Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 1 of 42 PageID #: 8629
`
`BIN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`NUVASIVE, INC.,
`
`
`
`
`
`
`
`v.
`
`
`GLOBUS MEDICAL, INC.,
`
`Defendant and
`Counterclaim-Plaintiff.
`
`
`
`
`
`
`Plaintiff and
`Counterclaim-Defendant,
`
`C. A. No. 1:10-CV-00849-LPS
`
`
`
`NUVASIVE, INC.’S ANSWERING BRIEF IN OPPOSITION TO
`GLOBUS MEDICAL, INC.’S MOTIONS FOR PARTIAL SUMMARY JUDGMENT
`
`
`
`
`Frank E. Scherkenbach, scherkenbach@fr.com
`Fish & Richardson P.C.
`One Marina Park Drive
`Boston, MA 02210
`Phone: 617-542-5070
`Fax: 617-542-8906
`
`Todd G. Miller, miller@fr.com
`Michael A. Amon, amon@fr.com
`Fish & Richardson P.C.
`12390 El Camino Real
`San Diego, CA 92130
`Phone: 858-678-5070
`Fax: 858-678-5099
`
`
`
`
`
`William J. Marsden, Jr. (#2247)
`marsden@fr.com
`Fish & Richardson P.C.
`222 Delaware Avenue, 17th Floor
`P. O. Box 1114
`Wilmington, DE 19899-1114
`Phone: 302-652-5070
`Fax: 302-652-0607
`
`Michael J. Kane, mjk@fr.com
`Fish & Richardson P.C.
`3300 Dain Rauscher Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Phone: 612-335-5070
`Fax: 612-288-9696
`
`Dated: October 29, 2013
`
`
`
`
`
`

`
`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 2 of 42 PageID #: 8630
`
`TABLE OF CONTENTS
`
`INTRODUCTION .................................................................................................1 
`
`NATURE AND STAGE OF THE PROCEEDINGS ............................................1 
`
`SUMMARY OF ARGUMENT .............................................................................1 
`
`STATEMENT OF FACTS ....................................................................................3 
`
`A. 
`
`B. 
`
`C. 
`
`D. 
`
`NuVasive’s XLIF Procedure ......................................................................3 
`
`NuVasive’s XLIF Patent Portfolio .............................................................4 
`
`NuVasive’s Patented Surgical Technique ..................................................6 
`
`Globus’ Entry Into the Lateral Market .....................................................10 
`
`1. 
`
`2. 
`
`Globus’ 2010 MARS 3V Retractor System .................................11 
`
`Globus’ 2012 MARS 3V Retractor System .................................12 
`
`LEGAL STANDARD FOR SUMMARY JUDGMENT .....................................12 
`
`ARGUMENT .......................................................................................................13 
`
`A. 
`
`As a Matter of Law, Nuvasive Did Not Grant an Implied
`License to the Asserted Patent to Any Surgeon .......................................13 
`
`1. 
`
`2. 
`
`3. 
`
`In Wang, a customer licensed a manufacturer to make
`the customer’s patented design ....................................................15 
`
`In De Forest, the government was licensed subject only
`to an agreement to negotiate appropriate compensation,
`if any, at a later date .....................................................................18 
`
`Globus Has No Cases Supporting Its Argument That
`Training Customers Creates An Implied License ........................19 
`
`B. 
`
`C. 
`
`Globus’ 2010 MARS 3V Retractor System and 2012
`Redesigned Retractor System Both Meet the “rigidly coupled”
`Limitation of the ’801 Patent ...................................................................20 
`
`The 2012 Redesigned MARS 3V Retractor System Satisfies the
`“Closed Position” limitation of the ’801 patent, Precluding
`Summary Judgment For Globus. .............................................................22 
`
`i
`
`
`I. 
`
`II. 
`
`III. 
`
`IV. 
`
`V. 
`
`VI. 
`
`
`
`

