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`EXHIBIT F
`TO DASHE DECLARATION
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`

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`Case 3:18-cv-00347-CAB-MDD Document 296-8 Filed 11/25/20 PageID.26828 Page 2 of 25
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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’ 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
`
`
`
`EXHIBIT F
`PAGE 118
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`DEFENDANTS’ 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.
`GENERAL STATEMENT AND RESERVATION OF RIGHTS
`I.
`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
`amend or supplement these contentions or any charts appended hereto, including
`
`-2-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT F
`PAGE 119
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`

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`pursuant to the Court’s Case Management Orders (Doc. Nos. 101 and 109). Further,
`additional prior art not included in these Amended Invalidity Contentions and/or facts,
`documents, and things whether known or unknown to Defendants may become relevant
`to Defendants’ defenses. Accordingly, Defendants reserve their right to revise,
`supplement, or amend these Amended Invalidity Contentions as additional grounds or
`evidence of invalidity are identified in this case, in response to any of Plaintiff’s
`arguments, following the Court’s issuance of a Markman ruling, and/or to address any
`additional patents or claims that are asserted hereafter. Defendants also reserve their
`right to identify references that would disclose, practice, or render obvious any
`limitation(s) Plaintiff alleges are missing from the prior art in these Amended Invalidity
`Contentions.
`Defendants’ disclosures with respect to each prior art reference identified herein
`should not be considered exhaustive. This approach does not preclude Defendants from
`relying on any non-cited portion of the identified prior art references. Because the prior
`art to Plaintiff’s patents is so prolific as to its disclosure of minimally invasive tools and
`implants to perform lateral spinal fusion surgery, failure to describe any prior art
`reference as disclosing any particular limitation is not an admission that such reference
`does not disclose such limitation. Additionally, disclosure of a particular prior art
`reference that refers, relies upon, or discusses other material is also a disclosure of the
`other material.
`Defendants take no position here regarding the appropriate construction of any
`claim term, if any. Statements purporting to describe claim limitations or apply prior
`art to claim limitations are not to be taken as admissions that such terms are definite or
`comply with 35 U.S.C. §§ 101 and 112. Defendants maintain that Plaintiff’s
`Infringement Contentions are insufficient to show infringement of any asserted claim
`under any claim construction. These Amended 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.
`
`-3-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT F
`PAGE 120
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`Defendants object to the disclosure of information and/or documents that are
`protected by the attorney-client privilege, attorney work-product doctrine, or any other
`applicable privilege or immunity. Defendants reserve the right to object to the
`admissibility of these Amended Invalidity Contentions or the information contained
`herein.
`IDENTIFICATION OF PRIOR ART
`II.
`A. Priority Date
`1. Priority Date of the ’801 Patent
`In its Infringement Contentions, Plaintiff contends that the ’801 patent is entitled
`to a priority date at least as early as February 27, 2003, which is the filing date of U.S.
`Provisional Application No. 60/450,806. Plaintiff bears the burden of proving, on a
`claim-by-claim basis, that the provisional application provides written description
`support for each and every limitation of the asserted claims. Plaintiff has not met this
`burden. Plaintiff has similarly failed to meet its burden of showing it is entitled to any
`other priority date earlier than the date of filing. Further, Plaintiff is not entitled to a
`priority date of February 27, 2003, at least because the Provisional Application fails to
`disclose or provide support for the following, as claimed by the ’801 patent: retractor
`blades with “generally concave inner-facing surface[s];” “pivoting” or “pivotable” arm
`members” with “pivot[ing]” movements. Defendants reserve their right to rebut or
`further challenge any priority date argument advanced by Plaintiff, or rely on additional
`prior art references.
`2. Priority Date of the ’780 Patent
`In its Infringement Contentions, Plaintiff contends that the ’780 patent is entitled
`to a priority date at least as early as September 25, 2003, which is the filing date of U.S.
