UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US), LLC,
`Petitioner,
`
`v.
`
`CIPLA LTD.,
`
`Patent Owner.
`
`Case IPR2020-00371
`Patent No. 9,901,585
`
`PATENT OWNER PRELIMINARY RESPONSE
`
`
`
`
`
`

`

`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`INTRODUCTION ........................................................................................... 1
`
`THE PETITION FAILS TO MEET ITS THRESHOLD SHOWING
`BECAUSE IT FAILS TO CITE PRIOR ART IN SUPPORT OF
`UNPATENTABILITY .................................................................................... 5
`
`A.
`
`B.
`
`The Board Should Deny the Petition under 35 U.S.C. § 314(a)
`Because It Lacks the Required Specificity. ........................................... 5
`
`The Board Should Not Consider Evidence Included in Expert
`Declarations But Not Cited in the Petition. ........................................... 8
`
`C.
`
`The Petition Likely Fails to Name a Real Party-in-Interest. ...............10
`
`III. BACKGROUND ...........................................................................................11
`
`A.
`
`The ’620 Patent Prosecution History and the Examiner’s
`Consideration of Cramer, Segal and the Teachings of the PDR 1999
`During Prosecution ..............................................................................11
`
`1.
`
`2.
`
`3.
`
`4.
`
`Cramer Was Extensively Considered during Prosecution. .......11
`
`Segal Was Also Considered during Prosecution. .....................13
`
`PDR 1999 Is Cumulative of the Azelastine and Fluticasone
`Monotherapy References Considered by the Examiner. ..........14
`
`Objective Indicia of Nonobviousness. ......................................16
`
`B.
`
`C.
`
`D.
`
`E.
`
`The ’723 Patent Prosecution History ..................................................17
`
`The ’428 Patent Prosecution History ..................................................18
`
`The ’585 Patent Prosecution History ..................................................19
`
`Background of Related Proceedings ...................................................20
`
`IV. BOARD SHOULD DENY INSTITUTION OF THE PETITION BECAUSE
`IT PRESENTS SUBSTANTIALLY THE SAME ART PREVIOUSLY
`CONSIDERED BY THE OFFICE ................................................................20
`
`i
`
`

`

`
`
`A. Absent a Showing of Material Error, the Director May Decline
`Institution Where the Petition Merely Rehashes Arguments and Art
`Already Considered in Prosecution. ....................................................21
`
`B.
`
`Petitioner Relies on Substantially the Same Art and Arguments
`Overcome During Prosecution. ...........................................................24
`
`V.
`
`THE BOARD SHOULD DENY THE PETITION UNDER 35 U.S.C.
`§ 314(A) BECAUSE
`INSTITUTION WOULD RESULT
`IN AN
`INEFFICIENT USE OF BOARD RESOURCES .........................................29
`
`A.
`
`The Board Should Exercise Its Discretion Not to Institute Follow-On
`Petitions ...............................................................................................29
`
`VI. PETITIONER HAS NOT DEMONSTRATED A REASONABLE
`LIKELIHOOD THAT THE CHALLENGED CLAIMS WOULD HAVE
`BEEN OBVIOUS ..........................................................................................33
`
`A.
`
`Clinical Treatment Options for Allergic Rhinitis As of the Priority
`Date Were Numerous. .........................................................................35
`
`B. Dymista and Duonase Were Breakthrough Combination AR
`Therapies. ............................................................................................39
`
`C. Overview of the Asserted Art. .............................................................40
`
`D.
`
`Petitioner’s Prior Art References Do Not Render the Challenged
`Claims Obvious. ..................................................................................43
`
`ii
`
`

