administrative Patent Judges.
`
`
`SCHEINER, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing of
`Decision Denying Institution of Inter Partes Review
`37 C.F.R § 42.71(d)
`
`
`
`
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`IPR2018-00685
`Patent 8,741,929 B2
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`
`I. INTRODUCTION
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`Apotex Inc. and Apotex Corp. (collectively, “Petitioner”) filed a
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`Petition (Paper 2, “Pet.”), requesting an inter partes review of claims 1–4, 8,
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`9, 15, and 20 of U.S. Patent No. 8,741,929 B2 (Ex. 1001, “the ’929 patent”)
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`on three asserted grounds:
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`
`
`Claims
`
`35 U.S.C. §
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`Reference(s)/Basis
`
`I
`
`1–4, 8, 9, 15, 20 103(a)
`
`Drach,1 Zeldis2
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`II
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`4, 20
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`103(a)
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`Drach, Zeldis, Querfeld3
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`III
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`1–4, 8, 9, 15, 20 102(a)
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`Celgene Press Release4
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`Petitioner supported its challenges with the Declaration of Michael J.
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`Thirman, M.D., dated February 23, 2018 (Ex. 1002).
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`
`
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`1 Johannes Drach at al., Treatment of Mantle Cell Lymphoma: Targeting the
`Microenvironment, 5 EXPERT REV. ANTICANCER THER. 477–485 (2005) (Ex.
`1003, “Drach”). We refer to the page numbers of the exhibit, rather than the
`page numbers of the journal article.
`2 Jerome B. Zeldis, U.S. Patent Application Publication US 2004/0029832
`A1, published February 12, 2004 (Ex. 1004, “Zeldis”).
`3 Christiane Querfeld et al., Preliminary Results of a Phase II Study of CC-
`5013 (Lenalidomide, Revlimid®) in Patients with Cutaneous T-Cell
`Lymphoma, 106 BLOOD 3351 (2005) (Ex. 1005, “Querfeld”).
`4 Celgene Press Release, titled “Revlimid® (Lenalidomide) Clinical Results
`in Non-Hodgkins Lymphoma Presented at the 11th Congress of the European
`Hematology Association” (2006) (Ex. 1006, “Celgene Press Release”).
`2
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`IPR2018-00685
`Patent 8,741,929 B2
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`Celgene Corporation (“Patent Owner”) filed a Preliminary Response
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`(Paper 6, “Prelim. Resp.”).
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`In the Decision on Institution (Paper 8, “Decision” or “Inst. Dec.”),
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`we determined that the Petition failed to establish a reasonable likelihood
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`that Petitioner would prevail in establishing the unpatentability of at least
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`one claim challenged in the Petition, and declined to institute an inter partes
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`review on any of the three grounds asserted. Specifically, with respect to
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`grounds I and II, we declined to institute pursuant to our discretion under
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`35 U.S.C. § 325(d). Inst. Dec. 22–26. With respect to ground III, we
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`determined that Petitioner had not met its burden of establishing that the
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`Celgene Press Release was available as a printed publication. Id. at 27–31.
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`Petitioner’s Request for Rehearing (Paper 9, “Req. Reh’g”) seeks
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`rehearing of our decision to deny institution of grounds I and II only.
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`For the reasons set forth below, we deny the relief requested.
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`II. STANDARD OF REVIEW
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`
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`A party requesting rehearing bears the burden of showing that a
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`decision should be modified. 37 C.F.R. § 42.71(d). The party must identify
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`all matters it believes the Board misapprehended or overlooked, and the
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`place where each matter was addressed previously in a motion, an
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`opposition, or a reply. Id. When rehearing a decision on petition, we review
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`the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of
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`discretion occurs when a “decision was based on an erroneous conclusion of
`
`law or clearly erroneous factual findings, or . . . a clear error of judgment.”
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`3
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`IPR2018-00685
`Patent 8,741,929 B2
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`PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567
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`(Fed. Cir. 1988) (citations omitted).
