`Paper No. _______
`Date Filed: October 12, 2017
`
`
`Filed On Behalf Of:
`Novartis Pharmaceuticals Corporation
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BRECKENRIDGE PHARMACEUTICAL, INC.,
`
`
`
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`
`
`
`Case IPR2017-01592
`
`Patent No. 8,410,131
`
`
`
`
`
`PATENT OWNER’S PRELIMINARY
`RESPONSE UNDER 37 C.F.R. § 42.107
`
`
`
`
`
`

`

`
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`Introduction ...................................................................................................... 1
`
`II.
`
`POSA And Invention Date .............................................................................. 3
`
`III. Claim Construction .......................................................................................... 3
`
`A.
`
`“Solid Excretory System Tumors” ........................................................ 4
`
`1.
`
`Patent Owner’s Construction Is Supported By The
`Specification And The Ordinary And Customary
`Meaning ...................................................................................... 4
`
`2.
`
`Breckenridge’s Proposed Construction Is Incorrect ................... 7
`
`B.
`
`C.
`
`“Advanced Solid Excretory System Tumor[s]” .................................... 8
`
`“Kidney Tumor” .................................................................................... 9
`
`D. Other Claim Terms .............................................................................. 10
`
`IV. Breckenridge Fails To Show That The Priority Documents
`Lack Written Description Support For The ’131 Patent Claims ................... 10
`
`A.
`
`The ’131 Patent Claims Are Entitled To The February
`19, 2001 Priority Date Of GB ’072 ..................................................... 13
`
`1.
`
`2.
`
`3.
`
`“Solid Excretory System Tumors” ........................................... 13
`
`“Advanced Solid Excretory System Tumor[s]” ....................... 16
`
`“Kidney Tumor[s]” ................................................................... 17
`
`B.
`
`Breckenridge’s Flawed Analysis Elevates Form Over
`Substance ............................................................................................. 18
`
`V.
`
`The Board Should Deny Institution On Grounds 1-2 Because
`Wasik Does Not Anticipate Or Render Obvious The
`Challenged Claims ......................................................................................... 21
`
`A. Wasik Did Not Disclose Solid Tumors ............................................... 21
`
`
`
`i
`
`

`

`
`
`1. Wasik Disclosed Only Lymphomas ......................................... 22
`
`2.
`
`3.
`
`The Prosecution Histories Of The ’131 Patent
`Family Members And Of Wasik Confirm That
`Wasik Disclosed Only Lymphomas ......................................... 24
`
`The Portions Of Wasik Upon Which Breckenridge
`Relies Disclosed Only Lymphomas .......................................... 25
`
`4. Wasik Did Not Incorporate By Reference Any
`Teachings Concerning Solid Tumors ....................................... 27
`
`B. Wasik Did Not Disclose Inhibiting Growth Of Advanced
`Tumors ................................................................................................. 30
`
`C. Wasik Did Not Render Obvious Any Challenged Claim ................... 32
`
`VI. The Board Should Deny Institution On Grounds 2-5 Because
`Breckenridge Has Failed To Show A Motivation To Select
`Everolimus To Treat Solid Excretory System Tumors ................................. 33
`
`VII. The Board Should Deny Institution On Grounds 3-5 Because
`Breckenridge Has Failed To Show A Motivation To Combine
`The Rapamycin Art With The Everolimus Art Or A Motivation
`To Combine The Temsirolimus Art With The Everolimus Art .................... 37
`
`A. None Of The References In Ground 3 Disclosed That
`Rapamycin And Everolimus Have The Same Mechanism
`Of Action For Antitumor Activity ...................................................... 39
`
`B.
`
`C.
`
`D.
`
`None Of The References In Ground 4 Disclosed That
`Temsirolimus And Everolimus Have The Same
`Mechanism Of Action For Antitumor Activity ................................... 41
`
`None Of The References In Ground 5 Disclosed That
`Temsirolimus And Everolimus Have The Same
`Mechanism Of Action For Antitumor Activity ................................... 43
`
`Everolimus, Unlike Temsirolimus, Was Known To Have
`Immunosuppressant Activity, Which Was Associated
`With Increased Rates Of Kidney Cancer ............................................ 44
`
`
`
`ii
`
`

