Paper No. ___
`Filed: February 24, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.
`Petitioners,
`
`v.
`
`NUVASIVE, INC.,
`Patent Owner.
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`—————————————————
`Case IPR2019-00362
`Patent 8,361,156
`_____________________________
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE PURSUANT
`TO 37. C.F.R. § 42.64(c)
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`Filed: February 24, 2020
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.
`Petitioners,
`
`v.
`
`NUVASIVE, INC.,
`Patent Owner.
`
`—————————————————
`Case IPR2019-00362
`Patent 8,361,156
`_____________________________
`
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE PURSUANT
`TO 37. C.F.R. § 42.64(c)
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`I. STATEMENT OF PRECISE RELIEF REQUESTED
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`Pursuant to 37 C.F.R. §§ 42.62 and 42.64(c) and the Federal Rules of Evidence,
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`Patent Owner respectfully moves to exclude Exhibits 1053-1056, 1059-1062, and
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`1065, pursuant to 37 C.F.R. § 42.64(c).
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`Patent Owner timely objected to exhibits 1053-1056, 1059-1062, and 1065 and
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`reliance thereon. Paper 35.
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`II. STATEMENT OF REASONS FOR THE RELIEF REQUESTED
`A. Exhibits 1053 and 1054 should be excluded for being new evidence
`used to support new argument
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`Exhibits 1053 and 1054 were not submitted until after Patent Owner had
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`filed its Patent Owner Response. Petitioner cites these exhibits in support of a
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`prima facie case of obviousness raised for the first time in Petitioner’s Reply. Such
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`late evidence is improper and may not be used to support a conclusion of
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`obviousness. 2018 Revised Trial Practice Guide (“Petitioner may not submit new
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`evidence or argument in reply that it could have presented earlier, e.g. to make out
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`a prima facie case of unpatentability.”); Intelligent Bio-Systems, Inc. v. Illumina
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`Cambridge, Ltd., 821 F.3d 1359, 1370 (Fed. Cir. 2016) (“[W]e find that the Board
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`did not err in refusing the reply brief as improper under 37 C.F.R. § 42.23(b)
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`because IBS relied on an entirely new rationale to explain why one of skill in the
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`art would have been motivated to combine [the prior art references].”). As such,
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`-1-
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`exhibits 1053 and 1054 are not relevant to the grounds of review. FRE 401; FRE
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`402.
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`Petitioner relies on exhibit 1053 for the purpose of filling a gap in the prima
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`facie case that Patent Owner identified in its response to the petition. In particular,
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`the petition relies on the modularity concept of Michelson (EX1032) to supply the
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`alleged motivation to modify the primary reference (i.e., Frey or Brantigan) in both
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`Grounds 1 and 2. E.g., Pet. 4-5, 30, 47-48. In its Response, Patent Owner
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`established, inter alia, that Petitioner had misapprehended Michelson as disclosing
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`sequential insertion of modular members into the disc space. Patent Owner’s
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`experts explained that Michelson describes combining modular components before
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`insertion in the disc space. In Reply, Petitioner does not rebut Patent Owner’s
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`evidence. Instead, Petitioner pivots to a new reference, Michelson ’770 (EX1053),
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`disclosing insertion of two independent cylindrical implants. Reply at 10 (citing
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`EX1053, 10:10-13, 10:13-16). Other than sharing a common inventor the content
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`of Michelson ’770 (EX1053) is separate and unrelated to Michelson (EX1032) that
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`was relied upon in the petition. Indeed, neither the term modular nor the concept of
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`modularity is found in the newly submitted Michelson ’770 patent.
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`Petitioner relies on exhibit 1054 also for the purpose of filling a gap in the
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`prima facie case that Patent Owner identified in its response to the petition. In
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`particular, the petition relies exclusively on Baccelli as allegedly illustrating
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`-2-
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`markers in the medial plane of the implant (central region). Pet. 45 (citing EX1002,
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`¶199). The petition further asserts without a shred of supporting evidence that a
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`POSA would be motivated to add such markers to other implants (e.g., Frey,
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`Brantigan). Patent Owner established that Petitioner misapprehended the content of
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`Baccelli and that the proffered rationale was based on nothing more than the ipse
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`dixit testimony of Petitioner’s expert witness, Dr. Branch. POR 21-26. Patent
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`Owner also established that this rationale was the same as that rejected by the
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`Federal Circuit as being based wholly on hindsight. Id. In Reply, Petitioner does
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`not rebut Patent Owner’s arguments and evidence but instead pivots to exhibit
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`1054 and argues that the “lateral (C) and antero-posterior (D) radiographs of a
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`transversely oriented BAK cage show that POSAs knew the benefits of ‘aligning
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`markers with the spinous process and the lateral ends of the vertebrae’ before
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`the ’334 patent without ‘impermissible hindsight.’”
