Case 3:18-cv-00347-CAB-MDD Document 1 Filed 02/13/18 PageID.1 Page 1 of 126
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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
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`NUVASIVE, INC., a Delaware
`corporation,
`
` Plaintiff,
`
`v.
`
`ALPHATEC HOLDINGS, INC., a
`Delaware corporation and ALPHATEC
`SPINE, INC., a California corporation,
`
` Defendants.
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`
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`
`
`CASE NO. ___________
`
`COMPLAINT FOR PATENT
`INFRINGEMENT
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`JURY TRIAL DEMANDED
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`PATENT INFRINGEMENT COMPLAINT
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`'18
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`CV0347
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`BLM
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`GPC
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`Plaintiff NuVasive, Inc. (“NuVasive”) hereby files this Complaint against
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`Defendants Alphatec Holdings, Inc. and Alphatec Spine, Inc. (collectively,
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`“Alphatec” or “Defendants”) for Alphatec’s infringement of NuVasive’s U.S.
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`Patent No. 7,819,801; U.S. Patent No. 8,355,780; U.S. Patent No. 8,439,832; U.S.
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`Patent No. 9,833,227; U.S. Patent No. 8,753,270; U.S. Patent No. 8,361,156; U.S.
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`Design Patent No. D750,252; and U.S. Design Patent No. D652,519 (collectively,
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`“the NuVasive Patents”). On personal knowledge as to NuVasive’s own actions
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`and on information and belief as to the actions of others, NuVasive alleges as
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`follows:
`I.
`THE PARTIES
`1.
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`Plaintiff NuVasive is a Delaware corporation with its principal place
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`of business at 7475 Lusk Boulevard, San Diego, California 92121.
`2.
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`On information and belief, Defendant Alphatec Holdings, Inc. is a
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`Delaware corporation with its principal place of business at 5818 El Camino Real,
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`Carlsbad, California 92008.
`3.
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`On information and belief, Defendant Alphatec Spine, Inc. is a
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`California corporation with its principal place of business at 5818 El Camino Real,
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`Carlsbad, California 92008.
`4.
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`On information and belief, Defendant Alphatec Spine, Inc. operates as
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`a wholly-owned subsidiary of Defendant Alphatec Holdings, Inc.
`II.
`JURISDICTION AND VENUE
`5.
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`This Complaint arises under the patent laws of the United States, Title
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`35 of the United States Code. This Court has subject matter jurisdiction over this
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`action under 35 U.S.C. § 271 et seq., 28 U.S.C. §§ 1331 and 1338(a).
`6.
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`The Court has personal jurisdiction over Defendants because each
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`Defendant transacts substantial business in the State of California, directly or
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`through intermediaries, regularly does or solicits business in California, has
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`committed acts in California giving rise to the causes of action alleged in this
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`PATENT INFRINGEMENT COMPLAINT
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`Complaint, maintains continuous and systematic contacts in California,
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`purposefully avails itself of the privileges of doing business in California, and/or
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`derives substantial revenue from goods and services provided to individuals in
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`California. In addition, each Defendant is registered to do business in the State of
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`California and maintains an agent for service of process in California.
`7.
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`Venue is proper in this judicial district pursuant to 28 U.S.C.
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`§ 1400(b) because each Defendant: (1) resides in this District, and/or (2) has
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`committed acts of infringement and has a regular and established place of business
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`in this District.
`III. FACTUAL BACKGROUND
`A. NuVasive—The Pioneer Of Minimally Invasive Spine Surgery
`And Lateral Interbody Fusion Procedures
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`8.
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`NuVasive, founded in 1997, is a leading medical device company
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`focused on minimally disruptive surgical products and procedurally integrated
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`solutions for the spine. NuVasive pioneered the market for minimally invasive
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`spine surgery and lateral interbody fusion procedures. NuVasive has established
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`itself as the market leader, and has a built a reputation as an innovator, of lateral
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`spinal fusion technologies.
`9.
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`Spinal fusion surgery, at a basic level, is used to “fuse” two adjacent
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`vertebrae of the spine together so that they heal into a single, solid bone. It is
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`commonly performed to correct chronic back pain caused by diseased or damaged
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`intervertebral discs. The procedure involves removing some, or all, of the diseased
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`or damaged disc and inserting a spinal implant in the resulting disc space. The
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`inserted implant restores height and induces bone growth between adjacent
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`vertebrae.