`Provisional Application No. 60/506,136. Plaintiff bears the burden of proving, on a
`claim-by-claim basis, that the provisional application provides written description
`support for each and every limitation of the asserted claims. Plaintiff has not met this
`burden. Plaintiff has similarly failed to meet its burden of showing it is entitled to any
`
`-4-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT F
`PAGE 121
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`

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`other priority date earlier than the date of filing. Further, Plaintiff is not entitled to a
`priority date of September 25, 2003, at least because the Provisional Application fails
`to disclose or provide support for the following, as claimed by the ’780 patent:
`“pivoting” movement of the “pivotable arm members;” first, second, and third retractor
`blades “adjacent” to one another in the closed position; “blade holder assembly;” and
`“elongate member.” Defendants reserve their right to rebut or further challenge any
`priority date argument advanced by Plaintiff, or rely on additional prior art references.
`3. Priority Date of the ’832 Patent
`In its Infringement Contentions, Plaintiff contends that the ’832 patent is entitled
`to a priority date at least as early as January 16, 2003, which is the filing date of U.S.
`Provisional Application No. 60/440,905. Plaintiff bears the burden of proving, on a
`claim-by-claim basis, that the provisional application provides written description
`support for each and every limitation of the asserted claims. Plaintiff has not met this
`burden. Plaintiff has similarly failed to meet its burden of showing it is entitled to any
`other priority date earlier than the date of filing. Further, Plaintiff is not entitled to a
`priority date of January 16, 2003, at least because the Provisional Application fails to
`disclose or provide support for the following, as claimed by the ’832 patent: an
`“elongate inner element;” “fixation element;” and dilators having a “distal end being
`angled relative to a longitudinal axis of said dilator such that said stimulation electrode
`is angled relative to said longitudinal axis. Defendants reserve their right to rebut or
`further challenge any priority date argument advanced by Plaintiff, or rely on additional
`prior art references.
`4. Priority Date of the ’227 Patent
`In its Infringement Contentions, Plaintiff contends that the ’227 patent is entitled
`to a priority date at least as early as June 26, 2002, which is the filing date of U.S.
`Provisional Application No. 60/392,214. 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
`
`-5-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT F
`PAGE 122
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`burden. Plaintiff has similarly failed to meet its burden of showing it is entitled to any
`other priority date earlier than the date of filing. Further, Plaintiff is not entitled to a
`priority date of June 26, 2002, at least because the Provisional Application fails to
`disclose or provide support for the following, as claimed by the ’227 patent:
`“electrically stimulating, using a stimulation electrode along a distal region of a dilator
`of the plurality of dilators, the nerves of the psoas muscle for monitoring a nerve
`response, and advancing the dilator along the lateral, trans-psoas path, based on the
`monitoring, to avoid directly contacting the nerves of the psoas muscle” and
`“electrically stimulating, using a stimulation electrode along a distal region of the first
`dilator or the second dilator, the nerves of the psoas muscle for monitoring a nerve
`response and advancing the first dilator or the second dilator, based on the monitoring,
`along the lateral, trans-psoas path to avoid impairment of the nerves of the psoas
`muscle.” Defendants reserve their right to rebut or further challenge any priority date
`argument advanced by Plaintiff, or rely on additional prior art references.
`5. Priority Date of the ’270 Patent
`In its Infringement Contentions, Plaintiff contends that the ’270 patent is entitled
`to a priority date at least as early as January 16, 2004, which is the filing date of U.S.
`Application No. 10/759,811. Plaintiff bears the burden of proving, on a claim-by-claim
`basis, that the earlier application provides written description support for each and every
`limitation of the asserted claims. Plaintiff has not met this burden. Plaintiff has
`similarly failed to meet its burden of showing it is entitled to any other priority date
`earlier than the date of filing. Further, Plaintiff is not entitled to a priority date of
`January 16, 2004, at least because the Application fails to disclose or provide support
`for the following, as claimed by the ’270 patent: a “corresponding groove along an
`interior face” of the retractor blade; and a “longitudinal slot extending through the
`proximal portion in a direction generally parallel to the longitudinal axis.” Defendants
`reserve their right to rebut or further challenge any priority date argument advanced by
`Plaintiff, or rely on additional prior art references.
