throbber
Case 3:18-cv-00347-CAB-MDD Document 342-4 Filed 10/29/21 PageID.31386 Page 1 of 17
`
`
`
`
`EXHIBIT 3
`TO TRENT TANNER DECLARATION ISO
`NUVASIVE’S COMBINED MOTIONS IN LIMINE
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 342-4 Filed 10/29/21 PageID.31387 Page 2 of 17
`
`Nuvasive, Inc. v. Alphatec Holdings, Inc. et al (S.D. Cal. 3:18-cv-00347-CAB-MDD)
`
`Alphatec First Amended Trial Exhibit List (10/22/21)
`
`ALPHATEC RESERVES THE RIGHT TO ADD, REMOVE, OR OTHERWISE AMEND EXHIBITS ON THIS PRELIMINARY EXHIBIT LIST
`
`DTX No.
`100
`101
`
`Date
`1/15/2013
`5/14/2013
`
`U.S. Patent No. 8,355,780 (Miles et al.)
`U.S. Patent No. 8,439,832 (Miles et al.)
`
`Description
`
`102
`
`103
`
`104
`
`105
`106
`
`107
`108
`109
`110
`111
`112
`113
`114
`
`115
`
`116
`117
`118
`119
`120
`121
`
`122
`123
`124
`125
`126
`127
`128
`129
`130
`131
`132
`
`133
`134
`135
`136
`137
`
`138
`139
`140
`141
`142
`143
`
`144
`
`145
`
`10/26/2010 U.S. Patent No. 7,819,801 (Miles et al.)
`
`5/22/2018
`
`U.S. Patent No. 9,974,531 (Miles et al.)
`
`1/4/2011
`
`Prosecution history for U.S. Patent No. 8,439,832
`
`2/27/2004
`
`11/20/2009
`10/17/2017
`6/4/2012
`3/22/2013
`9/11/2012
`4/3/2013
`12/20/2013
`3/11/2014
`
`3/10/2014
`
`4/3/2013
`12/20/2013
`4/5/2015
`4/6/2010
`
`2/8/2012
`
`10/16/2012
`4/24/2012
`4/3/2015
`9/20/2011
`4/3/2015
`3/11/2014
`3/11/2014
`7/7/2014
`10/30/2019
`10/30/2019
`11/9/2016
`
`12/7/2016
`4/17/2019
`2/6/2003
`7/1/2014
`4/24/2012
`
`3/21/2013
`3/22/2013
`6/4/2012
`6/25/2012
`5/31/2017
`
`9/15/2014
`
`12/19/2016
`
`INTENTIONALLY SKIPPED
`Prosecution history for U.S. Patent No. 7,819,801
`
`Prosecution history for U.S. Patent No. 8,335,780
`Prosecution history for U.S. Patent No. 9,974,531
`Declaration of Dr. Jim Youssef Under 37 C.F.R. 1.132 for Inter Partes Application No. 95/001,888
`IPR2013-00206, Petition
`IPR2013-00206, Declaration of Dr. Paul McAfee, M.D. (P.T.A.B. Mar. 21, 2013)
`IPR2013-00206, Corrected Petition
`IPR2013-00206, Patent Owner’s Response to Petition
`IPR2013-00206, Paper No. NuVasive 1029, Declaration of Dr. Paul McAfee, M.D. (P.T.A.B. Mar. 11,
`2014).
`IPR2013-00206, Paper No. NuVasive 1030, Declaration of Dr. Robert E. Jacobson, M.D. (P.T.A.B. Mar. 10,
`2014)
`IPR2013-00208, Corrected Petition for Inter Partes Review of U.S. Patent No. 8,251,997
`IPR2013-00208, Patent Owner’s Response
`IPR2014-00075, Paper 49, Final Written Decision (U.S. Patent No. 8,016,767)
`U.S. Patent No. 7,691,057 (Miles et al.)
`Right of Appeal Notice U.S. Patent No. 7,582,058
`In re Reexamination of U.S. Patent of Patrick Miles et al., Request for Inter Partes Reexamination of the ’801
`Patent (Feb. 9, 2012)
`In re Reexamination of Miles, Right of Appeal Notice (Oct. 16, 2012), ’801 Patent Reexam
`In re Reexamination of Miles, Non-Final Office Action (April 24, 2012), ’801 Patent Reexam
`IPR2014-00074, Final Written Decision, (U.S. Patent No. 8,192,356), Paper 49
`Press Release titled "Jury Awards Medtronic $101 Million in Patent Suit Against NuVasive"
`IPR2014-00073, Final Written Decision, (U.S. Patent No. 8,192,356), Paper 48
`IPR2013-00206, Petitioner's Reply to Patent Owner's Response (U.S. Patent No. 8,251,997)
`IPR2013-00208, Reply to Patent Owner’s Response
`IPR20014-00034, Obenchain ’782 Declaration
`IPR2019-00361; IPR2019-0032; IPR2019-00546, Declarations of Matthew Link
`IPR2019-00361; IPR2019-0032; IPR2019-00546, Declarations of Jim. A. Youssef, M.D
`In re: NuVasive, Inc., Nos. 2015-1672, 2015-1673, (Fed. Cir. Nov. 9, 2016) (IPR2013-00507, IPR2013-
`00508)
`In re: NuVasive, Inc., No. 2015-1670, (Fed. Cir. Dec. 7 2016) (IPR2013-00506)
`IPR2019-00361, Patent Owner's Preliminary Response
`U.S. Patent Pub. No. 2003/0028249 (Ex. 1008, IPR2019-00361) (Bacelli)
`In re Reexamination of Miles, Patent Board Decision (Jul. 1, 2014), ’801 Patent Reexam
`In re Reexamination of Miles, Decision on Request for Inter Partes Reexamination (April 24, 2012), ’801
`Patent Reexam
`INTENTIONALLY SKIPPED
`IPR2013-00208, Declaration of Dr. Paul McAfee, M.D.
