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`PAUL D. TRIPODI II
`State Bar No. 162380
`ptripodi@wsgr.com
`Wilson Sonsini Goodrich & Rosati P.C.
`633 West Fifth Street, Suite 1550
`Los Angeles, CA 90071
`Telephone: 323-210-2900
`Fax: 866-974-7329
`NATALIE J. MORGAN
`State Bar No. 211143
`nmorgan@wsgr.com
`Wilson Sonsini Goodrich & Rosati P.C.
`12235 El Camino Real
`San Diego, CA 92130
`Telephone: 858-350-2300
`Fax: 858-350-2399
`WENDY L. DEVINE
`State Bar No. 246337
`wdevine@wsgr.com
`Wilson Sonsini Goodrich & Rosati P.C.
`One Market Plaza
`Spear Tower, Suite 3300
`San Francisco, California 94105-1126
`Telephone: 415-947-2000
`Fax: 415-947-2099
`Attorneys for Plaintiff NuVasive, Inc.
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`SAN DIEGO DIVISION
`
`CASE NO. 18-cv-0347-MDD-
`CAB
`MEMORANDUM OF POINTS
`AND AUTHORITIES IN
`SUPPORT OF MOTION FOR
`PRELIMINARY INJUNCTION
`Judge: Hon. Cathy Ann Bencivengo
`Courtroom: 4C
`Hearing Date: April 30, 2018
`JURY TRIAL DEMANDED
`REDACTED VERSION
`
`))))))))))))))))
`
`NUVASIVE, INC., a Delaware
`corporation,
` Plaintiff,
`v.
`ALPHATEC HOLDINGS, INC., a
`Delaware corporation, and ALPHATEC
`SPINE, INC., a California corporation,
` Defendants.
`
`MEMO ISO MOTION FOR
`PRELIMINARY INJUNCTION
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`TABLE OF CONTENTS
`
`I.
`II.
`
`V.
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`INTRODUCTION ........................................................................................... 1
`BACKGROUND ............................................................................................. 1
`A.
`NuVasive ............................................................................................... 1
`B.
`XLIF And The Asserted Patents ........................................................... 3
`C.
`Alphatec and Its Infringing Products .................................................... 4
`LEGAL STANDARDS ................................................................................... 6
`III.
`IV. ARGUMENT .................................................................................................. 7
`A.
`NuVasive is Likely to Succeed on the Merits ....................................... 7
`1.
`Alphatec Is Liable for Patent Infringement ................................ 7
`2.
`Assignor Estoppel Precludes Alphatec from Asserting an
`Invalidity Defense ..................................................................... 13
`Alphatec Cannot Raise a Substantial Question of Validity ...... 15
`3.
`Absent an Injunction, NuVasive will be Irreparably Harmed ............ 16
`1.
`Alphatec’s Infringement Will Imminently Cause
`NuVasive to Lose Customers, Market Share, and Business
`Opportunities ............................................................................ 17
`Alphatec’s Infringement Will Imminently Cause
`NuVasive to Lose Good Will and Harm its Reputation ........... 22
`Irreversible Price Erosion is Imminent ..................................... 23
`Alphatec’s Infringement is the Cause of NuVasive’s
`Irreparable Harm ....................................................................... 23
`The Balance of Hardships Favors NuVasive ...................................... 25
`C.
`The Public Interest Weighs in Favor of a Preliminary Injunction ...... 26
`D.
`CONCLUSION ............................................................................................. 26
`
`B.
`
`2.
`
`3.
`4.
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`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`ActiveVideo Networks, Inc. v. Verizon Commc’n, Inc., 694 F.3d 1312
`(Fed. Cir. 2012) ............................................................................................... 25
`Apple, Inc. v. Samsung Elecs. Co., 678 F.3d 1314 (Fed. Cir. 2012) ......................... 19
`Apple, Inc. v. Samsung Elecs. Co., 809 F.3d 633 (Fed. Cir. 2015) ............... 20, 23, 25
`Bio-Tech. Gen. Corp. v. Genentech, Inc., 80 F.3d 1553 (Fed. Cir. 1996) ................ 21
`Blackberry Ltd. v. Typo Prod. LLC, No. 14-cv-00023-WHO, 2014 WL
`1318689 (N.D. Cal. Mar. 28, 2014) ................................................................ 18
`CA, Inc. v. New Relic, Inc., No. CV 12-5468 (AKT), 2015 U.S. Dist.
