UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`HOLOGIC, INC.,
`Petitioner
`
`v.
`
`ENZO LIFE SCIENCES, INC.
`Patent Owner
`
`____________
`
`U.S. Patent No. 7,064,197
`
`SYSTEM, ARRAY AND NON-POROUS SOLID SUPPORT
`COMPRISING FIXED OR IMMOBILIZED NUCLEIC ACIDS
`____________
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`Exhibit 2105 Page 1
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`Enzo Exhibit 2105
`Hologic, Inc. v. Enzo Life Sciences, Inc.
`Case IPR2016-00822
`
`

`
`
`
`I.
`
`
`TABLE OF CONTENTS
`Introduction ...................................................................................................... 1
`
`II. Grounds for Standing ....................................................................................... 1
`
`III. Mandatory Notices Under 37 C.F.R. § 42.8(b) ............................................... 2
`
`A.
`
`B.
`
`Real Party–In–Interest ........................................................................... 2
`
`Related Matters ...................................................................................... 2
`
`IV. Lead and Back-up Counsel; Electronic Service .............................................. 3
`
`V.
`
`Fee Payment ..................................................................................................... 3
`
`VI. Statement of Precise Relief Requested ............................................................ 4
`
`A.
`
`B.
`
`C.
`
`Claims for Which Review is Requested ................................................ 4
`
`Statutory Grounds of Challenge ............................................................ 4
`
`Level of Ordinary Skill in the Art at the Time of the Claimed
`Invention ................................................................................................ 7
`
`VII. Prosecution History of the ’197 Patent and the State of the Art ..................... 8
`
`A. Hybridizable Nucleic Acids Bound to Solid Supports .......................... 8
`
`B.
`
`C.
`
`Summary of Prosecution History .......................................................... 9
`
`Specification of the ’197 Patent ..........................................................10
`
`VIII. Claim Construction ........................................................................................12
`
`A.
`
`B.
`
`“Non-Porous Solid Support” ...............................................................12
`
`“Hybridizable form” ............................................................................14
`
`IX. The Challenged Claims of the ’197 Patent Are Unpatentable ......................15
`
`A. Ground 1: Claims 1, 6, 8, 9, 12, 13, 14, 15, 16, 27, 31, 32, 33,
`34, 41, 61, 62, 63, 68, 69, 70, 72, 73, 74, 79, 100, 191, 192,
`
`i
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`Exhibit 2105 Page 2
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`Enzo Exhibit 2105
`Hologic, Inc. v. Enzo Life Sciences, Inc.
`Case IPR2016-00822
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`193, 194, 212, 213, 219, 222, 225, 226, 227, 230, 233, and 236
`are anticipated by Fish. ........................................................................15
`
`1.
`
`Independent claims 1, 6, 8, 9, 12, 13, 14, 15, and 27 ...............17
`
`a.
`
`b.
`
`c.
`
`“A non-porous solid support,” “[a] system
`comprising a non-porous solid support,” or “[a]
`non-porous glass or a non-porous plastic solid
`support.” ..........................................................................18
`
`“one or more amine(s), hydroxyl(s) or epoxide(s)
`thereon” ...........................................................................20
`
`“single stranded nucleic acid”/ “nucleic acid”/
`“DNA or RNA”“is fixed or immobilized in
`hybridizable form to said non-porous solid support
`via said one or more amine(s), hydroxyl(s) or
`epoxide(s)” ......................................................................21
`
`2.
`
`Dependent claims 16, 31, 32, 33, 34, 41, 61, 62, 63, 68,
`69, 70, 72, 73, 74, 79, 100, 191, 192, 193, 194, 212, 213,
`219, 222, 225, 226, 227, 230, 233, and 236. .............................30
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`g.
`
`h.
`
`i.