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`III. DISCUSSION
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`35 U.S.C. § 325(d)
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`In the Decision, we evaluated Petitioner’s arguments and evidence
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`with respect to grounds I and II, together with the prosecution history of the
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`’929 patent, in light of the non-exclusive factors outlined in Becton,
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`Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at
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`17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph).
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`Inst. Dec. 22–26. The Becton, Dickinson factors are as follows:
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`(a) the similarities and material differences between the asserted
`art and the prior art involved during examination; (b) the
`cumulative nature of the asserted art and the prior art evaluated
`during examination; (c) the extent to which the asserted art was
`evaluated during examination, including whether the prior art
`was the basis for rejection; (d) the extent of the overlap between
`the arguments made during examination and the manner in
`which Petitioner relies on the prior art or Patent Owner
`distinguished the prior art; (e) whether Petitioner has pointed
`out sufficiently how the Examiner erred in its consideration of
`the asserted prior art; and (f) the extent to which additional
`evidence and facts presented in the Petition warrant
`reconsideration of the asserted prior art or arguments.
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`Factors (a), (b), and (d) relate to whether the art and arguments
`
`presented in the petition are the same or substantially the same as those
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`previously presented to the Office. Advanced Bionics, LLC v. Med-El
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`Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 10 (Feb. 13,
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`4
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`IPR2018-00685
`Patent 8,741,929 B2
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`2020) (precedential). Factors (c), (e), and (f) “relate to whether the
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`petitioner has demonstrated a material error by the Office” in its prior
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`consideration of that art or arguments. Id. If the same or substantially the
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`same art or arguments were previously presented to the Office, we then
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`consider whether petitioner has demonstrated the Office erred. Id.
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`In evaluating the Petition and accompanying evidence in light of the
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`Becton, Dickinson factors, we determined that grounds I and II were “based
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`on substantially the same prior art and arguments previously presented to the
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`office,” and that Petitioner had “neither sufficiently pointed out how the
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`Examiner erred, nor provided additional evidence or facts that warrant
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`reconsideration of the Examiner’s decision.” Inst. Dec. 26. Accordingly,
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`we exercised our discretion under 35 U.S.C. §325(d) and denied institution
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`of grounds I and II on that basis.
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`According to Petitioner, our analysis erred in several crucial respects.
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`We will address each of these purported errors in turn, but first, to provide
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`context, we reproduce illustrative claim 1, and briefly discuss the basis of
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`our decision to deny institution. Claim 1 is as follows:
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`A method of treating mantle cell lymphoma in a human, which
`comprises (a) administering to a human having mantle cell
`lymphoma from about 5 mg to about 25 mg per day of 3-(4-
`amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione[5]
`or a pharmaceutically acceptable salt or hydrate thereof for 21
`days followed by seven days rest in a 28 day cycle; and (b)
`
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`5 The compound recited in claim 1 is “also known as lenalidomide,
`Revlimid® or Revimid®.” Ex. 1001, 1:19–23.
`5
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`IPR2018-00685
`Patent 8,741,929 B2
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`repeating step (a), wherein the mantle cell lymphoma is
`relapsed, refractory, or relapsed and refractory to conventional
`therapy.
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`Ex. 1001, 23:63–24:4.
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`The Examiner issued a final office action rejecting the claims that
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`eventually issued as challenged claims 1–4, 8, 9, 15, and 20 as obvious over
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`Zeldis, in view of three additional references: Damaj,6 Wilson,7 and
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`Kaufmann.8 Ex. 2007 (excerpt of the file history of the ’929 patent), 4, 36,
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`61; Inst. Dec. 14, 22. In particular, the Examiner found that one of skill in
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`the art would “have been imbued with at least a reasonable expectation that
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`[lenalidomide] would be effective in treating mantle cell lymphoma given
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`the broad spectrum anticancer [activity] of this compound as demonstrated
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`by Zeldis.” Ex. 2007, 69; Inst. Dec. 16. Nevertheless, after considering the
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`Declaration of Dr. Lei Zhang (Ex. 10089) and Goy, an underlying reference
`
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`6 G. Damaj et al., Thalidomide Therapy Induces Response in Relapsed
`Mantle Cell Lymphoma, 17 LEUKEMIA 1914–1915 (2003) (Ex. 2009,
`“Damaj”).
