throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
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`
`
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`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
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`
`
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`
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`
`
`
`MEDTRONIC, INC.
`Petitioner
`
`v.
`
`NUVASIVE, INC.
`Patent Owner
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2013-00506
`Patent 8,361,156
`
`
`
`
`
`
`
`
`
`
`PATENT OWNER’S OBJECTION TO EVIDENCE UNDER
`37 CFR § 42.64(b)(1)
`
`1
`
`NUVASIVE 2039
`Medtronic v. NuVasive
`IPR2013-00506
`IPR2013-00507
`IPR2013-00508
`
`

`
`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`Under 37 C.F.R. 42.64(b)(1), Patent Owner, NuVasive, Inc., objects to
`
`exhibits, including objections to the exhibits filed on September 5, 2014, as
`
`follows. Most of the exhibits are not relevant to inter partes review of the
`
`challenged patent under the grounds and arguments contained in the Petition or
`
`under the grounds adopted in the Institution Decision. Rather, most of the exhibits
`
`identified below are not prior art, are not references upon which inter partes
`
`review has been granted, and will serve only to confuse the issues if permitted.
`
`Many of the exhibits contain hearsay, are not authenticated, and suffer from other
`
`admissibility and relevance issues. Moreover, the exhibits identified below are
`
`inadmissible under Federal Rule of Evidence 403 because they are substantially
`
`more prejudicial than probative at this late stage of the proceedings, after the
`
`Patent Owner’s Response.
`
`
`
`
`
`
`
`
`
`Title
`
`Declaration of Loic
`Josse
`
`Objections
`
`
`Documents
`IPR2013-
`IPR2013-
`IPR2013-
`00508
`00506
`00507
`Ex. 1116 Ex. 1014 Ex. 1116 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 602 (lack of
`personal knowledge)
`Fed. R. Evid. 802
`(hearsay)
`Fed. R. Evid. 901 (failure
`to authenticate)
`
`2
`
`

`
`Premarket Approval
`Suppl. Decision for
`BAK Interbody
`Fusion System
`
`NASS Memo, "Re:
`Lateral Interbody
`Fusion (XLIF,
`DLIF) of the
`Lumbar Spine",
`Dated January 5,
`2010
`VerteStack System
`Brochure
`
`Butterfly Surgical
`Technique
`
`AlphaTec ARC
`Portal Access
`System GLIF
`Surgical Technique
`Guide
`
`US 7,815,682
`
`US 6,723,097
`
`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`
`Ex. 1118 Ex. 1016 Ex. 1118 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`
`Ex. 1017
`
`
`
`
`
`Ex. 1120
`
`
`
`Ex. 1120 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1123 Ex. 1021 Ex. 1123 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Ex. 1129 Fed. R. Evid. 401-403
`(relevance; more
`
`
`
`
`
`Ex. 1023
`
`
`
`Ex. 1028
`
`
`
`Ex. 1129
`
`
`
`3
`
`

`
`US 8,623,088
`
`Ex. 1131
`
`
`
`Ex. 1132
`
`
`
`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`
`prejudicial than probative)
`Ex. 1131 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Ex. 1132 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`
`NuVasive
`Maximum Access
`Surgery
`Tranforaminal
`Lumbar Interbody
`Fusion Booklet
`European Patent
`Application No.
`1290985A2
`VerteStack 510k-
`K031780
`
`Sulzer Spine-Tech
`BAK Interbody
`Fusion System
`Brochure
`
`Shih-Tien Wang et
`al., Comparison of
`Stabilites between
`Obliquely and
`Conventionally
`Inserted Bagby and
`Kuslich Cages as
`Posterior Lumbar
`Interbody Fusion in
`a Cadever Model,
`66 J. CHIN. MED.
`ASSOC. 676 (2003)
`
`Ex. 1133 Ex. 1031
`
`
`
`Ex. 1134
`
`
`
`Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Ex. 1134 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`Ex. 1135 Ex. 1033 Ex. 1135 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1136 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1136
`
`
`
`4
`
`

