IPR2016-00383
`Patent Owners’ Preliminary Response
`Filed on behalf of Patent Owners Genentech, Inc. and City of Hope by:
`
`David L. Cavanaugh
`Reg. No. 36,476
`Heather M. Petruzzi
`Reg. No. 71,270
`Robert J. Gunther, Jr.
`Pro Hac Vice Application
`Pending
`Wilmer Cutler Pickering
`Hale and Dorr LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`
`
`Adam R. Brausa
`Reg. No. 60,287
`Daralyn J. Durie
`Pro Hac Vice Application
`Pending
`Durie Tangri LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`Jeffrey P. Kushan
`Reg. No. 43,401
`Peter S. Choi
`Reg. No. 54,033
`Sidley Austin LLP
`1501 K Street, N.W.
`Washington, D.C.
`20005
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`GENZYME CORPORATION,
`Petitioner
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE
`Patent Owners
`____________________________________________
`
`Case IPR2016-00383
`Patent 6,331,415
`____________________________________________
`
`PATENT OWNERS’ PRELIMINARY RESPONSE UNDER
`37 C.F.R. § 42.107
`
`

`

`Patent Owners’ Preliminary Response IPR2016-00383
`
`
`TABLE OF CONTENTS
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`
`
`INTRODUCTION ............................................................................................... 1 
`
`I. 
`
`II.  THE ’383 PETITION SHOULD BE DENIED UNDER 35 U.S.C. § 325(D) ... 5 
`
`A.  Legal Framework ............................................................................................. 5 
`
`B.  Sanofi Could Have Raised Its Arguments Based on Salser, Southern, and
`Ochi in Its First Petition But Did Not .............................................................. 9 
`
`C.  The Grounds Presented in the ’383 Petition Are Substantially the Same as
`Those Presented in the ’1624 Petition ........................................................... 12 
`
`D.  Sanofi Is Impermissibly Using Patent Owners’ Preliminary Response in
`the ’1624 IPR to Inform Its Arguments in This Proceeding .......................... 15 
`
`E.  Sanofi’s Second Bite at the Apple Will Unfairly Prejudice Patent Owners
`and Waste Board Resources ........................................................................... 18 
`
`III.  THE PETITION SHOULD BE DENIED BECAUSE, IN VIEW OF THE
`INSTITUTION OF THE ’1624 IPR, SANOFI WILL BE ESTOPPED
`FROM PURSUING THIS IPR ...................................................................... 20 
`
`IV. 
`
`FIELD OF THE INVENTION OF THE CABILLY ’415 PATENT ............. 22 
`
`A.  Prior Art Antibody Production Techniques ................................................... 22 
`
`B.  The Cabilly ’415 Patent ................................................................................. 26 
`
`C.  Claim Construction ........................................................................................ 29 
`
`D.  Person of Ordinary Skill ................................................................................ 30 
`
`V.  THE ASSERTED PRIOR ART ........................................................................ 30 
`
`A.  Salser (Ex. 1002) ........................................................................................... 30 
`
`B.  Ochi (Ex. 1003) ............................................................................................. 35 
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`C.  Southern (Ex. 1004) ....................................................................................... 36 
`
`VI.  THE PETITION SHOULD BE DENIED BECAUSE NO GROUND
`ESTABLISHES A REASONABLE LIKELIHOOD OF SUCCESS ............ 36 
`
`A.  GROUND 1: The ’383 Petition Fails to Demonstrate a Reasonable
`Likelihood of Showing That Salser Anticipates Claims 1-4, 9, 11, 12, 15-20
`and 33 ............................................................................................................. 37 
`
`1.  Salser Does Not Disclose the Production of Immunoglobulins ................ 37 
`
`2.   Salser Does Not Disclose Transformation of a Single Host Cell with
`Multiple DNA Sequences Encoding Immunoglobulin Heavy and Light
`Chains ......................................................................................................... 43 
`
`3.   The Petition Does Not Cite Any Relevant Example of Protein Expression
`in Salser ...................................................................................................... 46 
`
`4. 