`7 Edward A. Wilson et al., Response to Thalidomide in Chemotherapy-
`Resistant Mantle Cell Lymphoma: a Case Report, 119 BRITISH JOURNAL OF
`HAEMATOLOGY 128–130 (2002) (Ex. 2008, “Wilson”).
`8 Hannes Kaufmann et al., Antitumor Activity of Rituximab Plus
`Thalidomide in Patients with Relapsed/Refractory Mantle Cell Lymphoma,
`104 BLOOD 2269-2271 (2004) (Ex. 2010, “Kaufmann”).
`9 Declaration of Lei Zhang, M.D., submitted under 37 C.F.R. § 1.132, and
`dated October 15, 2013 (Ex. 1008, “Zhang Declaration” or “Zhang Decl.”).
`6
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`IPR2018-00685
`Patent 8,741,929 B2
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`(Ex. 200610), the Examiner ultimately concluded that Applicant’s evidence
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`of unexpected results outweighed the evidence supporting the initial
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`determination that it would have been prima facie obvious for one of
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`ordinary skill in the art to use lenalidomide to treat mantle cell lymphoma.
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`Ex. 2007, 81–82; Inst. Dec.18.
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`In the Decision, we observed that the Zeldis reference relied on by
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`Petitioner in grounds I and II is the same reference relied on by the
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`Examiner during prosecution. Moreover, we noted that Petitioner’s
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`challenges with respect to Zeldis were based on essentially the same
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`disclosures relied on during prosecution. Inst. Dec. 22. That is, both the
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`Examiner and Petitioner relied on Zeldis as disclosing that lenalidomide, an
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`analog of thalidomide, is a preferred immunomodulatory compound in
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`treating various forms of lymphoma, including non-Hodgkin’s lymphomas
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`and B-cell lymphomas; that lenalidomide is more potent than thalidomide in
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`several respects; and that it can be safely administered according to the
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`claimed dosage schedule. Inst. Dec. 14–15, 22 (citing Ex. 2007, 62–70;
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`Pet. 16–17).
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`
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`We further observed that Drach, an article reviewing treatment
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`protocols for mantle cell lymphoma (MCL), although not relied on during
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`prosecution, was listed on an IDS and indicated as considered by the
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`
`10 Andre Goy et al., Single-Agent Lenalidomide in Patients with Mantle-Cell
`Lymphoma Who Relapsed or Progressed After or Were Refractory to
`Bortezomib: Phase II MCL-001 (EMERGE) Study, 31 JOURNAL OF CLINICAL
`ONCOLOGY 3688–3695 (2013) (Ex. 2006, “Goy”).
`7
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`Patent 8,741,929 B2
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`Examiner, and was also cited in the Background section of the ’939 patent.
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`Inst. Dec. 22–23 (citing Ex. 2007, 28; Ex. 1001, 2:4–6). Moreover, we
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`noted that Damaj, Wilson, and Kaufmann each were summarized in Drach,
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`and that the Examiner cited each of those references as evidence that it was
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`known to administer thalidomide to patients with relapsed and/or refractory
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`mantle cell lymphoma. Inst. Dec. 16, 22 (citing Ex. 2007, 4, 36, 61). We
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`further noted that the Examiner also clarified that “mantle cell lymphoma is
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`a type of non-Hodgkin’s lymphoma/B-cell lymphoma.” Inst. Dec. 16; Ex.
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`2007, 69.
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`We noted that Querfeld discloses the results of a Phase II clinical
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`study in which lenalidomide was administered orally to patients with
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`cutaneous T-cell lymphoma, and three of eight patients experienced an
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`objective response after 1 to 3 cycles. Inst. Dec. 11; Ex. 1005, 2. Querfeld
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`was not relied on during prosecution, but we determined that the reference is
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`cumulative to Zeldis, in that it is relied on in this proceeding for teaching the
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`same 28-day cycles disclosed in Zeldis: 25 mg/day for 21 days, with seven
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`days rest between cycles—albeit for treating cutaneous T-cell lymphoma.