`IPR2013-00208, Petition for IPR of U.S. Patent 8,251,997
`Reexamination of 7,691,057, Declaration of Dr. Jim Youssef
`Inter Partes Reexam for U.S. Patent No. 7,819,801, Declaration of Dr. Jim Youssef
`Opinion, United States Court of Appeals for the Federal Circuit In Re: NuVasive, Inc., Case No. 2015-1841,
`(IPR2014-0075)
`Decision on Appeal, Appeal 2014-002497, Inter Partes Reexamination Control 95/001,202 (U.S. Patent No.
`7,207,949)
`Final Decision on Appeal Under 37 C.F.R. §41.77(f), Appeal 2016-008303, Reexamination Control
`95/001,888 (U.S. Patent No. 7,691,057)
`
`Beginning Bates No.
`ATEC_LLIF000848819
`ATEC_LLIF000848855
`
`Ending Bates No.
`ATEC_LLIF000848854
`ATEC_LLIF000848887
`
`ATEC_LLIF000848920
`
`ATEC_LLIF000848958
`
`ATEC_LLIF000849060
`
`ATEC_LLIF000849100
`
`ATEC_LLIF000851247
`
`ATEC_LLIF000851512
`
`ATEC_LLIF000849101
`
`ATEC_LLIF000850261
`ATEC_LLIF000854081
`APPX00356
`ATEC_LLIF000061281
`ATEC_LLIF000061347
`ATEC_LLIF000061505
`ATEC_LLIF000062136
`ATEC_LLIF000063841
`
`ATEC_LLIF000850260
`ATEC_LLIF000851246
`ATEC_LLIF000854414
`APPX00366
`ATEC_LLIF000061346
`ATEC_LLIF000061452
`ATEC_LLIF000061570
`ATEC_LLIF000062209
`ATEC_LLIF000063970
`
`ATEC_LLIF000065065
`
`ATEC_LLIF000065076
`
`ATEC_LLIF000066610
`ATEC_LLIF000067240
`ATEC_LLIF000108645
`ATEC_LLIF000126756
`ATEC_LLIF000129008
`ATEC_LLIF000131828
`
`ATEC_LLIF000132525
`ATEC_LLIF000133525
`ATEC_LLIF000847361
`ATEC_LLIF000970732
`NUVA_ATEC0068487
`NUVA_ATEC0103119
`NUVA_ATEC0107633
`NUVA_ATEC0247545
`
`ATEC_LLIF000066675
`ATEC_LLIF000067313
`ATEC_LLIF000108683
`ATEC_LLIF000126788
`ATEC_LLIF000129020
`ATEC_LLIF000131831
`
`ATEC_LLIF000132534
`ATEC_LLIF000133533
`ATEC_LLIF000847391
`ATEC_LLIF000970732
`NUVA_ATEC0068522
`NUVA_ATEC0103144
`NUVA_ATEC0107658
`NUVA_ATEC0247566
`
`ATEC_LLIF000132111
`ATEC_LLIF000133511
`
`ATEC_LLIF000132122
`ATEC_LLIF000133522
`
`Appx00356
`
`Appx00366
`
`Deposition Exhibit
`
`Doc No.
`
`Plaintiff's Objections
`
`Schermerhorn (01-09-20) Ex.1
`Sachs (06-05-18) Ex. 18
`Finley (11-15-19) Ex. 3
`Youssef (01-10-20) Ex. 28
`Youssef (04-27-18) Ex. 14
`Finley (11-15-19) Ex. 6
`Schermerhorn (01-09-20) Ex. 3
`
`[253-10]
`
`Schermerhorn (01-09-20) Ex. 10
`
`[260-7]
`
`Schermerhorn (01-09-20) Ex. 14
`
`[260-8]
`
`[49-49]
`[49-61]
`
`[49-62]
`
`[49-63]
`
`Page 1 of 16
`
`EXHIBIT 3, Page 84 of 99
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 342-4 Filed 10/29/21 PageID.31388 Page 3 of 17
`
`Nuvasive, Inc. v. Alphatec Holdings, Inc. et al (S.D. Cal. 3:18-cv-00347-CAB-MDD)
`
`Alphatec First Amended Trial Exhibit List (10/22/21)
`
`ALPHATEC RESERVES THE RIGHT TO ADD, REMOVE, OR OTHERWISE AMEND EXHIBITS ON THIS PRELIMINARY EXHIBIT LIST
`
`DTX No.
`146
`
`Date
`7/1/2014
`
`Description
`Decision on Appeal, Appeal 2013-009128, Reexamination Control 95/001,888 (U.S. Patent No. 7,691,057)
`
`Beginning Bates No.
`
`Ending Bates No.
`
`Deposition Exhibit
`
`147
`148
`
`149
`
`150
`151
`152
`153
`154
`
`155
`
`156
`
`157
`158
`159
`160
`
`161
`
`162
`163
`
`164
`
`165
`166
`
`167
`
`168
`200
`201
`202
`203
`204
`205
`206
`207
`208
`209
`
`210
`211
`212
`213
`214
`215
`216
`217
`218
`219
`220
`221
`222
`223
`
`7/1/2014
`
`7/10/2014
`
`INTENTIONALLY SKIPPED
`NuVasive, Inc. v. Warsaw Orthopedic, Inc., No. IPR2013-00206, Final Written
`Decision (P.T.A.B. July 10, 2014)
`NuVasive, Inc. v. Warsaw Orthopedic, Inc., No. IPR2013-00208, Final Written
`Decision (P.T.A.B. July 10, 2014)
`Right of Appeal Notice, Reexamination Control 95/001,888 (U.S. Patent No. 7,691,057)
`8/22/2012
`Determination of Reexam Ordered, Reexamination Control 95/001,888 (U.S. Patent No. 7,691,057)
`4/4/2012
`Receipt of Original Reexam Request, Reexamination Control 95/001,888 (U.S. Patent No. 7,691,057)
`12/9/2012
`8/18/2008 Medtronic Sofamor Danek USA, Inc. v. NuVasive, Inc., No. 308-cv-01512, Complaint (Dkt. 1)
`9/29/2011 Medtronic Sofamor Danek USA, Inc. v. NuVasive, Inc., No. 308-cv-01512, 2011 Phase I Jury Verdict (Dkt.