`
` Salser Does Not Disclose a Vector Including Both Heavy and Light Chain
`Sequences as Required by Claim 15 .......................................................... 50 
`
`5.  The Board Has Already Rejected Substantially Similar Anticipation
`Grounds Based on Bujard .......................................................................... 51 
`
`B.  GROUND 2: The Petition Fails to Demonstrate a Reasonable Likelihood of
`Showing Claims 1-4, 9, 11, 12, 14-20, and 33 Are Obvious Over Salser in
`View of Ochi .................................................................................................. 52 
`
`C.  GROUND 3: Petitioner Has Failed to Demonstrate a Reasonable Likelihood
`of Showing Claims 2, 18, and 20 Are Obvious Over Salser in View of
`Southern ......................................................................................................... 58 
`
`VII.  CONCLUSION .............................................................................................. 60 
`
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`Patent Owners’ Preliminary Response IPR2016-00383
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`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Federal Cases
`
`Amgen Inc. v. AbbVie Inc.,
`IPR2015-01514, Paper 9 ..................................................................................... 54
`
`Apotex Inc. v. Wyeth LLC,
`IPR2015-00873, Paper 8 ..................................................................................... 22
`
`Atofina v. Great Lakes Chem. Corp.,
`441 F.3d 991 (Fed. Cir. 2006) ............................................................................ 39
`
`BLD Servs., LLC v. LMK Techs., LLC,
`IPR2015-00721, Paper 9 ..................................................................................... 17
`
`Butamax Advanced Biofuels LLC v. Gevo, Inc.,
`IPR2014-00581, Paper 8 ....................................................................................... 9
`
`Cuozzo Speed Technologies, LLC v. Lee,
`No. 15-446 (Jan. 15, 2016) ................................................................................. 29
`
`Ecolochem, Inc. v. S. Cal. Edison Co.,
`227 F.3d 1361 (Fed. Cir. 2000) .................................................................... 46, 50
`
`Eli Lilly & Co. v. Zenith Goldline Pharm., Inc.,
`471 F.3d 1369 (Fed. Cir. 2006) .................................................................... 39, 40
`
`Ex Parte Lettmann,
`Appeal No. 2008-1185, 2008 WL 552716 (BPAI Feb. 29, 2008) ..................... 39
`
`Finisar Corp. v. DirecTV Group, Inc.,
`523 F.3d 1323 (Fed. Cir. 2008) .................................................................... 46, 50
`
`Finnigan Corp. v. Int’l Trade Comm’n,
`180 F.3d 1354 (Fed. Cir. 1999) .......................................................................... 43
`
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`Ford Motor Co. v. Paice LLC,
`IPR2014-00767, Paper 14 ............................................................................... 7, 12
`
`Ford Motor Co. v. Paice LLC,
`IPR2014-00884, Paper 38 ................................................................................... 22
`
`Gnosis S.p.A. v. Merck & Cie,
`IPR2013-00117, Paper 71 ................................................................................... 40
`
`HTC Corp. v. NFC Tech., LLC,
`IPR2015-00384, Paper 11 ............................................................................passim
`
`Impax Labs., Inc. v. Aventis Pharm. Inc.,
`468 F.3d 1366 (Fed. Cir. 2006) .......................................................................... 39
`
`In re Baxter Travenol Labs,
`952 F.2d 388 (Fed. Cir. 1991) ............................................................................ 40
`
`Ineos USA LLC v. Berry Plastics Corp.,
`783 F.3d 865 (Fed. Cir. 2015) ............................................................................ 40
`
`Jiawei Tech. (HK) Ltd. v. Richmond,
`IPR2015-00580, Paper 22 ..................................................................................... 6
`
`LG Elecs., Inc. v. ATI Techs. ULC,
`IPR2015-00327, Paper 13 ................................................................................... 12
`
`Medtronic, Inc. v. Robert Bosch Healthcare Sys., Inc.,
`IPR2014-00436, Paper 17 ..................................................................................... 7
`
`Metabolite Labs., Inc. v. Lab Corp. of Am. Holdings,
`370 F.3d 1354 (Fed. Cir. 2004) .......................................................................... 42
`
`NetApp Inc. v. Crossroads Sys., Inc.,
`IPR2015-00776, Paper 12 ................................................................................... 12
`
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) .................................................................... 45, 50
`
`Nora Lighting, Inc. v. Juno Mfg., LLC,
`IPR2015-00601, Paper 13 ..................................................................................... 5
`
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`Roche Molecular Sys., Inc. v. Illumina, Inc.,