`

`
`
`VIII. The Board Should Deny Institution On Ground 3 And Ground 5
`Because Breckenridge Fails To Establish That Luan Is Prior Art ................ 45
`
`A.
`
`B.
`
`Breckenridge Has Not Shown That Luan Published In
`May 2001 ............................................................................................. 46
`
`Luan Did Not Publish Before The ’131 Patent’s Priority
`Date ...................................................................................................... 49
`
`C.
`
`Luan Is Antedated By GB ’072 ........................................................... 50
`
`1.
`
`2.
`
`Prior Invention And Constructive Reduction To
`Practice ...................................................................................... 50
`
`Luan Is Antedated Because GB ’072 Shows Prior
`Invention Of At Least As Much Of The Claimed
`Invention As Is Shown By Luan ............................................... 51
`
`IX. Constitutionality Of Inter Partes Review ...................................................... 52
`
`X.
`
`Conclusion ..................................................................................................... 53
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`iii
`
`

`

`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Alcon Research Ltd. v. Barr Labs., Inc.,
`745 F.3d 1180 (Fed. Cir. 2014) .....................................................................21
`
`Ashland Oil, Inc. v. Delta Resins & Refractories, Inc.,
`776 F.2d 281 (Fed. Cir. 1985) .......................................................................31
`
`Bilstad v. Wakalopulos,
`386 F.3d 1116 (Fed. Cir. 2004) .....................................................................12
`
`Coalition for Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics,
`Inc., IPR2015-01850 et al.
`(Patent Tr. & App. Bd. Mar. 9, 2017), Paper 72 .................................... 38, 46
`
`Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche Inc.,
`IPR2015-01792 (Patent Tr. & App. Bd. Mar. 11, 2016) Paper 14 ...............37
`
`Cordis Corp. v. Medtronic AVE, Inc.,
`339 F.3d 1352 (Fed. Cir. 2003) .....................................................................13
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) ..................................................................................... 4
`
`Eli Lilly & Co. v. Actavis Elizabeth LLC,
`731 F. Supp. 2d 348 (D.N.J. 2010) ................................................................34
`
`Eli Lilly & Co. v. Actavis Elizabeth LLC,
`435 Fed. App’x 917 (Fed. Cir. 2011) ............................................................34
`
`Eli Lilly & Co. v. Sicor Pharms., Inc.,
`705 F. Supp. 2d. 971 (S.D. Ind. 2010) .................................................... 51, 52
`
`Ex Parte Saito,
`Appeal 2008-5777, 2008 WL 5371879 (B.P.A.I. Dec. 22, 2008) .................50
`
`Fitbit, Inc. v. BodyMedia, Inc.,
`IPR2016-00707 (Patent. Tr. & App. Bd. Sept. 8, 2016), Paper 9 .................11
`
`Frazer v. Schlegel,
`498 F.3d 1283 (Fed. Cir. 2007) .....................................................................51
`
`
`
`iv
`
`

`

`
`
`In re Hedges,
`783 F.2d 1038 (Fed. Cir. 1986) .............................................................. 24, 34
`
`In re Mulder,
`716 F.2d 1542 (Fed. Cir. 1983) .....................................................................50
`
`In re Stempel,
`241 F.2d 755 (C.C.P.A. 1957) ................................................................ 51, 52
`
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) ....................................................................... 4
`
`In re Wertheim,
`541 F.2d 257 (C.C.P.A. 1976) .......................................................................19
`
`Innogenetics N.V. v. Abbott Labs.,
`512 F.3d 1363 (Fed. Cir. 2008) .....................................................................37
`
`InSite Vision Inc. v. Sandoz, Inc.,
`783 F.3d 853 (Fed. Cir. 2015) ................................................................ 33, 36
`
`IntelGenX Corp. v. ICOS Corp.,
`IPR2016-00678 (Patent Tr. & App. Bd. Sept. 1, 2016), Paper 13 ................32
`
`Johns Manville Corp. v. Knauf Insulation, Inc.,
`IPR2015-01633 (Patent Tr. & App. Bd. Jan. 4, 2016), Paper 10 ..................31
`
`Kyocera Wireless Corp. v. Int’l Trade Comm’n,
`545 F.3d 1340 (Fed. Cir. 2008) .....................................................................28
`
`L.A. Biomedical Research Inst. at Harbor-UCLA Med. Ctr v. Eli Lilly &
`Co., 849 F.3d 1049 (Fed. Cir. 2017) .............................................................19
`
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) .......................................................................49
`
`MCM Portfolio LLC v. Hewlett-Packard Co.,
`812 F.3d 1284 (Fed. Cir. 2015) .....................................................................52
`
`Medtronic, Inc. v. Norred,
`IPR2014-00111 (Patent. Tr. & App. Bd. Apr. 23, 2015) Paper 47 ...............50
`
`
`
`v
`
`

