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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`_____________________________
`
`Case IPR2013-00206
`Patent No. 8,251,997
`_____________________________
`
`
`
`WARSAW’S MOTION TO EXCLUDE PURSUANT TO 37 C.F.R. § 42.64
`
`
`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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`

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`
`TABLE OF CONTENTS
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`Page
`INTRODUCTION ........................................................................................... 1 
`I. 
`PROCEDURAL HISTORY ............................................................................ 1 
`II. 
`III.  ARGUMENT ................................................................................................... 2 
`A. 
`EXHIBITS 1001 AND 1014: THE CROCK AFFIDAVIT .................. 2 
`i. 
`Exhibit 1014 and pages 54–85 of Exhibit 1001 are inadmissible
`hearsay and irrelevant under FRE 401–402 and 37 C.F.R. §§
`42.22, 42.104 ............................................................................... 2 
`Paragraphs 18–22 of the Crock Affidavit are inadmissible under
`35 U.S.C. § 311 ........................................................................... 4 
`EXHIBITS 1015–1021: CROCK EXHIBITS ...................................... 4 
`i. 
`Exhibits 1015–1021 are inadmissible as irrelevant under FRE
`401–402 and 37 C.F.R. §§ 42.22 & 42.104 ................................ 5 
`EXHIBIT 1029: SECOND MCAFEE DECLARATION ..................... 5 
`i. 
`Paragraphs 4, 7, 9–10, 37–39, 43–45, and 48–49 are
`inadmissible under 35 U.S.C. § 311 ........................................... 5 
`EXHIBIT 1030: JACOBSON DECLARATION ................................. 8 
`i. 
`Paragraphs 4–6, 8, and 10 are inadmissible under 35 U.S.C.
`§ 311 ............................................................................................ 9 
`Paragraphs 4–6, 8, and 10 are inadmissible as irrelevant under
`FRE 401 and 402....................................................................... 10 
`EXHIBIT 1032: MILES DECLARATION ........................................ 11 
`i. 
`Paragraph 9 of Exhibit 1032 is inadmissible under FRE 702 ... 11 
`EXHIBITS 1036 & 1037: FRIEDMAN ARTICLES ......................... 12 
`i. 
`Exhibits 1036 and 1037 are inadmissible as irrelevant under
`FRE 401 and 402....................................................................... 12 
`Exhibits 1036 & 1037 are inadmissible under 35 U.S.C. § 311
` ................................................................................................... 13 
`EXHIBITS 1046, 1049, & 1050 ......................................................... 13 
`
`ii. 
`
`ii. 
`
`ii. 
`
`B. 
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`C. 
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`D. 
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`E. 
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`F. 
`
`G. 
`
`
`
`i
`
`

`

` 
`
`i. 
`
`H. 
`
`Exhibits 1046, 1049, & 1050 are inadmissible as irrelevant
`under FRE 401 and 402 ............................................................ 14 
`EXHIBIT 1067: MCAFEE 1998 ARTICLE....................................... 14 
`i. 
`Exhibit 1067 is inadmissible as irrelevant under FRE 401 and
`402 ............................................................................................. 14 
`IV.  PETITIONER’S REPLY EVIDENCE .......................................................... 15 
`
`
`
`
`ii
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`