`IPR2015-01091, Paper 18 ..................................................................................... 7
`
`Samsung Elecs. Co. Ltd. v. Rembrandt Wireless Techs., LP,
`IPR2015-00555, Paper 20 ............................................................................... 7, 10
`
`Samsung Elecs. Co., Ltd. v. Surpass Tech Innovation LLC,
`IPR2015-00885, Paper 7 ..................................................................................... 16
`
`Sanofi-Aventis U.S. LLC v. Genentech, Inc.,
`IPR2015-01624, Paper 1 ..............................................................................passim
`
`Sanofi-Aventis U.S. LLC v. Genentech, Inc.,
`IPR2015-01624, Paper 14 ................................................................................... 18
`
`Sanofi-Aventis U.S. LLC v. Genentech, Inc.,
`IPR2015-01624, Paper 15 ............................................................................passim
`
`Sanofi-Synthelabo v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006) .......................................................................... 39
`
`Toyota Motor Corp. v. Cellport Sys., Inc.,
`IPR2015-01422, Paper 8 ..............................................................................passim
`
`Toyota Motor Corp. v. Cellport Sys., Inc.,
`IPR2015-01423, Paper 7 ..................................................................................... 16
`
`Trintec Indus., Inc. v. Top-U.S.A. Corp.,
`295 F.3d 1292 (Fed. Cir. 2002) .......................................................................... 43
`
`Unilever v. The Procter & Gamble Co.,
`IPR2014-00506, Paper 17 ................................................................................... 17
`
`Unilever v. The Procter & Gamble Co.,
`IPR2014-00628, Paper 21 ..................................................................................... 7
`
`US Endodontics, LLC v. Gold Standard Instruments, LLC,
`IPR2015-01476, Paper 13 ................................................................................... 16
`
`ZTE Corp. v. ContentGuard Holdings, Inc.,
`IPR2013-00454, Paper 12 ................................................................................... 17
`
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`Patent Owners’ Preliminary Response IPR2016-00383
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`Federal Statutes
`
`35 U.S.C. § 314 .......................................................................................................... 5
`
`35 U.S.C. § 325(d) ............................................................................................passim
`
`35 U.S.C. § 325(e) ............................................................................................... 8, 21
`
`Regulations
`
`37 C.F.R. § 42.1(b) .................................................................................................. 19
`
`37 C.F.R. § 42.100(b) .............................................................................................. 29
`
`77 Fed. Reg. 442 ...................................................................................................... 21
`
`77 Fed. Reg. 48756 .............................................................................................. 6, 20
`
`Other Authorities
`
`157 Cong. Rec. S1042 (daily ed. Mar. 1, 2011) ........................................................ 6
`
`H.R. Rep. 112-98 (2011) ...................................................................................... 6, 20
`
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`Patent Owners’ Preliminary Response IPR2016-00383
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`I.
`
`INTRODUCTION
`
`In July 2015, Sanofi, through its wholly owned subsidiary, sanofi-aventis
`
`U.S. LLC, filed a petition in IPR2015-01624 (the “’1624 IPR”), contending that
`
`certain claims of U.S. Patent No. 6,331,415 (the “Cabilly ’415 patent”) are
`
`unpatentable over prior art. Five months later, and more than a month after Patent
`
`Owners filed their preliminary response in that proceeding, Sanofi, through another
`
`wholly owned subsidiary, Genzyme Corp., filed the present petition (“the ’383
`
`Petition”) in which it similarly challenges the patentability of the Cabilly ’415
`
`patent. This second petition should be rejected for two reasons.
`
`First, the Board should dismiss the ’383 Petition using the authority of 35
`
`U.S.C. § 325(d), as it raises not just one, but nearly all of the factors that the Board
`
`has identified as warranting dismissal of petitions under that authority. Those
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`factors include: (i) that the same real party-in-interest has challenged the same
`
`patent in a prior petition; (ii) that the petitioner knew about and could have asserted
`
`the references and grounds asserted in the second petition in the first petition; (iii)
`
`that the patentability grounds raised in the second petition are substantially the
`
`same as those asserted in the first petition; and (iv) that consolidation is not
`
`possible, which unfairly provides the petitioner with a “second bite” at issues
`
`raised in the first proceeding via a second petition.
