`Filed August 14, 2014
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`Filed on behalf of: Sequenom, Inc.
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`By: Michael J. Wise (mwise@perkinscoie.com)
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`Patrick D. Morris (pmorris@perkinscoie.com)
`Perkins Coie LLP
`1888 Century Park East, Suite 1700
`Los Angeles, CA 90067-1721
`Telephone: (310) 788-3210
`Facsimile: (310) 788-3399
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SEQUENOM, INC.
`Petitioner
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`v.
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`THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR
`UNIVERSITY
`Patent Owner
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`SEQUENOM REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(d)
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`Case IPR2014-00337
`Patent 8,195,415
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`TABLE OF CONTENTS
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`IPR2014-00337
`Patent 8,195,415
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`INTRODUCTION .......................................................................................... 1
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`BACKGROUND ............................................................................................ 3
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`
`I.
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`II.
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`III. LEGAL STANDARD .................................................................................... 5
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`IV. ARGUMENT .................................................................................................. 6
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`A.
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`B.
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`Lo I Qualifies as Prior Art under 35 U.S.C. § 102(e) .......................... 6
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`Sequenom Will Suffer Prejudice if It Cannot Rely on Lo I and
`Other Prior Art References Cited in the Petition ............................... 11
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`V.
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`CONCLUSION ............................................................................................. 13
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`-i-
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`TABLE OF AUTHORITIES
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`IPR2014-00337
`Patent 8,195,415
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`
`Cases
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`Ex Parte Argasinski,
`Appeal 2008-3200, Decision on Appeal, 2009 WL 460669
`(B.P.A.I. Feb. 24, 2009) .......................................................................... 1, 7, 9, 10
`
`Focal Therapeutics, Inc. v. Senorx, Inc.,
`IPR2014-00116, Paper 8, 2014 WL 1651257 (P.T.A.B. Apr. 22,
`2014) ........................................................................................................... 2, 7, 10
`
`Ex Parte Gilde,
`Appeal 2011-012641, Decision on Appeal, 2014 WL 1154004
`(P.T.A.B. Mar. 20, 2014) ............................................................................ 2, 7, 10
`
`Ex Parte Green,
`Appeal 2010-002449, Decision on Appeal, 2011 WL 5116559
`(B.P.A.I. Oct. 25, 2011) ...............................................................................passim
`
`Lacavera v. Dudas,
`441 F.3d 1380 (Fed. Cir. 2006) ........................................................................ 5-6
`
`Ex parte Yamaguchi,
`88 U.S.P.Q. 2d 1606 (B.P.A.I. 2008) ..........................................................passim
`
`Statutes
`35 U.S.C. § 102(e) ............................................................................................passim
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`35 U.S.C. § 103 ...................................................................................................... 4, 6
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`35 U.S.C. § 111(b) .................................................................................................... 6
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`35 U.S.C. § 111(b)(5)............................................................................................. 8-9
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`35 U.S.C. § 119(e) ................................................................................................. 4, 8
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`35 U.S.C. § 122(b) ............................................................................................. 1, 6, 8
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`35 U.S.C. § 122(b)(2)(A)(iii) ..................................................................................... 8
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`-ii-
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`TABLE OF AUTHORITIES
` (continued)
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`IPR2014-00337
`Patent 8,195,415
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`Page
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`Regulations
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`37 C.F.R. § 1.14(a)(1)(iv) .......................................................................................... 9
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`37 C.F.R. § 1.14(a)(1)(iv)-(vi) ................................................................................... 8
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`37 C.F.R. § 1.211(a) ................................................................................................... 9
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`37 C.F.R. § 42.71(c) ................................................................................................... 5
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`37 C.F.R. § 42.71(d) .............................................................................................. 1, 5
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`-iii-
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`IPR2014-00337
`Patent 8,195,415
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`I.
`
`INTRODUCTION
`Petitioner Sequenom, Inc. ("Sequenom") requests a rehearing under 37
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`C.F.R. § 42.71(d) regarding the Board's July 16, 2014 Decision Denying Institution
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`of Inter Partes Review (Paper 11). The Board denied Sequenom's petition
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`"because Lo I [a provisional patent application] is neither a patent nor an
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`application for patent published under 35 U.S.C. § 122(b)" so the Board concluded
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`that Lo I "does not qualify under 35 U.S.C. § 102(e) as prior art to the claims of the
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`'415 patent." Paper 11 at 4.