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` 
`
`TABLE OF AUTHORITIES
`
`Page
`
`Cases 
`Abbott Labs. v. Sandoz, Inc.
`566 F.3d 1282 (Fed. Cir. 2009) ....................................................................... 8
`In re Baxter Travenol Labs.
`952 F.2d 388 (Fed. Cir. 1991) .................................................................. 8, 10
`Kyocera Corp. v. Softview LLC
`IPR2013-00004, slip op. at 33 (PTAB March 27, 2014) .............................. 15
`Scripps Clinic & Research Found. v. Genentech, Inc.
`927 F.2d 1565 (Fed. Cir. 1991) ................................................................ 8, 10
`Sundance, Inc. v. DeMonte Fabricating Ltd.
`550 F.3d 1356 (Fed. Cir. 2008) ..................................................................... 12
`Statutes 
`35 U.S.C. § 102 .......................................................................................................... 4
`35 U.S.C. § 311 ................................................................................................ passim
`Rules 
`Federal Rule of Evidence 401 .......................................................................... passim
`Federal Rule of Evidence 402 .......................................................................... passim
`Federal Rule of Evidence 702 ........................................................................... 11, 12
`Federal Rule of Evidence 802 .................................................................................... 2
`Regulations 
`37 C.F.R. § 42.104 ........................................................................................ 2, 3, 4, 5
`37 C.F.R. § 42.22 .......................................................................................... 2, 3, 4, 5
`37 C.F.R. § 42.64(c) ............................................................................................ 1, 15
`37 C.F.R. § 42.65(b)(1) .............................................................................................. 2
`
` 
`
`
`
`iii
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`

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`
`I.
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.64(c), Warsaw Orthopedic, Inc. (“Patent Owner”
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`or “Warsaw”) hereby moves to exclude the following evidence submitted by
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`NuVasive, Inc. (“NuVasive” or “Petitioner”) in the above-captioned inter partes
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`review (“IPR”). Much of petitioner’s evidence is inadmissible as irrelevant or
`
`outside the permissible scope of an IPR proceeding. By way of example,
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`Petitioner submitted several exhibits in support of its petition and reply that were
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`not cited in these documents. In other instances, Petitioner presents irrelevant and
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`improper evidence of alleged prior public use, such as Dr. Jacobson’s alleged
`
`surgeries, that find no place in this proceeding because they do not bear on what
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`prior art patents and printed publications disclose to a person of ordinary skill in
`
`the art. See 35 U.S.C. § 311 (“A petitioner in an inter partes review may request to
`
`cancel 1 or more claims of a patent . . . only on the basis of prior art consisting of
`
`patents and printed publications.”). NuVasive’s improper attempt to broaden the
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`scope of this IPR should be recognized as such and denied.  
`
`II. PROCEDURAL HISTORY
`NuVasive filed a petition for inter partes review on March 22, 2013 (Paper
`
`
`
`1), Warsaw filed a preliminary response on June 25, 2013 (Paper 11), and the
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`Board instituted trial on September 23, 2010 (Paper 17). On October 7, 2013,
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`Warsaw timely filed its objections to Petitioner’s evidence submitted in the
`
`preliminary proceedings on this matter. (Paper 20.) Warsaw then filed its Patent
`1
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`

`

` 
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`Owner response on December 20, 2013 (Paper 32) and Petitioner replied on March
`
`11, 2014 (Paper 43). On March 18, 2014, Warsaw timely filed its objections to
`
`Petitioner’s reply evidence under 37 C.F.R. § 42.65(b)(1). (Paper 45.)
`
`III. ARGUMENT
`The following exhibits are inadmissible under either the Federal Rules of
`
`Evidence (“FRE”), Part 42 of Title 37 of the Code of Federal Regulations, or
`
`Chapter 31 of Title 35 of the United States Code.
`
`A. EXHIBITS 1001 AND 1014: THE CROCK AFFIDAVIT
`Petitioner submitted an affidavit from Dr. Henry Crock (“Crock Affidavit”)
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`
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`as Appendix B to the Declaration of Dr. McAfee. (See Ex. 1001 at 54–85.)
`
`Without any explanation, Petitioner later submitted the same Crock Affidavit as
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`Exhibit 1014 in support of its reply. NuVasive’s petition and reply do not explain
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`the relevance of the Crock Affidavit.
`
`i.
`
`Exhibit 1014 and pages 54–85 of Exhibit 1001 are
`inadmissible hearsay and irrelevant under FRE 401–402
`and 37 C.F.R. §§ 42.22, 42.104
`Warsaw objected to Exhibit 1001 based on FRE 401, 402, and 802 in Paper
`
`
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`20, and to Exhibit 1014 on the same grounds, as well as 37 C.F.R. §§ 42.22 and
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`42.104 in Paper 45. The Crock Affidavit was sworn and executed in Australia,
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`under the laws of that country. (Crock Affidavit at 2, 31.) Dr. Crock did not swear
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`or declare that his testimony was true and correct under the laws of the United
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`States. As such, the entire Crock Affidavit is hearsay under FRE 801 and 802.
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`
`
`2
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`