`
`Claims 16, 222, and 230 .................................................30
`
`Claims 32, 72, 226, and 227 ...........................................30
`
`Claims 33, 41, 73, 212, 225, and 233 .............................30
`
`Claims 34, 74, and 213 ...................................................31
`
`Claims 31, 68, and 192 ...................................................31
`
`Claim 61, 100, and 191 ...................................................32
`
`Claims 62, 69, and 193 ...................................................32
`
`Claims 63, 70, and 194 ...................................................32
`
`Claims 79, 219, and 236 .................................................33
`
`B. Ground 2: Claims 31, 64, 68, 101, 192, and 195 are obvious
`under 35 U.S.C. § 103(a) in view of Fish ...........................................33
`
`ii
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`Exhibit 2105 Page 3
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`Case IPR2016-00822
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`

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`a.
`
`b.
`
`Claims 31, 68, and 192 ...................................................35
`
`Claims 64, 101, and 195 .................................................37
`
`C. Ground 3: Claims 38, 78, and 218 would have been obvious
`under 35 U.S.C. § 103(a) based on Fish in view of Gilham. ..............37
`
`D. Ground 4: Claims 1, 6, 8, 9, 12, 13, 14, 15, 27, 31, 32, 34, 61,
`62, 63, 68, 69, 70, 72, 74, 79, 100, 191, 192, 193, 194, 213,
`219, 226, 227, and 236 are anticipated under 35 U.S.C. § 102(b)
`by VPK. ...............................................................................................39
`
`1.
`
`The Challenged Claims Are Entitled to a Priority Date
`No Earlier Than the Filing of the CIP Application (Appl.
`No. 06/732,374) ........................................................................40
`
`a.
`
`b.
`
`The legal requirements for claiming priority..................41
`
`The original disclosure of the 1983 application
`does not provide written description support for
`the element “non-porous solid support.” ........................42
`
`2.
`
`Claims 1, 6, 8, 9, 12, 13, 14, 15, 27, 31, 32, 34, 61, 62,
`63, 68, 69, 70, 72, 74, 79, 100, 191, 192, 193, 194, 213,
`219, 226, 227, and 236 are anticipated by VPK. ......................45
`
`a.
`
`b.
`
`Independent claims 1, 6, 8, 9, 12, 13, 14, 15, and
`27 ....................................................................................45
`
`Dependent claims 31, 32, 34, 61, 62, 63, 68, 69,
`70, 72, 74, 79, 100, 191, 192, 193, 194, 213, 219,
`226, 227, and 236 are anticipated by VPK. ....................49
`
`E.
`
`F.
`
`Ground 5: Claims 16, 38, 64, 78, 101, 195, 218, 222, and 230
`would have been obvious under 35 U.S.C. § 103(a) based on
`Noyes in view of VPK and further in view of Ramachandran. ..........51
`
`Ground 6: Claims 33, 41, 73, 212, 225, and 233 would have
`been obvious under 35 U.S.C. § 103(a) based on VPK in view
`of Metzgar. ..........................................................................................56
`
`XI. Conclusion .....................................................................................................60
`
`iii
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`Exhibit 2105 Page 4
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`Enzo Exhibit 2105
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`Case IPR2016-00822
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`

`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`
`
`Cases
`Ariad Pharm., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) .......................................................................... 41
`
`ButamaxTM Advanced Biofuels LLC v. Gevo, Inc.,
`IPR2013-00539, paper no. 33 (PTAB March 3, 2015) ...................................... 40
`
`Continental Can Co. v. Monsanto Co.,
`948 F.2d 1264 (Fed.Cir.1991) ............................................................................ 16
`
`In re Cruciferous Sprout Litig.,
`301 F.3d 1343 (Fed.Cir. 2002) ........................................................................... 15
`
`Eli Lilly & Co. v. Barr Labs.,
`251 F.3d 955 (Fed. Cir. 2001) ............................................................................ 16
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................................ 33
`
`In re Huang,
`100 F.3d 135 (Fed. Cir. 1996) ............................................................................ 59
`
`Institut Pasteur & Universite Pierre et Marie Curie v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) .......................................................................... 59
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .......................................................................... 59
`
`KSR Int’l Co. v Teleflex Inc.,
`550 U.S. 398 (2007) .....................................................................................passim
`
`In re Kubin,
`561 F.3d 1351 (Fed. Cir. 2009) .......................................................................... 34
`
`iv
