Case 3:18-cv-00347-CAB-MDD Document 342-8 Filed 10/29/21 PageID.31426 Page 1 of 7
`
`
`
`
`EXHIBIT 7
`TO TRENT TANNER DECLARATION ISO
`NUVASIVE’S COMBINED MOTIONS IN LIMINE
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 342-8 Filed 10/29/21 PageID.31427 Page 2 of 7
`
`NIMALKA R. WICKRAMASEKERA (SBN: 268518)
`nwickramasekera@winston.com
`DAVID P. DALKE (SBN: 218161)
`ddalke@winston.com
`LEV TSUKERMAN (SBN: 319184)
`ltsukerman@winston.com
`WINSTON & STRAWN LLP
`333 S. Grand Avenue
`Los Angeles, CA 90071-1543
`Telephone: (213) 615-1700
`Facsimile:
`(213) 615-1750
`
`BRIAN J. NISBET (Pro Hac Vice)
`bnisbet@winston.com
`SARANYA RAGHAVAN (Pro Hac Vice)
`sraghavan@winston.com
`WINSTON & STRAWN LLP
`35 West Wacker Drive
`Chicago, IL 60601-9703
`Telephone: (312) 558-5600
`Facsimile: (312) 558-5700
`
`CORINNE STONE HOCKMAN (Pro Hac Vice)
`chockman@winston.com
`WINSTON & STRAWN LLP
`1111 Louisiana Street, 25th Floor
`Houston, TX 77002-5242
`Telephone: (713) 651-2600
`Facsimile: (713) 651-2700
`
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. AND ALPHATEC SPINE, INC.
`
`UNITED STATES DISTRICT COURT
`
`SOUTHERN DISTRICT OF CALIFORNIA
`
`SAN DIEGO DIVISION
`
`NUVASIVE, INC., a Delaware
`corporation,
`
`Plaintiff,
`
`v.
`
`ALPHATEC HOLDINGS, INC., a
`Delaware corporation and
`ALPHATEC SPINE, INC., a
`California corporation,
`
`Defendants.
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`[Assigned to Courtroom 4C – Honorable
`Cathy Ann Bencivengo]
`
`REBUTTAL REPORT OF BARTON L.
`SACHS, M.D., M.B.A., F.A.C.P.E.,
`F.A.C.H.E. (DAMAGES)
`
`Complaint Filed: February 13, 2018
`Jury Trial Demanded
`
`REBUTTAL EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A., F.A.C.P.E., F.A.C.H.E.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`EXHIBIT 7, Page 120 of 125
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 342-8 Filed 10/29/21 PageID.31428 Page 3 of 7
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION .............................................................................................. 1
`
`DEMAND FACTORS AND CONSIDERATIONS......................................... 2
`
`III. THERE IS NO FUNCTIONAL RELATIONSHIP AMONG THE
`ACCUSED PRODUCTS.................................................................................... 4
`
`IV. ALPHATEC’S ACCUSED PRODUCTS OFFER TECHNICAL
`ADVANTAGES OVER THE PATENTED FEATURES............................... 7
`
`V.
`
`NO EVIDENCE OF DEMAND FOR NUVASIVE’S PRODUCTS
`HAS BEEN TIED TO THE PATENTED FEATURES................................ 13
`
`VI. ANALYSIS OF TECHNOLOGY COVERED IN LICENSE
`AGREEMENTS................................................................................................ 13
`
`VII.
`
`INSIGNIFICANT TECHNICAL OR CLINICAL CONTRIBUTION
`BY THE PATENTS-IN-SUIT ......................................................................... 17
`
`REBUTTAL EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A., F.A.C.P.E., F.A.C.H.E.
`
`ii
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`EXHIBIT 7, Page 121 of 125
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 342-8 Filed 10/29/21 PageID.31429 Page 4 of 7
`
`I.
`
`INTRODUCTION
`
`1.