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`Each of these factors is present here: (i) Sanofi is explicitly identified as the
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`real party-in-interest in both petitions (filed by the same counsel); (ii) Sanofi knew
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`about the references and grounds cited in the ’383 Petition at the time it filed the
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`’1624 Petition—the ’1624 Petition relies on the same three references that provide
`
`the basis for the ’383 Petition (“Salser” (Ex. 1002), “Southern” (Ex. 1004), and
`
`“Ochi” (Ex. 1003)); (iii) often using verbatim language, the petitions raise
`
`substantially the same patentability grounds; both cite a primary reference
`
`(“Bujard” (Sanofi-Aventis U.S. LLC v. Genentech, Inc., IPR2015-01624, Ex. 1002)
`
`versus Salser) for its use of the plural term “genes” and inclusion of certain
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`proteins in a laundry list of potential targets; and both rely on similar, if not
`
`identical, secondary references, including the same Southern article; and (iv)
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`because of Sanofi’s five-month delay in filing the ’383 Petition, consolidation is
`
`not possible, which means that if trial is instituted, Sanofi unfairly will get two
`
`chances to press substantially the same grounds.1 Any one of these considerations
`
`would warrant denial of the ’383 Petition; together, they make a compelling
`
`argument for the Board to exercise its discretion under section 325(d).
`
`Second, the ’383 Petition fails on the merits because it does not establish a
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`reasonable basis for finding any contested claim unpatentable. Salser—the
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`1 To conserve Board resources, Patent Owners asked Petitioner to withdraw the
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`duplicative ’383 Petition, but Petitioner refused to do so, without any substantive
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`explanation. Ex. 2025, Email from Patent Owners to Petitioner (Feb. 17, 2016).
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`Patent Owners’ Preliminary Response IPR2016-00383
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`primary reference for each ground—plainly does not disclose every element of the
`
`claimed invention, and is directed to a completely different problem than the one
`
`the Cabilly inventors solved. Salser, in Petitioner’s own words, is directed to
`
`“gene replacement therapy,” i.e., attempting to fix a genetic deficiency (e.g., sickle-
`
`cell anemia) by introducing cells expressing a particular protein into a host
`
`organism that is expressing mutant forms of that same protein. Salser is
`
`“specifically focused on treatments for hemoglobin-based genetic deficiencies.”
`
`Paper 2 at 29. This is a far different enterprise than the Cabilly ’415 patent, which
`
`uses cultured host cells to produce functional antibodies targeting specific antigens
`
`by co-expressing immunoglobulin heavy and light chain DNA in the host cells, and
`
`which recovers functional antibodies. The host cells in the Cabilly ’415 patent
`
`function as the factories that produce these functional antibodies.
`
`Even if the materially different objective and purpose of the Salser process is
`
`ignored, it does not provide any guidance or suggestion that is relevant to the
`
`Cabilly ’415 patented invention. Nowhere in Salser is there any mention of
`
`antibodies or immunoglobulins. Nor does Salser anywhere address the issues of
`
`culturing host cells to produce and isolate proteins, much less complex multimeric
`
`proteins like immunoglobulins.
`
`The particular focus of the Salser method—correction of deficient
`
`expression of the beta-globin gene cluster—also provides no suggestion to produce
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`Patent Owners’ Preliminary Response IPR2016-00383
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`two or more constituent polypeptides of a multimeric protein in a single host cell.
`
`Most notably, that method aims to produce only a single polypeptide—the beta
`
`chain of the hemoglobin protein. Although Salser discusses strategies to introduce
`
`a beta-globin gene cluster, which includes multiple discrete “genes,” that gene
`
`cluster in cells only functions to produce one of the components of the hemoglobin
`
`protein—a beta chain. The five “multiple genes” in that gene cluster are not all
`
`expressed together, nor do any of the expression products from the beta-globin
`
`cluster combine with one another to form a multimeric protein.
`
`Salser thus provides no insight into the challenge of producing a multimeric
`
`protein by transfecting a host cell to contain and express DNA sequences encoding
`
`the constituent polypeptides of that multimeric protein. And, given the focus of
`
`Salser on gene replacement therapy, it provides no insight into the challenge of
`
`isolating functional immunoglobulins produced in a co-transformed host cell.
