Case 3:18-cv-00347-CAB-MDD Document 253-11 Filed 01/18/20 PageID.22533 Page 1 of
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`
`EXHIBIT 11
`
`TO THE DECLARATION OF BRIAN J. NISBET
`IN SUPPORT OF DEFENDANTS’ MOTION
`FOR SUMMARY JUDGMENT OR, IN THE
`ALTERNATIVE, SUMMARY ADJUDICATION
`
`

`

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`Case: 17-1666 Document: 25 Page: 1 Filed: 08/01/2017
`
`No. 2017-1666
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`NUVASIVE, INC.,
`Appellant,
`
`v.
`
`JOSEPH MATAL, PERFORMING THE FUNCTIONS AND
`DUTIES OF THE UNDER SECRETARY OF COMMERCE
`FOR INTELLECTUAL PROPERTY AND DIRECTOR
`OF THE U.S. PATENT AND TRADEMARK OFFICE,
`Intervenor.
`
`Appeal from the United States Patent and Trademark Office,
`Inter Partes Reexamination Control No. 95/001,888
`
`NUVASIVE’S OPENING BRIEF
`
`Michael T. Rosato
`Andrew S. Brown
`Sonja R. Gerrard
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`(206) 883-2500
`
`Richard Torczon
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street, NW
`Washington, DC 20006
`(202) 973-8800
`
`August 1, 2017
`
`Paul D. Tripodi, II
`Grace J. Pak
`WILSON SONSINI GOODRICH & ROSATI
`633 West 5th Street, Suite 1550
`Los Angeles, CA 90071
`(323) 210-2900
`
`Counsel for Appellant NuVasive, Inc.
`
`

`

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`U.S. Patent No. 7,691,057 Claim 17 (Appx1049-1050)
`
`17. A method of accessing a surgical target site within a spine,
`comprising the steps of:
`
`(a) creating a distraction corridor along a lateral, trans-psoas
`path to a targeted lumbar spinal disc in a lumbar spine using a
`distraction assembly comprising at least two dilators that are
`sequentially inserted along the lateral, trans-psoas path to the
`targeted lumbar spinal disc, and performing neuromonitoring during
`at least a portion of the time the distraction assembly is used in
`creating the distraction corridor along the lateral, trans-psoas path,
`wherein the neuromonitoring comprises causing the emission of a
`plurality of electrical stimulation signals from a stimulation electrode
`provided on a distal portion of at least one component of the
`distraction assembly and monitoring for resulting electromyographic
`(EMG) activity after the emission of each stimulation signal, and
`wherein the component of the distraction assembly is coupled to a
`control unit of a neuromonitoring system that is capable of displaying
`to a user an indication of at least one of proximity and direction of a
`nerve to the stimulation electrode provided on the component of the
`distraction
`assembly
`based
`on
`the monitored
`resulting
`electromyographic (EMG) activity;
`
`(b) slidably advancing a plurality of retractor blades of a
`retraction assembly along an outermost dilator of the at least two
`dilators of
`the distraction assembly,
`the retraction assembly
`
`i
`
`
`

`

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`comprising a handle assembly coupled to the plurality of retractor
`blades such that the retractor blades extend generally perpendicularly
`relative to arm portions of the handle assembly, each of said plurality
`of retractor blades having a generally concave inner face and a
`generally convex exterior face, said handle assembly being capable of
`moving said plurality of retractor blades from a closed position to an
`open position, said closed position being characterized by said
`plurality of retractor blades being positioned to abut one another and
`form a closed perimeter, said open position characterized by said
`plurality of retractor blades being positioned generally away from one
`another and forming an open perimeter;
`
`(c) simultaneously introducing said plurality of retractor blades
`over the outermost dilator of said distraction assembly along the
`lateral, trans-psoas path to the targeted lumbar spinal disc while in
`said closed position;
`
`(d) actuating said handle assembly to move said plurality of
`retractor blades to the open position so that the plurality of retractor
`blades create an operative corridor along the lateral, trans-psoas path
`to the targeted lumbar spinal disc;
`
`(e) releasably engaging a fixation element with at least one of
`the plurality of retractor blades so that a distal portion of the fixation
`element extends distally from the at least one retractor blade and
`penetrates into a lateral aspect of the lumbar spine, wherein the
`fixation element secures the at least one retractor blade to the lumbar
`spine;
`
`ii
`
`
`

