`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________
`
`BECTON, DICKINSON AND COMPANY,
`Petitioner
`
`v.
`
`ENZO LIFE SCIENCES, INC.
`Patent Owner
`
`_____________
`
`Case IPR2017-00181
`
`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
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`1
`1
`2
`2
`2
`
`3
`4
`4
`4
`4
`
`8
`
`I.
`Introduction
`Grounds for Standing
`II.
`III. Mandatory Notices Under 37 C.F.R. § 42.8(b)
`A.
`Real Party-In-Interest
`B.
`Related Matters
`C.
`Lead and Back-up Counsel; Postal, Hand-Delivery, and
`Electronic Service
`Fee Payment
`D.
`VII. Statement of Precise Relief Requested
`A.
`Claims for Which Review Is Requested
`B.
`Statutory Grounds of Challenge
`C.
`Level of Ordinary Skill in the Art at the Time of the Claimed
`Invention
`VIII. Summary of the Prosecution History of the ’197 Patent and the State of
`the Art
`A. Hybridizable Nucleic Acids Bound to Solid Supports
`B.
`Specification of the ’197 Patent
`C.
`Summary of Prosecution History
`IX. Claim Construction
`A.
`“Non-Porous Solid Support”
`B.
`“Hybridizable form”
`C.
`“Array”
`The Challenged Claims of the ’197 Patent Are Unpatentable
`A. Ground 1: Claims 17, 19, 25, 105, 106, 114, 116, 119, 128, 129,
`16
`150, 152, 178, 180, 186, and 187 are anticipated by Fish
`1.
`Independent claims 17, 19, and 25 ........................................... 17
`2.
`Dependent claims 105, 106, 114, 116, 119, 128, 129, 150, 152,
`178, 180, 186, and 187. ............................................................. 28
`
`9
`9
`10
`11
`12
`12
`14
`15
`16
`
`X.
`
`
`
`i
`
`
`
`Ground 2: Claims 130, 131, 151, and 154 are obvious under 35
`31
`U.S.C. § 103(a) in view of Fish.
`1.
`Claim 131 .................................................................................. 33
`2.
`Claims 130 and 154 .................................................................. 34
`3.
`Claim 151 .................................................................................. 35
`Ground 3: Claims 120 and 189 are obvious under 35 U.S.C. §
`103(a) based on Fish in view of Metzgar and further in view of
`Sato.
`D. Ground 4: Claims 113 and 185 would have been obvious under
`35 U.S.C. § 103(a) based on Fish in view of Gilham.
`Ground 5: Claim 17, 19, 25, 105, 106, 114, 119, 120, 128, 129,
`131, 150, 151, 152, 178, 180, 186, and 189 would have been
`obvious under 35 U.S.C. § 102(b) based on VPK in view of
`Metzgar.
`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
`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
`Claims 17, 19, 25, 105, 106, 114, 119, 120, 128, 129, 131, 150,
`151, 152, 178, 180, 186, and 189 would have been obvious based
`on VPK in view of Metzgar. ..................................................... 46
`Ground 6: Claims 113, 116, 130, 154, 185, and 187 are obvious
`under 35 U.S.C. § 103(a) based on Noyes in view of VPK and
`54
`further in view of Metzgar and Ramachandran.
`1.
`Claims 116 and 187 .................................................................. 57
`2.
`Claims 113 and 185 .................................................................. 57
`3.
`Claims 130 and 154 .................................................................. 58
`XI. Secondary Considerations, Even if Considered, Fail to overcome the
`Evidence of Obviousness
`XII. Conclusion
`
`
`
`
`B.
`
`
`
`
`
`ii
`
`C.
`
`E.
`
`F.
`
`2.
`3.
`
`4.
