Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 1 Filed: 02/03/2014
`
`2013-1576, -1577
`__________________________________________________________________
`
`
`
`United States Court Of Appeals United States Court Of Appeals United States Court Of Appeals United States Court Of Appeals
`
`
`
`for the Federal Circuitfor the Federal Circuitfor the Federal Circuit for the Federal Circuit
`
`WARSAW ORTHOPEDIC, INC.,
`Plaintiff/Counterclaim Defendant-Appellant,
`
`and
`
`MEDTRONIC SOFAMOR DANEK USA, INC.,
`Counterclaim Defendant-Appellant,
`
`and
`
`
`
`
`
`
`
`
`
`
`MEDTRONIC PUERTO RICO OPERATIONS CO. and MEDTRONIC
`SOFAMOR DANEK DEGGENDORF, GMBH,
`Counterclaim Defendants,
`
`v.
`
`NUVASIVE, INC,
`
`Defendant/Counterclaimant-Cross-Appellant,
`__________________________________________________________________
`
`APPEALS FROM THE U.S. DISTRICT COURT FOR THE SOUTHERN DISTRICT OF CALIFORNIA IN CASE
`NO. 08-CV-1512, JUDGES CATHY ANN BENCIVENGO AND MICHAEL M. ANELLO
`__________________________________________________________________
`
`NUVASIVE’S OPENING BRIEF
`__________________________________________________________________
`
`
`
`Frank E. Scherkenbach
`Todd G. Miller
`Michael J. Kane
`Fish & Richardson P.C.
`Michael A. Amon
`Fish & Richardson P.C.
`One Marina Park Drive
`Craig E. Countryman
`3200 RBC Plaza
`Boston, MA 02110-2804
`Fish & Richardson P.C.
`60 South Sixth Street
`
`12390 El Camino Real
`Minneapolis, MN 55402
`San Diego, CA 92130
`
`
`February 3, 2014
`
`
`
`
`
` 1
`
`NUVASIVE 1069
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`IPR2013-00208
`
`

`

`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 2 Filed: 02/03/2014
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`CERTIFICATE OF INTEREST
`
`Counsel for NuVasive, Inc., certifies the following:
`
`1.
`
`The full name of every party or amicus represented by me is: NuVasive,
`
`Inc.
`
`2.
`
`The name of the real party in interest (if the party named in the caption
`
`is not the real party in interest) represented by me is: N/A.
`
`3.
`
`All parent corporations and any publicly held companies that own 10
`
`percent or more of the stock of the party or amicus curiae represented by me are:
`
`N/A.
`
`4.
`
`5.
`
`N/A. There is no such corporation as listed in paragraph 3.
`
`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 are:
`
`Fish & Richardson P.C.: *Craig R. Compton, Frank E. Scherkenbach, *John
`E. Gartman, Keeley Vega, Kelly C. Hunsaker, *Kimberly Kennedy, Michael E.
`Florey, *Nicholas V. Martini, *Thomas S. McClenahan, Todd G. Miller, Craig
`E. Countryman, John M. Farrell, Jonathan J. Lamberson, and Neil Warren.
`
`
`
`
`
`
`
`Morrison & Foerster LLP: Deanne E. Maynard; Brian R. Matsui; and Ryan J.
`Malloy.
`
`Chaz De La Garza & Associates, LLC: Charles H. De La Garza
`
`*No longer with firm
`
`Dated: February 3, 2014
`
`
`
`
`
`
`
`
`
`
`/s/ Craig E. Countryman
`Craig E. Countryman
`
`
`
`
`
`i
`
`
`
` 2
`
`