`

`
`
`Medtronic, Inc. v. Norred,
`640 Fed. Appx. 994 (Fed. Cir. 2016) ............................................................50
`
`Microsoft Corp. v. Proxyconn, Inc.,
`789 F.3d 1292 (Fed. Cir. 2015) ...................................................................6, 8
`
`Monarch Knitting Mach. Corp. v. Sulzer Morat GmbH,
`139 F.3d 877 (Fed. Cir. 1998) .......................................................................36
`
`Oil States Energy Servs., LLC v. Greene’s Energy Grp.,
`LLC, 137 S.Ct. 2239 (June 12, 2017) ............................................................53
`
`Par Pharm., Inc. v. Novartis AG,
`IPR2016-0078, 2016 WL 2849201 (Patent Tr. & App. Bd. Apr.. 28,
`2016) ..............................................................................................................32
`
`Pozen Inc. v. Par Pharm., Inc.,
`696 F.3d 1151, (Fed. Cir. 2012) ....................................................................13
`
`Schott Gemtron Corp. v. SSW Holding Co.,
`IPR2014-00367 (Patent Tr. & App. Bd. May 26, 2015) Paper 62 ................39
`
`ServiceNow, Inc. v. Hewlett-Packard Co.,
`IPR2015-00716 (Patent Tr. & App. Bd. Aug. 26, 2015), Paper 13 ..............46
`
`Unigene Labs. Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .....................................................................37
`
`Union Oil Co. of Cal. v. Atlantic Richfield Co.,
`208 F.3d 989 (Fed. Cir. 2000) .......................................................................16
`
`Valeo N. Am., Inc. v. Magna Elecs. Inc.,
`IPR2015-01410 (Patent Tr. & App. Bd. Dec. 22, 2016) Paper 23 ................50
`
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) .....................................................................12
`
`Vizio, Inc. v. Nichia Corp.,
`IPR2017-00558 (Patent Tr. & App. Bd. July 7, 2017) Paper 9 ....................39
`
`Wasica Fin. GmbH v. Cont’l Auto. Sys.,
`853 F.3d 1252 (Fed. Cir. 2017) .....................................................................29
`
`
`
`vi
`
`

`

`
`
`Statutes
`
`35 U.S.C. § 102(a) ...................................................................................................49
`
`35 U.S.C. § 112 ................................................................................................. 10, 50
`
`35 U.S.C. § 119(a) ...................................................................................................51
`
`35 U.S.C. § 316(e) ...................................................................................................49
`
`Rules
`
`37 C.F.R. § 42.100(b) ................................................................................................ 4
`
`37 C.F.R. § 42.104(b)(4) ................................................................................... 32, 33
`
`37 C.F.R. § 42.65(a) .................................................................................................31
`
`Fed. R. Evid. 801(c) .................................................................................................47
`
`Fed. R. Evid. 802 .....................................................................................................47
`
`
`
`
`
`
`
`
`
`
`
`
`vii
`
`

