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`EXHIBIT C
`TO DASHE DECLARATION
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`Case 3:18-cv-00347-CAB-MDD Document 296-5 Filed 11/25/20 PageID.26762 Page 2 of 22
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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
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`CORINNE STONE HOCKMAN (pro hac vice)
`chockman@winston.com
`WINSTON & STRAWN LLP
`1111 Louisiana Street, 25th Floor
`Houston, TX 77002-5242
`Telephone: (713) 651-2600
`Facsimile: (713) 651-2700
`
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. AND ALPHATEC SPINE, INC.
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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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`NUVASIVE, INC., a Delaware
`corporation,
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`Plaintiff,
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`ALPHATEC HOLDINGS, INC., a
`Delaware corporation and ALPHATEC
`SPINE, INC., a California corporation,
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`Defendants.
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`v.
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`Case No. 3:18-CV-00347-CAB-MDD
`
`[Assigned to Courtroom 4C – Honorable
`Cathy Ann Bencivengo]
`
`DEFENDANTS’ UPDATED
`PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT
`NOS. 8,361,156 AND 8,187,334
`
`
`
`Complaint Filed: February 13, 2018
`
`DEFENDANT ALPHATEC HOLDINGS, INC.’S UPDATED PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
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`EXHIBIT C
`PAGE 55
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`Case 3:18-cv-00347-CAB-MDD Document 296-5 Filed 11/25/20 PageID.26763 Page 3 of 22
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`Amended Complaint Filed: September 13,
`2018
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`Jury Trial Demanded
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S UPDATED PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
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`Case No. 3:18-CV-00347-CAB-MDD
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`EXHIBIT C
`PAGE 56
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`Case 3:18-cv-00347-CAB-MDD Document 296-5 Filed 11/25/20 PageID.26764 Page 4 of 22
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`DEFENDANTS’ UPDATED PRELIMINARY INVALIDITY CONTENTIONS
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`FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
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`In accordance with the applicable rules of this Court, Defendants Alphatec
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`Holdings, Inc. and Alphatec Spine, Inc. (collectively, “Alphatec”) hereby provide the
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`following Updated Preliminary Invalidity Contentions for the following patents and
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`claims asserted by Plaintiff NuVasive, Inc. (“NuVasive”) in its Updated Preliminary
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`Infrringement Contentions served on October 1, 2020 (“Infringement Contentions”):
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`• Claims 1, 2, 5, 10, 13, 15, 18, 19, 24, and 27 of U.S. Patent No. 8,361,156 (the
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`“’156 patent”);
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`• Claims 16 and 18 of U.S. Patent No. 8,187,334 (the “’334 patent”) (collectively,
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`the “Asserted Claims” of the “Implant Patents”).
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`Defendants’ Updated Preliminary Invalidity Contentions specifically address the
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`above-listed claims of the Implant Patents. Defendants contend that each of the
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`Asserted Claims is invalid as demonstrated herein. Defendants expressly reserve the
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`right to disclose invalidity contentions with respect to other claims of these patents
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`and/or other patents, and to respond to or rebut NuVasive’s arguments for claims
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`asserted or arguments made following its Infringement Contentions. Defendants
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`incorprorate all previous invalidity contentions, including their contentions in the Joint
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`Discovery Plan (Doc. No. 292).
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`I.
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`GENERAL STATEMENT AND RESERVATION OF RIGHTS
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`These invalidity contentions are preliminary, and based upon information
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`currently available to Defendants, prior to completion of fact discovery or expert
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`discovery related to the Implant Patents. Therefore, Defendants reserve the right to
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`amend or supplement these Updated Preliminary Invalidity Contentions, including
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`pursuant to the Court’s Scheduling Order (Doc. No. 293) and should NuVasive provide
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`any additional positions regarding validity in response to Alphatec’s interrogatories.
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`Further, additional facts, documents, and things, whether known or unknown to
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`Defendants, may become relevant to Defendants’ defenses. Accordingly, Defendants
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S UPDATED PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`
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`EXHIBIT C
`PAGE 57
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`reserve their right to revise, supplement, or amend these Updated Preliminary Invalidity
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`Contentions as additional grounds or evidence of invalidity are identified in this case,
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`in response to any of Plaintiff’s arguments, and/or to address any additional patents or
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`claims that are asserted hereafter.
