UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`NUVASIVE, INC.
`Petitioner
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`v.
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`WARSAW ORTHOPEDICS, INC.
`Patent Owner
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`Case IPR2013-00206
`Patent 8,251,997
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO EXCLUDE
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`Case IPR2013-00206
`Attorney Docket No: 13958-112IP2
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`TABLE OF CONTENTS
`I. PROCEDURAL HISTORY .................................................................................................. 1
`II. ARGUMENT ....................................................................................................................... 1
`A. EXHIBITS 1001 AND 1014: THE CROCK AFIDAVIT .................................................. 1
`i. The Crock Affidavit (Ex. 1001, pp. 54-85 and Ex. 1014) is uncompelled direct
`testimony in this proceeding and therefore is not hearsay, and even if it were
`hearsay, it is proper for experts to rely upon hearsay. .............................................. 3
`ii. The Crock Affidavit is also not excludable under FRE 401-402 or 37 CFR §§
`42.22, 42.104 ................................................................................................................... 4
`iii. Paragraphs 18–22 of the Crock Affidavit are not inadmissible under 35 U.S.C. §
`311 ................................................................................................................................... 6
`B. EXHIBITS 1015–1021: CROCK EXHIBITS ................................................................... 6
`C. EXHIBIT 1029: SECOND MCAFEE DECLARATION .................................................. 7
`i. Paragraphs 4, 7, 9–10, 37–39, 43–45, and 48–49 of the Second McAfee
`Declaration are admissible ........................................................................................... 8
`D. EXHIBIT 1030: JACOBSON DECLARATION ............................................................ 10
`i. Paragraphs 4–6, 8, and 10 are admissible and relevant ....................................... 11
`E. EXHIBIT 1032: MILES DECLARATION ..................................................................... 12
`F. EXHIBITS 1036 & 1037: FRIEDMAN ARTICLES ....................................................... 13
`G. EXHIBITS 1046, 1049, & 1050 .................................................................................... 14
`H. EXHIBIT 1067: MCAFEE 1998 ARTICLE .................................................................. 14
`III. NUVASIVE’S REPLY EVIDENCE .................................................................................. 15
`IV. CONCLUSION ................................................................................................................ 15
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`Statutes
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`Case IPR2013-00206
`Attorney Docket No: 13958-112IP2
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`TABLE OF AUTHORITIES
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`28 U.S.C. § 1746 ................................................................................................................ 3, 4
`35 U.S.C. § 311 ...................................................................................................................... 6
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`Rules
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`F.R.E. 801(c)(1) ...................................................................................................................... 3
`F.R.E. 801 ............................................................................................................................... 4
`F.R.E. 802 ............................................................................................................................... 4
`F.R.E. 703 ............................................................................................................................... 4
`F.R.E. 401 ............................................................................................................................... 4
`F.R.E. 402 ............................................................................................................................... 4
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`Regulations
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`37 CFR § 42.64(b)(1) .............................................................................................................. 1
`37 CFR § 42.64(b)(2) .............................................................................................................. 2
`37 CFR § 42.51(b)(1)(ii) .......................................................................................................... 2
`37 CFR § 42.53(a) .................................................................................................................. 3
`37 CFR § 1.68 .................................................................................................................... 3, 4
`37 CFR § 42.65 ...................................................................................................................... 4
`37 CFR § 42.22 .................................................................................................................. 4, 5
`37 CFR § 42.104 ................................................................................................................ 4, 5
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`INTRODUCTION
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`Case IPR2013-00206
`Attorney Docket No: 13958-112IP2
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`Petitioner NuVasive, Inc. opposes Warsaw’s motions to exclude, filed Apr. 25, 2014.
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`Warsaw ignores appropriate uses of evidence. For example, much of the evidence in
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`question is offered to rebut incorrect statements of Warsaw and its expert, Dr. Sachs. Other
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`evidence is offered for background on the state of the art and knowledge of a person of skill
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`in the art, in addition to rebuttal. As set forth below, Warsaw’s objections must be denied.
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`I. PROCEDURAL HISTORY
`The timeline presented by Warsaw is generally accurate. That said, NuVasive does
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`not agree that Warsaw’s objections were with “sufficient particularity to allow correction.” 37
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`CFR § 42.64(b)(1). Warsaw’s objections were general, and did not identify the particular
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`issues it now addresses in its motion. See Papers 20 and 45.