`10. NuVasive invented a spinal fusion procedure named the eXtreme
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`Lateral Interbody Fusion, or “XLIF.” Before XLIF, the surgical community
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`believed lateral approaches to the spine (i.e., approaching the spine from the side
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`of the patient) during spine surgeries, which required moving through the nerve-
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`rich psoas muscle, posed too high of a risk of nerve damage to be workable. That
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`changed, however, when NuVasive invented XLIF: the first spinal surgery using a
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`lateral, transpsoas approach to the spine.
`11. NuVasive invented not only the surgical methods, but also the first
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`devices for performing lateral spinal surgeries. These devices include access tools
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`which are used to create an operative corridor from the side of the patient to the
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`spine. These access tools are compatible with neuromonitoring, which NuVasive
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`also invented. The neuromonitoring compatible access tools allow a surgeon to
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`locate nerves while navigating a path to the spine. NuVasive also invented
`CoRoent® implants, which include implants specially designed for lateral insertion.
`In comparison to spinal fusion procedures using other approaches, XLIF offers a
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`number of benefits, including minimal disruption to the soft tissue, reduced
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`operative time, shorter postoperative recovery time and less time in the hospital,
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`lower complication rates, and smaller incision, among many more.
`12. From 2001-2004, NuVasive expended substantial capital (between
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`$20,000,000 and $30,000,000) and human resources in developing its innovations
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`and in the commercialization of XLIF. Ex. A (IPR2014-00075, July 8, 2014
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`Declaration of Patrick Miles) at ¶ 10.
`13. When XLIF was first introduced in 2003, it was met with substantial
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`skepticism from the majority of the spine surgeon community. Id. at ¶ 12.
`14. NuVasive put substantial resources into educating the spinal
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`community to overcome that skepticism and show that XLIF was indeed a safer
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`and more effective solution for spinal fusion, especially in the lower lumbar
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`region. Id. at ¶ 14.
`15. Through NuVasive’s education efforts, surgeons began adopting
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`XLIF into their practices at an ever-increasing rate, and saw improved patient
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`outcomes. NuVasive saw the sea-change in attitude in a variety of ways, including
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`through the growth of NuVasive’s business, through the interest at industry
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`meetings, through the number of surgeons contacting NuVasive for training on
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`XLIF over the years, and through publications regarding XLIF’s revolutionary
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`approach. Id. at ¶ 16.
`16. NuVasive created the commercial market for lateral fusion products.
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`Id. at ¶ 23. There was no lateral fusion market at the time of launch of the XLIF
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`procedure. It is a testament to the procedure (and the instruments which enabled it)
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`that NuVasive was able to essentially create a new market. Id. at ¶ 30.
`17. NuVasive experienced unprecedented growth for a small spinal
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`startup. Id. at ¶ 25. The growth of NuVasive has been a direct result of XLIF
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`success. Id. XLIF has redefined minimally disruptive surgery by providing an
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`efficient, reproducible lateral procedure that is minimally disruptive with
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`associated benefits (e.g., less blood loss, etc.). Id. And, at the center of
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`NuVasive’s success has been its XLIF procedure and associated equipment, which
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`are at the core of NuVasive’s business. Id. at ¶ 27.
`B. NuVasive’s XLIF Technology
`18. One of the key components of NuVasive’s XLIF technology is a
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`system of specialized access tools that are compatible with neuromonitoring that
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`NuVasive developed as part of the XLIF platform to create a small operative
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`corridor through the side of the patient and through the nerve-rich psoas muscle to
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`access the spine.
`19. The access tools include sequential dilators, which are a series of
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`successively larger dilators used to create and then incrementally widen an opening
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`to the spine. Specifically, once a smaller dilator has been inserted, a larger dilator
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`is slid over the previously inserted smaller dilator. The sequential dilators include
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`directional electrodes at their distal ends which electrically stimulate nerves in the
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`psoas muscle. The nerve responses are monitored and used by surgeons to assist in
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`creating a surgical path to the spine.
