`U.S. Patent No. 8,444,696
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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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`Patent Number: 8,444,696
`Issue Date: May 21, 2013
`ANATOMIC SPINAL IMPLANT HAVING
`ANATOMIC BEARING SURFACES
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`Case IPR2013-00395
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`WARSAW’S OPPOSITION TO PETITIONER’S MOTION TO EXCLUDE
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`TABLE OF AUTHORITIES
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`Other Authorities
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`Fed. R. Evid. 1002 .................................................................................................2, 5
`Fed. R. Evid. 401 ...................................................................................................2, 3
`Fed. R. Evid. 403 ...................................................................................................2, 4
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`EXHIBITS
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`WARSAW2001 Affidavit of Mr. Luke Dauchot.
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`WARSAW2002 Affidavit of Mrs. Nimalka Wickramasekera.
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`WARSAW2003 U.S. Patent No. 4,834,757 to Brantigan
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`WARSAW2004 U.S. Patent No. 5,425,772 to Brantigan
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`WARSAW2005 Declaration of Dr. Charles L. Branch, Jr., M.D.
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`WARSAW2006 Curriculum vitae of Dr. Charles L. Branch, Jr., M.D.
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`WARSAW2007 Comparison of claim 1 of the ‘696 patent and claim 1 of the
`‘430 patent.
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`WARSAW2008 Comparison of claim 4 of the ‘696 patent and claim 5 of the
`‘430 patent.
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`WARSAW2009 Deposition transcript of Dr. John W. Brantigan, M.D. taken
`April 7, 2014.
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`WARSAW2010 Declaration of Lori Ferrell, CPA, CGMA.
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`WARSAW2011 CLYDESDALE® Spinal System Product Information.
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`I. INTRODUCTION.
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`Under 37 C.F.R. § 42.64, Patent Owner Warsaw Orthopedic, Inc.
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`respectfully responds in opposition to Petitioner’s Motion to Exclude (“Motion to
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`Exclude”). In response, Patent Owner submits that Petitioner NuVasive’s
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`positions in the Motion to Exclude are not well founded. Patent Owner provided
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`the claim comparisons (Exhibits 2007 and 2008) that NuVasive seeks to exclude
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`for the convenience of the Board. The claim comparisons of Exhibits 2007 and
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`2008 provide a simple (but powerful) means for rebutting NuVasive’s indication
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`that the inter partes reexamination of U.S. Patent No. 8,021,430 (“’430 patent”) is
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`somehow germane to the present Inter Partes Review.
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`II. BACKGROUND.
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`In the Corrected Petition for Inter Partes Review of July 9, 2013 (“Corrected
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`Petition”), NuVasive (at page 5, line 19 to page 8, line 10) indicated that the inter
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`partes reexamination (U.S. Control No. 95/002,380) of the ‘430 patent was
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`somehow relevant to the claims of the ‘696 patent. In doing so, NuVasive
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`discusses the rejections presented in the Request for Inter Partes Reexamination of
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`the ‘430 patent at page 6, lines 8-16 of the Corrected Petition.
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`In response, Patent Owner provided the claim comparisons of Exhibits 2007
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`and 2008 with Patent Owner’s Response of April 11, 2014 (“Patent Owner’s
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`Response”). Exhibit 2007 provides a comparison between independent claim 1 of
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`the ‘696 patent and independent claim 1 of the ‘430 patent, and Exhibit 2008
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`provides a comparison between independent claim 4 of the ‘696 patent and
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`independent claim 5 of the ‘430 patent. The differences between the claims
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`highlighted by the claim comparisons of Exhibits 2007 and 2008 illustrate that the
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`rejections presented in the Request for Inter Partes Reexamination of the ‘430
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`patent are not germane to at least the patentability of independent claims 1 and 4 of
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`the ‘696 patent.
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`III. ARGUMENT
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`NuVasive now complains that Exhibits 2007 and 2008 should be excluded
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`under the Federal Rules of Evidence (FRE). According to NuVasive, Exhibits
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`2007 and 2008 are (1) not relevant under FRE 401, (2) prejudicial under FRE 403,
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`and (3) not the best available evidence under FRE 1002. Patent Owner vehemently
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`disagrees. It is noted that NuVasive does not challenge that Exhibits 2007 and
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`2008 provide an accurate comparison of independent claims 1 and 4 of the ‘696
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`patent with independent claims 1 and 5 of the ‘430 patent, respectively. Instead, it
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`appears that NuVasive incorrectly believes that the Board is incapable of
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`evaluating the probity of the claim comparisons. Patent Owner disagrees. Exhibits
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`2007 and 2008 serve to illustrate the differences between independent claims 1 and
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`4 of the ‘696 patent with independent claims 1 and 5 of the ‘430 patent,
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`respectively, to show that the rejections presented in the Request for Inter Partes
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`Reexamination of the ‘430 patent are not germane to at least the patentability of
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`independent claims 1 and 4 of the ‘696 patent. Patent Owner believes that the
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`Board is fully capable of determining the probity of such comparisons.