`
`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 3 of 42 PageID #: 8631
`
`D. 
`
`The Court Should Deny Globus’ Motion for Summary
`Judgment of No Willfulness ....................................................................26 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`Legal Standard .............................................................................26 
`
`Globus’ implied license defense is objectively
`unreasonable ................................................................................27 
`
`The reexaminations of the asserted patents do not factor
`against a finding of willfulness ....................................................28 
`
`Globus failed to prove that there is no genuine issue of
`material fact as to the objective reasonableness of its
`remaining defenses for the asserted patents .................................29 
`
`E. 
`
`Globus is not entitled to Summary Judgment On NuVasive’s
`Damages Claim ........................................................................................30 
`
`1. 
`
`2. 
`
`3. 
`
`The Asserted Patents Claim Systems and Methods for
`Inserting Spinal Implants .............................................................31 
`
`Globus Achieves Revenue for the Use of the Infringing
`System and Performance of the Infringing Methods via
`Sales of Implants and Disposables ...............................................32 
`
`NuVasive Apportions to Exclude Any Revenue Not
`Directly Attributable to the Claims of the Asserted
`Patents ..........................................................................................33 
`
`VII.  CONCLUSION ....................................................................................................35 
`
`
`
`
`
`ii
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`

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`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 4 of 42 PageID #: 8632
`
`TABLE OF AUTHORITIES
`
`
`
`CASES
`
`A.C. Aukerman Co. v. R.L. Chaides Constr. Co.,
`960 F.2d 1020 (Fed.Cir.1992)..................................................................................................19
`
`Abraxis Bioscience, Inc. v. Mayne Pharma, Inc.,
`467 F.3d 1370 (Fed. Cir. 2006)................................................................................................13
`
`Anderson v. Liberty Lobby, Inc.,
`477 U.S. 242 (1986) .................................................................................................................12
`
`Apple, Inc. v. Samsung Elecs. Co., Ltd.,
`920 F. Supp. 2d 1079 (N.D. Cal. 2013) ...................................................................................30
`
`Bandag Inc. v Al Bolster’s Tire Stores, Inc.,
`750 F.2d 903 (Fed. Cir. 1984)..................................................................................................14
`
`Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc.,
`682 F.3d 1003 (Fed. Cir. 2012)....................................................................................27, 28, 30
`
`Caterpillar Inc. v. Sturman Indus., Inc.,
`387 F.3d 1358 (Fed. Cir. 2004)................................................................................................12
`
`Charles Mach. Works, Inc. v. Vermeer Mfg. Co.,
`723 F.3d 1376 (Fed. Cir. 2013)................................................................................................25
`
`Cook Inc. v. Endologix, Inc.
`2012 WL 3779198 (S.D. Ind. August 30, 2012) ......................................................................30
`
`CSB-System Intern. Inc. v. SAP America, Inc.,
`2012 WL 1439059 (E.D. Pa. April 25 2012) ...........................................................................30
`
`De Forest Radio Tel. Co. v. United States,
`273 U.S. 236 (1927) .....................................................................................................15, 18, 19
`
`Felix v. American Honda Motor Corp., Inc.,
`562 F.3d 1167 (Fed. Cir. 2009)..........................................................................................21, 24
`
`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd.,
`344 F.3d 1359 (Fed. Cir. 2003)..........................................................................................21, 24
`
`Georgia-Pacific Corporation v. United States Plywood Corp.,
`318 F. Supp. 1116 (S.D.N.Y. 1970) ...........................................................................................2
`
`
`
`iii
`
`