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`II. ARGUMENT
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`A. EXHIBITS 1001 AND 1014: THE CROCK AFIDAVIT
`NuVasive submitted, with its Petition as appendices to the Dr. McAfee’s declaration,
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`a 1982 Crock paper and a Crock Affidavit that is the subject of Warsaw’s motion to exclude.
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`Ex. 1001, pp. 40-53 (1982 Crock paper), pp. 54-85 (Crock Affidavit). The Crock Affidavit is
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`made under oath. See Ex. 1001, p. 56; see also Ex. 1014, p. 2. The affidavit complies with
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`Australian Law, and Warsaw makes no contention to the contrary.
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`Dr. McAfee cites – in a section of his declaration titled “Background Knowledge One
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`of Skill in the Art Would have Had Prior to the Filing of the ‘997 Patent” – the 1982 Crock
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`paper and Crock Affidavit as state of the art evidence, that lateral approaches to the spine
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`were known before the ‘997 patent’s earliest claimed priority (1995), and that knowledge
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`came not only from Jacobson, but also from other sources such Dr. Crock’s 1982 paper.
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`See Ex. 1001, ¶ 11. On Oct. 21, 2013, in response to Warsaw’s objections (Paper 19),
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`NuVasive served Warsaw with the Crock Affidavit as a separate exhibit (later filed as Ex.
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`1014), and with a complete set of appendices to the Dr. Crock Affidavit (later filed as Ex.
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`1015-1021). See NuVasive transmittal letter, Oct. 21, 2013, serving supplemental evidence
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`pursuant to 37 C.F.R. § 42.64(b)(2).
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`Though Warsaw could have cross examined Dr. Crock on this direct testimony as
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`routine discovery, 37 CFR § 42.51(b)(1)(ii), Warsaw chose not to do so. Instead, Warsaw
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`responded with testimony of its expert, Dr. Sachs (Ex. 2038), who contended, incorrectly,
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`that the 1982 Crock paper does not disclose a lateral approach and translaterally positioned
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`implant. See Ex. 2038, ¶¶ 46-48. Dr. Sachs went further, stating lateral approaches had
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`never been done before 1995. See id., ¶ 48. Finally, Dr. Sachs stated, in essence, Dr.
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`Crock testified falsely about his 1982 paper and lateral work in his Affidavit. See id., ¶ 48.
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`Dr. Sachs did this, despite Warsaw having not cross examined Dr. Crock on the issues.
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`NuVasive, with its Reply, offered evidence responding the Dr. Sachs’ opinions
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`related to Dr. Crock’s teachings. See, e.g., Ex. 1029, ¶¶ 7, 9, 10, 100. NuVasive submitted
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`the Dr. Crock Affidavit, this time as a separate exhibit (Ex. 1014), as well as a complete set
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`of appendices to the Affidavit (Ex. 1015-1021). Following the Reply, Warsaw again made
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`Attorney Docket No: 13958-112IP2
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`no request of NuVasive to cross-examine Dr. Crock, choosing instead to file the present
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`motion to exclude.
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`i. The Crock Affidavit (Ex. 1001, pp. 54-85 and Ex. 1014) is uncompelled
`direct testimony in this proceeding and therefore is not hearsay, and
`even if it were hearsay, it is proper for experts to rely upon hearsay.
`The Crock Affidavit (Ex. 1001, pp. 54-85; Ex. 1014) is uncompelled direct testimony
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`properly submitted in the form of an affidavit in compliance with 37 CFR § 42.53(a). The
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`Federal Rules of Evidence define “hearsay,” in part, as “a statement that … the declarant
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`does not make while testifying at the current trial or hearing.” F.R.E. 801(c)(1). That is not
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`the case here. The Crock Affidavit is an in-Court statement, and not hearsay.
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`Warsaw incorrectly contends the Dr. Crock Affidavit is hearsay because it was
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`executed in Australia and did not swear or declare that the testimony was true and correct
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`under the laws of the United States. See Warsaw Motion to Exclude, p. 2. But, Warsaw
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`cites to no requirement that an affidavit be executed in the United States, or that the affidavit
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`declare that the testimony is true and correct under the United States. Although that an
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`unsworn declaration in lieu of an affidavit requires certain statements and references to U.S.