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`FRE 402 provides that “[i]rrelevant evidence is not admissible.” 37 C.F.R.
`
`§ 42.104 requires that a petition for IPR must identify “the relevance of the
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`evidence to the challenge raised, including identifying specific portions of
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`evidence that support the challenge.” Section 42.22 similarly requires that each
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`petition must include “a detailed explanation of the significance of the evidence.”
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`Id. § 42.22. The “Board may exclude or give no weight to the evidence where a
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`party has failed to state its relevance or to identify specific portions of the evidence
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`that support the challenge.” Id. § 42.104.
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`
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`Here, the Crock Affidavit is irrelevant to the grounds of unpatentability at
`
`issue in this proceeding. (See Paper 17.) Dr. Crock does not opine on any of the
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`relevant references and provides no discussion of the ’997 patent. Instead, Dr.
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`Crock opines on surgeries he allegedly performed abroad and several of his
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`publications that NuVasive chose not to include in its petition.
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`Further, NuVasive fails to state the relevance of the Crock Affidavit or
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`otherwise cite specific portions of the affidavit that support its challenge. See 37
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`C.F.R. §§ 42.22, 42.104. NuVasive’s petition includes one passing reference to Dr.
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`Crock and cites to Dr. McAfee’s original declaration at paragraph 11. (See Paper 5
`
`at 7.) But that portion of Dr. McAfee’s declaration attempts to generalize Dr.
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`Crock’s alleged work without citing any specific part of the Crock Affidavit.
`
`NuVasive’s reply also fails to cite any portion of the Crock Affidavit or even
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`3
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`

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`attempt to establish its relevance to this proceeding. Accordingly, the Crock
`
`Affidavit should be excluded in its entirety as irrelevant and non-compliant with
`
`FRE 402 and 37 C.F.R. §§ 42.22 and 42.104.
`
`ii.
`
`Paragraphs 18–22 of the Crock Affidavit are inadmissible
`under 35 U.S.C. § 311
`
`
`
`Warsaw also objected to Exhibit 1014 based on 35 U.S.C. § 311 in Paper 45.
`
`As noted above, the entirety of Exhibit 1014 is inadmissible as irrelevant under
`
`FRE 401 and 402 and improper under 37 C.F.R. §§ 42.22 and 42.104. Paragraphs
`
`18 through 22 are furthermore inadmissible under § 311 because they exceed the
`
`scope of inter partes review. The law is clear: a petition for IPR can only be
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`based on “prior art consisting of patents and printed publications.” 35 U.S.C.
`
`§ 311. Dr. Crock testifies regarding prior surgical operations performed abroad in
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`paragraphs 18 through 22. These procedures are not prior art under any section of
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`35 U.S.C. § 102. At best, these procedures would be evidence of alleged prior
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`public use if they were performed in the United States. But Congress expressly
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`limited the prior art in an IPR to patents and printed publications. As such, Dr.
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`Crock’s alleged prior public use evidence in paragraphs 18–22 is inadmissible.
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`B.
`EXHIBITS 1015–1021: CROCK EXHIBITS
`Exhibits 1015–1021 are exhibits to the Crock Affidavit. Together, these
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`exhibits constitute hundreds of pages of publications authored by Dr. Crock, a
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`“Practice Note” allegedly pertaining to the Federal Court of Australia, and Dr.
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`4
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`

