`U.S. Patent No. 7,064,197
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`HOLOGIC, INC.,
`Petitioner
`
`
`v.
`
`
`ENZO LIFE SCIENCES, INC.,
`Patent Owner
`
`__________________
`
`
`Case IPR2016-00820
`
`U.S. Patent No. 7,064,197
`TITLE: SYSTEM, ARRAY AND NON-POROUS SOLID SUPPORT
`COMPRISING FIXED OR IMMOBILIZED NUCLEIC ACIDS
`Issue Date: June 20, 2006
`
`______________
`
`
`
`
`ENZO’S PATENT OWNER PRELIMINARY RESPONSE
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Case IPR2016-00820
`U.S. Patent No. 7,064,197
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`TABLE OF CONTENTS
`
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`Page
`
`II. OVERVIEW OF THE ’197 PATENT ............................................................ 2
`
`III. OVERVIEW OF THE PETITION .................................................................. 4
`
`IV. THE BOARD SHOULD DENY
`INSTITUTION ON ALL
`GROUNDS BECAUSE PETITIONER DID NOT ESTABLISH
`THAT FISH, GILHAM, VPK, NOYES, OR RAMACHANDRAN
`QUALIFY AS A PRINTED PUBLICATION. ............................................... 6
`
`A. A Petitioner Must Make A Threshold Showing In The Petition
`That A Reference Constitutes A Prior Art Printed Publication. ........... 6
`
`B. Neither Attorney Argument, Nor Copyright Dates, Nor Library
`Stamps Can Establish A Threshold Showing Of Public
`Accessibility. ......................................................................................... 7
`
`C.
`
`Petitioner Did Not Make A Threshold Showing Of Public
`Accessibility For Any Of Its Non-Patent References. .......................... 9
`
`V.
`
`THE BOARD SHOULD DENY INSTITUTION ON GROUND 1
`BECAUSE
`PETITIONER DID NOT
`ESTABLISH A
`REASONABLE LIKELIHOOD THAT FISH ANTICIPATES ANY
`OF 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, OR 236. .................................................. 11
`
`A.
`
`Independent Claims 1, 6, 8, 9, 12, 13, 14, 15, And 27 ........................ 11
`
`1.
`
`2.
`
`Fish Does Not Disclose Nucleic Acid Strands Fixed Or
`Immobilized To A Non-Porous Solid Support. ........................ 13
`
`Fish Does Not Expressly Or Inherently Disclose Nucleic
`Acid Strands In Hybridizable Form. ......................................... 14
`
`i.
`
`The Hybridization Described In Diehl Is Wholly
`Inapplicable To Fish. ...................................................... 17
`
`
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`i
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`U.S. Patent No. 7,064,197
`ii.
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`The ’197 Patent Prosecution History Does Not Support
`Petitioner’s Inherency Theory. ....................................... 21
`
`3.
`
`Fish Does Not Disclose A Non-Porous Solid Support. ............ 22
`
`B. 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 ....................................................... 24
`
`VI. THE BOARD SHOULD DENY INSTITUTION ON GROUND 2
`BECAUSE
`PETITIONER DID NOT
`ESTABLISH A
`REASONABLE LIKELIHOOD THAT FISH, STANDING ALONE,
`RENDERS OBVIOUS ANY OF CLAIMS 31, 64, 68, 101, 192, OR
` ............................................................................................................. 26
`195.
`
`A.
`
`Claims 31, 68, And 192 ....................................................................... 27
`
`B.
`
`Claims 64, 101, And 195 ..................................................................... 29
`
`VII. THE BOARD SHOULD DENY INSTITUTION ON GROUND 3
`BECAUSE
`PETITIONER DID NOT
`ESTABLISH A
`REASONABLE LIKELIHOOD THAT FISH IN VIEW OF GILHAM
`RENDERS OBVIOUS ANY OF CLAIMS 38, 78, OR 218. ....................... 31
`
`A.
`
`B.
