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`EXHIBIT 2
`TO TRENT TANNER DECLARATION ISO
`NUVASIVE’S COMBINED MOTIONS IN LIMINE
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`Confidential – Outside Counsel Only
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`NIMALKA R. WICKRAMASEKERA (SBN: 268518)
`nwickramasekera@winston.com
`DAVID P. DALKE (SBN: 218161)
`ddalke@winston.com
`WINSTON & STRAWN LLP
`333 S. Grand Avenue
`Los Angeles, CA 90071-1543
`Telephone: (213) 615-1700
`Facsimile:
`(213) 615-1750
`
`GEORGE C. LOMBARDI (Pro Hac Vice)
`glombardi@winston.com
`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
`800 Capitol Street, Suite 2400
`Houston, TX 77002-2925
`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
`Case No. 3:18-CV-00347-CAB-MDD
`NUVASIVE, INC., a Delaware
`corporation,
`
`
`[Assigned to Courtroom 4C – Honorable
`Cathy Ann Bencivengo]
`
`
`v.
`[Magistrate: Hon. Mitchell D. Dembin]
`
`
`DEFENDANTS’ SUPPLEMENTAL
`ALPHATEC HOLDINGS, INC., a
`RESPONSES TO PLAINTIFF
`Delaware corporation and
`NUVASIVE, INC.’S INTERROGATORIS
`ALPHATEC SPINE, INC., a
`NOS. 2, 7, 11, AND 17
`California corporation,
`
`
`
`Defendants.
`Confidential – Outside Counsel Only
`
`
`Complaint Filed: February 13, 2018
`
`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, AND 17)
`
`
`
`
`Plaintiff,
`
` CASE NO. 3:18-CV-00347-CAB-MD
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`EXHIBIT 2, Page 38 of 83
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`Transcend. (ATEC_LLIF000966784 at 787).
`
`Transcend)
`(ATEC
`clearance
`FDA
`2019:
`12,
`• August
`(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=
`K191311 ) (ATEC_LLIF000966729-734).
`
`• September 9, 2019: User Validation Lab for Transcend LIF Spacer
`(ATEC_LLIF000966990;
`ATEC_LLIF000967018;
`ATEC_LLIF000967046;
`ATEC_LLIF000966989;
`ATEC_LLIF000969348).
`
`also
`
`see
`
`• September 10, 2019: Submit Letter to FDA notifying them of design
`change for the Transcend. Alphatec added more sizes of the Transcend
`Implant to include a graft slide slot. (ATEC_LLIF000966735).
`
`• September 2019: First sale and surgery (ATEC_LLIF000965881).
`
`Transcend
`of
`Launch
`Commercial
`2019:
`22,
`• October
`(https://investors.alphatecspine.com/news-releases/news-release-
`details/alphatec-enhances-its-lateral-portfolio-commercial-launch).
`
`The consulting surgeons involved in the conception and development of
`Transcend were K. Brandon Strenge
`(ATEC_LLIF000966990), Clint Hill
`(ATEC_LLIF000967018), and William Taylor (ATEC_LLIF000967046). (See also
`ATEC_LLIF000969348).
`Alphatec incorporates the deposition Scott Robinson.
`INTERROGATORY NO. 7:
`Describe in detail the circumstances surrounding Alphatec’s knowledge of each
`of the Patents-in-Suit and any Related Patent Application or Patent and any design-
`around attempts for the Accused Products taken in light of Alphatec’s knowledge of
`each patent or patent application.
`RESPONSE TO INTERROGATORY NO. 7:
`In addition to the General Objections, Defendants object to this Interrogatory as
`compound and as containing multiple discrete subparts, which in the aggregate exceed
`the number of interrogatories permissible under the CivLR 33.1(a).
