Trials@uspto.gov
`Tel: 571.272.7822
`
` Paper No: 78
` Entered: September 8, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS VI, LLC,
`Petitioner,
`
`v.
`
`CELGENE CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2015-01096 (Patent 6,315,720 B1)
`Case IPR2015-01102 (Patent 6,315,720 B1)
`Case IPR2015-01103 (Patent 6,315,720 B1)1
`____________
`
`Before MICHAEL P. TIERNEY, Vice Chief Administrative Patent Judge,
`GRACE KARAFFA OBERMANN, and TINA E. HULSE, Administrative
`Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`DECISION
`Granting Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`1 Patent Owner filed a substantially identical Request for Rehearing in each
`proceeding. IPR2015-01096, Paper 74; IPR2015-01102, Paper 76;
`IPR2015-01103, Paper 77. This Decision addresses issues common to all
`cases. Accordingly, we issue a single Decision to be entered in each case.
`For convenience, we refer to papers filed in IPR2015-01096.
`
`
`Tel: 571.272.7822
`
` Paper No: 78
` Entered: September 8, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS VI, LLC,
`Petitioner,
`
`v.
`
`CELGENE CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2015-01096 (Patent 6,315,720 B1)
`Case IPR2015-01102 (Patent 6,315,720 B1)
`Case IPR2015-01103 (Patent 6,315,720 B1)1
`____________
`
`Before MICHAEL P. TIERNEY, Vice Chief Administrative Patent Judge,
`GRACE KARAFFA OBERMANN, and TINA E. HULSE, Administrative
`Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`DECISION
`Granting Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`1 Patent Owner filed a substantially identical Request for Rehearing in each
`proceeding. IPR2015-01096, Paper 74; IPR2015-01102, Paper 76;
`IPR2015-01103, Paper 77. This Decision addresses issues common to all
`cases. Accordingly, we issue a single Decision to be entered in each case.
`For convenience, we refer to papers filed in IPR2015-01096.
`
`
`
`IPR2015-01096 (Patent 6,315,720 B1)
`IPR2015-01102 (Patent 6,315,720 B1)
`IPR2015-01103 (Patent 6,315,720 B1)
`
`
`
`
`I. INTRODUCTION
`On November 25, 2016, Celgene Corporation (“Patent Owner”) filed
`a Request for Rehearing of the Final Written Decision. Paper 74 (“Req.”).
`In the Final Written Decision, we held that claims 1–32 of U.S. Patent
`No. 6,315,720 B1 (“the ’720 patent”) are unpatentable. Paper 73, (“Dec.”).
`The Request for Rehearing is confined to our holding that claim 10 is
`unpatentable. Req. 1; see Dec. 27–28 (addressing claim 10).
`For reasons that follow, we grant the Request for Rehearing. We are
`persuaded that the Final Written Decision should be modified as to claim 10.
`Specifically, we hold that Petitioner fails to establish by a preponderance of
`the evidence that claim 10 of the ’720 patent is unpatentable. This Decision
`does not disturb our holding, stated in the Final Written Decision, that
`Petitioner establishes by a preponderance of the evidence that claims 1–9
`and 11–32 are unpatentable. Dec. 34.
`
`II. ANALYSIS
`Patent Owner asserts that the Board overlooked or misapprehended
`evidence and arguments showing that the subject matter of claim 10 would
`not have been obvious under 35 U.S.C. § 103(b). Req. 1.
`In pertinent part, 37 C.F.R. § 42.71(d) states:
`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.
`
`
`
`2
`
`
`
`IPR2015-01096 (Patent 6,315,720 B1)
`IPR2015-01102 (Patent 6,315,720 B1)
`IPR2015-01103 (Patent 6,315,720 B1)
`
`
`Claim 10 depends from claim 7, which depends from claim 1.
`Claim 1 requires, inter alia, defining a set of information to be obtained
`from a patient. Ex. 1001, 18:30–31. Claim 7 further requires that the
`“information to be obtained” from the patient “includes the results of
`diagnostic testing.” Id. at 18:59–60. Claim 10 requires that “said diagnostic
`testing comprises genetic testing.” Id. at 18:66–67.