`401)
`Medtronic Sofamor Danek USA, Inc. v. NuVasive, Inc., No. 308-cv-01512, Counterclaim 058 (Dkt. 81)
`
`9/4/2009
`
`4/28/2009 Medtronic Sofamor Danek USA, Inc. v. NuVasive, Inc., No. 308-cv-01512, Counterclaim 949 (Dkt. 48)
`
`6/4/2012
`
`8/14/2009
`4/17/2015
`
`7/3/2012
`
`12/30/2016
`
`Reply to Office Action (Reexamination of 7,691,057)
`INTENTIONALLY SKIPPED
`Non-Final Action in the Reexamination of U.S. Patent Nos. 7,207,949 (Application No. 95/001,202)
`Reexamination Certificate Issued in the Reexamination of U.S. Patent Nos. 7,207,949 (Application No.
`95/001,202)
`Third Party Requester Comments in the Reexamination of U.S. Patent Nos. 7,207,949 (Application No.
`95/001,202)
`INTENTIONALLY SKIPPED
`Reexamination Certificate in the Reexamination of U.S. Patent No. 7,582,058 (Application No. 95/001,247)
`
`7/15/2011
`
`11/10/2016
`11/16/2016
`
`12/16/2016
`
`Second Amended Complaint for Patent Infringement (NuVasive, Inc. v. Globus Medical, Inc., Case No. 1:10-
`cv-00849-LPS)
`Reuters Legal Article titled "Federal Circuit affirms invalidity of NuVasive spine implant patent"
`PTABWatch Article titled "APA Requires Notice of and Opportunity to Respond to Grounds for
`Cancellation"
`IP Watchdog Article titled "Federal Circuit Remands Inter Partes Review Decision Invalidating NuVasive
`Patent"
`LAW360 Article titled "Fed. Cir. Affirms PTAB's Invalidation of NuVasive Patents"
`5/10/2017
`NuVasive Solid MaXcess III Marketing Requirements Document
`9/28/2008
`11/13/2008 DHF MaXcess III Solid – Design Verification Memo
`9/13/2006
`NuVasive MaXcess III Marketing Requirements Document
`11/13/2008 DHF MaXcess III – Design Validation Memo
`2/25/2004 MaXcess Access System – Product Requirements Document
`9/12/2006 MaXcess III - Product Requirements Document
`5/30/2003
`NuVasive, Product Requirements Documents - Tissue Retractor System
`8/29/2005
`DHF MaXcess II – Product Requirements
`2/17/2010 MaXcess IV Retractor System – Tolerance Analysis
`Email from Jonathan Brenner to Caroline Hester et al re Follow up: Proceduralization Gate II - LSPS,
`8/29/2018
`attaching LSPS Procedural Phase Gate PII Meeting presentation
`NuVasive Dilators (Physical Product)
`NuVasive MaXcess I Retractor (Physical Product)
`NuVasive MaXcess II Retractor (Physical Product)
`NuVasive MaXcess III Retractor (Physical Product)
`NuVasive MaXcess III Solid Retractor (Physical Product)
`NuVasive MaXcess 4 Retractor (Physical Product)
`NuVasive MaXcess 4 Solid Retractor (Physical Product)
`NuVasive Intradiscal Shim (Physical Product)
`NuVasive Shim Inserter (Physical Product)
`NuVasive K-Wire (Physical Product)
`NuVasive Light Cable (Physical Product)
`NuVasive Light Source Connector (Physical Product)
`NuVasive Fourth Blade / Anterior Retractor (Physical Product)
`NuVasive Fourth Blade Attachment / Anterior Crossbar (Physical Product)
`
`ATEC_LLIF000970733
`ATEC_LLIF000970735
`
`ATEC_LLIF000970734
`ATEC_LLIF000970738
`
`ATEC_LLIF000970739
`
`ATEC_LLIF000970741
`
`ATEC_LLIF000970742
`NUVA_ATEC0009126
`NUVA_ATEC0009160
`NUVA_ATEC0009305
`NUVA_ATEC0009364
`NUVA_ATEC0009372
`NUVA_ATEC0009394
`NUVA_ATEC0009667
`NUVA_ATEC0009775
`NUVA_ATEC0013067
`NUVA_ATEC0292852
`
`ATEC_LLIF000970743
`NUVA_ATEC0009136
`NUVA_ATEC0009160
`NUVA_ATEC0009314
`NUVA_ATEC0009365
`NUVA_ATEC0009386
`NUVA_ATEC0009413
`NUVA_ATEC0009699
`NUVA_ATEC0009789
`NUVA_ATEC0013076
`NUVA_ATEC0292931
`
`Link (04-19-18) Ex. 2
`
`Finley (11-15-19) Ex. 13
`
`Finley (11-15-19) Ex. 12
`
`Finley (11-15-19) Ex. 11
`
`Finley (11-15-19) Ex. 16
`
`Plaintiff's Objections
`
`Doc No.
`[49-64]
`
`[251-8]
`
`[251-9]
`
`Page 2 of 16
`
`EXHIBIT 3, Page 85 of 99
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 342-4 Filed 10/29/21 PageID.31389 Page 4 of 17
`
`Nuvasive, Inc. v. Alphatec Holdings, Inc. et al (S.D. Cal. 3:18-cv-00347-CAB-MDD)
`
`Alphatec First Amended Trial Exhibit List (10/22/21)
`
`ALPHATEC RESERVES THE RIGHT TO ADD, REMOVE, OR OTHERWISE AMEND EXHIBITS ON THIS PRELIMINARY EXHIBIT LIST
`
`DTX No.
