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`NUVASIVE 1032
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00208
`
`
`
`NUVASIVE 1032
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00208
`
`
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`|, Patrick Miles of San Diego, California, declare that:
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`1.
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`I am currently President of Global Products and Services at NuVasive, Inc., in
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`San Diego, California.
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`l have worked at NuVasive since January of 2001. Prior to my
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`current position, I 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, I worked for ORATEC from 1999
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`through 2001. ORATEC is a medical device company outside the spinal field. Prior to that,
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`from 1996 through April 1999, I worked at Sofamor Danek (which was acquired by
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`Medtronic in 1998, becoming Medtronic Sotamor 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, I have been involved at varying levels with
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`the research, development, and marketing of NuVasive's XLIF (eXtreme Lateral Interbody
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`Fusion) system and procedure.
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`I started working on the XLIF products and systems in
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`2001.
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`I 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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`I have been involved in the
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`commercialization and development of XLIF and its associated products since its launch.
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`I
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`am currently listed as an inventor on 51 issued US. patents assigned to NuVasive, many of
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`which are related to NuVasive’s XLIF solution.
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` 2
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`4.
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`I 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 US. Patent No.
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`8,251 ,997 to Dr. Gary Michelson (the “’997 patent"), specifically matter numbers lPR2013~
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`00208 and IPR2013~00208 in connection with providing my rebuttal testimony, I have
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`reviewed the following documents:
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`. U.S. Patent No. 8,251,997 to Michelson (Exhibit 1002).
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`.
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`In the inter partes review proceeding lPR2013-00208:
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`o Warsaw's Patent Owner Response (especially pages 55-60);
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`0 Ex. 2038, Declaration of Barton L. Sachs (especially 1111138139);
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`.
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`In the inter partes review proceeding lPR2013-00206:
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`oWarsaw's Patent Owner Response (especially pages 5580);
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`0 Ex. 2038, Declaration of Barton L. Sachs (especially 111(138-139).
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`. Additional exhibits cited below.
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`5.
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`My testimony, explained below, is based on my education and experience in
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`the spinaE orthopedics field, including my work experience at Sofamor Danek (and later
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`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 involvement in certain events.
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`8.
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`On page 57 of the Patent Owner Response, Warsaw states 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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`2
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`NuVasive's XLlF solution, including its family of CoRoent XL fusion implants for use in XLiF,
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`have enjoyed commercial success in the spinal orthopedics market place, and in fact
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`created the market for lateral fusion products.
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`It is my opinion that XLIF's success is due to
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`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 were initially 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
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`into 2004.
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`Initially, NuVasive‘s XLIF solution was met with substantiai skepticism within the
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`spinal orthopedics community. During those early years, we put substantial resources into
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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 success led to
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`competitors in the marketplace, the first of those being iVledtronic Sofamor Danek with its
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`“DLlF” surgical technique and equipment in the 2006/2007 timeframe. See Medtronic DLlF
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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 approach is "Innovative”l. NuVasive currently has a
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`patent infringement lawsuit pending in US. District Court against Medtronic, accusing its
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`DLlF system of infringing 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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`3
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`developed by NuVasive. Those other companies include, among others, Globus Medical,
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`Inc. with its Lateral Lumbar lnterbody Fusion (“LLIF”) solution introduced in the 2010
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`timeframe. See id. NuVasive also has a patent infringement lawsuit pending in US. District
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`Court against Globus Medical because Globus’ LLlF 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.e., “trans—psoas") using tools and techniques that
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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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`number of 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 back to at least the 19803, was limited 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 prior lateral techniques failed to achieve any level of success in the
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`marketplace.
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`9.
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`Some key factors to XLIF's success include: (A) a surgical finger-sweep and
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`finger guidance technique to help create a safe passage through the retroperitoneal space
`and deliver surgical instruments safely to the spine (see, e.g., U.S. Patent No. I7,905,840,
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`Exhibit 1059); (B) a minimally disruptive access system with integrated nerve monitoring
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`capabitities designed to gradually dilate a path to the spine through the highly innervated
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`psoas muscle (see, e.g., US. 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 surgical site with the ability to customize the operative corridor (see, e.g., US. 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 removal of
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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 my review, the ‘997 patent does not claim or even
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`mention any of these features.
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`10.
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`NuVasive expended substantial capital and human resources in developing
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`its innovations and in the commercialization of XLIF.
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`I estimate that about $20—30lVl was
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`expended by NuVasive on the initial development of NuVasive's XLlF solution from the
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`middle of 2001 to the Fall of 2004. Since that time, NuVasive has continued its
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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 feedback is
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`overwhelmingly positive," and concluding that NuVasive‘s technology is “much more
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`5
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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. 1 (crediting NuVasive with the development of the
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`procedure); Ehrhardt, Birmingham Medical News (Ex. 1052) (noting that a lateral procedure
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`was difficult to reproduce in the 1990’s until the “breakthrough” XLIF equipment in 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 “iargely avoided in the past" before XLIF made the 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" and that the approach is “lnnovative");
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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 lnterbody 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 of reliable, 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 use in lateral procedures, called the
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`CoRoent XL family of implants, have generally flat upper and lower surfaces designed to
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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 impiants illustrated in Dr. Michelso-n’s ‘997 patent based on my
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`review. For example, a drawing of one version of the CoRoent Xi. implants from
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`NuVasive’s US. Patent No. 8,187,334 (Exhibit 1085) (left) is compared with a drawing from
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`Dr. Michetson’s preferred cylindrical lumbar cage impiant of the ‘997 patent (Exhibit 1002,
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`nghU.
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`NuVasive CoRoent Implant
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`Michelson ‘997 Implants
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`13.
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`I 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
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`knowledge of those competitive systems, all of them include at least the nerve monitoring
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`capability that NuVasive pioneered to traverse the innervated psoas muscle, as well as
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`stimulated sequential dilation, split-blade retractors, and implants designed for lateral
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`insertion. See Dr. Sachs Decl. at 11 138 (listing lateral fusion solutions from Globus Medical,
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`Synthes, DuPuy and Stryker).
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`14.
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`I have reviewed pages 59-60 of Warsaw’s Patent Owner Response, and I
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`disagree with the statement there that Mr. Valentine, Mr. Lukianov, and | engaged in
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`“copying of claimed technology by a competitor.” We did no such thing. The XLIF-retated
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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 wereinvolved with or had access to
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`at Sofamor Danek in the 19905. I had no personal knowledge of Dr. Michelson’s lateral
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`solution or any patent filings on that, when I was working at Sofamor Danek. Moreover, I
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`am aware from my involvement in the litigation 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‘s lateral 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, l 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's reference on page 60 of its Patent Owner Response to
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`Sofamor Danek‘s “ELIF" project for which I was responsible is misleading. The “ELIF“
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`project at Sofamor Danek fell under my oversight responsibility. As such, I 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 I was involved with the
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`project at Sofamor Danek. I 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 lnterbody Fusion." That is simply not true. ELlF was a failed
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`project, in part, because the data showed that the access corridor was not predictable and
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`there was a danger of potentially tearing the vena cava blood vessel (one of the body’s
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`great vessels).
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`16.
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`I personally came up with the name ”eXtreme Lateral lnterbody Fusion" and
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`the "XLlF" acronym for that name after 1 came to NuVasive, and came up wtth that name
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`and acronym with no knowledge of ELlF ever having been an acronym for "Extreme Lateral
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`lnterbody Fusion."
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`17.
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`l hereby declare that all 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 that willful 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 lssued thereon.
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`Dated: March 10, 2014
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`By: NW
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`Patrick Miles
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`10
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`10
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