`13
`
`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
`
`
`
` CASE NO. 3:18-CV-00347-CAB-MD
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`EXHIBIT 2, Page 39 of 83
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`Defendants further object to this Interrogatory as overbroad, unduly burdensome,
`not relevant to the claims or defenses of this case, and not proportional to the needs of
`the case, in requesting the “circumstances surrounding Alphatec’s knowledge . . . and
`any design-around attempts.” Defendants further object to this Interrogatory as vague
`and ambiguous as to “Alphatec’s knowledge.” Defendants further object to this
`Interrogatory as overbroad, unduly burdensome, not relevant to the claims or defenses
`of this case, and not proportional to the needs of the case to the extent that it requests
`information about products other than the Accused Alphatec Components. Defendants
`further object to the extent this Interrogatory seeks information protected from
`discovery by the attorney-client privilege, the work product doctrine, or any other
`privilege or immunity. Defendants further object to this Interrogatory as seeking
`disclosure of private, confidential, trade secret, proprietary, or commercially and
`competitively sensitive information, the disclosure of which would result in substantial
`competitive injury to Defendants. Defendants expressly reserve the right to supplement
`this response upon further factual and legal development.
`Subject to and without waving the foregoing General and Specific Objections,
`Defendants respond: In connection with the prosecution of U.S. Patent No. 9,693,762,
`individuals employed by Defendants had knowledge of ‘801 patent, and related patents
`assigned to Plaintiff, U.S. Patent Nos. 8,016,767, 7,582,058, 7,691,057 and 7,207,949,
`as of August 5, 2015. Defendants became aware of the asserted patents as a basis for
`Plaintiff’s claims as of the filing of Plaintiff’s Complaint in this action on February 13,
`2018.
`SUPPLEMENTAL RESPONSE TO INTERROGATORY NO. 7:
`Subject to and without waiver of all previously asserted General and Specific
`objections regarding this Interrogatory, and following its meet and confer efforts with
`NuVasive, Alphatec supplements its previous response as follows: The following
`Patents-in-Suit and any Related Patent Application or Patent appear in Alphatec’s
`systems as of the listed dates:
`
`14
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`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
`
`
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`
` CASE NO. 3:18-CV-00347-CAB-MD
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`EXHIBIT 2, Page 40 of 83
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`Patent / Application
`7,819,801 / 10/789,797
`8,355,780 / 12/623,016
`8,361,156 / 13/441,092
`8,439,832 / 12/984,368
`60/450,806
`60/506,136
`60/440,905
`60/392,214
`8,016,767 / 11/789,284
`7,207,949 / 11/137,169
`PCT/US2004/031768
`8,187,334 / 13/079,645
`8,403,841 / 12/636,860
`7,691,057 / 10/759,811
`8,523,768 / 13/466,531
`8,343,046 / 13/417,499
`8,133,173 / 12/650,301
`8,708,899 / 13/575,035
`8,672,840 / 13/466,398
`8,182,423 / 12/649,604
`8,192,356 / 12/635,418
`7,935,051 / 12/428,081
`7,582,058 / 10/608,362
`
`Date
`2/16/2013
`2/24/2013
`2/1/2014
`5/15/2013
`5/15/2013
`5/15/2013
`5/15/2013
`5/15/2013
`2/17/2013
`2/13/2013
`5/15/2013
`2/1/2014
`4/28/2013
`2/16/2013
`5/15/2013
`2/24/2013
`2/22/2013
`5/15/2013
`2/17/2013
`2/23/2013
`2/23/2013
`2/17/2013
`2/16/2013
`
`To the extent that knowledge of named inventors on any Patents-in-Suit and any
`Related Patent Application or Patent can be imputed to Alphatec, Alphatec acquired
`15
`
`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
`
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`EXHIBIT 2, Page 41 of 83
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`that knowledge as of the date those inventors joined Alphatec.
`Alphatec became aware of the asserted patents as a basis for NuVasive’s claims
`as of the filing of Plaintiff’s Complaint in this action on February 13, 2018.
`Alphatec has no further non-privileged information responsive to this
`Interrogatory.
`SECOND SUPPLEMENTAL RESPONSE TO INTERROGATORY NO. 7:
`Alphatec incorporates by reference the deposition testimonies and documents and
`exhibits cited therein from the following witnesses: Dr. Barton Sachs, Blake Inglish,
`Brad Anderson, Bryan Larsen, Carl McMillin, Dr. Charles Branch, Chris Burton, Eric
`Finley, Dr. Jim Youssef, John English, Jonathan Costabile, Dr. Keith Ugone, Kelli
`Howell, Kevin Neels, Kyle Malone, Matthew Link, Mike Aleali, Dr. Neville Alleyne,
`Patrick Miles, Dr. Payam Moazzaz, Robert Judd, Rory Schermerhorn, Scott Robinson,
`Frank Chang, Greg Lucier, and Stephen Kunin.