`

`
`
`1.
`
`Rather than Motivate the POSA to Combine Azelastine and
`Fluticasone into a Fixed-Dose Combination Nasal Spray, the
`Prior Art Taught Away from This Combination ......................44
`
`b.
`
`c.
`
`The Prior Art Discouraged the Conjunctive Use of
`Corticosteroids and Antihistamines ................................46
`The Prior Art Did Not Motivate the Combination of
`Azelastine and Fluticasone in a Fixed-Dose Combination
`Nasal Spray .....................................................................48
`Azelastine And Fluticasone Have Incompatible Dosing
`Schedules ........................................................................50
`The POSA Would Not Have Had a Reasonable Expectation of
`Success ......................................................................................51
`
`d.
`
`2.
`
`VII. SECONDARY CONSIDERATIONS SUPPORT NON-OBVIOUSNESS ..52
`
`A.
`
`The Claimed Invention Exhibits Unexpected Results. .......................52
`
`B. Others Failed to Develop the Claimed Invention. ...............................53
`
`C. Meda Licensed the Challenged Patents. ..............................................54
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`I.
`
`The Prior Art Was Skeptical of the Claimed Invention. .....................54
`
`Embodiments of the Claimed Invention Were Commercially
`Successful. ...........................................................................................55
`
`The Invention Satisfied a Long-Felt But Unmet Need for Better AR
`Treatment. ............................................................................................56
`
`The Invention Was Widely Copied. ....................................................58
`
`Industry Leaders Praised the Invention. ..............................................58
`
`The Board Should Not Institute Because Petitioner Ignored Objective
`Evidence Credited in the Prosecution History. ...................................59
`
`VIII. CONCLUSION ..............................................................................................61
`
`iii
`
`

`

`
`
`TABLE OF AUTHORITIES
`
`CASES
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte
`GmbH,
`IPR2019-01469, 2020 WL 740292 (Feb. 13, 2020) ....................................passim
`Akzo N.V. v. USITC,
`808 F.2d 1471 (Fed. Cir. 1986) .......................................................................... 44
`Anglefix, LLC v. Wright Med. Tech., Inc.,
`No. 13-2407, 2015 WL 9581865 (W.D. Tenn. Dec. 30, 2015) .......................... 60
`Aquestive Therapeutics, Inc. v. Neurelis, Inc.,
`IPR2019-00450, 2019 WL 3504247 (PTAB Aug. 1, 2019) ............................... 28
`Aylus Networks, Inc. v. Apple Inc.,
`856 F.3d 1353 (Fed. Cir. 2017) .......................................................................... 60
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, 2017 WL 6405100 (PTAB Dec. 15, 2017) ................. 21, 24, 28
`Boehringer Ingelheim Vetmedica, Inc. v. Schering- Plough Corp.,
`320 F.3d 1339 (Fed. Cir. 2003) .......................................................................... 53
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) ............................................................ 3, 4, 34, 35
`Cisco Sys., Inc., v. C-Cation Techs., LLC,
`IPR2014-00454, 2014 WL 4352301 (PTAB Aug. 29, 2014) ............................... 8
`Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche, Inc.,
`IPR2015-01792, 2016 WL 1081666 (PTAB Mar. 11, 2016) ............................. 60
`CSL Behring GmBH v. Shire Viropharma Inc.,
`IPR2019-00459, 2019 WL 2866004 (PTAB July 2, 2019) .......................... 25, 28
`Demaco Corp. v. F. Von Langsdorff Licensing Ltd.,
`851 F.2d 1387 (Fed. Cir. 1988) .......................................................................... 55
`Fidelity Nat’l Info. Servs., Inc., v. DataTreasury Corp.,
`IPR2014-00489, 2014 WL 4059220 (PTAB Aug. 13, 2014) ............................... 8
`
`iv
`
`