`
`35
`
`38
`
`40
`
`59
`61
`
`
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Federal Cases
`Ariad Pharm., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) .......................................................................... 42
`
`ButamaxTM Advanced Biofuels LLC v. Gevo, Inc.,
`IPR2013-00539 (P.T.A.B. March 3, 2015) ........................................................ 41
`
`Continental Can Co. v. Monsanto Co,
`948 F.2d 1264 (Fed. Cir. 1991) .......................................................................... 17
`
`In re Cruciferous Sprout Litig.,
`301 F.3d 1343 (Fed. Cir. 2002) .......................................................................... 17
`
`Eli Lilly & Co. v. Barr Labs.,
`251 F.3d 955 (Fed. Cir. 2001) ............................................................................ 17
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................................ 31
`
`In re Huang,
`100 F.3d 135 (Fed. Cir. 1996) ............................................................................ 60
`
`Institut Pasteur & Universite Pierre et Marie Curie v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) .......................................................................... 60
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .......................................................................... 60
`
`KSR Int’l Co. v Teleflex Inc.,
`550 U.S. 398 (2007) .....................................................................................passim
`
`In re Kubin,
`561 F.3d 1351 (Fed. Cir. 2009) .......................................................................... 32
`
`Leapfrog Enterprises Inc. v. Fisher-Price Inc.,
`485 F.3d 1157 (Fed. Cir. 2007) .......................................................................... 61
`
`LizardTech v. Earth Resource Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005) .......................................................................... 43
`iii
`
`
`
`
`
`
`
`Lockwood v. American Airlines, Inc.,
`107 F.3d 1565 (Fed. Cir. 1997) .......................................................................... 45
`
`Newell Cos., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 60
`
`In re O’Farrell,
`853 F.2d 894 (Fed. Cir. 1988) ............................................................................ 32
`
`In re Omeprazole Patent Litigation,
`483 F.3d 1364 (Fed. Cir. 2007) .......................................................................... 16
`
`Purdue Pharma LP v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2013) .......................................................................... 44
`
`Rambus Inc. v. Rea,
`731 F.3d 1248 (Fed. Cir. 2013) .......................................................................... 60
`
`Schering Corp. v. Geneva Pharmaceuticals,
`339 F.3d 1373 (Fed. Cir. 2003) .......................................................................... 28
`
`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) .................................................................... 17, 28
`
`Tronzo v. Biomet,
`156 F.3d 1154 (Fed. Cir. 1998) .......................................................................... 45
`
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) .......................................................................... 42
`
`Verizon Services Corp. v. Cox Fibernet Virginia, Inc.,
`602 F.3d 1325 (Fed. Cir. 2010) .......................................................................... 17
`
`In re Wesslau,
`353 F.2d 238 (CCPA 1965) ................................................................................ 32
`
`Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC,
`683 F.3d 1356 (Fed. Cir. 2012) .......................................................................... 60
`
`
`
`iv
`
`
`
`
`
`Federal Statutes
`35 U.S.C. § 102 .................................................................................................passim
`
`35 U.S.C. § 103 .................................................................................................passim
`
`35 U.S.C. § 112 ...................................................................................... 11, 41, 42, 43
`
`35 U.S.C. § 120 ........................................................................................................ 41
`
`35 U.S.C. § 311 .......................................................................................................... 4
`
`35 U.S.C. § 315(c) ..................................................................................................... 1
`
`Regulations
`
`37 C.F.R. § 42.8(b) .................................................................................................... 2
`
`37 C.F.R. § 42.15(a) ................................................................................................... 4
`
`37 C.F.R. § 42.22 ....................................................................................................... 1
`
`37 C.F.R. § 42.100(b) .............................................................................................. 12
`
`37 C.F.R. § 42.103(a) ................................................................................................. 4
`
`37 C.F.R. § 42.104(a) ................................................................................................. 1
`
`37 C.F.R. § 42.104(b)(4) .................................................................................... 12, 16
`
`37 C.F.R. § 42.104(b)(5) .......................................................................................... 16
`
`37 C.F.R. § 42.122(b) ................................................................................................ 1
`
`Other Authorities
`
`M.P.E.P. § 2287(III) ................................................................................................... 4
`
`
`
`
`
`
`
`v
`
`
`
`
`
`LIST OF EXHIBITS
`
`Description
`Exhibit
`Ex. 1001 U.S. Patent No. 7,064,197 (issued June 20, 2006) (“the ’197 Patent”).
