`
`IPR2019-00971
`U.S. Patent 9,856,287
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`FRESENIUS KABI USA, LLC AND FRESENIUS KABI SWISSSBIOSIM
`GmbH.,
`Petitioners
`
`v.
`AMGEN INC. and AMGEN MANUFACTURING, LIMITED,
`Patent Owners
`______________________
`Case IPR2019-00971
`Patent 9,856,287
`______________________
`
`
`
`PATENT OWNERS’ PRELIMINARY RESPONSE
`UNDER 37 C.F.R. § 42.107
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`
`Exhibit
`EX2001
`EX2002
`EX2003
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`IPR2019-00971
`U.S. Patent 9,856,287
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`LIST OF EXHIBITS
`
`
`Description
`Prosecution History of U.S. Patent 9,856,287
`Declaration of Sayem Osman
`Excerpt of Joint Claim Construction Chart (Amgen Inc., et al. v.
`Kashiv Biosciences, LLC, No 2:18-cv-03347-CCC-MF, DE 101, at
`Appx. D (D.N.J. March 22, 2019))
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`TABLE OF CONTENTS
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`IPR2019-00971
`U.S. Patent 9,856,287
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`I.
`II.
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`B.
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`C.
`
`Page
`Introduction ...................................................................................................... 2
`The Challenged Claims Of The ’287 Are Directed To A Novel
`Invention .......................................................................................................... 7
`III. The Petition Should Be Rejected Under 37 C.F.R. §42.102(a)(3) And
`§311(c)(2) Because A PGR Was Instituted On This Patent ............................ 8
`IV. The Board Should Exercise Its Discretion And Deny Institution Under
`35 U.S.C. §325(d) .......................................................................................... 10
`A.
`Petitioners’ Ground 1 (Vallejo) Art Is the Same as That Already
`Considered by the Board ..................................................................... 14
`Petitioners’ Ground 2 (Ruddon) Relies on Substantially the
`Same Art and Substantially the Same Arguments as Considered
`in the PGR ........................................................................................... 15
`Petitioners’ Ground 3 (Ruddon in View of Clark 1998 in Light
`of Schafer “or” Gilbert) and Ground 4 (Vallejo in Combination
`With Ruddon and Clark 1998, in Light of Schafer “or” Gilbert)
`Rely on Substantially the Same Art and Arguments as the PGR ....... 16
`Petitioners’ §§102 And 103 Prior Art And Arguments Are
`Either Identical To Or Substantially The Same Art And
`Arguments Already Considered And Rejected By The
`Examiner ............................................................................................. 19
`The Board Should Exercise Its Discretion And Deny Institution Under
`35 U.S.C. §314(a) .......................................................................................... 23
`A. General Plastic Factors Support Denial of Institution ........................ 23
`1.
`Factor 1: Whether Petitioners Are the Same ........................... 23
`2.
`Factor 2: Knowledge of Prior Art ............................................ 25
`3.
`Factor 3: Availability of Information from Prior
`Proceedings ............................................................................... 26
`Factor 4: Timing of Instant Petition ......................................... 28
`Factor 5: Petitioners’ Explanation ........................................... 29
`
`D.
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`V.
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`4.
`5.
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`ii
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`
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`B.
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`C.
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`Factors 6 and 7: Board Considerations of Finite
`Resources/One-Year Time Line ............................................... 30
`Additional Factors Warrant Denial ........................................... 30
`7.
`VI. Petitioners Failed To Provide Sufficient Claim Construction Analysis
`Of Key Claim Terms ..................................................................................... 32
`VII. The Petition Failed To Establish Anticipation Or Obviousness Of Any
`Challenged Claim .......................................................................................... 38
`A.
`Petitioners Failed To Show That Claims 1, 4, 8-10, 12, 14-16,
`19, 23-26, and 20-30 Are Anticipated By Vallejo (Ground 1) ........... 39
`1.
