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`EXHIBIT D
`TO DASHE DECLARATION
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`Case 3:18-cv-00347-CAB-MDD Document 296-6 Filed 11/25/20 PageID.26784 Page 2 of 20
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`NIMALKA R. WICKRAMASEKERA (SBN: 268518)
`nwickramasekera@winston.com
`DAVID P. DALKE (SBN: 218161)
`ddalke@winston.com
`WINSTON & STRAWN LLP
`333 S. Grand Avenue
`Los Angeles, CA 90071-1543
`Telephone: (213) 615-1700
`Facsimile:
`(213) 615-1750
`
`GEORGE C. LOMBARDI (pro hac vice)
`glombardi@winston.com
`BRIAN J. NISBET (pro hac vice)
`bnisbet@winston.com
`SARANYA RAGHAVAN (pro hac vice)
`sraghavan@winston.com
`WINSTON & STRAWN LLP
`35 West Wacker Drive
`Chicago, IL 60601-9703
`Telephone: (312) 558-5600
`Facsimile: (312) 558-5700
`
`CORINNE STONE HOCKMAN (pro hac vice)
`chockman@winston.com
`WINSTON & STRAWN LLP
`800 Capitol Street, Suite 2400
`Houston, TX 77002-2529
`Telephone: (713) 651-2600
`Facsimile: (713) 651-2700
`
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. AND ALPHATEC SPINE, INC.
`
`UNITED STATES DISTRICT COURT
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`SOUTHERN DISTRICT OF CALIFORNIA – SAN DIEGO DIVISION
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`Plaintiff,
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`NUVASIVE, INC., a Delaware
`corporation,
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`
`v.
`
`ALPHATEC HOLDINGS, INC., a
`Delaware corporation and ALPHATEC
`SPINE, INC., a California corporation,
`
`Defendants.
`
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`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`[Assigned to Courtroom 4C – Honorable
`Cathy Ann Bencivengo]
`
`
`DEFENDANTS’ FINAL INVALIDITY
`CONTENTIONS FOR U.S. PATENT
`NOS. 8,361,156 AND 8,187,334
`
`Complaint Filed: February 13, 2018
`Amended Complaint Filed: September 13,
`2018
`
`Jury Trial Demanded
`
`
`DEFENDANTS’ FINAL 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 D
`PAGE 76
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`DEFENDANTS’ FINAL INVALIDITY CONTENTIONS FOR
`U.S. PATENT NOS. 8,361,156 AND 8,187,334
`In accordance with the applicable rules of this Court, defendants Alphatec
`
`Holdings, Inc. and Alphatec Spine, Inc. (collectively, “Alphatec” or “Defendants”)
`hereby provide the following Final Invalidity Contentions for the following patents and
`claims asserted by plaintiff NuVasive, Inc. (“NuVasive” or “Plaintiff”) in its Final
`Infringement Contentions served on November 6, 2020 (“Infringement Contentions”):
`• Claims 1, 5, 10, 18, and 24 of U.S. Patent No. 8,361,156 (the “’156 patent”);
`• Claims 16 and 18 of U.S. Patent No. 8,187,334 (the “’334 patent”) (collectively,
`the “Asserted Claims” of the “Implant Patents”).
`Defendants’ Final Invalidity Contentions specifically address the above-listed claims of
`the Implant Patents. Defendants contend that each of the Asserted Claims is invalid as
`demonstrated herein. Defendants expressly reserve the right to disclose invalidity
`
`contentions with respect to other claims of these patents and/or other patents, and to
`respond to or rebut NuVasive’s arguments for claims asserted or arguments made
`following its Infringement Contentions. Defendants incorprorate all previous invalidity
`contentions, including their contentions in the Joint Discovery Plan (Doc. No. 292).
`GENERAL STATEMENT AND RESERVATION OF RIGHTS
`I.
`These invalidity contentions are based upon information currently available to
`Defendants, prior to completion expert discovery related to the Implant Patents.
`Therefore, Defendants reserve the right to amend or supplement these Final Invalidity
`Contentions, including pursuant to the Court’s Scheduling Order (Doc. No. 293).
`Further, additional 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 Final Invalidity Contentions as
`additional grounds or evidence of invalidity are identified in this case, in response to
`any of Plaintiff’s arguments, and/or to address any additional patents or claims that are
`asserted hereafter.