`
`Alphatec incorporates by reference the expert reports and the documents cited
`therein of: Dr. Jim Youssef, Dr. Barton Sachs, Dr. Charles Branch, Blake Inglish, Dr.
`Keith Ugone, and Stephen Kunin.
`THIRD SUPPLEMENTAL RESPONSE TO INTERROGATORY NO. 7:
`Subject to and without waiver of all previously asserted General and Specific
`objections regarding this Interrogatory, Alphatec supplements its previous response as
`follows:
`Alphatec had knowledge of the patents-in-suit from Warsaw Orthopedic, Inc. v.
`NuVasive Inc., No. 3:12-cv-02738, (Costabile Dep. Tr. 68:13–21), and was aware of
`Medtronic’s IPRs and the subsequent appeals. Medtronic filed IPRs for the ’334 and
`’156 patents, both of which the PTAB instituted. In February 2015, the PTAB issued
`Final Written Decisions, invalidating claims 1–5, 10, 11, 14–17, and 19–28 of the ’334
`patent and claims 1–14, 19–20, and 23–27 of the ’156 patent. NuVasive appealed and
`in late 2016, the Federal Circuit vacated and remanded the PTAB’s decision relating to
`claims 16 and 17 of the ’334 patent and vacated the PTAB’s decision relating to’156
`16
`
`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
`
`
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` CASE NO. 3:18-CV-00347-CAB-MD
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`EXHIBIT 2, Page 42 of 83
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`patent for additional narrow findings regarding the motivation to combine prior art
`references. The IPRs were subsequently terminated in 2017 pursuant to the parties
`settling the litigation.
`Because of the large, public lawsuit, the development team for the Battalion
`lateral system was specifically instructed not to copy any competitor’s intellectual
`property. Costabile Dep. Tr. 67:24–68:21. Indeed, no one on the development team
`suggested it. Id.
`There are several different non-infringing, clinically and commercially viable
`design alternatives to Alphatec’s Battalion™ Lateral Spacers. For instance, alternative
`designs in the prior art and/or on the market include different numbers, types, and/or
`placements of the radiopaque markers that do not infringe one or more of the following
`claim elements: (1) “first radiopaque marker [that] extends into said first sidewall at a
`position proximate to said medial plane” as required by claim 1 of the ’156 Patent; (2)
`“second radiopaque marker [that] extends into the second sidewall at a position
`proximate to said medial plane” as required by claim 1 of the ’156 Patent; (3) “a third
`of said at least three radiopaque markers [that] is at least partially positioned in said
`central region” as required by claim 1 of the ’334 Patent; and/or (4) “a fourth radiopaque
`marker in said central region at a position spaced apart from said third radiopaque
`marker,” as required by claim 16 of the ’334 Patent. Alphatec also incorporates by
`reference its responses to Interrogatory No. 17.
`FOURTH SUPPLEMENTAL RESPONSE TO INTERROGATORY NO. 7:
`Subject to and without waiver of all previously asserted General and Specific
`objections regarding this Interrogatory, Alphatec supplements its previous response as
`follows:
`For years, Alphatec monitored various public litigations and post-grant
`proceedings before the Patent Office that cast substantial doubt over the validity of
`NuVasive’s patent portfolio and also informed Alphatec of NuVasive’s patents. Among
`these proceedings, Alphatec monitored Medtronic’s challenge to the validity of the ’334
`17
`
`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
`
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`EXHIBIT 2, Page 43 of 83
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`and ’156 patents in Warsaw Orthopedic, Inc. v. NuVasive Inc., No. 3:12-cv-02738.