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`Leapfrog Enterprises Inc. v. Fisher-Price Inc.,
`485 F.3d 1157 (Fed. Cir. 2007) .......................................................................... 60
`
`LizardTech v. Earth Resource Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005) .......................................................................... 42
`
`Lockwood v. American Airlines, Inc.,
`107 F.3d 15¶ (Fed. Cir. 1997) ............................................................................. 44
`
`Newell Cos., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 59
`
`In re O’Farrell,
`853 F.2d 894 (Fed. Cir. 1988) ............................................................................ 34
`
`In re Omeprazole Patent Litigation,
`483 F.3d 1364 (Fed.Cir. 2007) ........................................................................... 15
`
`Purdue Pharma LP v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2013) .................................................................... 43, 44
`
`Rambus Inc. v. Rea,
`731 F.3d 1248 (Fed. Cir. 2013) .......................................................................... 59
`
`Schering Corp. v. Geneva Pharmaceuticals,
`339 F.3d 1373 (Fed. Cir. 2003) .......................................................................... 29
`
`Technology Licensing Corp. v. Videotek, Inc.,
`545 F.3d 1316 (Fed. Cir. 2008) .................................................................... 41, 44
`
`Trintec Indus., Inc. v. Top-U.S.A. Corp.,
`295 F.3d 1292 (Fed. Cir. 2002) .................................................................... 16, 29
`
`Tronzo v. Biomet,
`156 F.3d 1154 (Fed. Cir. 1998) .......................................................................... 44
`
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) .......................................................................... 41
`
`Verizon Services Corp. v. Cox Fibernet Virginia, Inc.,
`602 F.3d 1325 (Fed. Cir. 2010) .......................................................................... 16
`
`v
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`Exhibit 2105 Page 6
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`Enzo Exhibit 2105
`Hologic, Inc. v. Enzo Life Sciences, Inc.
`Case IPR2016-00822
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`

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`In re Wesslau,
`353 F.2d 238 (CCPA 1965) ................................................................................ 34
`
`Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC,
`683 F.3d 1356 (Fed. Cir. 2012) .......................................................................... 59
`
`Federal Statutes
`
`35 U.S.C. § 102 ........................................................................................................ 15
`
`35 U.S.C. §102(a) .................................................................................................... 40
`
`35 U.S.C. § 102(b) ............................................................................................passim
`
`35 U.S.C. § 103 ........................................................................................................ 40
`
`35 U.S.C. § 103(a) ............................................................................................passim
`
`35 U.S.C. § 112 .................................................................................................. 41, 43
`
`35 U.S.C. § 120 ........................................................................................................ 42
`
`35 U.S.C. § 311 .......................................................................................................... 4
`
`Regulations
`
`37 C.F.R. § 42.8(b) .................................................................................................... 2
`
`37 C.F.R. §§ 42.100 ................................................................................................... 1
`
`37 C.F.R. § 42.100(b) .............................................................................................. 12
`
`37 C.F.R. § 42.104(a) ................................................................................................. 1
`
`37 C.F.R. § 42.104(b)(4) .................................................................................... 12, 15
`
`37 C.F.R. § 42.104(b)(5) .......................................................................................... 15
`
`Other Authorities
`
`M.P.E.P. § 2287(III)................................................................................................... 4
`
`vi
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`Exhibit 2105 Page 7
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`Enzo Exhibit 2105
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`Case IPR2016-00822
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`Exhibit 2105 Page 8
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`Enzo Exhibit 2105
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`Case IPR2016-00822
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`Exhibit 2105 Page 9
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`Enzo Exhibit 2105
`Hologic, Inc. v. Enzo Life Sciences, Inc.