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`20. As part of the specialized access tools, NuVasive also developed a
`line of retractors which are referred to as the MaXcess® retractors. During the
`XLIF procedure, the MaXcess® retractor slides over the largest sequential dilator
`and gently enlarges and holds open the operating corridor. The MaXcess®
`retractors include an access driver and three independently adjustable blades: (1) a
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`posterior blade (located towards the back of the patient), also referred to as the “C”
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`or “central” blade; (2) a caudal blade (located towards the feet of the patient), also
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`referred to as the “L” or “left” blade; and (3) a cephalad blade (located towards the
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`head of the patient), also referred to as the “R” or “right” blade. The three-bladed
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`design allows a surgeon to anchor the posterior blade using an Intradiscal Shim and
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`stabilize the position of the retractor using an articulating arm. During the XLIF
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`procedure, one end of the articulating arm is attached to the retractor while the
`other end is secured to the operating table. One of the blades of the MaXcess®
`retractor can also be equipped with a neuromonitoring electrode. The special
`design of the MaXcess® retractors provides maximum access to the target area of
`the spine with minimal disruption to the surrounding tissue, as illustrated in the
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`figures below (screenshots of “MaXcess SD” video at 0:50, 0:25, 0:41,
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`respectively, available at https://www.youtube.com/watch?v=J3aLnVD_ymU).
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`The XLIF surgery also utilizes NuVasive’s CoRoent® line of
`21.
`implants. As depicted below, the CoRoent® XLIF implants are sized to span the
`entire width of the vertebral body to provide maximum vertebral body support. In
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`comparison, implants inserted through non-lateral spinal fusion surgeries have a
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`much smaller footprint and therefore provide weaker intervertebral support. Due
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`to anatomical structures surrounding the spine, inserting implants having
`dimensions as large as CoRoent® using non-lateral spinal fusion surgeries (such as
`ALIF, PLIF, or TLIF)1 would involve unacceptable risk. However, such implants
`are routinely inserted using a lateral approach to the spine with NuVasive’s XLIF
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`technology.
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`//
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`//
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`//
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`1 “ALIF” refers to a spinal fusion surgery utilizing an anterior approach to the
`spine, “PLIF” a posterior approach to the spine, and “TLIF” a “transforaminal,” or
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`angled approached to the spine from the posterior.
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`NuVasive’s CoRoent® implant (Ex. B at 7)
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`Comparison of NuVasive’s CoRoent® implant to Implants Placed in Non-
`Lateral Procedures
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` XLIF ALIF PLIF TLIF
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`22. NuVasive’s CoRoent® line of implants also includes radiopaque
`markers for a surgeon to determine whether the implant is correctly placed in the
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`disc space. These markers are specially placed after considering the dimensions of
`CoRoent® and its intended orientation on the vertebral disc.
`23. NuVasive is the pioneer of XLIF. To that end, NuVasive has and
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`continues to offer on-site training sessions for surgeons to learn XLIF first-hand.
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`In addition, NuVasive describes and demonstrates the XLIF procedure and
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`instrumentation through XLIF Surgical Technique Guides, including a 2003, 2006,
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`2007, and 2013 edition. E.g., Ex. D (NuVasive XLIF Surgical Technique (2013)
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`(“2013 NuVasive Surgical Guide”)); Ex. E (NuVasive XLIF Surgical Technique
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`(2007) (“2007 NuVasive Surgical Guide”)).
`24. Over 400 published clinical studies support the XLIF procedure and
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`hundreds of surgeons worldwide have successfully performed the XLIF procedure
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`on thousands of patients.
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`25.
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`In order to protect its investments and cutting-edge intellectual
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`property relating to XLIF, as well as other advancements in spinal developments,
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`NuVasive regularly seeks and obtains patents from the United States Patent and
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`Trademark Office (“USPTO”). As of February 13, 2018, NuVasive has been
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`granted over 350 patents in the United States and has numerous pending patent
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`applications.
`C. Alphatec Has Struggled Since Its Inception In 2006 And, After
`Failing In Its Introduction Of Guided Lumbar Interbody Fusion
`(“GLIF”), Attempted To Reinvent Itself By Introducing Its
`Battalion™ Lateral Technology
`26. Alphatec is a medical device company that provides hardware,
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`equipment, and implants for use in spinal surgery. Since its inception, Alphatec
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`has incurred net losses every year. In a 2018 corporate presentation, Alphatec
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`described its history with phrases such as “Poor Decisions/Challenges,” “Missed
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`globalization expectations,” and “Invested in technologies that never
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`commercialized.” Ex. F (Alphatec Corporate Presentation (January 2018)) at 4.