`
`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 5 of 42 PageID #: 8633
`
`Hoechst Celanese Corp. v. BP Chemicals Ltd.,
`78 F.3d 1575, 1584 (Fed. Cir. 1996)........................................................................................28
`
`iLOR, LLC v. Google, Inc.,
`631 F.3d 1372 (Fed. Cir. 2011)................................................................................................27
`
`In re Seagate Tech., LLC,
`497 F.3d 1360 (Fed. Cir. 2007)....................................................................................26, 27, 30
`
`Leggett & Platt, Inc. v. Hickory Spring Mfg. Co.,
`285 F.3d 1353 (Fed. Cir. 2002)................................................................................................13
`
`Markman v. Westview Instruments, Inc.,
`52 F.3d 967 (Fed. Cir. 1995), aff’d, 517 U.S. 370 (1996) .......................................................13
`
`Met-Coil Sys. Corp. v. Korners Unlimited, Inc.,
`803 F.2d 684 (Fed. Cir. 1986)..................................................................................................14
`
`Optical Disc Corp. v. Del Mar Avionics,
`208 F.3d 1324 (Fed. Cir. 2000)................................................................................................13
`
`Plumley v. Mockett,
`836 F. Supp. 2d 1053 (C.D. Cal. 2010) ...................................................................................29
`
`Powell v. Home Depot U.S.A., Inc.,
`663 F.3d 1221 (Fed. Cir. 2011)................................................................................................30
`
`Robert Bosch, LLC v. Pylon Mfg. Corp.,
`719 F.3d 1305 (Fed. Cir. 2013)................................................................................................27
`
`Safoco, Inc. v. Cameron Intern. Corp.,
`2009 WL 2424108 (S.D. Tex. July 31, 2009) ....................................................................28, 29
`
`Saint-Gobain Autover USA, Inc. v. Xinyi Glass North Amer., Inc.,
`707 F. Supp. 2d 737 (N.D. Ohio 2010) ....................................................................................27
`
`St. Clair Intellectual Property Consultants, Inc. v. Matsushita Elecs. Industrial Co., Ltd.,
`2009 WL 1649675 (D. Del. June 10, 2009) .............................................................................28
`
`St. Clair Intellectual Property Consultants, Inc. v. Palm, Inc.,
`2009 WL 1649751 (D. Del. June 10, 2009) .............................................................................29
`
`Tarkus Imaging, Inc. v. Adobe Systems, Inc.,
`2012 WL 2175788 (D. Del. June 14, 2012) .............................................................................22
`
`Tesco Corp. v. Weatherford Intern. Inc.,
`750 F. Supp. 2d 780 (S.D. Tex. 2010) ...............................................................................28, 29
`
`
`
`iv
`
`

`
`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 6 of 42 PageID #: 8634
`
`TGIP, Inc. v. AT&T Corp.,
`527 F. Supp. 2d 561 (E.D. Tex. 2007) .....................................................................................29
`
`Tomita Technologies USA, LLC v. Nintendo Co., Ltd.,
`2013 WL 163975 (S.D.N.Y Jan. 15, 2013) .............................................................................27
`
`Wang Laboratories, Inc. v. Mitsubishi Elect. Am. Inc.,
`103 F.3d 1571 (Fed. Cir. 1997)........................................................................................ passim
`
`Warner-Jenkinson Co., Inc. v. Hilton Davis Chem. Co.,
`520 U.S. 17 (1997) ...................................................................................................................13
`
`Warsaw Orthopedic Inc. v. NuVasive, Inc.,
`S.D. Cal. Case No. 3:08-cv-01512 ...........................................................................................34
`
`Windbond Elec. Corp. v. Int’l Trade Comm’n,
`262 F.3d 1363 (Fed. Cir. 2001), opinion corrected, 275 F.3d 1344 (Fed. Cir. 2001) ............19
`
`STATUTES
`
`35 U.S.C. § 284 ..............................................................................................................................35
`
`
`
`v
`
`