`Warsaw and Medtronic filed suit against NuVasive in August 2012. In March 2013,
`NuVasive asserted that Medtronic infringed the ’334 and ’156 patents. In response,
`Medtronic initiated IPRs against the ’334 and ’156 patents in October 2013, both of
`which the PTAB instituted in February 2014. After the Patent Office decided to
`examine the validity of the ’334 and ’156 patents, Alphatec started official development
`of its LLIF system in July 2014 and first developed the prototypes of Battalion in August
`2014. See Response to Interrogatory No. 2. In February 2015, the PTAB issued Final
`Written Decisions for the ’334 and ’156 patent IPRs. There, the PTAB invalidated
`claims 1–5, 10, 11, 14–17, and 19–28 of the ’334 patent and claims 1–14, 19–20, and
`23–27 of the ’156 patent. The Final Written Decisions found all challenged claims of
`the ’156 patent and all but one of the challenged claims of the ’334 patent invalid as
`obvious over several prior art references.
`It was not until November and December 2016 – after the FDA cleared
`Alphatec’s Battalion product – that the Federal Circuit issued its decision regarding
`NuVasive’s appeal of the PTAB’s findings for the ’334 and ’156 patent IPRs. The
`Federal Circuit affirmed the majority of the PTAB’s invalidity findings with respect to
`the ’334 patent, but vacated and remanded the PTAB’s decision relating to claims 16
`and 17 of the ’334 patent due to procedural violations and vacated the PTAB’s decision
`relating to the ’156 patent on very narrow findings regarding the sufficiency of the
`PTAB’s analysis showing a motivation to combine prior art references. The Federal
`Circuit however did not disturb the PTAB’s findings concerning the disclosures of the
`prior art references obviating the ’334 and ’156 patents. Though the Federal Circuit
`returned the ’334 and ’156 patents to the PTAB to address these narrow issues, the
`validity of the claims of the ’334 and ’156 patents remained in substantial doubt.
`The ’334 and ’156 patent IPRs were terminated in May 2017 pursuant to the
`settlement of Warsaw Orthopedic, Inc. v. NuVasive, Inc. without the PTAB completing
`its analysis of the invalidity of the claims of the ’156 and ’334 patents.
`18
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`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
`
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`EXHIBIT 2, Page 44 of 83
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`In addition to litigations involving the ’334 and ’156 patents, Alphatec monitored
`other litigations and post-grant proceedings involving related NuVasive patents that cast
`further doubt on the validity of NuVasive’s patent portfolio.
`For example, in Medtronic Sofamor Danek USA, Inc. v. Nuvasive, Inc., No. 3:08-
`cv-01512, Medtronic filed suit against NuVasive asserting that NuVasive infringed,
`among others, U.S. Patent No. 5,860,973, which had claims directed towards a spinal
`implant, and U.S. Patent No. 6,945,933, which had claims directed to a spinal access
`system. In September 2011, the trial for Phase I of this litigation concluded with the
`jury finding both patents valid and infringed by NuVasive. The Federal Circuit affirmed
`the jury verdict with respect to validity and infringement of the ’973 and ’933 patents.
`Alphatec monitored this litigation. Alphatec noted that in February 2015, during the
`development of Battalion system, Medtronic’s ’973 patent expired. And, in January
`2016, Alphatec entered nonexclusive patent license agreement with Warsaw Orthopedic
`for the ’933 patent. ATEC_LLIF000262386.
`
`In the same suit, NuVasive counterclaimed that Medtronic infringed U.S. Patent
`Nos. 7,207,949 (related to U.S. Patent No. 8,355,780) and 7,582,058 (related to U.S.
`Patent No. 9,833,227). The claims of these patents were directed to systems and
`methods for accessing a spine surgical site. But in June 2009, Medtronic filed a request
`for inter partes reexamination of the ’949 patent (Application No. 95/001,202). In
`August 2009, the PTAB granted the request. After back and forth between the parties,
`the Examiner rejected claims 2, 8, and 12–14 of the ’949 patent which were directed to
`“[a] system for accessing a surgical target site,” and claims 16–27 and 29–38 of the ’949
`patent which were directed to “[a] method of accessing a spinal target site.” In
`September 2014, the PTAB affirmed rejection of the claims of the ’949 patent.
`In October 2009, Medtronic filed a request for inter partes reexamination of the
`’058 patent (Application No. 95/001,247). After initial arguments and discussion
`between the parties, the examiner withdrew the grounds of rejection in its short Right
`of Appeal Notice. In March 2013, during the appeal of the ’058 patent reexamination,
`19
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`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
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`the PTAB invalidated claims 1, 2, and 4–8 of the ’058 patent (Application No.