`

`
`
`
`
`
`
`LIST OF EXHIBITS
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2001
`
`2002
`
`2003
`
`Expert Declaration Of Howard A. Burris,
`III, M.D.
`
`Burris Decl.
`
`Curriculum Vitae Of Howard A. Burris,
`III, M.D.
`
`Burris C.V.
`
`Laughlin, E.H., Coming To Terms With
`Cancer: A Glossary Of Cancer-Related
`Terms, pages 4, 126, 140, 173-174, 188-
`190 (2002)
`
`Laughlin
`
`2004
`
`Altman, R. & Sarg, M.J., The Cancer
`Dictionary, pages 51-52, 278 (1992)
`
`Altman
`
`2005
`
`2006
`
`2007
`
`Sutcliffe, S.B. & Gospodarowicz, M.K.,
`Chapter 25, “Primary Extranodal
`Lymphomas,” The Lymphomas
`(Canellos, G.P. et al. eds. 1998)
`
`Molina, A. & Pezner, R.D., Chapter 30,
`“Non-Hodgkin’s Lymphoma,” Cancer
`Management: A Multidisciplinary
`Approach: Medical, Surgical, &
`Radiation Oncology, 4th Edition (Pazdur,
`R., et al. eds. 2000)
`
`Sutcliffe, S.B. & Gospodarowicz, M.K.,
`“Clinical Features And Management Of
`Localized Extranodal Lymphomas,”
`Haematological Oncology, Volume 2
`pages 189-222 (Keating, A., et al. eds.
`1992)
`
`Sutcliffe 1998
`
`Pazdur
`
`Sutcliffe 1992
`
`2008
`
`Lynch, C.F. & Cohen, M.B., “Urinary
`System,” Cancer 75(1 Suppl.): 316-329
`(1995)
`
`Lynch & Cohen
`
`viii
`
`

`

`
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`Ligato, S. et al., “Benign Tumors And
`Tumor-Like Lesions Of The Adult
`Kidney Part I: Benign Renal Epithelial
`Neoplasms,” Adv. Anat. Pathol. 6(1): 1-
`11 (1999)
`
`Glenn, G.M. et al., Chapter 75, “The
`Molecular Genetics Of Renal Cell
`Carcinoma,” Principles And Practice Of
`Genitourinary Oncology (Raghavan, D.,
`et al. eds. 1997)
`
`Hyland, S. & Wilkinson, D., Chapter 14,
`“The Nurse Practitioner And The
`Organization Of Support Services For
`The Patient With Genitourinary Cancer,”
`Principles And Practice Of Genitourinary
`Oncology (Raghavan, D., et al. eds. 1997)
`
`Vasey, P.A., “Immunotherapy For Renal
`Carcinoma: Theoretical Basis And
`Current Standard Of Care,” Br. J. Clin.
`Pharmacol. 50: 521-529 (2000)
`
`Kawai, K., et al., “Ex Vivo Gene Therapy
`Using Granulocyte-Macrophage Colony-
`Stimulating Factor-Transduced Tumor
`Vaccines,” Mol. Urol. 4(2): 43-46 (2000)
`
`Adjei, A.A., “Signal Transduction
`Pathway Targets For Anticancer Drug
`Discovery,” Cur. Pharm. Design 6: 361-
`378 (2000)
`
`Ligato
`
`Raghavan-Glenn
`
`Raghavan-Hyland
`
`Vasey
`
`Kawai
`
`Adjei
`
`ix
`
`

`

`
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`Gordon, M.S. et al., “Phase I Safety And
`Pharmacokinetic Study Of Recombinant
`Human Anti-Vascular Endothelial
`Growth Factor In Patients With
`Advanced Cancer,” J. Clin. Oncol. 19(3):
`843-850 (2001)
`
`Penn, I. & Starzl, T.E.,
`“Immunosuppression And Cancer,”
`Transplant Proc. 5(1): 943-947 (1973)
`
`January 19, 2016 Office Action,
`Prosecution File History Of U.S. Patent
`Application No. 13/893,537
`
`January 27, 2016 Office Action,
`Prosecution File History Of U.S. Patent
`Application No. 13/893,589
`
`October 17, 2006 Official
`Communication and February 26, 2007
`Applicant Response (received February
`27, 2007), Prosecution File History Of
`European Patent Application No. 01 903
`095.6-2112 (International Application
`No. PCT/US01/01537)
`
`Gordon
`
`Penn & Starzl
`
`
`
`
`
`
`
`x
`
`