`Petitioners Failed To Show Vallejo Teaches The
`Limitation “Thiol-Pair Buffer Strength To Maintain The
`Solubility Of The Preparation/Solution” .................................. 39
`Petitioners Improperly Mix And Match Different
`Embodiments ............................................................................ 42
`Petitioners Failed To Present Any Argument Applying
`Their Assumed Construction Of “Is Calculated” And
`Cited Art Other Than Vallejo In Arguing “Anticipation” ........ 44
`Petitioners Fail To Establish That Claims 16, 19-21, 23-26, and
`29-30 Are Anticipated By Ruddon (Ground 2)................................... 46
`1.
`Petitioners Failed To Show Ruddon Discloses A Process
`That Properly Refolds Proteins Into Biologically Active
`Forms......................................................................................... 46
`Petitioners Failed To Show Ruddon Teaches The
`Limitation “Thiol-Pair Buffer Strength To Maintain The
`Solubility Of The Solution” ...................................................... 47
`Petitioners Failed To Present Any Argument Applying
`Their Assumed Construction Of “Is Calculated” And
`Cited Art Other Than Ruddon In Arguing “Anticipation”
`(Claims 23-25, And 30) ............................................................ 47
`Petitioners’ Obviousness Grounds Are Unclear, Confusing, and
`Legally Insufficient (Grounds 3 and 4) ............................................... 48
`1.
`Grounds 3 And 4 Are A Combination Of Multiple
`Poorly-Delineated Grounds ...................................................... 51
`
`
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`IPR2019-00971
`U.S. Patent 9,856,287
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`6.
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`2.
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`3.
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`2.
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`3.
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`iii
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`IPR2019-00971
`U.S. Patent 9,856,287
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`2.
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`3.
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`Petitioners Do Not Clearly Identify Which “Gilbert”
`Reference Is Intended To Be Part Of Grounds 3 And 4 ........... 53
`Petitioners Do Not Clearly Identify The Base Reference
`For Ground 3 And Fail To Explain The Modifications To
`The Base Reference For Grounds 3 And 4 Or Analyze
`The Motivation To Combine .................................................... 54
`Petitioners Failed To Articulate A Reasonable
`Expectation Of Success For Grounds 3 And 4 ......................... 59
`Petitioners Failed To Present Any Argument Applying Its
`Assumed Construction Of “Is Calculated” ............................... 61
`VIII. Conclusion ..................................................................................................... 61
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`4.
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`5.
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`IPR2019-00971
`U.S. Patent 9,856,287
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`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`
`CASES
`10X Genomics, Inc. v. Bio-Rad Labs., Inc.,
`IPR2018-00301, Pap. 18 (June 15, 2018) ........................................................... 60
`Abiomed Inc. v. Maquet Cardiovascular, LLC,
`IPR2017-02134, Pap. 7 (April 16, 2018) ...................................................... 25, 26
`Activision Blizzard, Inc. v. Acceleration Bay, LLC,
`IPR2016-00931, Pap. 13 (June 23, 2016) ..................................................... 13, 14
`Adidas AG v. Nike, Inc.,
`IPR2016-00920, Pap. 6 (Oct. 20, 2016) ................................................. 55, 56, 57
`Adt LLC v. Applied Capital, Inc.,
`IPR2017-01825, Pap. 7 (Jan. 24, 2018) .............................................................. 57
`Alcatel-Lucent USA Inc. v. Oyster Optics, LLC,
`IPR2018-00257, Pap. 14 (June 4, 2018) ............................................................. 31
`Am. Honda Motor Co. v. Intellectual Ventures II LLC,
`IPR2018-00347, Pap. 10 (June 27, 2018) ........................................................... 28
`Am. Honda Motor Co. v. Intellectual Ventures II LLC,
`IPR2018-00348, Pap. 10 (June 27, 2018) ........................................................... 31