`
`Petitioner Did Not Establish That Fish In View Of Gilham
`Meets All Of The Limitations Of Claims 38, 78, Or 218. .................. 31
`
`Petitioner Did Not Establish That A POSITA Would Have
`Combined Fish And Gilham Or That A POSITA Would Have
`Had A Reasonable Expectation Of Success. ....................................... 31
`
`VIII. THE BOARD SHOULD DENY INSTITUTION ON GROUND 4
`BECAUSE PETITIONER DID NOT ESTABLISH THAT VPK
`ANTICIPATES ANY OF 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, OR 236. .................................................................................. 36
`
`A.
`
`The Challenged Claims Are Entitled To The Filing Date Of The
`1983 Application. ................................................................................ 37
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`1.
`
`
`
`The 1983 Application’s Examples Of Non-Porous Solid
`Supports Provide Sufficient Written Description For The
`Genus Of “Non-Porous Solid Supports.” ................................. 38
`
`2.
`
`Factually
`On
`Rely
`Arguments
`Petitioner’s
`Distinguishable Cases, Incorrect Statements Of Law, Or
`Both. ........................................................................................ 42
`
`B. VPK Does Not Anticipate Any Challenged Claim. ............................ 44
`
`1.
`
`2.
`
`Independent Claims 1, 6, 8, 9, 12-15, And 27 .......................... 45
`
`Claims 31, 32, 34, 61, 62, 63, 68, 69, 70, 72, 74, 79, 100,
`191, 192, 193, 194, 213, 219, 226, 227, And 236 .................... 47
`
`IX. THE BOARD SHOULD DENY INSTITUTION ON GROUND 5
`BECAUSE PETITIONER DID NOT ESTABLISH THAT VPK IN
`VIEW OF NOYES AND RAMACHANDRAN RENDERS
`OBVIOUS ANY OF CLAIMS 16, 38, 64, 78, 101, 195, 218, 222, OR
` ............................................................................................................. 49
`230.
`
`A.
`
`B.
`
`Petitioner Did Not Establish That Noyes, VPK, And
`Ramachandran Meet All Of The Limitations Of Any
`Challenged Claim. ............................................................................... 49
`
`Petitioner Did Not Establish That A POSITA Would Combine
`VPK, Noyes, And Ramachandran. ...................................................... 51
`
`X.
`
`THE BOARD SHOULD DENY INSTITUTION ON GROUND 6
`BECAUSE PETITIONER DID NOT ESTABLISH THAT VPK IN
`VIEW OF METZGAR RENDERS OBVIOUS ANY OF CLAIMS 33,
`41, 73, 212, 225, OR 233. .............................................................................. 55
`
`XI. THE BOARD SHOULD DENY INSTITUTION ON PETITIONER’S
`REDUNDANT CHALLENGES. .................................................................. 56
`
`XII. CONCLUSION .............................................................................................. 60
`
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`iii
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`Cases
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc.,
`694 F.3d 1312 (Fed. Cir. 2012) ..................................................................... 31, 51
`
`Agilent Techs., Inc. v. Affymetrix, Inc.,
`567 F.3d 1366 (Fed. Cir. 2009) ............................................................................ 15
`
`Apple, Inc. v. DSS Tech. Mgm’t,
`Case IPR2015-00369, Paper 9 (PTAB June 25, 2015) ............................. 8, 10, 36
`
`Bilstad v. Wakalopulos,
`386 F.3d 1116 (Fed. Cir. 2004) ..................................................................... 38, 42
`
`CFMT, Inc. v. Yieldup Int’l. Corp.,
`349 F.3d 1333 (Fed. Cir. 2003) ............................................................... 26, 31, 55
`
`Cisco Sys., Inc. v. Constellation Techs. LLC,
`Case IPR2014-00914, Paper 11 (PTAB Jan. 2, 2015) ........................................... 6
`
`Coalition for Affordable Drugs IV LLC v. Pharmacyclics LLC,
`Case IPR2015-01076, Paper 33 (PTAB Oct. 19, 2015) .................................. 7, 10
`
`Dish Network L.L.C. v. Dragon Intellectual Property, LLC, Case IPR2015-00499,
`Paper 7 (PTAB July 17, 2015) ............................................................................... 9
`
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) .............................................................................. 6
`
`Hartness Int’l Inc. v. Simplimatic Eng’g Co.,
`819 F. 2d 1100 (Fed. Cir. 1987) .................................................................... 24, 46
`
`Hewlett-Packard Co. v. U.S. Philips Corp.,
`Case IPR2015-01505, Paper 15 (PTAB Dec. 16, 2015) ........................................ 7
`
`Hilgraeve, Inc. v. Symantec Corp.,
`271 F. Supp. 2d 964 (E.D. Mich. 2003) .......................................................... 8, 10
`
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`IdeaVillage Prods., Corp. v. Choon’s Design, LLC,
`Case IPR2015-01143, Paper 6 (PTAB Nov. 9, 2015) ..................................... 8, 10
`
`In re Fine,
