Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`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 REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(d)
`AND SUGGESTION FOR REHEARING BY EXPANDED PANEL
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`

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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`TABLE OF CONTENTS
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`Page
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`I.
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`INTRODUCTION AND RELIEF REQUESTED .......................................... 1
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`II. GOVERNING LAWS, RULES, AND PRECEDENT ................................... 2
`
`III. THE BOARD SHOULD GRANT ENZO’S REQUEST FOR
`REHEARING AND REVERSE THE INSTITUTION DECISION
`BECAUSE PETITIONER FAILED TO ESTABLISH THE PUBLIC
`ACCESSIBILITY OF ITS NON-PATENT REFERENCES. ......................... 3
`
`A.
`
`B.
`
`C.
`
`Enzo Showed In Its Preliminary Response That Petitioner Did
`Not Establish That Its Non-Patent References Were “Printed
`Publications” Because Petitioner Failed To Adduce Admissible
`Evidence Of Public Accessibility. ......................................................... 4
`
`The Institution Decision Was An Abuse Of Discretion Because
`The Federal Rules Of Evidence Were Not Applied. ............................. 5
`
`The Panel Abused Its Discretion By Failing To Hold Petitioner
`To Its Burden Of Establishing The Public Accessibility Of Its
`Non-Patent References And By Adopting Positions That
`Petitioner Did Not Raise. ...................................................................... 7
`
`IV. ENZO RESPECTFULLY SUGGESTS REHEARING BY AN
`EXPANDED PANEL THAT INCLUDES THE CHIEF JUDGE. ...............10
`
`A.
`
`B.
`
`Consideration By An Expanded Panel Is Warranted To Bring
`Uniformity To The Board’s Conflicting Decisions Concerning
`The Standard For Establishing That A Non-Patent Reference Is
`A Publicly Accessible “Printed Publication.” .....................................11
`
`The Evidentiary Standard For Establishing That A Non-Patent
`Reference Is A Publicly Accessible “Printed Publication” Is An
`Issue Of Exceptional Importance, And The Board’s Decision In
`This Proceeding Conflicts With Federal Circuit Precedent. ...............13
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`V.
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`CONCLUSION ..............................................................................................14
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`i
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`TABLE OF AUTHORITIES
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`Cases
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`Page(s)
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`Apple, Inc. v. DSS Tech. Mgm’t, Case IPR2015-00369, Paper 9
`(PTAB June 25, 2015) ............................................................................. 4, 6, 8, 12
`
`Cisco Sys., Inc. v. Constellation Techs. LLC, Case IPR2014-00914, Paper 11
`(PTAB Jan. 2, 2015) ...........................................................................................4, 9
`
`Coalition for Affordable Drugs IV LLC v. Pharmacyclics LLC,
`Case IPR2015-01076, Paper 33 (PTAB Oct. 19, 2015) ......................................... 4
`
`Daicel Corp. v. Celanese Int’l. Corp., Case IPR2015-00173, Paper 15
`(PTAB June 26, 2015) ......................................................................................3, 10
`
`emnos USA Corp. v. Dunnhumby, Ltd., Case CBM2015-00162, Paper 7
`(PTAB Dec. 30, 2015) ..........................................................................................12
`
`Hewlett-Packard Co. v. U.S. Philips Corp., Case IPR2015-01505, Paper 15
`(PTAB Dec. 16, 2015) ......................................................................................4, 14
`
`In re: Magnum Oil Tools Int’l, Ltd., No. 2015-1300, 2016 WL 3974202
`(Fed. Cir. July 25, 2016) .............................................................................. 8, 9, 13
`
`Indoor Skydiving Germany GmbH v. IFLY Holdings LLC, Case IPR2015-01272,
`Paper 14 (PTAB Jan. 5, 2016) ................................................................................ 8
`
`Service v. Dulles, 354 U.S. 363 (1957) ...................................................................... 6
`
`ServiceNow, Inc. v. Hewlett-Packard Co., Case IPR2015-00707, Paper 12
`(PTAB Aug. 26, 2015) .........................................................................................12
`
`Standard Innovation Corp. v. Lelo, Inc., Case IPR2014-00148, Paper 41
`(PTAB Apr. 23, 2015) ............................................................................................ 5
`
`TRW Automotive US LLC v. Magna Elecs. Inc., Case IPR2015-00960, Paper 9
`(PTAB Oct. 5, 2015)...................................................................................... 4, 7, 9
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`Wagner v. United States, 365 F.3d 1358 (Fed. Cir. 2004) ........................................ 5
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`ii
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
`Statutes
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`35 U.S.C. § 311 ................................................................................................. 4, 7, 9