`LEXIS 46438 (E.D.N.Y. Mar. 30, 2015) ........................................................ 14
`Carroll Touch, Inc. v. Electro Mech. Sys., Inc., 15 F.3d 1573 (Fed. Cir.
`1993) ................................................................................................................ 14
`Celsis in Vitro, Inc. v. CellzDirect, Inc., 664 F.3d 922 (Fed. Cir. 2012) ............ 16, 24
`Douglas Dynamics, LLC v. Buyers Prods. Co., 717 F.3d 1336 (Fed.
`Cir. 2013) ................................................................................................... 16, 22
`Eisai Co., Ltd. v. Teva Pharms. USA, Inc., Nos. 05-5727(HAAS)(ES),
`07-5489(HAAS)(ES), 2008 WL 1722098 (D.N.J. Mar. 28, 2008) ................ 25
`Hybritech, Inc. v. Abbott Labs., 849 F.2d 1446 (Fed. Cir. 1988) .............................. 24
`In re NuVasive, Inc., 842 F.3d 1376 (Fed. Cir. 2016) ........................................... 1, 15
`Intel Corp. v. United States Int’l Trade Comm’n, 946 F.2d 821 (Fed.
`Cir. 1991) ......................................................................................................... 14
`Interconnect Planning Corp. v. Feil, 774 F.2d 1132 (Fed. Cir. 1985) ...................... 16
`Limelight Networks, Inc. v. Akamai Tech., Inc., 134 S. Ct. 2111 (2014) .................... 7
`M-I LLC v. FPUSA, LLC, No. SA:15-CV-406-DAE, 2015 WL
`6738823 (W.D. Tex. Nov. 4, 2015) ................................................................ 20
`Mag Aerospace Indus. v. B/E Aerospace, Inc., 816 F.3d 1374 (Fed. Cir.
`2016) .......................................................................................................... 13, 14
`Mentor Graphics Corp. v. EVE-USA, Inc., 870 F.3d 1298 (Fed. Cir.
`2017) ................................................................................................................ 13
`Mentor Graphics Corp. v. Quickturn Design Sys., Inc., 150 F.3d 1374
`(Fed. Cir. 1998) ............................................................................................... 13
`
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`Metalcraft of Mayville, Inc. v. Toro Co., 848 F.3d 1358 (Fed. Cir.
`2017) ................................................................................................................ 18
`Minnesota Mining & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294 (Fed.
`Cir. 2002) ........................................................................................................... 7
`Mylan Institutional LLC v. Aurobindo Pharma Ltd., 857 F.3d 858 (Fed.
`Cir. 2017) ......................................................................................................... 23
`Oakley, Inc. v. Sunglass Hut Int’l, 316 F.3d 1331 (Fed. Cir. 2003) ...................... 7, 14
`PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558 (Fed. Cir.
`1996) ................................................................................................................ 24
`Pfizer, Inc. v. Teva Pharms. USA, Inc., 429 F.3d 1364 (Fed. Cir. 2005) .................. 24
`Purdue Pharma L.P. v. Boehringer Ingelheim GmbH, 237 F.3d 1359
`(Fed. Cir. 2001) ......................................................................................... 15, 22
`Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368 (Fed. Cir. 2006) .............. 16, 21, 24
`Shamrock Tech., Inc. v. Med. Sterilization, Inc., 903 F.2d 789 (Fed. Cir.
`1990) .......................................................................................................... 13, 14
`Tinnus Enters., LLC v. Telebrands Corp., 846 F.3d 1190 (Fed. Cir.
`2017) ................................................................................................................ 22
`Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372 (Fed. Cir.
`2009) ................................................................................................................ 15
`Tivo Inc. v. EchoStar Commc’n Corp., 446 F. Supp. 2d 664 (E.D. Tex.
`2006), rev’d in part on other grounds, 516 F.3d 1290 (Fed. Cir.
`2008) ................................................................................................................ 18
`Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7 (2008) ..................................... 6
`STATUTES
`35 U.S.C. §271 ............................................................................................................. 7
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`NuVasive
`
`Alphatec
`
`XLIF
`
`Link Decl.
`
`Youssef Decl.