`224
`225
`
`226
`227
`228
`229
`
`230
`
`231
`
`232
`233
`234
`235
`236
`237
`
`238
`239
`240
`241
`242
`243
`
`244
`245
`246
`247
`
`248
`249
`300
`301
`302
`303
`304
`305
`306
`307
`308
`309
`310
`
`311
`312
`
`313
`314
`315
`316
`317
`318
`319
`320
`321
`322
`323
`324
`
`Date
`
`2013
`
`2007
`2013
`
`2008
`
`2008
`
`2014
`2005
`2006
`
`2011
`2013
`
`2007
`6/3/2002
`3/15/2007
`10/25/2007
`11/29/2007
`10/13/2008
`
`4/27/2011
`4/8/2013
`6/10/2011
`10/18/2011
`
`Description
`NuVasive Access Driver Handles (Physical Product)
`2013 XLIF Surgical Technique
`
`Technical File – NuVasive MaXcess Access System
`INTENTIONALLY SKIPPED
`2007 XLIF Surgical Technique (MaXcess III Retractor)
`eXtreme Lateral Interbody Fusion (XLIF®) 3 (J. Allan Goodrich and Ildemaro J. Volcan, eds., 2d ed. 2013)
`
`eXtreme Lateral Interbody Fusion (XLIF®) 4 (J. Allan Goodrich and Ildemaro J. Volcan, eds., 1st ed. 2008)
`(“XLIF® 1st ed.”)
`eXtreme Lateral Interbody Fusion (XLIF®) 4 (J. Allan Goodrich and Ildemaro J. Volcan, eds., 1st ed. 2008)
`(“XLIF® 1st ed.”) (colored version)
`2014 XLIF Surgical Technique Guide
`2005 XLIF 90 Surgical Technique
`2006 XLIF Surgical Technique Guide: MaXcess II
`INTENTIONALLY SKIPPED
`2011 XLIF Surgical Technique Guide
`eXtreme Lateral Interbody Fusion (XLIF®) 3 (J. Allan Goodrich and Ildemaro J. Volcan, eds., 2d ed. 2013)
`(colored version)
`NuVasive’s 2007 XLIF Surgical Technique (MaXcess III Retractor) (colored version)
`Email from Eric Finley to Pat Miles re German Surgeries
`XLIF University (collection of documents for NuVasive’s salesmen)
`Email from Jim Gharib re Medtronic monitoring
`Email from Albert Pothier to Eric Finley and others re meeting with surgeons
`Email from Peter Spenuzza re competitive summary with attachment
`
`Email from Eric Finley to Mike Serra et al re electrode predicates
`Email from Matt Twite re XLIF Nav
`NuVasive's VIP Surgeon Scouting Report
`Email from Albert Pothier re competitive update
`
`2012
`
`2012 Spreadsheet re Instrumentation Usage by Manufacturer
`NuVasive's presentation titled "Lateral Approach - Experience Counts!"
`Operative Reports from Scripps Memorial Hospital from Dr. Neville Alleyne
`2/14/2017
`Drawings, Battalion, LLIF RETRACTOR BODY (27426-01_02 Retractor Body.pdf)
`11/2/2015
`Drawings, Battalion, LLIF RETRACTOR RIGHT HANDLE (27426-02_02 Right handle.pdf)
`9/4/2015
`Drawings, Battalion, LLIF RETRACTOR LEFT HANDLE (27426-03_02 Left handle.pdf)
`9/4/2015
`Drawings, Battalion LLIF 4TH BLADE ATTACHMENT (27426-04_01 4th blade attachment.pdf)
`8/5/2015
`Drawings, Battalion, LLIF 4TH BLADE, XXMM x XXXMM (27427-XXX-XXX_01 4th blade.pdf)
`8/5/2015
`Drawings, Battalion, LLIF SHIM INSERTER (27434_03 Shim inserter.pdf)
`10/5/2015
`Drawings, Battalion, LLIF INTRADISCAL SHIM (27435_03 Shim.pdf)
`10/2/2015
`Drawings, Battalion, LLIF Right Cable (27436_01 Light cable.pdf)
`9/9/2015
`Drawings, Battalion, LLIF Right Blade (27440-XXX_01 Right blade.PDF)
`8/3/2015
`10/20/2015 Drawings, Battalion, LLIF Right Blade, Carbon-Peek, XXXmm, Rev. 01 (27442-XXX_02 Right blade.pdf)
`
`Beginning Bates No.
`
`Ending Bates No.
`
`Deposition Exhibit
`
`Doc No.
`
`Plaintiff's Objections
`
`ATEC_LLIF000073008
`ATEC_LLIF000074554
`NUVA_ATEC0009254
`
`ATEC_LLIF000073032
`ATEC_LLIF000074574
`NUVA_ATEC0009279
`
`Malone (11-08-19) Ex. 4
`
`ATEC_LLIF000074510
`ATEC_LLIF000166436
`
`ATEC_LLIF000074541
`ATEC_LLIF000166884
`
`Malone (11-08-19) Ex. 3
`
`Link (10-29-20) Ex. 3
`
`Finley 10
`
`Finley 14
`
`ATEC_LLIF000166885
`
`ATEC_LLIF000167183
`
`NUVA_ATEC0111995
`
`NUVA_ATEC0112293
`
`NUVA_ATEC0015567
`NUVA_ATEC0040546
`NUVA_ATEC0040574
`
`NUVA_ATEC0015614
`NUVA_ATEC0040573
`NUVA_ATEC0040601
`
`NUVA_ATEC0111938
`NUVA_ATEC0112971
`
`NUVA_ATEC0111973
`NUVA_ATEC0113418
`
`NUVA_ATEC0016170
`NUVA_ATEC0244096
`NUVA_ATEC0288892
`NUVA_ATEC0288899
`NUVA_ATEC0288908,
`NUVA_ATEC0290619
`NUVA_ATEC0288942
`NUVA_ATEC0289025
`NUVA_ATEC0290889
`NUVA_ATEC0291822
`NUVA_ATEC0292096
`NUVA_ATEC0299979
`NUVA_ATEC0306822
`ALLEYNE000013
`ATEC_LLIF000001862
`ATEC_LLIF000001869
`ATEC_LLIF000001871
`ATEC_LLIF000001873