`Amgen Inc. v. F. Hoffman-La Roche Ltd.,
`580 F.3d 1340 (Fed. Cir. 2009) ............................................................................ 0
`AOL Inc. v. Coho Licensing LLC,
`IPR2014-00966, Pap. 6 (Nov. 20, 2014) ............................................................ 51
`Apple, Inc. v. ContentGuard Holdings, Inc.,
`IPR2015-00358, Pap. 9 (July 2, 2015) ............................................. 50, 51, 54, 57
`Apple Inc. v. Memory Integrity, LLC,
`IPR2015-00159, Pap. 12 (May 11, 2015) ............................................................. 0
`
`v
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`TABLE OF AUTHORITIES (CONTINUED)
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`Page(s)
`
`
`Axon Enter., Inc. v. Digital Ally, LLC,
`IPR2017-00515, Pap. 10 (July 6, 2016) ................................................................... 57
`Baker Hughes Oilfield Ops., Inc. v. Smith Int’l, Inc.,
`IPR2016-01451, Pap. 8 (Dec. 22, 2016) ....................................................... 13, 14
`CareFusion Corp. v. Baxter Int’l, Inc.,
`IPR2016-01456, Pap. 9 (Feb. 6, 2017) ............................................................... 35
`Chevron Oronite Co. v. Infieum USA LP,
`IPR2018-00923, Pap. 9 (Nov. 7, 2018) .......................................................... 6, 38
`Clim-A-Tech Indus., Inc. v. Ebert,
`IPR2017-01863, Pap. 13 (Feb. 12, 2018) ..................................................... 50, 54
`Conopco, Inc. v. Procter & Gamble Co.,
`IPR2014-00506, Pap. 17 (July 7, 2014) ....................................................... 14, 15
`Costco Wholesale Corp. v. Robert Bosch LLC,
`IPR2016-00035, Pap. 23 (Aug. 12, 2016) .......................................................... 41
`Costco Wholesale Corp. v. Robert Bosch LLC,
`IPR2016-00042, Pap. 28 (July 7, 2016) ....................................................... 54, 55
`Crown Operations Int’l, Ltd. v. Solutia Inc.,
`289 F.3d 1367 (Fed. Cir. 2002) .......................................................................... 39
`Cultec, Inc. v. Stormtech LLC,
`IPR2017-00777, Pap. 7 (Aug. 22, 2017) ............................................................ 13
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) ........................................................................................ 23
`Deeper, UAB v. Vexilar, Inc.,
`IPR2018-01310, Pap. 7 (Jan. 24, 2019) .......................................................... 7, 38
`Dish Network Corp. v. Customedia Techs., LLC,
`IPR2017-00936, Pap. 13 (Aug. 24, 2017) .......................................................... 55
`
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`U.S. Patent 9,856,287
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`TABLE OF AUTHORITIES (CONTINUED)
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`Page(s)
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`
`
`Dominion Dealer Sols., LLC v. Autoalert, Inc.,
`IPR2013-00225, Pap. 15 (Oct. 10, 2013) ........................................................... 57
`Dr. Reddy’s Labs., Inc. v. Celgene Corp.,
`IPR2018-01507, Pap. 7 (Feb. 11, 2019) ............................................................. 49
`Dr. Reddy’s Labs. S.A. v. Indivior UK Ltd.,
`IPR2019-00328, Pap. 19 (June 3, 2019) ............................................................. 17
`Edge Endo, LLC v. Scianamblo,
`IPR2018-01322, Pap. 15 (Jan. 14, 2019) ............................................................ 15
`Endo Pharm. Inc. v. Depomed, Inc.,
`IPR2014-00653, Pap. 12 (Sept. 29, 2014) .......................................................... 38
`Dep’t of Justice v. EnvisionIt, LLC,
`IPR2017-00186, Pap. 8 (May 3, 2017) ............................................................... 55
`Expedia, Inc. v. Int’l Bus. Mach. Corp.,
`IPR2019-00404, Pap. 8 (June 5, 2019) ............................................................... 33
`Feit Elec. Co. v. Philips Lighting N. AM. Corp.,
`IPR2018-00790, Pap. 9 (Oct. 10, 2018) ............................................................. 55
`Fluidmaster, Inc. v. Danco, Inc.,
`IPR2017-00770, Pap. 13 (July 28, 2017) ........................................................... 40
`Free-Flow Packaging Int’l, Inc. v. Automated Packaging Sys., Inc.,
`IPR2016-00351, Pap. 7 (June 27, 2016) ............................................................. 50
`Front Row Techs., LLC v. MLB Adv. Media, L.P.,
`IPR2015-01932, Pap. 7 (March 25, 2016) ......................................................... 58