`

`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 3 Filed: 02/03/2014
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`
`
`TABLE OF CONTENTS
`
`Page
`
`Certificate of Interest ...................................................................................... i
`
`Statement of Related Cases ........................................................................... x
`
`Statement of Jurisdiction ..............................................................................xi
`
`Statement of the Issues for NuVasive’s Cross-Appeal ........................... xii
`
`Statement of the Issues for Warsaw’s Appeal ......................................... xiii
`
`Statement of the Facts .................................................................................. 1
`
`I.
`
`Technology Background on Spinal Fusion Surgery. .......... 1
`
`II. Warsaw’s ’973 Patent. ............................................................ 3
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`The ’973 Patent Tries to Distinguish Its Implant
`Based on the “Oversized” Dimensions. .................. 3
`
`The Prior Art Brantigan Commercial Implants
`Have the Same Dimensions Claimed in the ’973
`Patent. ........................................................................... 6
`
`The Brantigan ’327 Patent Discloses Implants for
`Lateral Insertion With The Same Dimensions As
`The ’973 Patent. .......................................................... 8
`
`The District Court Rejects Warsaw’s
`Constructions at Markman. ........................................ 8
`
`The Trial: Warsaw Distinguishes the Brantigan
`Implants Based Solely On Its Rejected Claim
`Construction Positions. .............................................. 9
`
`The Result: the Jury Upholds Validity Based on
`Warsaw’s Erroneous Claim Construction
`Arguments. ................................................................. 12
`
`III. Warsaw’s ’933 Patent. .......................................................... 13
`
`ii
`
`
`
` 3
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`

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`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 4 Filed: 02/03/2014
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`TABLE OF CONTENTS (continued)
`
`Page
`
`
`
`A.
`
`The ’933 Patent Claims a Two-Blade Retractor in
`Which “Each” Blade Laterally Moves and Pivots. 13
`
`B. NuVasive’s Products Are Three-Blade Retractors
`in Which One Blade Does Not Laterally Move
`and Pivot. ................................................................... 15
`
`C. Warsaw’s Infringement Case under the Doctrine
`of Equivalents. ........................................................... 16
`
`IV. Warsaw’s Damages Presentation, and the Jury’s Award. 17
`
`A. Warsaw’s “Lost Profits” Were Funds That
`Supposedly Would Have Been Transferred to It
`by Other Medtronic Entities. .................................. 17
`
`B. Most Warsaw “Lost Profits” Were From
`Unpatented Products. ............................................... 18
`
`V. Warsaw’s Appeal of Post-Trial Damages-Related
`Rulings. .................................................................................. 20
`
`A. Ongoing Royalties. .................................................... 20
`
`B.
`
`Supplemental Damages. ........................................... 21
`
`VI. NuVasive’s ’236 Patent. ....................................................... 22
`
`A. NuVasive’s Nerve-Monitoring Creates a Safe and
`Reproducible Lateral Procedure. ............................. 22
`
`B. Medtronic’s Infringing NIM-Eclipse System. ....... 23
`
`Summary of the Argument ......................................................................... 25
`
`Argument ...................................................................................................... 27
`
`I.
`
`The Judgment on the ’973 Patent Should be Reversed or
`Vacated Based on Anticipation and Obviousness. .......... 27
`
`A.
`
`The Brantigan Implants Anticipate the Asserted
`Claims. ........................................................................ 27
`
`iii
`
`
`
`
` 4
`
`