`27. Alphatec reported that in 2006, the year that Alphatec went public, its
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`net loss was nearly $26 million. Ex. G (Excerpt from Alphatec Holdings Form 10-
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`K Annual Report 2006) at 56.
`28. On information and belief, Alphatec tried, but failed, to achieve
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`success with a “lateral” spinal procedure and system. That procedure and system
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`was named “Guided Lumbar Interbody Fusion,” or “GLIF.” GLIF approached the
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`spine at an angle between the side and back of the patient.
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`//
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`//
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`//
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`Ex. H (Alphatec Spine Arc Portal Access
`System Guided Lumbar Interbody Fusion
`Surgical Technique Guide) at 1.
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`29. Starting from at least as early as 2008, Alphatec was developing
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`prototypes and designing products for GLIF. Ex. I (Excerpt from Alphatec
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`Holdings Form 10-K Annual Report 2008) at 12. Alphatec’s press releases
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`mention only one GLIF procedure ever being performed – in 2011. Ex. J (January
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`4, 2011 Alphatec Press Release).
`30. On information and belief, Alphatec stopped publicly discussing
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`GLIF as of Alphatec’s Annual Report for 2013.
`31. By 2013, Alphatec’s net losses had increased to approximately $82
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`million, compared to a net loss of nearly $26 million in 2006, the year that
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`Alphatec went public. Ex. K (Excerpt from Alphatec Holdings Form 10-K Annual
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`Report 2013) at 41; Ex. G (Alphatec Holdings Form 10-K Annual Report 2006) at
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`56. In just seven years, Alphatec’s net losses had grown by over 300%.
`32. Alphatec reported that Alphatec’s debt due to contractual obligations
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`(including lines of credit) and commercial commitments increased from $27
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`million in 2006 to nearly $190 million in 2013. Ex. G (Alphatec Holdings Form
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`10-K Annual Report 2006) at 68; Ex. K (Alphatec Holdings Form 10-K Annual
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`Report 2013) at 51.
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`33. Alphatec reported that at the end of 2013, Alphatec’s stock price was
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`about $2 dollars, compared to about $5 at the end of 2009. Ex. K (Alphatec
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`Holdings Form 10-K Annual Report) at F-28; Ex. L (Excerpt from Alphatec
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`Holdings Form 10-K Annual Report 2009) at F-33.
`34.
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`In an effort to accumulate cash, Alphatec implemented major changes
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`to its business in 2014-2015, including shifting its research and development
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`resources, and refocusing its product portfolio pipeline, toward the lateral market
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`for spine, the market that NuVasive had created. Ex. M (Excerpt from Alphatec
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`Spine 2014 Annual Report) at 1. According to Alphatec’s public statements, a few
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`years later, in April 2017, Alphatec made a limited release of a lateral spinal
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`surgery system, named the “Battalion™ Lateral System.” Ex. N. On information
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`and belief, it took Alphatec several years to launch Battalion™ Lateral System
`
`after initiating its lateral development program in part because Alphatec was
`distracted by financial hardships and efforts to restructure its business.
`35. At the end of 2015, Alphatec’s financial circumstances had become
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`dire. Alphatec reported that at the end of 2015, Alphatec failed to comply with its
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`financial covenants under its credit facility agreements, constituting an event of
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`default. Ex. O (Excerpt from Alphatec Holdings Form 10-K Annual Report 2015)
`
`at 28. Alphatec’s 2015 Annual Report expressly stated “[t]here is substantial doubt
`
`concerning our ability to continue as a going concern.” Id. at 27.
`36. Alphatec reported that in 2015, Alphatec incurred an annual net loss
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`of approximately $178 million, and its stock prices declined to $0.30. Id. at 39, 50.
`
`Alphatec was in danger of being delisted for failing to comply with NASDAQ’s
`
`requirement of maintaining a closing bid of $1.00 per share. Id. at 31-32.