`
`In the face of these omissions, the ’383 Petition attempts to stitch together
`
`unrelated phrases from Salser and, using improper hindsight, attempts to credit
`
`Salser with guidance and teachings that simply are not there. It uses these faulty
`
`arguments both in an anticipation ground and in obviousness grounds where there
`
`is no discernable motivation for a person of ordinary skill to combine the
`
`references with a reasonable expectation of success in performing the claimed
`
`invention. The Federal Circuit has made clear that unsupported and hindsight-
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`Patent Owners’ Preliminary Response IPR2016-00383
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`driven assertions like these cannot serve as the basis to invalidate patent claims.
`
`The Petition thus falls far short of the standard required by 35 U.S.C. § 314,
`
`and should be denied.
`
`II. THE ’383 PETITION SHOULD BE DENIED UNDER 35 U.S.C. §
`325(d)
`
`
`
`A. Legal Framework
`
`35 U.S.C. § 325(d) allows the Board to exercise its discretion to deny
`
`institution of a petition for inter partes review when “another proceeding or matter
`
`involving the patent is before the Office” and “the same or substantially the same
`
`prior art or arguments previously were presented to the Office.” 35 U.S.C. §
`
`325(d). See, e.g., HTC Corp. v. NFC Tech., LLC, IPR2015-00384, Paper 11 at 9-11
`
`(relying on section 325(d) to deny a second petition where “[the prior art]
`
`references applied against [the claims] in the present Petition are substantially the
`
`same as those applied in [an] earlier Petition”); Nora Lighting, Inc. v. Juno Mfg.,
`
`LLC, IPR2015-00601, Paper 13 at 9-13 (denying petition asserting prior art that
`
`was “duplicative” of art presented during reexamination).
`
`This provision aims to ensure that post-grant proceedings are not used to
`
`subject patent owners to “repeated litigation and administrative attacks on the
`
`validity of a patent. Doing so would frustrate the purpose of the section as
`
`providing quick and cost effective alternatives to litigation.” America Invents Act,
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`Patent Owners’ Preliminary Response IPR2016-00383
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`H.R. Rep. 112-98, pt. 1 at 48 (2011) (hereinafter “AIA H.R. Rep.”).2 Furthermore,
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`one of the “core functions” of the IPR rules requiring a petitioner to identify the
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`real party-in-interest is to “assure proper application of the statutory estoppel
`
`provisions . . . [and] to prevent parties from having a ‘second bite at the apple’ . . .
`
`.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48756 at 48759 (Aug. 14,
`
`2012); see also AIA H.R. Rep., pt. 1 at 48 (“In utilizing the post-grant review
`
`process, petitioners [and] real parties in interest . . . are precluded from improperly
`
`mounting multiple challenges to a patent . . . .”).
`
`Accordingly, the Board has interpreted section 325(d) to preclude a “second
`
`bite at the apple” where a petitioner knows about the cited references at the time it
`
`files an earlier petition and fails to provide an adequate explanation for its failure
`
`to assert grounds based on those references at that time. See, e.g., Jiawei Tech.
`
`(HK) Ltd. v. Richmond, IPR2015-00580, Paper 22 at 4 (denying institution where
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`“[t]here is no question . . . that [the references] were available to Petitioner at the
`
`time of filing the earlier Petition” because “the prior art presented in the instant
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`2 During Congressional hearings on the AIA, Senator Kyl stated the bill “impose[s]
`
`limits on serial challenges” to a patent and that section 325(d) “allows the Patent
`
`Office to reject any request for a proceeding . . . if the same or substantially the
`
`same prior art or arguments previously were presented to the Office with respect to
`
`that patent.” 157 Cong. Rec. S1042 (daily ed. Mar. 1, 2011) (Stat. of Sen. Kyl).
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`proceeding . . . also was presented in the earlier proceeding”). For example, the
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`Board invoked section 325(d) to deny a second petition in Ford Motor Co. v. Paice
`
`LLC, when a reference underlying the grounds “was relied on in explaining the
`
`state of the art” in an earlier petition, even though the second petition also cited
`
`additional, new prior art. IPR2015-00767, Paper 14 at 6-7; see also Samsung
`
`Elecs. Co. Ltd. v. Rembrandt Wireless Techs., LP, IPR2015-00555, Paper 20 at 7-9
`
`(denying petition under section 325(d) where petitioner asserted same prior art in
`
`earlier petitions); Unilever v. The Procter & Gamble Co., IPR2014-00628, Paper
`
`21 at 11 (denying petition where “Unilever does not argue that the other references
`
`applied in the instant Petition . . . were unknown or unavailable at the time of filing
`
`the [first] Petition.”); HTC Corp., IPR2015-00384, Paper 11 at 10 (denying petition
`
`where “Petitioner provides no explanation, however, as to why [reference] was not
`
`or could not have been applied in the earlier Petition”).