`ATEC_LLIF000001874
`ATEC_LLIF000001877
`ATEC_LLIF000001878
`ATEC_LLIF000001880
`ATEC_LLIF000001882
`ATEC_LLIF000001883
`
`NUVA_ATEC0016170
`NUVA_ATEC0244406
`NUVA_ATEC0288893
`NUVA_ATEC0288899
`NUVA_ATEC0288908,
`NUVA_ATEC0290619
`NUVA_ATEC0288943
`NUVA_ATEC0289025
`NUVA_ATEC0290891
`NUVA_ATEC0291822
`NUVA_ATEC0292143
`NUVA_ATEC0299979
`NUVA_ATEC0306895
`ALLEYNE000017
`ATEC_LLIF000001868
`ATEC_LLIF000001870
`ATEC_LLIF000001872
`ATEC_LLIF000001873
`ATEC_LLIF000001874
`ATEC_LLIF000001877
`ATEC_LLIF000001879
`ATEC_LLIF000001881
`ATEC_LLIF000001882
`ATEC_LLIF000001883
`
`Drawings, Battalion, LLIF Left Blade, XXXmm, Rev. 1 (27450-XXX_01 Left blade.PDF)
`8/3/2015
`10/20/2015 Drawings, Battalion LLIF Left Blade, Carbon-Peek, XXXmm, Rev. 2 (27452-XXX_02 Left blade.pdf)
`
`ATEC_LLIF000001884
`ATEC_LLIF000001885
`
`ATEC_LLIF000001884
`ATEC_LLIF000001885
`
`10/17/2015
`
`Drawings, Battalion LLIF Center Blade, Rev. 1 (27460-XXX_01 Center blade.PDF)
`8/3/2015
`10/20/2015 Drawings, Battalion LLIF Center Blade, Rev. 1 (27460-XXX_01 Center blade.PDF)
`Lateral Lumbar Interbody Fusion - Retractor System (DHF#15-003)
`Prototype Development/Evaluation 6.1.1
`Initiate DHF/ Design Team Assignment 6.1.2
`Product Requirement Specification 6.1.3
`10/26/2015
`Risk Management File 6.1.4
`10/26/2015
`10/26/2015 Design & Development Plan (DDP) 6.1.5
`Design Input Review 6.1.6
`Part Numbers/ Engineering Drawings 6.2.1
`1/13/2017
`4/29/2016 Material/Process Specifications 6.2.2
`4/27/2016
`Design Interface Analysis (DIA) 6.2.3
`
`ATEC_LLIF000001886
`ATEC_LLIF000001887
`ATEC_LLIF000001898
`ATEC_LLIF000001900
`ATEC_LLIF000001902
`ATEC_LLIF000001905
`ATEC_LLIF000001907
`ATEC_LLIF000001909
`ATEC_LLIF000001911
`ATEC_LLIF000001921
`ATEC_LLIF000001923
`ATEC_LLIF000001925
`
`ATEC_LLIF000001886
`ATEC_LLIF000001887
`ATEC_LLIF000001898
`ATEC_LLIF000001901
`ATEC_LLIF000001904
`ATEC_LLIF000001906
`ATEC_LLIF000001908
`ATEC_LLIF000001910
`ATEC_LLIF000001919
`ATEC_LLIF000001922
`ATEC_LLIF000001924
`ATEC_LLIF000001926
`
`Page 3 of 16
`
`EXHIBIT 3, Page 86 of 99
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 342-4 Filed 10/29/21 PageID.31390 Page 5 of 17
`
`Nuvasive, Inc. v. Alphatec Holdings, Inc. et al (S.D. Cal. 3:18-cv-00347-CAB-MDD)
`
`Alphatec First Amended Trial Exhibit List (10/22/21)
`
`ALPHATEC RESERVES THE RIGHT TO ADD, REMOVE, OR OTHERWISE AMEND EXHIBITS ON THIS PRELIMINARY EXHIBIT LIST
`
`Deposition Exhibit
`
`Doc No.
`
`Plaintiff's Objections
`
`Robinson (10-29-19) Ex. 6
`Aleali (10-30-20) Ex.8
`
`Beginning Bates No.
`ATEC_LLIF000001927
`ATEC_LLIF000001929
`ATEC_LLIF000001934
`ATEC_LLIF000001936
`ATEC_LLIF000001939
`ATEC_LLIF000001945
`ATEC_LLIF000001949
`ATEC_LLIF000001951
`ATEC_LLIF000002059
`ATEC_LLIF000002061
`ATEC_LLIF000002096
`ATEC_LLIF000002145
`ATEC_LLIF000002147
`ATEC_LLIF000002151
`ATEC_LLIF000002154
`ATEC_LLIF000002224
`ATEC_LLIF000002284
`ATEC_LLIF000002354
`
`Ending Bates No.
`ATEC_LLIF000001928
`ATEC_LLIF000001932
`ATEC_LLIF000001935
`ATEC_LLIF000001938
`ATEC_LLIF000001944
`ATEC_LLIF000001948
`ATEC_LLIF000001950
`ATEC_LLIF000002057
`ATEC_LLIF000002060
`ATEC_LLIF000002095
`ATEC_LLIF000002144
`ATEC_LLIF000002146
`ATEC_LLIF000002150
`ATEC_LLIF000002153
`ATEC_LLIF000002162
`ATEC_LLIF000002254
`ATEC_LLIF000002342
`ATEC_LLIF000002397
`
`ATEC_LLIF000002408
`
`ATEC_LLIF000002409
`
`ATEC_LLIF000002410
`ATEC_LLIF000003765
`ATEC_LLIF000003769
`ATEC_LLIF000003773
`ATEC_LLIF000003777
`ATEC_LLIF000003780
`ATEC_LLIF000003782
`ATEC_LLIF000003783
`ATEC_LLIF000003784
`ATEC_LLIF000003785
`
`ATEC_LLIF000002443
`ATEC_LLIF000003768
`ATEC_LLIF000003772
`ATEC_LLIF000003776
`ATEC_LLIF000003779
`ATEC_LLIF000003781
`ATEC_LLIF000003782
`ATEC_LLIF000003783
`ATEC_LLIF000003784
`ATEC_LLIF000003806
`
`12/12/2016
`1/26/2017
`
`Date
`1/30/2017
`4/29/2016
`11/30/2016
`
`12/1/2016
`
`Description
`Device Master Record (DMR) 6.2.4 6.3.7 6.4.8
`Design Output Review 6.2.5
`SKIF Creation/ Set Configuration 6.3.1
`Design Verification/Validation Protocols 6.3.3
`Pre-Production Part Build 6.3.4
`Design Verification Documentation/Reports 6.3.5
`10/14/2016 Quality Plan 6.3.6