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`Law (see 28 U.S.C. § 1746; 37 CFR § 1.68), that is not required for affidavits. Moreover, it
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`is not Warsaw that should be criticizing direct testimony formalities. Unlike the Crock
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`Affidavit which complies with all formalities, the Dr. Sachs declaration that Warsaw
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`submitted does not comply with the formalities for unsworn declarations in lieu of affidavits
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`Attorney Docket No: 13958-112IP2
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`set forth in 28 U.S.C. § 1746 and 37 CFR § 1.68. See Ex. 1038 (lacking any reference to
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`penalty of perjury as required by Statute and 37 CFR § 1.68).
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`Accordingly, the Crock Affidavit is not hearsay, and may not be excluded as hearsay
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`under FRE 801 and 802. Moreover, even if the Crock Affidavit were hearsay under FRE
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`801, which it is not the case here, an expert (i.e., Dr. McAfee) may rely properly rely upon
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`hearsay under FRE 703. See Ex. 1001, ¶ 11. Also, 37 CFR § 42.65 requires experts, such
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`as Dr. McAfee, to “disclose the underlying facts or data on which the opinion is based” or
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`the opinion will be given little or no weight. See id.; Ex. 1029, ¶¶ 7, 9, 10, 100.
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`ii. The Crock Affidavit is also not excludable under FRE 401-402 or 37
`CFR §§ 42.22, 42.104
`“Evidence is relevant if: (a) it has any tendency to make a fact more or less probable
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`than it would be without the evidence; and (b) the fact is of consequence in determining the
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`action.” FED. R. EVID. 401. The Crock Affidavit is relevant at least for two reasons. First, it
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`is relevant to the state of the art at the time of the earliest claimed priority date, 1995. Dr.
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`McAfee testifies lateral approaches to the spine and laterally placed implants were well
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`known from many sources, not just Jacobson, before 1995. See Ex. 1001 (First McAfee
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`Decl.), ¶ 11; see also Ex. 1029 (Second McAfee Decl.), ¶¶ 7, 9, 10, 100. In other words,
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`Jacobson is not some isolated reference describing a lateral approach that few surgeons
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`knew about; lateral approaches and laterally placed implants were both well known before
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`1995. Dr. Sachs disagrees, saying not only that Jacobson does not disclose a lateral
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`approach, but no other reference discloses a lateral approach either. See Ex. 2038, ¶¶ 46-
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`48. The Crock Affidavit is relevant even though it is not a prior art reference included in an
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`invalidity ground. Indeed, Warsaw’s expert Dr. Sachs is attempting to create a grossly
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`incorrect assumption about the state of the art in 1995, that lateral approaches had never
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`been done before 1995. See Ex. 2038, ¶¶ 46-48. That is false, and NuVasive is permitted
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`to rebut that, as it has done. See Ex. 1029, ¶¶ 7, 9, 10, 100. Second, the Crock Affidavit is
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`relevant to the credibility of Dr. Sachs, who has misrepresented Dr. Crock’s work, and who
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`dismissed Dr. Crock’s statement under oath to the contrary despite Warsaw having opted to
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`not cross-examine Dr. Crock at all, on those issues or otherwise.
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`Warsaw’s contention that the Crock Affidavit must be excluded for certain alleged
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`rules violations (37 CFR §§ 42.22, 42.104) also misses the mark. First, the purpose of a
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`motion to exclude is not to argue rules violations, but rather is to address evidentiary issues.
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`Moreover, NuVasive explains the relevance of Dr. Crock’s work and the state of the art in
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`1995 regarding lateral approaches and laterally placed implants, for example in its Petition
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`(e.g., p. 7). Also, both McAfee declarations rely upon the Crock Affidavit. Ex. 1001, ¶ 11;
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`Ex. 1029, ¶¶ 7, 9, 10, 100. That these are background state of the art matters, as opposed
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`to references used in the invalidity grounds, is of no moment. Again, Warsaw and Dr.
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`Sachs are attempting to give a grossly inaccurate picture of the state of the art in 1995, and
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`should not be entitled to do so while attempting to exclude any rebuttal.
