Case IPR2016-00822
`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 IPR2016-00822
`
`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 IPR2016-00822
`U.S. Patent No. 7,064,197
`
`
`
`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,
`SATO, 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 17, 19, 25, 105, 106, 114, 116, 119, 128, 129, 150, 152,
`178, 180, 186, OR 187. .................................................................................. 11
`
`A.
`
`Independent Claims 17, 19, And 25 .................................................... 11
`
`1.
`
`2.
`
`Fish Does Not Disclose Nucleic Acid Strands Fixed Or
`Immobilized To A Non-Porous Solid Support. ........................ 12
`
`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. ...................................................... 16
`
`
`
`i
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`ii.
`
`
`
`The ‘197 Patent Prosecution History Does Not Support
`Petitioner’s Inherency Theory. ....................................... 20
`
`3.
`
`4.
`
`Fish Does Not Disclose An “Array.” ........................................ 22
`
`Fish Does Not Disclose “A Non-Porous Solid Support.”......... 22
`
`B. Dependent Claims 105, 106, 114, 116, 119, 128, 129, 150, 152,
`178, 180, 186, And 187 ....................................................................... 23
`
`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 130, 131, 151, OR 154. ........... 26
`
`VII. THE BOARD SHOULD DENY INSTITUTION ON GROUND 3
`BECAUSE
`PETITIONER DID NOT
`ESTABLISH A
`REASONABLE LIKELIHOOD THAT FISH
`IN VIEW OF
`METZGAR AND SATO RENDERS OBVIOUS CLAIM 120 OR
`CLAIM 189. .................................................................................................. 30
`
`A.
`
`B.
`
`Petitioner Did Not Establish That Fish In View Of Metzgar
`And Sato Meets All Of The Limitations Of Claims 120 Or 189. ....... 30
`
`Petitioner Did Not Establish That A POSITA Would Have
`Combined Fish, Metzgar, And Sato 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 A
`REASONABLE LIKELIHOOD THAT FISH IN VIEW OF GILHAM
`RENDERS OBVIOUS CLAIM 113 OR CLAIM 185. ................................. 35
`
`A.
`
`B.
`
`Petitioner Did Not Establish That Fish In View Of Gilham
`Meets All Of The Limitations Of Claims 113 Or 185. ....................... 35
`
`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. ....................................... 36
`
`
`
`ii
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`

`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`
`IX. THE BOARD SHOULD DENY INSTITUTION ON GROUND 5
`BECAUSE PETITIONER DID NOT ESTABLISH THAT VPK IN
`VIEW OF METZGAR RENDERS OBVIOUS ANY OF CLAIMS 17,
`19, 25, 105, 106, 114, 119, 120, 128, 129, 131, 150, 151, 152, 178,
`180, 186, OR 189. .......................................................................................... 40
`
`A.
`
`The Challenged Claims Are Entitled To The Filing Date Of The
`1983 Application. ................................................................................ 41
`
`1.
`
`2.
`
`The 1983 Application’s Examples Of Non-Porous Solid
`Supports Provide Sufficient Written Description For The
`Genus Of “Non-Porous Solid Supports.” ................................. 42
`
`Factually
`On
`Rely
`Arguments
`Petitioner’s
`Distinguishable Cases, Incorrect Statements Of Law, Or
`Both. 46
`
`B. VPK In View Of Metzgar Does Not Render Obvious Any
`Challenged Claim. ............................................................................... 49
`
`1.
`
`VPK In View Of Metzgar Does Not Teach, Suggest, Or
`Disclose Every Limitation Of Any Challenged Claim. ............ 49
`
`i.
`
`ii.
`
`Independent Claims 17, 19, And 25 ............................... 49
`
`Dependent Claims 105, 106, 114, 119, 120, 128, 129,
`131, 150, 151, 152, 178, 180, 186, And 189 .................. 50
`
`2.
`
`Petitioner Did Not Establish A Reason To Combine VPK
`And Metzgar. ............................................................................ 52
`
`X.
`
`THE BOARD SHOULD DENY INSTITUTION ON GROUND 6
`BECAUSE PETITIONER DID NOT ESTABLISH THAT VPK IN
`VIEW OF NOYES, METZGAR, AND RAMACHANDRAN
`RENDERS OBVIOUS ANY OF CLAIMS 113, 116, 130, 154, 185,
`OR 187. .......................................................................................................... 53
`
`A.
`
`Petitioner Did Not Establish That The Combination Of Noyes,
`VPK, Metzgar, And Ramachandran Meets All Limitations Of
`The Challenged Claims. ...................................................................... 53
`
`
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`B.
`
`
`
`Petitioner Did Not Establish A Reason To Combine VPK,
`Metzgar, Noyes, And Ramachandran. ................................................ 55
`
`XI. THE BOARD SHOULD DENY INSTITUTION ON PETITIONER’S
`REDUNDANT CHALLENGES. .................................................................. 58
`
`XII. CONCLUSION .............................................................................................. 61
`
`
`
`
`
`
`
`
`
`iv
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`