`
`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 7 of 42 PageID #: 8635
`
`I.
`
`INTRODUCTION
`
`NuVasive, Inc. (“NuVasive”) opposes Globus Medical, Inc.’s (“Globus”) motion for
`
`partial summary judgment on various issues, including non-infringement, implied license, and
`
`damages. [D.I. 188].
`
`II.
`
`NATURE AND STAGE OF THE PROCEEDINGS
`
`This is a patent infringement case initiated by NuVasive on October 5, 2010. [D.I. 1.]
`
`Fact and expert discovery are both complete. [D.I. 18 and May 9, 2013 Order Granting Stip. To
`
`Amend Schedule (D.I. 177).] No date has been set for a pretrial hearing or for trial.
`III.
`SUMMARY OF ARGUMENT
`
`1. Globus’ motion for summary judgment of implied license fails to cite even a single
`
`case where the act of training a third party customer created an implied license to a method
`
`patent, let alone an implied license that would excuse a defendant’s (as opposed to the third party
`
`customer’s) infringement. Globus relies solely on cases that have no applicability to the facts of
`
`this case. As such, Globus fails to meet its burden to show that there are no genuine disputes of
`
`fact and that it is entitled to judgment as a matter of law. Globus’ motion for summary judgment
`
`of implied license should be denied.
`
`2. Globus’ motion for summary judgment of non-infringement of the “rigidly coupled”
`
`limitation relies on a claim interpretation that the Court previously rejected. Further, as
`
`discussed in detail below, whether Globus accused MARS 3V retractor systems meet the “rigidly
`
`coupled” limitation presents a genuine factual dispute for the jury. Globus’ motion for summary
`
`judgment of non-infringement of the “rigidly coupled” limitation should be denied.
`
`3. Globus’ motion for summary judgment of non-infringement of the “closed position”
`
`for its 2012 redesigned MARS 3V retractor system relies on an erroneous prosecution history
`
`estoppel argument. NuVasive did not amend its claims during prosecution to overcome prior art.
`
`
`
`
`
`

`
`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 8 of 42 PageID #: 8636
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`Even assuming that it did, which is not the case, the evidence suggests that NuVasive’s
`
`amendments adding “closed position” had no more than a “tangential relation to the equivalent in
`
`question.” Accordingly, prosecution history estoppel is inapplicable. Moreover, Globus has not
`
`met its burden to show claim vitiation. Finally, Globus’ motion presents genuine factual disputes
`
`that must be resolved by the jury. Accordingly, Globus’ motion for non-infringement of the
`
`“closed position” limitation should be denied.
`
`4. Globus’ motion for summary judgment of no willful infringement should be denied.
`
`Globus’ implied license defense is objectively unreasonable because it is predicated on an
`
`incorrect legal theory for which Globus does not and cannot cite any supporting cases. Globus’
`
`reliance on reexaminations of the asserted patents to support its invalidity defense is misplaced
`
`because the asserted claims stand affirmed as originally issued. And, Globus failed to meet its
`
`burden of proving that there is no genuine issue of material fact as to the objective
`
`reasonableness of its remaining defenses. Thus, the Court should permit NuVasive’s willfulness
`
`case to be tried to the jury.
`
`5. Globus’ motion for summary judgment on certain damages issues should also be
`
`denied. Dr. Sullivan’s analysis is based on sound methodology because it uses the framework
`
`set forth in Georgia-Pacific Corporation v. United States Plywood Corp., 318 F. Supp. 1116
`
`(S.D.N.Y. 1970), a widely used methodology for assessing patent damages. Dr. Sullivan did not
`
`attempt to award NuVasive the total profit it would have gained by excluding Globus from the
`
`marketplace. He instead properly limited his analysis to considering only the portion of the
`
`profitability attributable to the patented inventions. He provided factual basis for his
`
`apportionments, which at a minimum pose genuine factual disputes for the jury. Moreover, Dr.
`
`Sullivan appropriately calculated the revenue associated with the use of the patented system and
`
`
`
`2
`
`