`Ex. 1002 Declaration of Dr. Norman Nelson (including his CV as Exhibit A).
`Ex. 1003 Excerpt from File History of the ’197 Patent (Amendment dated
`October 31, 2003).
`Ex. 1004 U.S. Appl. No. 06/461,469 (“the ’469 application”).
`Ex. 1005 File History of U.S. Appl. No. 06/732,374 (“the ’374 application”).
`Ex. 1006 Falk Fish and Morris Ziff, “A Sensitive Solid Phase Micro-
`radioimmunoassay For Anti-Double Stranded DNA Antibodies,”
`Arthritis and Rheumatism, Vol. 24, No.3 (March 1981) (“Fish”).
`Ex. 1007 Barbara E. Noyes and George R. Stark, “Nucleic Acid Hybridization
`Using DNA Covalently Coupled to Cellulose,” Cell, vol. 5, 301-310
`(July 1975) (“Noyes”).
`Ex. 1008 A. C. Van Prooijen-Knegt, et al. “In Situ Hybridization of DNA
`Sequences in Human Metaphase Chromosomes Visualized by an
`Indirect Fluorescent Immunocytochemical Procedure.” Experimental
`Cell Research 141, 397-407 (October 1982) (“VPK”).
`Ex. 1009 U.S. Patent No. 3,572,892 (patented March 30, 1971) (“Metzgar”).
`Ex. 1010 District court's Claim Construction Order for terms in the ’197 Patent.
`Ex. 1011 Excerpt from File History of the ’197 Patent (Communication dated
`August 10, 2007, and associated Exhibit 6).
`Ex. 1012 Submission in EP Patent 0117440 (App. 84100836.0-2106) dated June
`7, 2000.
`Excerpt from File History of the ’197 Patent (Amendment dated May
`25, 2005).
`Ex. 1014 Excerpt from File History of the ’197 Patent (Office Action dated Sept.
`29, 2005).
`Ex. 1015 A. C. Van Prooijen-Knegt, et al. “Spreading and staining of human
`metaphase chromosomes on aminoalkylsilane-treated glass slides.”
`Histochemical Journal 14, 333-344 (1982).
`Excerpt from File History of EP Patent 0117440 (Enzo November 3,
`1997, Submission).
`Ex. 1017 Taylor et al., “Impact of surface chemistry and blocking strategies on
`DNA microarrays,” Nucleic Acids Research, Vol. 31, 2003.
`Ex. 1018 Aotsuka et al., “Measurement of anti-double stranded DNA Antibodies
`in major immunoglobulin classes.” Journal of Immunological Methods,
`28, 149-62 (1979).
`
`Ex. 1016
`
`Ex. 1013
`
`
`
`vi
`
`
`
`
`
`Description
`Exhibit
`Ex. 1019 P. T. Gilham, “Immobilized Polynucleotides and Nucleic Acids,”
`published in Immobilized Biochemicals and Affinity
`Chromatography(R. B. Dunlap (ed.)), 1974 (Ex. 1019) (“Gilham”).
`Ex. 1020 U.S. Patent Publication No. 2002/0164626 to Diehl et al., published
`November 7, 2002.
`Ex. 1021 Diehl et al., “Manufacturing DNA microarrays of high spot
`homogeneity and reduced background signal,” Nucleic Acids
`Research, Vol. 31 , 2001 (“Diehl”).
`Ex. 1022 Excerpt from File History of the ’197 Patent (Office Action dated
`November 26, 2004).
`Ex. 1023 Patent Owner’s Opening Claim Construction Brief for terms in the
`’197 Patent filed June 24, 2014 in related litigations.
`Ex. 1024 Excerpt from the ’197 Patent File History (Supplemental amendment
`filed November 8, 2005).
`Ex. 1025 Excerpt from the ’197 Patent File History (Response filed June 30,
`2004).
`Ex. 1026 Excerpt from the ’197 Patent File History (Response filed September
`27, 1991).