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`iii. Paragraphs 18–22 of the Crock Affidavit are not inadmissible under
`35 U.S.C. § 311
`Warsaw also seeks to exclude paragraphs 18-22 of the Crock Affidavit because it
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`allegedly exceeds the scope of inter partes review in that the Affidavit refers to surgical
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`activity that is not a patent or printed publication. While it is true that 35 U.S.C. § 311 limits
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`invalidity grounds that may be advanced in inter partes review to printed publication
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`grounds, there is no evidentiary rule that the only evidence that is relevant in inter partes
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`review proceedings is evidence set forth in printed publications, and indeed Warsaw cites to
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`no such rule in support of its position. See Motion to Exclude, p. 4. Paragraphs 18-22 of
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`the Crock Affidavit are relevant to the state of the art regarding lateral procedures and
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`implants in 1995 (an issue raised by Warsaw’s expert, Dr. Sachs), and to the credibility of
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`Dr. Sachs. See Ex. 2038, ¶¶ 46-48. As explained above, these issues are relevant in the
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`present proceeding.
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`B. EXHIBITS 1015–1021: CROCK EXHIBITS
`Exhibits 1020-1026 are a complete set of the appendices to the Crock Affidavit (Ex.
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`1014). Of these, Exhibit 1018 is the appendix with the 1982 Crock paper describing a
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`lateral approach and showing a translaterally placed implant (also provided at Ex. 1001, pp.
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`40-53). In addition, Ex. 1018 is particularly relevant to the state of the art, in that it is Dr.
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`Crock’s 1982 paper describing a lateral approach and translaterally positioned implant,
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`referenced by Dr. McAfee (see Ex. 1001, ¶¶ 11). These documents, while voluminous, are
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`provided for completeness of the Crock Affidavit. For the same reasons as explained above
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`with respect to the Crock Affidavit, the Board need only consider Exhibits 1015-1021 as
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`relevant background material on the state of the art and to impeach the opinions and
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`credibility of Dr. Sachs. They have never been offered for any other purpose.
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`C. EXHIBIT 1029: SECOND MCAFEE DECLARATION
`The Second McAfee Declaration (Ex. 1029) is presented for the exclusive purpose of
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`rebutting arguments and factual statements made in the Patent Owner Response and the
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`Sachs Declaration (Ex. 2038). While the Second McAfee Declaration is lengthy, that is only
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`due to the fact that there are so many incorrect or misleading statements in the Patent
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`Owner Response or the Sachs Declaration that required a fair and proper rebuttal. Every
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`paragraph of the Second McAfee Declaration (except for the first two and last two
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`paragraphs) specifically references the page of Patent Owner Response or paragraph
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`number of the Sachs Declaration to which it directly responds. See Ex. 1029. All of the
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`evidence in the Second McAfee Declaration was prompted by the Patent Owner Response
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`and the Sachs Declaration; it was not, and is not, required for NuVasive’s case-in-chief.
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`Contrary to Warsaw’s arguments here, at no point does Dr. McAfee or NuVasive urge the
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`Board to use an instance of prior public use as prior art to invalidate the ‘997 patent.
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`Attorney Docket No: 13958-112IP2
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`i. Paragraphs 4, 7, 9–10, 37–39, 43–45, and 48–49 of the Second McAfee
`Declaration are admissible
`Warsaw seeks to exclude paragraphs 4, 7, 9–10, 37–39, 43–45, and 48–49 of the
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`Second McAfee Declaration as “impermissible alleged prior public use evidence.” See
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`Warsaw’s Motion to Exclude, p. 5-6. Warsaw accuses NuVasive and Dr. McAfee of
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`“disregard[ing] the limited scope of inter partes review and seek[ing] to inject impermissible
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`alleged prior public use evidence into this case.” Id. This is not true.
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`NuVasive does not now and has never asked the Board to base any grounds of
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`invalidity on prior public use. A complete prima facie case of obviousness was made in the
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`Petition and its accompanying exhibits. The Board need not rely on any evidence of public
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`use to support a prima facie case of obviousness. NuVasive asks the Board to invalidate
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`the claims of the ‘997 patent only on the grounds proposed in the Petition, all of which are
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`based exclusively on patents and printed publications.