`
`However, Alphatec negotiated with NASDAQ and was able to obtain an extended
`
`deadline of September 2016 to regain compliance. Ex. P (Excerpt from Alphatec
`
`Holdings Form 10-Q Quarterly Report for the Period Ending June 30, 2016) at 31.
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`37. Meanwhile, Alphatec continued to face financial hardships. It failed
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`to comply with its financial covenants with its credit facilities in 2016 for the
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`months of January, February, March, April, May, and June. Ex. Q (Excerpt from
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`Alphatec Holdings Form 10-K Annual Report 2016) at 29.
`38. Alphatec reported that in July 2016, Alphatec sold its international
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`business to Globus Medical, Inc. in exchange for $80 million in cash and a credit
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`line of $30 million (the “Globus Transaction”). Id. at 8.
`39. Alphatec reported that as part of the Globus Transaction, Alphatec
`
`agreed to exit the international market for a certain period of time. Id.
`40. Alphatec reported that in 2016, Alphatec reduced its workforce to
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`“reduce operating expenses” and “more appropriately size the Company’s
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`resources to better reflect the needs of a U.S.-focused organization.” Ex. R
`
`(October 5, 2016 Alphatec Press Release).
`41. Alphatec reported that after the Globus Transaction, Alphatec
`
`regained compliance with NASDAQ’s listing requirements. Ex. Q (Alphatec
`
`Holdings Form 10-K Annual Report 2016) at 32.
`42. Alphatec reported that in connection with the Globus Transaction,
`
`“[t]his enhanced liquidity will enable the company to support the continued
`
`expansion in the U.S. of … the launches of our new Battalion Lateral System ….”
`
`Ex. S (July 26, 2016 Alphatec Press Release).
`D. A Full Release Of Alphatec’s BattalionTM Lateral Technology
`Took Place In October Of 2017
`43. According to Alphatec’s public statements, Alphatec made a limited
`
`release of the Battalion™ Lateral System with the Squadron™ Lateral Retractor,
`
`which is specifically designed for use in a lateral, transpsoas procedure (“Alphatec
`
`Lateral Procedure”) in April 2017. Ex. N (April 7, 2017 Alphatec Press Release).
`
`On information and belief, Alphatec initiated a full launch of its Battalion™
`
`PATENT INFRINGEMENT COMPLAINT
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`Case 3:18-cv-00347-CAB-MDD Document 1 Filed 02/13/18 PageID.13 Page 13 of 126
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`
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`Lateral System with the Squadron™ Lateral Retractor in October of 2017. Exhibit
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`T (November 9, 2017 Alphatec Press Release) at 1.
`44. The Alphatec Battalion™ Lateral Thoracolumbar Surgical Technique
`
`Guide (“Alphatec Surgical Guide”), attached hereto as Exhibit U, describes the
`
`Battalion™ Lateral System and the Alphatec Lateral Procedure.
`45. The Battalion™ Lateral System includes the Battalion™ Lateral
`
`Spacer (i.e., an implant). Ex. U at 2, 28.
`46. The Battalion™ Lateral System includes the Initial Dilator. Id. at 6.
`47. The Battalion™ Lateral System includes the Secondary Dilator. Id. at
`
`8.
`
`48. The Battalion™ Lateral System includes the Squadron™ Lateral
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`Retractor Body. Id. at 17.
`49. The Battalion™ Lateral System includes the Squadron™ Lateral
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`Retractor Right Blade. Id. at 6-7, 13.
`50. The Battalion™ Lateral System includes the Squadron™ Lateral
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`Retractor Left Blade. Id.
`51. The Battalion™ Lateral System includes the Squadron™ Lateral
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`Retractor Posterior Blade. Id.
`52. The Battalion™ Lateral System includes the Squadron™ Lateral
`
`Retractor Left Handle Arm. Id. at 9.
`53. The Battalion™ Lateral System includes the Squadron™ Lateral
`
`Retractor Right Handle Arm. Id.
`54. The Battalion™ Lateral System includes the Intradiscal Shim. Id. at
`
`19.
`
`55. On information and belief, through at least the Alphatec Surgical
`
`Guide, Alphatec instructs surgeons to implement the Battalion™ Lateral System.