`Design Verification Review 6.3.8
`Production Documentation Release 6.4.1
`Design Validation/Transfer Review 6.4.10
`Design Validation Reports 6.4.2
`Cleaning Validation 6.4.3
`Instructions For Use (IFU) 6.4.5
`Manufacturing Documentation 6.4.7
`Conduct Internal Training 6.4.9
`Design Verification Review 6.3.8
`Design Validation Reports 6.4.2
`Conduct Internal Training 6.4.9 (Alphatec Spine Research and Development – LLIF Implant System) -
`Alphatec Presentation: “2017 LLIF Information Session” (December 2016)
`INTENTIONALLY SKIPPED
`1/25/2017 Memorandum from R. Black to DHF 15-003 File re Independent Review of Lateral Lumbar Interbody
`Fusion instruments
`11/18/2015 Alphatec Presentation: “Product Line: Planning / Input (Phase 1 to 2)”
`8/6/2015
`Drawing, Battalion LLIF Retractor Body
`8/4/2015
`Drawing, Battalion LLIF Retractor Body, Frame Arm, Right
`8/4/2015
`Drawing, Battalion LLIF Retractor Body, Frame Arm, Left
`8/4/2015
`Drawing, Battalion LLIF Retractor Body Frame
`8/4/2015
`Drawing, Battalion LLIF Retractor Body Center Blade, Rack
`8/4/2015
`Drawing, Battalion LLIF Retractor Body Blades, Lock
`8/4/2015
`Drawing, Battalion, LLIF Retractor Body Rack, Adjustment Knob
`8/4/2015
`Drawing, Battalion LLIF Retractor Body Adjustment Knob, Screw
`6/16/2014
`Alphatec PowerPoint titled “Lateral Lumbar Interbody Fusion System – Market Need / Business Case PH:1”
`
`3/28/2013
`2/12/2013
`
`7/14/2014
`
`1/10/2017
`N/A
`7/31/2014
`9/14/2015
`12/1/2015
`12/1/2015
`12/1/2015
`
`9/9/2015
`6/29/2016
`
`9/18/2017
`
`7/18/2019
`9/10/2019
`1/5/2017
`6/1/2013
`3/31/2015
`3/21/2015
`12/11/2015
`
`Alphatec PowerPoint – Direct Lateral (03/28/13)
`Alphatec’s PowerPoint - Direct Lateral – Lateral Retractor Systems – Concepts & Key Features (February
`12, 2013)
`INTENTIONALLY SKIPPED
`Alphatec Integrated Project Charter re LLIF System
`INTENTIONALLY SKIPPED
`LIT-84746A LLIF Battalion Lateral Implant Guide
`MMKT-000679 - Squadron Lateral Sales Demo Video
`Drawing, SHIM, Rev. X2
`Engineering Drawing, Battalion , LLIF Intradiscal Shim, Rev. 03
`Engineering CAD Drawings, Battalion, LLIF Right Blade Body, XXXmm, Rev. A
`Engineering CAD Drawing, Battalion, LLIF Right Blade, XXXmm, Rev. A
`Engineering CAD Drawings, Battalion, LLIF Left Blade, Body, XXXmm, Rev. A
`INTENTIONALLY SKIPPED
`Engineering CAD Drawings, Battalion, LLIF Intradiscal Shim, Rev. A
`Engineering CAD Drawings, Battalion, LLIF Retractor Body, Rev. B
`INTENTIONALLY SKIPPED
`Squadron Lateral Surgical Technique Guide (LIT-84745D)
`INTENTIONALLY SKIPPED
`LIF Lateral Interbody Fusion Instrument Set Configuration Guide (LIT-84869A)
`LIF Lateral Interbody Fusion Surgical Technique Guide (LIT-84885B)
`Battalion Lateral Lumbar Spacer System Surgical Technique Guide
`Executed Project Development Agreement between Alphatec Spine, Inc. and Dr. Payam Moazzaz
`Product Development Agreement Alphatec Design
`Lateral Prototype Evaluation – TP-100XXX Lateral Prototype Lab 2 (March 21, 2015)
`Battalion LLIF Validation Lab – TP-100830
`Battalion LLIF User Validation – Retractor System
`
`ATEC_LLIF000004376
`ATEC_LLIF000004548
`
`ATEC_LLIF000004386
`ATEC_LLIF000004561
`
`Robinson (10-29-19) Ex. 9
`
`ATEC_LLIF000004800
`
`ATEC_LLIF000004816
`
`ATEC_LLIF000004935
`ATEC_LLIF000004943
`ATEC_LLIF000144440
`ATEC_LLIF000149858
`ATEC_LLIF000150866
`ATEC_LLIF000150868
`ATEC_LLIF000150869
`
`ATEC_LLIF000004942
`ATEC_LLIF000004943
`ATEC_LLIF000144440
`ATEC_LLIF000149859
`ATEC_LLIF000150867
`ATEC_LLIF000150868
`ATEC_LLIF000150870
`
`ATEC_LLIF000154049
`ATEC_LLIF000155447
`
`ATEC_LLIF000154050
`ATEC_LLIF000155453
`
`ATEC_LLIF000167230
`
`ATEC_LLIF000167257
`
`ATEC_LLIF000167258
`ATEC_LLIF000167276
`ATEC_LLIF000167294
`ATEC_LLIF000168555
`ATEC_LLIF000168572
`ATEC_LLIF000188196
`ATEC_LLIF000188833
`
`ATEC_LLIF000167275
`ATEC_LLIF000167293
`ATEC_LLIF000167322
`ATEC_LLIF000168571
`ATEC_LLIF000168585
`ATEC_LLIF000188225
`ATEC_LLIF000188852
`
`Aleali (10-30-20) Ex. 5
`
`Aleali (10-30-20) Ex. 7
`
`Alleyne (11-04-19) Ex. 3
`Moazzaz (11-11-19) Ex. 13
`Alleyne (11-04-19) Ex. 10
`
`[253-7]
`
`Page 4 of 16
`
`DTX No.