`
`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 9 of 42 PageID #: 8637
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`the performance of the patented methods. There is no dispute that Globus records all revenue for
`
`its LLIF procedure by tracking the implants and disposables used in that procedure. Dr. Sullivan
`
`performed several calculations in order to allocate a portion of that revenue to
`
`implants/disposables and a portion to actual performance/use of the claimed methods/system. In
`
`doing so, Dr. Sullivan expressly excluded anything that could be considered a “convoyed” or
`
`“collateral” sale. Because Dr. Sullivan’s analysis is based on sound methodology, Globus’
`
`motion for summary judgment should be denied.
`
`IV.
`
`STATEMENT OF FACTS
`
`A.
`
`NuVasive’s XLIF Procedure
`
`An estimated ten million adults suffer from chronic, often debilitating back pain in the
`
`United States. This back pain, often afflicting the lumbar portion of the spine, may be caused by
`
`serious injury or congenital disease to the discs of the spine. Prior to 2003, surgery for treating
`
`these back problems – either from a posterior (back) or anterior (front) approach – was risky,
`
`complicated, painful, invasive and often unsuccessful.
`
`After years of research, development and testing, NuVasive revolutionized spine surgery
`
`starting in 2003 by introducing the tools and a procedure to approach the lumbar spine from the
`
`side of the body in a safe, reproducible and minimally disruptive manner. This side or lateral
`
`approach to the lumbar spine – called eXtreme Lateral Interbody Fusion (“XLIF”) – allows
`
`surgeons to safely access the discs of the lumbar spine through a nerve dense muscle (the
`
`“psoas” muscle) while avoiding additional injury to the patient. Prior to NuVasive and its XLIF,
`
`a lateral transpsoas approach to the lumbar spine was a high risk procedure that surgeons avoided
`
`because of the risk of nerve damage and other surgical complications. [See Ex. A (2012-4-27
`
`Youssef Report) at ¶ 225.] It was only after NuVasive introduced its XLIF procedure and
`
`
`
`3
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`

`
`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 10 of 42 PageID #: 8638
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`associated tools that spine surgeons first began to realize the benefits of a direct lateral,
`
`transpsoas approach to the lumbar spine.
`
`In the process, NuVasive created a new market for lateral spine surgery and associated
`
`products which have provided significant patient benefit in the form of less operative time, less
`
`blood loss, less scarring, faster recovery, and generally improved outcomes. [See e.g., Ex. A
`
`(2012-4-27 Youssef Report) at ¶ 226.] Today, tens of thousands of people have benefited from
`
`NuVasive’s XLIF procedure.
`
`B.
`
`NuVasive’s XLIF Patent Portfolio
`
`NuVasive spent considerable time, effort and resources to develop the procedure and
`
`tools for XLIF. As part of that development, NuVasive’s engineers and collaborating surgeons
`
`developed novel methods and tools for spine surgery, and for the XLIF procedure.1 The three
`
`patents at issue here, U.S. Patent Nos. 7,691,057 (“the ’057 patent”); 7,819,801 (“the ’801
`
`patent”) and 7,905,840 (“the ’840 patent”), all relate to the method and tools for performing
`
`XLIF, and specifically for creating a safe passage through the nerve-dense psoas muscle to a
`
`lateral aspect of the lumbar spine. One important advancement of the disclosed systems is the
`
`distraction assembly. The distraction assembly disclosed by the patents aids in providing a safe
`
`passage through nerve-rich tissue like the psoas. The distraction assembly may include one or
`
`more dilators designed to be used in conjunction with neuromonitoring, which allows the
`
`surgeon to determine the presence, proximity, and/or direction of nerves in the psoas muscle with
`
`respect to the dilator. [See e.g., Ex. B (’840 patent) at 3:39-43; 14:38-63; 15:13-21.] While a
`
`dilator is passed through the tissue, the nerves may be identified in a variety of ways, including
`
`
`1As of 2012, NuVasive had a portfolio of 178 issued U.S. Patents, and 241 pending U.S.
`applications, many of which are directed to the XLIF procedure and tools. [See Ex. C (2012
`Annual Report) at 8.]
`
`
`
`
`4
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`

