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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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`MEDTRONIC, INC.
`Petitioner
`v.
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`NUVASIVE, INC.
`Patent Owner
`---------------------------------------
`
`Case IPR2013-00506
`Patent 8,361,156
`---------------------------------------
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`
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`PETITIONER’S RESPONSE TO PATENT OWNER’S
`MOTION TO EXCLUDE EVIDENCE
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`ACTIVE 27735328v5 10/20/2014
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`IPR2013-00506
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`Petitioner Docket No. 108136.00029
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`EXHIBITS
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`MSD 1101 – Declaration of Richard Hynes, M.D. Regarding U.S. Patent No.
`8,361,156
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`MSD 1102 – Declaration of Mary Phelps Regarding Telamon Verte-Stack PEEK
`Vertebral Body Spacer
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`MSD 1103 – U.S. Patent Application Publication No. 2002/0165550
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`MSD 1104 – U.S. Patent Application Publication No. 2003/0028249
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`MSD 1105 – U.S. Patent No. 5,860,973
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`MSD 1106 – Synthes Vertebral Spacer-PR Brochure
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`MSD 1107 - Telamon Verte-Stack PEEK Vertebral Body Spacer Brochure
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`MSD 1108 – Telamon Implantation Guide
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`MSD 1109 – Prosecution History of U.S. Patent No. 8,187,334
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`MSD 1110 – Prosecution History of U.S. Patent No. 7,918,891
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`MSD 1111 – First Amended Complaint, filed on October 6, 2008, and Judgment
`Following Jury Verdict, entered on September 29, 2011, in Warsaw
`Orthopedics, Inc. v, NuVasive, Inc., Case No. 3:08-CV-01512,
`Southern District of California
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`MSD 1112 – Curriculum Vitae of Richard Hynes, M.D.
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`MSD 1113 – S.H. Zhou et al., Geometrical Dimensions of the Lower Lumbar
`Vertebrae – Analysis of Data from Digitised CT Images, 9 EUR SPINE
`J 242, 244 (2000)
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`MSD 1114 – U.S. Patent No. 6,241,770
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`MSD 1115 – U.S. Patent No. 8,361,156
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`MSD 1116 – Declaration of Loic Josse
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`MSD 1117 – Jie Zhao et al., Posterior Lumbar Interbody Fusion Using
`Posterolateral Placement of a Single Cylindrical Threaded Cage,
`25(4) SPINE 425 (2000)
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`MSD 1118 – Premarket Approval Suppl. Decision for BAK Interbody Fusion
`System
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`MSD 1119 – [Reserved]
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`MSD 1120 – VerteStack System Brochure
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`MSD 1121 – [Reserved]
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`MSD 1122 – [Reserved]
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`MSD 1123 – Butterfly Surgical Technique
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`MSD 1124 – [Reserved]
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`MSD 1125 – [Reserved]
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`MSD 1126 – [Reserved]
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`MSD 1127 – [Reserved]
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`MSD 1128 – [Reserved]
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`MSD 1129 – U.S. Patent No. 6,723,097
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`MSD 1130 – [Reserved]
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`MSD 1131 – U.S. Patent No. 8,623,088
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`MSD 1132 – NuVasive Maximum Access Surgery Tranforaminal Lumbar
`Interbody Fusion Booklet
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`MSD 1133 – European Patent Application No. 1290985A2
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`MSD 1134 – VerteStack 510k – K031780
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`MSD 1135 – Sulzer Spine-Tech BAK Interbody Fusion System Brochure
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`MSD 1136 – Shih-Tien Wang et al., Comparison of Stabilities between Obliquely
`and Conventionally Inserted Bagby and Kuslich Cages as Posterior
`Lumbar Interbody Fusion in a Cadaver Model, 66 J. CHIN. MED.
`ASSOC. 676 (2003)
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`MSD 1137 – Zimmer Spine BAK Interbody Fusion Systems Brochure
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`MSD 1138 – BAK PMA Clearance – p950002
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`MSD 1139 – Jie Zhao et al., Posterior lumbar interbody fusion using one diagonal
`fusion cage with transpedicular screw/rod fixation, 12 EUR. SPIN J.