`Fustibal LLC v. Bayer Healthcare LLC,
`IPR2016-01490, Pap. 9 (Feb. 8, 2017) ............................................................... 15
`Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Pap. 19 (Sept. 6, 2017) ............................................................ 23
`
`vii
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`U.S. Patent 9,856,287
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`TABLE OF AUTHORITIES (CONTINUED)
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`Page(s)
`
`
`Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) .......................................................................... 23
`Healthcare Logistics, Inc. v. Kit Check, Inc.,
`IPR2019-00385, Pap. 7 (June 3, 2019) ............................................................... 56
`Hengdian Grp. DMEGC Magnetics Co., v. Hitachi Metals, Ltd.,
`IPR2017-01313, Pap. 7 (Nov. 6, 2017) .............................................................. 21
`Hologic, Inc. v. Enzo Life Scis. Inc.,
`IPR2018-00019, Pap. 21 (Nov. 28, 2018) .................................................... 33, 35
`Hospira, Inc. v. Genentech, Inc.,
`IPR2017-00739, Pap. 16 (July 27, 2017) ........................................................... 13
`InfoBionic, Inc. v. Braemer Mfg., LLC,
`IPR2016-01236, Pap. 8 (Dec. 23, 2016) ............................................................. 50
`Instrumentation Lab. Co. v. Hemosonics, LLC,
`IPR2018-00264, Pap. 8 (May 10, 2018) ............................................................. 28
`Intel Corp. v. Godo Kaisha IP Bridge 1,
`IPR2018-00753, Pap. 11 (Oct. 9, 2018) ............................................................. 12
`Intex Recreation Corp. v. Team Worldwide Corp.,
`IPR2019-00245, Pap. 7 (May 15, 2019) ............................................................... 9
`Investors Exch., LLC. v. NASDAQ Tech. AB,
`IPR2018-01796, Pap. 11 (May 6, 2019) ............................................................. 45
`InVue Sec. Prods. Inc. v. Mobile Tech, Inc.,
`PGR2019-00019, Pap. 7 (May 29, 2019) ..................................................... 45, 52
`John Crane, Inc. v. Finalrod IP, LLC,
`IPR2016-01827, Pap. 6 (Jan. 31, 2017) .................................................. 50, 55, 56
`Juniper Networks Inc. v. Finjan, Inc.,
`IPR2019-00060, Pap. 7 (Apr. 29, 2019) ................................................. 10, 16, 17
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`U.S. Patent 9,856,287
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`TABLE OF AUTHORITIES (CONTINUED)
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`Page(s)
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`
`
`Juniper Networks, Inc. v. Parity Networks, LLC,
`IPR2018-01642, Pap. 11 (April 10, 2019) .................................................... 26, 29
`Linear Tech. Corp. v. In-Depth Test LLC,
`IPR2015-00421, Pap. 15 (July 21, 2015) ........................................................... 57
`Lifewave, Inc. v. Edward Blendermann,
`IPR2016-00571, Pap. 7 (Sep. 7, 2016) ............................................................... 40
`In re Magnum Oil Tools, Int’l. Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .......................................................................... 49
`Microsoft Corp. v. Biscotti, Inc.,
`878 F.3d 1052 (Fed. Cir. 2017) .......................................................................... 42
`Neology, Inc. v. Star Sys., Int’l Ltd.,
`IPR2019-00367, Pap. 9 (June 6, 2019) ......................................................... 10, 18
`NetApp Inc. v. Crossroads Sys. Inc.,
`IPR2015-00777, Pap. 12 (Sept. 3, 2015) ................................................ 13, 15, 26
`Nichia Corp. v. Document Sec. Sys., Inc.,
`IPR2019-00398, Pap. 10 (April 15, 2019) .......................................................... 26
`Nintendo Co. v. Genuine Enabling Tech LLC,
`IPR2018-00543, Pap. 7 (Aug. 6, 2018) .............................................................. 59
`Olympus Corp. v. Maxell, Ltd.,
`IPR2018-00905, Pap. 9 (Nov. 19, 2018) ............................................................ 59
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .................................................................... 33, 36
`Robert Bosch LLC v. Orbital Australia PTY Ltd.,
`IPR2015-01249, Pap. 9 (Dec. 21, 2015) ............................................................. 35
`Roland Corp. v. inMusic Brands, Inc.