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`A. Relevance under FRE 401.
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`NuVasive complains that the claim comparisons of Exhibits 2007 and 2008
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`are not relevant. However, as discussed above, NuVasive indicated in the
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`Corrected Petition that the inter partes reexamination (U.S. Control No.
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`95/002,380) of the ‘430 patent was somehow relevant to the claims of the ‘696
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`patent. It is noted that NuVasive repeats these indications in the Motion to
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`Exclude (page 1, line 19 to page 2, line 5; and page 3, lines 9-14). As such, Patent
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`Owner should not be precluded from providing evidence to rebut the indication
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`presented by NuVasive in the Corrected Petition and Motion to Exclude. The
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`claim comparisons of Exhibits 2007 and 2008 provide effective counterpoints to
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`NuVasive’s indication that the prosecution of the ‘430 patent is somehow relevant
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`to independent claims 1 and 4 of the ‘696 patent. NuVasive has raised the
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`indication that the inter partes reexamination of the ‘430 patent was somehow
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`relevant, and thus, Patent Owner should be given an opportunity for rebuttal.
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`Furthermore, it is noted that NuVasive’s position that Exhibits 2007 and 2008 are
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`not relevant appears to undercut their position that the inter partes reexamination
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`of the ‘430 patent is somehow relevant.
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`B. Prejudice under FRE 403.
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`NuVasive complains that the claim comparisons of Exhibits 2007 and 2008
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`are prejudicial. However, as discussed above, NuVasive does not challenge that
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`Exhibits 2007 and 2008 provide accurate comparisons of independent claims 1 and
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`4 of the ‘696 patent with independent claims 1 and 5 of the ‘430 patent,
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`respectively. Furthermore, NuVasive does not adequately show how Exhibits
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`2007 and 2008 are prejudicial under any of the grounds enumerated by FRE 403.
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`Exhibits 2007 and 2008 are what they are – comparisons of independent claims 1
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`and 4 of the ‘696 patent with independent claims 1 and 5 of the ‘430 patent,
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`respectively. It seems that NuVasive’s position assumes that the Board is
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`incapable of evaluating the probity of the claim comparisons of Exhibits 2007 and
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`2008. Patent Owner disagrees. The Board need not be “sheltered” from the claim
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`comparisons – they can evaluate the probity of the comparisons on their own
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`volition.
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`Furthermore, it is noted that NuVasive had an opportunity to rebut Patent
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`Owner’s counterpoints relying on these exhibits, but did not provide such a rebuttal
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`in the Petitioner’s Reply to Patent Owner’s Response. As such, Patent Owner
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`submits that Exhibits 2007 and 2008 are not prejudicial, and that, if any prejudice
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`were to occur involving these exhibits, it would occur because NuVasive declined
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`to proffer a rebuttal to Patent Owner’s counterpoints relying on these exhibits.
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`C. Best evidence under FRE 1002.
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`NuVasive complains that the claim comparisons of Exhibits 2007 and 2008
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`are not the best evidence, and that the ‘430 patent and its reexamination certificate
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`instead should have been submitted. Patent Owner, disagrees. Exhibits 2007 and
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`2008 are meant to show comparisons of independent claims 1 and 4 of the ‘696
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`patent with independent claims 1 and 5 of the ‘430 patent, respectively. The ‘430
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`patent and its reexamination certificate do not adequately provide such claim
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`comparisons. Exhibits 2007 and 2008 are the best evidence for illustrating such
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`claim comparisons, and thus, the objection under FRE 1002 should be inapplicable
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`to Exhibits 2007 and 2008.
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`Furthermore, notwithstanding Patent Owner’s disagreement that the ‘430
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`patent and its reexamination certificate should have been submitted instead of
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`Exhibits 2007 and 2008, Patent Owner submits that NuVasive has itself remedied
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`their evidentiary objections. The ‘430 patent and its reexamination certificate have
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`been submitted in the present Inter Partes Review – the ‘430 patent and its
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`reexamination certificate are attached to the Motion to Exclude as Appendix A.
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`IV. CONCLUSION.
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`Given the reasoning discussed above, Patent Owner submits that NuVasive’s
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`Motion to Exclude should be denied.
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`Dated: July 10, 2014
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`Respectfully Submitted,
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`/Thomas H. Martin/
`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 IPR2013-00395
`U.S. Patent No. 8,444,696
`Our Ref: 101.0051-06IPR
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of WARSAW’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE as served in its entirety via electronic mail to
`APSI@fr.com (referencing Attorney Docket No. 13958-0113IP1; and cc’ing
`schaefer@fr.com and hawkins@fr.com):
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`Stephen R. Schaefer
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
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`Michael T. Hawkins
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
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`Date of Service:
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`July 10, 2014
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`Signature:
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`/Thomas H. Martin/
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`Thomas H. Martin, Reg. No. 34,383