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`NUVASIVE 1032
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
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`NUVASIVE - EXHIBIT 2002
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
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`|, Patrick Miles of San Diego, California, declare that:
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`1,
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`| am currently President of Global Products and Services at NuVasive,Inc., in
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`San Diego, California.
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`| have worked at NuVasive since January of 2001. Prior to my
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`currentposition, | served as President of the Americas from January 2010 to October 2011,
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`Executive Vice President of Product Marketing and Development from January 2007 to
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`December 2009, Senior Vice President of Marketing from December 2004 to January 2007,
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`and Vice President of Marketing from January 2001 to December 2004.
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`2,
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`Prior to starting with NuVasive in 2001, | worked for ORATEC from 1999
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`through 2001. ORATECis a medical device company outside the spinalfield. Prior to that,
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`from 1996 through April 1999, | worked at Sofamor Danek (which was acquired by
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`Medtronic in 1998, becoming Medtronic Sofamor Danek) as Director of Marketing for
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`Minimally Invasive Systems and Cervical Spine Systems.
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`3.
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`Throughout my time at NuVasive, | have beeninvolved at varying levels with
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`the research, development, and marketing of NuVasive’s XLIF (eXtreme LateralInterbody
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`Fusion) system and procedure,
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`| started working on the XLIF products and systemsin
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`2001.
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`| was involved with the launch of the XLIF procedure and products at the North
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`American Spine Society (‘NASS”) meeting in 2003.
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`| have beeninvolvedin the
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`commercialization and development of XLIF andits associated products since its launch.
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`|
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`am currentlylisted as an inventor on 51 issued U.S,patents assigned to NuVasive, many of
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`which are related to NuVasive’s XLIF solution.
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`4,
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`| submit this declaration to correct certain facts and positions stated by
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`Warsaw Orthopedics in Patent Office proceedings related to the validity of U.S. Patent No.
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`8,251,997 to Dr. Gary Michelson (the 997 patent’), specifically matter numbers IPR2013-
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`00208 and IPR2013-00206. In connection with providing my rebuttal testimony, | have
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`reviewed the following documents:
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`e U.S, Patent No. 8,251,997 to Michelson (Exhibit 1002).
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`e
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`In the inter partes review proceeding IPR2013-00208:
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`o Warsaw's Patent Owner Response (especially pages 55-60);
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`o Ex. 2038, Declaration of Barton L. Sachs (especially ]136-139);
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`e
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`In the infer partes review proceeding IPR2013-00206:
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`oWarsaw's Patent Owner Response(especially pages 55-60):
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`o Ex. 2038, Declaration of Barton L. Sachs (especially J]136-139).
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`e Additional exhibits cited below.
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`5.
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`My testimony, explained below,is based on my education and experiencein
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`the spinal orthopedicsfield, including my work experience at Sofamor Danek(andlater
`Medtronic Sofamor Danek} from 1996 to 1999 and at NuVasive from 2001 to present, my in
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`depth experience with NuVasive's XLIF solution and the competitive landscape, and my
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`personal knowledge and involvementin certain events.
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`6,
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`On page 57 of the Patent Owner Response, Warsawstates that "[t]he
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`success of these embodying products is due to the patent features of the ‘997 patent."
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`NuVasive's XLIF solution, including its family of CoRoent XL fusion implants for use in XLIF,
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`have enjoyed commercial successin the spinal orthopedics marketplace, andin fact
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`created the marketforlateral fusion products.
`It is my opinion that XLIF’s successis due to
`NuVasive's own proprietary innovation and its extensive efforts to commercialize XLIF.
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`7.
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`The development of the XLIF solution at NuVasive began in 2001. The XLIF
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`systems and procedure wereinitially released at the North American Spine Society Annual
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`Meeting in late 2003. Our commercialization efforts continued after the 2003 NASS meeting
`into 2004.