`

` 
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`Crock’s CV. Exhibit 1018 was also submitted as Appendix A to Exhibit 1001, Dr.
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`McAfee’s original declaration. (See Ex. 1001 at 40–53.)  
`
`i. Exhibits 1015–1021 are inadmissible as irrelevant under
`FRE 401–402 and 37 C.F.R. §§ 42.22 & 42.104
`Warsaw objected to Exhibit 1001 based on FRE 401 and 402 in Paper 20,
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`and Exhibits 1001 and 1015–1021 on the same grounds, as well as 37 C.F.R.
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`§§ 42.22 & 42.104 in Paper 45. These exhibits are inadmissible for the same
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`reasons as the Crock Affidavit itself: they do not relate to any ground of
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`unpatentability at issue in this proceeding and Petitioner fails to state their
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`relevance to this IPR. Indeed, NuVasive never attempted to explain the relevance
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`of these exhibits and publications. Therefore, these exhibits should be excluded as
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`irrelevant and inadmissible under FRE 402 and 37 C.F.R. §§ 42.22 and 42.104.
`
`C. EXHIBIT 1029: SECOND MCAFEE DECLARATION
`Petitioner submitted a Second McAfee Declaration in support of its March
`
`11, 2014 reply. The Second McAfee Declaration is 128 pages long and, as
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`outlined below, compromised by impermissible prior public use evidence.
`
`i. Paragraphs 4, 7, 9–10, 37–39, 43–45, and 48–49 are
`inadmissible under 35 U.S.C. § 311
`Petitioner and Dr. McAfee disregard the limited scope of an inter partes
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`review and seek to inject impermissible alleged prior public use evidence into this
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`case. The relevant inquiry in this proceeding is whether the combination of prior
`
`art in the instituted grounds of unpatentability render the claims of the ’997 patent
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`5
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`

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` 
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`obvious. And a petition can only be based on “prior art consisting of patents and
`
`printed publications.” 35 U.S.C. § 311. Warsaw objected to Exhibit 1029 under
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`35 U.S.C. § 311 in Paper 45.
`
` Dr. McAfee wrongly relies on Dr. Jacobson’s declaration (Exhibit 1030)
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`about the alleged surgeries he performed prior to 1995 and on two publications
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`(Exhibits 1036 and 1037) that allegedly teach Dr. Jacobson’s “direct lateral
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`surgical method,” which is substantively different from the procedure described in
`
`the Jacobson ’374 patent. Similarly, Dr. McAfee wrongly relies on the Crock
`
`Affidavit (Exhibit 1014) in paragraphs 7 and 9 of his second declaration about the
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`surgeries Dr. Crock allegedly performed prior to 1995. These surgeries and
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`publications are not relevant to whether the challenged claims are unpatentable in
`
`light of the prior art patents and printed publications in the instituted claims—i.e.,
`
`whether the disclosures of the patents and printed publications, as understood by a
`
`person of ordinary skill in the art, render the challenged claims unpatentable. See
`
`35 U.S.C. § 311. For example, Dr. McAfee seeks to recast this inquiry into what
`
`Dr. Jacobson was doing prior to 1995, not what the Jacobson ’374 reference
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`discloses to a person of ordinary skill in the art. As further evidence of Dr.
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`McAfee’s misapplication of the law, he dismisses the opinions of Warsaw’s expert,
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`Dr. Sachs, because “he never spoke with Dr. Jacobson, and never contacted any
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`person that practiced Dr. Jacobson’s patented method during the 1980s, never
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`6
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`