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`Regulations
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`37 C.F.R. § 42.108(c) ................................................................................................. 9
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`37 C.F.R. § 42.2 ......................................................................................................... 6
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`37 C.F.R. § 42.62(a) ...............................................................................................4, 6
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`37 C.F.R. § 42.71(c) ................................................................................................... 3
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`37 C.F.R. § 42.71(d) ..............................................................................................2, 4
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`Rules
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`FED. R. EVID. 801 ....................................................................................................... 4
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`FED. R. EVID. 802 ...................................................................................................4, 6
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`Other Authorities
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`Anish Desai, Christopher Marando, & Amanda Do Couto, PTAB Approaches To
`Accessibility Of Printed Publication, LAW360
`(Oct.
`3,
`2016),
`http://www.law360.com/articles/845934/print?section=ip ..................................11
`
`Michael R. Weiner, APJs Dispute Requirements for a Reference to Qualify as a
`Printed
`Publication,
`PTABWATCH
`(Oct.
`15,
`2015),
`http://www.ptabwatch.com/2015/10/apjs-dispute-requirements-for-a-reference-
`to-qualify-as-a-printed-publication.......................................................................11
`
`Patent Trial and Appeal Board Standard Operating Procedure 1, Rev. 14 .............11
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`All emphases are added unless otherwise noted.
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`iii
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`Enzo
`Exhibit No.
`2101
`2102
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`2103
`2104
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`2105
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`2106
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`2107
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`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.
`Anish Desai, Christopher Marando, & Amanda Do Couto, PTAB
`Approaches To Accessibility Of Printed Publication, LAW360 (Oct.
`3, 2016), http://www.law360.com/articles/845934/print?section=ip.
`Michael R. Weiner, APJs Dispute Requirements for a Reference to
`Qualify as a Printed Publication, PTABWATCH (Oct. 15, 2015),
`http://www.ptabwatch.com/2015/10/apjs-dispute-requirements-for-
`a-reference-to-qualify-as-a-printed-publication.
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`iv
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`I.
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`INTRODUCTION AND RELIEF REQUESTED
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`Patent Owner Enzo Life Sciences, Inc. (“Enzo”) respectfully requests
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`rehearing and reversal of the Panel’s Institution Decision (Paper 8, “Institution
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`Decision”) in this inter partes review of U.S. Patent No. 7,064,197 (“the ’197
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`Patent”). As Enzo explained in its Preliminary Response (Paper 7, “Preliminary
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`Response”), the Petition should have been denied because Petitioner Hologic, Inc.
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`(“Petitioner”) provided no admissible evidence in the Petition that the Non-Patent
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`References1 were publicly accessible “printed publications” prior to the priority
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`date or invention date of the ’197 Patent. Contrary to the Federal Rules of
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`Evidence and Petitioner’s burden of establishing the public accessibility of the
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`Non-Patent References through admissible evidence, the Panel concluded that
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`inadmissible hearsay—the dates printed on those references—sufficed to show
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`public accessibility, an argument Petitioner did not even raise in the Petition. The
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`Institution Decision therefore reflects an abuse of discretion because trial was
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`instituted based on inadmissible evidence, contrary to the Federal Rules of
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`Evidence and USPTO regulations. The Institution Decision was also an abuse of
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`discretion in that it reached arguments that Petitioner never made.