`

`
`
`General Plastic Industrial Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, 2017 WL 3917706 (PTAB Sept. 6, 2017) ........................ 29, 30
`In re Stepan Co.,
`868 F.3d 1342 (Fed. Cir. 2017) .......................................................................... 35
`Kayak Software Corp. v. Int’l Bus. Machs. Corp.,
`CBM2016-00075, 2016 WL 11034653 (PTAB Dec. 15, 2016) ........................ 21
`Knoll Pharm. Co. v. Teva Pharm. USA, Inc.,
`367 F.3d 1381 (Fed. Cir. 2004) .......................................................................... 53
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 34
`Lassen Therapeutics 1, Inc. v. Singapore Health Servs. PTE Ltd.,
`PGR2019-00053, 2020 WL 603883 (PTAB Feb. 6, 2020) ................................ 58
`Merial Ltd. v. Virbac,
`IPR2014-01279, 2015 WL 331290 (PTAB, Jan. 22, 2015) ............................... 61
`Mexichem Amanco Holdings S.A. de C.V. v. Honeywell Int’l, Inc.,
`IPR2013–00576, 2014 WL 3977112 (PTAB Aug. 15, 2014) ............................ 54
`NetApp Inc. v. Realtime Data LLC,
`IPR2017-01195, 2017 WL 4574548 (PTAB Oct. 12, 2017) .............................. 30
`NHK Spring Co. v. Intri-Plex Techs., Inc.,
`IPR2018-00752, 2018 WL 4373643 (PTAB Sept. 12, 2018) ...................... 22, 29
`Oil States Energy Servs., LLC v. Greene’s Energy Grp., LLC,
`138 S. Ct. 1365 (2018) ........................................................................................ 29
`Omron Oilfield & Marine Inc. v. MD/TOTCO,
`IPR2013-00265, 2013 WL 8595961 (PTAB Oct. 31, 2013) .............................. 61
`Pfizer Inc. v. Teva Pharm. USA, Inc.,
`460 F. Supp. 2d 659 (D.N.J. 2006) ..................................................................... 53
`Reactive Surfaces Ltd. v. Toyota Motor Corp.,
`IPR2019-00867, 2019 WL 4492905 (PTAB Sept. 18, 2019) ............................ 34
`
`v
`
`

`

`
`
`Regeneron Pharm., Inc. v. Kymab Ltd.,
`IPR2019-01580, 2020 WL 1312961 (PTAB Mar. 18, 2020) ............................. 21
`Robert Bosch Tool Corp. v. SD3, LLC,
`IPR2016-01751, 2017 WL 1096609 (PTAB Mar. 22, 2017) ............................. 60
`Schumer v. Lab. Comput. Sys., Inc.,
`308 F.3d 1304 (Fed. Cir. 2002) ............................................................................ 7
`Signal IP, Inc. v. Fiat U.S.A., Inc.,
`No. 14-13864, 2016 WL 5027595 (E.D. Mich. Sept. 20, 2016) ........................ 60
`Tempur Sealy Int’l Inc. v. Select Comfort Corp.,
`IPR 2014-01419, (PTAB Feb. 17, 2015) ........................................................ 8, 10
`Teoxane S.A. v. Allergan, PLC,
`IPR2017-02002, 2018 WL 1247024 (PTAB Mar. 9, 2018) ................................. 7
`Valve Corp. v. Elec. Scripting Prods., Inc.,
`IPR2019-00062, 2019 WL 1490575 (PTAB Apr. 2, 2019) ............................... 30
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) .......................................................................... 58
`Zetec, Inc. v. Westinghouse Electric Co.,
`IPR2014-00384, 2014 WL 3704254 (PTAB July 23, 2014) ................................ 7
`STATUTES
`35 U.S.C. § 312(a)(3) ................................................................................................. 6
`35 U.S.C. § 314(a) ..................................................................................... 5, 7, 29, 30
`35 U.S.C. § 316(a)(11) ............................................................................................. 32
`35 U.S.C. § 325(d) ............................................................................................passim
`REGULATIONS
`37 C.F.R. 42.51(b)(1)(ii) .......................................................................................... 54
`37 C.F.R. § 1.132 ............................................................................................... 13, 16
`37 C.F.R. § 42.6(a)(3) ................................................................................................ 8
`
`vi
`
`

`

`
`
`37 C.F.R. § 42.24(a)(1) ............................................................................................ 62
`37 C.F.R. § 42.24(b)(1) ............................................................................................ 62
`37 C.F.R. § 42.24(d) ................................................................................................ 62
`37 C.F.R. § 42.104(b)(4) ............................................................................................ 6
`37 C.F.R. § 42.108(b) ................................................................................................ 7
`OTHER AUTHORITIES
`H.R. Rep. No. 112-98 (2011), reprinted in 2011 U.S.C.C.A.N. 67 ........................ 32
`
`vii
`
`

