`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`DR. REDDY’S LABORATORIES, INC.,
`
`Petitioner
`
`v.
`
`GENENTECH, INC., HOFFMANN-LA ROCHE AG, AND ABBVIE INC.,
`
`Patent Owner.
`__________________________
`
`PTAB Case No. PGR2022-00023
`
`Patent No. 10,993,942
`__________________________
`
`PETITION FOR POST-GRANT REVIEW OF
`U.S. PATENT NO. 10,993,942
`
`__________________________
`
`

`

`TABLE OF CONTENTS
`
`
`Page
`
`V.
`
`INTRODUCTION ....................................................................................... 1
`I.
`II. MANDATORY NOTICES ......................................................................... 2
`A.
`Real Parties-In-Interest (37 C.F.R. § 42.8(b)(1)) .............................. 2
`B.
`Related Matters (37 C.F.R. § 42.8(b)(2)) .......................................... 2
`C.
`Identification of Counsel (37 C.F.R. § 42.8(b)(3)) and
`Service Information (37 C.F.R. § 42.8(b)(4)) ................................... 3
`III. GROUNDS FOR STANDING .................................................................... 4
`IV.
`IDENTIFICATION OF CHALLENGE AND STATEMENT OF
`THE PRECISE RELIEF REQUESTED ..................................................... 4
`STATEMENT OF REASONS FOR THE RELIEF
`REQUESTED .............................................................................................. 5
`A.
`Summary of the Argument ................................................................ 5
`B.
`Scientific Background ....................................................................... 6
`C.
`Summary of the ’942 patent .............................................................. 9
`1.
`Effective Filing Date ............................................................... 9
`2.
`Person of Ordinary Skill in the Art ....................................... 10
`3.
`Disclosure .............................................................................. 11
`4.
`Claims ................................................................................... 15
`5.
`Prosecution History ............................................................... 17
`Proposed Claim Construction.......................................................... 21
`Post-Grant Review Is Proper ........................................................... 24
`Ground 1: Claims 1-3, 5-6, 14, 25-27, and 30 of the
`’942 patent Lack Written Description ............................................. 26
`1.
`The written description standard ........................................... 27
`2.
`The specification makes clear that the invention is
`limited to a combination therapy, not an escalating-
`dose monotherapy ................................................................. 29
`
`D.
`E.
`F.
`
`- i -
`
`

`

`TABLE OF CONTENTS
`(continued)
`
`Page
`
`3.
`
`4.
`
`The specification does not disclose the claimed
`escalating-dose regimes for GDC-0199. ............................... 42
`Even if it were to disclose the elements separately,
`the disclosure provides no description of their
`combination. .......................................................................... 46
`VI. DISCRETIONARY DENIAL WOULD BE INAPPROPRIATE ............. 48
`VII. CONCLUSION .......................................................................................... 53
`
`
`- ii -
`
`

`

`
`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) .....................48, 49, 50, 51, 52
`
`Apple Inc. v. Parus Holdings, Inc.,
`IPR2020-00687, Paper 9 (PTAB Sept. 23, 2020) ............................................... 52
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) ........................................ 27, 28, 29, 48
`
`Biogen Int’l GmbH v. Mylan Pharms. Inc.,
`18 F.4th 1333 (Fed. Cir. 2021) ...................................................28, 37, 45, 47, 48
`
`Collegium Pharm., Inc. v. Purdue Pharma L.P.,
`PGR2018-00048, Paper 58 (PTAB Nov. 19, 2021) ......................... 24, 25, 45, 48
`
`Commonwealth Sci. & Indus. Rsch. Org. v. BASF Plant Sci. Co.,
`PGR2020-00057, Paper 35 (PTAB Oct. 1, 2021) .............................................. 21
`
`Eli Lilly & Co. v. Teva Pharms. Int’l GmbH,
`8 F.4th 1331 (Fed. Cir. 2021) ............................................................................. 23
`
`Forest Labs., LLC v. Sigmapharm Labs., LLC,
`918 F.3d 928 (Fed. Cir. 2019) ............................................................................ 31
`
`Fujikawa v. Wattanasin,
`93 F.3d 1559 (Fed. Cir. 1996) ................................................................ 46, 47, 48
`
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1473 (Fed. Cir. 1998) ...................................................................passim
`
`ICU Med., Inc. v. Alaris Med. Sys., Inc.,
`558 F.3d 1368 (Fed. Cir. 2009) ........................................................ 27, 30, 33, 40
`
`In re Boesch,
`617 F.2d 272 (CCPA 1980) ................................................................................ 44
`
`- iii -
`
`