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`Defendants take no position here regarding the appropriate construction of any
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`claim term, if any. For example, statements purporting to describe claim limitations are
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`not to be taken as admissions that such terms are definite or comply with 35 U.S.C. §
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`112. Defendants maintain that Plaintiff’s Infringement Contentions are insufficient to
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`show infringement of any asserted claim under any claim construction. These Updated
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`Preliminary Invalidity Contentions shall not be treated as an admission that any of
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`Defendants’ accused products infringe the Asserted Claims or as an admission to the
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`scope of any of the Asserted Claims.
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`Defendants object to the disclosure of information and/or documents that are
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`protected by the attorney-client privilege, attorney work-product doctrine, or any other
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`applicable privilege or immunity. Defendants reserve the right to object to the
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`admissibility of these Updated Preliminary Invalidity Contentions or the information
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`contained herein.
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`II.
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`PRIORITY DATE
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`A. Priority Date of the ’156 Patent
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`In its Infringement Contentions, Plaintiff contends that the ’156 patent is entitled
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`to a priority date at least as early as March 29, 2004, which is the filing date of U.S.
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`Provisional Application No. 60/557,536 (“Provisional Application”). Plaintiff bears the
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`burden of proving, on a claim-by-claim basis, that the Provisional Application provides
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`written description support for each and every limitation of the Asserted Claims.
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`Plaintiff has not met this burden. Defendants reserve their right to challenge the priority
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`date claimed by Plaintiff for the ’156 patent.
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`Plaintiff is not entitled to a priority date of March 29, 2004 at least because the
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`Provisional Application fails to disclose or provide support for the following, as claimed
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S UPDATED PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`
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`EXHIBIT C
`PAGE 58
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`Case 3:18-cv-00347-CAB-MDD Document 296-5 Filed 11/25/20 PageID.26766 Page 6 of 22
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`by the ’156 patent: “at least first and second radiopaque markers oriented generally
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`parallel to a height of the implant, wherein said first radiopaque marker extends into
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`said first sidewall at a position proximate to said medial plane, and said second
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`radiopaque marker extends into said second sidewall at a position proximate to said
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`medial plane” as recited in claim 1, and “the first and second radiopaque markers are
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`substantially equally spaced apart from said proximal end of said proximal wall by a
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`first longitudinal distance” as recited in claim 2. Plaintiff asserts that the following
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`portions of the Provisional Application provide support for the priority date for these
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`claim limitations: p. 2, ll. 6-9; p. 4, ll. 4-7, 9-12, 14-21; p. 5, ll. 4-7, 16-21; p. 6, ll. 1-3;
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`p. 7, ll. 1-21; p. 8, ll. 1-2; p. 10, ll. 13-21; p. 11, ll. 1-3, 5-14, 19-21; p. 12, ll. 1-7, 21; p.
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`13, ll. 1, 8-9, 11-20; p. 14, ll. 1-4, 6-21; p. 15, ll. 1-7; p. 27, ll. 1-16; p. 28, ll. 2-4; and
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`Figs. 1-6. (NuVasive’s Third Supplemental Response to Interrogatory No. 9 (2020-09-
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`18).) Plaintiff is wrong. While the Provisional Application describes using “spike
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`elements” as “anti-migration features” (see, e.g., Provisional Application at 5:16-6:3,
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`14:1-21, Figs. 2-5), it contains no description of “radiopaque markers” as the term
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`would have been understood by a person of ordinary skill in the art. For instance, the
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`Provisional Application provides no support for using “anti-migration features” as
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`“markers” used for visualization of the implant. Notably, the Provisional Application
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`describes using other features of the implant for visualization (see, e.g., Provisional
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`Application at 12:19-13:9), but not the “spike elements” which are instead only
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`described as being used for anti-migration purposes. The concept of “radiopaque
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`markers” was first added in March 29, 2005 as part of U.S. Patent Application No.