`837 F.2d 1071 (Fed. Cir. 1988) ............................................................... 26, 31, 55
`
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ................................................................. 30, 32, 54
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) .............................................................................. 51
`
`In re Lister,
`583 F.3d 1307, (Fed. Cir. 2009) ...................................................................... 8, 10
`
`In re Oelrich,
`666 F.2d 578 (CCPA 1981) .................................................................................. 15
`
`In re Rasmussen,
`650 F.2d 1212 (CCPA 1981) ................................................................................ 38
`
`In re Ratti,
`270 F.2d 810 (CCPA 1959) ..................................................................... 30, 33, 54
`
`In re Smythe,
`480 F.2d 1376 (CCPA 1973) ......................................................................... 38, 41
`
`Kinetic Techs., Inc. v. Skyworks Solutions, Inc.,
`Case IPR2014-00529, Paper 8 (PTAB Sept. 23, 2014) ................................ 51, 52
`
`KSR Int’l Co. v. Teleflex, Inc.,
` 550 U.S. 398 (2007) ..................................................................................... 29, 31
`
`Lampi Corp. v. American Power Prods., Inc.,
`228 F.3d 1365 (Fed. Cir. 2000) ..................................................................... 37, 44
`
`Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co.,
`Case CBM2012-00003, Paper 7 (PTAB Oct. 25, 2012) ............................... 56, 58
`
`LizardTech v. Earth Resource Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005) ............................................................................ 42
`
`
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`v
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`Lockwood v. Am. Airlines, Inc., 107 F.3d 1565 (Fed. Cir. 1997) ............................ 37
`
`Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363 (Fed. Cir. 2009) 37, 42
`
`Par Pharm., Inc. v. TWI Pharms., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) ............................................................... 26, 31, 55
`
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000) ............................................................................ 42
`
`Ralston Purina Co. v. Far-Mar-Co, Inc.,
`777 F.2d 1570 (Fed. Cir. 1985) ............................................................................ 37
`
`ServiceNow, Inc. v. Hewlett-Packard Co., Case IPR2015-00707, Paper 14 (PTAB
`Nov. 2, 2015) .......................................................................................................... 8
`
`Standard Innovation Corp. v. Lelo, Inc.,
`Case IPR2014-00148, Paper 41 (PTAB Apr. 23, 2015) ................................. 8, 10
`
`Tech. Licensing Corp. v. Videotek, Inc.,
`545 F.3d 1316 (Fed. Cir. 2008) ............................................................................ 43
`
`TriVascular, Inc. v. Samuels,
` 812 F.3d 1056 (Fed. Cir. 2016) ........................................................................... 52
`
`Tronzo v. Biomet,
`156 F.3d 1154 (Fed. Cir. 1998) ............................................................................ 43
`
`TRW Automotive US LLC v. Magna Elecs. Inc.,
`Case IPR2015-00960, Paper 9 (PTAB Oct. 5, 2015) .................................. 7, 8, 10
`
`Ultratec, Inc. v. Sorenson Commc’ns, Inc.,
`Case IPR2013-00288, Paper 23 (PTAB Jan. 10, 2014). ...................................... 57
`
`Verdegaal Bros. v. Union Oil Co. of California,
`814 F.2d 631 (Fed. Cir. 1987) ................................................................. 11, 44, 46
`
`Wright Medical Tech., Inc. v. Biomedical Enterprises, Inc.,
` Case IPR2015-00786, Paper 7 (PTAB Aug. 10, 2015) .................................. 8, 10
`
`
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`U.S. Patent No. 7,064,197
`Statutes
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`
`
`35 U.S.C. § 311 .......................................................................................................... 6
`
`Regulations
`
`37 C.F.R. § 42.1(b) .................................................................................................. 57
`
`37 C.F.R. § 42.62(a) ................................................................................................... 8
`
`Rules
`
`Fed. R. Evid. 801 ....................................................................................................... 8
`
`Fed. R. Evid. 802 ....................................................................................................... 8
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`Case IPR2016-00820
`U.S. Patent No. 7,064,197
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`
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`Enzo
`Exhibit No.
