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`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 ORTHOPEDIC, INC.
`Patent Owner
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`_____________________________
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`Case IPR2013-00206
`Patent No. 8,251,997
`_____________________________
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`WARSAW’S REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE
`PURSUANT TO 37 C.F.R. § 42.64
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`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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`A.
`B.
`C.
`D.
`E.
`F.
`G.
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`TABLE OF CONTENTS
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`Page
`Exhibits 1001 (pp. 54-85) and 1014: The Crock Affidavit ............................. 1
`Exhibits 1015–1021: Crock Exhibits ............................................................... 2
`Exhibit 1029: Second McAfee Declaration ..................................................... 2
`Exhibit 1030: Jacobson Declaration ................................................................ 3
`Exhibit 1032: Miles Declaration...................................................................... 4
`Exhibits 1036 & 1037: Friedman Articles ....................................................... 5
`Exhibit 1067: McAfee 1998 Article ................................................................ 5
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`i
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`TABLE OF AUTHORITIES
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`Page
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`Cases
`Pro-Mold and Tool Co., Inc. v. Great Lakes Plastics, Inc.
`75 F.3d 1568 (Fed. Cir. 1999) ......................................................................... 4
`Stewart-Warner Corp. v. City of Pontiac, Mich.
`767 F.2d 1563 (Fed. Cir. 1985) ....................................................................... 4
`Statutes
`35 U.S.C. § 311 .......................................................................................................... 5
`35 U.S.C. § 42.104 ..................................................................................................... 1
`35 U.S.C. § 42.22 ....................................................................................................... 1
`Federal Rules of Evidence 401 .................................................................................. 5
`Federal Rules of Evidence 402 .................................................................................. 5
`Federal Rules of Evidence 702 ..............................................................................4, 5
`Regulations
`37 C.F.R. 42.61 .......................................................................................................... 1
`37 C.F.R. 42.64 .......................................................................................................... 1
`77 Fed. Reg. 48756 (Aug. 14, 2012) ......................................................................... 1
`77 Fed. Reg. 48768 (Aug. 14, 2012) ......................................................................... 1
`MPEP § 2123 ............................................................................................................. 5
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`ii
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`NuVasive agrees that evidence of prior activities cannot form the basis of
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`any rejection. Yet, it is precisely through such activities, couched as “state of the
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`art” and “rebuttal” evidence, that NuVasive attempts to fill critical gaps in the
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`relevant inquiry: what the asserted references teach a person of ordinary skill in the
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`art. For the reasons set forth below and in Warsaw’s motion to exclude, the
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`challenged NuVasive evidence should be excluded.
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`A. Exhibits 1001 (pp. 54-85) and 1014: The Crock Affidavit
`NuVasive does not dispute that it failed to address the relevance of the
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`Crock Affidavit in its petition, as required by 35 U.S.C. §§ 42.22 and 42.104.
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`NuVasive instead argues that “the purpose of a motion to exclude is not to argue
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`rules violations.” (Paper 59 at 5.) NuVasive is wrong. A motion to exclude may
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`challenge the admissibility of evidence. 37 C.F.R. 42.64; 77 Fed. Reg. 48756,
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`48768 (Aug. 14, 2012). And Section 42.61 states that “[e]vidence that is not taken,
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`sought, or filed in accordance with this subpart is not admissible.” NuVasive’s
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`improperly submitted evidence is the proper subject of this motion.
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`NuVasive then argues that the Crock Affidavit was submitted to rebut Dr.
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`Sachs’ testimony on the state of the art in 1995. But NuVasive mischaracterizes
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`both the procedural history of this IPR and the testimony of Dr. Sachs it purports to
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`rebut. First, Dr. Sachs’ statements were in rebuttal to Dr. McAfee’s original
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`testimony and were submitted after the Crock Affidavit was originally filed.
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`1
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`NuVasive’s argument that it will be prejudiced by excluding the Crock Affidavit is
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`false because Dr. McAfee’s original testimony was included with NuVasive’s
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`petition. Second, Dr. Sachs did not testify that “no other reference discloses a
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`direct lateral approach” or that “lateral approaches had never been done before
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`1995.” (Paper 59 at 5.) Rather, Dr. Sachs testified that “direct lateral interbody
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`implant fusion procedure[s were not performed] prior to 1995.” (Ex. 2038 ¶ 42.)
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`NuVasive criticizes Warsaw for not cross-examining Dr. Crock (now 84
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`years old), who stated that “my physical health is such that I am not able to handle
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`undue stress” and “I am not able to travel long distances to the United States to
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`participate in legal proceedings.” (Crock Affidavit ¶ 14.) NuVasive’s argument
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`that Warsaw should have gone to Australia to depose a man in poor health
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`regarding irrelevant issues is without merit.
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`Exhibits 1015–1021: Crock Exhibits
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`B.
`For the reasons stated above, the exhibits attached to the Crock Affidavit
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`(Exhibits 1015-1021) should also be excluded.
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`C. Exhibit 1029: Second McAfee Declaration
`Paragraphs 4, 7, 9–10, 37–39, 43–45, and 48–49 all rely on improper public
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`use evidence to supplement the disclosures of the prior art at issue in this
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`proceeding and should be excluded. NuVasive argues the procedures allegedly
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`performed by Dr. Jacobson and Dr. Crock are relevant to rebut the opinions of Dr.