`IPR2018-00335, Pap. 14 (July 2, 2018) ....................................................... 40, 41
`
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`U.S. Patent 9,856,287
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`TABLE OF AUTHORITIES (CONTINUED)
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`Page(s)
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`
`
`Samsung Elecs. Co. v. ELM 3DS Innovations, LLC,
`IPR2017-01305, Pap. 11 (Oct. 17, 2017) ............................................... 24, 27, 29
`Sandoz, Inc. v. Genentech, Inc.,
`IPR2017-02036, Pap. 13 (Mar. 4, 2018) ............................................................ 21
`SAS Institute, Inc. v. Iancu,
`138 S. Ct. 1348 (2018) ...................................................................................... 2, 6
`SharkNinja Operating LLC v. Flexible Techs., Inc.,
`IPR2018-00903, Pap. 8, (Oct. 17, 2018) ...................................................... 33, 34
`Shenzhen Silver Star Intelligent Tech. Co. v. iRobot Corp.,
`IPR2017-02050, Pap. 8 (March 12, 2018) .................................................... 13, 14
`Shopkick Inc. v. Novitaz, Inc.,
`IPR2015-00279, Pap. 7 (May 29, 2005) ............................................................. 58
`In re Stepan Co.,
`868 F.3d 1342 (Fed. Cir. 2017) .......................................................................... 60
`SynQor, Inc. v. Artesyn Techs., Inc.,
`709 F.3d 1365 (Fed. Cir. 2013) .......................................................................... 42
`Taiwan Semiconductor Mfg. Co., v. Godo Kaisha IP Bridge 1,
`IPR2017-00931, Pap. 9 (Aug. 16, 2017) ............................................................ 14
`TCL Corp. v. Telefonaktiebolaget LM Ericsson,
`IPR2015-01584, Pap. 74 (Jan. 24, 2017) ...................................................... 40, 41
`Teoxane S.A. v. Allergan, PLC,
`IPR2017-01906, Pap. 15 (March 9, 2018) .............................................. 50, 53, 54
`TRW Auto. U.S. LLC v. Magna Elecs. Inc.,
`IPR2014-01347, Pap. 25 (Jan. 6, 2016) .............................................................. 49
`Unified Patents, Inc. v. Berman,
`IPR2016-01571, Pap. 10 (Dec. 14, 2016) ........................................................... 11
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`TABLE OF AUTHORITIES (CONTINUED)
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`Page(s)
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`
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`Valve Corp. v. Elec. Scripting Prods., Inc.,
`IPR2019-00062, Pap. 11 (Apr. 2, 2019) ................................................. 25, 26, 29
`West Pharm. Servs., Inc. v. Sanofi-Aventis Deutschland GmbH,
`IPR2018-01162, Pap. 7 (Dec. 6, 2018) ............................................................... 22
`Zetec, Inc. v. Westinghouse Elec. Co.,
`IPR2014-00384, Pap. 10 (Jul. 23, 2014) ............................................................ 53
`STATUTES
`35 U.S.C. § 102 .................................................................................................. 12, 35
`35 U.S.C. § 103 .................................................................................................. 12, 35
`35 U.S.C. § 311(c) ......................................................................................... 9, 29, 62
`35 U.S.C. § 311(c)(2) ......................................................................................... 1, 3, 9
`35 U.S.C. § 312(a) ................................................................................................... 55
`35 U.S.C. § 312(a)(3) ................................................................................... 50, 52, 53
`35 U.S.C. § 314 ............................................................................................ 1, 2, 4, 62
`35 U.S.C. § 314(a) ............................................................................................passim
`35 U.S.C. § 325(d) ............................................................................................passim
`REGULATIONS
`37 C.F.R. § 41.102(c)(3) ............................................................................................ 1
`37 C.F.R. § 42.100(b) .............................................................................................. 33
`37 C.F.R. § 42.102 ..................................................................................................... 9
`37 C.F.R. § 42.102(a)(3) .......................................................................................... 10
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`Page(s)
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`37 C.F.R. § 42.102(c) ................................................................................................. 3
`37 C.F.R. § 42.104(b) .............................................................................................. 34
`37 C.F.R. § 42.104(b)(3) .................................................................................... 32, 33
`37 C.F.R. § 42.104(b)(4) .................................................................................... 32, 50