`
`The Board has applied this principle even where a second petition involved a
`
`different nominal petitioner but the same real party-in-interest as a previously
`
`instituted IPR, as is the case here. See Medtronic, Inc. v. Robert Bosch Healthcare
`
`Sys., Inc., IPR2014-00436, Paper 17 at 12 (“We have taken into account that
`
`Petitioner here is a real party-in-interest in the ongoing inter partes review of the
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`’469 patent. See Cardiocom, IPR2013-00451, Paper 26.”); see also Roche
`
`Molecular Sys., Inc. v. Illumina, Inc., IPR2015-01091, Paper 18 at 12-13 (denying
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`second petition involving different nominal petitioner, noting “both the Petitioner
`
`in this case, Roche, and the Petitioner in IPR2014-01093, Ariosa, are both
`
`designated as real parties-in-interest in both proceedings”).
`
`The Board has also identified other considerations that weigh against
`
`institution of a second IPR of a single patent. For example, in Toyota Motor Corp.
`
`v. Cellport Systems, Inc., the Board denied the second of two petitions for IPR of
`
`the same patent pursuant to section 325(d). IPR2015-01422, Paper 8 at 18-22. In
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`addition to the similarities between the two petitions, the Board noted, inter alia,
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`that (i) the timing of the second petition raised the potential for gamesmanship
`
`because the petitioner was able to preview the arguments included in the patent
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`owner’s preliminary response to the first petition; (ii) the 4 ½ month delay between
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`the two petitions made consolidation impractical, and separate proceedings would
`
`undermine the interests of judicial economy; and (iii) the petitioner had not
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`adequately explained the reasons for the 4 ½ month delay and gave no reason why
`
`it could not have included the allegedly new reference in the initial petition.3 Id.
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`Each of these considerations applies here.
`
`
`3 The Board further explained that co-pending post-grant proceedings may also
`
`give rise to estoppel under 35 U.S.C. § 325(e). IPR2015-01422, Paper 8 at 20-21;
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`see also infra Section III.
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`
`B.
`
`Sanofi Could Have Raised Its Arguments Based on Salser,
`Southern, and Ochi in Its First Petition But Did Not
`
`Sanofi is a real party-in-interest in both the ’1624 IPR and this proceeding.
`
`See Paper 2 at 58 (“Sanofi, the ultimate parent company of Genzyme, is the real
`
`party-in-interest for Petitioner.”); Sanofi-Aventis, IPR2015-01624, Paper 1 at 59
`
`(“Sanofi (the ultimate parent company of sanofi-aventis U.S. LLC), sanofi-aventis
`
`U.S. LLC, and Regeneron Pharmaceuticals, Inc. are the real parties-in-interest for
`
`Petitioners.”).4 And Sanofi was aware of the three references (Salser, Ochi, and
`
`Southern) that it now relies on when the ’1624 Petition was filed. Indeed, all three
`
`of the references and their purportedly relevant disclosures are discussed in
`
`the ’1624 Petition, and all three are exhibits to that Petition. See Sanofi-Aventis,
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`IPR2015-01624, Paper 1 at 23 (Salser (Ex. 1038)); 9-10, 21 (Ochi (Ex. 1021)); 2-3,
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`23, 33-34, 47-50 (Southern (Ex. 1004)). Therefore, Sanofi cannot and “does not
`
`contend that the newly cited references were not known or available to it at the
`
`time it filed the [first] IPR.” Butamax Advanced Biofuels LLC v. Gevo, Inc.,
`
`IPR2014-00581, Paper 8 at 12 (denying petition under section 325(d) expressly
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`directed to curing deficiencies of first petition). Instead, Sanofi “simply presents
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`arguments now that it could have made in [the first petition] had it merely chosen
`
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`4 The same counsel also filed both petitions. Compare IPR2015-01624, Paper 1 at
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`59, with IPR2016-00383, Paper 2 at 59-60.
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`Patent Owners’ Preliminary Response IPR2016-00383
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`to do so.” Samsung, IPR2015-00555, Paper 20 at 8-9. This is precisely the type of
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`serial filing section 325(d) was designed to prevent.