`Ex. 1027 Assignment record of the ’197 Patent from USPTO assignment
`database.
`Ex. 1028 K. B. Ramachandran and D. D. Perlmutter, “Effects of Immobilization
`of the Kinetics of Enzyme-Catalyzed Reactions. I. Glucose Oxidase in
`a Recirculation Reactor System,” Biotechnology and Bioengineering,
`Vol. XVIII, 669-684 (1976) (“Ramachandran”).
`Ex. 1029 Excerpt from the EP Patent 0117440 File History (Enzo submission
`filed December 28, 1994).
`Ex. 1030 Excerpt from the ’197 Patent File History (Response filed July 30,
`1999).
`Ex. 1031 Excerpt from the ’197 Patent File History (Office Action dated
`December 8, 1998).
`Ex. 1032 Webpage of Pat Brown Lab in Stanford University showing
`preparation.
`Technical bulletin from Sigma-Aldrich providing information on
`poly-L-lysine (PLL).
`Sato et al., “Cell Surface Charge and Cell Division in Escherichia coli
`after X radiation.” Radiation Research 87, 646-656 (1981) (“Sato”).
`
`Ex. 1033
`
`Ex. 1034
`
`
`
`vii
`
`
`
`
`
`I.
`
`Introduction
`Petitioner Becton, Dickinson and Company (“BD”) requests inter partes
`
`review (“IPR”) of claims 17, 19, 25, 105, 106, 113, 114, 116, 119, 120, 128, 129,
`
`130, 131, 150, 151,152, 154, 178, 180, 185, 186, 187, and 189 (“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 (USPTO
`
`assignment record.) 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 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 an 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 an IPR; and (3) this Petition is being filed concurrently with a
`
`proper Motion for Joinder under 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22,
`
`1
`
`42.122(b).
`
`
`
`
`
`
`
`
`
`III. Mandatory Notices Under 37 C.F.R. § 42.8(b)
`
`A. Real Party-In-Interest
`
`Becton, Dickinson and Company is the real party-in-interest.
`
`B. Related Matters
`
`Petitioner identifies the following judicial proceedings in which the ’197
`
`Patent has been asserted as related matters. “DED” stands for District of Delaware.
`
`Caption
`
`Number
`
`Dist.
`
`Filed
`
`Enzo Life Sciences, Inc. v. Hologic, Inc.
`
`l-15-cv-00271 DED Mar. 27, 2015
`
`Pending
`
`Enzo Life Sciences, Inc. v. Siemens
`
`l-12-cv-00505 DED Apr. 20, 2012
`
`Healthcare Diagnostics, Inc.
`
`Concluded
`
`Enzo Life Sciences, Inc. v. Affymetrix, Inc.
`
`l-12-cv-00433 DED Apr. 6, 2012
`
`Concluded
`
`Enzo Life Sciences, Inc. v. Agilent
`
`l-12-cv-00434 DED Apr. 6, 2012
`
`Technologies Inc.
`
`Concluded
`
`Enzo Life Sciences, Inc. v. Illumina Inc.
`
`l-12-cv-00435 DED Apr. 6, 2012
`
`Concluded
`
`Enzo Life Sciences, Inc. v. Abbott
`
`l-12-cv-00274 DED Mar. 6, 2012
`
`Laboratories et al.
`
`Pending
`
`
`
`- 2 -
`
`
`
`
`
`Caption
`
`Number
`
`Dist.
`
`Filed
`
`Enzo Life Sciences, Inc. v. Becton Dickson
`
`l-12-cv-00275 DED Mar. 6, 2012
`
`and Company et al.
`
`Pending
`
`Enzo Life Sciences, Inc. v. Life Technologies
`
`l-12-cv-00105 DED Jan. 30, 2012
`
`Corporation
`
`Concluded
`
`Enzo Life Sciences, Inc. v. Roche
`
`1-12-CV-00106 DED Jan. 30, 2012
`
`Molecular Systems Inc. et al.