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`1 The “Non-Patent References” are Fish (Ex. 1006), Sato (Ex. 1034), Gilham (Ex.
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`1019), VPK (Ex. 1008), Noyes (Ex. 1007), and Ramachandran (Ex. 1028).
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`(Preliminary Response at 7.)
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`1
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`Enzo respectfully seeks rehearing of this case by an expanded panel that
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`includes the Chief Judge. Rehearing by an expanded panel is warranted to ensure
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`uniform application of the Federal Rules of Evidence to the Board’s institution
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`decisions. The Institution Decision conflicts with several decisions from other
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`panels that have correctly required admissible evidence—more than just a hearsay
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`copyright date, library date stamp, or bare attorney argument—to establish a
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`reference’s public accessibility prior to the filing date or invention date of the
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`subject patent. In addition, rehearing by an expanded panel is also appropriate
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`because the Institution Decision conflicts with Federal Circuit precedent holding
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`that a petitioner bears the burden to establish the public accessibility of an alleged
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`prior art reference. In short, the expanded panel should resolve these conflicts by
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`holding that the Federal Rules of Evidence apply throughout inter partes reviews,
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`and as a result, admissible evidence is necessary to establish a non-patent
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`reference’s public accessibility at the institution stage.
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`II. GOVERNING LAWS, RULES, AND PRECEDENT
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`Under 37 C.F.R. § 42.71(d), “[a] party dissatisfied with a decision may file a
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`request for rehearing without prior authorization from the Board.” 37 C.F.R. §
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`42.71(d). The party requesting rehearing bears the burden of showing that the
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`decision should be modified. Id. “The request must specifically identify all
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`matters the party believes the Board misapprehended or overlooked, and the place
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`2
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`where each matter was previously addressed in a motion, an opposition, or a
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`reply.” Id.
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`The Board applies an abuse of discretion standard in reviewing institution
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`decisions. 37 C.F.R. § 42.71(c). “An abuse of discretion may arise if a decision is
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`based on an erroneous interpretation of law, if a factual finding is not supported by
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`substantial evidence, or if an unreasonable judgment is made in weighing relevant
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`factors.” Daicel Corp. v. Celanese Int’l. Corp., Case IPR2015-00173, Paper 15, at
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`2 (PTAB June 26, 2015) (internal quotations and citations omitted).
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`III. THE BOARD SHOULD GRANT ENZO’S REQUEST FOR
`REHEARING AND REVERSE THE INSTITUTION DECISION
`BECAUSE PETITIONER FAILED TO ESTABLISH THE PUBLIC
`ACCESSIBILITY OF ITS NON-PATENT REFERENCES.
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`The Institution Decision hinges on two erroneous interpretations of law.
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`First, despite USPTO regulations mandating application of the Federal Rules of
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`Evidence in institution decisions, those Rules were not applied in reaching the
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`conclusion in the Institution Decision that Petitioner’s putative copyright dates
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`sufficed to make a “threshold showing” of public accessibility for Petitioner’s
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`Non-Patent References. Second, Petitioner was not required to satisfy its burden of
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`establishing the public accessibility of the Non-Patent References. Instead, the
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`Institution Decision relied on grounds that Petitioner did not raise in the Petition.
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`3
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`A. Enzo Showed In Its Preliminary Response That Petitioner Did
`Not Establish That Its Non-Patent References Were “Printed
`Publications” Because Petitioner Failed To Adduce Admissible
`Evidence Of Public Accessibility.
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`
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`Pursuant to 37 C.F.R. § 42.71(d), Enzo hereby specifies the manner in which
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`Enzo addressed the issues raised herein. Enzo argued that Petitioner has the
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`burden of establishing in its Petition the public accessibility of its non-patent
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`references, i.e., that those references qualify as prior art “printed publications.”