`In the Final Written Decision, we found that the subject matter of
`claim 10 would have been obvious, even though “the references of record do
`not disclose or suggest genetic testing.” Dec. 27–28. On that point, we
`credited Dr. Fudin’s declaration testimony that genetic testing was a known
`diagnostic procedure as of the effective filing date of the ’720 patent. Id.
`at 28. We reasoned that Dr. Fudin’s testimony was consistent with FDA
`Meeting Minutes (Ex. 1013), which contained a statement from a Dr.
`Holmes, said to represent the American College of Medical Genetics and the
`Teratology Society. Ex. 1013, 137. Specifically, Mr. Holmes stated that:
`It may seem strange to you that a genetics society would be
`standing here, commenting on potential environmental
`exposures with awful fetal effects, but many clinical geneticists
`around the country are expected to provide counseling to
`pregnant women about exposures in pregnancies, so the
`geneticists, in fact, are often the clinical teratologists. And I am
`speaking myself as an active clinical teratologist in the Boston
`area.
`
`Id.
`
`Based on that objective support, we held “that the genetic testing of
`dependent claim 10 represents a combination of known elements for their
`known use to achieve a predictable result, genetic testing to obtain
`information for diagnosis and treatment.” Dec. 28. Having reconsidered the
`
`
`
`3
`
`
`
`IPR2015-01096 (Patent 6,315,720 B1)
`IPR2015-01102 (Patent 6,315,720 B1)
`IPR2015-01103 (Patent 6,315,720 B1)
`
`record on rehearing, however, we find that this finding is not supported by a
`preponderance of the evidence.
`As an initial matter, Patent Owner argues that the Board improperly
`shifted the burden of proof by holding that Patent Owner “did not dispute
`that genetic testing was known in the art for obtaining diagnostic
`information.”2 Req. 3 (quoting Dec. 27). Patent Owner, in fact, timely
`disputed that genetic testing would have been understood as common in the
`art, and identified a gap in Petitioner’s evidence on that point. Req. 3 (citing
`PO Resp. 45–56). Specifically, Patent Owner pointed to the absence of
`disclosure in the asserted prior art, which teaches various other tests but not
`genetic testing. PO Resp. 46. Patent Owner argued that the lack of
`disclosure in the record evidence “undermines Dr. Fudin’s opinion that such
`testing was ‘common.’” Id.
`We agree that the proper focus is not whether Patent Owner disputed
`that fact, but whether Petitioner came forward with evidence sufficient to
`demonstrate that genetic testing was known and would have been used in the
`combination required by claim 10. We also agree that the lack of disclosure
`in the prior art of record—coupled with the record’s disclosure of other
`types of tests—cuts against a finding “that genetic testing would be used, let
`alone that it would have been common.” Req. 3. Dr. Fudin states that “[i]t
`was common in the art at the time of” the invention “to conduct genetic
`
`2 Patent Owner asserts that in its Patent Owner Response it did dispute that
`genetic testing was known in the art or common. Req. 3. Other than citing
`its entire argument regarding claim 10, which we already address throughout
`this Decision, Patent Owner does not identify any specific argument or
`evidence that we overlooked or misapprehended in connection with this
`assertion. Id.
`
`
`
`4
`
`
`
`IPR2015-01096 (Patent 6,315,720 B1)
`IPR2015-01102 (Patent 6,315,720 B1)
`IPR2015-01103 (Patent 6,315,720 B1)
`
`testing at the same time as the pregnancy testing taught in” the prior art, but
`directs us to no disclosure in the asserted prior art, or any other objective
`evidence, on point. Pet. 27–31 (citing Ex. 1021 ¶¶ 141–143).
`On that point, Dr. Fudin does not cite, or otherwise explain the
`significance of, the disclosure in the FDA Meeting Minutes that we relied
`upon in the Final Written Decision. Ex. 1021 ¶¶ 140–143. PO Resp. 45–46;
`Pet. 58 (citing Ex. 1021 ¶¶ 229–231); Dec. 28. That disclosure, cited for the
`first time in Petitioner’s Reply3, does not refer to genetic testing, much less
`suggest using genetic testing in the combination required by claim 10.