`95/001,247) which were directed to “[a] method of accessing a surgical target site.”
`Medtronic presented another strong invalidity challenge to NuVasive’s access
`patents in Warsaw Orthopedic, Inc. v. NuVasive Inc., No. 3:12-cv-02738.
`In October 2013, Medtronic filed two IPRs for U.S. Patent No. 8,192,356 (related
`to U.S. Patent No. 9,833,227) seeking review of claims 21, 22, 24–26, 30, and 33–37.
`In April 2014, the PTAB instituted review. Then, in April 2015, the PTAB invalidated
`claims 21, 22, 24, 30, and 33-37 which were directed to “[a] system for accessing a
`spinal disc of a lumbar spine through an operative corridor.”
`Also, in October 2013, Medtronic filed IPR for U.S. Patent No. 8,016,767
`(related to U.S. Patent No. 8,355,780) seeking review of claims 1, 2, 4, 5, 10, 15, 17,
`and 18. In April 2014, the PTAB instituted review as to all claims sought for the ’767
`patent. And, in April 2015, the PTAB invalidated claims 1, 2, 4, 5, 10, 15, 17, and 18
`of the ’767 patent, which were directed to “[a] method of accessing a surgical target
`site.”
`
`Additionally, Alphatec monitored NuVasive, Inc. v. Globus Medical, Inc., No
`1:10-cv-00849. In October 2010, NuVasive filed suit against Globus alleging that
`Globus was infringing, among others, U.S. Patent No. 7,691,057 (related to U.S. Patent
`Nos. 8,439,832 and 8,753,270). In February 2012, Globus filed a request for inter
`partes reexamination of the ’057 patent (Application No. 95/001,888). The Examiner
`ordered reexamination of claims 17–22 and 24–27, which were directed to “[a] method
`of accessing a surgical target site within a spine.” In April 2012, the Patent Office filed
`a decision granting the request for inter partes reexamination of the ’057 patent. After
`additional back and forth between the parties, the Examiner withdrew the grounds of
`rejection in its short Right of Appeal Notice. In July 2014, the PTAB reversed the
`Examiner in the inter partes reexamination of the ’057 patent finding that claims 17–
`22 and 24–27 to be unpatentable. In November 2018, the Federal Circuit vacated and
`remanded the PTAB’s obviousness determination for the ’057 patent on very narrow
`20
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`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
`
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` CASE NO. 3:18-CV-00347-CAB-MD
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`EXHIBIT 2, Page 46 of 83
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`grounds related to secondary considerations.
`The proceedings were well known and disclosed by NuVasive in its public
`financial filings. See e.g., NuVasive 2013 Annual Report (Form 10-K), 21–22, 31 (Mar.
`3, 2014); NuVasive 2014 Annual Report (Form 10-K), 22–23, 33–34 (Feb. 25, 2015);
`NuVasive 2015 Annual Report (Form 10-K), 25–26 (Feb. 11, 2016); NuVasive 2016
`Annual Report (Form 10-K), 105–106 (Feb. 9, 2017). And all of this litigation, both
`before district courts and before the Patent Office, was widely publicized by multiple
`sources and well known across the industry including within Alphatec. See e.g.,
`ATEC_LLIF000970732–747. Because of the large, public nature of this litigation, the
`development team for the Battalion lateral system was specifically instructed not to
`copy any competitor’s intellectual property. Costabile Dep. Tr. 67:24–68:21. Indeed,
`no one on the development team suggested it. Id.
`As explained in Alphatec’s Response to Interrogatory No. 1, Alphatec’s Battalion
`and Transcend implants do not infringe any valid claim of the ’156 patent or ’334 patent.