`37 C.F.R. § 42.104(b)(5) .......................................................................................... 50
`37 C.F.R. § 42.107 ..................................................................................................... 1
`37 C.F.R. § 42.108(a) ............................................................................................... 23
`37 C.F.R. § 42.108(c) ............................................................................................. 2, 4
`37 C.F.R. § 42.120 ..................................................................................................... 2
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`Pursuant to 37 C.F.R. §42.107,1 Patent Owners2 Amgen Inc. and Amgen
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`IPR2019-00971
`U.S. Patent 9,856,287
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`
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`Manufacturing, Limited (collectively, “Amgen”) submit this Preliminary Response
`
`to the above-captioned Petition for Inter Partes Review of U.S. Patent No.
`
`9,856,287 (“Petition” or “Pet.” Pap. 3), which should be denied in its entirety: for
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`being filed before the termination of instituted PGR2019-00001 under §311(c)(2)
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`and §41.102(c)(3); pursuant to the Board’s discretion under §§314 and 325(d); for
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`Petitioners’ failure to take affirmative positions with respect to the correctness of,
`
`and failure to provide any analysis or record citations supporting, the constructions
`
`they identify; Petitioners’ failure to address whether Claims 1, 4-6, 8-10, 12, and
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`14-15 are indefinite (as asserted in PGR2019-00001); and Petitioners’ failure to
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`show a reasonable likelihood of prevailing on any asserted ground. Further,
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`
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` 1
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` All emphasis/annotations added, and all statutory and regulatory citations are to
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`35 U.S.C. or 37 C.F.R., as the context indicates, unless otherwise stated.
`
`2 Petitioners, apparently copying Petitioners in PGR2019-00001, listed both
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`Amgen Inc. and Amgen Manufacturing, Limited in the caption as “Patent Owner.”
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`Amgen Manufacturing, Limited is an exclusive licensee. Nevertheless, consistent
`
`with the caption, this Preliminary Response refers collectively to both parties as
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`“Patent Owners.”
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`1
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`

`

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`because of the procedural and substantive failings of the Petition, institution would
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`IPR2019-00971
`U.S. Patent 9,856,287
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`not be in the interest of justice, or an efficient use of the Board’s limited time and
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`resources. And, in light of SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018),
`
`even if Petitioners had made their threshold showing for some claims or grounds—
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`they have not—the Board, in its discretion, should deny institution under §314(a)
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`for these additional reasons on all challenged claims and grounds in the Petition.
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`I.
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`Introduction
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`Petitioners’ submission failed to provide the Board the basic evidence
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`required to institute any inter partes review. If the Board nonetheless institutes
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`trial on the Challenged Claims,3 Amgen will address in detail in its §42.120
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`Response the numerous substantive errors and shortcomings in Petitioners’
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`arguments and their purported evidence. Here, however, where testimonial
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`evidence purporting to raise an issue of material fact “will be viewed in the light
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`most favorable to the petitioner” (§42.108(c)), Amgen addresses only a subset of
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`the Petition’s procedural and substantive shortcomings. Because of these threshold
`
`failures, the Petition should be denied and no IPR instituted under §314.