`2001
`2002
`
`2003
`2004
`
`2005
`
`PATENT OWNER’S EXHIBIT LIST
`
`DESCRIPTION
`
`Declaration of Gregory Buck, Ph.D.
`Declaration of Dollie M.W. Kirtikar, Ph.D., submitted in U.S.
`Patent App. No. 08/486,070 (Oct. 28, 2003).
`Robberson, D. L. and Davidson, N., Biochemistry 11, 533 (1972).
`Schott, Herbert, “Special Methods for the Immobilization of RNA
`and Polyribonucleotides,” in Affinity Chromatography,
`Chromatographic Science Series, Vol. 27 (allegedly 1984).
`Petitioner’s Petition for Inter Partes Review of U.S. Patent No.
`7,064,197 in Case IPR2016-00822.
`
`
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`viii
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`U.S. Patent No. 7,064,197
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`I.
`
`INTRODUCTION
`
`
`
`Patent Owner Enzo Life Sciences, Inc. (“Enzo” or “Patent Owner”) submits
`
`this preliminary response to the petition (Paper 1, the “Petition”) filed on March
`
`30, 2016 by Hologic, Inc. (“Hologic” or “Petitioner”). The Petition challenges
`
`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 (collectively, “the challenged claims”) of
`
`U.S. Patent No. 7,064,197 (Ex. 1001, “the ’197 Patent”) on six grounds of alleged
`
`unpatentability.
`
`Enzo respectfully requests that the Board deny institution. Petitioner did not
`
`carry its burden to establish that any of the non-patent references on which it relies
`
`qualify as “printed publications.” Without those references, Petitioner cannot
`
`prevail on any of its six grounds.
`
`Even if the Board treats all of Petitioner’s references as prior art, Petitioner
`
`still cannot prevail on any of its six grounds. Petitioner’s anticipation and
`
`obviousness challenges fail because Petitioner’s alleged prior art, alone or in
`
`combination, does not meet all the limitations of any challenged claim.
`
`Petitioner’s obviousness grounds also fail to establish a reason to combine or
`
`modify references the way that Petitioner proposes. The declaration testimony of
`
`Gregory Buck, Ph.D., a professor and research scientist with more than thirty-five
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`years of experience in molecular biology and nucleic acid detection (Ex. 2001
`
`¶¶ 7-24), confirms that the claims are patentable over Petitioner’s alleged prior art.
`
`Accordingly, the Board should deny institution on all grounds. However,
`
`should the Board institute trial, the Board should not institute trial on Petitioner’s
`
`numerous redundant challenges.
`
`II. OVERVIEW OF THE ’197 PATENT
`
`The ’197 Patent generally relates to novel and non-obvious techniques for
`
`nucleic acid detection involving non-porous solid supports. Nucleotide sequences
`
`can be attached to non-porous solid supports in hybridizable form for use in
`
`hybridization detection tests. (Ex. 1001, at 6:23-32, 8:37-60, 9:22-30, 11:25-39.)
`
`Non-radioactive labels or signaling moieties can be used to identify hybridized
`
`nucleic acid strands that indicate the presence of a nucleic acid of interest from a
`
`sample. (Ex. 1001, at 6:15-48, 7:35-49.) Among other applications, the
`
`techniques of the ’197 Patent can be used for detecting a pathogen or diagnosing a
`
`disease by detecting the presence or quantity of certain genetic material, such as
`
`nucleotide sequences or genes from a sample. (Ex. 1001, at 1:27-32, 5:40-44,
`
`5:60-6:9, 6:23-32.)