`

`
`
`TABLE OF ABBREVIATIONS
`Allergic rhinitis .................................................................................................... AR
`
`Approved Drug Products with Therapeutic
`Equivalence Evaluations ................................................................. Orange Book
`
`Argentum Pharmaceuticals LLC v. Cipla Ltd.,
`IPR2017-00807 (PTAB) ............................................................... Argentum IPR
`
`European Patent Application
`Publication No. EP 0,780,127 (Ex. 1011) ................................................ Cramer
`
`European Patent Office ...................................................................................... EPO
`
`Food and Drug Administration .......................................................................... FDA
`
`Information disclosure statement ........................................................................ IDS
`
`International Patent Application
`Publication No. WO 98/488391 (Ex. 1012) ................................................ Segal
`
`Meda Pharmaceuticals, Inc. .............................................................................. Meda
`
`Meda Pharmaceuticals, Inc. v. Apotex Inc.,
`No. 14-cv-01453 (D. Del.) ............................................................ Apotex Litigation
`
`Patent Owner Cipla Ltd. ................................................................................... Cipla
`
`Patent Trial and Appeal Board ......................................................................... Board
`
`Physicians’ Desk Reference (1999)
`at 1122-1124 and 3191-3192 (Ex. 1010) ............................................. PDR 1999
`
`The ’620 patent, the ’723 patent, the ’428 patent
`and the ’585 patent ..................................................................... Dymista Patents
`
`U.S. Patent No. 8,163,723 ....................................................................... ’723 patent
`
`U.S. Patent No. 8,168,620 ....................................................................... ’620 patent
`
`U.S. Patent No. 9,259,428 ....................................................................... ’428 patent
`
`viii
`
`

`

`
`
`U.S. Patent No. 9,901,585 ....................................................................... ’585 patent
`
`United States Patent and Trademark Office ................................................... Office
`
`ix
`
`

`

`
`
`Exhibit
`2001
`2002
`2003
`2004
`2005
`2006
`
`2007
`
`2008
`
`2009
`2010-11
`
`2012
`
`2013-17
`
`2018
`
`2019
`2020
`
`2021
`
`2022
`
`TABLE OF EXHIBITS
`Description
`Excerpts from the Image File Wrapper for the ’620 Patent
`Drugs@FDA entry for Flonase
`Drugs@FDA entry for Astelin
`Apotex Products (Apr. 29, 2020)
`Drugs@FDA entry for Dymista
`Dymista Prescribing Information
`Duonase Nasal Spray Prescribing Information, available at
`https://www.ciplamed.com/content/duonase-nasal-spray
`Center for Drug Evaluation and Research, Cross Discipline
`Team Leader Review for Dymista, available at
`https://www.accessdata.fda.gov/drugsatfda_docs/
`nda/2012/202236Orig1s000CrossR.pdf
`Aria Workshop Report
`Intentionally Left Blank
`Mylan Press Release, Mylan Completes Acquisition of
`Meda (Aug. 5, 2016), http://newsroom.mylan.com/2016-08-
`05-Mylan-Completes-Acquisition-of-Meda
`Intentionally Left Blank
`Akerlund et al., Clinical Trial Design, Nasal Allergen
`Challenge Models, and Considerations of Relevance to
`Pediatrics, Nasal Poyposis, and Different Classes of
`Medication, 115 J. ALLERGY CLIN. IMMUNOL. S460 (2005)
`Astelin Approval Letter
`Flonase Label
`Commercial and Stakeholder Perspectives: Allergic
`Rhinitis, Is there life after Claritin (Sept. 2004)
`Blais, Efficacy, Safety, and Patient Preference of Inhaled
`Nasal Corticosteroids: A Review of Pertinent Published
`Data, 22 ALLERGY & ASTHMA PROC. S5 (2001)
`
`x
`
`