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`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 11 of 42 PageID #: 8639
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`by placing a visual indicator at the exposed, proximal end of a dilator (outside the body) that
`
`corresponds with electrical stimulation that is emitted at the distal end of the dilator (closest to
`
`the surgical target site). [See e.g., id. at 6:44-52; 11:1-7.] The distraction assembly, which
`
`preferably includes two or more sequential dilators increasing in size, creates a corridor through
`
`nerve-rich tissue (like the psoas muscle) which can gradually be increased in diameter,
`
`minimizing the risk of neurologic injury. [See e.g., id. at 6:67-7:6; 9:47-60; 15:13-21; Fig. 12.]
`
`Distraction assembly
`
`Vertebrae
`
`Disc space
`
`
`
`A second important advancement of the disclosed systems is a retraction assembly that is
`
`used to maintain or expand the operative corridor to the target site. [See e.g., id. at 3:15-21.] In
`
`a preferred embodiment, the retraction assembly may have three blades that are used to maintain
`
`or expand the operative corridor. [See e.g., id. at 7:58-67; Figs. 15-16 (12, 16, 18).]
`
`Disc space
`
`
`
`
`
`The retraction assembly also includes a shim – which is a sharp, arrow-like fixation
`
`element – that may be inserted in a groove in the center blade of the retraction assembly, and
`
`driven into the disc space. [See e.g., id. at 3:61-4:14.] The retraction assembly, which may be
`
`expanded, allows the surgeon to safely create a corridor large enough to permit easy passage of
`
`
`
`5
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`

`
`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 12 of 42 PageID #: 8640
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`the necessary tools and implants for accomplishing the fusion surgery, but small enough to
`
`minimize potential harm to the nerves. [See e.g., id. at 16:65-17:3.] Equally important, the
`
`retraction assembly creates an operative corridor that provides the surgeon with an unobstructed,
`
`three dimensional view directly to the disc space.
`
`A third, fundamental development of the disclosed systems, which as noted above can be
`
`incorporated into the dilators which are used for distraction (as well as the retractor blades) is the
`
`use of neuromonitoring to help identify and avoid motor nerves in nerve-rich tissues like the
`
`psoas. The disclosed neuromonitoring system uses monitored electrical stimulation of the
`
`nerves, called “triggered EMG” (electromyography), to allow surgeons to determine the
`
`presence, proximity, and/or direction of nerves with respect to their instruments in real time -- as
`
`if they had a nerve detecting RADAR. [See e.g., id. at 10:53-63; 11:8-18; 11:44-12:1; 12:16-48.]
`
`This provides surgeons the ability to actively negotiate around or past nerves in tissue, and avoid
`
`the harm resulting from cutting or compressing those nerves. [See e.g., id. at 12:1-6.]
`
`C.
`
`NuVasive’s Patented Surgical Technique
`
`Improving on past experimental surgical techniques, the asserted ’057 and ’840 patents
`
`teach novel surgical techniques that allow surgical instruments to be safely passed through
`
`nerve-rich tissue to a surgical target site. Notably, the disclosed methods include the use of two
`
`small incisions that allow surgeons to get access instruments safely through the psoas muscle so
`
`surgeons can establish direct, visual access to the target site in a less invasive (i.e., causing less
`
`tissue damage) manner than traditional “open” spine surgery. The patient is placed on his side
`
`(in what is called the lateral decubitus position) and taped so as to not move. [See e.g., Ex. B
`
`[840 patent] at Fig. 23.] Surface electrodes or needles are placed at various major muscle groups
`
`on the patient’s body for neuromonitoring purposes. [See e.g., id. at 11:57-59.[
`
`
`
`6
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`