`

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`(f) inserting an implant through the operative corridor created
`by the plurality of retractor blades along the lateral, trans-psoas path
`to the targeted lumbar spinal disc.(emphasis added).
`
`iii
`
`
`

`

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`CERTIFICATE OF INTEREST
`
`Counsel for NuVasive, Inc. certifies the following.
`
`1.
`
`2.
`
`The full name of every party represented by me is: NuVasive, Inc.
`
`The name of the real party in interest (please only include any real
`
`party in interest NOT identified in Question 3) represented by me is: NuVasive,
`
`Inc.
`
`3.
`
`The parent corporations and any publicly held companies that own 10
`
`percent or more of the stock in the party represented by me are: None.
`
`4.
`
`The names of all law firms and the partners or associates that
`
`appeared for the party or amicus now represented by me in the trial court or agency
`
`or are expected to appear in this Court (and who have not or will not enter an
`
`appearance in this case) are:
`
`Fish & Richardson P.C., including Stephen R. Schaefer, Stuart Nelson, Neil
`A. Warren, Michael T. Hawkins, Frank Scherkenbach, and Michael A.
`Amon
`
`
`August 1, 2017
`
`
`
`
`
`
`
`
`
`
` /s/ Michael T. Rosato
`Michael T. Rosato
`Counsel for Appellee NuVasive, Inc.
`
`
`
`
`
`
`
`
`
`iv
`
`
`

`

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`TABLE OF CONTENTS
`
`Certificate of Interest ............................................................................................... iv 
`
`Table of Contents ....................................................................................................... v 
`
`Table of Authorities ............................................................................................... viii 
`
`Related Cases ........................................................................................................... xi 
`
`Jurisdiction .............................................................................................................. xii 
`
`Issues on Appeal ..................................................................................................... xii 
`
`Introduction ................................................................................................................ 1 
`
`Statement of the Case ................................................................................................. 2 
`
`I. 
`
`Invention—XLIF (eXtreme Lateral Interbody Fusion) ........................ 2 
`
`A. 
`
`B. 
`
`State of the Art in Spinal Surgery ............................................... 3 
`
`XLIF Surgical Procedure Defied Conventional Wisdom as to
`the Possibility of Safely and Reproducibly Traversing the Psoas
`Muscle in a Lateral Surgery ........................................................ 7 
`
`C. 
`
`XLIF is a Commercial Success Story ....................................... 12 
`
`II. 
`
`Asserted Prior Art ................................................................................ 14 
`
`A.  Kossmann Discloses a Vertebral Replacement Surgery ........... 14 
`
`B. 
`
`C. 
`
`Branch Discloses Retraction Devices for Minimally Invasive
`Spinal Surgery ........................................................................... 17 
`
`Koros Discloses Variable Length Blades for Use with a
`Retractor Assembly ................................................................... 18 
`
`D.  Kelleher Discloses Nerve Monitoring in Spinal Surgery, But
`Not Monitoring Psoas Nerves ................................................... 19 
`
`III. 
`
`Inter Partes Reexamination Proceeding ............................................. 20 
`v
`
`
`