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`11/093,409, which has the same specification as the ’156 patent and to which the ’156
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`patent claims priority. Importantly, the ’156 specification includes myriad disclosures
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`which are not included in the Provisional Application, of which the following disclose
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`the use of radiopaque markers as visual enhancement aids: 2:53–3:10, 6:49–56, 9:62–
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`10:9, 11:48–12:11, and Figs. 18–23. None of these disclosures are in the Provisional
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`Application. A highlighted copy of the ’156 Patent showing the changes from the
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S UPDATED PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`
`
`EXHIBIT C
`PAGE 59
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`Case 3:18-cv-00347-CAB-MDD Document 296-5 Filed 11/25/20 PageID.26767 Page 7 of 22
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`Provisional Application is attached hereto as Exhibit A. For instance, among the added
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`descriptions and figures over the Provisional Application, the ’156 specification
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`provides: “The spinal fusion implant of the present invention may be provided with any
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`number of features for enhancing the visualization of the implant during and/or after
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`implantation into a spinal target site. According to one aspect of the present invention,
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`such visualization enhancement features may take the form of the spike elements used
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`for anti-migration . . . In any event, when the spike elements are provided having
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`radiodense characteristics and the implant is manufactured from a radiolucent material
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`(such as, by way of example only, PEEK and/or PEKK), the spike elements will be
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`readily observable under X-ray or fluoroscopy such that a surgeon may track the
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`progress of the implant during implantation and/or the placement of the implant after
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`implantation.” ’156 patent at 2:53-3:10. These disclosures were expressly added in
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`March 29, 2005 because the Provisional Application did not provide support for the
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`claimed invention, and in particular the use of “radiopaque markers” in the implant.
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`Indeed, if the Provisional Application provided sufficient disclosure, Plaintiff would
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`not have needed to file such a substantively different non-provisional application.
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`Further, Plaintiff is not entitled to a priority date of March 29, 2004 at least
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`because the Provisional Application fails to disclose or provide support for the
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`following, as claimed by the ’156 Patent: “said longitudinal length is greater than said
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`maximum lateral width” as recited in claim 1, and “said longitudinal length is greater
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`than 40 mm” as recited in claim 5. Plaintiff asserts that the following portions of the
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`Provisional Application provide support for the priority date for these claim limitations:
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`p. 2, ll. 6-9; p. 4, ll. 4-7, 9-12, 14-21; p. 5, ll. 4-7, 16-21; p. 6, ll. 1-3; p. 7, ll. 1-21; p. 8,
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`ll. 1-2; p. 10, ll. 13-21; p. 11, ll. 1-3, 5-14, 19-21; p. 12, ll. 1-7, 21; p. 13, ll. 1, 8-9, 11-
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`20; p. 14, ll. 1-4, 6-21; p. 15, ll. 1-7; p. 27, ll. 1-16; p. 28, ll. 2-4; and Figs. 1-6.
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`(NuVasive’s Third Supplemental Response to Interrogatory No. 9 (2020-09-18).)
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`Plaintiff is wrong. The Provisional Application only describes an implant for lumbar
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`fusion “having a length ranging from 9 and 18 mm, a height ranging between 8 and 16
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S UPDATED PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
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`EXHIBIT C
`PAGE 60
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`mm, and a width ranging between 25 and 45 mm” (Provisional Application at 4:18-21,
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`11:12-14) and an implant for cervical fusion “having a length of about 11 mm, a height
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`ranging between 5 and 12 mm, and a width about 14 mm.” (Provisional Application at
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`4:21-5:2.) Thus, the Provisional Application contains no description of an implant
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`having a longitudinal length longer than its maximum lateral width or a longitudinal
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`length longer than 40 mm. The geometry claimed by these claim limitations of claim 1
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`and claim 5 was first added in March 29, 2005 as part of U.S. Patent Application No.