`
`Ex. __
`
`Inglish Decl.
`
`’801 patent
`’780 patent
`’832 patent
`’227 patent
`’270 patent
`’156 patent
`Miles patents
`PTAB
`’801 Patent Reexam
`Battalion system
`Battalion spacer
`Squadron
`
`TABLE OF ABBREVIATIONS
`
`NuVasive, Inc.
`Alphatec Holdings, Inc. and Alphatec Spine, Inc.
`(collectively)
`eXtreme Lateral Interbody Fusion
`Declaration of Matthew Link filed simultaneously
`herewith
`Declaration of Jim A. Youssef, M.D. filed
`simultaneously herewith
`Exhibits attached to the Declaration of Wendy L.
`Devine filed simultaneously herewith
`Declaration of Blake Inglish filed simultaneously
`herewith
`U.S. Patent No. 7,819,801
`U.S. Patent No. 8,355,780
`U.S. Patent No. 8,439,832
`U.S. Patent No. 9,833,227
`U.S. Patent No. 8,753,270
`U.S. Patent No. 8,361,156
`The ’801, ’780, ’832, ’227 and ’270 patents
`Patent Trial and Appeal Board
`Reexamination No. 95/001,889
`Battalion™ Lateral System
`Battalion™ Lateral Spacer
`Squadron™ Lateral Retractor
`
`** All internal quotations omitted and citation omitted unless otherwise noted.
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`I.
`
`INTRODUCTION
`NuVasive’s proprietary, minimally-invasive lateral surgery system (known as
`“XLIF”) represents more than a billion-dollar, decade-long investment. NuVasive
`has invested not only in developing and commercializing the XLIF system itself, but
`also in training, developing, and maintaining close relationships with spinal surgeons
`who perform XLIF procedures, the distributors who maintain and provide the
`necessary equipment, and in relationships with hospitals where XLIF procedures
`take place. To protect its sizable investment, NuVasive sought and received over
`100 patents, including the specific patents that are asserted in this case.
`Alphatec, on the other hand, failed miserably for years in its own attempt to
`develop a lateral offering known as GLIF. After abandoning GLIF in 2013,
`Alphatec was desperate for an entrée into the lateral market and decided to blatantly
`copy NuVasive’s patented XLIF system and components. Alphatec began to roll out
`its new “Battalion” system in phases beginning in April 2017 to lackluster interest.
`After its full launch in the Fall of 2017, Alphatec began to marry its infringing
`Battalion system with concentrated, escalating efforts to steal away NuVasive’s
`employees, distributors, and surgeon relationships, in an effort to directly
`misappropriate the market that NuVasive developed for XLIF. Most recently, on
`March 8, 2018, Alphatec announced that it has acquired a neuromonitoring solution
`to complete its offering of the three fundamental aspects of NuVasive’s intellectual
`property – access equipment, specialized implants, and neuromonitoring.
`Accordingly, NuVasive brings this preliminary injunction motion to prevent
`Alphatec from inflicting imminent irreparable harm to NuVasive and XLIF.
`II.
`BACKGROUND
`A.
`NuVasive
`NuVasive was founded in 1997 as a small startup company, operating out of
`the garage of its co-founder, and focused on the development of surgical treatments
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`for degenerative disc disease in the spine. Link Decl., Ex. 1 at ¶ 10; Doc. No. 1-2 at
`7. Today, NuVasive is a public company with over $1 billion in annual revenues,
`offering a comprehensive and cutting-edge spinal product portfolio that benefits
`patients across the country and around the globe. Link Decl. at ¶ 6.
`NuVasive’s transformation began in 2001, when it began development of a
`procedural offering now known as XLIF. Doc. No. 1-2 at 7. Prior to XLIF,
`treatments for patients with chronic lower back pain due to diseased or damaged
`spinal discs required large, open surgical approaches to the spine with substantial
`downsides, such as significant blood loss, pain, long hospital stays, and high risk of
`serious complications. Link Decl. at ¶¶ 7-8. These complex procedures were also
`expensive. Id. at ¶ 8. NuVasive recognized this market need and, after investing
`years and tens of millions of dollars in research and development, launched its
`minimally-invasive, lateral access solution—XLIF— in 2003. Id. at ¶¶ 10-11. In
`contrast to traditional procedures, XLIF utilized specialized access equipment
`combined with neuromonitoring to create a minimally-invasive lateral approach
`through the nerve-rich psoas muscle and to deliver a large, oversized implant for
`spinal fusion. Id. at ¶¶ 12-18.