`

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`A.  Globus Requested Inter Partes Reexamination ........................ 20 
`
`B. 
`
`C. 
`
`D. 
`
`E. 
`
`The Examiner Determined the Claims Nonobvious ................. 22 
`
`The Board Reversed the Examiner’s Conclusion of
`Nonobviousness ........................................................................ 25 
`
`The Examiner Again Determined the Claims Nonobvious ...... 27 
`
`The Board Again Reversed the Examiner ................................ 28 
`
`Summary of the Argument ....................................................................................... 31 
`
`Standard of Review .................................................................................................. 33 
`
`Argument.................................................................................................................. 34 
`
`I. 
`
`The Board Erred in its Obviousness Analysis..................................... 34 
`
`A. 
`
`There is No Rationale to Combine ........................................... 36 
`
`1. 
`
`2. 
`
`The Examiner Correctly Found No Motivation to
`Combine the Surgery of Kossmann with the Surgical
`Tools of Branch and Koros, But the Board Reversed .... 38 
`
`The Examiner Correctly Found No Motivation to Use the
`EMG Nerve Monitoring of Kelleher During a Lateral,
`Trans-Psoas Spinal Surgery, But the Board Reversed ... 43 
`
`B. 
`
`The Board Overlooked the State of the Art .............................. 46 
`
`II. 
`
`The Board Erred in its Construction of “Lateral, Trans-Psoas Path” . 49 
`
`A. 
`
`B. 
`
`The Board’s Construction is Not Based on the Evidence of
`Record ....................................................................................... 49 
`
`“Lateral” Describes an Approach From the Patient’s Lateral
`Aspect ........................................................................................ 51 
`
`III.  The Board Erred in the Analysis of Objective Evidence of
`Nonobviousness ................................................................................... 52 
`
`vi
`
`
`

`

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`A. 
`
`B. 
`
`There is a Nexus between XLIF and the Claimed Invention ... 54 
`
`The Board’s Alternative Rationales for Disregarding Objective
`Evidence Are Legally Erroneous .............................................. 57 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`The Board Erred by Requiring Widespread Efforts and
`No Alternatives to Show Long-Felt Need ...................... 58 
`
`The Board Erred by Disregarding Fact Testimony and
`Peer-Reviewed Articles Showing Initial Skepticism
`Followed by Praise ......................................................... 59 
`
`The Board Erred by Requiring the Claimed Invention be
`the Thing Sold to Show Commercial Success ................ 61 
`
`The Board Erred by Not Considering the Evidence as a
`Whole .............................................................................. 62 
`
`Conclusion ............................................................................................................... 62 
`
`Certificate of Service 
`
`Certificate of Compliance 
`
`
`
`
`
`vii
`
`
`

`

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`TABLE OF AUTHORITIES
`
`CASES
`Apple Inc. v. ITC, 725 F.3d 1356 (Fed. Cir. 2013) .................................................. 52
`
`Page
`----
`
`ArcelorMittal France v. AK Steel Corp., 700 F.3d 1314 (Fed. Cir.
`2012) .............................................................................................................. 61
`
`Baltimore & Ohio R.R. Co., 393 U.S. 87 (1968) .................................................... 54
`
`Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064 (Fed. Cir.2015) ................................ 36
`
`Brand v. Miller, 487 F.3d 862 (Fed. Cir. 2007) ....................................................... 54
`
`ClassCo, Inc. v. Apple, Inc., 838 F.3d 1214, (Fed. Cir. 2016) ................................ 54
`
`Crocs, Inc. v. ITC, 598 F.3d 1294 (Fed. Cir. 2010) ................................................. 52
`
`Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955
`(Fed. Cir. 1986) .............................................................................................. 52
`
`Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369 (Fed
`Cir. 2006) ....................................................................................................... 58
`
`Eurand, Inc. v. Mylan, Inc., 676 F.3d 1063 (Fed. Cir. 2012) .................................. 58
`
`Fonar Corp. v. GE, 107 F.3d 1543 (Fed. Cir. 1997) ............................................... 56
`
`Graham v. John Deere Co. of Kan. City, 383 U.S. 1 (1966) ................................... 33
`
`In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) ....................................................... 32
`
`In re Kahn, 441 F. 3d 977 (Fed. Cir. 2006) ............................................................. 34
`
`In re Kotzab, 217 F.3d 1365 (Fed. Cir. 2000) ......................................................... 33
`
`In re Lee, 277 F.3d 1338 (Fed. Cir. 2002) ............................................................... 42
`
`In re McKenna, 203 F.2d 717 (C.C.P.A. 1953) ................................................. 60, 61
`
`In re Nuvasive, 842 F.3d 1376 (Fed. Cir. 2016) ...................................................... 42
`
`viii
`
`
`