`There are several other different non-infringing, clinically and commercially viable
`design alternatives that could be incorporated into the Alphatec’s Battalion and
`Transcend™ Implant. In addition to the commercially available alternatives identified
`in Alphatec’s Response to Interrogatory No. 17, alternative designs, some of which are
`in the prior art and/or are commercially available already, include different numbers,
`types, and/or placements of the radiopaque markers that do not infringe at least one or
`more of the following claim elements: (1) “at least first and second radiopaque markers
`oriented generally parallel to a height of the implant” as required by the ’156 patent, (2)
`“first radiopaque marker [that] extends into said first sidewall at a position proximate
`to said medial plane” as required by claim 1 of the ’156 Patent; (2) “second radiopaque
`marker [that] extends into the second sidewall at a position proximate to said medial
`plane” as required by claim 1 of the ’156 Patent; (3) “at least three radiopaque markers;
`wherein a first of the at least three radiopaque markers is at least partially positioned in
`said distal wall, a second of said at least three radiopaque markers is at least partially
`21
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`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
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` CASE NO. 3:18-CV-00347-CAB-MD
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`EXHIBIT 2, Page 47 of 83
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`positioned in said proximal wall, and a third of said at least three radiopaque markers is
`at least partially positioned in said central region” as required by claim 1 of the ’334
`Patent; and/or (4) “a fourth radiopaque marker in said central region at a position spaced
`apart from said third radiopaque marker,” as required by claim 16 of the ’334 Patent.
`Any of these design alternatives would require minimal time and cost to
`implement and would be viable and acceptable.
`Alphatec also incorporates by reference its responses to Interrogatory No. 17.
`INTERROGATORY NO. 11:
`
`Separately for each and every Patent-in-Suit, identify any contention that
`NuVasive’s claims are barred, in whole or in part, by any equitable doctrine, including
`without limitation, the doctrines of implied waiver, equitable estoppel, judicial estoppel,
`and/or unclean hands, including but not limited to Alphatec’s contentions regarding
`judicial estoppel set forth in its Amended Counterclaims (Doc. No. 125) ¶¶ 18, 35, 54,
`71, 88, 103, 119, 139, and 156, and set forth in detail the full factual and legal bases for
`Alphatec’s contention separately for each basis, identify all persons with knowledge of
`such facts, and identify all documents relating to such contention.
`RESPONSE TO INTERROGATORY NO. 11:
`
`In addition to the General Objections, Defendants object to this
`Interrogatory as compound and as containing multiple discrete subparts, which in the
`aggregate exceed the number of interrogatories permissible under the CivLR 33.1(a).
`Defendants further object to this Interrogatory as overbroad, unduly burdensome, not
`relevant to the claims or defenses of this case, and not proportional to the needs of the
`case, in requesting information regarding “any contention” and seeking identification
`of “all persons with knowledge” and “all documents relating to such contention.”
`Defendants further object to this Interrogatory as unduly burdensome because the
`Interrogatory requests separate identification for each patent-in-suit. Defendants further
`object to the extent this Interrogatory seeks information protected from discovery by
`
`22
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`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
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`
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` CASE NO. 3:18-CV-00347-CAB-MD
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`EXHIBIT 2, Page 48 of 83
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`the attorney-client privilege, the work product doctrine, or any other privilege or
`immunity.
`Subject to and without waiving the foregoing General and Specific Objections,
`Defendants respond:
`With respect to the Patents-in-Suit, NuVasive is precluded from taking any action
`inconsistent with the adverse judgment, including obtaining any claims that are not
`patentably distinct from a finally refused or canceled claim. Likewise, NuVasive is
`judicially estopped from taking any contrary position to that which it has previously
`asserted. Therefore, NuVasive is collaterally and judicially estopped from taking any
`positions inconsistent with (1) those it has taken in other proceedings and litigations
`concerning the Patents-in-Suit, related and family patents, related and similar
`technologies, and/or in challenging third parties’ patents; or (2) those found by triers of
`fact, including juries, the USPTO, PTAB, and courts (including the Federal Circuit) in
`those proceedings and litigations. As such, and without limitation, NuVasive is
`estopped from taking any positions inconsistent with those it has taken in connection
`with, and the findings established with respect to, for example:
`• IPR2013-00206;
`• IPR2013-00208;
`• IPR2013-00506;
`• IPR2013-00507;
`• IPR2013-00508;
`• IPR2014-00073;
`• IPR2014-00074;
`• IPR2014-00075;
`• Reexamination No. 95/001,202;
`• Reexamination No. 95/001,247;
`• Reexamination No. 95/001,888;
`• Reexamination No. 95/001,889;
`23
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`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
`
`
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` CASE NO. 3:18-CV-00347-CAB-MD
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`EXHIBIT 2, Page 49 of 83
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`• In re: NuVasive, Inc., No. 2015-1670;
`• In re: Warsaw Orthopedic, Inc., Nos. 2015-1050, 2015-1058;
`• NuVasive v. Iancu, No. 2017-1666;
`• Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 2013-1576, -1577; and
`• Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case No. 3:08-cv-1512-CAB-
`MDD.