`

`TABLE OF AUTHORITIES
`(continued)
`
`Page(s)
`
`In re Wilder,
`736 F.2d 1516 (Fed. Cir. 1984) .......................................................................... 31
`
`LizardTech, Inc. v. Earth Res. Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005) .......................................................................... 47
`
`Medtronic Corevalve LLC v. Speyside Med., LLC,
`IPR2021-00244, Paper 9 (PTAB Aug. 18, 2021) ............................................... 50
`
`Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings,
`370 F.3d 1354 (Fed. Cir. 2004) .......................................................................... 22
`
`Microsurgical Tech, Inc. v. Regents of Univ. of Colo.,
`PGR2021-00026, Paper 12 (PTAB June 16, 2021) ............................................ 24
`
`N. Telecom, Inc. v. Datapoint Corp.,
`908 F.2d 931 (Fed. Cir. 1990) ............................................................................ 40
`
`Netapp, Inc. v. Proven Networks, LLC,
`IPR2020-01436, Paper 11 (PTAB Apr. 9, 2021) ............................................... 50
`
`Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.,
`868 F.3d 1013 (Fed. Cir. 2017) .......................................................................... 22
`
`Novozymes A/S v. DuPont Nutrition Biosciences APS,
`723 F.3d 1336 (Fed. Cir. 2013) .................................................................... 29, 47
`
`Nuvo Pharm. (Ir.) Designated Activity Co. v. Dr. Reddy’s Labs. Inc.,
`923 F.3d 1368 (Fed. Cir. 2019) .......................................................................... 28
`
`Oticon Med. AB v. Cochlear Ltd.,
`IPR2019-00975, Paper 15 (PTAB Oct. 16, 2019) .............................................. 50
`
`PowerOasis, Inc. v. T-Mobile USA, Inc.,
`522 F.3d 1299 (Fed. Cir. 2008) .......................................................................... 25
`
`Regents of Univ. of Minn. v. AGA Med. Corp.,
`717 F.3d 929 (Fed. Cir. 2013) ............................................................................ 31
`
`- iv -
`
`

`

`TABLE OF AUTHORITIES
`(continued)
`
`Page(s)
`
`Ruckus Wireless, Inc. v. Innovative Wireless Sols., LLC,
`824 F.3d 999 (Fed. Cir. 2016) ............................................................................ 31
`
`Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC,
`962 F.3d 1362 (Fed. Cir. 2020) .......................................................................... 22
`
`Snap, Inc. v. SRK Tech. LLC,
`IPR2020-00820, Paper 15 (PTAB Oct. 21, 2020) .............................................. 51
`
`Sony Mobile Commc’ns AB v. Ancora Techs., Inc.,
`IPR2021-00663, Paper 17 (PTAB June 10, 2021) ............................................. 52
`
`Supercell Oy v. GREE, Inc.,
`PGR2021-00034, Paper 10 (PTAB July 7, 2021) .............................................. 49
`
`Union Oil Co. of Cal. v. Atl. Richfield Co.,
`208 F.3d 989 (Fed. Cir. 2000) ............................................................................ 28
`
`Univ. of Rochester v. G.D. Searle & Co.,
`358 F.3d 916 (Fed. Cir. 2004) ............................................................................ 27
`
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795 (Fed. Cir. 1999) ............................................................................ 21
`
`W. Digit. Corp. v. Kuster,
`IPR2020-01391, Paper 10 (PTAB Feb. 16, 2021) .............................................. 50
`
`STATUTES
`
`35 U.S.C. § 103 ........................................................................................................ 19
`
`35 U.S.C. § 112 .................................................................................................passim
`
`35 U.S.C. § 112(a) ................................................................................................... 27
`
`35 U.S.C. § 119 ........................................................................................................ 25
`
`35 U.S.C. § 120 ........................................................................................................ 25
`
`- v -
`
`