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`11/093,409, which has the same specification as the ’156 patent and to which the ’156
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`patent claims priority. Importantly, the specification of the ’156 patent includes myriad
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`disclosures which are not included in the Provisional Application, of which the
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`following disclose the dimensions of the implant: 2:17–25, 5:15–19, 8:66–9:3, 11:48–
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`12:11, and Figs. 18–23. A highlighted copy of the ’156 patent showing the changes
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`from the Provisional Application is attached hereto as Exhibit A. For instance, the ’156
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`specification provides: “For lumbar fusion, the spinal fusion implant of the present
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`invention may be dimensioned, by way of example only, having a width ranging
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`between 9 and 18 mm, a height ranging between 8 and 16 mm, and a length ranging
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`between 25 and 45 mm. For cervical fusion, the spinal fusion implant of the present
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`invention may be dimensioned, by way of example only, having a width about 11 mm,
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`a height ranging between 5 and 12 mm, and a length about 14 mm.” ’156 patent at
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`2:17-25. These disclosures were expressly added in March 29, 2005 because the
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`Provisional Application did not provide support for the claimed invention. Indeed, if
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`the Provisional Application provided sufficient disclosure, Plaintiff would not have
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`needed to file such a substantively different non-provisional application.
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`B. Priority Date of the ’334 Patent
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`In its Infringement Contentions, Plaintiff contends that the ’334 patent is entitled
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`26
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`to a priority date at least as early as March 29, 2004, which is the filing date of U.S.
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`27
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`Provisional Application No. 60/557,536. Plaintiff bears the burden of proving, on a
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`28
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`claim-by-claim basis, that the Provisional Application provides written description
`-5-
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S UPDATED PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`
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`EXHIBIT C
`PAGE 61
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`support for each and every limitation of the Asserted Claims. Plaintiff has not met this
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`burden. Defendants reserve their right to challenge the priority date claimed by Plaintiff
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`for the ’334 patent.
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`Plaintiff is not entitled to a priority date of March 29, 2004 at leat because the
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`Provisional Application fails to disclose or provide support for the following, as claimed
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`by the ’334 Patent: “at least three radiopaque markers; wherein a first of the at least
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`three radiopaque markers is at least partially positioned in said distal wall, a second of
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`said at least three radiopaque markers is at least partially positioned in said proximal
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`wall, and a third of said at least three radiopaque markers is at least partially positioned
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`in said central region” as recited in claim 1, and “further comprising a fourth radiopaque
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`marker situated within said implant, said fourth radiopaque marker positioned in said
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`central region at a position spaced apart from said third radiopaque marker” as recited
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`in claim 16. Plaintiff asserts that the following portions of the Provisional Application
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`provide support for the priority date for these claim limitations: p. 2, ll. 6-9; p. 4, ll. 4-
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`7, 9-12, 14-21; p. 5, ll. 4-7, 16-21; p. 6, ll. 1-3; p. 7, ll. 1-21; p. 8, ll. 1-2; p. 10, ll. 13-
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`21; p. 11, ll. 1-3, 5-14, 19-21; p. 12, ll. 1-7, 21; p. 13, ll. 1, 8-9, 11-20; p. 14, ll. 1-21; p.
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`15, ll. 1-7; p. 27, ll. 1-16; p. 28, ll. 2-4; and Figs. 1-6. (NuVasive’s Third Supplemental
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`Response to Interrogatory No. 9 (2020-09-18).) Plaintiff is wrong. While the
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`Provisional Application describes using “spike elements” as “anti-migration features”
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`(see, e.g., Provisional Application at 5:16-6:3, 14:1-21, Figs. 2-5), it contains no
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`description of “radiopaque markers” as the term would have been understood by a
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`person of ordinary skill in the art. For instance, the Provisional Application provides
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`no support for using “anti-migration features” as “markers” used for visualization of the
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`implant. Notably, the Provisional Application describes using other features of the
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`implant for visualization (see, e.g., Provisional Application at 12:19-13:9), but not the
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`“spike elements,” which are instead only described as being used for anti-migration
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`purposes. The concept of “radiopaque markers” was first added in March 29, 2005 as
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`part of U.S. Patent Application No. 11/093,409, which has the same specification as the
`-6-
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S UPDATED PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
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`EXHIBIT C
`PAGE 62
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`Case 3:18-cv-00347-CAB-MDD Document 296-5 Filed 11/25/20 PageID.26770 Page 10 of
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`’334 patent and to which the ’334 patent claims priority. Importantly, the ’334
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`specification includes myriad disclosures which are not included in the Provisional
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`Application, of which the following disclose the use of radiopaque markers as visual
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`enhancement aids: 2:53–3:10, 6:49–56, 9:62–10:9, 11:48–12:11, and Figs. 18–23. A
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`highlighted copy of the ’334 Patent showing the changes from the Provisional
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`Application is attached hereto as Exhibit B. For instance, among the added descriptions
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`and figures over the Provisional Application, the ’334 specification provides: “The
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`spinal fusion implant of the present invention may be provided with any number of
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`features for enhancing the visualization of the implant during and/or after implantation
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`into a spinal target site. According to one aspect of the present invention, such
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`visualization enhancement features may take the form of the spike elements used for
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`anti-migration . . . In any event, when the spike elements are provided having radiodense
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`characteristics and the implant is manufactured from a radiolucent material (such as, by
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`way of example only, PEEK and/or PEKK), the spike elements will be readily
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`observable under X-ray or fluoroscopy such that a surgeon may track the progress of
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`the implant during implantation and/or the placement of the implant after implantation.”