`

`
`
`I.
`
`
`
`Introduction
`
`Novartis Pharmaceuticals Corporation (“Novartis”) respectfully submits this
`
`Preliminary Response to the Petition of Breckenridge Pharmaceutical, Inc.
`
`(“Breckenridge”) seeking inter partes review of claims 1-3 and 5-9 of United
`
`States Patent No. 8,410,131 (“the ’131 patent,” Ex. 1001) on five Grounds (Paper
`
`1, “Petition” or “Pet.”).
`
`
`
`Claims 1-3 and 5-9 of the ’131 patent are directed to methods for “inhibiting
`
`growth of solid excretory system tumors in a subject, said method consisting of
`
`administering to said subject a therapeutically effect amount of [everolimus].”
`
`Breckenridge’s Petition is fatally flawed for the following reasons.
`
`
`
`First, Breckenridge’s primary reference in Grounds 1-2, Wasik, did not
`
`disclose, teach, or suggest a method for inhibiting the growth of a “solid excretory
`
`system tumor[]” or an “advanced” solid excretory system tumor, as those terms are
`
`used in the ’131 patent. Rather, the only disclosures of tumors in Wasik were
`
`lymphomas, which are a type of non-solid tumor arising from the cells of the
`
`lymphatic system, and which are expressly excluded from the scope of the
`
`challenged ’131 patent claims. Thus, Wasik neither anticipates the ’131 patent
`
`claims as alleged in Ground 1, nor renders the claims obvious, either alone or in
`
`combination with Breckenridge’s other cited references, as alleged in Ground 2.
`
`
`
`
`
`1
`
`

`

`
`
`
`
`Second, Breckenridge’s obviousness challenges in Grounds 2-5 fail as a
`
`matter of law because Breckenridge did not compare what was known in the prior
`
`art regarding other options for treating advanced renal cell carcinoma (“RCC”)
`
`with what was known about the claimed compound everolimus. And without
`
`considering the full scope of the prior art, Breckenridge could not—and did not—
`
`provide any reason to select everolimus over the other available options for
`
`treating advanced RCC.
`
`
`
`Third, Breckenridge has failed to provide any credible reasons why a person
`
`of ordinary skill in the art (“POSA”) would have combined the references in
`
`Grounds 3-5. Breckenridge essentially alleges that a POSA would have been
`
`motivated to combine the references in Grounds 3-5 relating to rapamycin,
`
`temsirolimus, and everolimus because a POSA would have understood that they
`
`had the same mechanism of action. But none of the art cited in Grounds 3-5 refers
`
`to everolimus’s mechanism of action for antitumor activity, let alone establishes
`
`that everolimus had the same mechanism of action for antitumor activity as
`
`rapamycin or temsirolimus.
`
`
`
`Fourth, Breckenridge has failed to establish that the Luan abstract is prior art
`
`for at least three reasons: (1) Breckenridge has not met its threshold showing that
`
`Luan actually published in May 2001; (2) even if Luan published in May 2001, it
`
`did not publish before the earliest priority date of the ’131 patent; and (3) even if
`
`
`
`
`
`2
`
`

`

`
`
`the ’131 patent is not entitled to its earliest priority date, Luan is not prior art
`
`because by May 2001 the inventors had already invented more of the claimed
`
`invention than is allegedly disclosed in Luan. Accordingly, the Board should deny
`
`institution on Grounds 3 and 5, which depend on Luan in combination with other
`
`references.
`
`
`
`For these reasons, Breckenridge cannot establish the anticipation or
`
`obviousness of claims 1-3 and 5-9 and of the ’131 patent. Novartis respectfully
`
`requests that the Board deny institution of inter partes review.
`
`II.
`
`POSA And Invention Date
`
`
`
`For the purposes of this Preliminary Response, Novartis adopts
`
`Breckenridge’s proposed definition of a POSA. See Pet. 14; Ex. 1010, Pantuck
`
`Decl. ¶ 20. However, unlike Breckenridge, Novartis evaluates anticipation and
`
`obviousness as of the ’131 patent’s February 19, 2001 priority date, not as of the
`
`February 18, 2002 filing date of PCT/EP02/01714. See, e.g., Pet. 13; Ex. 1010,
`
`Pantuck Decl. ¶ 16. And as explained below, the Board should deny institution on
`
`all grounds even if anticipation and obviousness are evaluated as of February 18,
`
`2002.
`
`III. Claim Construction
`
`During inter partes review, claim terms should be given their broadest
`
`reasonable construction in light of the specification in which they appear.
`
`
`
`
`
`3
`
`