`

`TABLE OF AUTHORITIES
`(continued)
`
`Page(s)
`
`35 U.S.C. § 282(b) ................................................................................................... 21
`
`35 U.S.C. § 314(a) ................................................................................................... 49
`
`35 U.S.C. § 324(a) ............................................................................................. 48, 49
`
`35 U.S.C. § 325(d) ................................................................................................... 48
`
`AIA § 3(n)(1)(A) .................................................................................................. 4, 24
`
`AIA § 6(f)(2)(A) .................................................................................................. 4, 24
`
`REGULATIONS
`
`37 C.F.R. § 42.6(c) ..................................................................................................... 4
`
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 2
`
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 2
`
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 3
`
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 3
`
`37 C.F.R. § 42.100(b) (2019) ................................................................................... 21
`
`37 C.F.R. § 42.204(a) ................................................................................................. 4
`
`83 Fed. Reg. 51,340 (Oct. 11, 2018) (codified at 37 C.F.R. pt. 42) ........................ 21
`
`
`
`- vi -
`
`

`

`
`
`
`
`EXHIBIT LIST
`
`EXHIBIT
`
`DESCRIPTION
`
`Ex. 1001 U.S. Patent No. 10,993,942 to Sampath et al. (“’942 patent”)
`
`Ex. 1002
`
`File History of ’942 patent
`
`Ex. 1003 Docket Report, AbbVie Inc. v. Alembic Pharms., Ltd., No. 1-20-cv-
`01009 (D. Del.)
`
`Ex. 1004 Docket Report, AbbVie Inc. v. Dr. Reddy’s Labs., Ltd., No. 1-20-cv-
`00968 (D. Del.)
`
`Ex. 1005
`
`Second Amended Complaint as to DRL Defendants, No. 1-20-cv-
`00968 (Oct. 21, 2021)
`
`Ex. 1006 U.S. Patent No. 9,529,251 to Sampath et al. (“’251 Patent”)
`
`Ex. 1007
`
`File History of ’251 Patent
`
`Ex. 1008
`
`File History of U.S. Patent Application No. 15/365,595
`
`Ex. 1009 VENCLEXTA Product Label (2016)
`
`Ex. 1010
`
`Provisional Application 61/698,379 to ’942 patent
`
`Ex. 1011 Amended Scheduling Order, No. 1-20-cv-00968, ECF No. 81 (Nov.
`8, 2021)
`
`Ex. 1012 Notice of Service of Infringement Contentions, No. 1-20-cv-00968,
`ECF No. 85 (Dec. 6, 2021)
`
`Ex. 1013 U.S. Patent Publication No. 2017/0281619 to Sampath et al.
`(published from U.S. Patent Application No. 15/365,595)
`
`Ex. 1014
`
`Stipulation and Order to Extend Time, No. 1-20-cv00968, ECF No.
`88 (Jan. 18, 2022)
`
`Ex. 1015-
`Ex. 1019
`
`INTENTIONALLY LEFT BLANK
`
`- vii -
`
`

`

`TABLE OF AUTHORITIES
`(continued)
`
`Page(s)
`
`EXHIBIT
`
`DESCRIPTION
`
`Ex. 1020 Declaration of Jeffrey A. Gordon, M.D.
`
`Ex. 1021 Curriculum Vitae for Dr. Gordon
`
`Ex. 1022
`
`T. van Meerten et al., CD20-Targeted Therapy: A Breakthrough in
`the Treatment of Non-Hodgkin’s Lymphoma, 67(7) NETH. J. MED.
`251 (2009)
`
`Ex. 1023 K. Bauer et al., Rituximab, Ofatumumab and Other Monoclonal
`Anti-CD20 Antibodies for Chronic Lymphocytic Leukaemia, 11(11)
`COCHRANE DATABASE SYST. REVS. (2012)
`
`Ex. 1024
`
`S. Cang et al., Novel CD20 Monoclonal Antibodies for Lymphoma
`Therapy, 5 J. HEMATOL. & ONCOL. 64 (2012)
`
`Ex. 1025
`
`E. Oflazoglu et al., Evolution of Anti-CD20 Monoclonal Antibody
`Therapeutics in Oncology, 2(1) MABS 14 (2010)
`
`Ex. 1026 M. Fanale et al., Phase I/Ib Study of the Novel CD20-Targeted
`Immunotoxin MT-3724 in Relapsed/Refractory Non-Hodgkin’s B-
`Cell Lymphoma, Proceedings of the 107th Annual Meeting of the
`American Association for Cancer Research; 2016 Apr 16-20; New
`Orleans, LA. Philadelphia (PA): AACR; 76 (14 Suppl) CANCER
`RSCH. Abstract No. CT049 (2016)
`
`Ex. 1027
`
`J. Morris et al., Antibody-Based Therapy of Leukaemia, 11 EXPERT
`REVS. MOL. MED. 1 (2009)
`
`Ex. 1028 A. Beck et al., Strategies and Challenges for the Next Generation of
`Therapeutic Antibodies, 10 NAT. REVS. IMMUNOL. 345 (2010)
`
`Ex. 1029
`
`J. Chipuk et al., The BCL-2 Family Reunion, 37 MOL. CELL 299
`(2010)
`
`- viii -
`
`