`

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`In re NuVasive, No. 2015-1841, slip op. (Fed. Cir. May 31, 2017) .................. 50, 51
`
`In re Piasecki, 745 F.2d 1468 (Fed. Cir. 1984) ....................................................... 62
`
`In re Rouffet, 149 F.3d 1350 (Fed. Cir. 1998) ......................................................... 37
`
`In re Suitco Surface, Inc., 603 F.3d 1255 (Fed. Cir. 2010) ..................................... 49
`
`In re Zurko, 258 F.3d 1379 (Fed. Cir. 2001) ........................................................... 43
`
`InTouch Techs., Inc. v. VGo Commun., Inc., 751 F.3d 1327 (Fed. Cir.
`2014) ........................................................................................................ 59, 60
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) .......................................... 34, 36
`
`Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292 (Fed. Cir. 2015) ............... 32, 33
`
`Millennium Pharm., Inc. v. Sandoz, Inc., Nos. 2015-2066, slip op.
`(Fed. Cir. July 17, 2017) ................................................................................ 58
`
`Mintz v. Dietz & Watson, Inc., 679 F.3d 1372 (Fed. Cir. 2012) .................. 36, 37, 48
`
`On-Line Careline, Inc. v. Am. Online, Inc., 229 F.3d 1080 (Fed. Cir.
`2000) .............................................................................................................. 32
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358 (Fed.
`Cir. 2008) ................................................................................................. 52, 60
`
`Outside the Box Innovations, LLC v. Travel Caddy, Inc., 695 F.3d
`1285 (Fed. Cir. 2012)..................................................................................... 46
`
`PPC Broadband v. Corning Optical Comm’ns RF, LLC, 815 F. 3d
`734 (Fed. Cir. 2016)....................................................................................... 54
`
`Panduit Corp. v. Dennison Mfg. Co., 774 F.2d 1082 (Fed. Cir. 1985) ................... 53
`
`Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324 (Fed. Cir.
`2009) .............................................................................................................. 48
`
`Rambus Inc. v. Rea, 731 F.3d 1248 (Fed. Cir. 2013) .............................................. 33
`
`Randall Mfg. v. Rea, 733 F.3d 1355 (Fed. Cir. 2013) ................................. 34, 47, 48
`
`ix
`
`
`

`

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`Rembrandt Wireless Techs., LP v. Samsung Elecs. Co., 853 F.3d 1370
`(Fed. Cir. 2017) .............................................................................................. 36
`
`Simmons Fastener Corp. v. Illinois Tool Works, 739 F.2d 1573 (Fed.
`Cir. 1984) ....................................................................................................... 52
`
`Standard Oil Co. v. American Cyanamid Co., 774 F.2d 448 (Fed. Cir.
`1985) .............................................................................................................. 34
`
`Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530 (Fed.Cir.1983) .......................... 52
`
`Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831 (2015) .............................. 33
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling
`United States, Inc., 699 F.3d 1340 (Fed. Cir. 2012) ..................................... 52
`
`TriMed, Inc. v. Stryker Corp., 608 F.3d 1333 (Fed. Cir. 2010) ............................... 52
`
`WBIP, LLC v. Kohler Co., 829 F.3d 1317 (Fed. Cir. 2016) .................................... 54
`
`
`PATENT TRIAL AND APPEAL BOARD CASES
`Medtronic, Inc. v. NuVasive, Inc., IPR2014-00075, Paper 49 ................................. 56
`
`
`
`x
`
`
`

`

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`RELATED CASES
`
`The captioned case is an appeal from an inter partes reexamination, Control
`
`No. 95/001,888, of U.S. Patent No. 7,691,057 (“the ’057 patent”) before the United
`
`States patent and Trademark Office, Patent Trial and Appeal Board (“the Board”)
`
`with Globus Medical, Inc. as Requester and NuVasive, Inc. as Patent Owner. No
`
`prior appeal from this inter partes reexamination was previously before this Court
`
`or any other court.
`
`This appeal is related to Case Nos. 15-1838, -1839, -1840, -1841, -1842, and
`
`-1843 which were appeals from inter partes reviews of four related patents. In No.
`
`15-1841, a written decision was issued overturning the Board’s decision based on
`
`an erroneous claim construction of the “lateral, trans-psoas path” term. In re
`
`NuVasive, No. 2015-1841, slip op. at 14 (Fed. Cir. May 31, 2017) (non-prec.).
`
`
`
`
`
`xi
`
`
`