`
`Pending
`
`Petitioner has requested inter partes review 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
`
`of the ’197 Patent in another petition (Case No. IPR2017-00172) filed on November
`
`3, 2016.
`
`C.
`
`Lead and Back-up Counsel; Postal, Hand-Delivery, and Electronic
`Service
`
`Lead counsel is Jamie T. Wisz (Reg. No. 58,429),
`
`Jamie.Wisz@WilmerHale.com, (tel.) (202) 663-6286, (fax) (202) 663-6363.
`
`Backup counsel is Heather Petruzzi (Reg. No. 71,270),
`
`Heather.Petruzzi@WilmerHale.com, (202) 663-6028, (fax) (202) 663-6363.
`
`Petitioner consents to postal and hand-delivery service of all documents at
`
`WILMER CUTLER PICKERING HALE AND DORR LLP, 1875 Pennsylvania
`
`
`
`- 3 -
`
`
`
`
`
`Ave., NW, Washington, DC 20006. Petitioner consents to electronic service of all
`
`documents.
`
`D.
`
`Fee Payment
`
`The required fees are submitted under 37 C.F.R. §§ 42.103(a) and 42.15(a). If
`
`any additional fees are due during this proceeding, the Office may charge such fees
`
`to Deposit Account No. 08-0219.
`
`VII. Statement of Precise Relief Requested
`A. Claims for Which Review Is Requested1
`
`Petitioner requests IPR and cancelation of claims 17, 19, 25, 105/17, 105/19,
`
`106/17, 106/19, 113/17, 113/19, 114/17, 114/19, 116/17, 116/19, 119/17, 119/19,
`
`120/17, 120/19, 128/17, 128/19, 129/17, 129/19, 130/17, 130/19, 131/17, 150,
`
`151,152, 154, 178/25, 180/25, 185/25, 186/25, 187/25, and 189/25 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
`
`
`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 -
`
`
`
`
`
`following prior art references and grounds of unpatentability2:
`
`Prior Art References
`
`Ref. 1:
`
`Falk Fish and Morris Ziff, “A Sensitive Solid Phase
`
`Microradioimmunoassay For Anti-Double Stranded DNA
`
`
`2 Petitioner has included all of the Grounds originally submitted in Hologic Inc. v.
`
`Enzo Life Sciences, Inc., IPR2016-00822 (“the Hologic IPR”) in an effort to
`
`demonstrate that the issues presented herein are the same as those in the Hologic
`
`IPR. As explained further in Petitioner’s Motion for Joinder, filed concurrently with
`
`this Petition, Petitioner is only requesting institution of the Grounds already
`
`instituted in the Hologic IPR: Ground 1 (claims 17, 19, 25, 105, 106, 114, 116, 119,
`
`128, 129, 150, 152, 178, 180, 186, and 187 as anticipated by Fish (Ex. 1006));
`
`Ground 2 (claims 130, 131, 151, 154 as obvious over Fish (Ex. 1006)); Ground 3
`
`(claims 120 and 189 as obvious over Fish (Ex. 1006), Metzgar (Ex. 1009), and Sato
`
`(Ex. 1034)); Ground 4 (claims 113 and 185 as obvious over Fish (Ex. 1006) and
`
`Gilham (Ex. 1019)); Ground 5 (claims 17, 19, 25, 105, 106, 114, 119, 120, 128, 129,
`
`131, 150–152, 178, 180, 186, and 189 as obvious over VPK (Ex. 1008) and Metzgar
`
`(Ex. 1009)); Ground 6 (claims 113, 116, 130, 154, 185, and 187 as obvious over
`
`Noyes (Ex. 1007), VPK (Ex. 1008), Metzgar (Ex. 1009), and Ramachandran (Ex.
`
`1028)).
`
`
`
`- 5 -
`
`
`
`
`
`
`
`Antibodies,” Arthritis and Rheumatism, Vol. 24, No. 3 (March
`
`1981) (“Fish”) (Ex. 1006).