`173 (2003)
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`MSD 1140 – NuVasive XLIF Surgical Technique – MaXcess II
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`MSD 1141 – NuVasive XLIF Surgical Technique – MaXcess
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`MSD 1142 – [Reserved]
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`MSD 1143 – NuVasive CoRoent XL 510k – K043405
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`MSD 1144 – [Reserved]
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`MSD 1145 – NuVasive XLIF Fact Sheet
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`MSD 1146 – Synthes Vertebral Spacer 510k – K011037
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`MSD 1147 – [Reserved]
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`MSD 1148 – U.S. Patent No. 5,772,661
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`MSD 1149 – [Reserved]
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`MSD 1150 – U.S. Patent No. 5,484,437
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`MSD 1151 – [Reserved]
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`MSD 1152 – Excerpt of Deposition of Richard Hynes, M.D.
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`MSD 1153 – [Reserved]
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`MSD 1154 – Diagram
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`MSD 1155 – Diagram
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`MSD 1156 – Diagram
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`MSD 1157 – Second Declaration of Dr. Richard A. Hynes
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`MSD 1158 – Zdeblick Documents
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`MSD 1159 – Sulzer Spine-Tech 2000 Price List
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`MSD 1160 – Excerpt of Declaration of Dr. John W. Brantigan, M.D., filed in
`IPR2013-00395 as Exhibit 1001
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`MSD 1161 – Excerpt of Trial Transcript in Medtronic Sofamor Danek, USA v.
`NuVasive, Inc., Case No. 08-CV-1512-MMA (S.D. Cal.) on
`September 1, 2011
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`MSD 1162 – Record of Oral Hearing in NuVasive Inc. v. Warsaw Orthopedic, Inc.,
`IPRs 2013-0026 and -00208, Paper 64 (PTAB June 5, 2014)
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`MSD 1163 – Excerpt of NuVasive, Inc.’s Opening Brief filed in Warsaw
`Orthopedic, Inc. v. NuVasive, Inc., Case No. 2013-1576 (Fed. Cir.)
`on February 3, 2014
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`MSD 1164 – Excerpt of Second Declaration of Dr. Paul McAfee, filed in IPR2013-
`00206 as Exhibit 1029
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`MSD 1165 – Declaration of Patrick Miles, filed in IPR2013-00206 as Exhibit 1032
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`MSD 1166 – NuVasive, Inc.’s Objections and Responses to Plaintiffs’ Second Set
`of Interrogatories (Nos. 11-13), served July 8, 2013
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`MSD 1167 – NuVasive Inc.’s Answering Brief in Opposition to Globus Medical,
`Inc.’s Motion for Partial Summary Judgment (Dkt. No. 216), filed in
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`NuVasive, Inc. v. Globus Medical, Inc., C. A. No. 1:10-CV-00849
`(D. Del.)
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`MSD 1168 – NuVasive, Inc. v. Warsaw Orthopedic, Inc., IPR2013-00206, Paper
`65 at 25-27 (PTAB July 10, 2014)
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`MSD 1169 – [Reserved]
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`MSD 1170 – Expert Report of Dr. Bruce E. Van Dam Regarding Validity of the
`Asserted Claims of U.S. Patent No. 5,860,973
`
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`MSD 1171 – Declaration of Patrick Miles, filed in IPR2014-00087 as Exhibit 2024
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`MSD 1172 – Excerpt of Transcript of Deposition of Patrick Miles, taken
`November 8, 2010
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`MSD 1173 – Excerpt of Transcript of Deposition of Dr. Hansen A. Yuan, taken
`August 22, 2014
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`MSD 1174 – Excerpt of Transcript of Deposition of Patrick Miles, taken
`September 4, 2014
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`MSD 1175 – NuVasive XLIF 90 Surgical Technique Brochure
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`MSD 1176 – Malberg M., Extreme Lateral Interbody Fusion (XLIF), in Regan J,
`Lieberman I, eds. Atlas of Minimal Access Surgery, 2nd ed. St
`Louis: Quality Medical Publishing, 2004
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`MSD 1177 – NuVasive TLIF Surgical Technique Brochure
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`MSD 1178 – Amendment to Agreement 550002080 By and Between the County
`of Santa Clara and NuVasive, Inc., dated October 25, 2011
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`MSD 1179 – NuVasive 2014 Reimbursement Guide
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`MSD 1180 – NuVasive XLIF Surgical Technique
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`MSD 1181 – Transcript of Deposition of Dr. Hansen A. Yuan, taken August 22,
`2014
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`MSD 1182 – Transcript of Conference Call with Board, dated October 14, 2014
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`MSD 1183 – Petitioner’s Notice of Supplemental Evidence, dated September 26,
`2014
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`MSD 1184 – Email correspondence, dated September 9, 2014
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`MSD 1185 – Email correspondence, dated September 17, 2014
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`IPR2013-00506
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`Petitioner Docket No. 108136.00029
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`I.
