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., and BECTON, DICKINSON AND COMPANY,
`Petitioner
`
`
`
`v.
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`
`
`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 MOTION TO EXCLUDE EVIDENCE
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`U.S. Patent No. 7,064,197
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`
`HOLOGIC, INC., and BECTON, DICKINSON AND COMPANY,
`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 MOTION TO EXCLUDE EVIDENCE
`
`
`
`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
`
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`TABLE OF CONTENTS
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`Pages
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`I.
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`INTRODUCTION ........................................................................................... 1
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`II.
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`BACKGROUND ............................................................................................. 2
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`III. ARGUMENT ................................................................................................... 3
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`IV. CONCLUSION ................................................................................................ 6
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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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`
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`Pages
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`Cases
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`Kayak Software Corp. v. Int’l Bus. Machs. Corp., Case CBM2016-00076,
`Paper 16 (PTAB Dec. 15, 2016) ...................................................................... 5
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`Regulations
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`37 C.F.R. § 42.64(c) ................................................................................................... 2
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`Rules
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`FRE 602 .................................................................................................................1, 3
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`ii
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`I.
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`INTRODUCTION
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`Patent Owner Enzo Life Sciences, Inc. (“Patent Owner” or “Enzo”) moves
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`to exclude certain paragraphs of and the Attachment to Petitioner’s Exhibit 1037—
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`a declaration submitted by Petitioner’s back-up counsel (hereinafter also referred
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`to as “declarant”) in support of Petitioner’s reply—under Federal Rule of Evidence
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`(“FRE”) 602 because the declarant lacks the requisite personal knowledge of the
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`matters in those paragraphs and the Attachment. In that declaration, Petitioner’s
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`back-up counsel attempted to authenticate a laboratory protocol—mentioned but
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`not described or detailed in the 2001 Diehl reference itself—that is supposedly
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`currently available on a website. Petitioner’s back-up counsel testified, among
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`other things, that the laboratory protocol described in a website printout that she
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`made on April 5, 2017 (attached as Attachment A to her declaration), is
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`purportedly the same protocol identified in the 2001 Diehl reference. (Ex. 1037 ¶¶
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`3, 5, Attachment A; see also Ex. 1032.) But Petitioner’s back-up counsel fails to
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`provide any testimony that would establish she has personal knowledge of the
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`laboratory protocol or that it is the same protocol cited in the 2001 Diehl article.
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`Based upon that lack of personal knowledge, paragraphs 3 and 5 and Attachment A
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`of her declaration should be excluded under FRE 602.
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`1
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`Pursuant to 37 C.F.R. § 42.64(c), Enzo confirms that the bases for this
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`motion to exclude were timely raised in Enzo’s objections to evidence filed on
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`April 12, 2017. (Paper 35.)
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`II. BACKGROUND
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`Petitioner relies on the 2001 Diehl reference to argue that one of its primary
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`anticipation references—the 1981 Fish reference—inherently discloses a nucleic
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`acid strand in “hybridizable form” attached to a PLL coated support. (Petition, 23-
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`25.) But Diehl does not disclose or detail the laboratory protocol used to prepare
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`PLL coated slides in the purported hybridization experiments discussed in the
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`reference. (Ex. 1021, 1) In comparing the disclosure in Fish to the laboratory
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`protocol allegedly used in the Diehl reference, Petitioner and its expert, Dr.
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`Norman Nelson, rely upon Exhibit 1032, a purported website printout of a
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`laboratory protocol. (Petition, 23-24 (citing Ex. 1002 ¶¶ 58, 59 (citing Ex. 1032
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`and Ex. 1033)); Petitioner Reply, 7 n. 1 (“See Ex. 1037 addressing Enzo’s concern
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`about Ex.1032.”).) Petitioner’s expert, Dr. Nelson, alleges that the printout marked
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`as Exhibit 1032 is the laboratory protocol cited in the 2001 Diehl reference and
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`lists
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`the web
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`address where
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`it was
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`purportedly
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`accessed
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`as
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`http://cmgm.stanford.edu/pbrown/protocols/1_slides.html. (Ex. 1002 ¶ 58 (citing
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`Ex. 1021, 1).) However, Diehl cites a different web address for the laboratory
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`2
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`protocol, which
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`is
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`no
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`longer
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`in
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`use.
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`
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`(Ex.
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`1021,
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`1
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`(citing
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`http://cmgm.stanford.edu/pbrown/MGuide).)
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`Petitioner filed Exhibit 1037—a declaration submitted by Petitioner’s back-
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`up counsel in support of Petitioner’s reply—addressing the purported laboratory
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`protocol in Exhibit 1032. In Exhibit 1037, the declarant testified that a new
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`website printout, Attachment A
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`to her declaration, was accessed at
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`http://cmgm.stanford.edu/pbrown/MGuide (a different web address from that
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`allegedly accessed by Dr. Nelson and submitted as Exhibit 1032) on April 5, 2017.
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`(Ex. 1037 ¶¶ 3, 5.) The declarant further testified that the web printout included as
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`Attachment A is purportedly the same protocol cited in the 2001 Diehl reference.