`
`-6-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT F
`PAGE 123
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`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
`• U.S. Patent No. 6,074,343 (“Nathanson”), issued June 13, 2000
`• U.S. Patent No. 5,728,046 (“Mayer”), issued March 17, 1998
`
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`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 F
`PAGE 124
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`• U.S. Patent No. 6,689,398 (“Obenchain ’398”), issued March 22, 2005
`• U.S. Patent No. 5,893,831 (“Koros ’831”), issued April 13, 1999
`• Leu et al., Percutaneous Fusion of the Lumbar Spine, Spine Vol. 6, No. 3, pp.
`593-604 (September 1992) (“Leu”), published September 1992
`• U.S. Patent No. 7,074,226 (“Roehm”), issued July 11, 2006
`• U.S. Patent No. 5,171,279 (“Mathews ’279”), issued December 15, 1992
`• U.S. Patent No. 5,792,044 (“Foley ’044”), issued August 11, 1998
`• European Spine Journal, The use of a retractor system (SynFrame) for open,
`minimal invasive reconstruction of the anterior column of the thoracic and
`lumbar spine, Thomas Kossmann et al. (“Kossmann”), published September 5,
`2001
`• U.S. Patent No. 5,313,962 (“Obenchain”), issued May 24, 1994
`• WO 01/37728 (“Kelleher”), published May 31, 2001
`• WO 03/005887 (“Blewett”), published January 23, 2003
`• Spine, Persistently Electrified Pedicle Stimulation Instruments in Spinal
`Instrumentation, Robert Rose et al. (“Rose”), published February 1, 1997
`• U.S. Patent No. 5,284,153 (“Raymond ’153”), issued February 8, 1994; U.S.
`Patent No. 5,284,154 (“Raymond ’154”), issued February 8, 1994 (collectively,
`“Raymond”)
`• U.S. Patent No. 5,474,558 (“Neubardt”), issued December 12, 1995
`• WO 00/66217 (“Epstein”), issued November 9, 2000
`• U.S. Patent No. 6,892,087 (“Osypka”), issued May 10, 2005
`• U.S. Patent No. 6,626,905 (“Schmiel”), issued September 30, 2003
`• U.S. Patent No. 5,772,661 (“Michelson ’661”), issued June 30, 1998
`• U.S. Patent No. 6,368,351 (“Glenn”), issued April 9, 2002
`• U.S. Patent No. 6,206,826 (“Mathews ’826”), issued March 27, 2001
`• U.S. Patent Application Publication No. 2002/0022847 (“Ray”), published
`February 21, 2002
`• U.S. Patent No. 6,500,180 (“Foley”), issued December 31, 2002
`• U.S. Patent No. 6,174,311 (“Branch ’311”), issued January 16, 2001
`• U.S. Patent No. 6,042,582 (“Ray ’582”), issued March 28, 2000
`• U.S. Patent No. 6,159,214 (“Michelson ’214”), issued December 12, 2000
`
`-8-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT F
`PAGE 125
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`• U.S. Patent No. 5,797,909 (“Michelson ’909”), issued August 25, 1998
`• U.S. Patent No. 6,139,493 (“Koros ’493”), issued October 31, 2000
`• U.S. Patent Publication No. 2003/0149341 (“Clifton”), published August 7, 2003
`• U.S. Patent No. 6,083,154 (“Liu”), issued July 4, 2000
`• U.S. Patent No. 6,929,606 (“Ritland”), issued August 16, 2005
`• U.S. Patent No. 5,458,599 (“Adobbati”), issued October 17, 1995
`• U.S. Patent No. 6,051,007 (“Hogendijk”), issued April 18, 2000
`• U.S. Patent No. 6,389,766 (“Branch ’766”), issued June 4, 2002
`• U.S. Patent No. 5,137,521 (“Wilkins”), issued August 11, 1992
`• U.S. Patent No. 5,147,316 (“Castillenti”), issued September 5, 1992
