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Case IPR2013-00395
`U.S. Patent No. 8,444,696
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`
`
`Patent Number: 8,444,696
`Issue Date: May 21, 2013
`ANATOMIC SPINAL IMPLANT HAVING
`ANATOMIC BEARING SURFACES
`
`________________
`
`
`
`Case IPR2013-00395
`
`___________________________________________________
`
`
`
`WARSAW’S OPPOSITION TO PETITIONER’S MOTION TO EXCLUDE
`
`
`
`
`

`
`

`
`TABLE OF AUTHORITIES
`
`  
`
`
`Other Authorities 
`
`Fed. R. Evid. 1002 .................................................................................................2, 5
`Fed. R. Evid. 401 ...................................................................................................2, 3
`Fed. R. Evid. 403 ...................................................................................................2, 4
`
`
`
`i
`
`
`

`
`

`
`  
`
`EXHIBITS
`
`
`WARSAW2001 Affidavit of Mr. Luke Dauchot.
`
`WARSAW2002 Affidavit of Mrs. Nimalka Wickramasekera.
`
`WARSAW2003 U.S. Patent No. 4,834,757 to Brantigan
`
`WARSAW2004 U.S. Patent No. 5,425,772 to Brantigan
`
`WARSAW2005 Declaration of Dr. Charles L. Branch, Jr., M.D.
`
`WARSAW2006 Curriculum vitae of Dr. Charles L. Branch, Jr., M.D.
`
`WARSAW2007 Comparison of claim 1 of the ‘696 patent and claim 1 of the
`‘430 patent.
`
`
`WARSAW2008 Comparison of claim 4 of the ‘696 patent and claim 5 of the
`‘430 patent.
`
`
`WARSAW2009 Deposition transcript of Dr. John W. Brantigan, M.D. taken
`April 7, 2014.
`
`
`WARSAW2010 Declaration of Lori Ferrell, CPA, CGMA.
`
`WARSAW2011 CLYDESDALE® Spinal System Product Information.
`
`

`
`ii
`
`

`
`  
`
`I. INTRODUCTION.
`
`Under 37 C.F.R. § 42.64, Patent Owner Warsaw Orthopedic, Inc.
`
`respectfully responds in opposition to Petitioner’s Motion to Exclude (“Motion to
`
`Exclude”). In response, Patent Owner submits that Petitioner NuVasive’s
`
`positions in the Motion to Exclude are not well founded. Patent Owner provided
`
`the claim comparisons (Exhibits 2007 and 2008) that NuVasive seeks to exclude
`
`for the convenience of the Board. The claim comparisons of Exhibits 2007 and
`
`2008 provide a simple (but powerful) means for rebutting NuVasive’s indication
`
`that the inter partes reexamination of U.S. Patent No. 8,021,430 (“’430 patent”) is
`
`somehow germane to the present Inter Partes Review.
`
`II. BACKGROUND.
`
`In the Corrected Petition for Inter Partes Review of July 9, 2013 (“Corrected
`
`Petition”), NuVasive (at page 5, line 19 to page 8, line 10) indicated that the inter
`
`partes reexamination (U.S. Control No. 95/002,380) of the ‘430 patent was
`
`somehow relevant to the claims of the ‘696 patent. In doing so, NuVasive
`
`discusses the rejections presented in the Request for Inter Partes Reexamination of
`
`the ‘430 patent at page 6, lines 8-16 of the Corrected Petition.
`
`In response, Patent Owner provided the claim comparisons of Exhibits 2007
`
`and 2008 with Patent Owner’s Response of April 11, 2014 (“Patent Owner’s
`
`Response”). Exhibit 2007 provides a comparison between independent claim 1 of
`

`
`1
`
`

`
`  
`
`the ‘696 patent and independent claim 1 of the ‘430 patent, and Exhibit 2008
`
`provides a comparison between independent claim 4 of the ‘696 patent and
`
`independent claim 5 of the ‘430 patent. The differences between the claims
`
`highlighted by the claim comparisons of Exhibits 2007 and 2008 illustrate that the
`
`rejections presented in the Request for Inter Partes Reexamination of the ‘430
`
`patent are not germane to at least the patentability of independent claims 1 and 4 of
`
`the ‘696 patent.
`
`III. ARGUMENT
`
`NuVasive now complains that Exhibits 2007 and 2008 should be excluded
`
`under the Federal Rules of Evidence (FRE). According to NuVasive, Exhibits
`
`2007 and 2008 are (1) not relevant under FRE 401, (2) prejudicial under FRE 403,
`
`and (3) not the best available evidence under FRE 1002. Patent Owner vehemently
`
`disagrees. It is noted that NuVasive does not challenge that Exhibits 2007 and
`
`2008 provide an accurate comparison of independent claims 1 and 4 of the ‘696
`
`patent with independent claims 1 and 5 of the ‘430 patent, respectively. Instead, it
`
`appears that NuVasive incorrectly believes that the Board is incapable of
`
`evaluating the probity of the claim comparisons. Patent Owner disagrees. Exhibits
`
`2007 and 2008 serve to illustrate the differences between independent claims 1 and
`
`4 of the ‘696 patent with independent claims 1 and 5 of the ‘430 patent,
`
`respectively, to show that the rejections presented in the Request for Inter Partes
`