`
`Ref. 2:
`
`Barbara E. Noyes and George R. Stark, “Nucleic Acid
`
`Hydribization Using DNA Covalently Coupled to Cellulose,” Cell,
`
`Vol. 5, 301-310 (July 1975) (“Noyes”) (Ex. 1007).
`
`Ref. 3:
`
`A. C. Van Prooijen-Knegt, et al. “In Situ Hybridization of DNA
`
`Sequences in Human Metaphase Chromosomes Visualized by an
`
`Indirect Fluorescent Immunocytochemical Procedure.”
`
`Experimental Cell Research, vol. 141, 397-407 (October 1982)
`
`(“VPK”) (Ex. 1008).
`
`Ref. 4:
`
`U.S. Patent No. 5,572,892 (patented March 30, 1971) (“Metzgar”)
`
`(Ex. 1009).
`
`Ref. 5:
`
`K. B. Ramachandran and D. D. Perlmutter, “Effects of
`
`Immobilization of the Kinetics of Enzyme-Catalyzed Reactions. I.
`
`Glucose Oxidase in a Recirculation Reactor System,”
`
`Biotechnology and Bioengineering, Vol. XVIII, 669-684 (1976)
`
`(“Ramachandran”) (Ex. 1028).
`
`Ref. 6:
`
`Sato et al., “Cell Surface Charge and Cell Division in Escherichia
`
`coli after X Radiation,” Radiation Research , vol. 87, 646-656
`
`(1981) (“Sato”) (Ex. 1034).
`
`- 6 -
`
`
`
`
`
`
`
`
`
`Ref. 7:
`
`P. T. Gilham, “Immobilized Polynucleotides and Nucleic Acids,”
`
`published in Immobilized Biochemicals and Affinity
`
`Chromatography (R. B. Dunlap (ed.)), 1974 (“Gilham”) (Ex.
`
`1019).
`
`Ground
`
`Grounds of Unpatentability
`
`1
`
`Claims 17, 19, 25, 105/17, 105/19, 106/17, 106/19, 114/17, 114/19,
`
`116/17, 116/19, 119/17, 119/19, 128/17, 128/19, 129/17, 129/19,
`
`131/17, 150,152, 178/25, 180/25, 186/25 and 187/25 are anticipated
`
`2
`
`3
`
`4
`
`5
`
`by Fish under 35 U.S.C. § 102(b).
`
`Claims 130/17, 130/19, 131/17, 151, and 154 are obvious under 35
`
`U.S.C. § 103(a) in view of Fish.
`
`Claims 120/17, 120/19 and 189/25 are obvious under 35 U.S.C. 3 §
`
`103(a) based on Fish in view of Metzgar and further in view of Sato.
`
`Claims 113/17, 113/19 and 185/25 would have been obvious under
`
`35 U.S.C. § 103(a) based on Fish in view of Gilham.
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`Claim 17, 19, 25, 105/17, 105/19, 106/17, 106/19, 114/17, 114/19,
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`119/17, 119/19, 120/17, 120/19, 128/17, 128/19, 129/17, 129/19,
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`131/17, 150, 151, 152, 178/25, 180/25, 186/26, and 189/25 would
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`have been obvious under 35 U.S.C. §103(a) based on VPK in view of
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`Metzgar.
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`6
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`Claims 113/17, 113/19, 116/17, 116/19, 130/17, 130/19, 154, 185/25,
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`and 187/25 are obvious under 35 U.S.C. § 103(a) based on Noyes in
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`view of VPK and further in view of Metzgar and Ramachandran.
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`C.
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`Level of Ordinary Skill in the Art at the Time of the Claimed
`Invention
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`The ’197 Patent has a purported effective filing date of January 27, 1983,
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`based on the filing date of Application No. 06/461,469—the earliest application in
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`the priority chain of the ’197 Patent. A continuation-in-part (CIP) application was
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`purportedly filed on May 9, 1985 (the “1985 CIP Application”). As discussed
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`below, none of the claims of the ’197 Patent challenged in this IPR is entitled to the
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`January 27, 1983 filing date. Petitioner, however, in a great abundance of caution,
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`advances separate grounds in view of both of the 1983 and 1985 dates.