`
`Traditionally, solid support hybridization assays were composed of porous
`
`materials, such as filters and membranes, and used radioactive signaling
`
`techniques. (Ex. 1001, at 6:23-32.) The use of porous supports had several
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`disadvantages. For example, nucleic acids immobilized in the pores of the support
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`were less accessible due to the means of fixation and as a result, less amenable to
`
`hybridization. (Ex. 2001 ¶ 45.) In addition, porous supports caused noise due to
`
`the difficulty in washing unhybridized nucleic acids from the pores of the supports.
`
`(Ex. 2001 ¶ 45.) The use of radioactive labels or signaling moieties involved a
`
`complicated and time-consuming process of exposing photographic film to a gel or
`
`filter containing radioactively-labeled nucleic acids in a dark room for several
`
`hours or sometimes even days. (Ex. 2001 ¶ 56.)
`
`The use of non-porous solid supports resulted in quicker and more effective
`
`hybridization assays. (Ex. 2001 ¶¶ 50-52.) For example, non-porous solid
`
`supports require fewer washing steps and facilitate more effective hybridization
`
`because the unhybridized labeled nucleic acids do not need to diffuse in and out of
`
`the pores of a filter or other porous membrane. (Ex. 2001 ¶¶ 50-51.) And, the use
`
`of non-porous solid supports along with non-radioactive labels facilitated
`
`automation and large scale commercial use based upon more rapid reaction times;
`
`the accessibility of the nucleic acids on the surface of the support; and the ability to
`
`detect the non-radioactive labels using equipment, such as scanners, that provide
`
`results in real-time or very close to real-time. (Ex. 2001 ¶ 52.)
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`III. OVERVIEW OF THE PETITION
`
`The Petition presents six grounds of alleged unpatentability, spanning 69
`
`claims. Those grounds are:
`
`- Ground 1: 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, 41/1, 61/1, 62/1, 63/1, 68, 69, 70, 72/6, 72/8,
`
`72/9, 73/6, 73/8, 73/9, 74/6, 74/8, 74/9, 79/6, 79/8, 79/9, 100/6, 100/9, 191,
`
`192, 193, 194, 212/27, 213/27, 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 are allegedly anticipated by Falk Fish and Morris Ziff, “A Sensitive
`
`Solid Phase Microradioimmunoassay For Anti-Double Stranded DNA
`
`Antibodies,” Arthritis and Rheumatism, Vol. 24, No.3 (March 1981) (Ex.
`
`1006, “Fish”);
`
`- Ground 2: Claims 31, 64/1, 68, 101/6, 101/9, 192, and 195 are allegedly
`
`obvious over Fish, standing alone;
`
`- Ground 3: Claims 38/1, 78/6, 78/8, and 218/27 are allegedly obvious over
`
`Fish in view of P. T. Gilham, “Immobilized Polynucleotides and Nucleic
`
`Acids,” Immobilized Biochemicals and Affinity Chromatography (R. B.
`
`Dunlap (ed.)), 1974 (Ex. 1019, “Gilham”);
`
`- Ground 4: Claims 1, 6, 8, 9, 12, 13, 14, 15, 27, 31, 32/1, 34/1, 61/1, 62/1
`
`63/1, 68, 69, 70, 72/6, 72/8, 72/9, 74/6, 74/8, 74/9, 79/6, 79/8, 79/9, 100/6,
`
`4
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`100/9, 191, 192, 193, 194, 213/27, 219/27, 226/12, 226/13, 226/14, 226/15,
`
`227/8, 227/9, and 236/1 are allegedly anticipated by 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) (Ex.
`
`1008, “VPK”);
`
`- Ground 5: Claims 16/1, 16/12, 16/13, 16/1 4, 16/15 , 38/1, 64/1, 78/6, 78/8,
`
`101/6, 101/9, 195, 218/27, 222/27, 230/6, 230/8, and 230/9 are allegedly
`
`obvious over VPK in view of Barbara E. Noyes and George R. Stark,
`
`“Nucleic Acid Hybridization Using DNA Covalently Coupled to Cellulose,”
`
`Cell, Vol. 5, 301-310 (July 1975) (Ex. 1007; “Noyes”) in further view of 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) (Ex. 1028, “Ramachandran”); and
`
`- Ground 6: Claims 33/1, 41/1, 73/6, 73/8, 73/9, 212/27, 225/27, 233/6, 233/8
`
`are allegedly obvious over VPK in view of U.S. Patent No. 5,572,892 to
`
`Metzgar (Ex. 1009, “Metzgar”).1
`
`
`1 Enzo expressly denies that Petitioner has established that Fish, Gilham, VPK,
`
`Noyes, and Ramachandran were publicly accessible as of the dates that Petitioner
`
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`IV. THE BOARD SHOULD DENY INSTITUTION ON ALL GROUNDS
`BECAUSE PETITIONER DID NOT ESTABLISH THAT FISH,
`GILHAM, VPK, NOYES, OR RAMACHANDRAN QUALIFY AS A
`PRINTED PUBLICATION.