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`Again, the purpose of the Second McAfee Declaration is exclusively to rebut the
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`incorrect arguments and statements made in the Sachs Declaration and the Patent Owner
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`Response. The identified paragraphs of the Second McAfee Declaration (¶¶ 4, 7, 9–10,
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`37–39, 43–45, and 48–49) address incorrect statements by Dr. Sachs and support the
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`rebuttal with citations to evidence. Dr. McAfee supports his positions with evidence from the
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`text and figures of the invalidating references, with evidence from other publications, and
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`with testimonial evidence from Dr. Jacobson, Dr. Brantigan, Dr. Crock, and himself. See
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`Ex. 1029, ¶¶ 4, 7, 9–10, 37–39, 43–45, and 48–49.
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`For example, ¶ 7 of the Second McAfee Declaration rebuts ¶ 42 of the Sachs
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`Declaration. In ¶ 42 of the Sachs Declaration, Dr. Sachs testified that he has “been a
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`practicing surgeon for over 30 years and am not aware of any surgeons who performed a
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`direct lateral interbody implant fusion procedure prior to 1995.” Warsaw demands that such
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`testimony of prior use (or lack thereof) be admitted without any rebuttal, but this demand is
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`unreasonable and improper. Dr. McAfee rightly responded by identifying both written and
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`testimonial evidence that such surgeries indeed were performed by Dr. Crock, Dr. Jacobson
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`and himself and that Dr. Sachs was actually aware of at least some of those surgeries at the
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`time. See Ex. 1029, ¶ 7. Such rebuttal evidence was relevant and proper.
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`Similarly, ¶ 9 of the Second McAfee Declaration rebuts ¶ 45 of the Sachs Declaration
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`where Dr. Sachs testifies that “it is not possible to harvest a suitable tricortical bone graft
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`from the iliac crest that is long enough to occupy substantially all of the transverse width of
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`the vertebral body.” Ex. 2038, ¶ 45 (emphasis added). Dr. McAfee explains and presents
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`evidence showing that it is not only possible, but that Dr. Crock had actually done it. See
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`Ex. 1029, ¶ 9. It is surprising that Warsaw would present testimony that something is
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`“impossible” and then ask the Board to exclude sworn testimonial evidence to the contrary.
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`The rest of the challenged paragraphs are also relevant to rebut testimony in the
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`Sachs Declaration. ¶ 4 of the Second McAfee Declaration rebuts ¶ 30 of the Sachs
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`Declaration. ¶ 10 of the Second McAfee Declaration rebuts ¶¶ 46-48 of the Sachs
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`Declaration. ¶ 37-38 of the Second McAfee Declaration rebut ¶ 76 of the Sachs Declaration
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`among others. ¶ 39 of the Second McAfee Declaration rebuts ¶ 75 of the Sachs
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`Declaration. ¶ 43 of the Second McAfee Declaration rebuts ¶¶ 78-83 of the Sachs
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`Declaration. ¶ 44 of the Second McAfee Declaration rebuts ¶ 79 of the Sachs Declaration.
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`¶ 45 of the Second McAfee Declaration rebuts ¶ 81 of the Sachs Declaration. ¶ 48 of the
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`Second McAfee Declaration rebuts ¶ 86 of the Sachs Declaration. ¶ 49 of the Second
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`McAfee Declaration rebuts ¶¶ 86 and 88 of the Sachs Declaration.
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`None of the challenged paragraphs from the Second McAfee Declaration alleges
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`that “prior use” surgeries constitute prior art for an obviousness ground. The testimony
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`regarding prior direct lateral surgeries is offered along with other documentary evidence to
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`corroborate the truth of Dr. McAfee’s testimony and impeach Dr. Sachs’ testimony.
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`D. EXHIBIT 1030: JACOBSON DECLARATION
`The Jacobson Declaration (Ex. 1030) is a declaration by Dr. Robert Jacobson, the
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`sole inventor in the Jacobson patent (Ex. 1004), and is directed exclusively to rebutting Dr.
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`Sachs’ erroneous interpretations of the Jacobson patent.