`

`TABLE OF AUTHORITIES
`(continued)
`
`Page(s)
`
`EXHIBIT
`
`DESCRIPTION
`
`Ex. 1030 M. Kang et al., Bcl-2 Inhibitors: Targeting Mitochondrial Apoptotic
`Pathways in Cancer Therapy, 15(4) CLIN. CANCER RSCH. 1126
`(2009)
`
`
`
`
`- ix -
`
`

`

`Petition for Post-Grant Review of U.S. Pat. No. 10,993,942
`PTAB Case No. PGR2022-00023
`
`I. INTRODUCTION
`
`The claims of U.S. Patent No. 10,993,942 patent are to methods of treating
`
`specific cancers by administering a compound called GDC-0199 in escalating
`
`doses at specific amounts and times. The claimed methods challenged here do not
`
`require any other therapeutic agent: each is a GDC-0199 monotherapy.
`
`The problem for Patent Owner is that it did not invent or disclose a
`
`monotherapy. Nor did it say it did, until almost a decade after its original priority
`
`application. Rather, the specification is clear that what Patent Owner described
`
`was only a combination therapy using both GDC-0199 and a companion antibody.
`
`The embodiments, examples, figures, and description singularly describe
`
`combination therapies. The specification explicitly calls the invention a
`
`combination therapy. And the patent’s title says “combination therapy.” A
`
`monotherapy is but hindsight.
`
`What’s more, Patent Owner’s specification also did not describe the claimed
`
`escalating-dose regimen. Pieces of it appear in lists of pick-and-choose
`
`possibilities, but the combination does not—nor do blaze marks or guidance. The
`
`details of the dose regimen were left unwritten until it was evident what the precise
`
`marketed product would be. Then after-the-fact claims were sought to match.
`
`Although the patent recites a 2012 priority date, an escalating-dose
`
`monotherapy appeared for the first time in the claims of the application filed
`
`– 1 –
`
`

`

`Petition for Post-Grant Review of U.S. Pat. No. 10,993,942
`PTAB Case No. PGR2022-00023
`
`almost a decade later, in 2020, which ultimately issued as the ’942 patent.
`
`Accordingly, the patent is not entitled to pre-AIA priority and it is subject to post-
`
`grant review.
`
`In short, it is more likely than not that at least one challenged claim is
`
`unpatentable, and a trial should be instituted. This is a one-issue case. This
`
`petition explains that claims 1-3, 5-6, 14, 25-27, and 30 are unpatentable under
`
`35 U.S.C. § 112 for failure to satisfy the written description requirement.
`
`Petitioner therefore respectfully requests that these claims be judged unpatentable
`
`and canceled.
`
`II. MANDATORY NOTICES
`
`A. Real Parties-In-Interest (37 C.F.R. § 42.8(b)(1))
`
`The real parties-in-interest for Petitioner are Dr. Reddy’s Laboratories Ltd.
`
`and Dr. Reddy’s Laboratories, Inc.
`
`B. Related Matters (37 C.F.R. § 42.8(b)(2))
`
`The ’942 patent is the subject of two district-court cases:
`
` AbbVie Inc. v. Alembic Pharms., Ltd., No. 1-20-cv-01009 (D. Del.).
`
` AbbVie Inc. v. Dr. Reddy’s Labs., Ltd., No. 1-20-cv-00968 (D. Del.).
`
`The cases are consolidated. See Ex. 1003 (docket report, ’009 case);
`
`Ex. 1004 (docket report, ’968 case). Plaintiffs amended their complaints in part to
`
`assert the ’942 patent on October 19, 2021. See Ex. 1004. Answers by the
`
`– 2 –
`
`