`
`Zimmer Spine BAK
`Interbody Fusion
`Systems Brochure
`
`BAK PMA
`Clearance -
`p950002
`
`Jie Zhao et al.,
`Posterior lumbar
`interbody fusion
`using one diagonal
`fusion cage with
`transpedicular
`screw/rod fixation,
`12 EUR. SPIN J.
`173 (2003)
`NuVasive XLIF
`Surgical Technique
`- MaXcess II
`
`NuVasive XLIF
`Surgical Technique
`- MaXcess
`
`NuVasive CoRoent
`XL 510k-K043405
`
`NuVasive XLIF
`Fact Sheet
`
`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`
`Ex. 1137 Ex. 1035 Ex. 1137 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1138 Ex. 1036 Ex. 1138 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1139 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1139
`
`
`
`Ex. 1140 Ex. 1038 Ex. 1140 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`Ex. 1141 Ex. 1039 Ex. 1141 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`Ex. 1143 Ex. 1041 Ex. 1143 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`Ex. 1145 Ex. 1043 Ex. 1145 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`5
`
`

`
`Synthes Vertebral
`Spacer 510k -
`K011037
`
`US 5,772,661
`
`US 5,484,437
`
`Excerpt of
`Deposition of
`Richard Hynes,
`M.D.
`Diagram
`
`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`
`Ex. 1154 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`Fed. R. Evid. 901 (failure
`to authenticate)
`Ex. 1155 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`Fed. R. Evid. 901 (failure
`to authenticate)
`Ex. 1156 Fed. R. Evid. 401-403
`
`Ex. 1146
`
`
`
`
`Ex. 1146 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`Ex. 1148 Ex. 1046 Ex. 1148 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`Ex. 1150 Ex. 1048 Ex. 1150 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`Ex. 1152 Fed. R. Evid. 403 (more
`prejudicial than
`probative)
`
`Ex. 1152
`
`
`
`Ex. 1154
`
`
`
`Diagram
`
`Ex. 1155
`
`
`
`Diagram
`
`Ex. 1156
`
`
`
`6
`
`

`
`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`Fed. R. Evid. 901 (failure
`to authenticate)
`Ex. 1157 Ex. 1055 Ex. 1157 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 602 (lack of
`personal knowledge)
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1158 Ex. 1056 Ex. 1158 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`Ex. 1159 Ex. 1057 Ex. 1159 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`Ex. 1160 Ex. 1058 Ex. 1160 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`
`Ex. 1161 Ex. 1059 Ex. 1161 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`
`7
`
`Second Declaration
`of Dr. Richard A.
`Hynes
`
`Zdeblick
`Documents
`
`Sulzer Spine-Tech
`2000 Price List
`
`Excerpt of
`Declaration of Dr.
`John W. Brantigan,
`M.D., Filed in
`IPR2013-00395 as
`Exhibit 1001
`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
`Record of Oral
`Hearing in
`NuVasive Inc. V.
`Warsaw
`Orthopedic, Inc.,
`IPRs 2013-0026 and
`-00208, Paper 64
`(PTAB June 5,
`2014)
`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
`Excerpt of Second
`Declaration of Dr.
`Paul McAfee, filed
`in IPR2013-00206
`as Exhibit 1029
`Declaration of
`Patrick Miles, Filed
`in IPR2013-00206
`as Exhibit 1032
`NuVasive, Inc.'s
`Objections and
`Responses to
`Plaintiffs' Second
`Set of
`Interrogatories
`
`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`
`Ex. 1162 Ex. 1060 Ex. 1162 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`
`Ex. 1163 Ex. 1061 Ex. 1163 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1164 Ex. 1062 Ex. 1164 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`
`Ex. 1165 Ex. 1063 Ex. 1165 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`Ex. 1166 Ex. 1064 Ex. 1166 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`
`8
`
`