`

`
`
`Exhibit
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`2036
`2037
`2038
`2039
`
`Description
`Carr et al., A Novel Intranasal Therapy of Azelastine with
`Fluticasone for the Treatment of Allergic Rhinitis, 129 J
`ALLERGY CLIN. IMMUNOL. 1282 (2012)
`Barnes et al., Effects of Levocetirizine as add-on Therapy to
`Fluticasone in Seasonal Allergic Rhinitis, 36 CLINICAL &
`EXPERIMENTAL ALLERGY 676 (2006)
`Proposed Joint Pretrial Order (Public Version), Meda
`Pharm. Inc. v. Apotex Inc., No. 14-1453-LPS (D. Del Nov.
`21, 2016), ECF No. 137
`Allergic Rhinitis-Global Drug Forecast and Market
`Analysis to 2024
`Glaxo EPO Opposition, EP 1519731 (Jan. 14, 2010)
`2006 Cipla-Meda License Agreement with Quality
`Agreement (PTX1016)
`2011 First Amendment to Cipla-Meda Agreement
`(PTX0282)
`EP 1519731
`Astelin Day Life Cycle Plan (Nov. 1, 2002)
`Email regarding Astelin Nasal Spray Life Cycle
`Management Projects (Oct. 30, 2002)
`Wikipedia entry for “Physician’s Desk Reference,”
`available at https://en.wikipedia.org/wiki/Physicians%
`27_Desk_Reference
`DataMonitor, Pipeline and Commercial Insight: Allergic
`Rhinitis (July 2010)
`Jarosz Declaration from Argentum IPR
`Carr Declaration from Argentum IPR
`Smyth Declaration from Argentum IPR
`D’Addio Declaration from Argentum IPR
`Meda Notebook
`
`xi
`
`

`

`
`
`Exhibit
`2040
`
`
`
`Description
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/
`202236Orig1s000SumR.pdf
`
`xii
`
`

`

`
`
`I.
`
`INTRODUCTION
`
`Patent Owner Cipla Ltd. (“Patent Owner”) submits this Preliminary
`
`Response to GlaxoSmithKline Consumer Healthcare Holdings (US), LLC’s
`
`(“Petitioner”) Petition seeking inter partes review of U.S. Patent No. 9,901,585
`
`(“the ’585 patent”). Petitioner’s request should be denied because it fails both on
`
`threshold issues and the merits.
`
`At the outset, the Petition fails to particularly cite to the prior art such that
`
`the Patent Trial and Appeal Board (“Board”) and Patent Owner can determine the
`
`art upon which the Petition relies. While the Petition purports to identify prior art
`
`that when combined render the claims obvious, it does little more than portray a
`
`collage of teachings across numerous references. The Petition compounds this
`
`error by attempting to incorporate dozens of additional references cited only in
`
`expert declarations and nowhere described in the Petition.
`
`The Petition also suffers from another significant threshold shortcoming—it
`
`fails to address, much less overcome, the fact that the U.S. Patent and Trademark
`
`Office (“Office”) has already considered and rejected the arguments and art set
`
`forth in the Petition. The Board’s precedent demands that where a petitioner relies
`
`on substantially the same prior art and arguments considered during prosecution,
`
`that petitioner must establish error in the Examiner’s analysis. Petitioner made no
`
`effort to make this showing, simply parroting previously rejected arguments. As set
`
`1
`
`