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`i. Paragraphs 4–6, 8, and 10 are admissible and relevant
`Warsaw seeks to exclude ¶¶ 4-6, 8, and 10 of the Jacobson Declaration because
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`they refer to “impermissible alleged prior public use evidence” and on the basis of
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`relevance. See Warsaw’s Motion to Exclude, p. 9. But, NuVasive does not ask the Board
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`to base any rejections on prior public use. This is true of the direct lateral procedures
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`actually performed by Dr. Jacobson, which NuVasive agrees are neither patents nor printed
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`publications. NuVasive does, however, ask the Board to consider Dr. Jacobson’s testimony
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`when evaluating substance and veracity of Dr. Sachs’ testimony regarding the Jacobson
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`patent (which does qualify as a publication).
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`For example, Dr. Sachs testifies that “[t]hough Jacobson uses the word ‘lateral,’ the
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`term does not mean direct lateral.” Ex. 2038, ¶ 75. The entire Jacobson declaration
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`(including ¶¶ 4-6, 8, and 10) is directed to disputing this incorrect statement and other,
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`related, statements by Dr. Sachs. For example, in ¶ 4, Dr. Jacobson states “I believe it is
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`clear - from the figures and the text of my '374 patent, especially in view of the timeframe of
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`the early 1980s during which I developed and had a patent filed on my lateral procedure -
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`that my '374 patent discloses a direct lateral approach.” Dr. Jacobson then goes on to
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`support that statement by citing text and figures of the Jacobson patent and by also
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`explaining how things actually work in practice. Ex. 1030, ¶ 4.
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`In ¶ 5, Dr. Jacobson explains that he used the term “lateral” in his patent instead of
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`“direct lateral” because that was the technical parlance of the time in the early 1980s. In ¶¶
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`6-7, Dr. Jacobson explains that the difference between posterolateral methods and Dr.
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`Jacobson’s direct lateral method was “well known among spine surgeons and others in the
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`spinal community in the 1980s.” In ¶ 8, Dr. Jacobson discusses publications that
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`“corroborate that my approach was a 90 degree lateral approach to the spine.” In ¶¶ 9-10,
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`Dr. Jacobson addresses testimony in ¶ 88 of the Sachs declaration, discussing what it
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`means to be an “implant” and why the disclosed procedure “would necessarily involve
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`implanting something.” All of this testimony is relevant to address and put into context
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`contrary and, in NuVasive’s view, incorrect testimony by Dr. Sachs. This rebuttal testimony
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`should not be excluded simply because some of it does not also qualify as a patent or
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`printed publication. Dr. Jacobson’s testimony regarding his ‘374 patent and how it was
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`understood by others in the 1980s is pertinent to impeaching Dr. Sachs’ mischaracterization
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`of the Jacobson patent and his work before 1995. The Board is capable of assessing ¶¶ 4-
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`6, 8, and 10 of the Jacobson Declaration for its proper purposes (as identified above)
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`without improperly adopting a “prior use” rejection that was never proposed.
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`E. EXHIBIT 1032: MILES DECLARATION
`The Miles Declaration (Ex. 1032) is a declaration by Patrick Miles, the President of
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`Global Products and Services at NuVasive, relating to allegations of copying and
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`commercial success. Warsaw objects to part of a single sentence in ¶ 9 of the Miles
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`Declaration as including an improper expert opinion regarding the ‘997 patent.
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`To be clear, Mr. Miles does not opine on what is required by the claims of the ‘997
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`patent. Ex. 1032, ¶ 9. Mr. Miles is simply discussing commercial success, explaining that
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`NuVasive has “a patented fusion implant design that, unlike the implants disclosed in the
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`'997 patent, does not require the removal of portions of the adjacent vertebrae.” Ex. 1032, ¶
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`9 (emphasis added). Regardless of what the claims of the ‘997 patent require, it does not
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`take an expert to know that the ‘997 patent discloses dowel implants that require removal of
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`portions of vertebrae. See e.g. Ex. 1002, ‘997 patent, 13:58-59 (“The drill 250 reams out
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`arcs of bone”). This is simply a fact issue, not an expert opinion. If the Board disagrees, it
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`can simply give little or no weight to the phrase “unlike the implants disclosed in the ‘997
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`patent” in ¶ 9 of the Miles Declaration. The presence of those eight words does not change
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`the ultimate testimony of Mr. Miles regarding “[s]ome key factors of XLIF’s success”—a
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`topic on which Mr. Miles is more than qualified to provide relevant testimony. Ex. 1032, ¶ 9.