`
`2
`
`

`
`  
`
`Reexamination of the ‘430 patent are not germane to at least the patentability of
`
`independent claims 1 and 4 of the ‘696 patent. Patent Owner believes that the
`
`Board is fully capable of determining the probity of such comparisons.
`
`A. Relevance under FRE 401.
`
`NuVasive complains that the claim comparisons of Exhibits 2007 and 2008
`
`are not relevant. However, as discussed above, NuVasive indicated in the
`
`Corrected Petition that the inter partes reexamination (U.S. Control No.
`
`95/002,380) of the ‘430 patent was somehow relevant to the claims of the ‘696
`
`patent. It is noted that NuVasive repeats these indications in the Motion to
`
`Exclude (page 1, line 19 to page 2, line 5; and page 3, lines 9-14). As such, Patent
`
`Owner should not be precluded from providing evidence to rebut the indication
`
`presented by NuVasive in the Corrected Petition and Motion to Exclude. The
`
`claim comparisons of Exhibits 2007 and 2008 provide effective counterpoints to
`
`NuVasive’s indication that the prosecution of the ‘430 patent is somehow relevant
`
`to independent claims 1 and 4 of the ‘696 patent. NuVasive has raised the
`
`indication that the inter partes reexamination of the ‘430 patent was somehow
`
`relevant, and thus, Patent Owner should be given an opportunity for rebuttal.
`
`Furthermore, it is noted that NuVasive’s position that Exhibits 2007 and 2008 are
`
`not relevant appears to undercut their position that the inter partes reexamination
`
`of the ‘430 patent is somehow relevant.
`

`
`3
`
`

`
`B. Prejudice under FRE 403.
`
`  
`
`NuVasive complains that the claim comparisons of Exhibits 2007 and 2008
`
`are prejudicial. However, as discussed above, NuVasive does not challenge that
`
`Exhibits 2007 and 2008 provide accurate comparisons of independent claims 1 and
`
`4 of the ‘696 patent with independent claims 1 and 5 of the ‘430 patent,
`
`respectively. Furthermore, NuVasive does not adequately show how Exhibits
`
`2007 and 2008 are prejudicial under any of the grounds enumerated by FRE 403.
`
`Exhibits 2007 and 2008 are what they are – comparisons of independent claims 1
`
`and 4 of the ‘696 patent with independent claims 1 and 5 of the ‘430 patent,
`
`respectively. It seems that NuVasive’s position assumes that the Board is
`
`incapable of evaluating the probity of the claim comparisons of Exhibits 2007 and
`
`2008. Patent Owner disagrees. The Board need not be “sheltered” from the claim
`
`comparisons – they can evaluate the probity of the comparisons on their own
`
`volition.
`
`Furthermore, it is noted that NuVasive had an opportunity to rebut Patent
`
`Owner’s counterpoints relying on these exhibits, but did not provide such a rebuttal
`
`in the Petitioner’s Reply to Patent Owner’s Response. As such, Patent Owner
`
`submits that Exhibits 2007 and 2008 are not prejudicial, and that, if any prejudice
`
`were to occur involving these exhibits, it would occur because NuVasive declined
`
`to proffer a rebuttal to Patent Owner’s counterpoints relying on these exhibits.
`

`
`4
`
`

`
`C. Best evidence under FRE 1002.
`
`  
`
`NuVasive complains that the claim comparisons of Exhibits 2007 and 2008
`
`are not the best evidence, and that the ‘430 patent and its reexamination certificate
`
`instead should have been submitted. Patent Owner, disagrees. Exhibits 2007 and
`
`2008 are meant to show comparisons of independent claims 1 and 4 of the ‘696
`
`patent with independent claims 1 and 5 of the ‘430 patent, respectively. The ‘430
`
`patent and its reexamination certificate do not adequately provide such claim
`
`comparisons. Exhibits 2007 and 2008 are the best evidence for illustrating such
`
`claim comparisons, and thus, the objection under FRE 1002 should be inapplicable
`
`to Exhibits 2007 and 2008.
`
`Furthermore, notwithstanding Patent Owner’s disagreement that the ‘430
`
`patent and its reexamination certificate should have been submitted instead of
`
`Exhibits 2007 and 2008, Patent Owner submits that NuVasive has itself remedied
`
`their evidentiary objections. The ‘430 patent and its reexamination certificate have
`
`been submitted in the present Inter Partes Review – the ‘430 patent and its
`
`reexamination certificate are attached to the Motion to Exclude as Appendix A.
`
`IV. CONCLUSION.
`
`Given the reasoning discussed above, Patent Owner submits that NuVasive’s
`
`Motion to Exclude should be denied.
`

`
`5
`
`  
`

`
`

`
`Dated: July 10, 2014
`
`
`
`Respectfully Submitted,
`
`/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
`
`6
`
`  
`
`
`

`
`

`
`Case IPR2013-00395
`U.S. Patent No. 8,444,696
`Our Ref: 101.0051-06IPR
`
`   
`
`CERTIFICATE OF SERVICE
`
`
`
`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):
`
`
`Stephen R. Schaefer
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`
`Michael T. Hawkins
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`
`
`
`Date of Service:
`
`
`
`July 10, 2014
`
`
`
`
`
`
`
`Signature:
`
`
`
`
`
`
`
`
`/Thomas H. Martin/
`
`Thomas H. Martin, Reg. No. 34,383

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