`
`I am a practicing spine surgeon, specializing in minimally invasive
`
`surgery, spinal arthroplasty and spine deformities, spine reconstruction, and deformity
`
`surgery. A complete statement of my rate, qualifications and my CV were included
`
`with my previously prepared Rebuttal Report of Barton L. Sachs, M.D., M.B.A.,
`
`F.A.C.P.E., F.A.C.H.E. submitted on November 22, 2019.
`
`2.
`
`Defendants Alphatec Holdings, Inc. and Alphatec Spine (collectively,
`
`“Alphatec”) retained me as an expert to analyze certain aspects of U.S. Patent Nos.
`
`8,439,832 (the “’832 patent”); 9,833,227 (the “’227 patent”); 8,355,780 (the “’780
`
`patent”); 9,974,531 (the “’531 patent”); 9,924,859 (the “’859 patent”); 8,753,270 (the
`
`“’270 patent”); 7,819,801 (the “’801 patent”) (collectively, the “patents-in-suit”).
`
`In
`
`forming my opinions as set forth in this report, I have relied upon my education,
`
`research, training, and decades of experience in the area of spinal surgery and spinal
`
`fusion surgery, and documents considered and contained herein.
`
`3.
`
`During the preliminary injunction phase of this case, I provided an opinion
`
`regarding invalidity and non-infringement of some of the patents-in-suit. I expressly
`
`incorporate herein by reference my earlier opinion and accompanying exhibits. (Doc.
`
`No. 49-5.)
`
`4.
`
`I also previously prepared and submitted the Rebuttal Report of Barton L.
`
`Sachs, M.D., M.B.A., F.A.C.P.E., F.A.C.H.E., another expert report in this case (my
`
`“Rebuttal Report”). My Rebuttal Report was in response to Dr. Jim Youssef’s Opening
`
`Expert Report. My Rebuttal Report provided background regarding spinal surgery
`
`procedures, the state of the art, and an overview of the products at issue here, as well as
`
`offered my analysis and opinions on whether Alphatec infringes any asserted claim in
`
`this case, whether Alphatec copied NuVasive, noninfringing alternatives, and the harm
`
`to the public should Alphatec’s product be enjoined.
`
`I expressly incorporate by
`
`reference the entirety of my Rebuttal Report and accompanying exhibits.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`REBUTTAL EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A., F.A.C.P.E., F.A.C.H.E.
`
`EXHIBIT 7, Page 122 of 125
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 342-8 Filed 10/29/21 PageID.31430 Page 5 of 7
`
`products would not have found any of the available lateral products on the market to be
`
`acceptable substitutes to NuVasive’s MAS Platform of products, ‘but for’ Alphatec’s
`
`infringement.” (Youssef Damages Rpt. at ¶ 30.)
`
`V.
`
`NO EVIDENCE OF DEMAND FOR NUVASIVE’S PRODUCTS HAS
`
`BEEN TIED TO THE PATENTED FEATURES
`
`50. Dr. Youssef has not shown that demand for NuVasive’s products coupled
`
`in the “functional units” is tied to the patented features. In addition to demand not being
`
`tied to the MaXcess retractor, there are several products included in these “functional
`
`units” that are not covered by the asserted patents,
`
`including NuVasive’s
`
`neuromonitoring system.
`
`VI. ANALYSIS
`
`OF
`
`TECHNOLOGY
`
`COVERED
`
`IN
`
`LICENSE
`
`AGREEMENTS
`
`51.
`
`I have reviewed several patents that have been licensed in agreements
`
`involving either Alphatec or NuVasive to determine whether any of them concern the
`
`same technology as the patents-in-suit. (See Youssef Damages Rpt. at ¶¶ 7–15.)
`
`52. Alphatec-Warsaw Agreement:
`
`Three patents, U.S. Patent Nos.