`The XLIF procedure was groundbreaking. First, contrary to conventional
`wisdom, XLIF was able to provide a lateral approach through the psoas despite the
`high risk of serious neurological injury. Link Decl. ¶ 18; Youssef Decl. ¶ 35.
`Second, unlike traditional approaches that involved non-standardized and difficult-
`to-use instrumentation, XLIF’s elegant simplicity made the procedure accessible to
`surgeons of all skill levels. Youssef Decl. ¶ 38.
`XLIF’s 2003 launch was met with skepticism. Link Decl. ¶¶ 19-21. But
`NuVasive persisted, investing heavily for years to demonstrate to surgeons and
`hospitals the safety, efficacy, reproducibility, and superiority of XLIF. Id. at ¶ 22.
`NuVasive’s efforts included intensive surgeon training and outreach, development
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`of a sales force with exhaustive knowledge of XLIF products and procedures, and
`collecting and publishing clinical data that demonstrated the overall superiority of
`XLIF. Id. at ¶¶ 23-28. From 1999 to 2017, NuVasive invested about $1 billion to
`continuously develop, implement, and commercialize XLIF. Id. at ¶ 29.
`Over time, NuVasive’s efforts paid off. Physicians and patients began
`experiencing first-hand and then extolling the clear benefits of XLIF, and thousands
`of XLIF surgeries are now performed each year. Link Decl. ¶¶ 30-32; Youssef
`Decl. ¶¶ 41-42. Ultimately, despite the early skepticism, NuVasive’s proprietary
`XLIF platform created an entirely new, minimally-invasive lateral spinal fusion
`market conservatively worth $250-300 million annually. Link Decl. ¶ 33.
`B.
`XLIF And The Asserted Patents
`To protect its investment in developing this new, lateral market, NuVasive
`made a practice of securing patents covering its groundbreaking solution and many
`improvements developed since XLIF’s introduction in 2003. As set forth below
`and as practiced by NuVasive (Youssef Decl. ¶ 55), the asserted patents in this
`matter are directed to key elements of XLIF that allow for safe and reproducible
`lateral, trans-psoas spinal surgery.
`The Access Platform Patents. The ’801, ’780, ’832, ’227 and ’270 patents are
`directed to systems and methods for accessing a targeted disc space through a lateral,
`trans-psoas path. Youssef Decl. ¶¶ 80-81. The patents describe sequentially
`inserting access tools (such as dilators) along the lateral, trans-psoas path to create a
`distraction corridor. These tools are equipped with stimulation electrodes that output
`electrical stimulation so that the surgeon can monitor nerves while traversing the
`psoas muscle. A three-bladed retractor assembly is then inserted over the exterior of
`the outermost dilator. The three blades then expand to create an operative corridor
`of sufficient size to allow a spinal implant to pass through and into the targeted
`spinal disc space. The intradiscal shim has a proximal portion with a ridge structure
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`that allows it to attach to a groove on the retractor blade and a distal extension with a
`tapered tip region adapted to penetrate the disc space. By penetrating the disc space,
`the shim anchors and stabilizes the retractor blades while in the operating corridor.
`The Implant Patent. The ’156 patent describes a spinal implant that is
`introduced into the disc space of a patient’s spine from a lateral approach. Youssef
`Decl. ¶ 315. The spinal implant described may be a range of shapes and sizes, but
`the longitudinal length must be greater than the maximum lateral width. The spinal
`implant contains anti-migration elements along with two radiopaque markers
`oriented parallel to the height of the implant and proximate the medial plane.
`C.
`Alphatec and Its Infringing Products
`Although Alphatec’s existence pre-dates the launch of XLIF, it was not until
`five years after NuVasive pioneered lateral, trans-psoas surgery that Alphatec
`attempted to develop its own lateral product line, a dramatic failure known as GLIF.
`Doc. No. 1-26 at 9. GLIF differed significantly from XLIF, never gained any
`traction in the market, and was last mentioned publicly in 2013. Youssef Decl. ¶57.