`Initially, NuVasive’s XLIF solution was met with substantial skepticism within the
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`spinal orthopedics community. During those early years, we put substantial resourcesinto
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`training the spinal community to overcome that skepticism and show the spinal community
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`that the XLIF solution was indeed a safe and effective solution for spinal fusion especially in
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`the lower lumbar region. We have continued to improve the XLIF solution, specifically
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`expanding its usability to treat a wider array of spinal issues. Eventually, our successled to
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`competitors in the marketplace,the first of those being Medtronic Sofamor Danekwithits
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`“DLIF”surgical technique and equipmentin the 2006/2007 timeframe. See Medtronic DLIF
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`Marketing Plan (Ex. 1053}, p. 8 (Medtronic’s own document admitting that “NuVasive
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`pioneered the approach” and that the approachis “Innovative”). NuVasive currently has a
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`patentinfringement lawsuit pending in U.S. District Court against Medtronic, accusing its
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`DLIF system ofinfringing NuVasive patents. Additional competitors have also entered the
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`market with lateral fusion solutions that incorporate many of the important innovations
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`developed by NuVasive. Those other companiesinclude, among others, Globus Medical,
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`Inc. with its Lateral Lumbar Interbody Fusion (“LLIF”) solution introduced in the 2010
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`timeframe. See id. NuVasivealso has a patent infringement lawsuit pending in U.S. District
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`Court against Globus Medical because Globus’ LLIF solution also infringes NuVasive
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`patents.
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`8,
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`The success of NuVasive’s XLIF procedure and system is due, in part, to the
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`fact that our XLIF solution provides a safe and reproducible minimally disruptive lateral
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`access path through the psoas muscle(i.¢., “trans-psoas”) using tools and techniquesthat
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`minimize tissue trauma, reduce blood loss, and allow direct visualization and customization
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`of the operative corridor during lumbar spinal fusion procedures. XLIF allows a greater
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`numberof spine surgeons with varying skills and experience to perform a lateral approach
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`to the lumbar spine through the highly innervated psoas muscle. Prior to XLIF, the lateral
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`approach, which dates backto at least the 1980s, waslimited to a handful of highly skilled
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`surgeons performing techniques that were quickly abandoned because they provided mixed
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`results. Those priorlateral techniques failed to achieve any level of success in the
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`marketplace.
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`9,
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`somekey factors to XLIF’s successinclude: (A) a surgical finger-sweep and
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`finger guidancetechniqueto help create a safe passage through the retroperitoneal space
`and deliver surgical instruments safely to the spine (see, e.g., U.S. Patent No. 7,905,840,
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`Exhibit 1059); (B) a minimally disruptive access system with integrated nerve monitoring
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`capabilities designed to gradually dilate a path to the spine through the highly innervated
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`psoas muscle (see, e.g., U.S. Patent No. 8,000,535, 8,000,782 and D652,922, Exhibits
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`1061, 1062, 1064); (C) a bladed retractor system to aid in the direct visualization of the
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`spinal surgicalsite with the ability to customize the operative corridor(see, e.g., U.S. Patent
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`No. 8,192,356 and 8,016,767, Exhibits 1063 and 1070); and (D) a patented fusion implant
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`design that, unlike the implants disclosed in the ‘997 patent, does not require the removalof
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`portions of the adjacent vertebrae (see, e.g., U.S. Patent Nos. 8,187,334 and 8,361,156,
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`Exhibits 1065 and 1066). Based on myreview,the ‘997 patent does not claim or even
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`mention any of these features.
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`10.|NuVasive expended substantial capital and human resourcesin developing
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`its innovations and in the commercialization of XLIF.
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`| estimate that about $20-30M was
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`expended by NuVasive ontheinitial developmentof NuVasive's XLIF solution from the
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`middle of 2001 to the Fall of 2004. Since that time, NuVasive has continuedits
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`development work related to the XLIF solution and has continued to expend considerable
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`resources in connection with that.
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`11.
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`NuVasive's pioneering XLIF systems and procedure have enjoyed wide
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`acceptance from the spine surgeon community and praise from those in that community.
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`See Thompson Weisel Partners, Bending the Paradigm (Ex. 1051), p. 12 (crediting
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`NuVasive with “Pioneering” the MIS fusion market, noting that “Surgeon feedbackis
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`overwhelmingly positive,” and concluding that NuVasive's technology is “much more
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`physician friendly and useful than previous offerings from larger competitors, such as
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`Medtronic); A New Solution (Ex. 2051), p.
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`1 (crediting NuVasive with the developmentof the
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`procedure}; Ehrhardt, Birmingham Medical News (Ex. 1052) (noting that a lateral procedure
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`wasdifficult to reproduce in the 1990's until the “breakthrough” XLIF equipmentin 2004);
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`Thomas Weisel Partners - Bending the Paradigm (Ex. 1051), p. 58 (explaining that the
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`extreme lateral approach was “largely avoided in the past” before XLIF madethe path
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`viable); Medtronic DLIF Marketing Plan (Ex. 1053), p. 8 (Medtronic’s own document
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`admitting that “NuVasive pioneered the approach” andthat the approachis “Innovative’);
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`Rodgers, Experience and Early Results with a Minimally Invasive Technique for Anterior
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`Column Support Through eXtreme Lateral interbody Fusion (Ex. 1054), p. 28, 32 (stating
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`"XLIF technology is revolutionizing the care of patients” and that “It is impossible to
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`overemphasize the importance ofreliable, timely monitoring of the neural elements as the
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`surgeon traverses the psoas.”).