`

` 
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`discussed Dr. Jacobson’s patent with anyone of skill in the art, and never analyzed
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`any journal article or other paper that refers to Dr. Jacobson’s lateral method.” (Ex.
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`1029 ¶ 37.)1 Dr. McAfee’s reliance on the alleged methods practiced by Dr.
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`Jacobson and Dr. Crock is improper and impermissible.
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`Furthermore, Dr. McAfee relies extensively on the alleged surgeries of Dr.
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`Jacobson to improperly supplement the disclosures of the Jacobson ’374 patent.
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`Paragraphs 4, 7, 10, 37–39, 43–45, and 48–49 all rely on this alleged prior public
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`use evidence and should be excluded. For example, Dr. McAfee opines that
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`Jacobson ’374 discloses a direct lateral approach for performing an interbody
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`fusion procedure. (Ex. 1029 ¶ 49.) As support for this assertion, Dr. McAfee
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`states that “Dr. Jacobson independently confirmed that he used the direct lateral
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`access cannula described in the Jacobson patent to perform direct lateral fusion
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`surgeries . . . .” (Id.) This evidence taints Dr. McAfee’s analysis of Jacobson ’374
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`and takes it outside the admissible scope of evidence in an IPR. The same is true
`
`                                                            
`1
`Petitioner cites to this statement by Dr. McAfee as support for its assertion
`that “Warsaw’s expert Dr. Sachs rendered his flawed opinion that Jacobson
`discloses posterolateral without a proper inquiry.” (See IPR2013-00208, Paper 40
`at 6 (emphasis added).) Apparently, Petitioner also misunderstands the scope of an
`inter partes review, which does not require expert witnesses to consult with prior
`art authors before opining on the disclosure of their patents and printed
`publications.
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`7
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`for the other paragraphs cited above. (See, e.g., id. ¶ 38 (“all of this is
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`independently corroborated by the above-mentioned Friedman article that was
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`published after Dr. Jacobson personally taught Dr. Friedman same [sic] direct
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`lateral surgical method that is described in the Jacobson patent”).) It is both
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`illogical and legally improper to supplement the teachings of Jacobson ’374 with
`
`this extrinsic evidence. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed.
`
`Cir. 1991) (citing Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d
`
`1565, 1576–77 (Fed. Cir. 1991) (“The role of extrinsic evidence is to educate the
`
`decision-maker to what the reference meant to persons of ordinary skill in the field
`
`of the invention, not to fill gaps in the reference.”), overruled on other grounds by
`
`Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009).) Because these
`
`paragraphs exceed the scope of inter partes review and improperly address what
`
`Dr. Jacobson was doing and not what his ’374 patent teaches, they compromise Dr.
`
`McAfee’s obviousness analysis and should be excluded.
`
`D. EXHIBIT 1030: JACOBSON DECLARATION
`Exhibit 1030 is a declaration from Dr. Jacobson (“Jacobson Declaration”),
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`the inventor of the Jacobson ’374 reference, submitted by NuVasive in support of
`
`its reply in this proceeding. The Jacobson Declaration is focused primarily on the
`
`procedures allegedly practiced by Dr. Jacobson—that are substantively different
`
`from the procedure described in the Jacobson ’374 patent—and is compromised by
`
`
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`8
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`

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` 
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`inadmissible alleged prior public use evidence.
`
`i. Paragraphs 4–6, 8, and 10 are inadmissible under 35 U.S.C.
`§ 311
`Petitioner and Dr. Jacobson disregard the limited scope of an IPR and seek
`
`to inject impermissible alleged prior public use evidence into this case. As
`
`explained above, the relevant inquiry in this proceeding is whether the combination
`
`of prior art in the instituted grounds of unpatentability render the claims of the ’997
`
`patent obvious. This prior art is limited by the Board’s decision instituting trial
`
`and Congress’s clear direction that a petition can only be based on “prior art
`
`consisting of patents and printed publications.” 35 U.S.C. § 311. Warsaw
`
`objected to Exhibit 1030 under 35 U.S.C. § 311 in Paper 45.
`
`The Jacobson Declaration runs afoul of the limited scope of an IPR and
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`presents little more than inadmissible alleged prior public use evidence. In
`
`presenting this testimony, NuVasive seeks to expand the scope of this proceeding
`
`to include what Dr. Jacobson was allegedly doing prior 1995, not what the
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`Jacobson ’374 reference discloses to a person of ordinary skill in the art.
`
`Paragraphs 4–6, 8, and 10 are all compromised by this inadmissible evidence and
`
`should be excluded from this proceeding. For example, in an attempt to rebut Dr.
`
`Sachs’ opinion that Jacobson ’374 teaches a posterolateral approach to the spine,
`
`Dr. Jacobson testified that “the approach that I had developed and used at the time
`
`was a direct lateral approach, not a posterolateral approach.” (Ex. 1030 ¶ 4.) Dr.
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`
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`9
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`