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`’334 patent at 2:53-3:10. These disclosures were expressly added in March 29, 2005
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`because the Provisional Application did not provide support for the claimed invention,
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`and in particular the use of “radiopaque markers” in the implant. Indeed, if the
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`Provisional Application provided sufficient disclosure, Plaintiff would not have needed
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`to file such a substantively different non-provisional application.
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`Further, Plaintiff is not entitled to a priority date of March 29, 2004 at least
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`because the Provisional Application fails to disclose or provide support for the
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`following, as claimed by the ’334 patent: “wherein said implant has a longitudinal
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`length greater than 40 mm extending from a proximal end of said proximal wall to a
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`distal end of said distal wall” as recited in claim 1, “wherein said longitudinal length is
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`at least two and half times greater than said maximum lateral width” as recited in claim
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`1, and “wherein said maximum lateral width of said implant is approximately 18 mm”
`-7-
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S UPDATED PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`
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`EXHIBIT C
`PAGE 63
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`Case 3:18-cv-00347-CAB-MDD Document 296-5 Filed 11/25/20 PageID.26771 Page 11 of
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`as recited in claim 18. Plaintiff asserts that the following portions of the Provisional
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`Application provide support for the priority date for these claim limitations: p. 2, ll. 6-
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`9; p. 4, ll. 4-7, 9-12, 14-21; p. 5, ll. 4-7, 16-21; p. 6, ll. 1-3; p. 7, ll. 1-21; p. 8, ll. 1-2; p.
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`10, ll. 13-21; p. 11, ll. 1-3, 5-14, 19-21; p. 12, ll. 1-7, 21; p. 13, ll. 1, 8-9, 11-20; p. 14,
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`ll. 1-21; p. 15, ll. 1-7; p. 27, ll. 1-16; p. 28, ll. 2-4; and Figs. 1-6. (NuVasive’s Third
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`Supplemental Response to Interrogatory No. 9 (2020-09-18).) Plaintiff is wrong.
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`While the Provisional Application only describes an implant for lumbar fusion “having
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`a length ranging from 9 and 18 mm, a height ranging between 8 and 16 mm, and a width
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`ranging between 25 and 45 mm” (Provisional Application at 4:18-21, 11:12-14) and an
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`implant for cervical fusion “having a length of about 11 mm, a height ranging between
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`5 and 12 mm, and a width about 14 mm.” (Provisional Application at 4:21-5:2.) Thus,
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`the Provisional Application contains no description of an implant having a longitudinal
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`length longer than its maximum lateral width or a longitudinal length longer than 40
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`mm. The geometry claimed by these claim limitations of claim 1 and claim 18 was first
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`added in March 29, 2005 as part of U.S. Patent Application No. 11/093,409, which has
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`the same specification as the ’334 patent and to which the ’334 patent claims priority.