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`DEFENDANTS’ FINAL 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 D
`PAGE 77
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`Defendants take no position here regarding the appropriate construction of any
`claim term, if any. For example, statements purporting to describe claim limitations are
`not to be taken as admissions that such terms are definite or comply with 35 U.S.C. §
`112. Defendants maintain that Plaintiff’s Infringement Contentions are insufficient to
`show infringement of any asserted claim under any claim construction. These Final
`Invalidity Contentions shall not be treated as an admission that any 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 as to the
`admissibility of these Final Invalidity Contentions or the information contained herein.
`PRIORITY DATE
`II.
`
`A. 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 (“Provisional Application”). 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 Plaintiff for the ’156 patent.
`Plaintiff is not entitled to a priority date of March 29, 2004 at least because the
`Provisional Application fails to disclose or provide support for the following, as claimed
`by the ’156 patent: “at least first and second radiopaque markers oriented generally
`parallel to a height of the implant, wherein said first radiopaque marker extends into
`said first sidewall at a position proximate to said medial plane, and said second
`radiopaque marker extends into said second sidewall at a position proximate to said
`medial plane” as recited in claim 1. Plaintiff asserts that the following portions of the
`-2-
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`DEFENDANTS’ FINAL 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 D
`PAGE 78
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`Provisional Application provide support for the priority date for these 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; 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. 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 Figs. 1-6.
`(NuVasive’s Third Supplemental Response to Interrogatory No. 9 (2020-09-18).)
`Plaintiff is wrong. While the Provisional Application describes using “spike elements”
`as “anti-migration features” (see, e.g., Provisional Application at 5:16-6:3, 14:1-21,
`Figs. 2-5), it contains no description of “radiopaque markers” as the term would have
`been understood by a person of ordinary skill in the art. This understanding of a person
`of ordinary skill in the art is corroborated by contemporaneous evidence produced by
`NuVasive. See, e.g., NUVA_ATEC0251803-38
`
`
`. For instance, the Provisional Application provides no support
`
`for using “anti-migration features” as “markers” used for visualization of the implant.
`Notably, the Provisional Application describes using other features of the implant for
`visualization (see, e.g., Provisional Application at 12:19-13:9), but not the “spike
`elements” which are instead only described as being used for anti-migration purposes.
`The concept of “radiopaque markers” was first added on March 29, 2005 as part of non-
`provisional U.S. Patent Application No. 11/093,409, which has the same specification
`as the ’156 patent and to which the ’156 patent claims priority. Importantly, the ’156
`specification (as a result of the additions to non-provisional U.S. Patent Application No.
`11/093,409) includes myriad disclosures which are not included in the Provisional
`Application, of which the following disclose the use of radiopaque markers as visual
`enhancement aids: 2:53-3:10, 6:49-56, 9:62-10:9, 11:48-12:11, and Figs. 18-23. None
`of these disclosures are in the Provisional Application. A highlighted copy of the ’156
`patent showing the changes from the Provisional Application is attached hereto as
`Exhibit A. For instance, among the added descriptions and figures over the Provisional
`Application, the ’156 specification provides: “The spinal fusion implant of the present
`-3-
`
`
`DEFENDANTS’ FINAL 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 D
`PAGE 79
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`

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`invention may be provided with any number of features for enhancing the visualization
`of the implant during and/or after implantation into a spinal target site. According to
`one aspect of the present invention, such visualization enhancement features may take
`the form of the spike elements used for anti-migration . . . In any event, when the spike
`elements are provided having radiodense characteristics and the implant is
`manufactured from a radiolucent material (such as, by way of example only, PEEK
`and/or PEKK), the spike elements will be readily observable under X-ray or fluoroscopy
`such that a surgeon may track the progress of the implant during implantation and/or
`the placement of the implant after implantation.” ’156 patent at 2:53-3:10. These
`disclosures were expressly added on March 29, 2005 because the Provisional
`Application did not provide support for the claimed invention, and in particular, the use
`of “radiopaque markers” in the implant. Indeed, if the Provisional Application provided
`sufficient disclosure, Plaintiff would not have needed to file such a substantively
`
`different non-provisional application. Notably, NuVasive itself distinguished between
`spike elements and radiopaque markers during IPR2019-00361, IPR2019-00362, and
`IPR2019-00546 to argue that prior art reference U.S. Publication No. 2003/0028249
`(“Baccelli”) did not disclose the radiopaque markers claimed by the Implant Patents.