`Case IPR2016-00822
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`

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`I.
`
`Introduction
`Petitioner Hologic, Inc. (“Hologic”) requests inter partes review (“IPR”) of
`
`claims 1, 6, 8, 9, 12, 13, 14, 15, 16, 27, 31, 32, 33, 34, 38, 41, 61, 62, 63, 64, 68,
`
`69, 70, 72, 73, 74, 78, 79, 100, 101, 191, 192, 193, 194, 195, 212, 213, 218, 219,
`
`222, 225, 226, 227, 230, 233, and 236 (“the challenged claims”) of U.S. Patent No.
`
`7,064,197 (“the ’197 Patent”) (Ex. 1001) assigned to Enzo Life Sciences, Inc.
`
`(“Patent Owner” or “Enzo”) (Reel 17133, Frame 718) under 35 U.S.C. §§ 311-319
`
`and 37 C.F.R. §§ 42.100 et seq. See Ex. 1027 (assignment record from USPTO
`
`assignment database showing that the ’197 Patent is assigned to Enzo Life
`
`Sciences, Inc.). This Petition demonstrates there is a reasonable likelihood that
`
`Petitioner will prevail in proving, by a preponderance of the evidence, that the
`
`challenged claims of the ’197 patent are unpatentable over prior art not considered
`
`during prosecution. The challenged claims of the ’197 patent, as set forth above in
`
`this paragraph, should be found unpatentable and canceled.
`
`II. Grounds for Standing
`Petitioner certifies that the ’197 Patent is available for IPR and that the
`
`Petitioner is not barred or estopped from requesting IPR challenging the ’197
`
`Patent on the grounds identified. See 37 C.F.R. § 42.104(a). Specifically: (1)
`
`Petitioner is not the owner of the ’197 Patent; (2) Petitioner is not barred or
`
`estopped from requesting IPR; and (3) this Petition is being filed not more than one
`
`1
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`Exhibit 2105 Page 10
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`Enzo Exhibit 2105
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`Case IPR2016-00822
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`Exhibit 2105 Page 11
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`Enzo Exhibit 2105
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`Case IPR2016-00822
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`Exhibit 2105 Page 12
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`Enzo Exhibit 2105
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`If any additional fees are due during this proceeding, the Office may charge such
`
`fees to Deposit Account No. 06–0916.
`
`VI. Statement of Precise Relief Requested
`A. Claims for Which Review is Requested1
`Petitioner requests IPR and cancelation of claims 1, 6, 8, 9, 12, 13, 14, 15,
`
`16/1, 16/12, 16/13, 16/14, 16/15, 27, 31, 32/1, 33/1, 34/1, 38/1, 41/1, 61/1, 62/1,
`
`63/1, 64/1, 68, 69, 70, 72/6, 72/8, 72/9, 73/6, 73/8, 73/9, 74/6, 74/8, 74/9, 78/6,
`
`78/8, 79/6, 79/8, 79/9, 100/6, 100/9, 101/6, 101/9, 191, 192, 193, 194, 195,
`
`212/27, 213/27, 218/27, 219/27, 222/27, 225/27, 226/12, 226/13, 226/14, 226/15,
`
`227/8, 227/9, 230/6, 230/8, 230/9, 233/6, 233/8, 233/9, and 236/1 of the ’197
`
`Patent under 35 U.S.C. § 311.
`
`B.
`
`Statutory Grounds of Challenge
`
`The challenged claims are unpatentable and should be canceled in view of
`
`the following prior art references and grounds of unpatentability:
`
`
`
`
`1 Taking guidance from M.P.E.P. § 2287(III) (which discusses how to treat
`
`multiple dependent claims in reexamination proceedings), Petitioner represents the
`
`challenged multiple dependent claims as “x/y” where x is the dependent claim
`
`number and y is the claim from which x depends.