`

`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 5 Filed: 02/03/2014
`
`TABLE OF CONTENTS (continued)
`
`Page
`
`
`
`B.
`
`C.
`
`Brantigan ’327 Invalidates the Asserted Claims. ... 35
`
`At a Minimum, a Remand is Necessary to
`Determine Validity Without Warsaw’s Improper
`Claim Construction Arguments. ............................. 37
`
`II.
`
`Even if the Asserted ’973 Claims Are Not Invalid In
`Light of the Prior Art, They Are Indefinite. ..................... 38
`
`III. NuVasive Does Not Infringe the ’933 Patent as a Matter
`of Law. ................................................................................... 41
`
`A.
`
`Vitiation Bars Warsaw’s Infringement Theory. ..... 41
`
`B. Warsaw Cannot Show the Working Channel is
`Enlargeable by Laterally Moving and Pivoting
`“Each” Blade. ............................................................ 43
`
`IV. Warsaw’s Lost Profits Theory Was Legally
`Impermissible. ....................................................................... 45
`
`A. Warsaw Was Not Entitled to Recover Money
`Transferred to It by Other Medtronic Entities as
`“Lost Profits” Damages. .......................................... 45
`
`B.
`
`C.
`
`D.
`
`There Should Be No Lost Profits on Unpatented
`Components. ............................................................. 48
`
`The Damages Award Must Be Vacated if the
`Judgment on the ’973 or ’933 Patent is Set Aside. 51
`
`The Ongoing Royalty Should Be Vacated If this
`Court Changes the Lost Profits Award. ................. 51
`
`V.
`
`If the Court Reaches Warsaw’s Damages Appeal, It
`Should Affirm. ...................................................................... 52
`
`A.
`
`The District Court Correctly Denied
`Supplemental Damages. ........................................... 52
`
`iv
`
`
`
`
` 5
`
`

`

`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 6 Filed: 02/03/2014
`
`TABLE OF CONTENTS (continued)
`
`Page
`
`
`
`B.
`
`If the Court Affirms on Liability and Damages,
`the Ongoing Royalty Was Not an Abuse of
`Discretion. .................................................................. 55
`
`VI. The Court Should Affirm on the ’236 Patent. .................. 60
`
`A.
`
`B.
`
`C.
`
`The District Court Correctly Construed the
`“Stopping” Step. ....................................................... 60
`
`The District Court Correctly Construed “Stimulus
`Signal.”........................................................................ 62
`
`Substantial Evidence Supported the Jury’s
`Conclusion that Use of NIM-Eclipse Meets the
`“Stopping” Limitation. ............................................. 63
`
`D.
`
`Substantial Evidence Showed the Other Elements
`of Indirect Infringement. ......................................... 66
`
`Conclusion .................................................................................................... 68
`
`
`
`v
`
`
`
`
` 6
`
`

`

`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 7 Filed: 02/03/2014
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Pages
`
`Am. Calcar, Inc. v. Am. Honda Motor Co., Inc.,
`651 F.3d 1318 (Fed. Cir. 2011) ..................................................................................... 43
`
`Am. Seating Co. v. USSC Group, Inc.,
`514 F.3d 1262 (Fed. Cir. 2008) ............................................................................... 48, 49
`
`Apple, Inc. v. Samsung Elecs. Co., Ltd.,
`926 F. Supp. 1100 (N.D. Cal. 2013) ............................................................................. 52
`
`Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc.,
`670 F.3d 1171, as modified on rehearing, 682 F.3d 1003 (Fed. Cir. 2012) ..................... 58
`
`Boston Sci. Scimed, Inc. v. Cordis Corp.,
`554 F.3d 982 (Fed. Cir. 2009) ........................................................................................ 36
`
`Broadcom Corp. v. Qualcomm Inc.,
`543 F.3d 683 (Fed. Cir. 2008) ........................................................................................ 66
`
`Cable Television Assoc., Inc. v. Am. Cinema Editors, Inc.,
`937 F.2d 1572 (Fed. Cir. 1991) ..................................................................................... 40
`
`Cordis Corp. v. Boston Scientific Corp.,
`561 F.3d 1319 (Fed. Cir. 2009) ..................................................................................... 37
`
`Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) ..................................................................................... 50
`
`Dolly, Inc. v. Spalding & Evenflo Cos., Inc.,
`16 F.3d 394 (Fed. Cir. 1994) .......................................................................................... 44
`
`Ecolab, Inc. v. FMC Corp.,
`569 F.3d1335 (Fed. Cir. 2009) ....................................................................................... 55
`
`Exergen Corp. v. Wal-Mart Stores, Inc.,
`575 F.3d 1312 (Fed. Cir. 2009) ..................................................................................... 27
`
`Fantasy Sports Props. v. Sportsline.com,
`287 F.3d 1108 (Fed. Cir. 2002) ..................................................................................... 34
`
`Fujitsu Ltd. v. Tellabs, Inc.,
`2013 WL 2285794 (N.D. Ill. May 23, 2013) .......................................................... 47, 48
`
`vi
`
`
`
` 7
`
`

