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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
`
`
`
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`Plaintiff,
`
`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’ SUPPLEMENTAL
`AMENDED INVALIDITY
`CONTENTIONS
`
`
`
`Complaint Filed: February 13, 2018
`Jury Trial Demanded
`
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`
`
`Case No. 3:18-CV-00347-CAB-MDD
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`EXHIBIT 11 - Page 105
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`DEFENDANTS’ SUPPLEMENTAL AMENDED INVALIDITY
`CONTENTIONS
`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 regarding:
`• Claims 1, 2, 6, 15-17, 19-21, 23, 26, 28, and 29 of U.S. Patent No. 7,819,801 (the
`“’801 patent”);
`• Claims 21, 22, and 24-28 of U.S. Patent No. 8,355,780 (the “’780 patent”);
`• Claims 1-4, 6-10, 12-14, 16, 17, and 19 of U.S. Patent No. 8,439,832 (the “’832
`patent”);
`• Claims 1, 2, 4, 6, 13, 15-17, 19, 22, and 28 of U.S. Patent No. 9,833,227 (the
`“’227 patent”);
`• Claims 1, 2, 3, 4, 6, and 12 of U.S. Patent No. 8,753,270 (the “’270 patent”); and
`• Claims 1, 2, 5, 9, 10, 12-20, 24, and 27 of U.S. Patent No. 8,361,156 (the “’156
`patent”) (collectively, the “asserted claims”).
`The above-listed claims are the only patents and claims identified and asserted
`by Plaintiff NuVasive, Inc. in its Amended Disclosure of Asserted Claims and
`Infringement Contentions served on November 9, 2018 (“Infringement Contentions”).
`Accordingly, Defendants’ Amended Invalidity Contentions 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 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. Defendants reserve the right to
`
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`reserve their right to rebut or further challenge any priority date argument advanced by
`Plaintiff, or rely on additional prior art references.
`6. Priority Date of the ’156 Patent
`In its Infringement Contentions, Plaintiff contends that the ’156 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. Defendants reserve their right to challenge the priority date claimed by the
`Plaintiff for the ’156 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. 5,931,777 (“Sava”), issued August 3. 1999
`• U.S. Patent No. 6,196,969 (“Bester”), issued March 6, 2001
`• EP 0951868 (“Büttner-Janz”), issued October 27, 1999
`
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
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`because NuVasive itself relied on the Jacobson technique to invalidate other patents that
`claimed a lateral, transpsoas path. Cardpool, Inc. v. Plastic Jungle, Inc., 817 F.3d 1316,
`1323 (Fed. Cir. 2016) (discussing that “[t]he 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”
`(citation omitted)); 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.”).
`One or more of the asserted claims of the ’270 patent are anticipated, at least as
`set forth in the claim charts attached herewith as Appendix E. The alleged invention,
`including the use of a shim element that penetrates the disc space to anchor a releasably
`attached surgical access system that engages with the access system through the use of
`a ridge structure, was disclosed by each of at least Branch ’311 and Ray. In particular,
`for example and without limitation, Branch ’311 teaches a retractor to which a blade is
`attached, the blade having a wedge-shaped distractor tip that extends into the
`intervertebral space to provide anchorage. The proximal engagement portion of the
`blade in Branch ’311 contains a ridge structure having a slot that engages with a groove
`in the retractor. Similarly, for example and without limitation, Ray teaches a removable
`guide sleeve tip, with a distal portion containing flanges that extend into the disc space
`to mount a guide sleeve. The proximal engagement portion contains a slot for engaging
`with a ridge structure.
`C. 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
`
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`
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`below. Each of these instruments (and publically 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 ’780 patent, according to Plaintiff, each of the asserted
`claims is practiced by at least the MaXcess I, MaXcess II, MaXcess III, and MaXcess
`III Solid, Dilators, Shim and/or K-wire. 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.) Accordingly, the asserted claims of the ’780 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 ’832 patent, according to Plaintiff, each of the asserted
`claims is practiced by at least the MaXcess I, MaXcess II, MaXcess III, and MaXcess
`III Solid, Dilators, K-wire, Light cable/light source connector, and/or fourth blade
`attachment. Further, as stated by Plaintiff, NuVasive “launched aspects of XLIF in
`
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`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.) Accordingly, the asserted claims of the ’832 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 ’227 patent, according to Plaintiff, each of the asserted claims
`is practiced by NuVasive’s Dilators and Retractors (e.g., MaXcess I, MaXcess II,
`MaXcess III, MaXcess III Solid, MaXcess 4, and MaXcess 4 Solid). 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
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
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`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.) Accordingly, the asserted claims of the ’227 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 ’270 patent, according to Plaintiff, each of the asserted claims
`is practiced by its intradiscal shims. This Shim has been on sale and described at least
`as of September 12, 2006, with the launch of the MaXcess III system (also described in
`NuVasive’s 2007 XLIF Surgical Guide). Accordingly, the asserted claims of the ’270
`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 ’156 patent, according to Plaintiff, each of the asserted claims
`is practiced by the CoRoent XL implants (e.g., CoRoent XL, CoRoent XLCT, CoRoent
`XLF, CoRoent XLK, CoRoent XLT, CoRoent XLW, CoRoent XL-FW, CoRoent XL-
`H, CoRoent XLXW, CoRoent XL+, CoRoent XL+ Wide). NuVasive launched the
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
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`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 ’156 patent are subject to the on-
`sale bar based on the sales of the above instruments, which, according to NuVasive,
`embody the asserted claims.
`Further, the asserted claims of the ’156 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 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
`
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`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).
`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 ’156 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
`
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
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`nerves of the psoas muscle for monitoring a nerve response.” The ’227 patent fails to
`describe the method of nerve monitoring required by these claims, namely that the
`nerves of the psoas muscle must be stimulated using a stimulation electrode on the
`dilators. Thus, it fails to satisfy written description, because it does not convey to a
`POSA that the inventor was in possession of the invention. Purdue Pharma L.P. v.
`Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000).
`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_LLIF000137222-38101; ATEC_LLIF000159668-161310; and
`ATEC_LLIF000161312-161864.
`
`Dated: January 15, 2019
`
`WINSTON & STRAWN LLP
`
`
`
`By: /s/Nimalka R. Wickramasekera
`NIMALKA R. WICKRAMASEKERA
`STEPHEN R. SMEREK
`
`-303-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
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`Case No. 3:18-CV-00347-CAB-MDD
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`EXHIBIT 11 - Page 114
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`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
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`SERVICE LIST
`
`
`
`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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`-306-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
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`Case No. 3:18-CV-00347-CAB-MDD
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`EXHIBIT 11 - Page 117
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