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`F. EXHIBITS 1036 & 1037: FRIEDMAN ARTICLES
`The Friedman Articles (Ex. 1036 and 1037) are publications describing the same
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`direct lateral procedure disclosed in the Jacobson patent. See Ex. 1030, Jacobson
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`Declaration, ¶ 8; Ex. 1029, Second McAfee Declaration, ¶ 37. Though the Friedman
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`Articles actually are prior art printed publications, they are not offered as a reference in any
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`of the obviousness combinations. Instead, they are offered to corroborate the testimony of
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`Case IPR2013-00206
`Attorney Docket No: 13958-112IP2
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`Dr. McAfee and Dr. Jacobson and rebut the testimony of Dr. Sachs regarding whether the
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`Jacobson patent discloses a direct lateral procedure.
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`Dr. McAfee and Dr. Jacobson state that the Jacobson patent discloses a direct
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`lateral procedure (Ex. 1001, ¶¶11, 22-23; Ex. 1029, ¶¶36-48; Ex. 1030, ¶¶ 3-8), while Dr.
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`Sachs argues that “his approach to the disc space was not in a direct lateral plane,” “a
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`surgeon would not insert a spinal needle in a direct lateral approach to the lumbar spine,”
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`and “it cannot be a direct lateral approach” (Ex. 2038, ¶¶ 75-84, 87). The Friedman Articles,
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`which expressly thank Dr. Jacobson for teaching the surgical method to the author, are
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`relevant as a contemporaneous and unbiased source of information on the same method
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`described and taught in the Jacobson patent. See Ex. 1030, Jacobson Declaration, ¶ 8; Ex.
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`1029, Second McAfee Declaration, ¶ 37.
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`G. EXHIBITS 1046, 1049, & 1050
`Exhibits 1046, 1049, and 1050 are exhibits that were filed but not cited by NuVasive.
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`This was an error. NuVasive does not object to their exclusion.
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`H. EXHIBIT 1067: MCAFEE 1998 ARTICLE
`Ex. 1067 is an article by Dr. McAfee, et al. describing a clinical study in which Dr.
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`McAfee participated. In his declaration, Dr. McAfee lists himself, in addition to Dr. Crock
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`and Dr. Jacobson, as a surgeon who had performed direct lateral interbody fusion
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`procedures prior to 1995. Ex. 1029, ¶ 7. Dr. McAfee states “[a]lthough our results of our
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`‘Lateral BAK’ study were not published until 1998, the fact that we were doing the study was
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`well known within the spinal surgery community. I know that Dr. Sachs was aware of our
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`study at the time it was being done, and he is aware of the 1998 article that reports the
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`results of our Lateral BAK study.” Ex. 1029, ¶ 7 (emphasis added). Exhibit 1067, although
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`not prior art, corroborates Dr. McAfee’s testimony. This is relevant to show, once again, the
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`fallacy of Dr. Sachs’ testimony that “surgeons did not start performing direct lateral interbody
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`fusion surgeries until after 1995.” Ex. 2038, ¶ 48.
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`III. NUVASIVE’S REPLY EVIDENCE
`Warsaw alleges additional rule violations, but does not identify any such violations.
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`NuVasive maintains that it committed no such rule violations.
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`IV. CONCLUSION
`NuVasive requests that the evidence discussed above be admitted and considered
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`for all proper uses. NuVasive trusts that the Board is capable of doing so with the evidence
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`submitted by both parties.
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`
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`Date: May 9, 2014
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`
`Customer Number 26171
`Fish & Richardson P.C.
`Telephone: (612) 337-2508
`Facsimile: (612) 288-9696
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`Respectfully submitted,
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`
` /Stephen R. Schaefer, Reg. No. 37,927/
`Stephen R. Schaefer
`Reg. No. 37,927
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies that on
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`May 9, 2014, a complete and entire copy of this PETITIONER’S OPPOSITION TO PATENT
`OWNER’S MOTION TO EXCLUDE was provided via email to the Patent Owner by serving
`the correspondence email addresses of record as follows:
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`Thomas H. Martin
`Wesley C. Meinerding
`Martin & Ferraro, LLP
`1557 Lake O’Pines Street, NE
`Hartville, OH 44632
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`Email: tmartin@martinferraro.com
`Email: docketing@martinferraro.com
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`/Diana Bradley/
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`Diana Bradley
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(858) 678-5667
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