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`PRELIMINARY STATEMENT
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`Petitioner Medtronic, Inc. (“Petitioner”) respectfully submits this Response
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`to Patent Owner NuVasive, Inc.’s (“Patent Owner”) Motion to Exclude the
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`Declaration of Loic Josse and Appendices (Exhibit 1116) (the “Motion”). As
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`provided below, the Declaration of Loic Josse, and all of the appendices attached
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`thereto, has been sufficiently authenticated, and the admission of this evidence in
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`its current form has no prejudicial effect on Patent Owner. Accordingly, Petitioner
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`requests that the Board deny Patent Owner’s Motion to Exclude.
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`II. ARGUMENT
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`Patent Owner fails to articulate a legally sufficient reason to exclude the
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`Josse Declaration and Appendices A-F solely on the basis of redactions of
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`confidential and irrelevant information contained in Appendices A-C.
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`A.
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`Patent Owner Failed to Meet the Basic Requirements of a Motion
`to Exclude Evidence
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`The Motion is deficient at least because Patent Owner fails to identify where
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`in the record a sufficient objection to Exhibit 1116 originally was made, and where
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`in the record Exhibit 1116 was relied upon by Petitioner. A motion to exclude
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`evidence must:
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`(a) Identify where in the record the objection originally was made;
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`(b) Identify where in the record the evidence sought to be excluded was
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`relied upon by an opponent;
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`(c) Address objections to exhibits in numerical order; and
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`(d) Explain each objection.
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`Office Patent Trial Practice Guide, 77 Fed. Reg. 48765, 48767 (Aug. 14, 2012).
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`Patent Owner’s objections served on September 12, 2014, failed to provide
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`enough information to make the cursory objection to Exhibit 1116 of record in this
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`proceeding. 37 C.F.R. § 42.64(b) requires that evidentiary objections “must
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`identify the grounds for the objection with sufficient particularity to allow for
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`correction in the form of supplemental evidence.” The entirety of Patent Owner’s
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`objections to Exhibit 1116 is as follows: Fed. R. Evid. 401-403 (relevance; more
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`prejudicial than probative); Fed. R. Evid. 602 (lack of personal knowledge); Fed.
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`R. Evid. 802 (hearsay); Fed. R. Evid. 901 (failure to authenticate). Exhibit 2039, at
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`2. In a Notice of Supplemental Evidence served on Patent Owner on September
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`26, 2014, Petitioner notified Patent Owner of its failure to make objections to the
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`Josse Declaration with the required “sufficient particularity” and that because of
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`this deficiency it was “virtually impossible and incredibly burdensome for
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`Petitioner to correct any alleged evidentiary concerns” with Exhibit 1116. See
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`Exhibit 1183. Despite this, Patent Owner failed to provide Petitioner with
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`corrected objections specifically identifying concerns with Appendices A, B, or C.
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`Because Patent Owner never made an objection to Appendices A, B, or C to
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`Exhibit 1116 with sufficient particularity, no proper objection was ever actually
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`made of record in this proceeding. Therefore, the Motion cannot possibly meet the
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`requirement of “[i]dentify[ing] where in the record the objection originally was
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`made.” Additionally, the Motion fails to “[i]dentify where in the record [Exhibit
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`1116] was relied upon by [Petitioner].” Accordingly, for at least these reasons, the
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`Motion should be denied for failing to satisfy the basic requirements provided by
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`the Office Patent Trial Practice Guide.
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`B.
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`The Josse Declaration and Appendices D-F
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`The Josse Declaration itself and Appendices D-F to that declaration should
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`not be excluded because Patent Owner’s entire argument for exclusion is based
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`solely on the redactions to Appendices A-C. The testimony of Mr. Josse contained
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`in his declaration, which is signed and sworn under penalty of perjury, is his
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`testimony and requires no other authentication. See Exhibit 1116, at ¶ 7. This
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`testimony is based on personal knowledge, which he testified to and confirmed
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`during cross-examination at his deposition. See Exhibit 2038, at 13:18 to 14:3 (“Q.