`
`Petitioner did not establish
`
`that Fish, Gilham, VPK, Noyes, and
`
`Ramachandran (collectively, “Non-Patent References”) were publicly accessible
`
`printed publications. Petitioner failed to present any evidence of those references’
`
`public accessibility, relying instead on unsupported attorney argument, copyright
`
`notices, and/or library stamps—none of which are legally sufficient to establish
`
`public accessibility. Because each of Petitioner’s six grounds relies on one or
`
`more of the Non-Patent References—with Fish or VPK serving as a primary
`
`reference for all grounds—and because Petitioner has not made a threshold
`
`showing that any of those references was publicly accessible, the Board should
`
`deny institution.
`
`A. A Petitioner Must Make A Threshold Showing In The Petition
`That A Reference Constitutes A Prior Art Printed Publication.
`
`“A petitioner has the burden of proof to establish that a reference that serves
`
`as the basis of a ground of unpatentability asserted in an inter partes review
`
`qualifies as prior art.” Cisco Sys., Inc. v. Constellation Techs. LLC, Case IPR2014-
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`
`attributes to those references, as set forth in Section IV, below. Enzo only
`
`reproduces those dates here for consistent reference to Petitioner’s long-form
`
`citations.
`
`6
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`
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`Case IPR2016-00820
`U.S. Patent No. 7,064,197
`
`
`
`00914, Paper 11, at 23 (PTAB Jan. 2, 2015); see also 35 U.S.C. § 311(b); Dynamic
`
`Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1379-80 (Fed. Cir. 2015);
`
`Coalition for Affordable Drugs IV LLC v. Pharmacyclics LLC, Case IPR2015-
`
`01076, Paper 33, at 5-6 (PTAB Oct. 19, 2015). For each non-patent reference it
`
`asserts, the petitioner must provide admissible evidence to “make a threshold
`
`showing that the reference is a prior art ‘printed publication.’” Coalition for
`
`Affordable Drugs IV, Case IPR2015-01076, Paper 33, at 6 (internal quotations and
`
`citations omitted); Hewlett-Packard Co. v. U.S. Philips Corp., Case IPR2015-
`
`01505, Paper 15, at 3 (PTAB Dec. 16, 2015). Petitioner has failed to make a
`
`threshold showing of public accessibility for any of its Non-Patent References.
`
`B. Neither Attorney Argument, Nor Copyright Dates, Nor Library
`Stamps Can Establish A Threshold Showing Of Public
`Accessibility.
`
`Unsupported attorney argument cannot establish a threshold showing of
`
`public accessibility. Coalition for Affordable Drugs IV, Case IPR2015-01076,
`
`Paper 33, at 6-7 (holding that bare assertions that a reference was published,
`
`without supporting evidence, is insufficient to establish public accessibility); TRW
`
`Automotive US LLC v. Magna Elecs. Inc., Case IPR2015-00960, Paper 9, at 17-20
`
`(PTAB Oct. 5, 2015) (holding that bare assertions of publication coupled with
`
`copyright dates are insufficient to establish public accessibility). Nor can a
`
`reference’s copyright date, which is inadmissible hearsay when offered to prove
`
`7
`
`
`
`Case IPR2016-00820
`U.S. Patent No. 7,064,197
`
`
`
`the reference’s alleged creation or publication date, provide a threshold showing of
`
`public accessibility. 37 C.F.R. § 42.62(a) (explaining that Federal Rules of
`
`Evidence govern, inter alia, evidence admissibility in inter partes reviews); Fed.
