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`EXHIBIT 12
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`EXHIBIT 12 - Page 118
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`NIMALKA R. WICKRAMASEKERA (SBN: 268518)
`nwickramasekera@winston.com
`STEPHEN R. SMEREK (SBN: 208343)
`ssmerek@winston.com
`JASON C. HAMILTON (SBN: 267968)
`jhamilton@winston.com
`SHILPA A. COORG (SBN: 278034)
`scoorg@winston.com
`WINSTON & STRAWN LLP
`333 S. Grand Avenue
`Los Angeles, CA 90071-1543
`Telephone: (213) 615-1700
`Facsimile:
`(213) 615-1750
`
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. and
`ALPHATEC SPINE, INC.
`
`
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`UNITED STATES DISTRICT COURT
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`SOUTHERN DISTRICT OF CALIFORNIA
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`SAN DIEGO DIVISION
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`Plaintiff,
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`NUVASIVE, INC., a Delaware
`corporation,
`
`
`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]
`
`DEFENDANTS’ AMENDED
`INVALIDITY CONTENTIONS FOR
`U.S. PATENT NOS. 9,924,859;
`9,974,531; AND 8,187,334
`
`
`
`Complaint Filed: February 13, 2018
`Amended Complaint Filed: September 13,
`2018
`
`Jury Trial Demanded
`
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`FOR U.S. PATENT NOS. 9,924,859; 9,974,531; AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
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`
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`EXHIBIT 12 - Page 119
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`

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`DEFENDANTS’ AMENDED INVALIDITY CONTENTIONS FOR U.S.
`PATENT NOS. 9,924,859; 9,974,531; AND 8,187,334
`In accordance with the applicable rules of this Court, Defendants Alphatec
`Holdings, Inc. and Alphatec Spine, Inc. (collectively, “Alphatec”) hereby provide the
`following Amended Invalidity Contentions for the following patents asserted by
`Plaintiff NuVasive, Inc. (“NuVasive”) in its Disclosure of Asserted Claims and
`Infringement Contentions served on November 9, 2018 (“Infringement Contentions”)
`and its Amended Complaint (Doc. No. 110):
`• Claims 1-26 and 28-36 of U.S. Patent No. 9,924,859 (the “’859 patent”);
`• Claims 1-39 of U.S. Patent No. 9,974,531 (the “’531 patent”); and
`• Claims 6-9, 16, and 18 of U.S. Patent No. 8,187,334 (the “’334 patent”)
`(collectively, the “asserted claims” of the “Asserted Patents”).
`Defendants’ Amended Invalidity Contentions for Asserted Patents specifically address
`
`the above-listed patents and claims. Defendants contend that each of the asserted claims
`is invalid as demonstrated herein. Defendants expressly reserve the right to disclose
`invalidity contentions with respect to other claims of these patents and/or other patents,
`and to respond to or rebut NuVasive’s arguments for claims asserted or arguments made
`following its Infringement Contentions.
`I.
`GENERAL STATEMENT AND RESERVATION OF RIGHTS
`These invalidity contentions are preliminary, and based upon information
`available to Defendants at an early state of litigation, prior to claim construction,
`completion of fact discovery, or expert discovery, in light of the volume of asserted
`claims, including asserted claims with very long chains of dependency, and in light of
`the fact that NuVasive has not meaningfully responded to Alphatec’s interrogatory
`concerning NuVasive’s positions regarding validity. Therefore, Defendants reserve the
`right to amend or supplement these Amended Invalidity Contentions or any charts
`appended hereto, including pursuant to the Court’s Case Management Order (Doc. Nos.
`101and 109) and should NuVasive provide any positions regarding validity in response
`-2-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`FOR U.S. PATENT NOS. 9,924,859; 9,974,531; AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
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`EXHIBIT 12 - Page 120
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`