`Following the failure of GLIF, Alphatec began extensive, escalating efforts
`to find a way to enter the lateral market. Ex. B. Based on public reports,
`Alphatec’s first concrete action to that end was its April 2017 release of an initial
`line of implant products known as the “Battalion” system. Doc. No. 1-31 at 2-3.1
`By May 2017, Alphatec rolled out a limited user release of the Battalion system.
`Ex. C. In October 2017, Alphatec introduced a more comprehensive offering that
`combined its Battalion implants with specialized access equipment, such as dilators
`and the Squadron retractor. Doc. No. 1-38 at 5-8. As demonstrated in NuVasive’s
`Complaint and discussed below, it is now clear that Alphatec has carefully and
`
`1 NuVasive’s Complaint details Alphatec’s infringing Battalion Lateral System.
`Doc. No. 1 at ¶¶ 57-112.
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`systematically schemed not only to copy XLIF, but to use its infringing lateral
`platform specifically to harm NuVasive.
`Starting in September 2017 and continuing to today, Alphatec has taken
`continuous, escalating, and highly-public actions to inflict substantial and
`permanent harm on NuVasive. Alphatec’s first public and concrete action was an
`announcement in September 2017 to its shareholders that it was undergoing a
`significant “rebranding” effort. Link Decl., Ex. 23 (Sept. 2017 Presentation).
`Alphatec stated its new focus was on recruiting talent away from its competitors in
`order to support its “vital few” initiatives, which specifically included expanding
`its market share in the lateral surgery field with its Battalion system. Id. Since
`then, Alphatec has continuously and systematically looted key NuVasive
`executives and employees who have served for years in NuVasive’s XLIF research
`efforts and as the company’s interface with XLIF surgeons and the lateral market,
`including Pat Miles (inventor of many NuVasive patents relating to XLIF and the
`face of XLIF to the spinal surgical community), Quentin Blackford (NuVasive’s
`former CFO who has intimate familiarity with XLIF pricing and strategy, and
`current Alphatec board member), Matthew Curran (inventor of many aspects of
`XLIF products), Elizabeth Lukianov (NuVasive’s former Senior Associate
`Product Manager and daughter of NuVasive’s former long-time CEO Alex
`Lukianov), and Kelli Howell (one of NuVasive’ earliest employees involved in the
`clinical development, validation and acceptance of XLIF), as well as NuVasive
`sales personnel with deep ties to XLIF surgeons. Link Decl. ¶¶ 43-45, 47, 64.
`Alphatec has specifically promoted these individuals’ experience at NuVasive as
`the impetus for “new, transformational leadership.” Ex. D at 10-11.
`Alphatec is increasingly using these NuVasive personnel in an intensifying
`effort to target and convert XLIF surgeons to its calculatedly infringing lateral
`offering. Not only has Mr. Miles admitted to such activities, but NuVasive has
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`independently learned that beginning in late-2017 Alphatec’s ex-NuVasive
`employees have been aggressively soliciting XLIF surgeons, distributors, and
`hospital customers to switch to Alphatec’s infringing Battalion system. Link Decl.
`¶¶ 51-61. The targeted surgeons, for example, were responsible for about $23
`million in XLIF revenue from 2013 to 2018, and many serve as mentors who train
`other surgeons to perform XLIF surgery. Id. at ¶¶ 53-60.
`Just over two weeks ago, Alphatec publicly announced plans to complete its
`copycat offering through the purchase of neuromonitoring technology to pair with
`its infringing lateral access equipment and implants and its hiring of former
`NuVasive researcher James Gharib (a named inventor on several NuVasive
`patents) to implement these efforts. Link Decl. ¶ 62; see also Ex. D at 13-18
`(touting recent acquisition of neuromonitoring company). This final step in
`development of Alphatec’s platform is especially significant, because
`neuromonitoring greatly enhances Alphatec’s competitive posture in attempting to
`convert NuVasive’s customers to Alphatec’s infringing Battalion system. Link
`Decl. ¶ 62. Alphatec also announced that Dr. Luiz Pimenta, considered by many to
`be the father of XLIF and who has been an ambassador for NuVasive since the very
`beginning, is now its Chief Medical Officer. Link Decl., Exs. 25, 26 (Mar. 8, 2017
`Press Release and Earnings Call); Link Decl. ¶ 63. As a result of these most recent
`announcements, construction of Alphatec’s infringing platform appears to be
`nearing completion and is, therefore, a “much more meaningful and credible threat”
`to NuVasive’s XLIF business. Link Decl. ¶ 62.