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`Did you review the declaration which is MSD Exhibit 1014 before signing it? A.
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`Correct. I did review it before signing. Q. And did you agree with everything that
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`was written in the declaration MSD 1014? A. I agree with everything in my
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`declaration.”). Further, Patent Owner does not even attempt to argue that
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`Appendices D-F are in any way not authentic or otherwise problematic and they do
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`not contain any redactions. Accordingly, for these reasons, these documents
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`should not be excluded.
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`C. Appendices A-C
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`Appendices A-C attached to the Josse Declaration were redacted to remove
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`confidential and wholly irrelevant information. Petitioner submitted the Josse
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`Declaration solely for the purpose of rebutting the factually incorrect statements
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`made by Patent Owner in its Response, including the false assertion that an
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`embodiment of the Frey implant was never produced having a length greater than
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`40 mm. See IPR2013-00507, Patent Owner Response, at 35-37. In support of his
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`testimony, Mr. Josse submitted Appendices A-C, which included engineering
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`drawings, email correspondence, and other documents – of which he had firsthand
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`knowledge (see Ex. 1116, at ¶ 2 (testifying that he created engineering drawings in
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`Appendix A, received email in Appendix B, and received prescription from Dr.
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`Frey and other documents in Appendix C); Ex. 2038, at 61:17 to 62:7 (testifying
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`that he prepared engineering drawings in Appendix C) – indicating that the
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`Boomerang implant, an embodiment of Frey, having a length greater than 40 mm
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`was designed and produced by Petitioner.
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`In addition to information related to the length of these implants that was
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`relied on by Mr. Josse and cited to in Petitioner’s Reply, these documents also
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`contained information that is wholly irrelevant to this proceeding and confidential
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`trade secret. To protect the confidentiality of this trade secret and competitive
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`sensitive information from a direct competitor, as well as to avoid extraneous and
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`irrelevant information from complicating the record in this proceeding, Petitioner
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`redacted this information. 1
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`1.
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`Redactions do not negate authenticity of documents
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`The mere act of redacting does not make a document inauthentic. See Apex
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`Energy Group, LLC v. Apex Energy Solutions of Cincinnati LLC, 2014 WL
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`3667754, *4 (S.D. Ohio July 22, 2014) (holding that authentication of records was
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`not negated by redactions); see also Barnes v. VI P’ship, Ltd., 2010 WL 3079453,
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`1 Patent Owner’s argument regarding the other dimensions being relevant, even
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`though not the subject of nor mentioned in Mr. Josse’s testimony, merely because
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`they are confidential bears no weight on the issue of exclusion and is simply
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`untrue. The fact that these dimensions are a trade secret does not make them
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`relevant to patentability. Patent Owner’s stated offer of entering the default
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`protective order to “address Petitioner’s concerns” is misleading as this would
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`amount to an end run around the District Court’s protective order in related
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`litigation between the parties and avoids the fact that they were not entitled to this
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`information. Petitioner had previously offered a compromise protective order that
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`Patent Owner rejected without explanation.
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`*2 (M.D. Fla. Aug. 8, 2010) (holding that ability to authenticate redacted document
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`is unaffected where redacted information is irrelevant). The cases cited by Patent
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`Owner are inapposite to the present situation. In Siegal v. Am. Honda Motor Co.,
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`Inc., the plaintiff, in attempting to prove that a handlebar assembly on a motorcycle
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`was defective at the time of an accident, offered into evidence the motorcycle with
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`a handlebar assembly that the district court found had been physically altered
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`sometime after the accident. See Siegal v. Am. Honda Motor Co., Inc., 921 F.2d
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`15, 17 (1st Cir. 1990). In affirming the district court’s exclusion of the altered
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`handlebar assembly, the First Circuit held that the handlebar assembly was not
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`authentic because it was not what plaintiff “represented it to be.” Id. In Khan v.
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`Obama, the Court of Appeals for the District of Columbia noted that the heavily
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`redacted report, described by the district court as “perhaps the most redacted report
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`in history,” “made it impossible to determine the source and timing of the reports
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`or to assess their reliability.” Khan v. Obama, 655 F.3d 20, 30 (D.C. Cir. 2011).
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`Here, unlike in Siegal, Appendices A-C are exactly what Petitioner and Mr.