`
`4
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`Exhibit 2105 Page 13
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`Enzo Exhibit 2105
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`Case IPR2016-00822
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`Exhibit 2105 Page 14
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`Enzo Exhibit 2105
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`Case IPR2016-00822
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`Exhibit 2105 Page 15
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`Enzo Exhibit 2105
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`Exhibit 2105 Page 16
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`Enzo Exhibit 2105
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`and would have been familiar with nucleic acid chemistry, and (iii) have been
`
`knowledgeable of conventional techniques for attaching nucleic acids to other
`
`moieties like solid supports or labels. See Ex. 1002 at ¶21. This level of skill of
`
`the POSITA would have applied to all obviousness analyses in this
`
`Petition. Furthermore, all conclusions regarding obviousness apply as of the
`
`January 27, 1983, and May 9, 1985 filing dates, as well as one year prior to
`
`each date (January 27, 1982, and May 9, 1984).
`
`VII. Prosecution History of the ’197 Patent and the State of the Art
`A. Hybridizable Nucleic Acids Bound to Solid Supports
`As a POSITA would have known, two strands of nucleic acids hybridize to
`
`one another through hydrogen bonding between complementary nucleotides
`
`(bases) that naturally pair with one another. Ex. 1002 ¶24. Under the Watson-Crick
`
`base pairing model, the nucleotide “A” pairs with the nucleotide “T” on the
`
`opposite strand, and the nucleotide “C” pairs with the nucleotide “G” on the
`
`opposite strand. Id. In RNA molecules, “T” is replaced by “U” to form an “A-U”
`
`base pair.
`
`More than a year before the January 27, 1983, filing date of the first
`
`application, multiple techniques were available to the POSITA for binding single
`
`stranded nucleic acids in a hybridizable form to many different types of solid
`
`supports. Ex. 1002, ¶25. Exemplary uses of hybridizable single-stranded nucleic
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`8
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`acids bound to solid supports included identifying biological materials in samples
`
`and separating biological materials from samples. Id.
`
`Summary of Prosecution History
`
`B.
`During lengthy prosecution of the applications leading up to issuance of the
`
`’197 Patent, the Patent Owner apparently realized that it would not obtain claims
`
`encompassing porous solid supports in view of the extensive publications
`
`involving routine techniques such as dot or blot hybridization, Southern and
`
`Northern hybridizations, and nucleic acid affinity columns. See, e.g., Ex. 1005 at
`
`75-82 (Office Action in Appl. No. 06/732,374, rejecting claims based on Falkow et
`
`al., which the Examiner argued discloses polynucleotides immobilized on solid
`
`supports). Therefore, the Patent Owner amended the claims to require non-porous
`
`solid supports to distinguish them from documents that disclosed porous solid
`
`supports. Id. at pp. 84, 89-91.
`
`But after many rounds of claim amendments, the Patent Owner still faced
`
`prior art rejections in view of known in-situ hybridization techniques, which were
`
`performed on non-porous solid supports such as microscope slides. Ex. 1022 at pp.
`
`10-12 (Office Action rejecting the claims as anticipated by U.S. Patent No.
`
`4,732,847 to Stuart et al.). The in-situ hybridization prior art patent (Stuart) applied
`
`by the Examiner did not explicitly state the mechanism that bound the nucleic
`
`acids to the non-porous solid supports.
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`9
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`The Patent Owner then looked to the exemplary and conventional nucleic
`
`acid binding chemistry in its examples to allege that it was the first to use three
`
`chemical groups (amines, hydroxyls, or epoxides) on a non-porous solid support to
`
`attach hybridizable single-stranded nucleic acids to the solid support. Ex. 1013, p.