`See, e.g., IPR2019-00361, Paper 12 (Patent Owner’s Preliminary Response) at, e.g., 16,
`56-61; IPR2019-00362, Paper 11 (Patent Owner’s Preliminary Response) at, e.g., 16,
`34-39; IPR2019-00546, Paper 10 (Patent Owner’s Preliminary Response) at, e.g., 21-
`22, 44-48.
`Further, Plaintiff is not entitled to a priority date of March 29, 2004 at least
`because the Provisional Application fails to disclose or provide support for the
`following limitations which recite specific dimensions of the implant, as claimed by the
`’156 patent: “wherein said implant has a longitudinal length extending from a proximal
`end of said proximal wall to a distal end of said distal wall, said implant has a maximum
`lateral width extending from said first sidewall to said second sidewall along a medial
`plane that is generally perpendicular to said longitudinal length, and said longitudinal
`-4-
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`DEFENDANTS’ FINAL 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 D
`PAGE 80
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`length is greater than said maximum lateral width” as recited in claim 1, “a longitudinal
`aperture length extending generally parallel to the longitudinal length of said implant,
`and a lateral aperture width extending between said first sidewall to said second
`sidewall, wherein the longitudional aperture length is greater than the lateral aperture
`width” as recited in claim 1, “a position proximate to said medial plane” as recited in
`claim 1, “said longitudinal length is greater than 40 mm” as recited in claim 5, and “said
`maximum lateral width is greater than said height” as recited in claim 24. Plaintiff
`asserts that the following portions of the Provisional Application provide support for
`the priority date for these 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; 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. 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 Figs. 1-6. (NuVasive’s Third Supplemental Response to
`Interrogatory No. 9 (2020-09-18).) Plaintiff is wrong. The Provisional Application
`
`only describes an implant for lumbar fusion “having a length ranging from 9 and 18
`mm, a height ranging between 8 and 16 mm, and a width ranging between 25 and 45
`mm” (Provisional Application at 4:18-21, 11:12-14) and an implant for cervical fusion
`“having a length of about 11 mm, a height ranging between 5 and 12 mm, and a width
`about 14 mm.” (Provisional Application at 4:21-5:2.) Thus, the Provisional
`Application contains no description of an implant having a longitudinal length longer
`than its maximum lateral width or a longitudinal length longer than 40 mm. The
`geometry claimed by these claim limitations of claims 1, 5, and 24 was first added on
`March 29, 2005 as part of non-provisional U.S. Patent Application No. 11/093,409,
`which has the same specification as the ’156 patent and to which the ’156 patent claims
`priority. Importantly, the specification of the ’156 patent (as a result of the additions to
`non-provisional U.S. Patent Application No. 11/093,409) includes myriad disclosures
`which are not included in the Provisional Application, of which the following disclose
`the dimensions of the implant: 2:17-25, 5:15-19, 8:66-9:3, 11:48-12:11, and Figs. 18-
`23. A highlighted copy of the ’156 patent showing the changes from the Provisional
`-5-
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`DEFENDANTS’ FINAL 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 D
`PAGE 81
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`Application is attached hereto as Exhibit A. For instance, the ’156 specification
`provides: “For lumbar fusion, the spinal fusion implant of the present invention may be
`dimensioned, by way of example only, having a width ranging between 9 and 18 mm,
`a height ranging between 8 and 16 mm, and a length ranging between 25 and 45 mm.
`For cervical fusion, the spinal fusion implant of the present invention may be
`dimensioned, by way of example only, having a width about 11 mm, a height ranging
`between 5 and 12 mm, and a length about 14 mm.” ’156 patent at 2:17-25. These
`disclosures were expressly added on March 29, 2005 because the Provisional
`Application did not provide support for the claimed invention. Indeed, if the Provisional
`Application provided sufficient disclosure, Plaintiff would not have needed to file such
`a substantively different non-provisional application.
`B. Priority Date of the ’334 Patent
`In its Infringement Contentions, Plaintiff contends that the ’334 patent is entitled
`
`to a priority date at least as early as March 29, 2004, which is the filing date of U.S.
`Provisional Application No. 60/557,536. Plaintiff bears the burden of proving, on a
`claim-by-claim basis, that the Provisional Application provides written description
`support for each and every limitation of the Asserted Claims. Plaintiff has not met this
`burden. Defendants reserve their right to challenge the priority date claimed by Plaintiff
`for the ’334 patent.