`

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`Jacobson also testified that “shortly after I had developed my direct lateral
`
`procedure set forth in my ’374 patent, I began teaching that procedure to other
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`orthopedic and neurologic surgeons. … [And] approximately 50 spine surgeons
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`observed me perform the procedure described in my ’374 patent ….” (Id. ¶ 8.) Dr.
`
`Jacobson then improperly argues that this somehow shows that his ’374 patent
`
`discloses a direct lateral approach. (Id.) But this is nothing more than an attempt
`
`to introduce inadmissible prior public use evidence. As such, it should be excluded.
`
`ii.
`
`Paragraphs 4–6, 8, and 10 are inadmissible as irrelevant
`under FRE 401 and 402
`Warsaw objected to Exhibit 1030 based on FRE 401 and 402 in Paper 45.
`
`As discussed above, the Jacobson Declaration paragraphs 4–6, 8, and 10 all contain
`
`testimony about Dr. Jacobson’s alleged development and performance of an
`
`alleged direct lateral approach to the spine. However, what Dr. Jacobson or others
`
`may have done after filing the disclosure of the ’374 patent says nothing about the
`
`text and figures of the patent and how a person of ordinary skill in the art would
`
`understand the patent’s disclosure. NuVasive attempts to conflate the issues of
`
`what Dr. Jacobson was doing with what his ’374 patent discloses to a person of
`
`ordinary skill in the art. This is improper because “[t]he role of extrinsic evidence
`
`is to educate the decision-maker to what the reference meant to persons of ordinary
`
`skill in the field of the invention, not to fill gaps in the reference.” Scripps Clinic,
`
`927 F.2d at 1576–77; In re Baxter, 952 F.2d at 390. What Dr. Jacobson did is
`
`
`
`10
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`