`
`R. Evid. 801; Fed. R. Evid. 802; Standard Innovation Corp. v. Lelo, Inc., Case
`
`IPR2014-00148, Paper 41, at 13-17 (PTAB Apr. 23, 2015); Hilgraeve, Inc. v.
`
`Symantec Corp., 271 F. Supp. 2d 964, 974 (E.D. Mich. 2003) (“[T]he dates
`
`imprinted on these documents are hearsay when offered to prove the truth of the
`
`matter asserted, that is, that [the product] was accessible to the public as of the date
`
`set forth on the documents.”). Even if treated as admissible evidence, a reference’s
`
`copyright date, without more, is still insufficient to establish public accessibility.
`
`In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009); IdeaVillage Prods., Corp. v.
`
`Choon’s Design, LLC, Case IPR2015-01143, Paper 6, at 18 (PTAB Nov. 9, 2015);
`
`TRW Automotive, Case IPR2015-00960, Paper 9, at 17-20; Wright Medical Tech.,
`
`Inc. v. Biomedical Enterprises, Inc., Case IPR2015-00786, Paper 7, at 9-10 (PTAB
`
`Aug. 10, 2015); see also ServiceNow, Inc. v. Hewlett-Packard Co., Case IPR2015-
`
`00707, Paper 14, at 9-10 (PTAB Nov. 2, 2015) (“Specifically, on this record, we
`
`were not persuaded that the copyright notices are entitled to any greater weight
`
`than that afforded to hearsay in determining public accessibility.”).
`
`A library date stamp on a reference is also insufficient to make a threshold
`
`showing of public accessibility. Like a copyright date on a reference, a library date
`
`8
`
`
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`Case IPR2016-00820
`U.S. Patent No. 7,064,197
`
`
`
`stamp is inadmissible hearsay when offered to prove a reference’s alleged public
`
`accessibility. Apple, Inc. v. DSS Tech. Mgm’t, Case IPR2015-00369, Paper 9, at 12
`
`(PTAB June 25, 2015) (holding that a stamped legend indicating a thesis’s archival
`
`date was hearsay inadmissible to prove the truth of that archival date). And even if
`
`treated as admissible evidence, an uncorroborated library date stamp is still
`
`insufficient to establish public accessibility. Id. (“the stamp does not establish
`
`when, if ever, the thesis became publicly accessible”); Dish Network L.L.C. v.
`
`Dragon Intellectual Property, LLC, Case IPR2015-00499, Paper 7, at 10-11
`
`(PTAB July 17, 2015).
`
`C.
`
`Petitioner Did Not Make A Threshold Showing Of Public
`Accessibility For Any Of Its Non-Patent References.
`
`Petitioner failed to make a threshold showing of public accessibility for the
`
`Non-Patent References. For each Non-Patent Reference, Petitioner provided only
`
`attorney argument in support of the reference’s alleged public accessibility:
`
`Reference
`
`Petition
`
`Fish (Ex. 1006) “Fish was published March 1981 (Ex. 1006).” (Petition at 15.)
`
`Gilham
`1019)
`
`
`
`(Ex.
`
`“Since Gilham was published in 1974 . . . .” (Id. at 37.)
`
`VPK (Ex. 1008) “Therefore, VPK, which was published in 1982 . . . .” (Id. at 40.)
`
`Noyes
`1007)
`
`(Ex.
`
`“Since Noyes was published in July 1975 . . . .” (Id. at 52.)
`
`9
`
`
`
`Case IPR2016-00820
`U.S. Patent No. 7,064,197
`
`Reference
`
`Ramachandran
`(Ex. 1028)
`
`
`
`Petition
`
`“Ramachandran was published in 1976 . . . .” (Id.)
`
`
`Petitioner failed to provide any factual support for the purported publication dates
`
`of the Non-Patent References advanced in the Petition. Those uncorroborated
`
`conclusory allegations are legally insufficient to establish the public accessibility
`
`of any of those references. Coalition for Affordable Drugs IV, Case IPR2015-
`
`01076, Paper 33, at 6-7; TRW Automotive, Paper 9, at 17-20. And should
`
`Petitioner subsequently attempt to rely on the copyright dates and/or library stamps
`
`in the Non-Patent References as proof of public accessibility, those dates are
`
`inadmissible hearsay, and are therefore legally insufficient to establish public
`
`accessibility. Standard Innovation, Case IPR2014-00148, Paper 41, at 13-17
`
`(copyright dates are inadmissible hearsay); Hilgraeve, 271 F. Supp. 2d at 974 (E.D.