`Plaintiff is not entitled to a priority date of March 29, 2004 at least because the
`Provisional Application fails to disclose or provide support for the following, as claimed
`by the ’334 patent: “at least three radiopaque markers; wherein a first of the at least
`three radiopaque markers is at least partially positioned in said distal wall, a second of
`said at least three radiopaque markers is at least partially positioned in said proximal
`wall, and a third of said at least three radiopaque markers is at least partially positioned
`in said central region” as recited in claim 1, and “further comprising a fourth radiopaque
`marker situated within said implant, said fourth radiopaque marker positioned in said
`central region at a position spaced apart from said third radiopaque marker” as recited
`-6-
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`
`DEFENDANTS’ FINAL 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 D
`PAGE 82
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`

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`in claim 16. Plaintiff asserts that the following portions of the Provisional Application
`provide support for the priority date for these 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; 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. 13, ll. 1, 8-9, 11-20; p. 14, 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 Supplemental
`Response to Interrogatory No. 9 (2020-09-18).) Plaintiff is wrong. While the
`Provisional Application describes using “spike elements” as “anti-migration features”
`(see, e.g., Provisional Application at 5:16-6:3, 14:1-21, Figs. 2-5), it contains no
`description of “radiopaque markers” as the term would have been understood by a
`person of ordinary skill in the art. This understanding of a person of ordinary skill in
`the art is corroborated by contemporaneous evidence produced by NuVasive. See, e.g.,
`NUVA_ATEC0251803-38
`
`
`
`. For instance, the Provisional Application provides no support for using “anti-
`migration features” as “markers” used for visualization of the implant. Notably, the
`Provisional Application describes using other features of the implant for visualization
`(see, e.g., Provisional Application at 12:19-13:9), but not the “spike elements,” which
`are instead only described as being used for anti-migration purposes. The concept of
`“radiopaque markers” was first added on March 29, 2005 as part of non-provisional
`U.S. Patent Application No. 11/093,409, which has the same specification as the ’334
`patent and to which the ’334 patent claims priority. Importantly, the ’334 specification
`(as a result of the additions to non-provisional U.S. Patent Application No. 11/093,409)
`includes myriad disclosures which are not included in the Provisional Application, of
`which the following disclose the use of radiopaque markers as visual enhancement aids:
`2:53-3:10, 6:49-56, 9:62-10:9, 11:48-12:11, and Figs. 18-23. A highlighted copy of the
`’334 patent showing the changes from the Provisional Application is attached hereto as
`Exhibit B. For instance, among the added descriptions and figures over the Provisional
`Application, the ’334 specification provides: “The spinal fusion implant of the present
`-7-
`
`
`DEFENDANTS’ FINAL 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 D
`PAGE 83
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`invention may be provided with any number of features for enhancing the visualization
`of the implant during and/or after implantation into a spinal target site. According to
`one aspect of the present invention, such visualization enhancement features may take
`the form of the spike elements used for anti-migration . . . In any event, when the spike
`elements are provided having radiodense characteristics and the implant is
`manufactured from a radiolucent material (such as, by way of example only, PEEK
`and/or PEKK), the spike elements will be readily observable under X-ray or fluoroscopy
`such that a surgeon may track the progress of the implant during implantation and/or
`the placement of the implant after implantation.” ’334 patent at 2:53-3:10. These
`disclosures were expressly added on March 29, 2005 because the Provisional
`Application did not provide support for the claimed invention, and in particular the use
`of “radiopaque markers” in the implant. Indeed, if the Provisional Application provided
`sufficient disclosure, Plaintiff would not have needed to file such a substantively
`
`different non-provisional application. Notably, NuVasive itself distinguished between
`spike elements and radiopaque markers during IPR2019-00361, IPR2019-00362, and
`IPR2019-00546 to argue that prior art reference U.S. Publication No. 2003/0028249
`(“Baccelli”) did not disclose the radiopaque markers claimed by the Implant Patents.
`See, e.g., IPR2019-00361, Paper 12 (Patent Owner’s Preliminary Response) at, e.g., 16,
`56-61; IPR2019-00362, Paper 11 (Patent Owner’s Preliminary Response) at, e.g., 16,
`34-39; IPR2019-00546, Paper 10 (Patent Owner’s Preliminary Response) at, e.g., 21-
`22, 44-48.