`

`Petition for Post-Grant Review of U.S. Pat. No. 10,993,942
`PTAB Case No. PGR2022-00023
`
`defendants to the amended complaint were filed on November 16, 2021. Id. The
`
`Petitioner is a defendant in No. 1-20-cv-00968. Id.
`
`U.S. Patent No. 11,110,087, which shares a common specification and
`
`asserted priority claim with the ’942 patent, is also the subject of the litigation
`
`identified above. Ex. 1005, 1-2, 19.
`
`Three patent applications in the same patent family are pending as U.S.
`
`Patent Application Nos. 15/365,595 (filed Nov. 30, 2016), 17/193,795 (filed Mar.
`
`5, 2021), and 17/395,366 (filed Aug. 5, 2021).
`
`C.
`
`Identification of Counsel (37 C.F.R. § 42.8(b)(3)) and Service
`Information (37 C.F.R. § 42.8(b)(4))
`
`Lead Counsel
`
`Back-Up Counsel
`
`Brandon M. White (Reg. No. 52,354)
`Perkins Coie LLP
`700 13th St., NW, Suite 800
`Washington, DC 20005
`bmwhite@perkinscoie.com
`Tel: (202) 654-6206
`Fax: (202) 654-6211
`
`
`
`
`Jonathan I. Tietz (Reg. No. 76,753)
`Perkins Coie LLP
`700 13th St., NW, Suite 800
`Washington, DC 20005
`jtietz@perkinscoie.com
`Tel: (202) 942-8667
`Fax: (202) 654-6211
`
`Please direct all correspondence to lead counsel and back-up counsel at the
`
`contact information above. Petitioner consents to service by email at White-
`
`ptab@perkinscoie.com, Tietz-ptab@perkinscoie.com, and
`
`Venteclax@perkinscoie.com. A Power of Attorney is being filed concurrently.
`
`– 3 –
`
`

`

`Petition for Post-Grant Review of U.S. Pat. No. 10,993,942
`PTAB Case No. PGR2022-00023
`
`III. GROUNDS FOR STANDING
`
`As required by 37 C.F.R. § 42.204(a), Petitioner certifies that the ’942 patent
`
`is available for post-grant review and that Petitioner is not barred or estopped from
`
`requesting post-grant review on the grounds identified herein. Although the
`
`’942 patent claims priority from U.S. applications having filing dates earlier than
`
`the March 16, 2013 effective date of the first-inventor-to-file provisions of the
`
`AIA, for the reasons discussed in Sections V.E and F, at least one claim has a
`
`priority date that is on or after March 16, 2013. The patent is therefore subject to
`
`the first-inventor-to-file provisions of the AIA and post-grant review. Leahy-Smith
`
`America Invents Act, Pub. L. No. 112-29, §§ 3(n)(1)(A), 6(f)(2)(A), 125 Stat. 284,
`
`293, 311 (2011) (“AIA”).
`
`IV.
`
`IDENTIFICATION OF CHALLENGE AND STATEMENT OF THE
`PRECISE RELIEF REQUESTED
`
`Petitioner requests post-grant review and cancellation of claims 1-3, 5-6, 14,
`
`25-27, and 30 of the ’942 patent under 35 U.S.C. § 112, as set forth herein. The
`
`’942 patent should be reviewed under AIA § 112. Petitioner’s detailed statement
`
`of the reasons for the relief requested is set forth below in the section titled
`
`“Statement of Reasons for the Relief Requested.” See 37 C.F.R. § 42.204(b). In
`
`accordance with 37 C.F.R. § 42.6(c), copies of the exhibits are filed herewith. In
`
`addition, this Petition is accompanied by the Declaration of Jeffrey A. Gordon,
`
`M.D. (Ex. 1020).
`
`– 4 –
`
`