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`(Ex. 1037 ¶¶ 3, 5.)
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`III. ARGUMENT
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`Paragraphs 3 and 5 and Attachment A of Exhibit 1037 should be excluded
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`because the declarant lacks any personal knowledge that the laboratory protocol
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`that she purportedly accessed in April 2017 is the same protocol cited in the 2001
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`Diehl article. Under FRE 602, “a witness may testify to a matter only if evidence
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`is introduced sufficient to support a finding that the witness has personal
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`knowledge of the matter. Evidence to prove personal knowledge may consist of
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`the witness’s own testimony.” Petitioner has proffered no evidence to support a
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`3
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`finding that the declarant has ever had personal knowledge concerning the
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`laboratory protocol cited in the Diehl reference sixteen years ago.
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`In paragraphs 3 and 5 of Exhibit 1037, the declarant testified that the website
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`printout included as Attachment A is the same protocol cited in the Diehl
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`reference, an article written in 2001:
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`- “The
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`protocol
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`website
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`cited
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`in
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`Diehl
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`(http://cmgm.stanford.edu/pbrown/MGuide) is still in use today, and Ex.
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`1032 can still be accessed by first visiting the website as cited by Diehl,
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`clicking on Protocols, and then clicking on Slide Preparation under the
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`Protocols header.” (Ex. 1037 ¶ 3.)
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`- Attachment A to this Declaration is a true and correct copy of the
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`protocol cited in Diehl, retrieved from the above-cited website on April
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`5, 2017.” (Id. ¶ 5.)
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`However, Exhibit 1037 contains no testimony regarding the declarant’s personal
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`knowledge of the laboratory protocol cited in the 2001 Diehl reference. Declarant
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`admitted that she retrieved the laboratory protocol in Attachment A from the
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`website listed in Diehl on April 5, 2017—sixteen years after the publication of that
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`article. She provided no testimony regarding the contents of the website during the
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`relevant timeframe—when Diehl was published in 2001. The declarant did not
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`provide any testimony that the content found at the web address listed in Diehl has
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`4
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`not changed over the past sixteen years. In fact, she did not even allege that the
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`webpage purportedly accessed on April 5, 2017 is identical to the page that was
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`available at that web address in 2001. The declarant’s testimony regarding the
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`contents of the website at issue on April 5, 2017 cannot establish that the declarant
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`has personal knowledge of that website as it existed when it was cited by Diehl in
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`2001. Cf. Kayak Software Corp. v. Int’l Bus. Machs. Corp., Case CBM2016-
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`00076, Paper 16, at 7-8 (PTAB Dec. 15, 2016) (holding that a May 2016 web
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`printout of a university library’s thesis catalog, without more, was not probative of
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`the university’s cataloging practices in 1987).
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`Nor does the declarant allege that she has any other basis for personal
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`knowledge of the laboratory protocol cited in the 2001 Diehl article. The declarant
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`did not testify that she was present for any purported experiments described in the
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`Diehl reference or that she was involved in those experiments in any way. The
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`declarant did not state that she worked in the laboratory where the Diehl
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`experiments were purportedly performed or that she has any other personal
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`knowledge regarding the protocol used in that laboratory. Thus, the declarant has
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`provided no testimony to support her conclusion that Attachment A “is a true and
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`correct copy of the protocol cited in Diehl” in 2001.
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`In short, Petitioner has provided no facts to support a finding that the
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`declarant has personal knowledge of the contents of the laboratory protocol
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`5
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`website as of 2001, when it was cited in the Diehl article. Because the declarant
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`lacks sufficient personal knowledge to testify that the laboratory protocol described
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`in the April 5, 2017 printout attached as Attachment A is the same protocol cited in
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`the 2001 Diehl article, paragraphs 3 and 5 and Attachment A of Exhibit 1037
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`should be excluded under FRE 602.
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`IV. CONCLUSION
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`For the foregoing reasons, the Board should grant Enzo’s Motion to
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`Exclude.
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`Dated: April 24, 2017
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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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`6
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`Case IPR2016-00822
`U.S. Patent No. 7,064,197
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on April 24,
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`2017, a complete copy of the foregoing was served on counsel of record for the
`Petitioner by filing this document through PTAB E2E and by sending this
`document via electronic mail to the following addresses:
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`For Petitioner Hologic:
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`M. Paul Barker (Reg. No. 32,013)
`paul.barker@finnegan.com
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`Arpita Bhattacharyya (Reg. No. 63,681)
`arpita.bhattacharyya@finnegan.com
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`Thomas L. Irving (Reg. No. 28,619)
`tom.irving@finnegan.com
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`
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`Dated: April 24, 2017
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`
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`For Petitioner BD:
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`Jamie T. Wisz (Reg. No. 58,429)
`Jamie.Wisz@WilmerHale.com
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`Heather Petruzzi (Reg. No. 71,720)
`Heather.Petruzzi@WilmerHale.com
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`Nancy Lynn Schroeder (Reg. No.
`75,538)
`Nancy.Schroeder@WilmerHale.com
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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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`
`
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