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`(Preliminary Response at 6-7 (citing, inter alia, 35 U.S.C. § 311(b); Dynamic
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`Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1379-80 (Fed. Cir. 2015);
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`Hewlett-Packard Co. v. U.S. Philips Corp., Case IPR2015-01505, Paper 15, at 3
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`(PTAB Dec. 16, 2015); Coalition for Affordable Drugs IV LLC v. Pharmacyclics
`
`LLC, Case IPR2015-01076, Paper 33, at 5-6 (PTAB Oct. 19, 2015); Cisco Sys.,
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`Inc. v. Constellation Techs. LLC, Case IPR2014-00914, Paper 11, at 23 (PTAB
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`Jan. 2, 2015)).)
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`Enzo also argued that Petitioner cannot make the requisite “threshold
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`showing” of public accessibility without presenting evidence that is admissible
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`under the Federal Rules of Evidence. (Preliminary Response at 7-9 (citing, inter
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`alia, 37 C.F.R. § 42.62(a); FED. R. EVID. 801; FED. R. EVID. 802; TRW Automotive
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`US LLC v. Magna Elecs. Inc., Case IPR2015-00960, Paper 9, at 17-20 (PTAB Oct.
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`5, 2015); Apple, Inc. v. DSS Tech. Mgm’t, Case IPR2015-00369, Paper 9, at 12
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`4
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`(PTAB June 25, 2015); Standard Innovation Corp. v. Lelo, Inc., Case IPR2014-
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`00148, Paper 41, at 13-17 (PTAB Apr. 23, 2015)).)
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`Enzo further argued that the hearsay copyright dates, hearsay library date
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`stamps, and attorney argument on which Petitioner and the Institution Decision
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`relied were both inadmissible and insufficient to establish public accessibility of
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`the Non-Patent References. (Preliminary Response at 9-11.) Because Petitioner
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`did not make a threshold showing by admissible evidence that any of its Non-
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`Patent References were publicly accessible, institution should have been denied on
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`every ground. (Id. at 11.)
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`B.
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`The Institution Decision Was An Abuse Of Discretion Because
`The Federal Rules Of Evidence Were Not Applied.
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`In the Institution Decision, the Panel concluded that the hearsay dates on the
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`faces of the Non-Patent References hearsay dates were sufficient to make a
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`“threshold showing” that those references were publicly accessible prior to the
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`earliest effective filing date of the ’197 Patent. (Institution Decision at 6-7.) In so
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`doing, the Panel failed to apply the Federal Rules of Evidence as the law requires.
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`Copyright dates and other dates on a reference, when offered to establish the truth
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`of the publication date of such reference, constitute inadmissible hearsay under the
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`Federal Rules of Evidence, and are therefore insufficient to establish the public
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`accessibility of the Non-Patent References. The Panel’s conclusion to the contrary
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`constitutes an erroneous conclusion of law.
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`5
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`The Panel is bound by USPTO regulations. Wagner v. United States, 365
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`F.3d 1358, 1361 (Fed. Cir. 2004) (“[A]n agency is bound by its own regulations.”)
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`(citing Service v. Dulles, 354 U.S. 363, 388 (1957)). Among those regulations is
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`37 C.F.R. § 42.62(a)—a provision applicable to AIA proceedings, such as this
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`inter partes review—which provides that “the Federal Rules of Evidence shall
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`apply to a proceeding.” The reference to “proceeding” in that provision includes
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`“preliminary proceedings,” which include institution decisions. 37 C.F.R. § 42.2
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`(“Preliminary Proceeding begins with the filing of a petition for instituting a trial
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`and ends with a written decision as to whether a trial will be instituted”). As a
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`result, the Federal Rules of Evidence govern any determination as to whether a
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`non-patent reference qualifies as a prior art “printed publication.”