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`
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` 3
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` Claims 1, 4-6, 8-10, 12, 14-16, 19-21, 23-26, 29-30 of U.S. Patent No. 9,856,287
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`(“’287”).
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`2
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`

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`First, §311(c)(2) and §42.102(c) forbid the filing of an IPR before
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`IPR2019-00971
`U.S. Patent 9,856,287
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`PGR2019-00001 (hereinafter “the PGR” or “the ’287 PGR”) is terminated. See
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`§III.
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`Second, the same or substantially the same art, evidence and/or arguments
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`are already being considered by the Board in the PGR, and were already
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`considered by the Examiner and not found to render the claims unpatentable. See
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`§IV. Petitioners’ Ground 1 (alleging anticipation by Vallejo) overlaps with PGR
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`Ground 3 (alleging anticipation by Vallejo). Petitioners’ Ground 2 (alleging
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`anticipation by Ruddon) overlaps with PGR Ground 6 (alleging obviousness based
`
`on Ruddon). Petitioners’ Ground 3 (alleging obviousness based on Ruddon and
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`other references) and Ground 4 (alleging obviousness based on a combination of
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`Vallejo, Ruddon and other references) overlap with PGR Ground 6 (alleging
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`obviousness based on Ruddon in view of Vallejo) and PGR Ground 3 (alleging
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`anticipation by Vallejo). For this additional reason, the Petition should be denied
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`under §325(d).
`
`Third, the Petition is a follow-on petition that should not be instituted under
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`§314(a). See §V. For example, Petitioners knew of the art from the PGR, and had
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`Amgen’s POPR from the PGR in hand before filing the instant Petition. Moreover,
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`Petitioners failed to even address §314(a) and the General Plastic factors.
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`3
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`Fourth, Petitioners failed to provide an analysis of the proper construction of
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`IPR2019-00971
`U.S. Patent 9,856,287
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`terms it was required to address, or to take an affirmative position as to the
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`constructions they identify, instead summarily asserting that Petitioners “will
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`assume” constructions from the PGR while asserting they would do so “[f]or
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`purposes of this IPR only.” Pet. 20-21; see §VI. In so doing, Petitioners also
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`provided no citations to the record supporting the constructions they decided to
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`“assume,” apparently (and improperly) attempting to await some future litigation
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`to reveal their real positions regarding the proper constructions of the claims.
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`Fifth, although indefiniteness was raised (and instituted) in the PGR,
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`Petitioner fails to take any position as to the definiteness of claims 1, 4-6, 8-10, 12,
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`and 14-16, let alone provide any analysis setting forth how or why the terms it
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`seeks to invalidate should be understood by the Board. See §VI.
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`Sixth, Petitioners’ own arguments and evidence confirm they cannot make a
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`prima facie showing that, as a factual and legal matter for each asserted ground,
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`there is a reasonable likelihood of proving at least one Challenged Claim
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`unpatentable. See, e.g., §314; §42.108(c); §VII. For instance:
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`•
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`For Grounds 1 and 2, Petitioners failed to present any argument regarding
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`dependent claims requiring thiol-pair ratio and thiol-pair buffer strength to
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`be “calculated” (claims 8, 9, 14, 15, 23, 24, 25, and 30) under their identified
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`construction, inexplicably relying on additional references in asserting the
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`4
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`limitations added by these dependent claims would have been anticipated by
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`Vallejo or Ruddon;
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`•
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`For Grounds 1 and 2, Petitioners failed to address how any of their
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`references disclose maintaining the solubility of the solution even under
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`Petitioners’ identified construction;
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`•
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`For Ground 1, Petitioners failed to address how Vallejo discloses
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`maintaining the solubility of the preparation when that term is properly
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`understood;
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`•
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`For Ground 2, Petitioners failed to address that the process in Ruddon does
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`not result in a properly refolded protein, but results, instead, in a subunit
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`(hCG-β) that is competent to assemble with a second native (already folded)
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`subunit (hCG-α) to form a biologically active protein (hCG);
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`•
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`For Grounds 3 and 4, Petitioners’ obviousness arguments are unclear,
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`confusing and legally insufficient. Petitioners, inter alia, (a) fail to delineate
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`clearly what grounds they assert, using an ambiguous “and/or” approach that
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`could reflect as many as four different grounds for each of Grounds 4 and 5,
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`(b) fail to clearly specify the references and sections of the references
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`Petitioners rely on for each combination, let alone each given limitation, (c)
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`fail to clearly identify the base reference and how or why it is allegedly
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`5
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`U.S. Patent 9,856,287
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`modified in the proposed combination, (d) fail to provide any meaningful
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`explanation for reasonable expectation of success, (e) fail to provide any
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`argument that any value was actually calculated for the claims Petitioners
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`concede require calculation, and (f) fail to cite expert support for assertions
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`about what a POSITA would have known, understood, and expected.