`

`Petition for Post-Grant Review of U.S. Pat. No. 10,993,942
`PTAB Case No. PGR2022-00023
`
`The challenged claims of the ’942 patent are generally directed to methods
`
`of treating chronic lymphocytic leukemia (“CLL”) or small lymphocytic
`
`lymphoma (“SLL”) in a patient by administering a GDC-0199 monotherapy in
`
`escalating doses at specific amounts and for specific times. Although the patent
`
`recites a 2012 priority date, the escalating-dose monotherapy limitation appeared
`
`for the first time in the claims of the application filed in 2020 that ultimately issued
`
`as the ’942 patent.
`
`The challenged claims are unpatentable on the following grounds:
`
`Ground 1: Claims 1-3, 5-6, 14, 25-27, and 30 lack written description.
`
`V. STATEMENT OF REASONS FOR THE RELIEF REQUESTED
`
`A.
`
`Summary of the Argument
`
`This is a straightforward case: the claims lack adequate written description.
`
`The ’942 specification describes a combination therapy by administering two
`
`compounds, but its claims are directed to a monotherapy only requiring one.
`
`The patent’s specification does not describe the claimed escalating-dose
`
`GDC-0199 monotherapy. Indeed, the ’942 patent’s title calls the invention a
`
`“combination therapy” of a Bcl-2 inhibitor (e.g., GDC-0199) and an antibody. So
`
`does its summary, its abstract, and its embodiments. So too do all its examples and
`
`figures. Further, the specification focuses on not just any antibody, but an anti-
`
`CD20 antibody—and not just any anti-CD20 antibody, but the type II variety. That
`
`– 5 –
`
`

`

`Petition for Post-Grant Review of U.S. Pat. No. 10,993,942
`PTAB Case No. PGR2022-00023
`
`makes sense, given that the background discussion spills considerable ink on the
`
`relevance of CD20 protein expression in the target cancers and the role of this
`
`particular antibody.
`
`To no surprise, the claims that Patent Owner originally filed and obtained
`
`were for a combination therapy. But nearly a decade after its provisional
`
`application, Patent Owner filed new claims, quietly omitting any mention of an
`
`antibody at all and instead claiming a GDC-0199 monotherapy—without bothering
`
`to point out where the specification supported this disclosure. What’s more, Patent
`
`Owner claimed a specific combination of GDC-0199 dose amounts, times,
`
`duration, and sequence—a particular escalating-dose GDC-0199 monotherapy—
`
`that was not described in its specification. Nor is there guidance in the
`
`specification to select these parameters from a laundry list of options.
`
`These late-in-the-game claims are a hindsight-guided effort to broaden
`
`Patent Owner’s patent rights beyond what it disclosed to the public. That is,
`
`the ’942 patent’s specification does not demonstrate that Patent Owner possessed
`
`the full scope of the claimed invention at the time of filing, and the claims are
`
`invalid for lack of written description.
`
`B.
`
`Scientific Background
`
`This patent involves compounds that target two biologically significant
`
`proteins: CD20 and Bcl-2.
`
`– 6 –
`
`