`325
`326
`327
`328
`329
`330
`331
`332
`333
`334
`335
`336
`337
`338
`339
`340
`341
`342
`
`343
`344
`
`345
`346
`347
`348
`349
`350
`351
`352
`353
`354
`
`355
`356
`
`357
`358
`359
`360
`361
`362
`363
`364
`365
`366
`367
`368
`369
`370
`371
`372
`373
`374
`375
`376
`377
`378
`379
`
`EXHIBIT 3, Page 87 of 99
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 342-4 Filed 10/29/21 PageID.31391 Page 6 of 17
`
`Nuvasive, Inc. v. Alphatec Holdings, Inc. et al (S.D. Cal. 3:18-cv-00347-CAB-MDD)
`
`Alphatec First Amended Trial Exhibit List (10/22/21)
`
`ALPHATEC RESERVES THE RIGHT TO ADD, REMOVE, OR OTHERWISE AMEND EXHIBITS ON THIS PRELIMINARY EXHIBIT LIST
`
`DTX No.
`380
`381
`382
`383
`
`384
`
`385
`386
`
`387
`388
`389
`390
`391
`392
`393
`394
`395
`396
`397
`398
`399
`
`400
`401
`402
`403
`
`404
`405
`406
`
`407
`
`408
`409
`
`410
`
`411
`
`412
`413
`414
`415
`416
`417
`418
`419
`420
`421
`422
`423
`424
`425
`426
`427
`428
`
`Date
`
`8/3/2015
`10/2/2014
`
`3/10/2014
`
`Description
`ATEC Squadron Lateral Access System: Anterior Column, Sales Sheet
`INTENTIONALLY SKIPPED
`Alphatec's Battalion Lateral Animation Key Features and Benefits
`Executed Product Development Agreement - Alphatec Design between Alphatec Spine, Inc. and Future
`Solutions, LLC
`Alphatec Spine, Inc. Agreement Approval Sheet titled “Scientific Advisory Board” from March 5, 2014 until
`terminated
`Battalion™ Universal FDA Submission (excerpted)
`Executed Product Development Agreement - Development Design between Alphatec Spine, Inc. and
`Mohammad Etminan
`Executed Product Development Agreement between Alphatec Spine and Dr. Frank Kuwamura
`Set of 119 CAD files
`Engineering CAD Drawing
`Engineering CAD Drawing
`Engineering CAD Drawing
`Engineering Drawing
`Alphatec PowerPoint titled “Lateral Lumbar Interbody Fusion System”
`12/29/2019 Alphatec Spine Lateral Lumber Interbody System
`N/A
`Battalion™ LLIF User Validation document
`4/4/2016
`Alphatec 510(k) FDA Submission document
`9/8/2016
`September 2016 FDA Letter
`12/10/2019
`LIT-84859B ATEC LIF Parts List - Lateral Approach
`12/16/2019
`LIT-84909A Transcend LIF Lateral Interbody Spacer System Implant Guide
`
`12/29/2014
`3/14/2013
`
`9/1/2014
`
`11/23/2016
`
`2/19/2020
`2/25/2019
`
`2019
`
`3/28/2019
`
`2019
`
`1/5/2017
`2019
`
`4/7/2017
`
`9/2017
`
`11/00/2000
`
`TranscendTM LIF Implant Guide
`Drawings, Battalion, LLIF Retractor Body, Rev. H
`INTENTIONALLY SKIPPED
`Tedan_Minimally Invasive Surgical Instruments For Lateral Lumbar Spine -
`http://www.tedansurgical.com/spine/xl-lumbar/ at “Dilation Components
`INTENTIONALLY SKIPPED
`INTENTIONALLY SKIPPED
`“Alphatec Announces Commercial Launch of its First IdentiTi…” https://www.globenewswire.com/news-
`release/2019/03/28/1781332/0/en/Alphatec-Announces-Commercial-Launch-of-its-First-IdentiTi-Porous-
`Titanium-Interbody-System.html
`Battalion Lateral Lumber Spacer System (https://atecspine.com/product-portfolio/llif/battalion-lateral-spacer-
`system/)
`Alphatec’s Battalion Lateral Surgical Technique Guide
`“Squadron® Lateral Retractor," Alphatec website. (https://atecspine.com/product-portfolio/llif/battalion-
`lateral-access-system-and-squadron- retractor/, viewed on October 28, 2019.)
`Press Release - Alphatec Spine Launches Battalion Lateral System with Squadron Retractor to Support
`Minimally Invasive Lateral Access Procedures
`ATEC Presentation, "We Improve Lives By Providing Innovative Spine Surgery Solutions Through Our
`Relentless Pursuit of Superior Outcomes."
`Sachs, Barton, M.D. CV
`INTENTIONALLY SKIPPED
`Alphatec Initial Dilator (Physical Product)
`Alphatec Secondary Dilator (Physical Product)
`Alphatec Squadron™ Lateral Retractor Body (Physical Product)
`Alphatec Squadron™ Lateral Retractor Right Blade (Physical Product)
`Alphatec Squadron™ Lateral Retractor Left Blade (Physical Product)
`Alphatec Squadron™ Lateral Retractor Posterior Blade (Physical Product)
`Alphatec Squadron™ 4th Blade (Physical Product)
`Alphatec Squadron™ Lateral Retractor Right Handle Arm (Physical Product)
`Alphatec Squadron™ Lateral Retractor Left Handle Arm (Physical Product)
`Alphatec Squadron™ Lateral Retractor Attachment Cross Bar (Physical Product)
`Alphatec Squadron™ Lateral Retractor Right Arm Extender (Physical Product)
`Alphatec Squadron™ Lateral Retractor Left Arm Extender (Physical Product)
`Alphatec K-wire (Physical Product)
`Alphatec Intradiscal Shim (Physical Product)
`Alphatec Shim Inserter (Physical Product)
`
`Beginning Bates No.
`ATEC_LLIF000189938
`
`Ending Bates No.
`ATEC_LLIF000189953
`
`Deposition Exhibit
`
`Doc No.