`
`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 13 of 42 PageID #: 8641
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`The target disc space is identified using fluoroscopy–a form of x-ray. [See e.g., id., Fig.
`
`27.] In a preferred embodiment, the surgeon crosses two metal K-wires over the center of the
`
`target disc space seen using a flouroscope, and the location is marked on the patient’s skin using
`
`a pen. [See e.g., id. at Figs. 27-28.] This first mark, called the lateral incision mark, identifies
`
`the incision for the operative corridor. [See e.g., id. at 13:52-53; Fig. 28 (208).] Generally, the
`
`surgeon next makes a second mark about one finger length from the lateral incision mark toward
`
`the patient’s backside; this second mark is referred to as the postero-lateral mark. [See e.g., id. at
`
`13:54-56; Fig. 28 (209).]
`
`
`
`Vertebrae
`
`Disc
`
`
`
`
`
`The surgeon makes a small incision at the postero-lateral mark (hash 209 in Fig. 28
`
`shown above) and uses scissors and his finger to access the space behind the peritoneal sack
`
`(housing the bowels and other organs), known as the retroperitoneal space. [See e.g., id. at
`
`13:61-67.] Once in the retroperitoneal space, the surgeon preferably uses his finger to gently
`
`sweep the peritoneum forward, causing the contents of the abdomen to fall forward, and creating
`
`a safe surgical space through which the surgeon can subsequently create the operative corridor to
`
`the spine. [See e.g., id. at 14:9-14.] Generally, the surgeon next uses his finger to identify the
`
`psoas muscle, and then sweeps his finger upward within the retroperitoneal space toward the
`
`lateral incision mark (the “X” in Fig. 28 above). [See e.g., id. at 14:15-17; Fig. 30 (below).]
`
`
`
`7
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`

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`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 14 of 42 PageID #: 8642
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`Preferably, the surgeon makes a second small incision at the lateral incision mark and passes an
`
`initial dilator of the disclosed distraction assembly through the lateral incision to meet the
`
`surgeon’s finger in the retroperitoneal space. [ See e.g., id. at 14:17-23.] The surgeon safely
`
`guides the dilator to the surface of the psoas muscle, ensuring the tip of the dilator does not cause
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`any injury as it travels through the retroperitoneal space. [See e.g., id. at 14:29-34; Fig. 35
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`(below).]
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`Disc
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`Vertebra
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`Once the initial dilator reaches the surface of the psoas muscle, the surgeon connects the
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`dilator to the neuromonitoring system via an electrical connection device that is capable of
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`transmitting a stimulation signal from the neuromonitoring system to the initial dilator. [See e.g.,
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`id. at 14:45-58.] The surgeon advances the dilator through the psoas muscle toward the disc
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`space while triggered EMG—a form of neuromonitoring—sends an electrical impulse through
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`the electrical connection device, through the insulated dilator, and exits the dilator at the exposed
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`electrode near the distal end. [See e.g., id. at 11:44-59 Fig. 36.] If the dilator comes in close
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`proximity to a nerve as it is being advanced through the psoas muscle, the electric signal will
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`stimulate the nerve tissue, causing the muscle fibers associated with the nerve to contract. [See
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`e.g., id.] In a preferred embodiment, the neuromonitoring system will detect the muscle
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`contraction through the surface electrodes on the patient which are also connected to the
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`neuromonitoring system, alert the surgeon of this muscle contraction, and provide an indication
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`8
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`