`

`
`
`forth in Section III, infra, the prior art and arguments relied upon in the Petition’s
`
`Grounds were considered, “of record” and had been “previously evaluated, or
`
`disclose[d] information redundant to information of record.” Ex. 1008, 37. Cramer
`
`was considered extensively during prosecution, forming the basis of multiple
`
`rejections. And Petitioner’s additional art—Segal and PDR 1999—were either
`
`expressly considered and rejected, or cumulative of information considered and
`
`rejected during prosecution. Petitioner points to nothing new to distinguish the
`
`arguments and art examined—and overcome—during prosecution. For this reason
`
`alone, the Petition should not be instituted pursuant to 35 U.S.C. § 325(d).
`
`Setting aside the Petition’s defects, Petitioner’s obviousness assertion is
`
`rooted in a fundamentally flawed principle: that a combination of known elements
`
`is obvious even though the prior art provided no impetus to create—and in fact
`
`taught away from—that combination. The ’585 patent’s claims cover Dymista®, a
`
`novel nasal spray formulated by combining
`
`two active
`
`ingredients:
`
`the
`
`antihistamine, azelastine, and the corticosteroid, fluticasone. Dymista® was a
`
`breakthrough: it was the first fixed-dose combination nasal spray to treat allergic
`
`rhinitis (“AR”). Prior to Dymista®, and despite myriad available AR treatments, no
`
`one had successfully combined an intranasal antihistamine with an intranasal
`
`corticosteroid in a fixed-dose formulation.
`
`2
`
`

`

`
`
`There was a good reason for this. Indeed, the prior art discouraged such
`
`combinations because a fixed-dose formulation presented patients and physicians
`
`several treatment difficulties. Namely, a fixed-dose formulation prevented: 1) dose
`
`adjustments, 2) use of only one of the two medications, and 3) use of different
`
`medications. Moreover, the two medications had incompatible dosing regimens.
`
`The prior art provided no motivation to make such a combination. To the contrary,
`
`the prior art taught skilled artisans that a combined steroid-antihistamine product
`
`would offer no advantage over a steroid alone. And with no guidance in the prior
`
`art, the inventors created a formulation that not only overcame those challenges,
`
`but also invented a formulation that combined a medication delivered as a
`
`suspension with a different medication delivered as a solution. Petitioner fails to
`
`address at all why—in the face of these obstacles—a skilled artisan would be
`
`motivated to do what the inventors did. Notably, FDA recognized that the
`
`development of Dymista® was particularly complex and one that raised issues that
`
`had “not been previously encountered” in the development of nasal sprays with
`
`just one active ingredient. Ex. 2008, 4.
`
`Petitioner nonetheless asserts the ’585 patent is purportedly obvious because
`
`the inventors merely combined two known therapies. But, an “invention is not
`
`obvious just because all of the elements that comprise the invention were known in
`
`the prior art.” Broadcom Corp. v. Emulex Corp., 732 F.3d 1325, 1335 (Fed. Cir.
`
`3
`
`

`

`
`
`2013) (internal quotations and citation omitted). Rather, “a finding of obviousness
`
`at the time of invention requires a plausible rational[e] as to why the prior art
`
`references would have worked together.” Id. (internal quotations and citation
`
`omitted). This
`
`requirement
`
`is absent here—Petitioner’s overly-simplistic
`
`obviousness theory fails to provide any motivation to first select these two specific
`
`monotherapies, out of all the myriad possibilities, and then combine them. There
`
`was no suggestion in the prior art as to why one might want to bring fluticasone
`
`and azelastine together into a single formulation. Quite the opposite, the prior art
`
`provided many reasons not to make such a combination. It was only the inventors’
`
`ingenuity that brought Dymista to the market, where some 20 years later, it
`
`remains the only fixed-dose combination nasal spray approved by FDA for the
`
`treatment of AR.
`
`The nonobviousness of the ’585 patent is bolstered by objective evidence,
`
`including the extensive record demonstrating commercial success (ignored by
`
`Petitioner), unexpected results, and the satisfaction of a long-felt need. This
`
`evidence was relied on by the Examiner in the original prosecution of the earlier
`
`’620 patent and was addressed in the prior Argentum IPR, which the Examiner
`
`reviewed during prosecution of the ’585 patent. See Section III.D, infra.
`
`Petitioner’s failure to address the known record evidence is, alone, another basis
`
`sufficient to deny institution here.
`
`4
`
`