`Reply 25–26 (citing Ex. 10764, 137); see Req. 3 (arguing on rehearing that
`the Petitioner “relied solely on a single passage” in the FDA Meeting
`Minutes “that focuses on the geneticist acting as a clinical teratologist that
`might counsel patients on the risks of exposure”) (citing Reply 25–26;
`Ex. 1013, 137). Patent Owner correctly points out that “the cited passage
`says nothing about genetic testing, nor does it suggest such testing.” Req. 3
`(emphasis omitted); Ex. 1013, 137; Ex. 1076, 137.
`We find that the FDA Meeting Minutes fail to support adequately
`Dr. Fudin’s opinion testimony that genetic testing would have been common
`at the time of the invention. Contrary to “Dr. Fudin’s opinion that [genetic]
`testing was ‘common,’” the asserted prior art references do not disclose,
`teach, or suggest genetic testing, “despite disclosing various other types of
`
`
`3 The Petition cites other disclosures in the FDA Meeting Minutes to support
`arguments unrelated to the genetic testing limitation of claim 10. Pet. 13–14
`(citing Ex. 1013).
`4 The same material appears on page 137 of Exhibit 1013, which is cited in
`the Final Written Decision. Dec. 28.
`
`
`
`5
`
`
`
`IPR2015-01096 (Patent 6,315,720 B1)
`IPR2015-01102 (Patent 6,315,720 B1)
`IPR2015-01103 (Patent 6,315,720 B1)
`
`tests.” Req. 2; PO Resp. 46. Given that Dr. Fudin’s opinion on that point is
`unsupported by objective evidence, we assign his testimony little weight in
`the analysis of claim 10. Req. 2–3; PO Resp. 46 (citing 37 C.F.R. § 42.65(a)
`and Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294
`(Fed. Cir. 1985)). The gap in the disclosures of the prior art, occurring at or
`near the time of the invention, carries more weight than the much later,
`unsupported opinion of Dr. Fudin.
`Petitioner fails to demonstrate that it would have been obvious at the
`time of the invention to use genetic testing in the method of claim 10.
`Req. 3. The objective evidence on point consists of a single paragraph from
`the FDA Meeting Minutes, raised in Petitioner’s Reply, which is not relied
`upon in the relevant witness testimony, and does not disclose genetic testing.
`Accordingly, we hold that Petitioner fails to establish by a preponderance of
`the evidence that claim 10 is unpatentable.
`
`II. CONCLUSION
`For the foregoing reasons, Patent Owner establishes that the Final
`Written Decisions in each proceeding should be modified to hold that, based
`on the record developed in this proceeding, a preponderance of the evidence
`demonstrates that claim 10 is not proven unpatentable.
`III. ORDER
`
`It is
`ORDERED that the Request for Rehearing is granted;
`FURTHER ORDERED that the Final Written Decision is modified to
`hold that, based on the record developed in this proceeding, a preponderance
`of the evidence demonstrates that claim 10 is not proven unpatentable;
`
`
`
`6
`
`
`
`IPR2015-01096 (Patent 6,315,720 B1)
`IPR2015-01102 (Patent 6,315,720 B1)
`IPR2015-01103 (Patent 6,315,720 B1)
`
`
`FURTHER ORDERED that this Decision does not disturb the holding
`in the Final Written Decision that Petitioner establishes by a preponderance
`of the evidence that claims 1–9 and 11–32 are unpatentable.
`
`
`PETITIONER:
`Sarah E. Spires
`Parvathi Kota
`SKIERMONT PUCKETT LLP
`sarah.spires@skiermontpuckett.com
`parvathi.kota@skiermontpuckett.com
`
`PATENT OWNER:
`F. Dominic Cerrito
`Frank Calvosa
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`nickcerrito@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`Anthony M. Insogna
`Gasper LaRosa
`JONES DAY
`aminsogna@jonesday.com
`gjlarosa@jonesday.com
`
`
`
`
`
`
`7
`
`
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