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`Inst. Dec. 23; Ex. 1005, 2.
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`Turning to Petitioner’s arguments, Petitioner contends that Drach,
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`“which discloses the clinical use of lenalidomide and was not substantively
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`considered by the Examiner” (Req. Reh’g 1), “discloses substantially more
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`than what was substantively considered by the Examiner” (id.). In
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`particular, Petitioner contends that Drach discloses that lenalidomide “was
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`8
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`IPR2018-00685
`Patent 8,741,929 B2
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`successful in treating multiple myeloma (a B-cell cancer like MCL)” and
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`“was the subject of various clinical trials including those related to
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`lymphoma (MCL is a lymphoma).” Id. at 4. Petitioner contends we
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`erroneously found that Drach “was cumulative of references the Examiner
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`considered that focused only on the use of thalidomide to treat MCL” (id. at
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`1), even though “the publications before the Examiner make no reference to
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`lenalidomide whatsoever, much less the clinical application of that drug” (id.
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`at 4).
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`These arguments are unpersuasive. We did not find that Drach’s
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`disclosures regarding lenalidomide were cumulative to the references
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`considered by the Examiner. Rather, we observed that Petitioner relied on
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`Drach “in large part for its summaries of Damaj, Wilson, and Kaufmann . . .
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`and for the same reason as the Examiner: as evidence that it was known to
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`administer thalidomide to patients with patients with relapsed and/or
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`refractory mantle cell lymphoma.” Id. at 23 (emphasis added). “Thus,” we
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`continued, “Drach is cumulative to Damaj, Wilson, and Kaufmann in at
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`least that respect.” Id. (emphasis added).
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`In addition, Petitioner’s contention that “the publications before the
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`Examiner make no reference to lenalidomide whatsoever, much less the
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`clinical application of that drug” (Req. Reh’g 4), is misleading. It is true that
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`Damaj, Wilson, and Kaufmann do not mention lenalidomide. Nevertheless,
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`in the Decision we noted that Zeldis explicitly describes several Phase I
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`clinical studies designed to determine the maximum tolerated dose of
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`9
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`IPR2018-00685
`Patent 8,741,929 B2
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`lenalidomide in patients with relapsed multiple myeloma, malignant
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`melanoma, metastatic melanoma, carcinoma of the pancreas, renal
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`carcinoma, breast carcinoma, non-small cell lung carcinoma, adrenal
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`carcinoma, malignant mesothelioma, refractory solid tumors and/or
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`lymphomas. Inst. Dec. 8–9 (citing Ex. 1004 ¶¶ 238–247, 258). We further
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`noted that Zeldis teaches that lenalidomide “may be administered in an
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`amount of from about 5 to 25 mg per day,” and may be administered in four-
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`week cycles—25 mg/day for 21 days, with 7 days rest before resuming the
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`next cycle. Inst. Dec. 9 (citing Ex. 1004 ¶¶ 113, 229).
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`Similarly, Petitioner contends that we “misapprehended that the
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`Querfeld reference, which was not considered during prosecution, was
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`cumulative of the Zeldis reference.” Id. at 2. Petitioner acknowledges that
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`both Zeldis and Querfeld disclose the same dosage schedule—the same
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`schedule required by the claims (Req. Reh’g 7)—but contends that we
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`misapprehended that Querfeld “additionally discloses the use of such dosing
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`regimens in patients being treated for cutaneous T-Cell lymphoma during a
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`Phase II clinical trial” (id. at 7–8). According to Petitioner, “[t]his
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`distinction is crucial, because the clinical application of lenalidomide in a
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`phase II clinical study provides further evidence of reasonable expectation of
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`success . . . that lenalidomide could be used in the claimed dosages and
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`regimens for treatment of MCL.” Id. at 8. Petitioner contends “[t]his
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`distinction also undercuts allegations of unexpected results” and “Querfeld
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`10
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`IPR2018-00685
`Patent 8,741,929 B2
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`was relied upon by Petitioners and by Dr. Thirman for at least that purpose.”
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`Id.