`Specifically, as representative examples and without limitation, NuVasive is estopped
`from taking any position inconsistent with any and all of the following positions and
`findings:
`
`• The Jacobson technique (as discussed, for example, in Friedman) is, e.g.,
`not unacceptably dangerous, because NuVasive itself relied on the
`Jacobson technique to invalidate other patents that claimed a lateral, trans-
`psoas path. Rather, the teachings of Dr. Jacobson could be safely
`combined with the disclosures of other references to arrive at claims
`directed to performing direct lateral surgery with a retractor, and passing
`an implant through the operative corridor into the disc space. “That
`Jacobson is direct lateral is not only crystal clear from the reference itself,
`it is well corroborated. First, two published, peer-reviewed journal articles
`from the 1980’s describe Dr. Jacobson’s procedure…” IPR2013-00208,
`Petitioner’s Reply to Patent Owner’s Response, at 5 (internal citations
`omitted); see also IPR2013-00206, Petitioner’s Reply to Patent Owner’s
`Response.
`• Kossmann disclosed a trans-psoas approach, even though Kossmann’s
`disclosures were in the context of “very athletic patients” and “blunt
`dissection.” Doc. No. 49-64 (Reexamination No. 95/001,888, Decision on
`Appeal).
`• “[I]t is undisputed that Kossmann teaches a lateral approach to the spine.”
`NuVasive v. Iancu, No. 2017-1666, Opinion, at 22.
`24
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`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
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`
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` CASE NO. 3:18-CV-00347-CAB-MD
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`EXHIBIT 2, Page 50 of 83
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`• “[A]lthough Obenchain focuses on approaches other than a trans-psoas
`path, Obenchain discloses, nonetheless, that minimally invasive surgery of
`the lumbar spine can use a trans-psoas approach.” Doc. No. 49-65
`(IPR2014-00073, Final Written Decision) at 18; Doc. No. 49-66
`(IPR2014-00074, Final Written Decision) at 13.
`• “[A] skilled artisan would be motivated to combine the surgery described
`in Kossmann with the tools described in Branch and Koros.” NuVasive v.
`Iancu, 2017-1666, Opinion, at 22.
`• With regard to Leu, “[b]y the early 1990s … surgeons commonly
`employed the obvious choice of using one or more sequential dilators
`(rather than Jacobson’s speculum 10) over the initial guide needle to widen
`the surgical access path for thereafter introducing the final working
`cannula (Leu provides an example of this general prior art practice).”
`IPR2013-00206, Petition at 12.
`• “[A] person of ordinary skill in the art would have been prompted
`especially by the early 1990s to replace Jacobson’s speculum with
`sequential dilators (as suggested by Leu) so as to widen the surgical access
`path from the initial guide needle in a manner that reduces the trauma to
`the intervening tissue.” IPR2013-00206, Petition at 12.
`• “The resulting surgical method of Jacobson in view of Leu … provides the
`claimed step of withdrawing the second surgical instrument and the first
`surgical instrument from the body. For example, Jacobson shows in Figure
`6 that all introductory instruments should be withdrawn from the working
`cannula 11 so that a surgeon may introduce surgical tools into the cannula
`11. In the resulting surgical method of Jacobson in view of Leu, a person
`of ordinary skill in the art would have recognized that the surgeon would
`remove the guide needle or wire 8 and the sequential dilators (suggested
`by Leu…) from the working cannula so as to provide an access conduit for
`25
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`DEFENDANTS’ SUPPLEMENTAL RESPONSES TO PLAINTIFF NUVASIVE, INC.’S
`INTERROGATORIES (NOS. 2, 7, 11 AND 17)
`
`
`
` CASE NO. 3:18-CV-00347-CAB-MD
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`
`
`EXHIBIT 2, Page 51 of 83
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`

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`Case 3:18-cv-00347-CAB-MDD Document 342-3 Filed 10/29/21 PageID.31354 Pa

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