`
`6,945,933 (the “’933 patent”), 7,625,379 (the “’379 patent”), and 8,486,083 (the “’083
`
`patent”) (collectively, the “Warsaw Patents”), were licensed to Alphatec by Warsaw
`
`Orthopedic, Inc.
`
`53.
`
`The Warsaw Patents, which are generally directed toward access
`
`instruments that can be used in a lateral procedure, are comparable to the technology
`
`claimed in the patents-in-suit.
`
`54.
`
`The ’933 patent is directed to “instruments and methods for performing
`
`tissue retraction and surgeries through the retracted tissue in minimally invasive
`
`procedures.” (’933 patent at 1:7–10.) The disclosed procedures can be performed
`
`“through a working channel or passageway through skin and tissue of the patient
`
`provided by a retractor.” (’933 patent at 2:36–38.) The ’933 patent discloses that the
`
`retractor can be used with a lateral surgical approach. (’933 patent at 2:47–51.) The
`
`13
`REBUTTAL EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A., F.A.C.P.E., F.A.C.H.E.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`EXHIBIT 7, Page 123 of 125
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 342-8 Filed 10/29/21 PageID.31431 Page 6 of 7
`
`’933 patent also states “[p]rior to insertion of retractor, skin and tissue can be
`
`sequentially dilated via dilation instrument set which can include guidewires and/or one
`
`or more tissue dilators of increasing size.” (’933 patent at 6:47–51.) The ’933 patent
`
`discloses a retractor that includes a first portion and a second portion with a working
`
`channel between the two portions. (’933 patent at 2:52–64.) The working channel is
`
`substantially enclosed or circumscribed by the two portions of the retractor, and it can
`
`be enlarged be separating the two portions of the retractor, once the retractor is inserted
`
`into the patient. (’933 patent at 2:65–3:9.) The ’933 patent also discloses additional
`
`retractor blades to yield, for example, a three-bladed retractor. (’933 patent at 7:38–
`
`47.) Thus, the ’933 patent is comparable to the patents-in-suit, which are also directed
`
`toward instruments and methods for creating an operative corridor to the spine with a
`
`lateral approach, using instruments such as sequential dilators and retractors.
`
`55.
`
`The ’379 patent and the ’083 patent are also directed toward components
`
`that can be used in a lateral spinal procedure. (See ’379 patent at 3:23–26 (“The inserter
`
`instrument can be used in various approaches to the spine, including . . . lateral . . .”))
`
`However, the ’379 patent and the ’083 patent are directed primarily to an implant
`
`inserter instrument, which is different from the retractor and other access tools
`
`specifically claimed in the patents-in-suit. (See ’379 patent at Abstract, ’083 patent at
`
`Abstract.)
`
`56.
`
`I also disagree with Dr. Youssef’s assertion that because the Warsaw
`
`patents “are directed to a two-bladed retractor system, and other instruments, like those
`
`used in Medtronic’s Direct Lateral Interbody Fusion (‘DLIF’)” each of the patents-in-
`
`suit “individually provides a greater contribution to a safe and reproducible, minimally
`
`invasive, and clinically successful lumber interbody fusion procedure than the Warsaw
`
`Patents collectively.” (Youssef Damages Rpt. at ¶ 5.)
`
`57. As stated in my Rebuttal Report, I believe Medtronic’s two-blade retractor
`
`and DLIF procedure is a safe, acceptable, and noninfringing alternative to NuVasive’s
`
`XLIF product. (Sachs Rebuttal Rpt. at ¶ 481.) The Warsaw Patents, and in particular
`
`14
`REBUTTAL EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A., F.A.C.P.E., F.A.C.H.E.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`EXHIBIT 7, Page 124 of 125
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 342-8 Filed 10/29/21 PageID.31432 Page 7 of 7
`
`DATED: December 4, 2019
`
`By:
`
`Barton L. Sachs, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E.
`
`18
`REBUTTAL EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A., F.A.C.P.E., F.A.C.H.E.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`EXHIBIT 7, Page 125 of 125
`
`