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`The Board abused its discretion by overlooking controlling case law in Ex
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`parte Yamaguchi, 88 U.S.P.Q. 2d 1606 (B.P.A.I. 2008). In that case, the Board
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`held that even though provisional patent applications are not published under 35
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`U.S.C. § 122(b), they become public when corresponding utility applications are
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`published, and thus qualify as prior art under 35 U.S.C. § 102(e) "like a regular
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`utility application" and "constitute[] prior art for all that [they] teach[]."
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`Yamaguchi, 88 U.S.P.Q. 2d at 1611-12. Other panels of this Board have followed
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`the precedential decision in Yamaguchi and found that a provisional application to
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`which an application published under 35 U.S.C. § 122(b) claims priority qualifies
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`as § 102(e) prior art. Ex Parte Argasinski, Appeal 2008-3200, Decision on Appeal
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`at 3 n.2, 2009 WL 460669, at *4 n.2 (B.P.A.I. Feb. 24, 2009) ("We note that the
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`Ferreira 60/182,282 reference is the provisional application for the Ferreira utility
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`patent application publication, US 2001/0034661 A1. We consider Ferreira's
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`60/182,282 provisional application available as prior art in accordance with Ex
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`parte Yamaguchi[.]"); Ex Parte Green, Appeal 2010-002449, Decision on Appeal
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`1
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`
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`at 3 n.2, 2011 WL 5116559, at *5 n.2 (B.P.A.I. Oct. 25, 2011) ("Nevertheless, as in
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`IPR2014-00337
`Patent 8,195,415
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`the earlier decision, we rely exclusively on Kuwata's provisional application
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`('Kuwata '180') in this opinion—a document whose qualification as prior art is
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`undisputed.").
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`The Board has reached the same conclusion in recent decisions even without
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`citing Yamaguchi. See, e.g., Ex Parte Gilde, Appeal 2011-012641, Decision on
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`Appeal at 5-6, 2014 WL 1154004, at *3 (P.T.A.B. Mar. 20, 2014) ("Although the
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`Vermeulen provisional application was not published, it became disseminated and
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`available for public inspection upon the publication of the Vermeulen pre-grant
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`document. We hold the Vermeulen provisional application to be a valid prior-art
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`reference against the presently rejected claims."); Focal Therapeutics, Inc. v.
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`Senorx, Inc., IPR2014-00116, Paper 8 at 3-4, 15, 19, 2014 WL 1651257, at *2,
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`*10, *13 (P.T.A.B. Apr. 22, 2014) (relying on provisional applications that
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`correspond to published utility applications as prior art in an inter partes review).
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`Under the precedent of this Board, the Lo I provisional application that Sequenom
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`relies on in its Petition is prior art, and the Board erred in finding otherwise.
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`The Board's decision on this issue matters because the Lo I provisional
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`application has a filing date earlier than any prior invention date alleged by Patent
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`Owner in a previous proceeding, IPR2013-00390 (the "'390 IPR"). If Patent
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`Owner can make good on its prior invention claim in the '390 IPR, Sequenom's
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`ability to rely on the Lo I provisional application and its earlier filing date in this
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`proceeding would be critical to proving unpatentability.
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`2
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`IPR2014-00337
`Patent 8,195,415
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`For these reasons, Sequenom asks the Board to reconsider its decision and
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`institute an inter partes review based on the Petition.
`II. BACKGROUND
`In this proceeding, Sequenom requests inter partes review of U.S. Patent
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`No. 8,195,415 (the "'415 patent") (Ex. 1001) based on the Lo I provisional
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`application (U.S. Provisional Patent Application 60/951,438; Ex. 1003) in
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`combination with other prior art references.
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`Before filing the Petition, Sequenom requested, and the Board instituted, the
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`'390 IPR relating to the '415 patent. There, Sequenom originally sought inter
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`partes review for obviousness based on Lo I, as well as for anticipation and
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`obviousness based on the Lo II published patent application (U.S. Patent
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`Application Publication No. 2009/0029377; Ex. 1002). The Board denied
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`Sequenom's request relating to Lo I, but instituted a review based on Lo II. In
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`particular, the Board determined that Sequenom's arguments based on Lo I were
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`"redundant" of its arguments based on Lo II. Ex. 1017 at 21.