`

`
`
` 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142-
`
`46 (2016). Under the broadest reasonable construction standard, claim terms are
`
`given their ordinary and customary meaning, as would be understood by a POSA
`
`in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249,
`
`1257 (Fed. Cir. 2007).
`
`A.
`
`“Solid Excretory System Tumors”
`
`1.
`
`Patent Owner’s Construction Is Supported By The
`Specification And The Ordinary And Customary Meaning
`
`Claim 1 of the ’131 patent recites a method for inhibiting growth of “solid
`
`excretory system tumors.” Ex. 1001 at col. 17, ll. 43-44. A POSA would have
`
`understood “solid excretory system tumors” to mean: tumors and/or metastases,
`
`other than tumors and/or metastases of the blood or lymphatic system, which arise
`
`from the cells of the urinary excretory system. Ex. 2001, Burris Decl. ¶ 43. This
`
`understanding is consistent with the ordinary and customary meaning of solid
`
`tumors and the specification.
`
`Tumors were generally classified into two separate categories based on the
`
`type of cells from which they arise. Ex. 2001, Burris Decl. ¶ 31; Ex. 2003,
`
`
`
`
`
`4
`
`

`

`
`
`Laughlin1 at 126. Solid tumors were known to arise from cells other than
`
`lymphatic system and bone marrow cells. Ex. 2001, Burris Decl. ¶ 31; Ex. 2003,
`
`Laughlin at 126. Conversely, liquid tumors, which were also known as blood
`
`cancers, were known to arise from the lymphatic system and bone marrow cells.
`
`Ex. 2001, Burris Decl. ¶ 31; Ex. 2003, Laughlin at 126. This is not disputed by
`
`Breckenridge’s declarant, Dr. Pantuck. Ex 1010 ¶¶ 72, 124; Ex. 1041, Perez-
`
`Atayde at 816-17.
`
`The specification’s use of the term “solid tumors” is consistent with its
`
`ordinary and customary usage. The specification defines “solid tumors” as
`
`“tumors and/or metastases (wherever located) other than lymphatic cancer.” Ex.
`
`1001 at col. 2, ll. 20-21; Ex. 2001, Burris Decl. ¶ 40. The specification further
`
`defines “lymphatic cancer” to mean “tumors of blood and lymphatic system”
`
`including “haematopoletic [sic: hematopoietic] and related tissues.” Ex. 1001 at
`
`col. 4, ll. 20-30; Ex. 2001, Burris Decl. ¶ 40. Hematopoietic tissue referred to bone
`
`marrow. Ex. 2001, Burris Decl. ¶ 40; Ex. 1041, Perez-Atayde at 817.
`
`The specification also defines several different classes of “solid tumors,”
`
`including “excretory system tumors.” According to the specification, “excretory
`
`
`
`
` This glossary, which published a year after the ’131 patent priority date, reflects
`
` 1
`
`the understanding in the art in 2001. Ex. 2001, Burris Decl. ¶ 31.
`
`
`
`
`
`5
`
`

`

`
`
`system tumors” are defined as tumors arising from the cells of the urinary
`
`excretory system, which includes the “kidney, renal pelvis, ureter, bladder, [sic,
`
`and] other unspecified urinary organs.” Ex. 1001 at col. 2, ll. 28-29; Ex. 2001,
`
`Burris Decl. ¶ 41.
`
`The specification consistently refers to “excretory system tumors” as separate
`
`from other classes of solid tumors such as “gastrointestinal tract tumors,” which
`
`include the small intestine and colon (Ex. 1001 at col. 2, ll. 30-32), “respiratory
`
`tract tumors,” which include the lungs (Ex. 1001 at col. 2, ll. 43-45), and “skin
`
`tumors” (Ex. 1001 at col. 2, ll. 47-50). Ex. 2001, Burris Decl. ¶ 41; see also Ex.
`
`1010, Pantuck Decl. ¶ 41 (agreeing that epidermoid, lung, and colon tumors are not
`
`solid “excretory system tumors” as that term is defined in the specification).
`
`Accordingly, the specification limits “excretory system tumor[]” to tumors of the
`
`urinary excretory system. See Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292,
`
`1300 (Fed. Cir. 2015) (“The Board erred in concluding that the terms
`
`‘sender/computer’ and ‘receiver/computer’ were broad enough to include the
`
`intermediary gateway and caching computers” where “the specification
`
`consistently refers to the sender/computer, receiver/computer, gateway, and
`
`caching computers as separate and independent components of an overall
`
`system.”).
`
`
`
`
`
`
`
`6
`
`