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`PATENT INFRINGEMENT COMPLAINT
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`Case 3:18-cv-00347-CAB-MDD Document 1 Filed 02/13/18 PageID.14 Page 14 of 126
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`56. On information and belief, Alphatec conducts in-person training and
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`education courses for surgeons demonstrating the Alphatec Lateral Procedure
`
`using the Battalion™ Lateral System with the Squadron™ Lateral Retractor.
`E. A Comparison Of The Alphatec Surgical Guide And The
`NuVasive XLIF Surgical Technique Guide Shows That Alphatec’s
`BattalionTM Lateral Technology Was Copied From NuVasive
`57. The Alphatec Surgical Guide (Ex. U) and the NuVasive XLIF
`
`Surgical Technique Guides (Exs. D and E) are compared below.
`58. On information and belief, Alphatec’s research and development of
`
`the Alphatec Lateral Procedure and related instrumentation commenced in 2014.
`
`At that time, Alphatec was aware of NuVasive, XLIF, and NuVasive’s extensive
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`XLIF patent portfolio.
`59. On information and belief, all editions (from 2003-2013) of the
`
`NuVasive XLIF Surgical Technique Guides were also known to Alphatec
`
`throughout development of the Alphatec Lateral Procedure and related
`
`instrumentation.
`60. The cover of the 2013 edition of NuVasive’s XLIF Surgical
`
`Technique Guide (“2013 NuVasive Surgical Guide”) illustrates a top view of the
`MaXcess® retractor (as seen by the surgeon performing the operation) providing
`access to the target intervertebral disc. Ex. D at 1.
`61.
`
`In a similar manner, the Alphatec Surgical Guide illustrates the
`
`Squadron™ Lateral Retractor providing access to the target intervertebral disc.
`
`Ex. U at 1.
`
`//
`
`//
`
`//
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`
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`Case 3:18-cv-00347-CAB-MDD Document 1 Filed 02/13/18 PageID.15 Page 15 of 126
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`2013 NuVasive Surgical Guide Cover
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`Alphatec Surgical Guide Cover
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`62.
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`The 2013 NuVasive Surgical Guide describes the following XLIF
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`procedure steps: (1) Patient Positioning & Operating Room setup, (2) Anatomic
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`Identification And Initial Incisions, (3) Retroperitoneal Access, (4) Retroperitoneal
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`Approach, (5) Transpsoas Approach, (6) Retractor Assembly, (7) Access, (8)
`
`Annulotomy And Disc Space Preparation, (9) Implant Sizing, and (10) Implant
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`Placement. See Ex. D.
`63. The Alphatec Surgical Guide instructs surgeons how and when to
`
`perform these steps. See Ex. U.
`(i)
`XLIF Patient Positioning And Operating Room Setup
`64. NuVasive first instructs that the patient should be placed in the lateral
`
`decubitus position with the greater trochanter over a table break and secured to the
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`operating room table by tape at specific locations: (A) below the iliac crest, (B)
`
`over the thoracic region, (C) from the iliac crest to the knee, then secured to the
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`table, and (D) from the table to the knee, past the ankle, then secured to the table.
`
`E.g., Ex. E (2007 NuVasive Surgical Guide) at 12.
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`Case 3:18-cv-00347-CAB-MDD Document 1 Filed 02/13/18 PageID.16 Page 16 of 126
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`65. The Alphatec Surgical Guide instructs its surgeons to “[p]lace the
`
`patient in a lateral decubitus position on a bendable (breaking) table so that the
`
`patient’s greater trochanter sits directly above the table break.” Ex. U (Alphatec
`
`Surgical Guide) at 3. The Alphatec Surgical Guide further instructs that “the
`
`patient should be taped at the following locations: Below the iliac crest [;] Over the
`
`thoracic region [;] From the iliac crest to the knee … (tape will then be secured to
`
`the table) [; and] From under the table on the ipsilateral side, to the knee, past the
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`ankle and then to the contralateral side under the table.” Id.
`
`NuVasive XLIF Procedure
`
`Alphatec Lateral Procedure
`
`Ex. E (2007 NuVasive Surgical
`Guide) at 12 Fig. 1.
`
`Ex. U (Alphatec Surgical Guide) at 3.
`
`66. NuVasive then depicts the appropriate placement of the surgical
`
`equipment. E.g., Ex. E (2007 NuVasive Surgical Guide) at 12.