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`Importantly, the specification of the ’334 patent includes myriad disclosures which are
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`not included in the Provisional Application, of which the following disclose the
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`dimensions of the implant: 2:17–25, 5:15–19, 11:48–12:11, and Figs. 18–23. A
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`highlighted copy of the ’334 Patent showing the changes from the Provisional
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`Application is attached hereto as Exhibit B. For instance, the ’334 patent provides: “For
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`lumbar fusion, the spinal fusion implant of the present invention may be dimensioned,
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`by way of example only, having a width ranging between 9 and 18 mm, a height ranging
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`between 8 and 16 mm, and a length ranging between 25 and 45 mm. For cervical fusion,
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`the spinal fusion implant of the present invention may be dimensioned, by way of
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`example only, having a width about 11 mm, a height ranging between 5 and 12 mm,
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`and a length about 14 mm.” ’334 patent at 2:17-25. These disclosures were expressly
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`added in March 29, 2005 because the Provisional Application did not provide support
`-8-
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S UPDATED PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`
`
`EXHIBIT C
`PAGE 64
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`

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`Case 3:18-cv-00347-CAB-MDD Document 296-5 Filed 11/25/20 PageID.26772 Page 12 of
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`for the claimed invention. Indeed, if the Provisional Application provided sufficient
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`disclosure, Plaintiff would not have needed to file such a substantively different non-
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`provisional application.
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`III.
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`INVALIDITY UNDER 35 U.S.C. § 102
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`A. On-Sale Bar and Prior Public Use
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`The Asserted Claims are subject to the on-sale bar under 35 U.S.C. § 102(b). The
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`Asserted Claims of the Implant Patents are invalid under § 102(b), which states that a
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`person shall not be entitled to a patent if the alleged invention was in public use more
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`than one year prior to the date of the application for patent in the United States.
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`1. Entitled to March 29, 2005 As Earliest Priority Date
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`For at least the reasons explained above, Plaintiff has not met its burden to show
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`that the Implant Patents are entitled to a priority date as early as March 29, 2004, which
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`is the filing date of U.S. Provisional Application No. 60/557,536. Assuming that the
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`Implant Patents are only entitled to a priority date as early as March 29, 2005, each of
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`the devices discussed below were sold, offered for sale, used, offered for use,
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`demonstrated, disclosed, or displayed by Plaintiff more than one year prior to March
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`29, 2005. Therefore, for at least the reasons described below, the Implant Patents are
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`subject to the on-sale bar.
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`Plaintiff admits that at least some of its Cement Restrictors embody the Implant
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`Patents. (2020-10-06 Email from Tanner to Nisbet.) Documents produced by Plaintiff
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`indicate that Plaintiff’s Cement Restrictors were sold, offered for sale, used, offered for
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`use, demonstrated, disclosed, or displayed by Plaintiff before March 29, 2004. See, e.g.,
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`NUVA_ATEC0341176 (Sales Inventory Analysis – 2004); NUVA_ATEC0341177
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`(Sales Inventory Analysis – 2004); NUVA_ATEC0332451 (March 2004 email from
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`Matt Copp stating that NuVasive’s PEEK Cement Restrictor implants were “available
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`– ahead of the scheduled March 15th date”); NUVA_ATEC0341059 (March 2004 email
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`from Matt Copp stating that NuVasive’s PEEK Cement Restrictor implants were
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`“available – ahead of the scheduled March 15th date”); NUVA_ATEC0340867
`-9-
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S UPDATED PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`
`
`EXHIBIT C
`PAGE 65
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`

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`Case 3:18-cv-00347-CAB-MDD Document 296-5 Filed 11/25/20 PageID.26773 Page 13 of
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`(December 2003 email from Matt Copp about distributing Cement Restrictor sets
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`through NuVasive’s loaner program “[b]eginning very soon”). Further, publicly-
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`available documents indicate that PEEK Cement Restrictors were being used by
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`surgeons as they became commercially available. See, e.g., ATEC_LLIF000965979
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`(NuVasive, Inc., Registration Statement Under the Securities Act of 1933 (Form S-1)
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`(Mar. 5, 2004)); ATEC_LLIF000966310 at 966326 (NuVasive, Inc., Amendment No.