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`In view of post-SAS all-or-nothing institution, even if, arguendo, the Board
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`were to unearth a Ground with merit buried within Petitioners’ pile of arguments
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`and combinations reflecting as many as five to ten different challenges per claim,4
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`the Board should exercise its discretion here and deny institution, which would not
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`be an efficient use of the Board’s limited time and resources given Petitioners’
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`imprecise scattershot approach. See, e.g., SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348,
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`1355-56 (2018); Chevron Oronite Co. v. Infieum USA LP, IPR2018-00923, Pap. 9,
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`9-11 (Nov. 7, 2018) (informative) (denying institution on all claims when
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`Petitioners’ arguments and proofs were deficient with respect to a subset of
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` 4
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` As explained above, and in more detail below (infra, §VII.C.1), because of
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`Petitioners’ inappropriate use of an “and/or” approach in identifying secondary
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`references for Grounds 3 and 4, each reflects as many as four different grounds per
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`“Ground.”
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`6
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`claims); see also Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Pap. 7, 41-43 (Jan.
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`IPR2019-00971
`U.S. Patent 9,856,287
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`24, 2019) (informative) (denying institution because instituting trial with respect to
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`all twenty-three claims and on all four grounds based on evidence and arguments
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`directed to only two claims and one ground would not be an efficient use of the
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`Board’s time and resources.”); SAS Q&As, D3, at p. 8 (USPTO June 5, 2018),
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`available at https://www.uspto.gov/sites/default/files/documents/
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`sas_qas_20180605.pdf (noting that, although “[t]he Board does not contemplate a
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`fixed threshold for a sufficient number of challenges for which it will institute,” it
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`will “evaluate the challenges and determine whether, in the interests of efficient
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`administration of the Office and integrity of the patent system...the entire petition
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`should be denied under 35 U.S.C. § 314(a).”).
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`For these reasons, the Petition should be denied.
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`II. The Challenged Claims Of The ’287 Are Directed To A Novel Invention
`The ’287 is directed to a novel and efficient protein refolding method based
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`on control of redox conditions with reductant and oxidant (“redox”) reagents.
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`EX1001, 2:62-3:5. The goal of protein refolding is to increase and maximize yield
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`of properly folded proteins. EX1001, 1:32-38. Desired proteins are recombinantly
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`expressed in non-mammalian culture systems (e.g., bacteria). But, these expressed
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`proteins misfold and precipitate in intracellular limited-solubility intracellular
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`precipitates known as inclusion bodies. Id., 1:25-30. These inclusion bodies are
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`7
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`formed because the bacterial host cell is unable to fold recombinant proteins
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`IPR2019-00971
`U.S. Patent 9,856,287
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`properly. Id., 1:29-31. These host cells are collected and lysed, and then the
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`released inclusion bodies are solubilized in a denaturing solution to linearize the
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`proteins into individual protein chains. Id., 1:43-50.
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`Prior to the ’287, those skilled in the art needed to manipulate a large
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`number of variables—through trial and er