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`Under the Federal Rules of Evidence, hearsay is inadmissible absent
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`exceptions not established here. FED. R. EVID. 802. As relevant here, a date
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`imprinted on a reference, such as a copyright date or library date stamp, is hearsay
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`and cannot establish the reference’s public accessibility as of that date. FED. R.
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`EVID. 801; FED. R. EVID. 802; Apple, Case IPR2015-00369, Paper 9, at 12 (holding
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`that a stamped legend indicating a thesis’s archival date was hearsay inadmissible
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`to prove the truth of that archival date); Standard Innovation, Case IPR2014-
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`00148, Paper 41, at 13-17 (holding that a website printout’s copyright dates are
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`inadmissible hearsay to prove the truth of those websites’ publication dates).
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`6
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`Because hearsay is inadmissible, it cannot establish the public accessibility of a
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`reference at any point in an inter partes review, including the institution decision.
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`The Panel nevertheless instituted trial based on its determination that the
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`nominal dates printed on the Non-Patent References were sufficient to make a
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`threshold showing of public accessibility. (Institution Decision at 6-7.) In so
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`doing, the Panel failed to apply the Federal Rules of Evidence in the Institution
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`Decision—indeed, the Institution Decision failed entirely to discuss or cite the
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`Federal Rules of Evidence. (Institution Decision at 6-7.) The Panel’s decision to
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`institute trial based on inadmissible evidence was legally incorrect, and, therefore,
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`constitutes an abuse of discretion.
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`C. The Panel Abused Its Discretion By Failing To Hold Petitioner To
`Its Burden Of Establishing The Public Accessibility Of Its
`Non-Patent References And By Adopting Positions That
`Petitioner Did Not Raise.
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`
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`Petitioner has the burden of establishing public accessibility for each of its
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`Non-Patent References. That burden flows from clear statutory and Federal
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`Circuit law. 35 U.S.C. § 311(b); Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
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`800 F.3d 1375, 1379-80 (Fed. Cir. 2015). But as Enzo showed in its Preliminary
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`Response, Petitioner presented only unsupported attorney argument in support of
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`the Petition—which is wholly insufficient to meet that burden. (Preliminary
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`Response at 9-10 (citing Coalition for Affordable Drugs IV LLC, Case IPR2015-
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`01076, Paper 33, at 5-6; TRW Automotive, Case IPR2015-00960, Paper 9, at 17-
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`7
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`20).) Indeed, Petitioner did not even argue that the purported copyright dates and
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`library date stamps on the Non-Patent References showed public accessibility.
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`Nevertheless, the Panel sua sponte raised and decided in Petitioner’s favor
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`the argument that the dates printed on the Non-Patent References were both
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`admissible and sufficient to make a threshold showing of public accessibility.
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`(Institution Decision at 6-7.) In so doing, the Panel erred. The Panel reached an
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`argument never raised by Petitioner, which is prohibited by Federal Circuit law.
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`See In re: Magnum Oil Tools Int’l, Ltd., No. 2015-1300, 2016 WL 3974202, at *10
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`(Fed. Cir. July 25, 2016) (holding that the Board lacks authority to “raise, address,
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`and decide unpatentability theories never presented by the petitioner and not
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`supported by record evidence”); see also Indoor Skydiving Germany GmbH v.
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`IFLY Holdings LLC, Case IPR2015-01272, Paper 14, at 3 (PTAB Jan. 5, 2016)
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`(rejecting the petitioner’s invitation for the panel to determine sua sponte that non-
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`patent references were “printed publications”). Thus, when a petitioner fails to
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`establish the public accessibility of a non-patent reference, a panel cannot raise
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`new theories or grounds to support that the non-patent reference is a publicly
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`accessible “printed publication.” Rather, where a petitioner fails to present
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`admissible evidence establishing a non-patent reference’s public accessibility, a
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`panel should deny institution. See Dynamic Drinkware, 800 F.3d at 1379-80;
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`Apple, Case IPR2015-00369, Paper 9, at 12; see also 37 C.F.R. § 42.108(c) (“Inter
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`8
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`partes review shall not be instituted for a ground of unpatentability unless the
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`Board decides that the petition supporting the ground would demonstrate that there
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`is a reasonable likelihood that at least one of the claims challenged in the petition is
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`unpatentable.”).