`

` 
`
`irrelevant to the question presented in this proceeding, and Dr. Jacobson’s
`
`testimony on the subject should be excluded under FRE 401 and 402.  
`
`EXHIBIT 1032: MILES DECLARATION
`
`E.
`Petitioner submitted Exhibit 1032, a declaration from Mr. Patrick Miles,
`
`President of Global Products and Services at Petitioner. Warsaw objected to this
`
`exhibit in Paper 45 on the basis of, inter alia, FRE 702. (Paper 45 at 7.) Warsaw
`
`now moves to exclude a statement from paragraph 9 of Exhibit 1032 on the same
`
`ground. Petitioner relies on paragraph 9 of Exhibit 1032 in page 14 of its reply.
`
`i. Paragraph 9 of Exhibit 1032 is inadmissible under FRE 702
`Mr. Miles contends in paragraph 9 of his declaration that the ’997 patent
`
`requires the removal of portions of the adjacent vertebrae. (See Exhibit 1032 ¶ 9
`
`(“[s]ome key factors to XLIF’s success include: … a patented fusion implant
`
`design that, unlike the implants disclosed in the ‘997 patent, does not require the
`
`removal of portions of the adjacent vertebrae ….”) (emphasis added); id. ¶ 4.)
`
`This statement is inadmissible under FRE 702 because Mr. Miles lacks the
`
`background required to opine on the disclosure and “requirements” of the ’997
`
`patent. A person of ordinary skill in the art in the field of the ’997 patent is “a
`
`surgeon with extensive knowledge of the human anatomy, the use of devices in the
`
`human spine, and the biomechanical, anatomical, and physiological implications of
`
`such use.” (Exhibit 2038 ¶ 22 (emphasis added).) Neither Petitioner nor its expert,
`
`Dr. McAfee, disputes this. (See, e.g., Exhibit 1001 ¶¶ 4, 7)
`11
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`
`There is no evidence that Mr. Miles has the requisite background as a
`
`surgeon. (See Exhibit 1032 ¶¶ 1−5.) Therefore, Mr. Miles’s assertion in paragraph
`
`9 of his declaration that the ’997 patent requires removal of portions of adjacent
`
`vertebrae should be excluded as improper expert testimony. Sundance, Inc. v.
`
`DeMonte Fabricating Ltd., 550 F.3d 1356, 1363 (Fed. Cir. 2008) (“Indeed, where
`
`an issue calls for consideration of evidence from the perspective of one of ordinary
`
`skill in the art, it is contradictory to Rule 702 to allow a witness to testify on the
`
`issue who is not qualified as a technical expert in that art.”)
`
`F.
`EXHIBITS 1036 & 1037: FRIEDMAN ARTICLES
`Exhibits 1036 and 1037 are articles written by Dr. William Friedman
`
`relating to procedures that substantively differ from those described in the
`
`Jacobson ’374 patent. Petitioner submitted these articles with its reply papers as
`
`allegedly corroborating evidence for its position that Jacobson ’374 patent
`
`discloses a direct lateral approach to the spine. These exhibits are inadmissible as
`
`irrelevant and outside the scope of an inter partes review under 35 U.S.C. § 311.
`
`i. Exhibits 1036 and 1037 are inadmissible as irrelevant under
`FRE 401 and 402
`
`Warsaw objected to Exhibits 1036 and 1037 based on FRE 401 and 402 in
`
`Paper 45. These exhibits are irrelevant. The inquiry in this proceeding is whether
`
`the prior art patents and printed publications in the instituted grounds of
`
`unpatentability render the challenged claims unpatentable. This requires
`
`
`
`12
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`