`

`
`
`In view of the foregoing, a POSA would have understood that “excretory
`
`system tumors” are limited to tumors of the urinary excretory system. Ex. 2001,
`
`Burris Decl. ¶ 41.
`
`2.
`
`Breckenridge’s Proposed Construction Is Incorrect
`
`Breckenridge contends that “solid excretory tumors” means “benign or
`
`malignant tumors of the excretory system, including kidney, renal pelvis, ureter,
`
`bladder, other and unspecified urinary organs.” Pet. 16.
`
`There are several issues with Breckenridge’s proposed construction. First,
`
`Breckenridge’s proposed construction does not specifically require that the claimed
`
`tumors exclude tumors and/or metastases of the blood or lymphatic system. Thus,
`
`Breckenridge reads the “solid” limitation out of the claim. A POSA would have
`
`understood that the term “tumor” by itself, as used in Breckenridge’s proposed
`
`construction, could indicate a lymphoma, which is a type of non-solid tumor
`
`arising from the lymphatic system cells. Ex. 2001, Burris Decl. ¶¶ 32-33; Ex.
`
`2004, Ex. 2004, Altman at 51.
`
`Second, Breckenridge’s proposed construction does not define the tumor by
`
`the cell type of origin. Breckenridge’s construction is therefore inconsistent with
`
`the specification, which indicates that tumors are defined by the organ or tissue of
`
`the original tumor, not the location of the tumor or metastasis. Ex. 2001, Burris
`
`Decl. ¶ 42; Ex. 1001, col. 2, ll. 58-62.
`
`
`
`
`
`7
`
`

`

`
`
`Third, Breckenridge’s proposed construction does not limit the claimed
`
`tumors to tumors of the urinary excretory system. Rather, it encompasses a tumor
`
`that arises from cells other than urinary excretory system cells but is found, e.g.,
`
`through metastasis, in a urinary excretory system organ. For example, lymphomas
`
`were known to occur in virtually every organ in the body, including in organs such
`
`as the kidney and bladder, among others. Ex. 2001, Burris Decl. ¶ 33; Ex. 2003,
`
`Laughlin at 188; Ex. 2005, Sutcliffe 1998 at 449, 466; Ex. 2006, Pazdur at 591; Ex.
`
`2007, Sutcliffe 1992 at 194, 202, 209, 213. Breckenridge’s construction would
`
`improperly encompass non-solid lymphatic tumors located within the urinary
`
`excretory system.
`
`For these reasons, Breckenridge’s proposed construction is inconsistent with
`
`the claim language itself, the specification, and the ordinary and customary
`
`meaning of solid tumors, and should be rejected. Microsoft Corp. v. Proxyconn,
`
`Inc., 789 F.3d at 1298 (“Even under the broadest reasonable interpretation, the
`
`Board’s construction cannot be divorced from the specification and the record
`
`evidence, and must be consistent with the one that those skilled in the art would
`
`reach.”) (internal quotations and citations omitted).
`
`B.
`
`“Advanced Solid Excretory System Tumor[s]”
`
`Claim 2, which depends from claim 1, recites “advanced solid excretory
`
`system tumor[s].” A POSA would have understood “advanced solid excretory
`
`
`
`
`
`8
`
`

`

`
`
`system tumor[s]” to mean: locally advanced or metastatic tumors, other than
`
`tumors and/or metastases of the blood or lymphatic system, which arise from the
`
`cells of the urinary excretory system. Ex. 2001, Burris Decl. ¶ 44.
`
`The construction of “solid excretory system tumors” is defined in section
`
`III.A.1 to mean: tumors and/or metastases, other than tumors and/or metastases of
`
`the blood or lymphatic system, which arise from the cells of the urinary excretory
`
`system. Claim 2 further specifies an “advanced” solid excretory system tumor. A
`
`POSA would have understood that the term “advanced” refers to tumors that are
`
`locally advanced (i.e., the tumor has spread only to nearby tissues), or metastatic
`
`(i.e., the tumor has spread to distant tissues). Ex. 2001, Burris Decl. ¶ 37; Ex.
`
`2003, Laughlin at 4. Breckenridge and its declarant, Dr. Pantuck, agree that
`
`“advanced” refers to a locally advanced or metastatic tumor. Pet. 16-17; Ex. 1010
`
`¶¶ 80-85.
`
`C.
`
`“Kidney Tumor”
`
`Claim 3, which depends from claim 1, recites a “kidney tumor.” A POSA
`
`would have understood “kidney tumor” to mean: a tumor and/or metastasis, other
`
`than a tumor and/or metastasis of the blood or lymphatic system, which arises from
`
`the cells of the kidney. Ex. 2001, Burris Decl. ¶ 45. This understanding is
`
`consistent with the ordinary and customary meaning of solid tumors and the
`
`specification.
`
`
`
`
`
`9
`
`