`67. The Alphatec Surgical Guide depicts the appropriate placement of the
`
`surgical equipment. Ex. U (Alphatec Surgical Guide) at 3.
`
`//
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`//
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`//
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`Case 3:18-cv-00347-CAB-MDD Document 1 Filed 02/13/18 PageID.17 Page 17 of 126
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`
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`NuVasive XLIF Procedure
`
`Alphatec Lateral Procedure
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`
`
`Ex. U (Alphatec Surgical Guide) at 3. 2
`
`Ex. E (2007 NuVasive Surgical
`Guide) at 12 Fig. 4.
`(ii)
`XLIF Anatomic Landmark Identification And Initial
`Incisions
`68. NuVasive then instructs surgeons to localize the disc space using
`
`lateral fluoroscopy and mark the skin to serve as the location of the skin incision.
`E.g., Ex. D (2013 NuVasive Alphatec Surgical Guide) at 7.
`69.
`
`The Alphatec Surgical Guide instructs surgeons to “localize the
`
`operative level using true lateral fluoroscopy. With ink, make a mark on the skin
`
`to serve as the location for the initial skin incision at the operative level.” Ex. U
`
`(Alphatec Surgical Guide) at 4.
`
`//
`
`//
`
`//
`
`
`2 “FLUORO” in NuVasive’s figure and “C-Arm” in Alphatec’s figure refer to
`the same machine: a C-arm fluoroscopic X-ray machine.
`PATENT INFRINGEMENT COMPLAINT
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`Case 3:18-cv-00347-CAB-MDD Document 1 Filed 02/13/18 PageID.18 Page 18 of 126
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`NuVasive XLIF Procedure
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`Alphatec Lateral Procedure
`
`
`Ex. E (2007 NuVasive Surgical Guide)
`at 7 Fig. 9(3).
`(iii)
`XLIF Retroperitoneal Access
`70. NuVasive next teaches that the subcutaneous tissue layers “are
`
`
`Ex. U (Alphatec Surgical Guide)
`at 3.
`
`dissected using alternating blunt scissor and finger dissection.” E.g., Ex. D (2013
`
`NuVasive Surgical Guide) at 8. “Once inside the retroperitoneal space, the index
`
`finger is used to create space and release the peritoneum anteriorly []. When the
`
`peritoneum is released, the finger is then used to palpate the psoas muscle.” Id.
`71. Alphatec instructs surgeons to “dissect subcutaneous tissue layers by
`
`alternating with blunt scissors and finger dissection until the retroperitoneal space
`
`is reached. Once inside the retroperitoneal space, carefully sweep the peritoneum
`
`anteriorly. Once the peritoneum has been swept anteriorly, use the index finger to
`
`palpate the psoas muscle.” Ex. U (Alphatec Surgical Guide) at 4-5.
`
`//
`
`//
`
`//
`
`
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`PATENT INFRINGEMENT COMPLAINT
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`Case 3:18-cv-00347-CAB-MDD Document 1 Filed 02/13/18 PageID.19 Page 19 of 126
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`NuVasive XLIF Procedure
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`Alphatec Lateral Procedure
`
`
`Ex. D (2013 NuVasive Surgical Guide)
`at 8 Fig. 12.
`
`
`Ex. U (Alphatec Surgical Guide)
`at 5.
`
`72. Next, NuVasive describes that “[t]he index finger is brought up to the
`
`inside abdominal wall underneath the lateral skin mark []. This step ensures that a
`
`safe pathway exists between the abdominal wall and the psoas muscle.” E.g., Ex.
`
`D (2013 NuVasive Surgical Guide) at 9.
`73.
`
`The Alphatec Surgical Guide instructs surgeons to “[c]reate a safe
`
`pathway between the abdominal wall and the psoas muscle by using the index
`
`finger to sweep up to the inside of the abdominal wall directly underneath the
`
`lateral skin incision.” Ex. U (Alphatec Surgical Guide) at 5.
`
`NuVasive XLIF Procedure
`
`Alphatec Lateral Procedure
`
`
`Ex. D (2013 NuVasive Surgical Guide)
`at 9 Fig. 13.
`
`
`Ex. U (Alphatec Surgical Guide)
`at 5.
`
`PATENT INFRINGEM