`

`
`
`The Board should decline to institute this proceeding.
`
`II. THE PETITION FAILS TO MEET ITS THRESHOLD SHOWING
`BECAUSE IT FAILS TO CITE PRIOR ART IN SUPPORT OF
`UNPATENTABILITY
`
`At the outset, the Petition makes two substantial errors for which the Board
`
`should deny institution. First, the Petition does not cite any prior art with
`
`specificity but rather improperly canvases the prior art in support of its arguments.
`
`Second, the Petition fails to explain in the Petition why the prior art renders the
`
`patent unpatentable and instead resorts to circular citations to multiple, lengthy
`
`expert declarations. For either, or both, of these reasons, the Board should decline
`
`to institute.
`
`A.
`
`The Board Should Deny the Petition under 35 U.S.C. § 314(a)
`Because It Lacks the Required Specificity.
`
`The Petition should be denied because Petitioner does not adequately put
`
`Patent Owner on notice of the precise grounds for alleged unpatentability.
`
`Petitioner posits two primary grounds under which the challenged claims are
`
`allegedly obvious—each purportedly resting on the combination of two references.
`
`The Petition, however, creates a confounding record with a discussion of a
`
`multitude of additional references and does not identify precisely which claim
`
`elements are allegedly present in which references.
`
`To merit institution, the statute requires that “the petition identif[y], in
`
`writing and with particularity, each claim challenged, the grounds on which the
`
`5
`
`