`
`(Nos. 11-13), served
`July 8, 2013
`NuVasive Inc.'s
`Answering Brief in
`Opposing to Globus
`Medical, Inc.'s
`Motion for Partial
`Summary Judgment
`(Dkt. No. 216), filed
`in NuVasive, Inc. v.
`Globus Medical
`Inc., C.A. No. 1:10-
`CV-00849 (D. Del.)
`NuVasive, Inc. v.
`Warsaw
`Orthopedic, Inc.,
`IPR2013-00206,
`Paper 65 at 25-27
`(PTAB July 10,
`2014)
`VerteStack 510k-
`K040536
`
`Expert Report of Dr.
`Bruce E. Van Dam
`Regarding Validity
`of the Asserted
`Claims of US Patent
`No 5,860,973
`Declaration of
`Patrick Miles, filed
`in IPR2014-00087
`as Exhibit 2024
`Excerpt of
`
`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`
`Ex. 1167 Ex. 1065 Ex. 1167 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1168 Ex. 1066 Ex. 1168 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1067
`
`
`
`
`
`Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`Ex. 1170 Ex. 1068 Ex. 1170 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1171 Ex. 1069 Ex. 1171 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`Ex. 1172 Ex. 1070 Ex. 1172 Fed. R. Evid. 401-403
`
`9
`
`

`
`Transcript of
`Deposition of
`Patrick Miles, taken
`November 8, 2010
`Excerpt of
`Transcript of
`Deposition of Dr.
`Hansen A. Yuan,
`Taken August 22,
`2014
`Excerpt of
`Transcript of
`Deposition of
`Patrick Miles, taken
`September 4, 2014
`NuVasive XLIF 90
`Surgical Technique
`Brochure
`
`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
`NuVasive TLIF
`Surgical Technique
`Brochure
`
`Amendment to
`Agreement
`550002080 By and
`
`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`
`(relevance; more
`prejudicial than probative)
`
`
`Ex. 1173 Ex. 1071 Ex. 1173 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`
`Ex. 1174 Ex. 1072 Ex. 1174 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`
`Ex. 1175 Ex. 1073 Ex. 1175 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`Ex. 1176 Ex. 1074 Ex. 1176 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1177 Ex. 1075 Ex. 1177 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`Ex. 1178 Ex. 1076 Ex. 1178 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`10
`
`

`
`Between the County
`of Santa Clara and
`NuVasive, Inc.,
`Dated October 25,
`2011
`NuVasive 2014
`Reimbursement
`Guide
`
`NuVasive XLIF
`Surgical Technique
`
`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`
`Fed. R. Evid. 802
`(hearsay)
`
`Ex. 1179 Ex. 1077 Ex. 1179 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`Fed. R. Evid. 802
`(hearsay)
`Ex. 1180 Ex. 1078 Ex. 1180 Fed. R. Evid. 401-403
`(relevance; more
`prejudicial than probative)
`
`
`These objections are being timely served within five business days of
`
`
`
`service.
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Stuart A. Nelson/
`
`Stuart A. Nelson
`Reg. No. 63,947
`
`
`
`11
`
`
`
`
`
`Date: 9/12/2014
`
`
`Customer Number 26191
`Fish & Richardson P.C.
`Telephone: (612) 337-2508
`Facsimile: (612) 288-9696
`
`

`
`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.6(e)(4)(iii), the undersigned
`
`certifies that on September 12, 2014, a complete and entire copy of this Patent
`
`Owner’s Objection to Evidence under 37 CFR § 42.64(b)(1) was provided via
`
`email to the Petitioner by serving the email correspondence address of record as
`
`follows:
`
`Jeff E. Schwartz
`Seth A. Kramer
`Fox Rothschild LLP
`1030 15th Street, NW
`Washington, DC 20005
`
`Email: jeschwartz@foxrothschild.com
`Email: skramer@foxrothschild.com
`Email: ipdocket@foxrothschild.com
`
`
`
`
`
`
`
`
`
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`
`
`
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`
`
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`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/Diana Bradley/
`Diana Bradley
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`(858) 678-5667
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`12

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