`Further, Plaintiff is not entitled to a priority date of March 29, 2004 at least
`because the Provisional Application fails to disclose or provide support for the
`following limitations which recite specific dimensions of the implant, as claimed by the
`’334 patent: “wherein said implant has a longitudinal length greater than 40 mm
`extending from a proximal end of said proximal wall to a distal end of said distal wall”
`as recited in claim 1, “at least a portion of the central region defining a maximum lateral
`width” as recited in claim 1, “wherein said longitudinal length is at least two and half
`-8-
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`
`DEFENDANTS’ FINAL 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 D
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`times greater than said maximum lateral width” as recited in claim 1, “a longitudinal
`aperture length extending generally parallel to the longitudional length of said implant,
`and a lateral aperture width extending between said first sidewall to said second
`sidewall, wherein the longitudinal aperture lenth is greater than the lateral aperture
`width” as recited in claim 1, and “wherein said maximum lateral width of said implant
`is approximately 18 mm” as recited in claim 18. Plaintiff asserts that the following
`portions of the Provisional Application provide support for the priority date for these
`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;
`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.
`13, ll. 1, 8-9, 11-20; p. 14, 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 Supplemental Response to Interrogatory No. 9 (2020-09-18).)
`Plaintiff is wrong. The Provisional Application only describes an implant for lumbar
`fusion “having a length ranging from 9 and 18 mm, a height ranging between 8 and 16
`
`mm, and a width ranging between 25 and 45 mm” (Provisional Application at 4:18-21,
`11:12-14) and an implant for cervical fusion “having a length of about 11 mm, a height
`ranging between 5 and 12 mm, and a width about 14 mm.” (Provisional Application at
`4:21-5:2.) Thus, the Provisional Application contains no description of an implant
`having a longitudinal length longer than its maximum lateral width or a longitudinal
`length longer than 40 mm. The geometry claimed by these claim limitations of claim 1
`and claim 18 was first added on March 29, 2005 as part of non-provisional U.S. Patent
`Application No. 11/093,409, which has the same specification as the ’334 patent and to
`which the ’334 patent claims priority. Importantly, the specification of the ’334 patent
`(as a result of the additions to non-provisional U.S. Patent Application No. 11/093,409)
`includes myriad disclosures which are not included in the Provisional Application, of
`which the following disclose the dimensions of the implant: 2:17-25, 5:15-19, 11:48-
`12:11, and Figs. 18-23. A highlighted copy of the ’334 patent showing the changes
`from the Provisional Application is attached hereto as Exhibit B. For instance, the ’334
`patent provides: “For lumbar fusion, the spinal fusion implant of the present invention
`-9-
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`DEFENDANTS’ FINAL 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 D
`PAGE 85
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`may be dimensioned, by way of example only, having a width ranging between 9 and
`18 mm, a height ranging between 8 and 16 mm, and a length ranging between 25 and
`45 mm. For cervical fusion, the spinal fusion implant of the present invention may be
`dimensioned, by way of example only, having a width about 11 mm, a height ranging
`between 5 and 12 mm, and a length about 14 mm.” ’334 patent at 2:17-25. These
`disclosures were expressly added on March 29, 2005 because the Provisional
`Application did not provide support for the claimed invention. Indeed, if the Provisional
`Application provided sufficient disclosure, Plaintiff would not have needed to file such
`a substantively different non-provisional application.
`III. PRIOR PUBLIC USE AND ON-SALE BAR UNDER 35 U.S.C. § 102(B)
`The Asserted Claims of the Implant Patents are subject to the public use and on-
`sale bars under 35 U.S.C. § 102(b). The Asserted Claims of the Implant Patents 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 or on sale in this country more than one year prior
`to the date of the application for patent in the United States. For at least the reasons
`explained above, Plaintiff has not met its burden to show that the Implant Patents are
`entitled to a priority date as early as March 29, 2004, which is the filing date of U.S.
`Provisional Application No. 60/557,536. Assuming that the Implant Patents are only
`entitled to a priority date as early as March 29, 2005, which is the filing date of non-
`provisional U.S. Patent Application No. 11/093,409, each of the devices discussed
`below embody the Asserted Claims of the Implant Patents and were sold, offered for
`sale, used, offered for use, demonstrated, disclosed, or displayed by Plaintiff more than
`one year prior to March 29, 2005. Therefore, for at least the reasons described below,
`the Implant Patents are subject to the public use and on-sale bars.