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`Josse represent them to be, namely, redacted documents that indicate that an
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`embodiment of the Frey implant was indeed produced having a length greater than
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`40 mm. The redacted information is wholly irrelevant to the Josse Declaration
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`and the Petitioner’s purpose for submitting Exhibit 1116 in this proceeding.
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`Additionally, unlike in Khan, because Mr. Josse has testified to and been deposed
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`as to his firsthand knowledge of the source and reliability of the information
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`contained in Appendices A-C, there is no difficulty in determining the authenticity
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`of these documents.2 Mr. Josse swore to the accuracy of the non-redacted portions
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`of the documents, and testified that they are true and correct, albeit redacted,
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`copies. As a witness with personal knowledge, Mr. Josse is an ideal witness to
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`authenticate Appendices A-C. See Fed. R. Evid. 901(b)(1).
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`2.
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`Production of unredacted versions of Appendices A-C is not
`routine discovery
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`Additionally, production of Appendices A-C in their redacted form is all that
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`the rules required because Mr. Josse cited only to these redacted versions of these
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`documents in his declaration. The Rules do not require the production of
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`unredacted versions of exhibits. Instead, they merely require that “any exhibit
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`cited in a paper or testimony must be served with the citing paper or testimony.”
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`37 C.F.R. 42.51(b)(1)(i). In his declaration, Mr. Josse refers to Appendices A-C as
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`“redacted” documents. See Exhibit 1116, at ¶ 2 (“Attached hereto as Appendix A
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`is a redacted version of engineering drawings that I created in January 2000 that
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`2 If desired, Petitioner would allow the Board to examine unredacted versions of
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`Appendices A-C to confirm the authenticity of the documents. See Khan, 655 F.3d
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`at 30-31.
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`depict a boomerang implant having a length from end to end of 40.705 mm.”); id.
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`(“A true and correct copy of a redacted email string, on which I was copied,
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`between Dr. Frey and Ming Liu, an engineer at Medtronic, evidencing the creation
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`of these large Boomerang implants having a length greater than 40 mm for Dr.
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`Frey is attached hereto as Appendix B.”); id. (“The prescription we received from
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`Dr. Frey along with the associated redacted manufacturing document and drawings
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`is attached hereto as Appendix C.”). Therefore, Appendices A-C are the authentic
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`versions of the exhibits that Mr. Josse discusses in his declaration. By producing
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`the cited redacted documents, which are the actual exhibits being testified to,
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`Petitioner complied with all of the requirements of 37 C.F.R. 42.51(b)(1)(i). This
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`is wholly different than the situation in IPR2013-00208 referred to by Patent
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`Owner in the Motion. In that proceeding, a declarant referred to activity in Japan
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`but did not provide documentation pertaining to that Japanese activity. Once
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`brought to the Board’s attention, the party that offered the declarant’s testimony
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`filed a new declaration without referencing that Japanese activity. Here, Petitioner
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`has produced every document referred to by Mr. Josse in his declaration.
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`While not explicitly referred to in the Motion, to the extent that Patent
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`Owner implies that the unredacted versions of Appendices A-C fall under routine
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`discovery because it contains “information that is inconsistent with a position
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`advanced by [Petitioner] during the proceeding,” this is also unfounded. “Routine
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`discovery under 37 C.F.R. § 41.51(b)(1)(iii) is narrowly directed to specific
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`information known to the responding party to be inconsistent with a position
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`advanced by that party in the proceeding, and not broadly directed to any subject
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`area in general within which the requesting party hopes to discover such
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`inconsistent information.” Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, Case
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`IPR2012-00001, Paper 26, at 4 (PTAB Mar. 5, 2013). Patent Owner has never
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`identified any “specific information” that it knows to be inconsistent with any
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`position advanced by Petitioner.3 Instead, Patent Owner has only indicated that the
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`redactions prevented the “full analysis and cross-examination of those portions
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`which may be harmful” and that the redactions may have shielded information
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`“which may be harmful.” See Motion, at 9. These admissions confirm that Patent
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`Owner’s attempt to obtain unredacted versions of Appendices A-C is just a fishing
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`expedition that the Rules do not allow. See Garmin, at 5 (noting that discovery
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`available in Inter Partes Review proceeding “is significantly different from the
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`scope of discovery generally available under the Federal Rules of Civil Procedure”
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`and “is limited compared to that available in district court litigation”).