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` Second, the Panel failed to hold Petitioner to its burden of establishing the
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`unpatentability of the challenged claims, including establishing that the Non-Patent
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`References actually qualify as prior art “printed publications.” 35 U.S.C. § 311(b);
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`Dynamic Drinkware, 800 F.3d at 1379-80; TRW Automotive, Case IPR2015-
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`00960, Paper 9, at 17-20; Cisco, Case IPR2014-00914, Paper 11, at 23. The Panel
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`instead impermissibly shifted the burden of proof regarding the alleged “printed
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`publication” status of the Non-Patent References from Petitioner to Enzo. In
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`particular, the Panel instructed Enzo to “continue to challenge the sufficiency or
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`admissibility of the evidence” during trial. (Institution Decision at 7.) But Enzo
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`does not bear the burden of proving inadmissibility or non-accessibility of the
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`Non-Patent References, particularly when the Petition presented no admissible
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`evidence supporting a prima facie case of public accessibility. See In re: Magnum
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`Oil Tools, 2016 WL 3974202, at *6 (noting that shifting the burden of production
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`to the patent owner is “inapposite” when “the patentee’s position is that the patent
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`challenger failed to meet its burden of proving obviousness”). Thus, the Panel
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`erred in not requiring Petitioner to satisfy its burden to establish by admissible
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`9
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`evidence the public accessibility of each Non-Patent Reference. Dynamic
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`Drinkware, 800 F.3d at 1378.
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`In conclusion, the Panel’s Institution Decision rests on the following
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`erroneous legal conclusions:
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`-
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`the Panel decided that the inadmissible hearsay dates printed on Petitioner’s
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`Non-Patent References were sufficient to establish public accessibility;
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`-
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`the Panel raised and decided public accessibility arguments that Petitioner
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`never raised; and
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`-
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`the Panel impermissibly shifted the burden of proof on the issues of
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`admissibility and public accessibility from Petitioner to Enzo.
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`Because each of those erroneous legal conclusions justifies rehearing and reversal,
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`Daicel, IPR2015-00173, Paper 15, at 2, the Board should grant Enzo’s request for
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`rehearing, conclude that Petitioner failed to present sufficient evidence of public
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`accessibility, confirm
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`that hearsay evidence cannot establish
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`the public
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`accessibility or prior art status of the Non-Patent References, and deny institution.
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`IV. ENZO RESPECTFULLY SUGGESTS REHEARING BY AN
`EXPANDED PANEL THAT INCLUDES THE CHIEF JUDGE.
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`
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`Enzo respectfully submits that this case is appropriate for rehearing by an
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`expanded panel that includes the Chief Judge. Patent Trial and Appeal Board
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`Standard Operating Procedure 1 recognizes several reasons for expanding a panel
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`for rehearing. Expanding a panel is appropriate when “[c]onsideration by an
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`10
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`expanded panel is necessary to secure and maintain uniformity of the Board’s
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`decisions.” Patent Trial and Appeal Board Standard Operating Procedure 1, Rev.
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`14, at 3. Expanding a panel is also appropriate where “the proceeding or AIA
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`Review involves an issue of exceptional importance, such as where . . . a panel of
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`the Board renders a decision that conflicts with . . . an authoritative decision of the
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`Board’s reviewing courts.” Id. Both factors are present here.
`
`A. Consideration By An Expanded Panel Is Warranted To Bring
`Uniformity To The Board’s Conflicting Decisions Concerning The
`Standard For Establishing That A Non-Patent Reference Is A
`Publicly Accessible “Printed Publication.”