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`Not only were Salser, Southern, and Ochi cited in the prior Petition,5 the
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`following chart demonstrates that Sanofi cited them for the same purpose in both
`
`Petitions (emphasis added to indicate areas of commonality):
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`Reference Description in ’1624 Petition
`
`Description in ’383 Petition
`
`Salser
`
`“[Salser] teaches introducing and
`
`“The Salser patent discloses
`
`co-expressing multiple independent
`
`transforming a single host cell
`
`eukaryotic genes in a single
`
`with two DNA sequences . . . .”
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`mammalian host cell. The patent
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`’383 Petition at 36.
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`teaches that ‘when two or more
`
`“The . . . genetic material to be
`
`genes are to be introduced they may
`
`incorporated into the host cell . .
`
`be carried on a single chain, a
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`. can therefore include ‘two or
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`plurality of chains, or
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`more genes,’ ‘a single set of
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`combinations thereof.’ Ex. 1038,
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`genes’ or ‘a plurality of
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`3:51-53. ‘The DNA employed may
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`unrelated genes’ . . . and they
`
`provide for a single gene, a single
`
`can be ‘carried on a single
`
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`5 Southern is also relied upon by the Board to support Ground 3 of the trial
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`instituted in the ’1624 IPR. Sanofi-Aventis, IPR2015-01624, Paper 15 at 21-22.
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`Patent Owners’ Preliminary Response IPR2016-00383
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`set of genes, e.g., the beta-globin
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`chain, a plurality of chains, or
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`gene cluster, or a plurality of
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`combinations thereof.’” ’383
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`unrelated genes.’” ’1624 Petition
`
`Petition at 37-38.
`
`at 23.
`
`Ochi
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`“Ochi (I) . . . reported experiments
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`“Ochi (I) teaches that a foreign
`
`in which light chain DNA was
`
`light chain immunoglobulin
`
`successfully transformed into and
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`DNA sequence can be inserted
`
`expressed in mammalian host
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`into an expression vector and
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`cells.” ’1624 Petition at 21.
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`transformed into a mammalian
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`host cell that will successfully
`
`express the light chain
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`polypeptide.” ’383 Petition at
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`48.
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`Southern “The Southern prior art publication .
`
`“Southern taught the feasibility
`
`. . also teaches expressing multiple
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`of co-expression . . . of two
`
`genes of interest in a mammalian
`
`proteins of interest in a single
`
`host cell by using two vectors to co-
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`mammalian host cell when the
`
`transform the cell, with each vector
`
`respective genes are present on
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`containing a different gene of
`
`separate vectors.” ’383 Petition
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`interest.” ’1624 Petition at 23.
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`at 53.
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`Patent Owners’ Preliminary Response IPR2016-00383
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`Despite Sanofi’s awareness of Salser, Ochi, and Southern, Sanofi did not
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`raise any patentability grounds based on Salser or a combination of Salser and
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`these references in the first Petition. Consistent with the policy behind section
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`325(d), the Board should not give Sanofi a “second bite at the apple” by allowing it
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`to conduct a second, overlapping proceeding based on the ’383 Petition after it
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`gains the benefit of seeing Patent Owners’ arguments during the ’1624 IPR. The
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`’383 Petition should be denied because “what is presented in the instant Petition
`
`could have been presented” in the ’1624 Petition. Ford Motor Co., IPR2015-
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`00767, Paper 14 at 9.
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`C. The Grounds Presented in the ’383 Petition Are Substantially the
`Same as Those Presented in the ’1624 Petition
`
`The Board also should deny the ’383 Petition because the proffered grounds
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`and arguments are substantially the same as those raised in the ’1624 Petition. See,
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`e.g., LG Elecs., Inc. v. ATI Techs. ULC, IPR2015-00327, Paper 13 at 8-12
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`(declining to institute IPR where substantially the same arguments were presented
`
`in first petition); see also NetApp Inc. v. Crossroads Sys., Inc., IPR2015-00776,
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`Paper 12 at 6-8.
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`In both the ’1624 and ’383 Petitions, Sanofi cites references involving
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`insertion of DNA into a cell that incidentally use the plural form of the word
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`“genes” (or like terms) and purportedly refer to immunoglobulins. Both Petitions
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`then argue that th