`
`Mich. 2003) (same); see also In re Lister, 583 F.3d at 1311 (copyright date
`
`standing alone is insufficient to establish public accessibility); IdeaVillage Prods.,
`
`Case IPR2015-01143, Paper 6, at 18; TRW Automotive, Case IPR2015-00960,
`
`Paper 9, at 17-20; Wright Medical Tech., Case IPR2015-00786, Paper 7, at 9-10;
`
`Apple, Case IPR2016-00369, Paper 9, at 12 (library stamp fails to provide
`
`threshold showing of public accessibility). Moreover, Petitioner made no attempt
`
`to link any library date stamps to any alleged date of public accessibility. See
`
`10
`
`
`
`Case IPR2016-00820
`U.S. Patent No. 7,064,197
`
`
`
`Apple, Case IPR2016-00369, Paper 9, at 12 (“the stamp does not establish when, if
`
`ever, the thesis became publicly accessible”).
`
`Because Petitioner has not made the required threshold showing that any of
`
`the Non-Patent References were publicly accessible prior to any priority date of the
`
`’197 Patent—one or more of which Petitioner relied on in each ground—the Board
`
`should deny institution on all six grounds.
`
`V. THE BOARD SHOULD DENY INSTITUTION ON GROUND 1
`BECAUSE PETITIONER DID NOT ESTABLISH A REASONABLE
`LIKELIHOOD THAT FISH ANTICIPATES ANY OF 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,
`OR 236.
`
`The standard for anticipation is exacting: a “claim is anticipated only if each
`
`and every element as set forth in the claim is found, either expressly or inherently
`
`described, in a single prior art reference.” Verdegaal Bros. v. Union Oil Co. of
`
`California, 814 F.2d 628, 631 (Fed. Cir. 1987). Fish cannot anticipate the
`
`challenged claims because it does not disclose all of their limitations.
`
`A.
`
`Independent Claims 1, 6, 8, 9, 12, 13, 14, 15, And 27
`
`The ’197 Patent discloses
`
`techniques for conducting nucleic acid
`
`hybridization detection assays. The invention of the ’197 Patent involves the
`
`detection of nucleic acids through the hybridization of nucleic acid strands fixed to
`
`non-porous solid supports to other nucleic acid sequences with non-radioactive
`
`signaling moieties affixed to the resulting double-stranded nucleic acids.
`
`11
`
`
`
`Case IPR2016-00820
`U.S. Patent No. 7,064,197
`
`
`
`The challenged independent claims are directed to nucleic acid strands that
`
`are fixed to non-porous solid supports in hybridizable form, meaning that they are
`
`capable of binding through Watson-Crick base pairing to a complementary nucleic
`
`acid sequence. (See Petition at 14 (citing Ex. 1010, at 10).) In particular, among
`
`other limitations, each of claims 1, 6, 8, 9, 12, 13, 14, 15, and 27 (“the challenged
`
`independent claims”) require that a nucleic acid strand2 be “fixed or immobilized”
`
`to a “non-porous solid support” in “hybridizable form.”
`
`Fish, on the other hand, does not involve or disclose a nucleic acid
`
`hybridization
`
`detection
`
`assay.
`
`
`
`Fish
`
`purportedly
`
`describes
`
`a
`
`microradioimmunoassay for detecting antibodies of systemic lupus erythematosus
`
`(“SLE”) patients by binding radioactively-labeled antibodies to double-stranded
`
`DNA. (Ex. 1006, at 534.) Unlike the nucleic acid hybridization detection methods
`
`of the ’197 Patent, Fish’s approach for detecting antibodies does not involve or
`
`describe hybridization of nucleic acids. Further, Fish’s experimental data does not
`
`support the alleged disclosures relied upon by Petitioner. For example, as
`
`
`2 The term “nucleic acid strands” as used herein collectively refers to the following
`
`limitations of the challenged