`

`Petition for Post-Grant Review of U.S. Pat. No. 10,993,942
`PTAB Case No. PGR2022-00023
`
`CD20 and anti-CD20 antibodies. CD20 is a protein found on B-cells, a
`
`type of white blood cell. Ex. 1020 ¶ 41; Exs. 1022-1025. Its normal function
`
`within a healthy individual is to help B-cells engage in immune responses through
`
`its involvement in B-cell activation, proliferation, and differentiation. Id. But for
`
`patients with certain kinds of B-cell-based lymphomas and leukemias, CD20 is
`
`found in higher-than-normal amounts, and it is involved in the biological
`
`mechanisms that make those cancers harmful. Id. Accordingly, CD20 has become
`
`an important protein both for diagnosis and for treatment of certain B-cell-based
`
`cancers. Id.
`
`Among those therapies are a wide swath of antibodies that target CD20,
`
`which has been used as an anticancer strategy at least since the 1990s. Ex. 1020
`
`¶ 42; Exs. 1022, 1025-1027. Such antibodies often function to selectively
`
`recognize, bind, and “flag” unwanted cells for removal by the immune system by
`
`means of complement-mediated killing or antibody-dependent cellular
`
`cytotoxicity. Id. Others, like antibody-drug conjugates, might selectively bind to
`
`cancer cells and deliver targeted chemotherapy drugs or toxins specifically to those
`
`cells. Id.
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`Antibodies are structurally and functionally diverse and are often
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`characterized both by their structure and by the locations on target proteins at
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`which they bind. Ex. 1020 ¶ 43, Exs. 1022, 1028. In the context of this patent,
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`two particular classes of anti-CD20 antibodies (i.e., antibodies that bind selectively
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`to the CD20 protein) are relevant: type I and type II. Ex. 1020 ¶ 43; Ex. 1001,
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`1:61-2:19. The two types differ in their modes of CD20 binding and biological
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`activities. Ex. 1020 ¶ 43; Ex. 1001, 1:61-2:19. The ’942 patent points this out in
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`part, suggesting that type I antibodies are “potent in complement mediated
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`cytotoxicity, whereas type II antibodies . . . effectively initiate target cell death via
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`caspase-independent apoptosis with concomitant phophatidylserine exposure.”
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`Ex. 1001, 1:65-2:3. In effect, type II antibodies directly cause target cell death.
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`Ex. 1020 ¶ 43; Exs. 1022, 1028.
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`Bcl-2 and selective Bcl-2 inhibitors. A second set of proteins is the Bcl-2
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`family. Ex. 1020 ¶ 44; Exs. 1029-1030. Some proteins in this family promote cell
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`survival, and others drive apoptosis (i.e., programmed cell death). Id. Selective
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`inhibition of some of them, then, can help control either cell survival or cell death.
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`Id.
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`One selective Bcl-2 inhibitor is GDC-0199, also known by its chemical
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`name 2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)-4-(4-((2-(4-chlorophenyl)-4,4-
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`dimethylcyclohex-1-enyl)methyl)piperazin-1-yl)-N-(3-nitro-4-(((tetrahydro-2H-
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`pyran-4-yl)methyl)amino)phenylsulfonyl)benzamide. Ex. 1001, 14:59-67;
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`Ex. 1020 ¶ 45. It is pictured in the ’942 patent as Formula I:
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`Ex. 1001, 15:1-33.
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`C.
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`Summary of the ’942 patent
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`1.
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`Effective Filing Date
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`The ’942 patent was filed on March 23, 2020, with Deepak Sampath,
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`Christian Klein, Wayne John Fairbrother, Sari L. Heitner Enschede, Rod A.
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`Humerickhouse, Andrew W. Roberts, and John F. Seymour as inventors, and
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`currently listing Genentech, Inc., Hoffman-La Roche Inc., and AbbVie Inc. as
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`assignees (collectively, “Patent Owner”). It was filed as a continuation of
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`application No. 15/365,595 (filed November 30, 2016), which itself was a
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`continuation of application No. 14/020,761 (filed on September 6, 2013, and since
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`issued as U.S. Patent No. 9,539,251). The ’942 patent alleges priority from a
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`provisional application (No. 61/698,379) filed on September 7, 2012. That priority
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`application, like the ’942 patent, is titled “Combination Therapy of a Type II Anti-
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`CD20 Antibody with a Selective Bcl-2 Inhibitor.” Not surprisingly, the
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`specification thus concentrates exclusively on an antibody/inhibitor combination
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`therapy.
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`The ’942 patent alleges, through the provisional, a September 7, 2012
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`priority date. But, as discussed later, see infra Sections V.E-F, the claims lack
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`written description support in the provisional, which is missing much content from
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`the ’942 patent’s specification. So, the ’942 patent has an effective filing date later
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`than March 16, 2013, and it is eligible for PGR. See infra Section V.E.
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`2.
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`Person of Ordinary Skill in the Art
`
`The ’942 patent itself asserts that the relevant field is “combination therapy