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`a second longitudinally extending receptacle adjacent a second edge of the second
`blade,” as recited in claim 36. Defendants reserve their right to challenge the priority
`date claimed by Plaintiff for the ’531 patent.
`3.
`Priority Date of the ’334 Patent
`In its Infringement Contentions, Plaintiff contends that the ’334 patent is entitled
`to a priority date at least as early as March 29, 2004, which is the filing date of U.S.
`Provisional Application No. 60/557,536. Plaintiff bears the burden of proving, on a
`claim-by-claim basis, that the provisional application provides written description
`support for each and every limitation of the asserted claims. Plaintiff has not met this
`burden. Plaintiff is not entitled to a priority date of March 29, 2004, at least because
`the Provisional Application fails to disclose or provide support for the following, as
`claimed by the ’334 patent: “wherein said implant has a longitudinal length greater than
`40 mm extending from a proximal end of said proximal wall to a distal end of said distal
`
`wall,” “wherein said longitudinal length is at least two and half times greater than said
`maximum lateral width,” and “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 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 recited in claim 1, as well as “further comprising a
`fourth radiopaque marker situated within said implant, said fourth radiopaque marker
`positioned in said central region at a position spaced apart from said third radiopaque
`marker,” as recited in claim 16, and “wherein said maximum lateral width of said
`implant is approximately 18 mm,” as recited in claim 18. Defendants reserve their right
`to challenge the priority date claimed by Plaintiff for the ’334 patent.
`B.
`Identification of Prior Art
`The asserted claims are anticipated or rendered obvious by the prior art identified
`herein. Specifically, Defendants may rely on any or all of the prior art references
`disclosed in the below non-exhaustive list, either alone or in combination, under 35
`-7-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`FOR U.S. PATENT NOS. 9,924,859; 9,974,531; AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT 12 - Page 121
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`

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`Approach (LETRA): A New Technique for Accessing the Lumbar Spine, L. Pimenta
`(published March 17, 2004).
`Other inventors include the inventors and/or authors of the prior art references
`listed above, and the circumstances of invention are as described in those references
`and/or identified in the claim charts accompanying these Amended Invalidity
`Contentions.
`A.
`On-Sale Bar and Prior Public Use
`The asserted claims are subject to the on-sale bar under 35 U.S.C. § 102(b) and/or
`35 U.S.C. § 102(a)(1) (AIA). For at least the reasons explained above, Plaintiff has not
`met its burden to show that it is entitled to any priority date earlier than the filing date
`of each of the asserted patents. Each of the devices discussed below were sold by
`Plaintiff, NuVasive, Inc. and are subject to the on-sale bar for the reasons described
`below. Each of these instruments (and publicly available materials describing them)
`
`may also qualify as prior art under one or more sections of 35 U.S.C. § 102.
`With respect to the ’859 patent, Plaintiff has contended that each of the asserted
`claims is practiced by the MaXcess III and/or MaXcess IV Retractors, as well as one or
`more of the K-wire, Dilators, 4th blade/anterior Retractor, 4th Blade Attachment,
`Anterior Crossbar, and/or Access Driver Handles. (NuVasive Disclosure of Asserted
`Claims and Infringement Contentions served on June 29, 2018 at 29.) Further, as stated
`by Plaintiff, NuVasive “launched aspects of XLIF in October 2003 at the North
`American Spine Society (NASS) Annual Meeting, including its MaXcess access
`system.” (NuVasive’s Resp. to Alphatec’s Interrogatory No. 3 at 17; see also,
`NuVasive’s Suppl. Resp. to Alphatec’s Interrogatory No. 3 at 22-23 (“Based on a
`reasonable investigation of information from the personal knowledge of those relevant
`persons still at or employed by NuVasive to date, NuVasive has not identified a
`disclosure earlier than those provided in its prior response.”).) The “MaXcess III
`launched on September 12, 2006.” (Id.) The MaXcess IV was publically available and
`sold at least as of October 3, 2013, when NuVasive described in a press release that its
`-15-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`FOR U.S. PATENT NOS. 9,924,859; 9,974,531; AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT 12 - Page 122
`
`