`• U.S. Patent No. 6,059,790 (“Sand”), issued May 9, 2000
`• U.S. Patent No. 6,152,871 (“Foley ’871”), issued November 28, 2000
`• U.S. Patent No. 5,507,076 (“Anscher”), issued April 16, 1996
`• U.S. Patent No. 5,836,053 (“Davignon”), issued November 17, 1998
`• U.S. Patent. No. 6,279,203 (“Hundley”), issued August 28, 2001
`• U.S. Patent No. 4,644,613 (“Kedzierski”), issued February 24, 1987
`• U.S. Patent No. 5,035,232 (“Lutze”), issued July 30, 1991
`• U.S. Patent No. 4,872,734 (“Rechberg”), issued October 10, 1989
`• U.S. Patent No. 5,491,915 (“Robinson”), issued February 20, 1996
`• U.S. Patent No. 5,397,046 (“Savage”), issued March 14, 1995
`• U.S. Patent No. 6,080,105 (“Spears”), issued June 27, 2000
`• U.S. Patent No. 3,811,455 (“Thur”), issued May 21, 1974
`• EP No. 1033103 (“Kittelmann”), issued September 10, 2003
`• U.S. Patent No. 5,803,904 (“Mehdizadeh ’904”), issued September 8, 1998
`• U.S. Patent No. 6,030,390 (“Mehdizadeh ’390”), issued September 8, 1998
`• Synthes Spine, Vertebral Spacer – PR (“SVS-PR”), published 2002
`• Medtronic Sofamor Danek, Telamon – VERTE-STACK™ PEEK Vertebral
`Body Spacer (“Telamon Brochure”), published 2003; Medtronic Sofamor Danek,
`
`-9-
`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 F
`PAGE 126
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`Telamon® Posterior Impacted Fusion Devices (“Telamon Guide”), published
`2003 (collectively, “Telamon”)
`• U.S. Patent Application Publication No. 2002/016550 (“Frey”), published
`November 7, 2002
`• Boomerang™ Verte-Stack™ PEEK Vertebral Body Spacer, launched in 2003
`• U.S. Patent No. 5,860,973 (“Michelson ’973”), issued January 19, 1999
`• U.S. Patent No. 5,484,437 (“Michelson ’437”), issued January 16, 1996
`• U.S. Application Publication No. 2003/0028249 (“Baccelli”), published
`February 6, 2003
`• U.S. Patent No. 5,192,327 (“Brantigan”), issued March 9, 1993; commercial
`embodiment was developed in the 1990s
`• U.S. Patent No. 5,396,364 (“Kozak”), issued March 14, 1995
`• Berry et al., A Morphometric Study of Human Lumbar and Selected Thoracic
`Vertebrae, 12 Spine, 4, pp. 362-367 (1987) (“Berry”)
`
`Defendants incorporate herein the Declaration of Dr. Sachs in Support of
`Defendants’ Opposition to Plaintiff’s Motion for Preliminary Injunction (Doc. No. 49-
`5) and the exhibits thereto (Doc. Nos. 49-6 – 49-71). Defendants also reserve their right
`to incorporate herein the arguments and prior art identified with respect to the asserted
`and/or related patents in prior district court litigation and PTAB proceedings.
`III. Obviousness-Type Double Patenting
`As shown by Exhibits 1-6 attached hereto and for the reasons described in brief
`below, one or more asserted claims of the asserted patents are invalid for obviousness-
`type double patenting.
`One or more asserted claims of the ’801 patent are rendered invalid for
`obviousness-type double patenting by at least the following references: U.S. Patent
`Nos. 7,691,057; 8,114,019; 8,403,841; 8,355,780; 9,622,732; 8,753,270; 9,820,729;
`and/or 8,708,899.
`One or more asserted claims of the ’780 patent are rendered invalid for
`obviousness-type double patenting by at least the following references: U.S. Patent
`Nos. 7,892,173; 8,403,841; 8,133,173; and/or 8,945,004.