`
`4 (exemplary claim amendment of claim 3144 to recite that the claimed “non-
`
`porous solid support” comprises “one or more amine(s), hydroxyl(s) or epoxide(s)
`
`thereon” and that the fixation or immobilization of the nucleic acids is “via said
`
`one or more amine(s), hydroxyl(s) or epoxide(s)” and pp. 47 and 97-98 where the
`
`Patent Owner used that limitation to distinguish the claims over the Stuart patent).
`
`Failing to recognize prior art that showed attachment of nucleic acids in a
`
`hybridizable form to non-porous solid supports through at least one of those
`
`chemical groups, the Examiner allowed the claims. Ex. 1014, p. 3.
`
`Specification of the ’197 Patent
`
`C.
`The ’197 Patent describes non-porous solid supports with fixed or
`
`immobilized nucleic acids, and systems and arrays comprising such non-porous
`
`solid supports. Ex. 1001, Title and Abstract. The ’197 Patent discusses non-porous
`
`solid supports such as “glass, or alternatively, plastic, polystyrene, polyethylene,
`
`dextran, polypropylene, and like.” Ex. 1001, 6:2-6; 12:39-45. The ’197 Patent also
`
`identifies conventional microtiter well plates as non-porous solid supports to which
`
`nucleic acids can be fixed. Id. at 12:54-58. The patent also discusses glass plates
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`10
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`having “an array of depressions or wells” (id. at 8:65-9:5), and polystyrene plates
`
`(id. at 11:56-58; 12:7-26) as solid supports to which nucleic acids may be bound
`
`(fixed or immobilized). The Patent Owner also argued that the ’197 Patent
`
`describes treatment of the solid supports with amine providing compounds, epoxy
`
`compounds, and acid solutions to fix or immobilize nucleic acids. Ex. 1011 at pp
`
`40-41 (providing citations to the application for support); Ex. 1001 at Abstract
`
`(note that the Abstract discussing the three groups was not added until November
`
`8, 2005 (Ex. 1024 at pp. 50 and 52). The ’197 Patent also explains that
`
`polynucleotide analyte sequences fixed or immobilized to the solid supports may
`
`be hybridized to complementary polynucleotide or oligonucleotide probes. See
`
`e.g., Ex. 1001 at 5:61-6:9; 6:15-27; 8:65-9:5. Although not required by any of the
`
`challenged claims, the hybridizing probe may have a label capable of generating a
`
`soluble signal, and hybridization of the probe to the analyte may be detected or
`
`quantified using the soluble signal. Id. at 1:23-32; 6:15-32; 8:65-9:12.
`
`This Petition will show that the non-porous solid supports and systems
`
`claimed in the ’197 Patent previously had been disclosed in prior art not considered
`
`during prosecution of the applications leading to the ’197 Patent. The prior art
`
`shows every limitation of the challenged claims, including the limitations added to
`
`secure allowance of the patent.
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`11
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`Exhibit 2105 Page 20
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`Enzo Exhibit 2105
`Hologic, Inc. v. Enzo Life Sciences, Inc.
`Case IPR2016-00822
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`VIII. Claim Construction
`In an IPR, an unexpired patent’s claims generally receive the “broadest
`
`reasonable construction in light of the specification of the patent in which it
`
`appears.” 37 C.F.R. § 42.100(b). Unless otherwise noted, Petitioner proposes that
`
`the claim terms of the ’197 Patent be given their ordinary and customary meanings
`
`in the art. Petitioner, however, construes the following terms according to the
`
`intrinsic evidence and traditional canons of claim construction. Petitioner uses
`
`these constructions in its grounds for unpatentability. See 37 C.F.R. § 42.104(b)(4).
`
`“Non-Porous Solid Support”
`
`A.
