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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.
`
`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]
`DEFENDANTS’ PRELIMINARY
`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
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S PRELIMINARY 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 9 - Page 80
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`Case 3:18-cv-00347-CAB-MDD Document 300-10 Filed 01/08/21 PageID.27018 Page 3 of
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`DEFENDANTS’ PRELIMINARY 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 Preliminary Invalidity Contentions for the following patents asserted by
`Plaintiff NuVasive, Inc. in its Disclosure of Asserted Claims and Infringement
`Contentions served on June 29, 2018 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 “Newly Asserted Patents”).
`Defendants’ Preliminary Invalidity Contentions for Newly 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, to respond to or rebut NuVasive’s arguments for claims asserted
`or arguments made following its June 29, 2018 Infringement Contentions.
`GENERAL STATEMENT AND RESERVATION OF RIGHTS
`I.
`The invalidity contentions disclosed herein 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, and in light of the
`volume of asserted claims, including asserted claims with very long chains of
`dependency. Defendants reserve the right to amend or supplement these Preliminary
`Invalidity Contentions or any charts appended hereto, including pursuant to the Court’s
`Case Management Order (Doc. No. 101). Further, additional prior art not included in
`these Preliminary Invalidity Contentions and/or facts, documents, and things whether
`known or unknown to Defendants may become relevant to Defendants’ defenses.
`Accordingly, Defendants reserve their right to revise, supplement, or amend these
`-2-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S PRELIMINARY 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 9 - Page 81
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`of Defendants’ accused products infringe the asserted claims or as an admission to the
`scope of any of the asserted claims.
`Defendants object to the disclosure of information and/or documents that are
`protected by the attorney-client privilege, attorney work-product doctrine, or any other
`applicable privilege or immunity. Defendants reserve the right to object to the
`admissibility of these Preliminary Invalidity Contentions or the information contained
`herein.
`IDENTIFICATION OF PRIOR ART
`II.
`Priority Date
`A.
`Priority Date of the ’859 Patent
`1.
`In its Infringement Contentions, Plaintiff contends that the ’859 patent is entitled
`to a priority date at least as early as August 23, 2010, which is the filing date of U.S.
`Provisional Application No. 61/376,163. 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. Defendants reserve their right to challenge the priority date claimed by the
`Plaintiff for the ’859 patent.
`Priority Date of the ’531 Patent
`2.
`In its Infringement Contentions, Plaintiff contends that the ’531 patent is entitled
`to a priority date at least as early as September 25, 2003, which is the filing date of U.S.
`Provisional Application No. 60/506,136. 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. Defendants reserve their right to challenge the priority date claimed by the
`Plaintiff for the ’531 patent.
`Priority Date of the ’334 Patent
`3.
`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.
`-4-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S PRELIMINARY 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 9 - Page 82
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`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. Defendants reserve their right to challenge the priority date claimed by the
`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
`U.S.C. §§ 102(a), (b), (e), (f), or (g) and/or 35 U.S.C. § 103, or to show the state of the
`art at the relevant time:
`• The lateral percutaneous approach to discectomy, W.A. Friedman et al.
`(“Friedman”), published 1988; and further described
`in: Percutaneous
`Discectomy: An Alternative to Chemonucleolysis?, W. A. Friedman, published
`1983; Percutaneous discectomy: An Anatomical Study, S.L. Kanter, et al.,
`
`published 1985; and U.S. Patent No. 4,545,374 (“Jacobson”), issued October 8,
`1985
`• U.S. Patent No. 6,945,933 (“Branch”), issued September 20, 2005
`• German Patent Application No. 100 48 790.4 (“Cistac”), published April 25,
`2002
`• U.S. Patent No. 7,261,688 (“Smith”), issued August 28, 2007
`• U.S. Patent No. 5,681,265 (“Maeda”), issued October 28, 1997
`• U.S. Patent No. 5,928,139 (“Koros”), issued July 27, 1999
`• U.S. Patent No. 5,772,661 (“Michelson ’661”), issued June 30, 1998
`• U.S. Patent No. 6,368,351 (“Glenn”), issued April 9, 2002
`• U.S. Patent No. 5,171,279 (“Mathews ’279”), issued December 15, 1992
`• U.S. Patent No. 6,206,826 (“Mathews ’826”), issued March 27, 2001
`• U.S. Patent Application Publication No. 2002/0022847 (“Ray”), published
`February 21, 2002
`• U.S. Patent No. 6,500,180 (“Foley”), issued December 31, 2002
`• European Spine Journal, The use of a retractor system (SynFrame) for open,
`minimal invasive reconstruction of the anterior column of the thoracic and
`-5-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S PRELIMINARY 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 9 - Page 83
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`• Warsaw Orthopedic, Inc. v. NuVasive, Inc., 3:08-cv-1512 MMA (MDD), Doc.