`
`-10-
`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 F
`PAGE 127
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`One or more asserted claims of the ’832 patent are rendered invalid for
`obviousness-type double patenting by at least the following references: U.S. Patent
`Nos. 8,403,841; 7,892,173; 8,182,423; 9,974,531; 8,696,559; 8,747,307; and/or
`7,935,051.
`One or more asserted claims of the ’227 patent are rendered invalid for
`obviousness-type double patenting by at least the following references: U.S. Patent
`Nos. 8,768,450; 8,548,579; 7,722,613; and/or 8,708,899.
`One or more asserted claims of the ’270 patent are rendered invalid for
`obviousness-type double patenting by at least the following references: U.S. Patent
`Nos. 9,820,729; and/or 8,182,423.
`One or more asserted claims of the ’156 patent are rendered invalid for
`obviousness-type double patenting by at least the following references: U.S. Patent
`Nos. 8,187,334; 8,246,686; and/or 9,474,627.
`INVALIDITY UNDER 35 U.S.C. § 102
`IV.
`A. The Asserted Claims of the Asserted Patents Are Invalid under 35
`U.S.C. § 102(f)
`The asserted claims of the Asserted Patents are invalid under § 102(f), which
`states that a person shall not be entitled to a patent if “he did not himself invent the
`subject matter sought to be patented.” Between 1998 and 2003, Dr. Luiz Pimenta
`operated on 85 patients using his minimally invasive 90-degree lateral-decubitus Lateral
`Endoscopic Transpsoatic Retroperitoneal Approach (LETRA) prior to designing the
`device components, including access instruments and implants, later claimed by
`NuVasive. Dr. Pimenta’s early work was described in detail in numerous publications,
`including, but not limited to, The Lateral Endoscopic Transpsoatic Retroperitoneal
`Approach (LETRA): A New Technique for Accessing the Lumbar Spine, L. Pimenta
`(published March 17, 2004).
`Other inventors include the inventors and/or authors of the prior art references
`listed above, and the circumstances of invention are as described in those references
`
`-11-
`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 F
`PAGE 128
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`and/or identified in the claim charts accompanying these Amended Invalidity
`Contentions.
`B. The Asserted Claims of the ’227 and ’270 Patents Are Invalid under 35
`U.S.C. § 102
`One or more of the asserted claims of the ’227 patent are anticipated, at least as
`set forth in the claim charts attached herewith as Appendix D. The alleged invention,
`including the use of instruments such as a plurality of dilators equipped with
`neuromonitoring and a retractor with a plurality of retractor blades for minimally
`invasive lateral, trans-psoas surgery, was disclosed by at least Friedman. In particular,
`Friedman discloses that Dr. Jacobson had performed over 200 procedures using a lateral
`percutaneous approach as of 1985, using tools such as a nasal-type speculum, a 40
`French chest tube, and a trocar. Friedman at 1. Further, Friedman notes that Dr.
`Jacobson recommended the use of a nerve stimulator in conjunction with his technique.
`Friedman at 2. Dr. Jacobson’s procedures are also described in Percutaneous
`to Chemonucleolysis?, published
`in 1983, and
`Discectomy: An Alternative
`Percutaneous Discectomy: An Anatomical Study, published in 1985. Additionally, the
`direct lateral method, and instruments used in conjunction with that method, were the
`subject of Dr. Jacobson’s patent, issued in 1985. See Jacobson. Because Friedman—as
`well as the several other references disclosing Dr. Jacobson’s procedures from the early
`to mid-1980s—makes clear that the ’227 patent’s named inventors did not invent the
`claimed subject matter, one or more of the asserted claims of the ’227 patent are invalid
`as anticipated.
`Further, NuVasive is judicially estopped from arguing that the Jacobson
`technique (as discussed, for example, in Friedman) is, e.g., unacceptably dangerous
`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
`
`-12-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`
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`EXHIBIT F
`PAGE 129
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`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
`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
`
`-13-
`DEFENDANT ALPHATEC HOLDINGS, INC.’S AMENDED INVALIDITY CONTENTIONS
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`EXHIBIT F
`PAGE 130
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`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