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`Sequenom requested that the Board reconsider its ruling in the '390 IPR,
`noting that Lo I is not redundant of Lo II at least because Lo I's filing date is a full
`year earlier. Ex. 1018 at 7. That difference matters because while the Board was
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`still considering whether to institute a review in the '390 IPR, as part of
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`Interference No. 105,922 involving the '415 patent, Patent Owner filed a notice that
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`it intended to prove a conception date of December 18, 2007, which is earlier than
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`the filing date of Lo II but later than the filing date of Lo I. Ex. 1014 at 2.
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`3
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`Sequenom's request for rehearing also pointed out that the unpatentability
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`IPR2014-00337
`Patent 8,195,415
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`arguments relating to Lo I and Lo II are different, including because Sequenom
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`relies on different references in combination with Lo I. Ex. 1018 at 10.
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`Ultimately, the Board denied Sequenom's request for rehearing in the '390
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`IPR, stating that "Lo II expressly claims the benefit of Lo I under 35 U.S.C.
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`§ 119(e), and, indeed, incorporates by reference the entire contents of Lo I" and
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`"[t]hus, Lo II has the same effective patent-defeating date as Lo I for disclosure
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`that the two references have in common." Ex. 1019 at 4. The Board also stated
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`that "Sequenom's conjecture as to what evidence of prior invention [Patent Owner]
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`might file" was "too speculative a basis on which to distinguish its challenges." Id.
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`Not long after the Board denied Sequenom's request for rehearing, Patent Owner
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`submitted alleged prior invention evidence as part of its opposition, including
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`notebooks, emails, papers, and witness declarations. Ex. 1020 at 29-60 (citing
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`Exhibits 2109-2113, 2118-2135, 2138, and 2139 in the '390 IPR). The earliest of
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`that alleged evidence is dated December 18, 2007, which is nearly five months
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`after the filing date of Lo I.
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`Meanwhile, before the Board instituted the '390 IPR, Lo—a party for whom
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`Sequenom is the real party-in-interest in the '390 IPR and this proceeding—
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`requested permission to file a motion in Interference No. 105, 922 that the '415
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`patent's claims are unpatentable under §§ 102 and 103 based on Lo II, Lo I, and
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`other prior art references. Ex. 1021 at 1-2. The Board denied that request after it
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`had instituted the '390 IPR. Ex. 1022 at 2. In its decision, the Board explained that
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`4
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`Lo would have the opportunity to pursue the relief it was seeking during the inter
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`IPR2014-00337
`Patent 8,195,415
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`partes review involving Sequenom. Id. Lo asked the Board to reconsider its
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`ruling in light of the limited scope of the '390 IPR, but the Board declined. Ex.
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`1023, Ex. 1024.
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`In addition to its request for rehearing in the '390 IPR and Lo's efforts to
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`seek permission to file a motion in Interference No. 105,922, Sequenom also filed
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`its Petition in this proceeding, asking the Board to institute an inter partes review
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`based on Lo I in combination with other prior art. See Paper 5. But for the third
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`time, the Board denied Sequenom's request relating to Lo I, ruling that Lo I did not
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`qualify as prior art under 35 U.S.C. § 102(e) because it is an unpublished
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`provisional patent application. Paper 11 at 3-4. In doing so, however, the Board
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`erred in interpreting the law and thus abused its discretion.
`III. LEGAL STANDARD
`When rehearing a decision on a petition to institute an inter partes review,
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`the Board "will review the decision for an abuse of discretion." 37 C.F.R.
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`§ 42.71(c). The party requesting rehearing has the burden of showing the decision
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`should be modified, and "[t]he request must specifically identify all matters the
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`party believes the Board misapprehended or overlooked, and the place where each
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`matter was previously addressed in a motion, an opposition, or a reply." 37 C.F.R.
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`§ 42.71(d).