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`XLIF Decade Plate was “contoured specifically for the MaXcess IV retractor and
`CoRoent XL family of implants.” (http://ir.nuvasive.com/news-releases/news-release-
`details/nuvasiver-announces-us-launch-xlif-decadetm-
`plate?field_nir_news_date_value[min]=; last accessed 10/26/2018.) Accordingly, the
`asserted claims of the ’859 patent are subject to the on-sale bar based on the sales of the
`above instruments, which, according to NuVasive, embody the asserted claims.
`With respect to the ’531 patent, according to Plaintiff, each of the asserted claims
`is practiced by the MaXcess I, MaXcess II, MaXcess III, MaXcess III Solid, MaXcess
`4, and/or MaXcess 4 Solid Retractors, as well as one or more of the K-Wire, Dilators,
`Access Driver Handles, Universal Clip, Light Source/Connector, and CoRoent XL (e.g.,
`CoRoent XLCT, CoRoent XLF, CoRoent XLK, CoRoent XLT, CoRoent XLW,
`CoRoent XL-FW, CoRoent XL-H, CoRoent XLXW, CoRoent XL+, CoRoent XL+
`Wide). (NuVasive Amended Disclosure of Asserted Claims and Infringement
`
`Contentions at 34.) Further, as stated by Plaintiff, NuVasive “launched aspects of XLIF
`in October 2003 at the North American Spine Society (NASS) Annual Meeting,
`including its MaXcess access system, and specifically MaXcess I.” (NuVasive’s Resp.
`to Alphatec’s Interrogatory No. 3 at 17; see also, NuVasive’s Suppl. Resp. to Alphatec’s
`Interrogatory No. 3 at 22-23 (“Based on a reasonable investigation of information from
`the personal knowledge of those relevant persons still at or employed by NuVasive to
`date, NuVasive has not identified a disclosure earlier than those provided in its prior
`response.”).) According to a press release issued by NuVasive, the MaXcess II was
`launched
`in
`2005.
`
`(http://ir.nuvasive.com/news-releases/news-release-
`details/nuvasive-launches-five-new-products?field_nir_news_date_value[min]=;
`last
`accessed 10/26/2018.) The “MaXcess III launched on September 12, 2006.”
`(NuVasive’s Resp. to Alphatec’s Interrogatory No. 3 at 17; see also, NuVasive’s Suppl.
`Resp. to Alphatec’s Interrogatory No. 3 at 22-23 (“Based on a reasonable investigation
`of information from the personal knowledge of those relevant persons still at or
`employed by NuVasive to date, NuVasive has not identified a disclosure earlier than
`-16-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`FOR U.S. PATENT NOS. 9,924,859; 9,974,531; AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT 12 - Page 123
`
`

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`those provided in its prior response.”).) The MaXcess III Solid launched on November
`13, 2008. (Id.) The MaXcess IV had been publically available and sold at least as of
`October 3, 2013, when NuVasive described in a press release that its XLIF Decade Plate
`was “contoured specifically for the MaXcess IV retractor and CoRoent XL family of
`implants.”
`
`(http://ir.nuvasive.com/news-releases/news-release-details/nuvasiver-
`announces-us-launch-xlif-decadetm-plate?field_nir_news_date_value[min]=;
`last
`accessed 10/26/2018.) NuVasive launched the CoRoent XL implants “as part of XLIF”
`in October 2004 at NASS. (NuVasive’s Resp. to Alphatec’s Interrogatory No. 3 at 17;
`see also, NuVasive’s Suppl. Resp. to Alphatec’s Interrogatory No. 3 at 22-23 (“Based
`on a reasonable investigation of information from the personal knowledge of those
`relevant persons still at or employed by NuVasive to date, NuVasive has not identified
`a disclosure earlier than those provided in its prior response.”).) Accordingly, the
`asserted claims of the ’531 patent are subject to the on-sale bar based on the sales of the
`
`above instruments, which, according to NuVasive, embody the asserted claims.
`With respect to the ’334 patent, according to Plaintiff, each of the asserted claims
`is practiced by the CoRoent XL implants (e.g., CoRoent XLCT, CoRoent XLF,
`CoRoent XLK, CoRoent XLT, CoRoent XLW, CoRoent XL-FW, CoRoent XL-H,
`CoRoent XLXW, CoRoent XL+, CoRoent XL+ Wide). (NuVasive Amended
`Disclosure of Asserted Claims and Infringement Contentions at 37-38.) NuVasive
`launched the CoRoent XL implants “as part of XLIF” in October 2004 at NASS.
`(NuVasive’s Resp. to Alphatec’s Interrogatory No. 3 at 17; see also, NuVasive’s Suppl.
`Resp. to Alphatec’s Interrogatory No. 3 at 22-23 (“Based on a reasonable investigation
`of information from the personal knowledge of those relevant persons still at or
`employed by NuVasive to date, NuVasive has not identified a disclosure earlier than
`those provided in its prior response.”).) Accordingly, the asserted claims of the ’334
`patent are subject to the on-sale bar based on the sales of the above instruments, which,
`according to NuVasive, embody the asserted claims.
`
`-17-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`FOR U.S. PATENT NOS. 9,924,859; 9,974,531; AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT 12 - Page 124
`
`