`

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`JURISDICTION
`
`The Board issued its Final Decision on Appeal on December 19, 2016.
`
`Appx1. NuVasive filed timely notices of appeal on February 21, 2017 under
`
`35 U.S.C. §§ 141 and 142. This Court has jurisdiction under 28 U.S.C.
`
`§ 1295(a)(4)(A).
`
`ISSUES ON APPEAL
`
`Whether the Board’s conclusion that claims 17-22 and 24-27 are
`
`unpatentable as obvious should be reversed where:
`
`1.
`
`The Board erred in concluding that the claimed method would have
`
`been obvious without any reason to combine the four references with a rational
`
`underpinning and without any consideration of the state of the art.
`
`2.
`
`The Board erred in its construction of the term “lateral, trans-psoas
`
`path to the lumbar spine.” The proper interpretation of “lateral” is an approach
`
`from the patient’s lateral aspect.
`
`3.
`
`The Board erred by failing to consider unrebutted evidence of nexus
`
`between the commercial embodiment and the claims. The Board’s alternative
`
`arguments for disregarding objective indicia of nonobviousness are similarly
`
`legally erroneous.
`
`xii
`
`
`

`

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`INTRODUCTION
`
`The ’057 patent claims a novel and nonobvious method of performing spinal
`
`fusion surgery via a lateral, trans-psoas approach—a surgical approach from the
`
`side of the patient to the lumbar spine. The method requires traversing the nerve-
`
`rich psoas muscle, which conventional wisdom taught was unpredictable and
`
`unsafe.
`
`During the inter partes reexamination that is the subject of this appeal, twice
`
`the Examiner found the claims of the ’057 patent nonobvious. The Examiner found
`
`no motivation to combine the prior art references in the manner suggested by the
`
`Requester to create a surgery that conventional wisdom counseled against
`
`performing. The Board twice reversed the Examiner, but in reversing, the Board
`
`did not present the factfinding necessary to support its conclusion that there was
`
`motivation to combine nor did it take into account the state of the art prior to the
`
`inventive surgery claimed in the ’057 patent. The Board erred and its decision
`
`should be reversed.
`
`The Board also sua sponte construed the claim term “lateral, trans-psoas
`
`path” in the final decision. The Board erred by construing the term to include a
`
`surgical path “which is to the lateral side of the body, to any significant degree, as
`
`compared to an anterior puncture.” This construction is unreasonably broad and is
`
`1
`
`
`

`

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`in conflict with the specification of the ’057 patent. Moreover, the Board’s
`
`construction finds no support in the extrinsic record evidence either.
`
`NuVasive submitted extensive and unrebutted objective evidence of
`
`nonobviousness. NuVasive showed how an extremely successful commercial
`
`embodiment was encompassed by the claims. The Examiner relied on this
`
`evidence, in part, in coming to her conclusion that the claims were nonobvious.
`
`The Board, however, found various legally erroneous reasons not to consider
`
`NuVasive’s evidence. Additionally, the Board’s unreasonably broad construction
`
`of the “lateral, trans-psoas path” claim term led to the conclusion that the claims
`
`were not reasonably commensurate in scope. Under a proper legal analysis, the
`
`presented objective indicia are convincing evidence of nonobviousness.
`
`STATEMENT OF THE CASE
`
`This appeal is from an inter partes reexamination of the ’057 patent owned
`
`by NuVasive. NuVasive appeals the Board’s rulings that claims 17-22 and 24-27
`
`of the ’057 patent were unpatentable as obvious in view of the cited prior art.
`
`I.
`
`Invention—XLIF (eXtreme Lateral Interbody Fusion)
`
`The claims of the ’057 patent are directed to a method of inserting a spinal
`
`fusion implant into an intervertebral disc space using a lateral, trans-psoas
`
`approach. In 2003, NuVasive pioneered the surgical procedure that made the
`
`lateral, trans-psoas approach safe. NuVasive markets this innovation under the
`2
`
`
`