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`"An abuse of discretion occurs where the decision is based on an erroneous
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`interpretation of the law, on factual findings that are not supported by substantial
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`5
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`evidence, or represents an unreasonable judgment in weighing relevant factors."
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`IPR2014-00337
`Patent 8,195,415
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`Lacavera v. Dudas, 441 F.3d 1380, 1383 (Fed. Cir. 2006).
`IV. ARGUMENT
`A. Lo I Qualifies as Prior Art under 35 U.S.C. § 102(e)
`The Board overlooked its own controlling case law in finding that Lo I, as a
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`provisional patent application, is not prior art under § 102(e). Sequenom initially
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`raised this issue in its Petition, explaining that "Lo I is a provisional U.S. patent
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`application that is prior art to the '415 patent under §§ 102(e)/103(a) as of its filing
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`date for all it discloses." Paper 5 at 2. As support for that statement, Sequenom
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`cited the Board's precedential opinion in Ex parte Yamaguchi, 88 U.S.P.Q. 2d 1606
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`(B.P.A.I. 2008). In Yamaguchi, the Board held that under § 102(e) a provisional
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`application that becomes public when a corresponding utility application is
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`published under § 122(b) "is considered prior art for all that it teaches." Id. at
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`1612. The Board went on to explain and reiterate its holding:
`In sum, the statutory scheme of Title 35 indicates that
`Congress intended for "applications for patent" under
`§ 102(e) to apply to both regular utility applications and
`provisional applications, particularly when considering
`§ 111(b) and 102(e) together. As a published "application
`for patent" under this statutory framework, a provisional
`application—like a regular utility application—constitutes
`prior art for all that it teaches and, as such, promotes the
`progress of the useful arts.
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`Id. (emphasis added).
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`6
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`Patent 8,195,415
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`The Board has repeatedly followed Yamaguchi to find that provisional
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`applications are prior art. See, e.g., Argasinski, Decision on Appeal at 3 n.2, 2009
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`WL 460669, at *4 n.2 ("We note that the Ferreira 60/182,282 reference is the
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`provisional application for the Ferreira utility patent application publication, US
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`2001/0034661 A1. We consider Ferreira's 60/182,282 provisional application
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`available as prior art in accordance with Ex parte Yamaguchi[.]"); Green, Decision
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`on Appeal at 3 n.2, 2011 WL 5116559, at *5 n.2 ("Nevertheless, as in the earlier
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`decision, we rely exclusively on Kuwata's provisional application (‘Kuwata '180')
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`in this opinion—a document whose qualification as prior art is undisputed."). The
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`Board has reached the same result even without citing Yamaguchi. See, e.g., Gilde,
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`Decision on Appeal at 5-6, 2014 WL 1154004, at *3 ("Although the Vermeulen
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`provisional application was not published, it became disseminated and available
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`for public inspection upon the publication of the Vermeulen pre-grant document.
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`We hold the Vermeulen provisional application to be a valid prior-art reference
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`against the presently rejected claims."); Focal Therapeutics, Paper 8 at 3-4, 15, 19,
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`2014 WL 1651257, at *2, *10, *13 (relying on provisional applications that
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`correspond to published utility applications as prior art in an inter partes review).
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`Yamaguchi applies to Lo I as a provisional application that corresponds to a
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`published utility application (Lo II). Accordingly, Lo I is prior art under § 102(e).
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`The Board erred in denying Sequenom's Petition because it failed to
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`recognize the precedential findings in Yamaguchi about provisional applications as
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`prior art and interpreted that opinion too narrowly. In its decision, the Board
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`7
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`described Yamaguchi as holding that "a patent that claimed the benefit of an earlier
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`IPR2014-00337
`Patent 8,195,415
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`filed provisional application qualified as prior art, as of the filing date of the
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`provisional application, for all commonly disclosed subject matter." Paper 11 at 4.
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`As noted above, however, the holding of Yamaguchi is broader—the Board found
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`that a provisional application made public when a corresponding utility application
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`is published qualifies on its own as prior art for all that it teaches. 88 U.S.P.Q. 2d
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`at 1612.