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`12.
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` NuVasive's implants designed for usein lateral procedures, called the
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`CoRoent XL family of implants, have generally flat upper and lower surfaces designedto
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`bear against the adjacent vertebrae without requiring bony portions of the adjacent
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`vertebrae to be cut/drilled and removed.
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`In this manner, NuVasive’s CoRoent implants are
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`significantly unlike the implantsillustrated in Dr. Michelson’s °997 patent based on my
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`review. For example, a drawing of oneversion of the CoRoent XL implants from
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`NuVasive’s U.S. Patent No. 8,187,334 (Exhibit 1065)(left) is compared with a drawing from
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`Dr. Michelson’s preferred cylindrical lumbar cage implant of the ‘997 patent (Exhibit 1002,
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`right).
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`NuVasive CoRoentImplant Michelson ‘997 Implants
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`13.
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`| am also aware that other spine medical device companies have launched
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`lateral access solutions in an effort to compete with NuVasive’s XLIF. Based on my
`knowledge of those competitive systems, all of them include at least the nerve monitoring
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`capability that NuVasive pioneeredto traverse the innervated psoas muscle, as well as
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`stimulated sequential dilation, split-blade retractors, and implants designedforlateral
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`insertion. See Dr. Sachs Decl. at J 138 (listing lateral fusion solutions from Globus Medical,
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`Synthes, DuPuy and Stryker).
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`14.__| have reviewed pages 59-60 of Warsaw's Patent Owner Response, and|
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`disagree with the statementthere that Mr. Valentine, Mr. Lukianov, and | engagedin
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`“copying of claimed technology by a competitor.” We did no such thing. The XLIF-related
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`equipment and procedures conceived and developed at NuVasive during the 2001-2004
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`timeframe are substantially different from anything we were involved with or had access to
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`at Sofamor Danekin the 1990s. | had no personal knowledge of Dr. Michelson’slateral
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`solution or any patentfilings on that, when | was working at Sofamor Danek. Moreover,|
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`am aware from my involvementin thelitigation between Medtronic and NuVasive, that
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`neither Dr. Michelson nor Mr. Lukionov remember a meeting where Mr. Lukionov saw Dr.
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`Michelson’slateral solution. Nuvasive’s XLIF solution was the result of the significant effort
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`and resources NuVasive invested into developing a lateral solution that was contrary to the
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`accepted wisdom at the time between 2001-2004, as discussed above. Finally, | understand
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`that the ‘997 patent was not even issued as a patent until 2012, almost a decade after we
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`released our XLIF solution to the market.
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`15.
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`In addition, Warsaw'sreference on page 60ofits Patent Owner Responseto
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`Sofamor Danek’s “ELIF” project for which | was responsible is misleading. The “ELIF”
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`project at Sofamor Danekfell under my oversight responsibility. As such, | have personal
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`knowledge that ELIF was an endoscopic procedure.
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`Indeed ELIF was an acronym for
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`“Endoscopic Lumbar Interbody Fusion” during the entire time that | was involved with the
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`project at Sofamor Danek.| never heard ELIF referred to as “Extreme Lateral interbody
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`Fusion” during that time.
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`It was only in connection with NuVasive's legal disputes with
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`Medtronic (which started in 2008) that| first heard the contention that ELIF supposedly
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`referred to “Extreme Lateral Interbody Fusion.” That is simply not true. ELIF was a failed
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`project, in part, because the data showed thatthe access corridor was notpredictable and
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`there was a dangerof potentially tearing the vena cava blood vessel (one of the body's
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`great vessels),
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`| personally came up with the name “eXtremeLateral interbody Fusion” and
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`the "XLIF” acronym for that nameafter | came to NuVasive, and came up with that name
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`and acronym with no knowledge of ELIF ever having been an acronym for “Extreme Lateral
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`Interbody Fusion.”
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`17,
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`| hereby declare thatall statements made herein of my own knowledge are
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`true and that all statements made on information and belief are believed to be true; and
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`further that these statements were made with the knowledge thatwillful false statements
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`and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of
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`the Title 18 of the United States Code and that such willful false statements may jeopardize
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`the validity of the application or any patents issued thereon.
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`Dated: March 10, 2014
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`<>
`By;
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`Patrick Miles
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`9g
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`10
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