`No. 407-1 (NuVasive, Inc’s Memorandum of Points and Authorities in Support
`of Its Renewed Motion for Judgment as a Matter of Law or a New Trial), filed
`Oct. 27, 2011 (attached hereto at Exhibit 2)
`• Warsaw Orthopedic, Inc. v. NuVasive, Inc., 3:08-cv-1512 MMA (MDD), Doc.
`No. 407-3 (DTX-5118) (attached hereto at Exhibit 3)
`• Warsaw Orthopedic, Inc. v. NuVasive, Inc., 3:08-cv-1512 MMA (MDD), Doc.
`No. 407-5 (DTX-5134-R) (attached hereo at Exhibit 4)
`• Warsaw Orthopedic, Inc. v. NuVasive, Inc., 3:08-cv-1512 MMA (MDD), Doc.
`No. 407-4 (DTX-5131) (attached hereto at Exhibit 5)
`• Warsaw Orthopedic, Inc. v. NuVasive, Inc., 3:08-cv-1512 MMA (MDD), Doc.
`No. 407-6 (DTX-5150-R) (attached hereto at Exhibit 6)
`• Warsaw Orthopedic, Inc. v. NuVasive, Inc., 3:08-cv-1512 MMA (MDD), Doc.
`No. 407-14 (DTX-5995) (attached hereto at Exhibit 7)
`• Warsaw Orthopedic, Inc. v. NuVasive, Inc., 3:08-cv-1512 MMA (MDD), Doc.
`No. 407-15 (JX-1) (attached hereto at Exhibit 8)
`• Warsaw Orthopedic, Inc. v. NuVasive, Inc., 3:08-cv-1512 MMA (MDD), Doc.
`No. 407-10 (DTX-5881) (attached hereto at Exhibit 9)
`
`Defendants incorporate herein the Declaration of Dr. Sachs in Support of
`Defendants’ Opposition to Plaintiff’s Motion for Preliminary Injunction (Doc. No. 49-
`5) and the exhibits thereto (Doc. Nos. 49-6 - 49-71) at least with respect to the discussion
`of the above prior art references. Defendants also reserve their right to incorporate
`herein the arguments and prior art identified with respect to the asserted and/or related
`patents in prior district court litigation, including any appeals, as well as any post-grant
`proceedings before the PTAB and/or the U.S. Patent and Trademark Office, including
`but not limited to those discussed below.
`C.
`On-Sale Bar
`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
`
`-8-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S PRELIMINARY 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 9 - Page 84
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`Plaintiff, NuVasive, Inc. and are subject to the on-sale bar for the reasons described
`below.
`With respect to the ’859 patent, according to Plaintiff, 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 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 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+
`-9-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S PRELIMINARY 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 9 - Page 85
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`Wide). (NuVasive Disclosure of Asserted Claims and Infringement Contentions at 33.)
`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
`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
`-10-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S PRELIMINARY 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 9 - Page 86
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`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 Disclosure of
`Asserted Claims and Infringement Contentions at 36.) 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.
` Each of these instruments (and publically available materials describing them)
`also qualify as prior art under one or more sections of 35 U.S.C. § 102.
`INVALIDITY UNDER 35 U.S.C. § 103
`III.
`The asserted claims of the newly-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
`using a lateral percutaneous approach as of 1985. See Friedman at 149; see generally,
`-11-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S PRELIMINARY 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 9 - Page 87
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`

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`Case 3:18-cv-00347-CAB-MDD Document 300-10 Filed 01/08/21 PageID.27025 Page 10 of
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`Dated: October 30, 2018
`
`WINSTON & STRAWN LLP
`
`By: /s/Nimalka R. Wickramasekera
`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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`-121-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S PRELIMINARY 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 9 - Page 88
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`Case 3:18-cv-00347-CAB-MDD Document 300-10 Filed 01/08/21 PageID.27027 Page 12 of
`12
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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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`
`-123-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S PRELIMINARY 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 9 - Page 90
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