`

`
`
`The construction of “solid excretory system tumors” is defined in section
`
`III.A.1 to mean: tumors and/or metastases, other than tumors and/or metastases of
`
`the blood or lymphatic system, which arise from the cells of the urinary excretory
`
`system. Claim 3 further specifies that the claimed solid excretory system tumor is
`
`a kidney tumor.
`
`D. Other Claim Terms
`
`Breckenridge proposes constructions for the terms “a subject,” and “unit
`
`dosage form.” Pet. 16, 18. Novartis does not believe it is necessary to construe
`
`these terms at the present stage of the proceedings, and reserves its right to propose
`
`constructions for these and other terms at a later time, if appropriate.
`
`IV. Breckenridge Fails To Show That The Priority Documents Lack
`Written Description Support For The ’131 Patent Claims
`
`
`
`Breckenridge challenges the priority of claims 1-3 of the ’131 patent.2
`
`Breckenridge alleges that claims 1-3 are not entitled to a priority date earlier than
`
`the February 18, 2002 filing of PCT/EP02/01714 because the earlier priority
`
`applications—GB 0104072.4 (“GB ’072”) and GB 0124957.2 (“GB ’957”)—lack
`
`written description support under 35 U.S.C. § 112 for claims directed to “solid
`
`
`
`
` Breckenridge does not challenge the priority of claims 5-9 apart from its
`
` 2
`
`challenge to claim 1, upon which claims 5-9 depend. Pet. 13.
`
`
`
`
`
`10
`
`

`

`
`
`excretory system tumors,” “advanced solid excretory system tumor[s],” and
`
`“kidney tumor[s].” Pet. 11-13. Breckenridge presents no challenge to the
`
`“therapeutically effective” limitation of the claims. Nor does Breckenridge present
`
`any corresponding challenge to the enablement of the claims by any of the priority
`
`documents. Breckenridge’s priority challenge fails. As explained below, the
`
`priority date for each challenged claim is at least February 19, 2001, the filing date
`
`of the earliest GB ’072 priority application, because both GB ’072 and GB ’957
`
`provide written description support for the challenged claims.3 Fitbit, Inc. v.
`
`BodyMedia, Inc., IPR2016-00707 (Patent. Tr. & App. Bd. Sept. 8, 2016), Paper 9
`
`at 11, 13 (“With respect to priority, Petitioner would bear the ultimate burden of
`
`persuasion in an inter partes review.” (denying institution where Petitioner failed
`
`to demonstrate that the challenged claims were not adequately supported by the
`
`written description of the earliest priority application)).
`
`
`
`
` While GB ’072 and GB ’957 contain some differences, the relevant supporting
`
` 3
`
`description in GB ’072 that Patent Owner relies on at the present stage of this
`
`proceeding is identically disclosed in both applications. See Ex. 1013, GB ’957 at
`
`1-3 (disclosing everolimus as a preferred compound to treat solid tumors and
`
`advanced tumors, including RCC and genitourinary cancer); Ex. 1012, GB ’072 at
`
`1-3 (same).
`
`
`
`
`
`11
`
`

`

`
`
`Breckenridge’s priority analysis fails because it never addresses the legally
`
`operative question: whether GB ’072’s disclosure “reasonably conveys” to those
`
`skilled in the art that the inventors had possession of the claimed subject matter as
`
`of the filing date. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir.
`
`1991). Breckenridge acknowledges the portions of GB ’072 that expressly
`
`disclose urinary excretory system tumors, including RCC and bladder cancer. Pet.
`
`12. But Breckenridge fails to explain what these disclosures would have
`
`reasonably conveyed to those skilled in the art. See Bilstad v. Wakalopulos, 386
`
`F.3d 1116, 1125-26 (Fed. Cir. 2004) (vacating decision where “the Board never
`
`truly discussed . . . whether Bilstad’s wr