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`Further, the asserted claims of the ’334 patent are invalid under § 102(b), which
`states that a person shall not be entitled to a patent if the alleged invention was in public
`use more than one year prior to the date of the application for patent in the United States.
`At least as early as 1990, Dr. Brantigan developed and used non-bone, spinal
`fusion implants having dimensions of 42 mm (long) x 28 mm (wide) x 14 mm (height).
`See, e.g., NuVasive’s Opening Brief, Case No. 2013-1576 (Fed. Cir. Feb. 3, 2014), at 6
`(citing A11459-69, A11480-81, A11499-501, A11504; A15358; A15362-69; A15359-
`61; A15491-502; A17835-65, A17858; A18873). By June 1990, Dr. Brantigan ordered
`4 different spinal fusion implants of different dimensions, including one having the
`dimensions described above. Id.
`Further, Dr. Brantigan developed implants having a “width that is at least as great
`as the height.” See, e.g., NuVasive’s Memorandum of Points and Authorities in Support
`of its Renewed Motion for Judgment as a Matter of Law or a New Trial, Warsaw
`
`Orthopedic, Inc. v. NuVasive, Inc., Case No. 3:08-cv-1512-CAB-MDD (S.D. Cal. Oct.
`27, 2011), D.I. 407, 13 (“Warsaw JMOL” or “JMOL”). An implant having dimensions
`of 42 mm x 28 mm x 14 was sold and used in patients prior to 1995. Id., citing DTX-
`5118, DTX-5134, DTX-5131, DTX-5150, DTX-5995, Tr. at 1459:20-1461:8, 1463:19-
`1465:4, 1466:1-9, 1467:4-9, 1467:24-1469:14, 1480:3-1481:9, 1499:3-1501:22,
`1504:3-4 (Brantigan). At trial, Dr. Brantigan explained that these implants were sold
`by Acromed to hospitals and inserted into patients. Id. Dr. Brantigan’s testimony was
`supported by photographs, prescriptions, and technical drawings. Id. Dr. Brantigan’s
`implants also included openings to facilitate bone growth fusion. Id. citing DTX-5131,
`DTX-5134, DTX-5995. Further, Dr. Brantigan’s implants had “ratchetings.” Id. (citing
`DTX-5131, DTX-5134).
`In addition, the parties agreed that Berry discloses the ranges of average widths
`and depths of human thoracic and lumbar vertebrae, as reflected in the table NuVasive
`adapted from Berry. Id. (citing DTX5881; JX-1 at ¶¶ 71-76).
`
`-18-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`FOR U.S. PATENT NOS. 9,924,859; 9,974,531; AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT 12 - Page 125
`
`

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`In light of its above arguments, Plaintiff is judicially estopped from making
`arguments regarding the disclosures of these prior art references, including, for
`example, the Brantigan implant that contradicts its prior statements. Indeed, NuVasive
`itself made statements in prior proceedings regarding the similarities between the
`Brantigan implants and NuVasive’s CoRoent implants to invalidate other patents that
`claimed surgical implants. Cardpool, Inc. v. Plastic Jungle, Inc., 817 F.3d 1316, 1323
`(Fed. Cir. 2016) (“The doctrine of judicial estoppel is that where a party successfully
`urges a particular position in a legal proceeding, it is estopped from taking a contrary
`position in a subsequent proceeding where its interests have changed.”); see also,
`Trustees in Bankr. of N. Am. Rubber Thread Co. v. United States, 593 F.3d 1346, 1354
`(Fed. Cir. 2010) (“Judicial estoppel applies just as much when one of the tribunals is an
`administrative agency as it does when both tribunals are courts.”).
`Further, the commercial embodiment of the Frey reference—the Boomerang™
`
`Verte-Stack™ PEEK Vertebral Body Spacer—launched in 2003, thereby providing
`public use of the claimed invention prior to the critical date of the ’334 patent.
`The claim charts accompanying these Amended Invalidity Contentions further
`describe how these commercial embodiments included the elements recited in the
`Asserted Claims.
`V.
`INVALIDITY UNDER 35 U.S.C. § 103
`The asserted claims of the Asserted Patents are invalid as obvious in light of the
`totality of the prior art identified in Section II.B. The asserted claims combine elements
`that were well known in the prior art and that, when combined, do not yield
`unpredictable results. The asserted claims simply combine these well-known elements,
`using known methods, to arrive at predictable results.
`The alleged inventions, including the use of instruments such as dilators, three-
`bladed retractors, neuromonitoring, shims, K-wires, and large implants for minimally
`invasive lateral, trans-psoas surgery, were well known in the art prior to the alleged
`inventions. For example, Dr. Robert Jacobson had performed over 200 procedures
`-19-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`FOR U.S. PATENT NOS. 9,924,859; 9,974,531; AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT 12 - Page 126
`
`