`

`
`
`challenge to each claim is based, and the evidence that supports the grounds for
`
`challenge to each claim....” 35 U.S.C. § 312(a)(3) (emphasis added). Moreover,
`
`“[t]he petition must specify where each element of the claim is found in the prior
`
`art patents or printed publications relied upon.” 37 C.F.R. § 42.104(b)(4). Here, the
`
`Petition does not adequately put Patent Owner on notice of the precise grounds for
`
`alleged unpatentability.
`
`In Grounds 1 and 2, Petitioner challenges the patentability of the ’585
`
`patent’s claims with each ground purportedly resting on a combination of two
`
`references: PDR 1999 in view of Segal and Cramer in view of PDR 1999.
`
`The Petition, however, creates a confounding record with a discussion of a
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`multitude of additional references and does not identify precisely which claim
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`elements are allegedly present in which references. For example, in Ground 1, the
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`Petition identifies at least 7 additional references that appear to form the basis of
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`the Ground. See Pet. 8 (citing Drouin, Brooks, Dykewicz, Berger, Cauwenberge,
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`Spector, and Bousquet as supporting Ground 1). More references are then
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`discussed in the Petition’s discussion of the independent and dependent claims.
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`See, e.g., Pet. 10-30. The Petition does not particularize the teaching from the art in
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`the Ground, but instead cites numerous citations to other prior art references (often
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`in string cite form) absent explanation. Likewise, Petitioner does not include any
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`claim charts that map the cited references to the language of the claims. Neither the
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`6
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`Board nor Patent Owner should be expected to fill in the blanks to uncover
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`Petitioner’s arguments. See Teoxane S.A. v. Allergan, PLC, IPR2017-02002, 2018
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`WL 1247024, at *8 (PTAB Mar. 9, 2018) (citing DeSilva v. DiLeonardi, 181 F.3d
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`865, 866–67 (Fed. Cir. 1999) (“A brief must make all arguments accessible to the
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`judges, rather than ask them to play archeologist with the record.”)).
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`The Board should reject Petitioner’s invitation to play archeologist and
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`should instead follow the path of Zetec, Inc. v. Westinghouse Electric Co.,
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`IPR2014-00384, 2014 WL 3704254 (PTAB July 23, 2014), and exercise its
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`discretion under 35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(b) to deny institution.
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`Zetec, 2014 WL 3704254, at *7-10 (denying institution because “attempting to
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`evaluate fully the…underdeveloped assertions in the Petition to determine whether
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`Petitioner has shown that it would be likely to prevail in any unpatentability
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`challenge would place a significant burden on the Board and contravene the
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`efficient administration of the Office”); see also Schumer v. Lab. Comput. Sys.,
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`Inc., 308 F.3d 1304, 1316 (Fed. Cir. 2002) (“It is not our task . . . to attempt to
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`interpret confusing or general testimony to determine whether a case of invalidity
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`has been made out.”). As in Zetec, the Board should decline to expend its resources
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`scouring the numerous references cited by Petitioner to determine if the identified
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`combinations (or some other, unidentified combination) demonstrate a reasonable
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`likelihood that Petitioner would prevail. Zetec, 2014 WL 3704254, at *9
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`7
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`(“Appellant’s Brief is at best an invitation to the court to scour the record, research
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`any legal theory that comes to mind, and serve generally as an advocate for the
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`appellant. We decline the invitation.” (citations omitted)).
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`B.
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`The Board Should Not Consider Evidence Included in Expert
`Declarations But Not Cited in the Petition.
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`In deciding whether to institute this review, the Board should not consider
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`arguments included in the expert declarations but not discussed in the Petition. 37
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`C.F.R. § 42.6(a)(3) prohibits arguments being incorporated by reference from one
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`document to another in an IPR proceeding. This includes information in expert
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`declarations. See Tempur Sealy Int’l Inc. v. Select Comfort Corp., IPR 2014-01419,
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`Paper 7 at 7-8 (PTAB Feb. 17, 2015); Cisco Sys., Inc., v. C-Cation Techs., LLC,
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`IPR2014-00454, 2014 WL 4352301, at *5-6 (PTAB Aug. 29, 2014) (expanded
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`panel decision explaining that arguments not made in the Petition will not be
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`considered); Fidelity Nat’l Info. Servs., Inc., v. DataTreasury Corp., IPR2014-
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`00489, 2014 WL 4059220, at *5 (PTAB Aug. 13, 2014) (“Under our rules, the
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`petition must contain a ‘full statement of the reasons for the relief requested,
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`including a detailed explanation of the significance of the evidence....’ We,
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`therefore, decline to consider information presented in a supporting declaration,
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`but not discussed sufficiently in a petition.” (citation omitted)); see also Trial
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`Practice Guide Update (August 2018) at 4.
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`8
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`Just as Petitioner glosses over the Grounds, Petitioner also incorporates by
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`reference vast swaths of expert declarations with little, and often no, discussion in
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`the Petition. Indeed, in this Petition, setting aside Exhibits 1001-1008 which
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`contain the four challenged patents and excerpts from their file histories, the
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`Petition’s exhibit list identifies 52 exhibits, only 19 of which are cited in the
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`Petition. The remaining 33 exhibits1 are omitted from discussion in the Petition.
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`None of these omitted exhibits should be considered by the Board.
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`Petitioner’s attempts to impermissibly incorporate by reference is well
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`illustrated in the Petition’s limited discussion of certain secondary indicia of
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`nonobviousness. See Pet. 63-66. For example, the Petition gives short shrift to
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`overcoming the established unexpected results of the ’585 patent—devoting just
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`over two pages to the issue. Yet, the Petition incorporates 59 paragraphs spanning
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`24 pages from the Schleimer Declaration. Pet. 64 (incorporating paragraphs 473-
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`531 from the Schleimer Declaration). Worse, in those 59 paragraphs at least six
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`references are discussed in detail and none of them are cited in the Petition. The
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`Petition suffers the same problems with respect to the criticisms of the declaration
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`by one of the named inventors, Malhotra (“Malhotra Declaration”), submitted
`
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`1 The non-referenced exhibits are Exhibit Nos. 1014-1015, 1017-1018, 1020, 1025-
`1031, 1034, 1036-1037, and 1039-1056.
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`9
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`during prosecution of the earlier ’620 patent that evidenced the inoperability of
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`Example III in Cramer. See Pet. 65-66.
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`Petitioner’s attempts to discount the claimed invention’s satisfaction of a
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`long-felt and unmet need provide an even more egregious example. There, the
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`Petition includes just four lines, yet cites to 7 paragraphs in the Schleimer
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`declaration spanning three pages with reference to several additional exhibits in
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`that section, which are again not cited in the Petition. See Pet. 66. The line and a
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`half of argument on industry praise is similar facially improper. See Pet. 66.
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`Consistent with Tempur Sealy, the Board should decline to consider
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`information presented in the Schleimer and Donovan declarations, but not