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`Yamaguchi also dispenses with the Board's argument (Paper 11 at 3) that
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`provisional applications are not prior art under § 102(e) because they are not
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`published. As explained in Yamaguchi, both a provisional application and its
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`corresponding utility application become public when the corresponding utility
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`application is published under § 122(b):
`[W]hile provisional applications are not themselves
`published under 35 U.S.C. § 122(b)(2)(A)(iii), the
`corresponding regular utility application that claims priority
`to a provisional application under § 119(e) is generally
`published (with certain exceptions) after 18 months. Upon
`such publication, not only is the regular utility application
`laid open to the public, but its corresponding provisional
`application is likewise made available to the public. See 37
`C.F.R. § 1.14(a)(1)(iv)-(vi).
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`While the filing of a provisional application itself does not
`trigger the publication of that application, the conversion
`from a provisional to an application under § 111(b)(5) does
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`8
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`IPR2014-00337
`Patent 8,195,415
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`cause the application to be available to the public after 18
`months in most instances. Also, since § 111(b)(5) allows for
`conversion of a provisional application to a nonprovisional
`application, provisional applications can become U.S.
`Patents. Moreover, the filing of the provisional
`application's corresponding regular utility application will,
`in most instances, cause both applications to be available
`to the public 18 months after the provisional application
`filing date. See 37 C.F.R. § 1.211(a); see also 37 C.F.R.
`§ 1.14(a)(1)(iv).
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`88 U.S.P.Q. 2d at 1611 (emphasis added).
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`The Board reasoned that the extra step required before a provisional patent
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`application is published—the filing and publication of a corresponding utility
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`application—does not justify treating provisional applications any differently from
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`regular utility applications for purposes of § 102(e). Id. When a provisional
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`application is published, it qualifies as a published "application for patent" under
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`§ 102(e). Id. at 1612.
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`The panels in Argasinski and Green followed the law as set forth in
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`Yamaguchi and found that provisional applications corresponding to published
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`utility applications are prior art under § 102(e).
` In Argasinski, U.S. Provisional Patent Application No. 60/182,282
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`corresponded to U.S. Patent Application Publication No.
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`2001/0034661 (published on October 25, 2001). Decision on Appeal
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`at 3 & n.2, 2009 WL 460669, at *1, *4 n.2.
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` In Green, U.S. Provisional Patent Application No. 60/278,180
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`corresponded to U.S. Patent Application Publication No.
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`2003/0072031 (published on April 17, 2003). Decision on Appeal at
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`2, 3 n.2, 2011 WL 5116559, at *1, *5 n.2.
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`Even without citing Yamaguchi, other panels of the Board have relied on
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`provisional applications as prior art when they have corresponded to published
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`utility applications.
` In Gilde, the panel relied on U.S. Provisional Patent Application No.
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`60/570,962 as prior art where it was the basis for U.S. Patent
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`Application Publication No. 2007/0192862 (published on August 16,
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`2007). Decision on Appeal at 3, 5-6, 2014 WL 1154004, at *1, *3.
` In Focal Therapeutics, the panel relied on U.S. Provisional Patent
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`Application Nos. 60/949,963 and 60/875,776 as prior art where they
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`corresponded to U.S. Patent Application Publication Nos.
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`2009/0024225 (published on January 22, 2009) and 2008/0177179
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`(published on July 24, 2008), respectively. Paper 8 at 3-4, 15, 19,
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`2014 WL 1651257, at *2, *10, *13.
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`The result for Lo I should be the same as for the provisional applications at
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`issue in Argasinski, Green, Gilde, and Focal Therapeutics. In this proceeding, as
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`in each of those cases, a provisional application (Lo I) is § 102(e) prior art because
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`it was made public when a corresponding utility application (Lo II) was published.
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`The Lo II application, which is based on Lo I, was published on January 29, 2009.
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`Ex. 1002. At that point, Lo I became available to the public and therefore qualifies
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`as prior art under § 102(e). Indeed, Lo I is currently available to the public through
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`the Patent Office's Public Patent Application Information Retrieval website.
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`Based on the legal precedent in Yamaguchi and other Board decisions, the
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`Board abused its discretion in denying Sequenom's Petition and should reconsider
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`that decision.
`B.