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`elements 8 disposed within the distal region of the implant 10, and a pair of spike
`elements 9 disposed within the central region of the implant 10.” ’334 patent at 6:28-
`32. Therefore, claiming “a fourth radiopaque marker” encompasses numbers of spike
`elements different from than those described in the specification.
`Further, claim 18 recites “wherein said maximum lateral width of said implant is
`approximately 18 mm.” The specification of the ’334 patent does not support a
`maximum lateral width larger than 18 mm. (See, e.g., ’334 patent at 2:18-20 (“the spinal
`fusion implant of the present invention may be dimensioned, by way of example only,
`having a width ranging between 9 and 18 mm”).)
`VII. DOCUMENTS PRODUCED PURSUANT TO PATENT LOCAL RULE 3.4
`Pursuant to Patent L.R. 3.4(a) Alphatec refers to the following documents:
`ATEC_LLIF000000064-1154; ATEC_LLIF000001205-1614;
`ATEC_LLIF000001680-1874; ATEC_LLIF000001877-1887;
`
`ATEC_LLIF000003765-3784; ATEC_LLIF000004907-4943. Further, pursuant to
`Patent L.R. 3.4, Alphatec made the accused instrumentalities (Squadron™ Retractor,
`Initial Dilator, Secondary Dilator, K-wire, Intradiscal Shim, Shim Inserter, Light
`Cable and the Light Source Connector, 4th blade, and Battalion™ LLIF implant)
`available for inspection and copying, and NuVasive did inspect, photograph, and
`make video recordings of these instrumentalities on June 1, 2018. Alphatec has
`further agreed to produce a copy of the accused instrumentalities to NuVasive.
`Pursuant to Patent L.R. 3.4(b) Alphatec refers to the following documents:
`ATEC_LLIF000004863-4906; ATEC_LLIF000004944-5552;
`ATEC_LLIF000137222-138101; ATEC_LLIF000159668-161310; and
`ATEC_LLIF000161312-161864.
`
`Dated: January 16, 2019
`
`WINSTON & STRAWN LLP
`
`
`
`By: /s/Nimalka R. Wickramasekera
`-235-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`FOR U.S. PATENT NOS. 9,924,859; 9,974,531; AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT 12 - Page 127
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`

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`Case 3:18-cv-00347-CAB-MDD Document 300-13 Filed 01/08/21 PageID.27065 Page 11 of
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`NIMALKA R. WICKRAMASEKERA
`STEPHEN R. SMEREK
`JASON C. HAMILTON
`SHILPA A. COORG
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. AND
`ALPHATEC SPINE, INC.
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`FOR U.S. PATENT NOS. 9,924,859; 9,974,531; AND 8,187,334
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`Case No. 3:18-CV-00347-CAB-MDD
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`EXHIBIT 12 - Page 128
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`EXHIBIT 12 - Page 129
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`Case 3:18-cv-00347-CAB-MDD Document 300-13 Filed 01/08/21 PageID.27067 Page 13 of
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`SERVICE LIST
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`Paul D. Tripodi II, Esq.
`Grace J. Pak, Esq.
`Wilson Sonsini Goodrich & Rosati P.C.
`633 West Fifth Street, Suite 1550
`Los Angeles, CA 90071
`Telephone: (323) 210-2900
`Facsimile: (866) 974-7329
`Email: ptripodi@wsgr.com
`Email: gpak@wsgr.com
`
`Wendy L. Devine, Esq.
`Wilson Sonsini Goodrich & Rosati P.C.
`One Market Plaza
`Spear Tower, Suite 3300
`San Francisco, CA 94105
`Telephone: (415) 947-2000
`Facsimile: (415) 947-2099
`Email: wdevine@wsgr.com
`
`Natalie J. Morgan, Esq.
`Christina Elizabeth Dashe, Esq.
`Wilson Sonsini Goodrich & Rosati P.C.
`
`12235 El Camino Real, Suite 200
`San Diego, CA 92130
`Telephone: (858) 350-2363
`Facsimile: (858) 350-2399
`Email: nmorgan@wsgr.com
`Email: cdashe@wsgr.com
`
`Sara L. Tolbert, Esq.
`Wilson Sonsini Goodrich & Rosati P.C.
`650 Page Mill Road
`Palo Alto, CA 94304
`Telephone: (650) 493-9300
`Facsimile: (650) 565-5100
`Email: stolbert@wsgr.com
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`-238-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`FOR U.S. PATENT NOS. 9,924,859; 9,974,531; AND 8,187,334
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`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT 12 - Page 130
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