`All challenged independent claims, i.e., claims 1, 6, 8, 9, 12, 13, 14, 15, and
`
`27, recite the term “non-porous solid support.” Ex. 1001 (claims). This term should
`
`be given its ordinary and customary meaning in the art. And as admitted by the
`
`Patent Owner, certain solid supports were known in the art to be non-porous. For
`
`example, the ’197 patent states that a polynucleotide can be fixed “to a non-porous
`
`solid support, such as a conventional microtiter well . . . .” Ex. 1001, 12:54-61.
`
`Similarly, when arguing that its counterpart European patent application disclosed
`
`non-porous solid supports—despite failing to mention the word “non-porous”—the
`
`Patent Owner repeatedly asserted that containers in which reactions take place in
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`solution, such as the disclosed wells, must be non-porous. Ex. 1016, pp. 6-7.
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`Also, the Patent Owner readily admitted that the prior art technique of in-situ
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`hybridization was performed on glass slides, which necessarily are non-porous. Ex.
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`1026 at pp. 5 and 7 (The Examiner argued that “a transparent non-porous solid
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`support is embodied by glass slides,” as disclosed by Langer’s in-situ technique (p.
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`5), and the Patent Owner admitted that Langer et al. disclosed an in-situ
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`hybridization method that was performed on “nonporous solid supports that are
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`transparent or translucent.” (p. 7)).
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`And in its Opening Claim Construction Brief in the related litigations, the
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`Patent Owner noted that “non-porous” is a commonly understood term—citing the
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`Examiner’s understanding “that glass slides are ‘reasonably interpreted as the
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`commonly utilized non-porous microscope type slides which are well known in the
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`art.’” Ex. 1023, pp. 8-9 (citing Ex. 1022 (11-26-2004 Office Action, p. 10)).
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`Thus, the ordinary and customary meaning of “non-porous solid support”
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`should apply, which includes conventional laboratory equipment such as microtiter
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`wells and glass slides. In the related litigations involving the ’197 Patent, the
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`district court construed the term “non-porous” to mean “having no pores.” Ex.
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`1010, pp. 5-7. If adopted here, that construction would not change the conclusions
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`in this Petition, because the prior art applied in this Petition shows conventional
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`microtiter wells and glass slides, which the Petitioner admits are encompassed by
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`the claim language “non-porous solid support.”
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`“Hybridizable form”
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`B.
`The term “hybridizable form” is recited in all of the challenged independent
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`claims as a property of the fixed or immobilized single strand. This term should be
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`construed as “capable of binding through Watson-Crick base pairing.” This
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`construction is supported by the specification of the ’197 Patent, which states that
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`“[p]olynucleotide sequence-based detection techniques are characterized by a
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`sequence of steps comprising the non-covalent binding of a labelled polynucleotide
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`sequence or probe to a complementary sequence of the analyte [which can be
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`fixed] under hybridization conditions in accordance with the Watson-Crick base
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`pairing of adenine (A) and thymine (T), and guanine (G) and cytosine (C), and the
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`detection of that hybridization.” Ex. 1001, 2:22-34 (emphasis added). In the related
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`litigations involving the ’197 Patent, the defendants and the Patent Owner agreed
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`that the term “hybridizable form” should be construed as “capable of binding
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`through Watson-Crick base pairing.” Ex. 1010, p. 10.
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`Furthermore, the Patent Owner successfully asserted during the claim
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`construction phase of the related litigations, that when “two nucleic acids strands
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`[are] hybridized to each other,” “the claims and specification do not require, or
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`disclose, that [the] two strands hybridize ‘throughout their entire length.’” Ex.
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`1023, pp. 13-14, citing several passages of the ’197 patent that support that
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`position, including the passage quoted above. Petitioner agrees with the Patent
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`14
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`Case IPR2016-00822
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`Owner’s assertion that a POSITA, especially in view of the ’197 Patent’s
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`specification and claims, would understand that the immobilized nucleic acid
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`strand does not have to hybridize along its entire length in order to be considered
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`“hybridizable.” Ex. 1002, ¶24.