`Sequenom Will Suffer Prejudice if It Cannot Rely on Lo I and
`Other Prior Art References Cited in the Petition
`In light of Patent Owner's assertions about prior invention in the '390 IPR,
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`the prior art cited in Sequenom's Petition is important because it may ultimately
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`determine the patentability of the '415 patent's claims. While Patent Owner's
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`evidence relating to prior invention may have been a matter of speculation when
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`Sequenom filed its request for rehearing in the '390 IPR, Patent Owner has since
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`submitted its evidence of prior invention, the earliest of which is dated December
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`18, 2007. Ex. 1020 at 29-60 (citing Exhibits 2109-2113, 2118-2135, 2138, 2139 in
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`the '390 IPR). In that context, Lo I and two additional combination references
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`cited in the Petition are crucial because they have effective dates that Patent Owner
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`cannot overcome based on its alleged prior invention evidence.
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`To begin with, Lo I's earlier filing date would undermine the patentability of
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`the '415 patent's claims even if the Patent Owner's alleged prior invention evidence
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`in the '390 IPR were to hold up. Lo I has a filing date of July 23, 2007—a year
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`earlier than the July 23, 2008 filing date for Lo II. That difference matters because
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`Patent Owner has alleged prior invention as of December 18, 2007 in the '390 IPR.
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`11
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`Lo I's filing date is almost five months earlier. In effect, Patent Owner has already
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`conceded that it cannot antedate the filing date of Lo I.
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`Furthermore, in its Petition Sequenom relies on two additional combination
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`references that have earlier effective dates than prior art cited in the '390 IPR. The
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`Board instituted the '390 IPR on six grounds of unpatentability based on Lo II,
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`alone and in combination with other prior art. Ex. 1017 at 21-22. In its Petition
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`here, Sequenom includes 12 grounds of unpatentability based on Lo I in
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`combination with other prior art. Paper 5 at 5-6. The Petition describes
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`combinations with two additional prior art references—Green and Tarasov—that
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`were not included in the '390 IPR. Like Lo I, Green and Tarasov have effective
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`dates before December 18, 2007 (Paper 5 at 29, 40)—the earliest prior invention
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`date alleged by Patent Owner in the '390 IPR—and thus could have an impact on
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`the patentability of the '415 patent's claims.
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`Because the earlier effective dates of Lo I, Green, and Tarasov could tip the
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`scales in Sequenom's favor on unpatentability, Sequenom would suffer prejudice if
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`the Board does not consider that prior art. As an initial matter, the '415 patent is
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`currently being asserted against Sequenom in Verinata Health, Inc. v. Sequenom,
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`Inc., No. 3:12-cv-00865-SI, pending in U.S. District Court in the Northern District
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`of California. Estoppel may apply to prior art raised in the '390 IPR and this
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`proceeding, barring Sequenom from raising that art in the district court case. And
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`this is likely to be Sequenom's only chance to get the prior art before the Board.
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`The Board has already precluded arguments based on Lo I from being made in
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`12
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`Interference No. 105,922 under the assumption that Sequenom would be able to
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`IPR2014-00337
`Patent 8,195,415
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`raise those arguments during inter partes review proceedings. For Sequenom, it is
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`now or never.
`V. CONCLUSION
`Based on the foregoing, the Board should reconsider its July 16, 2014
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`Decision and institute inter partes review of '415 patent claims 1-17 on
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`unpatentability grounds 1-12 for obviousness based on Lo I in combination with
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`other prior art.
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`Dated: August 14, 2014
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`By:
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`Respectfully submitted,
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`/Michael J. Wise/
`Michael J. Wise, Reg. No. 34,047
`Patrick D. Morris, Reg. No. 53,351
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`For Petitioner Sequenom, Inc.
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`CERTIFICATE OF SERVICE
`I certify that a true and correct copy of the foregoing SEQUENOM
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`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(d) was served
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`electronically via email on the Patent Owner through its attorneys of record on this
`14th day of August, 2014 as follows:
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`R. Danny Huntington, Esq. (dhuntington@rfem.com)
`Sharon E. Crane, Ph.D., Esq. (scrane@rfem.com)
`Rothwell, Figg, Ernst & Manbeck, PC
`607 14th Street, NW, Suite 800
`Washington, DC 20005
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`/Patrick D. Morris/
`Patrick D. Morris
`Registration No. 53,351