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`These arguments are not persuasive. We agree with Petitioner that
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`Querfeld “provides further evidence of reasonable expectation of success,”
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`but as we explained in Decision, Querfeld teaches the same dosage schedule
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`taught by Zeldis, and the Examiner already found a reasonable expectation
`
`of success based on the art cited during prosecution. According to the
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`Examiner, “[t]he skilled artisan would thus have been imbued with at least a
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`reasonable expectation that [lenalidomide] would be effective in treating
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`mantle cell lymphoma given the broad spectrum anticancer [activity] of this
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`compound as demonstrated by Zeldis.” Inst. Dec. 16, 23; Ex. 2007, 69. As
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`for Petitioner’s contention that Querfeld was also relied on as undercutting
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`allegations of unexpected results, Petitioner does not identify, and we do not
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`find, where Querfeld is addressed in that context in the Petition or Dr.
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`Thirman’s Declaration.
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` Further, with respect to Drach, Petitioner contends that we
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`disregarded our own finding that Drach was “stronger evidence” of
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`obviousness than the references relied on during prosecution. Req. Reh’g 6.
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`Petitioner contends “Drach discloses a crucial teaching concerning the use of
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`lenalidomide to treat MCL, namely that ‘thalidomide and its analogs (e.g.,
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`lenalidomide) are therefore important agents for the new treatment paradigm
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`of targeting both the tumor cell and its microenvironment (mainly by
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`11
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`IPR2018-00685
`Patent 8,741,929 B2
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`interference with tumor-stromal interactions) [i.e. MCL].’” Id. (citing
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`Ex. 1003, 10).
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`Again, Petitioner’s argument is unpersuasive. In the Decision, we
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`acknowledged that Petitioner additionally relied on Drach’s “explicit
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`suggestion for using lenalidomide in MCL treatment.” Inst. Dec. 23.
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`Although we had reservations about whether Drach “makes an ‘explicit’
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`suggestion to use lenalidomide to treat MCL,” we agreed that it would be “a
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`logical inference, given Drach’s particular focus on treatment of mantle cell
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`lymphoma.” Id. We did not disregard our finding that Drach provided
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`“somewhat stronger evidence” of obviousness than the references relied on
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`during prosecution. Id. Rather, we agreed with Petitioner that Drach and
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`Zeldis would have provided a reason for one of ordinary skill in the art to
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`administer lenalidomide to patients with relapsed and/or refractory MCL.
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`Similarly, we agreed with the Examiner’s determination that the combined
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`teachings of Zeldis, Damaj, Wilson, and Kaufmann would have provided a
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`reason to do so. Nevertheless, a reason to modify a reference in the manner
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`required by the claims is only one aspect of the ultimate conclusion on
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`obviousness—which brings us to Petitioner’s contentions regarding the
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`impact of unexpected results on the ultimate conclusion of obviousness.
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`Petitioner contends that its witness, Dr. Thirman, “squarely disagreed
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`with the declaration of Dr. Zhang, which was submitted by Patent Owner
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`during prosecution, on the issue of unexpected results” as well as “many
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`factual assertions of Patent Owner in its Preliminary Response regarding
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`12
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`Patent 8,741,929 B2
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`reasonable expectation of success and unexpected results.” Id. Petitioner
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`contends “[s]uch factual disputes should have been viewed in a light most
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`favorable to the Petitioner and should ultimately be resolved at trial.” Id.
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`As we explained in the Decision, Petitioner bears the burden of
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`proving unpatentability in an inter partes review, but in this case, Petitioner
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`“ha[d] neither sufficiently pointed out how the Examiner erred, nor provided
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`additional evidence or facts that warrant reconsideration of the Examiner’s
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`decision.” Inst. Dec. 26. Although Dr. Thirman expressed disagreement
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`with the Examiner and Dr. Zhang on the issue of unexpected results, he did
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`not explain how the Examiner erred, nor did he point to any particular
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`“factual assertions of Patent Owner” that were in error, or address Dr.
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`Zhang’s Declaration and supporting evidence in any substantive way.