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`IX. The Challenged Claims of the ’197 Patent Are Unpatentable
`Pursuant to 37 C.F.R. § 42.104(b)(4), Section IX of this Petition now
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`explains how the challenged claims of the ’197 Patent are unpatentable under the
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`asserted grounds. Petitioner’s supporting evidence, and the relevance of the
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`evidence to the challenges raised, are also identified in Section IX, pursuant to 37
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`C.F.R. § 42.104(b)(5). The supporting evidence includes an expert declaration
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`from Petitioner’s Expert, Dr. Norman Nelson (Ex. 1002).
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`A. Ground 1: Claims 1, 6, 8, 9, 12, 13, 14, 15, 16, 27, 31, 32, 33, 34, 41, 61,
`62, 63, 68, 69, 70, 72, 73, 74, 79, 100, 191, 192, 193, 194, 212, 213, 219,
`222, 225, 226, 227, 230, 233, and 236 are anticipated by Fish.
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`The ’197 Patent was filed on June 7, 1995, and claims priority to U.S.
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`Application No. 06/461,469, filed on January 27, 1983. Fish was published March
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`1981 (Ex. 1006). As discussed in Section IX.D.1, infra, Petitioner disputes the
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`Patent Owner’s priority claim to the application filed in 1983. Nevertheless, since
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`Fish was published more than a year prior to the purported effective filing date
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`(January 27, 1983) of the ’197 Patent, it is prior art to the ’197 Patent under §
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`102(b).
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`Case IPR2016-00822
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`“Anticipation” under 35 U.S.C. § 102 requires disclosure of each and every
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`claim limitation in a single prior art reference, either explicitly or inherently. In re
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`Omeprazole Patent Litigation, 483 F.3d 1364, 1371 (Fed. Cir. 2007). Even if a
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`prior art reference lacks an express disclosure of a claim limitation, it may
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`nonetheless anticipate by inherency. In re Cruciferous Sprout Litig., 301 F.3d
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`1343, 1349 (Fed. Cir. 2002). The Federal Circuit has explained that “a prior art
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`reference may anticipate without disclosing a feature of the claimed invention if
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`that missing characteristic is necessarily present, or inherent, in the single
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`anticipating reference.” Verizon Services Corp. v. Cox Fibernet Virginia, Inc., 602
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`F.3d 1325, 1337 (Fed. Cir. 2010) (internal citations and quotation marks omitted);
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`Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir.1991). Thus,
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`inherent anticipation “requires that the missing descriptive material is ‘necessarily
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`present,’ not merely probably or possibly present, in the prior art.” Trintec Indus.,
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`Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1295 (Fed. Cir. 2002) (quoting In re
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`Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999). “A reference includes an inherent
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`characteristic if that characteristic is the ‘natural result’ flowing from the
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`reference's explicitly explicated limitations.” Eli Lilly & Co. v. Barr Labs., 251
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`F.3d 955, 970 (Fed. Cir. 2001).
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`Independent claims 1, 6, 8, 9, 12, 13, 14, 15, and 27
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`1.
`The challenged independent claims have many common limitations, as
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`shown below, which are addressed jointly to avoid repetition.
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`Claim 1, which is exemplary of all of the challenged independent claims,
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`recites: “A non-porous solid support comprising one or more amine(s), hydroxyl(s)
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`or epoxide(s) thereon, wherein at least one single-stranded nucleic acid is fixed or
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`immobilized in hybridizable form to said non-porous solid support via said one or
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`more amine(s), hydroxyl(s) or epoxide(s).”
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`There are two aspects where the nine independent claims differ. Other than
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`those two aspects where the claims differ, all nine claims recite the exact same
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`limitations. The differences among the independent claims are minor and do not
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`distinguish any of the claims over the prior art applied here. The same can be said
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`for the identical terms.
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`The first difference involves the preambles. The preambles are recited three
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`different ways: “a non-porous solid support” (claims 1