`

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`tradename “eXtreme Lateral Interbody Fusion,” or “XLIF.” A lateral trans-psoas
`
`approach goes through the psoas muscle, which contains a large network of nerves.
`
`Historically, surgeons avoided using such an approach for fear of damaging these
`
`nerves while penetrating the psoas muscle.
`
`A.
`
`State of the Art in Spinal Surgery
`
`Interbody fusion is a commonly used surgical procedure to address pain
`
`associated with damaged intervertebral discs. Appx2015. Interbody fusion surgery
`
`involves removing some or all of the damaged disc material and inserting an
`
`implant in place of the disc. Appx2017. The implant restores the height between
`
`adjacent vertebral bodies and induces bone growth leading to fusion between the
`
`two vertebral bodies. Appx2017; Appx2271, ¶24. The resulting fusion improves
`
`the stability of the spine and relieves the pain associated with damaged discs and
`
`compression of vertebrae. Id.
`
`A variety of surgical approaches exist for interbody fusion. These
`
`approaches are generally named for the aspect of the patient from which the
`
`surgical approach initiates. For instance, a posterior lumbar interbody fusion
`
`(“PLIF”) surgery initiates from the patient’s posterior aspect (i.e., the back of the
`
`patient). Similarly, an anterior lumbar interbody fusion (“ALIF”) surgery initiates
`
`from the patient’s anterior aspect (i.e., the front of the patient). A lateral lumbar
`
`interbody fusion (“LLIF”) surgery initiates from the patient’s lateral aspect (i.e.,
`3
`
`
`

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`the right or left side of the patient). Appx2243. NuVasive’s XLIF is an LLIF
`
`surgery as are the many lateral, trans-psoas surgeries now offered by NuVasive’s
`
`competitors. For example, Medtronic’s Direct Lateral Interbody Fusion (“DLIF”),
`
`Alphatec’s Guided Lateral Interbody Fusion (“GLIF”), and Globus’s Lateral
`
`Lumbar Interbody Fusion (“LLIF”). Appx1927.
`
`Interbody fusion surgery must balance numerous competing needs including
`
`safety, reproducibility, recovery time, and risk of complications. Balancing these
`
`competing needs led to the development of interbody fusion surgeries that typically
`
`approach the spine from either the front (anterior) or the rear (posterior) aspect of
`
`the patient. Appx2013-2017. Anterior approaches to interbody fusion surgery
`
`access the spine through the abdominal cavity, and as such, carry a risk of damage
`
`to internal organs and major blood vessels. Appx2272-2273, ¶¶26, 27. Posterior
`
`approaches, on the other hand, require the removal of bony processes from the
`
`spine and are associated with a higher incidence of neural complications from
`
`damage to paraspinal nerves emanating from the rear of the spinal column.
`
`Appx2274-2275, ¶¶29-30.
`
`In contrast, a lateral approach—inserting an implant through the side of the
`
`patient—has the advantage of providing the most direct route to the disc space.
`
`Additionally, the lateral approach would address most of the challenges associated
`
`with anterior and posterior approaches to the spine and provide a valuable
`
`4
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`alternative to patients not being served by the two historical approaches. Appx2002;
`
`Appx2015. Experimental lateral approaches to the lumbar spine were reported as
`
`early as the 1980s, but there was an obstacle to widespread adoption of these
`
`approaches. Appx2267, ¶16; Appx2276-2279, ¶¶33-38.
`
`The obstacle is the lumbar plexus, a network of nerves that originate in the
`
`spinal column and exit through the foramina, or openings, of the lumbar vertebra
`
`L1, L2, L3 and L4.1 Appx2268-2269, ¶¶18, 19. The nerves branch following exit
`
`from the foramina to form the lumbar plexus. Id.; Appx2562-2563. The psoas
`
`muscle attaches in the back to the transverse process of the vertebrae and in the
`
`front to the vertebral bodies and intervertebral discs (see also Appx2562-2563):
`
`Anterior
`
`Posterior
`
`Vertebral body
`
`Degenerative disc
`
`I ntervertebral
`foramen
`
`Psoas
`attachment
`
`Impinged
`nerve
`Transverse
`process
`
`Lumbar Spine
`
`
`
`Appx2271 (labels added)
`
`
`1 The vertebra of the spine are typically referred to by letter and number.
`Starting from the top of the spine, T1 refers to the first thoracic vertebra, L1 refers
`to the first lumbar vertebra, and S1 refers to the first sacral vertebra.
`5
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`