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`2 to Registration Statement Under the Securities Act of 1933 (Form S-1) (Apr. 26,
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`2004)) (“[s]pecifically, we have been informed that our PEEK product is being used by
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`some surgeons as a synthetic allograft”); ATEC_LLIF000966507 at 966523 (NuVasive,
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`Inc., Amendment No. 3 to Registration Statement Under the Securities Act of 1933
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`(Form S-1) (May 4, 2004)). Accordingly, the Asserted Claims of the Implant Patents
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`are subject to the on-sale bar for at least these reasons. Defendants reserve their right
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`to revise, supplement, or amend these Updated Preliminary Invalidity Contentions to
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`include additional documents, grounds, or evidence identified in this case to support
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`their contentions under 35 U.S.C. § 102(b).
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`2. Entitled to March 29, 2004 As Earliest Priority Date
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`Even if the Implant Patents are entitled to a priority date as early as March 29,
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`2004, they are still invalid under § 102(b). At least as early as 1990, Dr. Brantigan
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`developed and used non-bone, spinal fusion implants having dimensions of 42 mm
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`(long) x 28 mm (wide) x 14 mm (height). See, e.g., NuVasive’s Opening Brief, Case
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`No. 2013-1576 (Fed. Cir. Feb. 3, 2014), at 6 (citing A11459-69, A11480-81, A11499-
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`501, A11504; A15358; A15362-69; A15359-61; A15491-502; A17835-65, A17858;
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`23
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`A18873). By June 1990, Dr. Brantigan ordered 4 different spinal fusion implants of
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`different dimensions, including one having the dimensions described above. Id.
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`Further, Dr. Brantigan developed implants having a “width that is at least as great
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`as the height.” See, e.g., NuVasive’s Memorandum of Points and Authorities in Support
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`27
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`of its Renewed Motion for Judgment as a Matter of Law or a New Trial, Warsaw
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`28
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`Orthopedic, Inc. v. NuVasive, Inc., Case No. 3:08-cv-1512-CAB-MDD (S.D. Cal. Oct.
`-10-
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`DEFENDANT ALPHATEC HOLDINGS, INC.’S UPDATED PRELIMINARY INVALIDITY
`CONTENTIONS FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`
`
`EXHIBIT C
`PAGE 66
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`

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`Case 3:18-cv-00347-CAB-MDD Document 296-5 Filed 11/25/20 PageID.26774 Page 14 of
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`27, 2011), D.I. 407-1, 13. An implant having dimensions of 42 mm x 28 mm x 14 was
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`sold and used in patients prior to 1995. Id., 10-11 (citing DTX-5118, DTX-5134, DTX-
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`5131, DTX-5150, DTX-5995, Tr. at 1459:20-1461:8, 1463:19-1465:4, 1466:1-9,
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`1467:4-9, 1467:24-1469:14, 1480:3-1481:9, 1499:3-1501:22, 1504:3-4 (Brantigan)).
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`At trial, Dr. Brantigan explained that these implants were sold by Acromed to hospitals
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`and inserted into patients. Id., 11. Dr. Brantigan’s testimony was supported by
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`photographs, prescriptions, and technical drawings. Id. Dr. Brantigan’s implants also
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`included openings to facilitate bone growth fusion. Id., 13 (citing DTX-5131, DTX-
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`5134, DTX-5995). Further, Dr. Brantigan’s implants had “ratchetings.” Id. (citing
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`DTX-5131, DTX-5134). In addition, the parties agreed that Berry discloses the ranges
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`of average widths and depths of human thoracic and lumbar vertebrae, as reflected in
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`the table NuVasive adapted from Berry. Id., 11 (citing DTX5881; JX-1 at ¶¶ 70, 71,
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`74, 76).
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`In light of its above arguments, Plaintiff is judicially estopped from making
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`arguments regarding the disclosures of these prior art references, including, for
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`16
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`example, the Brantigan implant that contradicts its prior statements. Indeed, NuVasive
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`itself made statements in prior proceedings regarding the similarities between the
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`Brantigan implants and NuVasive’s CoRoent implants to invalidate other patents that
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`19
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`claimed surgical implants. Cardpool, Inc. v. Plastic Jungle, Inc., 817 F.3d 1316, 1323
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`(Fed. Cir. 2016) (“The doctrine of judicial estoppel is that where a party successfully
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`urges a particular position in a legal proceeding, it is estopped from taking a contrary
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`position in a subsequent proceeding where its interests have changed