`III. LEGAL STANDARDS
`“A plaintiff seeking a preliminary injunction must establish that he is likely
`to succeed on the merits, that he is likely to suffer irreparable harm in the absence
`of preliminary relief, that the balance of equities tips in his favor, and that an
`injunction is in the public interest.” Winter v. Natural Res. Def. Council, Inc., 555
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`U.S. 7, 20 (2008).
`IV. ARGUMENT
`All four factors strongly favor granting preliminary relief.
`A.
`NuVasive is Likely to Succeed on the Merits
`NuVasive is likely to succeed on the merits at trial because, as established
`below, Alphatec directly and indirectly infringes several claims of the asserted
`patents, and cannot raise a meritorious question regarding the validity or
`enforceability of those claims. See Oakley, Inc. v. Sunglass Hut Int’l, 316 F.3d
`1331, 1339-40 (Fed. Cir. 2003).
`1.
`Alphatec Is Liable for Patent Infringement
`Direct infringement. Alphatec has, and continues to, make, use, offer to sell,
`sell, and import the infringing Battalion system—all of which are acts of direct
`infringement of several claims of the ’801, ’780, ’832, ’270, and ’156 patents. 35
`U.S.C. §271; see also Youssef Decl. ¶¶ 79-205, 285-366. Alphatec also has, and
`continues to, perform each of the steps of several method claims of the ’832 and
`’227 patents, which constitutes additional acts of direct infringement. Limelight
`Networks, Inc. v. Akamai Tech., Inc., 134 S. Ct. 2111, 2117 (2014).
`Induced infringement. Surgeons using the Battalion system according to
`Alphatec’s instructions directly infringe several method claims of the ’227 and ’832
`patents. See Youssef Decl. ¶¶ 206-284. The Alphatec Surgical Guide provides
`instructions on use of the Battalion system, which is specifically designed to
`perform lateral, trans-psoas procedures (Youssef Decl. ¶ 58), and Alphatec conducts
`surgeon training courses to instruct surgeons on how to perform the claimed
`methods. Ex. G at 6. That Alphatec’s Surgical Guide so closely mimics
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`NuVasive’s Surgical Guides, combined with Alphatec’s knowledge of the patents, 2
`evidences Alphatec’s specific intent for surgeons to perform the claimed method
`steps using the Battalion system, and thereby infringe. Thus, Alphatec is liable for
`induced infringement. Minnesota Mining & Mfg. Co. v. Chemque, Inc., 303 F.3d
`1294, 1304-05 (Fed. Cir. 2002).
`a.
`The ʼ801, ʼ780, ’832,’227 and ’270 patents
`Alphatec’s Battalion system infringes claims 1, 2, 6, 15, 16, 19, 20, 23, 26,
`28 and 29 of the ʼ801 patent, claims 21, 22, 24-26 and 28 of the ʼ780 patent, claims
`1, 2, 4, 6-9, 12-14, 17 and 19 of the ’832 patent, claims 1, 2, 6, 13, 15, 17, 22 and 28
`of the ’227 patent and claims 1-4, 6, and 12 of the ’270 patent
`Dilators. Alphatec offers an Initial Dilator and a Secondary Dilator to
`distract the tissue along a lateral, trans-psoas path. Youssef Decl. ¶¶
`88, 135, 176, 208, 242, 258 (’801, [1B]; ’780, [21B]; ’832, [1B],
`[12B]; ’227, [1B], [16B]). The Secondary Dilator has a width that is
`larger than the Initial Dilator so that it can advance over the Initial
`Dilator. Id. at ¶¶ 135, 176, 208, 242, 268 (’780, [21B]; ’832, [1B],
`[12B]; ’227 [1B], [16B]). Both Dilators are advanced from one lateral
`side of the patient and negotiate past the nerves of the psoas muscle.