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`The application field for the ’197 patent is nucleic acid chemistry, including
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`techniques for attaching nucleic acids to other moieties like solid supports or labels.
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`A person having ordinary skill in this field (POSITA) as of both the 1983 and the
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`1985 filing dates would have (i) possessed or would have been actively pursuing an
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`advanced degree in organic chemistry and/or biochemistry, (ii) attained at least two
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`years of experience in a chemistry or biochemistry laboratory and would have been
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`familiar with nucleic acid chemistry, and (iii) have been knowledgeable of
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`conventional techniques for attaching nucleic acids to other moieties like solid
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`supports or labels. See Ex. 1002, ¶ 21. This level of skill of the POSITA would have
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`applied to all obviousness analyses in this Petition. Furthermore, all conclusions
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`regarding obviousness apply as of the January 27, 1983, and May 9, 1985 filing
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`dates, as well as one year prior to each date (January 27, 1983, and May 9, 1984).
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`VIII. Summary of the Prosecution History of the ’197 Patent and the State of
`the Art
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`A. Hybridizable Nucleic Acids Bound to Solid Supports
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`As the POSITA would have known, two strands of nucleic acids hybridize to
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`one another through hydrogen bonding between complementary nucleotides (bases)
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`that naturally pair with one another. Ex. 1002, ¶ 24. Under the Watson-Crick base
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`pairing model, the nucleotide “A” pairs with the nucleotide “T” on the opposite
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`strand, and the nucleotide “C” pairs with the nucleotide “G” on the opposite strand.
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`Id. In RNA molecules, “T” is replaced by “U” to form an “A-U” base pair.
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`More than a year before the January 27, 1983, filing date of the first
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`application, multiple techniques were available to the POSITA for binding single
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`stranded nucleic acids in a hybridizable form to many different types of solid
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`supports. Ex. 1002, ¶ 25. Exemplary uses of hybridizable single-stranded nucleic
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`acids bound to solid supports included identifying biological materials in samples
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`and separating biological materials from samples. Ex. 1002, ¶ 25.
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`B.
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`Specification of the ’197 Patent
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`The ’197 Patent describes non-porous solid supports with fixed or
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`immobilized nucleic acids, and systems and arrays comprising such non-porous
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`solid supports. Ex. 1001, at Title and Abstract. The ’197 Patent discusses
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`non-porous solid supports such as “glass, or alternatively, plastic, polystyrene,
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`polyethylene, dextran, polypropylene, and like.” Ex. 1001, at 6:2-6; 12:39-45. The
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`’197 Patent also identifies conventional microtiter well plates as non-porous solid
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`supports to which nucleic acids can be fixed. Id. at 12:54-58. The patent also
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`discusses glass plates having “an array of depressions or wells” (id. at 8:65-9:5), and
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`polystyrene plates (id. at 11:56-58; 12:7-26) as solid supports to which nucleic acids
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`may be bound (fixed or immobilized). Although not required by any of the
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`challenged claims, Patent Owner also argued that the ’197 Patent describes
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`treatment of the solid supports with amine providing compounds, epoxy
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`compounds, and acid solutions to fix or immobilize nucleic acids. Ex. 1011, ¶¶
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`40-41 (providing citations to the application for support); Ex. 1001, at Abstract (note
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`that the Abstract discussing the three groups was not added until November 8, 2005
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`(Ex. 1024, ¶¶ 50, 52)). The ’197 Patent also explains that polynucleotide analyte
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`sequences fixed or immobilized to the solid supports may be hybridized to
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`complementary polynucleotide or oligonucleotide probes. See e.g., Ex. 1001, at
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`5:61-6:9; 6:15-27; 8:65-9:5. Although not required by any of the challenged claims,
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`the hybridizing probe may have a label capable of generating a soluble signal, and
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`hybridization of the probe to the analyte may be detected or quantified using the
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`soluble signal. Id. at 1:23-32; 6:15-32; 8:65-9:12.