`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc.,
`694 F.3d 1312 (Fed. Cir. 2012) ............................................................................ 32
`
`Agilent Techs., Inc. v. Affymetrix, Inc.,
`567 F.3d 1366 (Fed. Cir. 2009) ............................................................................ 14
`
`Apple, Inc. v. DSS Tech. Mgm’t,
`Case IPR2015-00369, Paper 9 (PTAB June 25, 2015) ............................. 9, 10, 41
`
`Bilstad v. Wakalopulos,
`386 F.3d 1116 (Fed. Cir. 2004) ..................................................................... 43, 47
`
`CFMT, Inc. v. Yieldup Int’l. Corp.,
`349 F.3d 1333 (Fed. Cir. 2003) ......................................................... 26, 31, 36, 50
`
`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) .............................................................................. 7
`
`Hartness Int’l Inc. v. Simplimatic Eng’g Co.,
`819 F. 2d 1100 (Fed. Cir. 1987) ........................................................................... 24
`
`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
`
`
`
`v
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`

`

`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`
`
`
`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) .................................................................... passim
`
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ................................................................. 30, 38, 57
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) .............................................................................. 33
`
`In re Lister,
`583 F.3d 1307, (Fed. Cir. 2009) ...................................................................... 8, 10
`
`In re Oelrich,
`666 F.2d 578 (CCPA 1981) .................................................................................. 14
`
`In re Rasmussen,
`650 F.2d 1212 (CCPA 1981) ................................................................................ 43
`
`In re Ratti,
`270 F.2d 810 (CCPA 1959) ..................................................................... 30, 38, 57
`
`In re Smythe,
`480 F.2d 1376 (CCPA 1973) ......................................................................... 43, 46
`
`Kinetic Techs., Inc. v. Skyworks Solutions, Inc.,
`Case IPR2014-00529, Paper 8 (PTAB Sept. 23, 2014) .......................... 33, 52, 57
`
`KSR Int’l Co. v. Teleflex, Inc.,
` 550 U.S. 398 (2007) ......................................................................... 29, 32, 34, 36
`
`Lampi Corp. v. American Power Prods., Inc.,
`228 F.3d 1365 (Fed. Cir. 2000) ..................................................................... 42, 49
`
`Liberty Mut. Ins. Co. v. Progressive Cas. Inc.,
`Case CBM2012-00003, Paper 7 (PTAB Oct. 25, 2012) ............................... 59, 60
`
`LizardTech v. Earth Resource Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005) ............................................................................ 47
`
`
`
`vi
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`U.S. Patent No. 7,064,197
`
`
`
`Lockwood v. Am. Airlines, Inc.,
`107 F.3d 1565 (Fed. Cir. 1997) ............................................................................ 42
`
`Martek Biosciences Corp. v. Nutrinova, Inc.,
` 579 F.3d 1363, 1369 (Fed. Cir. 2009) ........................................................... 42, 47
`
`Par Pharm., Inc. v. TWI Pharms., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) ......................................................... 26, 31, 36, 50
`
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000) ............................................................................ 47
`
`Ralston Purina Co. v. Far-Mar-Co, Inc.,
`777 F.2d 1570 (Fed. Cir. 1985) ............................................................................ 42
`
`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) ............................................................................ 48
`
`TriVascular, Inc. v. Samuels,
` 812 F.3d 1056 (Fed. Cir. 2016) ........................................................................... 57
`
`Tronzo v. Biomet,
`156 F.3d 1154 (Fed. Cir. 1998) ............................................................................ 48
`
`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). ...................................... 60
`
`Verdegaal Bros. v. Union Oil Co. of California,
`814 F.2d 631 (Fed. Cir. 1987) .............................................................................. 11
`
`Wright Medical Tech., Inc. v. Biomedical Enterprises, Inc.,
` Case IPR2015-00786, Paper 7 (PTAB Aug. 10, 2015) .................................. 8, 10
`
`
`
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`

`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`Statutes
`
`
`
`35 U.S.C. § 311 .......................................................................................................... 6
`
`Regulations
`
`37 C.F.R. § 42.1(b) .................................................................................................. 59
`
`37 C.F.R. § 42.62(a) ................................................................................................... 8
`
`Rules
`
`Fed. R. Evid. 801 ....................................................................................................... 8
`
`Fed. R. Evid. 802 ....................................................................................................... 8
`
`
`
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`

`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`
`
`
`Enzo
`Exhibit No.
`2101
`2102
`
`2103
`2104
`
`2105
`
`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 IPR2016-00820.
`
`
`
`
`
`ix
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`

`

`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`
`I.
`
`INTRODUCTION
`
`
`
`Patent Owner Enzo Life Sciences, Inc. (“Enzo” or “Patent Owner”) submits
`
`this preliminary response to the petition (Paper 3, the “Petition”) filed on March
`
`30, 2016 by Hologic, Inc. (“Hologic” or “Petitioner”). The Petition challenges
`
`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 (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
`
`1
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`