` 
`
`consideration of the prior art references at issue from the perspective of a person of
`
`ordinary skill in the art. Exhibits 1036 and 1037 are not included in NuVasive’s
`
`petition or part of any instituted ground of unpatentability; they are offered only as
`
`evidence of what the Jacobson ’374 patent discloses. But these exhibits do not cite,
`
`mention, discuss, or otherwise reference the Jacobson ’374 patent or its teachings.
`
`As such, Exhibits 1036 and 1037 are irrelevant to the question of how a person of
`
`ordinary skill in the art would understand the teachings of Jacobson ’374. 
`
`ii. Exhibits 1036 & 1037 are inadmissible under 35 U.S.C.
`§ 311
`Warsaw objected to Exhibits 1036 and 1037 based on 35 U.S.C. § 311 in
`
`Paper 45. NuVasive offers these exhibits to show the approach of “Dr. Jacobson’s
`
`procedure.” Specifically, NuVasive submits Exhibits 1036 and 1037 as “articles
`
`from the 1980s [that] describe Dr. Jacobson’s procedure, and illustrate views Dr.
`
`Sachs says are needed to distinguish between lateral and posterolateral.” (Paper 43
`
`at 6.) But what Jacobson was doing, i.e., his surgical procedure, is not relevant to
`
`this proceeding. NuVasive, therefore, offers these exhibits as evidence of prior
`
`public use, which is impermissible prior art in an IPR and they should be excluded.  
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`G. EXHIBITS 1046, 1049, & 1050
`Exhibit 1046 is a diagram of the corporate structure of Medtronic, Inc. and
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`its relationship to certain affiliated entities. Exhibit 1049 is an article published in
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`The Scientific World Journal in 2012 and authored by Malham et al. and edited by
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`Dr. Luis Pimenta, a NuVasive-affiliated surgeon and inventor on several patents
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`assigned to NuVasive. (See, e.g., Exs. 1059–60.) Exhibit 1050 appears to be a
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`summary of a presentation given by Dr. Deukmedjian at a conference in 2013.
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`i. Exhibits 1046, 1049, & 1050 are inadmissible as irrelevant
`under FRE 401 and 402
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`Warsaw objected to Exhibits 1046, 1049, and 1050 based on FRE 401 and
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`402 in Paper 45. NuVasive apparently submitted these exhibits in support of its
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`reply, but it never cited to or otherwise used them in any paper filed in this
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`proceeding. Without any explanation of these exhibits, they are irrelevant.
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`Moreover, there is nothing about the corporate structure of Medtronic, Inc. that
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`affects the determination of obviousness in this proceeding. As such, Exhibits
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`1046, 1049, and 1050 are irrelevant and inadmissible under FRE 401 and 402.
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`Moreover, to the extent Petitioner relies on Exhibits 1049 and 1050 for the truth of
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`the matter asserted, they are hearsay. 
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`H. EXHIBIT 1067: MCAFEE 1998 ARTICLE
`Exhibit 1067 is an article written by Dr. McAfee that was published in 1998.
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`Petitioner appears to submit this exhibit as evidence of the state of the art in 1995.
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`i. Exhibit 1067 is inadmissible as irrelevant under FRE 401
`and 402
`Warsaw objected to Exhibit 1067 based on FRE 401 and 402 in Paper 45.
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`As noted above, this exhibit was published in 1998, years after Dr. Michelson’s
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`invention of the claimed subject matter of the ’997 patent. The article purports to
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`report a study conducted between March 1994 and September 1996. However, the
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`article provides no specificity as to when these surgical procedures were actually
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`performed. Petitioner also does not show that this study, which purportedly did not
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`conclude until the fall of 1996, was known to persons of ordinary skill in the art in
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`1995. As such, Petitioner has failed to show that this exhibit is relevant.  
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`IV. PETITIONER’S REPLY EVIDENCE
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`Petitioner’s reply papers present a number of rule violations, which Warsaw
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`presented in its motion to strike discussed during a conference call with the Board
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`on March 25, 2014. (See Paper 46.) During this conference call, the Board
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`declined to then strike NuVasive’s reply, but stated that it would address the issue
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`in the context of its consideration of the merits of the Petition. The Board also
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`declined further briefing on the issue. (Id.) Warsaw understands that a motion to
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`exclude is not the mechanism through which to challenge the scope of Petitioner’s
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`improper reply filing. Kyocera Corp. v. Softview LLC, IPR2013-00004, slip op. at
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`33 (PTAB March 27, 2014) (Paper 53) (“A motion to exclude is … [not] a proper
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`vehicle for arguing whether a reply or supporting evidence is of appropriate
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`scope.”) Pursuant to 37 C.F.R. § 42.64(c), Warsaw reserves its challenge to the
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`scope of NuVasive’s reply briefing and supporting evidence on appeal.
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`Dated: April 25, 2014
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`Respectfully Submitted,
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`/Thomas H. Martin/
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`Thomas H. Martin
`Registration No. 34,383
`Attorney for Patent Owner
`MARTIN & FERRARO, LLP
`1557 Lake O’Pines Street, NE
`Hartville, Ohio 44632
`Telephone: (330) 877-0700
`Facsimile: (330) 877-2030
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`Case IPR2013-00206
`U.S. Patent No. 8,251,997
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of these REQUEST FOR
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`ORAL ARGUMENT and MOTION TO EXCLUDE were served in their entirety
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`via electronic mail to APSI@fr.com (referencing Attorney Docket
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`No. 13958-0112IP2):
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`Stephen R. Schaefer
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`Michael T. Hawkins
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`3200 RBC Plaza
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`3200 RBC Plaza
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`60 South Sixth Street
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`60 South Sixth Street
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`Minneapolis, MN 55402
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`Minneapolis, MN 55402
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`Date of Service:
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`April 25, 2014
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`
`
`
`
`/Thomas H. Martin/
`Signature:
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`
`Thomas H. Martin, Reg. No. 34,383
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`