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`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 15 of 42 PageID #: 8643
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`of proximity to the nerve. [See e.g., id. at 12:16-40.] The surgeon uses the directional indicator
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`on the dilator to determine the direction of the nerve from the dilator tip. Knowing the proximity
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`and direction of the nerve from the dilator tip allows the surgeon to redirect the dilator, if
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`necessary, to avoid the nerve. [See e.g., id. at 12:1-6.]
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`Once the initial dilator is safely through the psoas and at the disc space, the surgeon may
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`repeat this process, sequentially placing two larger dilators of the distraction assembly – also
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`connected to the neuromonitoring system – over the initial dilator to widen the corridor to the
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`target disc. [See e.g., id. at 15:13-24.] After the final dilator is in place, the surgeon introduces
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`the retraction assembly over the outermost dilator, and advances the retraction assembly to the
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`target disc space, again using the neuromonitoring system to help avoid contact with nerves in
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`the psoas. [See e.g., id. at 15:25-38.]
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`With the retraction assembly in position, the dilators of the distraction assembly are
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`removed. [See e.g., id. at 15:55-58.] To further stabilize the retraction assembly, an intradiscal
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`shim may be placed down the grooved center blade and driven into the tough outer-surface of the
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`disc. [See e.g., id. at 15:32-35.] The left and/or right blades can now be opened to create a
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`customized operative corridor through which the surgeon can work. [See e.g., id. at 9:1-11;
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`10:3-10.]
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`9
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`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 16 of 42 PageID #: 8644
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`Disc
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`Vertebra
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`With the operative corridor established and disc exposure achieved, a surgeon generally
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`removes a portion of the damaged disc. [See e.g., id. at 16:3-8.] The surgeon may next
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`determine the appropriate size interbody fusion implant to be inserted in the disc space. The
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`surgeon then fills the appropriate implant with some bone growth promoting material and gently
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`impacts the implant into the disc space, thereby restoring disc height and indirectly
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`decompressing any nerve roots that may be causing the patient back or leg pain. [See e.g., id. at
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`16:8-21; Fig. 49.] Once the implant is in place, the retraction assembly is removed, and the outer
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`skin incisions are sutured. [See e.g., id. at 16:22-28.] Because the psoas muscle is gently
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`distracted rather than severed, there is minimal blood loss and there is generally no need to
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`suture the muscle fibers once the retraction assembly is removed. In addition, because the spinal
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`ligaments are not disturbed in the direct lateral approach exemplified here, the natural stability of
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`the spine provided by those spinal ligaments is maintained.
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`D.
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`Globus’ Entry Into the Lateral Market
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`Recognizing the success of NuVasive’s XLIF, in 2009 Globus launched a
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`
`
` [Ex. D (GLOBUS 19366) at GLOBUS19367.] With that implant, Globus
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`
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`10
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`

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`Case 1:10-cv-00849-LPS Document 216 Filed 11/05/13 Page 17 of 42 PageID #: 8645
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`provided surgeons a large, four bladed retractor called MARS (not accused here). Surgeons did
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`not like the MARS retractor system, finding it had many shortcomings as compared to
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`NuVasive’s system, including that it was too bulky for lateral lumbar interbody fusion (“LLIF”)
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`– the term Globus applied to its XLIF-knock-off procedure. [See e.g., Ex. D (GLOBUS19366) at
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`GLOBUS19367; see also Ex. E (Iott Depo. Ex. 2-13) at GLOBUS212262; Ex. F (8/31/11
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`Deposition of Andrew Iott) at 92:20-93:9.] Globus’ lateral implant sales suffered as a result of
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`the inferior MARS retractor system, so Globus designed a better, and infringing solution.
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`1.
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`Globus’ 2010 MARS 3V Retractor System
`
`In March 2010, Globus launched its MARS 3V retractor system, which was
`
` [See Ex. G
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`(GLOBUS161091) at GLOBUS161093.] The MARS 3V system includes, among other things,
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`insulated dilators that have an electrode at the distal end of each dilator for use in nerve detection
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`(a distraction system), a three bladed retractor with insulated retractor blades and electrodes at
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`the end of each retractor blade for use in nerve detection (retraction system), and a shim that
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`slides down a groove on the inner face of the posterior retractor blade and into the disc to help
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`stabilize the retractor once at the target spinal site (fixation element). In conjunction with the
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`release of the MARS 3V system, Globus also released a surgical technique guide for LLIF using
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`the MARS 3V system. That surgical technique guide is almost an exact copy of NuVasive’s
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`’840 patent figures and surgical technique guide for XLIF, including describing the use of a two-
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`incision technique clai