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`3 This is despite Patent Owner apparently having access to unredacted versions of
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`at least some of the documents included in Appendices A-C. See Motion, at 8, fn.
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`4.
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`On September 9, 2014, Petitioner made Patent Owner aware of Petitioner’s
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`understanding that unredacted versions of Appendices A-C did not fall under
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`routine discovery as contemplated by the Rules, but welcomed Patent Owner to
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`cite some authority that supported its position. See Email correspondence, dated
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`September 9, 2014 (Exhibit 1184), at 1. Petitioner reiterated its position to Patent
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`Owner on September 17, 2014, and again invited a response from Patent Owner.
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`See Email correspondence, dated September 17, 2014 (Ex. 1185), at 1-2. Patent
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`Owner never replied to this request, but instead waited until two and half weeks
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`later to make the present Motion, which amounts to a late discovery request after
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`the close of their discovery period.
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`In actuality, Patent Owner’s only recourse under the Rules for obtaining
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`unredacted versions of Appendices A-C was to request these documents from
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`Petitioner as additional discovery as contemplated by the Rules, or move the Board
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`for additional discovery by showing “that such additional discovery is in the
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`interests of justice.” 37 C.F.R. 42.51(2)(i). Patent Owner, however, never took
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`these steps, even after it was explained to them that this did not fall under routine
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`discovery.4 The Patent Owner failed, for example, to even attempt to justify its
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`4 This too differentiates from the situation referenced by Patent Owner in IPR2013-
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`00208 where NuVasive sought permission to file a motion for additional
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`request to Petitioner beyond its blanket demand as routine discovery. It did not
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`explain to Petitioner, or the Board, why it was otherwise entitled to this additional
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`discovery in the interests of justice or otherwise. Regardless, it is far too late in the
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`proceedings to debate the propriety of such non-routine discovery because this is
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`not a discovery motion and discovery is closed.
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`3.
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`No prejudice results from production of Appendices A-C
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`Further, because the information that was redacted from Appendices A-C is
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`irrelevant to the present proceeding, Patent Owner cannot claim any prejudice due
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`to the information being unavailable. The unredacted information provided in
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`Appendices A-C is true and correct, and was the only information cited by Mr.
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`Josse from these Appendices in his declaration and subsequently referred to by
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`Petitioner in its Reply. Patent Owner had the opportunity to cross-examine Mr.
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`Josse about what was redacted, if anything he was relying on was changed by the
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`redactions, or even if Appendices A-C were indeed authentic, but failed to do so.
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`
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`discovery. See IPR2013-00208, Paper 33, at 4. Here, NuVasive never requested
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`additional discovery from Petitioner nor sought it from the Board.
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`11
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`IPR2013-00506
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`
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`Petitioner Docket No. 108136.00029
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`III. CONCLUSION
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`
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`For at least the above reasons, Petitioner requests respectfully that the Board
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`deny Patent Owner’s Motion to Exclude Exhibit 1116.
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`Dated: October 20, 2014
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`Respectfully submitted,
`
` /Jeff E. Schwartz/ d
`Jeff E. Schwartz, Reg. No. 39,019
`Fox Rothschild LLP
`1030 15th Street, NW
`Washington, DC 20005
`Tele: 202-696-1470
`Fax: 202-461-3102
`
`Attorneys for Petitioner
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`
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`12
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`
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`IPR2013-00506
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`
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`Petitioner Docket No. 108136.00029
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on the 20th day of
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`October 2014 a complete and entire copy of “Petitioner’s Response to Patent
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`Owner’s Motion to Exclude Evidence” was provided via email to the Patent Owner
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`by serving the following email addresses:
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`
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`schaefer@fr.com
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`hawkins@fr.com
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`snelson@fr.com
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`IPR13958-0116IP2@fr.com
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`
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`Electronic service was used with the agreement of the Patent Owner’s counsel.
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`
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`Dated: October 20, 2014
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`ACTIVE 27735328v5 10/20/2014
`
` /Jeff E. Schwartz/
`Jeff E. Schwartz, Reg. No. 39,019
`Fox Rothschild LLP
`1030 15th Street, NW
`Washington, DC 20005
`Tele: 202-696-1470
`Fax: 202-461-3102
`
`Attorneys for Petitioner
`
`
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