`[253-18]
`
`Plaintiff's Objections
`
`ATEC_LLIF000204473
`ATEC_LLIF000254650
`
`ATEC_LLIF000204481
`ATEC_LLIF000254662
`
`ATEC_LLIF000436020
`
`ATEC_LLIF000436027
`
`Alleyne (11-04-19) Ex. 1
`
`ATEC_LLIF000664489
`ATEC_LLIF000705910
`
`ATEC_LLIF000665122
`ATEC_LLIF000705997
`
`ATEC_LLIF000854526
`ATEC_LLIF000854541
`ATEC_LLIF000854711
`ATEC_LLIF000854712
`ATEC_LLIF000854716
`ATEC_LLIF000854717
`ATEC_LLIF000855283
`ATEC_LLIF000862492
`ATEC_LLIF000888112
`ATEC_LLIF000888753
`ATEC_LLIF000908131
`ATEC_LLIF000964702
`ATEC_LLIF000964710
`
`ATEC_LLIF000854539
`ATEC_LLIF000854659
`ATEC_LLIF000854711
`ATEC_LLIF000854712
`ATEC_LLIF000854716
`ATEC_LLIF000854718
`ATEC_LLIF000855297
`ATEC_LLIF000862542
`ATEC_LLIF000888429
`ATEC_LLIF000889291
`ATEC_LLIF000908137
`ATEC_LLIF000964705
`ATEC_LLIF000964717
`
`ATEC_LLIF000964817
`COSTABILE00000167
`
`ATEC_LLIF000964824
`COSTABILE00000173
`
`Aleali (10-30-20) Ex. 9
`
`Aleali (10-30-20) Ex. 13
`Aleali (10-30-20) 6
`Robinson (11-04-20) 11
`
`ATEC_LLIF000167276
`
`ATEC_LLIF000167293
`
`[1-31]
`
`[27-36]
`
`Page 5 of 16
`
`EXHIBIT 3, Page 88 of 99
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 342-4 Filed 10/29/21 PageID.31392 Page 7 of 17
`
`Nuvasive, Inc. v. Alphatec Holdings, Inc. et al (S.D. Cal. 3:18-cv-00347-CAB-MDD)
`
`Alphatec First Amended Trial Exhibit List (10/22/21)
`
`ALPHATEC RESERVES THE RIGHT TO ADD, REMOVE, OR OTHERWISE AMEND EXHIBITS ON THIS PRELIMINARY EXHIBIT LIST
`
`DTX No.
`429
`430
`431
`
`432
`
`433
`
`434
`435
`436
`437
`438
`439
`
`440
`441
`442
`443
`444
`445
`446
`447
`448
`
`449
`450
`451
`
`500
`
`501
`
`502
`503
`504
`505
`506
`507
`508
`509
`510
`511
`512
`513
`514
`515
`
`516
`
`517
`518
`519
`520
`521
`522
`523
`524
`525
`
`Date
`
`Description
`
`INTENTIONALLY SKIPPED
`INTENTIONALLY SKIPPED
`Definition of Pivot by Lexico, Lexico, https://www.lexico.com/en/definition/pivot (last visited Nov. 21,
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`Primitive joint with three rotational degrees of freedom – MATLAB -
`https://www.mathworks.com/help/physmod/sm/mech/ref/spherical.html
`Lateral Lumbar Interbody Fusion - Retractor System (DHF#15-003) (01Phase 1 Planning Input.pdf) (binder
`cover)
`Phase II Output (binder cover)
`Phase III Design Verification (binder cover)
`Phase IV - Design Validation Transfer (binder cover)
`BDT Phase Gate Review Approval Form - LLIF Retractor System/ LLIF Implant System
`LLIF Validation Lab 011417 Notes from Scott Robinson
`Alphatec Spine presentation titled "Lateral Lumber Interbody Fusion Implant and Retractor System
`Commercialization (Phase 4 and 5)"
`Alphatec Spine case notes from Dr. Neville Alleyne re Battalion LLIF
`Alphatec Spine case notes from Dr. Payam Moazzaz re Battalion LLIF
`Alphatec Spine case notes from Dr. Mohammad Etminan re Battalion LLIF
`Engineering drawing re Battalion LLIF 4th Blade
`Engineering drawing re Battalion LLIF 4th Blade Attachment
`Engineering drawing re Battalion LLIF Retractor Left Handle
`Engineering drawing re Battalion LLIF Retractor Right Handle
`Alphatec Spine's Guided Lumber Interbody Fusion (GLIF) Surgical Guide
`Alphatec Spine's PS-100115 Procurement Specification for Battalion LLIF Disposable Insulated Dilators
`(TeDan Surgical)
`Alphatec video demonstrating product
`4/17/2013 Market Need / Assessment Request, Alphatec document dated April 17, 2013
`3/1/2016
`Email from Ren Tanaka re Alphatec Battalion LLIF Product Update
`
`11/16/2016
`
`1/31/2017
`
`2/14/2017
`2/15/2017
`2/21/2017
`3/14/2016
`11/24/2015
`6/4/2018
`6/4/2018
`
`2019
`
`Pivot, Dictionary.com,
`https://www.dictionary.com/browse/pivot (last visited December 3, 2019)
`Dovetails, Merriam Webster.com, https://www.merriam-webster.com/dictionary/dovetail (last visited Nov.
`22, 2015)
`INTENTIONALLY SKIPPED
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`4/18/1995
`U.S. Patent No. 5,407,293 to Crainich (Apr. 18, 1995) (“Crainich”)
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`U.S. Application Publication No. 2009/0036746 to Blackwell (February 5, 2009) (“Blackwell”)
`1/15/2013
`U.S. Patent No. 8,353,826 to Weiman (January 15, 2013) (“Weiman”)
`INTENTIONALLY SKIPPED
`Branch, Charles, M.D. CV
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`Thomas Kossmann, et al., The use of a retractor system (SynFrame) for open, minimal invasive
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`U.S. Patent No.7.261,688 (Smith)
`
`11/1/2019
`11/9/2018
`3/4/2014
`4/25/2002
`1988
`
`9/5/2001
`
`Beginning Bates No.
`
`Ending Bates No.
`
`Deposition Exhibit
`
`Doc No.
`
`Plaintiff's Objections
`
`ATEC_L

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