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`involving a type II anti-CD20 antibody and a selective Bcl-2 inhibitor for the
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`treatment of a patient suffering from cancer, particularly a CD20-expressing
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`cancer.” Ex. 1001, 1:20-23.
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`A person of ordinary skill in the art (“POSA”) in the field of the patent
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`between 2012 and 2013, or in 2020, would have held an MD with experience in
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`clinical oncology or pharmacology, a PhD in pharmacology, pharmaceutical
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`chemistry, cancer biology, or a related discipline, or a PharmD with experience in
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`clinical oncology. Ex. 1020 ¶ 38. A person of ordinary skill would also have
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`practical working knowledge of oncology. Id. A POSA would also have had
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`experience with the design of studies necessary for drug development. This
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`description is approximate, and additional experience could make up for less
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`education and vice versa. Id. That said, the points in this Petition would be
`
`unchanged under any reasonable definition of the person of ordinary skill. Id.
`
`3.
`
`Disclosure
`
`The ’942 patent is titled, “Combination Therapy of a Type II Anti-CD20
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`Antibody with a Selective Bcl-2 Inhibitor.” The Abstract explains that the “present
`
`invention” is a “combination therapy” involving such an antibody and such an
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`inhibitor “for the treatment of a patient suffering from cancer, particularly, a
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`CD20-expressing cancer.” Ex. 1001, Abstract. So too does the specification’s
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`description of its technical field and its summary of the invention. Id. at 1:18-23
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`(Technical Field), 3:60-65 (Summary).
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`The ’942 patent’s disclosure is about CD20 too. The Background of the
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`specification begins by citing various CD20 details: structural aspects (it is a
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`“hydrophobic transmembrane protein with a molecular weight of approximately 35
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`kD,” Ex. 1001, 1:27-30, with an “85 amino acid carboxyl-terminal region” located
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`“[w]ithin the cystoplasm,” id. at 1:45-46), location (it is “located on pre-B and
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`mature B lymphocytes” and “on the surface of greater than 90% of B cells from
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`peripheral blood or lymphoid organs,” id. at 1:30-37), presence in disease (it is
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`“present on both normal B cells as well as malignant B cells” and is particularly
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`“expressed on greater than 90% of B cell non-Hodgkin’s lymphomas,” id. at 1:35-
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`39), and speculated biological function (it is “thought that CD20 might be involved
`
`in regulating an early step(s) in the activation and differentiation process of B cells
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`and could function as a calcium ion channel,” id. at 1:55-60 (citations omitted)).
`
`Anti-CD20 antibodies get coverage too, with the specification pointing out that
`
`there are “two different types” that “differ significantly in their mode of CD20
`
`binding and biological activities.” Id. at 1:61-63 (emphasis added). Those are
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`“type I” (like rituximab) and “type II” (like GA101)—and the specification points
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`out some of the differences, including an entire chart devoted to the details. Id. at
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`1:60-2:18, 3:66-67. It is only this second class, type II, that the specification calls
`
`part of the “present invention.” See id., e.g., Id. at Title, Abstract, 1:17-23.
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`After the CD20 discussion, the Bcl-2 protein family appears. Ex. 1001,
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`2:20-3:57. The specification notes generally that the family “regulates
`
`programmed cell death triggered by developmental cues and in response to
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`multiple [s]tress signals.” Id. at 2:20-22. By some members of the family, “cell
`
`survival is promoted,” whereas by others “apoptosis is driven.” Id. at 2:25-29.
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`“Interactions between members” of “three factions of the Bcl-2 family dictate
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`whether a cell lives or dies,” the specification continues. Id. at 2:45-46. But just
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`how several of them work “remains poorly understood,” and with respect to
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`modulation of activity of some of them, “physiological relevance remains to be
`
`established.” Id. at 2:50-52, 2:61-65. The Background concludes by noting that
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`“various Bcl-2 inhibitors” exist that “have the same property of inhibiting
`
`prosurvival members of the Bcl-2 family of proteins.” Id. at 3:42-45. (The terms
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`“GDC-0199,” or even “ABT-199,” another name the patent uses for GDC-0199,
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`do not appear in that list of inhibitors, though many others do. Id. at 3:45-52; see
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`id. at 4:6-7.)
`
`The Summary of the Invention continues the focus on combination therapy.
`
`It begins by noting that “[p]rovided herein” are methods “comprising co-
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`administering” to a patient “a type II anti-CD20 antibody and a selective Bcl-2
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`inhibitor”—and co-administration that can be “simultaneous or sequential in either
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`order.” Id. at 3:61-65.
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`Summaries of various “embodiment[s]” of the “present invention” are then
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`provid