`
`
`
`The Board’s jurisprudence regarding the standard for establishing the
`
`alleged public accessibility of a non-patent reference at the institution stage has
`
`become increasingly fractured since the enactment of the AIA. The Board’s
`
`conflicting decisions have created uncertainty and led to unpredictable outcomes.
`
`E.g., Anish Desai, Christopher Marando, & Amanda Do Couto, PTAB Approaches
`
`To Accessibility Of Printed Publication, LAW360
`
`(Oct. 3, 2016),
`
`http://www.law360.com/articles/845934/print?section=ip (Ex. 2106, at 1) (noting
`
`that the Board’s printed publication jurisprudence is “not always clear”); Michael
`
`R. Weiner, APJs Dispute Requirements for a Reference to Qualify as a Printed
`
`Publication,
`
`PTABWATCH
`
`(Oct.
`
`15,
`
`2015),
`
`http://www.ptabwatch.com/2015/10/apjs-dispute-requirements-for-a-reference-to-
`
`qualify-as-a-printed-publication (Ex. 2107, at 2) (“Until the PTAB issues a
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`U.S. Patent No. 7,064,197
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`precedential opinion concerning these issues, the approach of a particular panel of
`
`APJs may be difficult to predict.”).
`
`The Institution Decision in this proceeding worsens that unpredictability. In
`
`particular, the Institution Decision conflicts with other panel decisions correctly
`
`denying institution when the petitioner presented only inadmissible evidence of a
`
`non-patent reference’s public accessibility, such as hearsay dates printed on a
`
`reference. E.g., emnos USA Corp. v. Dunnhumby, Ltd., Case CBM2015-00162,
`
`Paper 7, at 11 (PTAB Dec. 30, 2015) (noting that “[i]f Petitioner’s assertion is
`
`based on the ‘March 2002’ statement that appears on the cover of the Oracle Pro*C
`
`reference, that statement is hearsay, and Petitioner does not argue that any hearsay
`
`exception or exclusion applies” and denying institution for lack of public
`
`accessibility); ServiceNow, Inc. v. Hewlett-Packard Co., Case IPR2015-00707,
`
`Paper 12, at 16-17 (PTAB Aug. 26, 2015) (holding that copyright dates and dates
`
`on the face of non-patent reference were inadmissible hearsay and denying
`
`institution for lack of public accessibility); Apple, Case IPR2015-00369, Paper 9,
`
`at 12 (holding that a stamped legend indicating a thesis’s archival date was hearsay
`
`inadmissible to prove the truth of that archival date and denying institution for lack
`
`of public accessibility).
`
`
`
`Granting rehearing and holding that a reference’s public accessibility must
`
`be established by admissible evidence at the institution stage will bring clarity and
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`U.S. Patent No. 7,064,197
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`uniformity to an otherwise uncertain threshold issue for many AIA proceedings.
`
`Accordingly, rehearing by an expanded panel is warranted and necessary.
`
`B.
`
`The Evidentiary Standard For Establishing That A Non-Patent
`Reference Is A Publicly Accessible “Printed Publication” Is An
`Issue Of Exceptional Importance, And The Board’s Decision In
`This Proceeding Conflicts With Federal Circuit Precedent.