`Id. at ¶¶ 245, 270 (’227, [1C], [16C]). Both Dilators are equipped
`with stimulation electrodes at their distal ends, being angled to the
`longitudinal axis of the dilator, to deliver electrical stimulation for nerve
`monitoring along the lateral, trans-psoas path. Id. at ¶¶ 109, 111, 136, 176, 210,
`229, 248, 262, 272 (’801, [6A], [15A]; ’780, [21B]; ’832, [1B], [12B], [19A]; ’227,
`[1D], [13A], [16C]). Using neuromonitoring, surgeons advance the Dilators to
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`2 As alleged in the Complaint, at all relevant times, Alphatec had knowledge of
`the ’227 and ’832 patents. Doc. No. 1 at ¶¶263-271, 346-352. Alphatec has failed
`to respond to the Complaint to confirm or deny these allegations.
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`avoid damage to the psoas muscle nerves. Id. at ¶¶ 254, 272 (’227, [1D], [16C]).
`Retractor. Alphatec’s Squadron has three blades, the Left Blade, Right Blade
`and Posterior Blade, which are rigidly coupled and generally perpendicular to the
`body of the Retractor prior to introduction of the Retractor toward the targeted
`spinal site. Id. at ¶¶ 96, 97, 138, 142, 179, 186 (’801, [1D]; ’780,
`[21C], [21D]; ’832, [1C], [1E], [12E]). Each of the Blades
`curves towards the interior in a spherical shape such that they
`have a generally concave inner surface and are configured to
`make contact with the adjacent two blades in a closed/first
`position. Id. at ¶¶ 96, 165, 198 (’801, [1D]; ’780, [28A]; ’832,
`[7A]). The Posterior Blade contains a groove along its inner
`surface to attach the Intradiscal Shim. Id. at ¶115 (’801, [19A]). The Right and
`Left Blades are configured to receive a Light Cable to direct light through the
`operative corridor toward the targeted spinal disc. Youssef Decl. ¶ 201 (’832 [8A]).
`When the Left Blade, Right Blade and Posterior Blade are in a closed/first position,
`the Squadron slides over the exterior of the Secondary Dilator along the lateral,
`trans-psoas path. Id. at ¶¶104, 139, 145, 186, 214, 251, 254, 264, 274 (’801, [1F];
`’780, [21C], [21E]; ’832, [1E], [12E]; ’227, [1E], [1F], [15A], [16E]).
`Thereafter, the Left, Right and Posterior Blades can be expanded to a second
`position in order to form and maintain an operative corridor of
`sufficient size to pass an implant through the operative corridor and
`toward the target disc space. Id. at ¶¶ 105, 125, 145, 155, 190, 219,
`221, 254, 274 (’801, [1F], [29A]; ’780, [21E], [21H]; ’832, [1F],
`[12F], [13A]; ’227, [1F], [16D]). In particular, the Posterior Blade
`moves linearly relative to the Left and Right Blades in response to
`the manual rotation of a knob element on the Squadron. Id. at ¶¶ 93,
`148, 159, 256, 276 (’801, [1C];’780, [21F], [24A]; ’227, [2A], [17A]). In one
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`configuration, the Posterior Blade is stationary while the Right and Left Blades may
`move, and in another configuration, the Right and Left Blades remain stationary
`while the Posterior Blade moves. Id. at ¶¶ 93, 104, 192, 223, 256 (’801, [1C]; ’832,
`[2A], [14A]; ’227, [2A], [6A], [17A], [22A]). In addition, the Left and Right
`Blades can be moved in the cranial or caudal direction either independently or
`simultaneously or by increasing their Blade toe. Id. at ¶¶ 92, 119, 152, 163 (’801,
`[1C], [23A]; ’780, [21G], [26A]; ’227, [6A], [22A]). Prior to pivoting, each of the
`Blades is maintained generally parallel to one another. Id. at ¶ 196 (’832, [6A]).
`Intradiscal Shim. Alphatec’s Intradiscal
`Shim contains a proximal portion with a ridge
`that engages with the groove of the Posterior
`Blade to allow the Intradiscal Shim to
`penetrate into a disc space at a targeted spinal site and stabilize the Posterior Blade.
`Youssef Decl. ¶¶ 100, 101, 161, 290, 294 (’801, [1E], [20A]; ’780, [25A]; ’270,
`[1A], [1B]). The maximum longitudinal length of the Intradiscal Shim extends
`parallel to the Intradiscal Shim from its proximal-most end of the proximal portion
`to the distal-most end of the distal extension and has a length less than the
`maximum longitudinal