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`Essentially, Dr. Thirman summarized the teachings of Zeldis and
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`Drach (Ex. 1002 ¶¶ 62–82), and stated that those teachings “would have
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`provided a clear guidance/motivation for a [person of skill in the art] to use,
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`or substitute thalidomide with, lenalidomide as a treatment for relapsed
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`and/or refractory MCL with a reasonable expectation of success” (id. ¶ 77).
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`Again, on this particular point, we agree with Petitioner and Dr. Thirman.
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`On the subject of unexpected results, Petitioner relied on the
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`following testimony of Dr. Thirman:
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`The prior art teaches, at least, the following: (1) thalidomide
`was being used to treat relapsed and/or refractory MCL
`(Drach), (2) thalidomide had undesirable side effects (Drach),
`(3) lenalidomide was a less toxic, more potent, structurally
`similar analogue of thalidomide being suggested for MCL
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`13
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`IPR2018-00685
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`treatment (Drach and Zeldis), and (4) lenalidomide could be
`used for MCL treatment in the dosages, dosage forms and
`cycling regimen claimed by the challenged claims of the ’929
`patent (Zeldis, Querfield [sic], Celgene Press Release).
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`Ex. 1002 ¶ 109. “Thus,” according to Dr. Thirman, “the alleged unexpected
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`properties would have been expected.” Ex. 1002 ¶ 110.
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`As we explained in the Decision, however, the Examiner maintained
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`during prosecution that Zeldis, Damaj, Wilson, and Kaufmann would have
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`given one of ordinary skill in the art a reason to use lenalidomide to treat
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`patients with relapsed and/or refractory mantle cell lymphoma, but
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`concluded that the evidence of obviousness was outweighed by Applicant’s
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`evidence of unexpected results—particularly the 28% overall response rate
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`in patients with relapsed and/or refractory mantle cell lymphoma. Inst. Dec.
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`17 & n.11, 18. As we further explained, Drach—given its particular focus
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`on treating mantle cell lymphoma—is stronger evidence than Damaj,
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`Wilson, and Kaufmann that one of ordinary skill in the art would have had a
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`reason to treat MCL patients with lenalidomide, but Drach is no more
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`informative as to unexpected results than the references the Examiner relied
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`on in making out a prima facie case of obviousness. Id. at 25.
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`Essentially, Petitioner and Dr. Thirman disagree with the Examiner’s
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`conclusion that, on balance, the subject matter of the challenged claims
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`would not have been obvious, in light of the level of response in patients
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`with relapsed and/or refractory MCL (as described in Dr. Zhang’s
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`Declaration and the underlying Goy reference), despite one of ordinary skill
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`14
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`in the art having had a reason to administer lenalidomide to treat MCL.
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`Nevertheless, neither Petitioner nor Dr. Thirman advanced any argument or
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`evidence tending to establish that the Examiner erred in evaluating or
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`balancing the evidence of unexpected results. We maintain, as we did in the
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`Decision on Institution, that Petitioner neither sufficiently pointed out how
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`the Examiner erred, nor provided additional evidence or facts that warrant
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`reconsideration of the Examiner’s decision. Dec. Inst. 26.
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`IV. CONCLUSION
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`
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`For the foregoing reasons, Petitioner has not demonstrated that we
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`abused our discretion in declining to institute an inter partes review of
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`claims 1–4, 8, 9, 15, and 20 of the ’929 patent.
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`Accordingly, it is ORDERED that the Request for Rehearing is
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`V. ORDER
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`denied.
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`15
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`IPR2018-00685
`Patent 8,741,929 B2
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`PETITIONER:
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`John J. Molenda
`Vishal Gupta
`Won Seon Choi
`STEPTOE & JOHNSON LLP
`lenalidomide@steptoe.com
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`PATENT OWNER:
`
`F. Dominic Cerrito
`Frank C. Calvosa
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`nickcerrito@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`J. Patrick Elsevier, Ph.D.
`CELGENE CORPORATIOMN
`pelsevier@cegene.com
`Christopher J. Harnett
`Anthony M. Insogan
`JONES DAY
`charnett@jonesday.com
`aminsogna@jonesday.com
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`16
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