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`This Petition will show that the non-porous solid supports and arrays claimed
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`in the ’197 Patent previously had been disclosed in prior art not considered during
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`prosecution of the applications leading to the ’197 Patent, for example, in Fish (Ex.
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`1006), Noyes (Ex. 1007), VPK (Ex. 1008), Gilham (Ex. 1019), Metzgar (Ex. 1009),
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`Ramachandran (Ex. 1028) and Sato (Ex. 1034). Ex. 1002, ¶ 25. The prior art shows
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`every limitation of the challenged claims, including the limitations added to secure
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`allowance of the patent.
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`C.
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`Summary of Prosecution History
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`The challenged claims in this Petition (“the array claims”) had a very long
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`prosecution history. The array claims faced many rounds of office action rejections
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`under 35 U.S.C. § 112. See, e.g., Ex. 1022, pp. 6-9; Ex. 1014, pp. 4-8. However, the
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`array claims did not face prior art based rejections. Id. After Patent Owner
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`submitted multiple expert declarations to overcame the § 112 rejections, the
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`Examiner allowed the claims. See, e.g., Ex. 1003, pp. 95-126 (providing
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`voluminous attorney arguments and referring to expert declaration to overcome
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`§112 rejections); Ex. 1013, pp. 79-85 (referring to the Waldrop, Stavrianopoulos,
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`and Kirtikar declarations for overcoming new matter rejections of the array claims).
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`The Examiner incorrectly failed to recognize prior art that showed arrays comprising
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`non-porous solid supports with nucleic acids attached in a hybridizable form thereto.
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`IX. Claim Construction
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`In an IPR, an unexpired patent’s claims receive the “broadest reasonable
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`construction in light of the specification of the patent in which it appears.” 37 C.F.R.
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`§ 42.100(b). Unless otherwise noted, Petitioner proposes that the claim terms of the
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`’197 Patent be given their ordinary and customary meanings in the art. Petitioner,
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`however, construes the following terms according to the intrinsic evidence and
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`traditional canons of claim construction. Petitioner uses these constructions in its
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`grounds for unpatentability. See 37 C.F.R. § 42.104(b)(4).
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`“Non-Porous Solid Support”
`A.
`All challenged independent claims, i.e., claims, 17, 19, and 25, recite the term
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`“non-porous solid support.” Ex. 1001 (claims). This term should be given its
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`ordinary and customary meaning in the art. And as admitted by the Patent Owner,
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`certain solid supports were known in the art to be non-porous. For example, the ’197
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`patent states that a polynucleotide can be fixed “to a non-porous solid support, such
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`as a conventional microtiter well . . . .” Ex. 1001, at 12:54-61. Similarly, when
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`arguing that its counterpart European patent application disclosed non-porous solid
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`supports—despite failing to mention the word “non-porous”— Patent Owner
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`repeatedly asserted that containers in which reactions take place in solution, such as
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`the disclosed wells, must be non-porous. Ex. 1016, at 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, 7 (The Examiner argued that “a transparent non-porous solid support
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`is embodied by glass slides,” as disclosed by Langer’s in-situ technique (p. 5), and
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`the Patent Owner admitted that Langer et al. disclosed an in-situ hybridization
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`method that was performed on “nonporous solid supports that are transparent or
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`translucent.” (p. 7)). And in its Opening Claim Construction Brief in the related
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`litigations, the Patent Owner noted that “non-porous” is a commonly understood
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`term—citing the Examiner’s understanding “that glass slides are ‘reasonably
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`interpreted as the commonly utilized non-porous microscope type slides which are
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`well known in the art.’” Ex. 1023, pp. 8-9 (citing Ex. 1022 (11-26-2004 Office
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`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 district
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`court construed the term “non-porous” to mean “having no pores.” Ex. 1010, pp.
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`5-7. If adopted here, that construction would not change the conclusions in this
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`Petition, because the prior art applied in this Petition shows conventional microtiter
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`wells and glass slides, which the Patent Owner admits are encompassed by the claim
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`language “non-porous solid support.”
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`B.
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`“Hybridizable form”
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`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 fi