`

`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`years of experience in molecular biology and nucleic acid detection (Ex. 2101
`
`¶¶ 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
`
`2
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`disadvantages. For example, nucleic acids immobilized in the pores of the support
`
`were less accessible due to the means of fixation and as a result, less amenable to
`
`hybridization. (Ex. 2101 ¶ 45.) In addition, porous supports caused noise due to
`
`the difficulty in washing unhybridized nucleic acids from the pores of the supports.
`
`(Ex. 2101 ¶ 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. 2101 ¶ 56.)
`
`The use of non-porous solid supports resulted in quicker and more effective
`
`hybridization assays. (Ex. 2101 ¶¶ 50-51.) 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. 2101 ¶¶ 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. 2101 ¶ 52.)
`
`3
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`III. OVERVIEW OF THE PETITION
`
`The Petition presents six grounds of alleged unpatentability, spanning 34
`
`claims. Those grounds are:
`
`- Ground 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,
`
`150, 152, 178/25, 180/25, 186/25, and 187/25 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 130/17, 130/19, 131/17, 151, and 154 are allegedly
`
`obvious over Fish, standing alone;
`
`- Ground 3: Claims 120/17, 120/19, and 189/25 are allegedly obvious over
`
`Fish in view of U.S. Patent No. 3,572,892 to Metzgar (Ex. 1009, “Metzgar”)
`
`in further view of Sato et al., “Cell Surface Charge and Cell Division in
`
`Escherichia coli after X radiation.” Radiation Research 87, 646-656 (1981)
`
`(Ex. 1034, “Sato”);
`
`- Ground 4: Claims 113/17, 113/19, and 185/25 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”);
`
`4
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`
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`- Ground 5: Claims 17, 19, 25, 105/17, 105/19, 106/17, 106/19, 114/17,
`
`114/19, 119/17, 119/19, 120/17, 120/19, 128/17, 128/19, 129/17, 129/19,
`
`131/17, 150, 151, 152, 178/25, 180/25, 186/25, and 189/25 are allegedly
`
`obvious over 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”) in view of
`
`Metzgar; and
`
`- Ground 6: Claims 113/17, 113/19, 116/17, 116/19, 130/17, 130/19, 154,
`
`185/25, and 187/25 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 Metzgar, and in further view of 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”).1
`
`
`1 Enzo expressly denies that Petitioner has established that Fish, Sato, Gilham,
`
`VPK, Noyes, and Ramachandran were publicly accessible as of the dates that
`
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`
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`IV. THE BOARD SHOULD DENY INSTITUTION ON ALL GROUNDS
`BECAUSE PETITIONER DID NOT ESTABLISH THAT FISH, SATO,
`GILHAM, VPK, NOYES, OR RAMACHANDRAN QUALIFY AS A
`PRINTED PUBLICATION.
`
`Petitioner did not establish that Fish, Sato, 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. Without the Non-Patent References, which Petitioner relies
`
`on in every ground, Petitioner cannot prevail on any ground. Accordingly, 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-
`
`00914, Paper 11, at 23 (PTAB Jan. 2, 2015); see also 35 U.S.C. § 311(b); Dynamic
`
`
`Petitioner 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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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`
`
`
`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
`
`the reference’s alleged creation or publication date, provide a threshold showing of
`
`7
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`

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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`
`
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`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
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`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
`
`stamp is inadmissible hearsay when offered to prove a reference’s alleged public
`
`8
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`

`

`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`
`
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`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.)
`
`Sato (Ex. 1034)
`
`“Similar, Sato was published in 1981 . . . .” (Id. at 34-35.)
`
`Gilham
`1019)
`
`
`
`(Ex.
`
`“Since Gilham was published in 1974 . . . .” (Id. at 36.)
`
`VPK (Ex. 1008) “Therefore, VPK, which was published in 1982 . . . .” (Id. at 39.)
`
`Noyes
`1007)
`
`(Ex.
`
`“Since Noyes was published in July 1975 . . . .” (Id. at 53.)
`
`9
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`

`

`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`
`Reference
`
`Ramachandran
`(Ex. 1028)
`
`
`
`Petition
`
`“Ramachandran was published in 1976 . . . .” (Id.at 54.)
`
`
`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-
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`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
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`

`

`Case IPR2016-00822
`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 17, 19,
`25, 105, 106, 114, 116, 119, 128, 129, 150, 152, 178, 180, 186, OR 187.
`
`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 17, 19, And 25
`
`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 13 (citing Ex. 1010, at 10).) In particular, among
`
`other limitations, each of claims 17, 19, and 25 (“the challenged independent
`
`11
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`

`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`
`
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`claims”) require that “an array” of “single-stranded nucleic acids” 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. As explained below, that
`
`data is insufficient for a person of ordinary skill in the art (“POSITA”) to conclude
`
`that nucleic acid strands were actually fixed or immobilized to the plastic supports
`
`used in Fish, let alone in hybridizable form.
`
`As shown below, Fish does not anticipate any of the challenged claims
`
`because it does not disclose (1) nucleic acid strands “fixed or immobilized” (2) in
`
`“hybridizable form,” (3) in an “array” (4) that includes “a non-porous solid
`
`support.”
`