`Plaintiff admits that the CoRoent XL implants embody the Implant Patents. See
`NuVasive’s Fourth Supplemental Responses to Defendants’ Interrogatory Nos. 3 and
`13 (Implant Phase) dated October 10, 2020 at 23-24. Plaintiff also admits that at least
`some of its Cement Restrictors embody the Implant Patents. See 2020-10-06 Email
`-10-
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`DEFENDANTS’ FINAL 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 D
`PAGE 86
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`

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`from Tanner to Nisbet. Documents produced by Plaintiff indicate that Plaintiff’s
`Cement Restrictors having the identical structure as Plaintiff’s CoRoent XL implants
`were sold, offered for sale, used, offered for use, demonstrated, disclosed, or displayed
`by Plaintiff before March 29, 2004. See, e.g., NUVA_ATEC0341176
`
`; NUVA_ATEC0341177
`;
`NUVA_ATEC0341168
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`;
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`;
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`;
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`; NUVA_ATEC0016561-67
`;
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`; NUVA_ATEC0115139
`; NUVA_ATEC0016575; NUVA_ATEC0016212;
`-11-
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`NUVA_ATEC0340880–943
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`NUVA_ATEC0340872–874
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`NUVA_ATEC0341066
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`; NUVA_ATEC0340867
`
`DEFENDANTS’ FINAL INVALIDITY CONTENTIONS
`FOR U.S. PATENT NOS. 8,361,156 AND 8,187,334
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`; NUVA_ATEC0341153
`; NUVA_ATEC0341358
`
`NUVA_ATEC0341175
`NUVA_ATEC0341182-83
`NUVA_ATEC0340866
`NUVA_ATEC0332451
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`; NUVA_ATEC0341059
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`; NUVA_ATEC0341048
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`; NUVA_ATEC0341055
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`EXHIBIT D
`PAGE 87
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`

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` See, e.g., NUVA_ATEC0337885-89; NUVA_ATEC0337894-95;
`NUVA_ATEC0337880-84; NUVA_ATEC0337874-76; NUVA_ATEC0337868-69;
`NUVA_ATEC0337890-93; NUVA_ATEC0337877-79; NUVA_ATEC0337922-27;
`NUVA_ATEC0337896-98; NUVA_ATEC0337928-50; NUVA_ATEC0337899-903;
`NUVA_ATEC0337870-73; NUVA_ATEC0337904-21; NUVA_ATEC0338025-28;
`NUVA_ATEC0338073-74; NUVA_ATEC0338072.
`
`
` See, e.g., NUVA_ATEC0338205-208; NUVA_ATEC0338337-42;
`
`NUVA_ATEC0338346; NUVA_ATEC0338326-29; NUVA_ATEC0338323-25;
`NUVA_ATEC0338321-22; NUVA_ATEC0338330-33; NUVA_ATEC0338334-36;
`NUVA_ATEC0338352-56; NUVA_ATEC0338343-45; NUVA_ATEC0338376-400;
`
`NUVA_ATEC0338347-51; NUVA_ATEC0338357-75; NUVA_ATEC0338287-88;
`NUVA_ATEC0338290-91; NUVA_ATEC0338279-82; NUVA_ATEC0338311-20;
`NUVA_ATEC0338292-94.
`Further, publicly available documents indicate that PEEK Cement Restrictors
`were being used by surgeons as they became commercially available. See, e.g.,
`ATEC_LLIF000965979-6309 (NuVasive, Inc., Registration Statement Under the
`Securities Act of 1933 (Form S-1) (Mar. 5, 2004)); ATEC_LLIF000966310-506 at 326
`(NuVasive, Inc., Amendment No. 2 to Registration Statement Under the Securities Act
`of 1933 (Form S-1) (Apr. 26, 2004)) (“[s]pecifically, we have been informed that our
`PEEK product is being used by some surgeons as a synthetic allograft”);
`ATEC_LLIF000966507-719 at 523 (NuVasive, Inc., Amendment No. 3 to Registration
`Statement Under the Securities Act of 1933 (Form S-1) (May 4, 2004));
`NUVA_ATEC0342156 (NuVasive website advertising CoRoent platform (Feb. 8,
`2004)). In April 2004, the Cement Restrictor XL was renamed CoRoent XL, which
`embody the Implant Patents according to NuVasive’s Fourth Supplemental Responses
`-12-
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`NUVA_ATEC0016173.
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`DEFENDANTS’ FINAL 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
`
`EXHIBIT D
`PAGE 88
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`

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`Case 3:18-cv-00347-CAB-MDD Document 296-6 Filed 11/25/20 PageID.26797 Pag