`
`Confronting the standard for establishing the public accessibility of non-
`
`patent references is of exceptional importance, because it will permit the Board to
`
`resolve conflicts between the Institution Decision and the controlling Federal
`
`Circuit cases Dynamic Drinkware and In re: Magnum Oil Tools. Dynamic
`
`Drinkware, 800 F.3d at 1379-80; In re: Magnum Oil Tools, 2016 WL 3974202, at
`
`*10. As Enzo explained above and in its Preliminary Response, a petitioner
`
`always has the burden of establishing that each reference on which it relies
`
`qualifies as prior art. Dynamic Drinkware, 800 F.3d at 1379-80. Relieving a
`
`petitioner of that burden, as occurred in the Institution Decision, conflicts with the
`
`holding of Dynamic Drinkware. Id. The Institution Decision also relied on an
`
`argument that Petitioner did not make: that the hearsay dates printed on the
`
`Non-Patent References are somehow admissible or sufficient to establish public
`
`accessibility despite their inadmissibility. (Institution Decision at 6-7.) That the
`
`Institution Decision relied on arguments that Petitioner itself did not make conflicts
`
`with In re: Magnum Oil Tools, 2016 WL 3974202, at *10 (holding that the Board
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`lacks authority to “raise, address, and decide unpatentability theories never
`
`presented by the petitioner and not supported by record evidence”).
`
`
`
`In addition, clarifying that petitioners must establish the public accessibility
`
`of non-patent references based upon admissible evidence is exceptionally
`
`important because, as explained above, it has wide-ranging effects, applying to
`
`each AIA petition involving a non-patent reference. Moreover, instituting trial
`
`where the public accessibility of a reference is not established by admissible
`
`evidence subjects both patent owners and the Board to the unnecessary burden of
`
`an instituted trial where petitioners have failed to comply with a fundamental
`
`petition requirement. Hewlett-Packard, Case IPR2015-01505, Paper 15, at 3
`
`(“Petitioner has the burden to establish in its Petition a reasonable likelihood of
`
`success, including, among other things, making a threshold showing that the relied
`
`upon references are ‘printed publications’. . . .”) (emphasis in original).
`
`V. CONCLUSION
`
`
`
`Enzo respectfully requests that the Board grant Enzo’s request for rehearing
`
`and reverse the Institution Decision. In addition, the pressing need for uniformity
`
`in the evidentiary standards governing institution decisions addressing the public
`
`accessibility of non-patent references warrants rehearing by an expanded panel.
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`Dated: October 17, 2016
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`Respectfully submitted,
`
`/kkm/
`Kevin K. McNish (Reg. No. 65,047)
`kmcnish@desmaraisllp.com
`DESMARAIS LLP
`230 Park Avenue
`New York, NY 10169
`Telephone: 212-351-3400
`Facsimile: 212-351-3401
`
`Lead Counsel for Patent Owner
`Enzo Life Sciences, Inc.
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on October 17,
`
`2016, a complete copy of the foregoing was served on counsel of record for
`Petitioner by filing this document through PTAB E2E and by sending this
`document via electronic mail to the following addresses:
`
`M. Paul Barker (Reg. No. 32,013)
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, L.L.P.
`Stanford Research Park
`3300 Hillview Avenue
`Palo Alto, CA 94304-1203
`Telephone: 650.849.6620
`Facsimile: 650.849.6666
`paul.barker@finnegan.com
`
`Thomas L. Irving (Reg. No. 28,619)
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Telephone: 202.408.4082
`Facsimile: 202.408.4400
`tom.irving@finnegan.com
`
`Arpita Bhattacharyya
`63,681)
`Finnegan, Henderson,
`Garrett & Dunner, L.L.P.
`Two Seaport Lane, 6th Floor
`Boston, MA 02210-2001
`Telephone: 617.646.1675
`Facsimile: 617.646.1600
`arpita.bhattacharyya@finnegan.com
`
`Respectfully submitted,
`
`(Reg. No.
`
`Farabow,
`
`Dated: October 17, 2016
`
`
`
`
`
`/kkm/
`Kevin K. McNish (Reg. No. 65,047)
`kmcnish@desmaraisllp.com
`DESMARAIS LLP
`230 Park Avenue
`New York, NY 10169
`Telephone: 212-351-3400
`Facsimile: 212-351-3401
`
`Lead Counsel for Patent Owner
`Enzo Life Sciences, Inc.
`
`
`