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`The lumbar plexus runs through the psoas muscle in line with the
`
`intervertebral foramina, and as such, is found in the posterior portion of the muscle.
`
`Appx2595. The nerves of the lumbar plexus supply (innervate) the leg and pelvic
`
`region with sensory and motor neurons. Appx2562. Surgical corridors through the
`
`lumbar plexus are particularly challenging because these nerves are anatomically
`
`unique and tethered to the spinal column, and thus are not easily mobilized during
`
`surgery (for example, by using a surgical instrument to move the nerve away from
`
`the surgical path). Appx2268-2269, ¶19. Furthermore, damage to the nerve roots
`
`within the lumbar plexus can result in serious side effects, including impairment of
`
`motor function in the legs and extreme pain. Appx2268-2269, ¶19.
`
`Accordingly, despite the recognized benefits, surgeons historically avoided
`
`using a lateral approach, and conventional wisdom taught that such an approach
`
`should be avoided, for fear of damaging the essential nerve roots while penetrating
`
`the psoas muscle. Appx2267-2268, ¶¶16, 17; Appx2438-2439, ¶15. Those of
`
`ordinary skill in the art viewed the psoas muscle as a “no man’s land” or an
`
`“alligator-infested swamp” due to the perceived impossibility of safely and
`
`reproducibly avoiding the nerve roots of the lumbar plexus. Appx2431-2433, ¶7;
`
`Appx2438-2439, ¶15. Moreover, while nerve monitoring techniques were known,
`
`they were not viewed as providing a solution to the risk of damage to the lumbar
`
`plexus nerves. Appx2270-2271, ¶21; Appx2433-2434, ¶9.
`
`6
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`

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`B. XLIF Surgical Procedure Defied Conventional Wisdom as to the
`Possibility of Safely and Reproducibly Traversing the Psoas
`Muscle in a Lateral Surgery
`
`NuVasive developed its lateral lumbar interbody fusion procedure, XLIF, to
`
`address the need for a safe and reproducible lateral, trans-psoas surgical corridor to
`
`the spine. Appx1093-1094, ¶9.
`
`The XLIF surgical procedure is a minimally invasive approach to spinal
`
`fusion surgery that,
`
`unlike the traditional
`
`approaches, accesses the
`
`disc space from the
`
`lateral aspect of the
`
`patient (See figure
`
`reproduced from
`
`Psoas
`
`Appx2243, labels added).
`
`lateral
`
`XLIF Surgery
`
`Specifically, the XLIF surgical procedure accesses the disc space by creating an
`
`operative corridor through the psoas muscle. Appx2639. Because damage to the
`
`motor nerves of the psoas could lead to serious and usually irreversible
`
`consequences, specialized nerve monitoring is employed during placement and
`
`removal of the instruments used to access the disc space. Appx2280-2281, ¶¶41, 42.
`
`7
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`
`

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`The nerve monitoring employed with the XLIF surgical procedure is
`
`electromyography (EMG). Appx56, Fig. 16; Appx60, 3:46-55; Appx2281-2282,
`
`¶43. EMG nerve monitoring can assess the presence and location of motor neurons
`
`relative to an electrical nerve-stimulating device. Appx64, 12:36-41; Appx2281-
`
`2282, ¶43. Excitation of a motor neuron with a nerve-stimulating device causes the
`
`nerve to transmit its own electrical signal that, in turn, results in the contraction of
`
`the corresponding muscle. Appx64, 12:26-32. The contraction of the muscle can be
`
`monitored using electrodes attached to the muscle that detect the change in electric
`
`potential associated with
`
`muscle contraction.
`
`Appx62, 8:18-25.
`
`Claim 17 of the ’057
`
`patent, from which all of
`
`the challenged claims
`
`depend, covers the XLIF
`
`surgical procedure. Claim
`
`17 was amended during the
`
`inter partes reexamination
`
`to include neuromonitoring
`
`\0 ~
`
`30
`
`F]G.1
`
`8
`
`
`

`

`Case 3:18-cv-0034