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`Exhibit 1053 and 1054 were not cited in the petition materials and do not
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`address the grounds references actually relied upon (e.g., Michelson and Baccelli).
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`As such they are untimely, irrelevant to this proceeding, and more likely to cause
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`confusion and unreasonable prejudice and should be excluded under FRE 401, 402,
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`403.
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`-3-
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`B.
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`Exhibit 1055 should be excluded as irrelevant to any issues raised
`in this case
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`Exhibit 1055 was filed along with the Petitioner’s Reply and is cited at page
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`5 with no substantive discussion. The significance of this reference is not explained
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`in the briefing nor is it apparent from the document itself. As such, the exhibit is
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`irrelevant and more likely to cause confusion and unreasonable prejudice and
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`should be excluded under FRE 401, 402, and 403.
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`C. Exhibits 1056, 1059-1061, 1064, and 1065 should be excluded
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`Exhibits 1056, 1059-1061, 1064 and 1065 represent excerpts of transcripts,
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`declarations, briefing, and other documents. There are numerous bases for
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`exclusion including submission of incomplete documents and irrelevance to this
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`proceeding more likely to cause confusion and unreasonable prejudice than add
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`probative value. As such, these exhibits should be excluded under FRE 106, 401,
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`402, and 403.
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`Exhibits 1056, 1059-1061, and 1065 should be excluded as incomplete
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`documents from other legal proceedings. In each instance, Petitioner submitted
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`only select portions – cherry picked to support Petitioner’s arguments. Submission
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`of such partial documents is improper as it omits content and information that in
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`fairness should be considered at the same time. FRE 106. Moreover, as the
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`documents originate from other cases they are irrelevant to the present proceeding
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`resulting in confusion and undue prejudice. FRE 401, 402, 403.
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`-4-
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`Exhibits 1056 and 1060 represent a partial trial transcript and a portion of
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`the briefing associated with proceedings concerning an unrelated patent,
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`respectively. To the extent, these exhibits are considered relevant at all to this
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`proceeding, such a partial record is confusing and provides minimal detail as to
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`context.
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`Exhibits 1061 and 1065 represent excerpts from declarations of Dr. Youssef
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`and Mr. Link filed in the related district court case. To the extent, these are
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`considered relevant at all to this proceeding, such a partial record is confusing and
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`provides minimal detail as to context.
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`In an effort to disparage Dr. Youssef, Petitioner submits exhibits 1059 and
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`1064 to support the unsurprising assertion that a world class spine surgeon has
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`been compensated at fair market value for consulting services provided to
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`NuVasive outside of this proceeding. The submitted materials are incomplete in
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`that Petitioner fails to include information and evidence that in fairness ought to be
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`considered at the same time.
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`For instance, Petitioner fails to inform the Board that it is conventional for
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`medical device companies to consult with renowned surgeons and for such
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`consultation to be paid at fair market value. Petitioner’s own expert witness, Dr.
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`Branch, has a comparable consulting and royalty arrangement with Medtronic (a
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`direct competitor of NuVasive) which Dr. Branch characterized as fair market
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`-5-
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`value. Petitioner is well aware of this arrangement as it was discussed expressly
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`during Dr. Branch’s deposition associated with the district court case.
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`In fairness, industry convention and Dr. Branch’s own consulting activities should
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`be considered at the same time. FRE 106. To the extent Dr. Youssef’s
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`compensation (exhibits 1059 and 1064) for unrelated services as a world class
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`expert surgeon are at all relevant and not excluded, such a partial record is
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`confusing and provides minimal detail as to context and is more likely to cause
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`confusion and undue prejudice than add probative value.
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`-6-
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`D. Exhibits 1060 and 1062 were not cited in any briefing associated
`with this case and should be excluded as irrelevant
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`Exhibit 1060 and 1062 were filed along with the Petitioner’s Reply but were
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`not cited in the briefing. Accordingly, these exhibits are not relevant to the
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`proceeding and should be excluded. FRE 401; FRE 402.
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`III. CONCLUSION
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`For the reasons discussed above, the above-identified evidence should be
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`excluded from consideration by the Board in this proceeding.
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`Date: February 24, 2020
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`Respectfully submitted,
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`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
` Reg. No. 52,182
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`-7-
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`CERTIFICATE OF SERVICE
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`I certify that the foregoing Patent Owner’s Motion to Exclude Evidence was
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`served on February 24, 2020, on the Petitioner at the electronic service addresses
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`of the Petitioner as follows:
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`Jovial Wong
`Nimalka R. Wickramasekera
`David P. Dalke
`WINSTON & STRAWN LLP
`Alphatec-IPRs@winston.com
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`Date: February 24, 2020
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`Respectfully submitted,
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`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
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