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`Sachs. NuVasive misses the point. Warsaw objects to these paragraphs because
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`Dr. McAfee misdirects the inquiry into what Drs. Jacobson and Crock were doing,
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`rather than what their references disclose. For example, Dr. McAfee relies on Dr.
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`Jacobson’s testimony to supplement the disclosures of Jacobson ’374, not to
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`present a rebuttal to Dr. Sachs on the state of the art. (See, e.g., Ex. 1029 ¶ 49
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`(“Dr. Jacobson independently confirmed that he used the direct lateral access
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`cannula described in the Jacobson patent to perform direct lateral fusion
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`surgeries.”).) NuVasive does not even attempt to respond to this improper use of
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`the evidence.
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`D. Exhibit 1030: Jacobson Declaration
`Though NuVasive argues that Paragraphs 4–6, 8, and 10 of the Jacobson
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`Declaration serve to rebut Dr. Sachs’ testimony regarding Jacobson ’374, they
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`improperly extend the scope of the patent’s disclosure. NuVasive fails to address
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`how Dr. Jacobson’s alleged activities have any bearing on how a person of
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`ordinary skill would understand Jacobson ’374. These paragraphs conflate Dr.
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`Jacobson’s alleged activities with his patent’s disclosure by focusing on, for
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`example, (a) “the approach that I had developed and used at the time,” (¶ 4), (b) the
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`approach he “began teaching . . . to other orthopedic and neurologic surgeons,”
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`(¶ 8), and (c) the allograft bone he allegedly used in surgeries in the 1980’s (¶ 10).
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`NuVasive agrees that any rejection must be based on Dr. Jacobson’s patent
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`and not his activities. But it ignores that the pertinent inquiry is how a person of
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`3
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`ordinary skill, not Dr. Jacobson himself, would understand Dr. Jacobson’s patent.
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`See Stewart-Warner Corp. v. City of Pontiac, Mich., 767 F.2d 1563, 1570 (Fed.
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`Cir. 1985) (“section 103 is not concerned with the actual skill of the inventors …
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`but rather with the level of ordinary skill in the art”). Dr. Jacobson provides no
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`foundation to show that what he allegedly taught other surgeons in person equates
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`to how his patent “was understood by others in the 1980’s.”
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`E.
`Exhibit 1032: Miles Declaration
`Conceding that Mr. Miles is not qualified to present an expert opinion,
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`NuVasive argues that Mr. Miles “does not opine on what is required by the claims
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`of the ’997 patent.” (Paper 59 at 13.) This is false. After reciting features of
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`NuVasive’s XLIF product, Mr. Miles states that “the ’997 patent does not claim ...
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`any of these features.” (Ex. 1032 ¶9.) Under FRE 702, all of Paragraph 9 should
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`be excluded on this independent basis.
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`NuVasive also argues that Mr. Miles did not present an expert opinion
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`because he compares NuVasive’s implant design to features disclosed in the ’997
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`patent. But a comparison that relies on a disclosure—instead of the claims—is
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`legally irrelevant. See Pro-Mold and Tool Co., Inc. v. Great Lakes Plastics, Inc.,
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`75 F.3d 1568, 1573–74 (Fed. Cir. 1999) (considering the nexus between sales of a
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`device and the “claimed invention”). In any event, Mr. Miles is unqualified to
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`interpret whether the disclosed implants “require the removal of portions of the
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`4
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`adjacent vertebrae” (Ex. 1032 ¶ 9), as the ’997 patent states no such thing and
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`discloses several embodiments. Paragraph 9 is inadmissible under FRE 702.
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`Exhibits 1036 & 1037: Friedman Articles
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`F.
`Though NuVasive concedes that the Friedman Articles are “not offered as a
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`reference in any of the obviousness combinations,” it maintains that they are a
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`“source of information on the same method described and taught in the Jacobson
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`patent.” (Paper 59 at 14.) NuVasive’s attempt to expand the disclosure of
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`Jacobson ’374 is improper, as this proceeding concerns whether the patents and
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`printed publications of the instituted grounds render the challenged claims
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`unpatentable. These references are considered only for what they reasonably
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`suggest. MPEP § 2123. NuVasive provided no analysis from Dr. McAfee that the
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`references disclose the same procedure as that in Jacobson ’374. The articles do
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`not reference Jacobson ’374 and substantively differ from it. They should be
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`excluded under FRE 401, 402, and 35 U.S.C. § 311.
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`G. Exhibit 1067: McAfee 1998 Article
`NuVasive contends that Exhibit 1067 corroborates Dr. McAfee’s testimony
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`that the spinal surgery community, including Dr. Sachs, knew of his lateral study
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`while it was being conducted. (Paper 59 at 15.) Not so. The article does not
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`mention what information, if any, was disclosed prior to publication and offers no
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`evidence regarding who knew about it. Because NuVasive concedes that the
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`article was published in 1998 and is not prior art (id.), Exhibit 1067 is irrelevant.
`5
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`Dated: May 16, 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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`6
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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 WARSAW’S REPLY IN
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`SUPPORT OF ITS MOTION TO EXCLUDE PURSUANT TO 37 C.F.R. § 42.64
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`was served in its entirety via electronic mail to APSI@fr.com (referencing
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`Attorney Docket 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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`May 16, 2014
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`/Thomas H. Martin/
`Signature:
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`Thomas H. Martin, Reg. No. 34,383
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