`

`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 8 Filed: 02/03/2014
`
`TABLE OF AUTHORITIES (continued)
`
`Page(s)
`
`
`Geneva Pharms., Inc. v. GlaxoSmithKline PLC,
`349 F.3d 1373 (Fed. Cir. 2003) ..................................................................................... 39
`
`Genlyte Thomas Group LLC v. Arch Lighting Group, Inc.,
`278 Fed. App’x 1004 (Fed. Cir. 2008) .......................................................................... 54
`
`Global-Tech Appliances, Inc. v. SEB S.A.,
`131 S.Ct. 2060 (2011) ............................................................................................... 66, 67
`
`Howmedica Osteonics Corp. v. Tranquil Prospects, Ltd.,
`401 F.3d 1367 (Fed. Cir. 2005) ..................................................................................... 40
`
`i4i Ltd. P’ship v. Microsoft Corp.,
`598 F.3d 831 (Fed. Cir. 2010) ........................................................................................ 67
`
`Intamin Ltd. v. Magnetar Techs., Corp.,
`483 F.3d 1328 (Fed. Cir. 2007) ..................................................................................... 43
`
`IPXL Holdings, L.L.C. v. Amazon.com, Inc.,
`430 F.3d 1377 (Fed. Cir. 2005) ............................................................................... 25, 39
`
`Janes v. Wal–Mart Stores Inc.,
`279 F.3d 883 (9th Cir. 2002) ......................................................................................... 27
`
`Lucent Techs., Inc. v. Gateway, Inc.,
`580 F.3d 1301 (Fed. Cir. 2009) ..................................................................................... 54
`
`Markman v. Westview Instruments, Inc.,
`517 U.S. 370 (1996) ............................................................................................ 10, 11, 38
`
`Marrin v. Griffin,
`599 F.3d 1290 (Fed. Cir. 2010) ......................................................................... 30, 31, 32
`
`Mentor H/S, Inc. v. Medical Device Alliance, Inc.,
`244 F.3d 1365 (Fed. Cir. 2001) ..................................................................................... 67
`
`Orion IP, LLC v. Hyundai Motor America,
`605 F.3d 967 (Fed. Cir. 2010) .................................................................................. 27, 32
`
`Orthokinetics, Inc. v. Safety Travel Chairs, Inc.,
`806 F.2d 1565 (Fed. Cir. 1986) ..................................................................................... 40
`
`vii
`
`
`
`
` 8
`
`

`

`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 9 Filed: 02/03/2014
`
`TABLE OF AUTHORITIES (continued)
`
`Page(s)
`
`
`Oscar Mayer Foods Corp. v. Conagra, Inc.,
`869 F. Supp. 656 (W.D. Wis. 1994) ........................................................................ 52, 55
`
`Paice LLC v. Toyota Motor Corp.,
`504 F.3d 1293 (Fed. Cir. 2009) ............................................................................... 55, 59
`
`Paragon Solutions, LLC v. Timex Corp.,
`566 F.3d 1075 (Fed. Cir. 2009) ..................................................................................... 39
`
`Poly-America, L.P. v. GSE Lining Tech., Inc.,
`383 F.3d 1303 (Fed. Cir. 2004) .................................................................. 45, 46, 47, 48
`
`Presidio Components Inc. v. Am. Tech. Ceramics Corp.,
`2010 WL 3070370 (S.D.Cal. Aug. 5, 2010) .................................................................. 52
`
`Rite-Hite Corp. v. Kelley Co., Inc.,
`56 F.3d 1538 (Fed. Cir. 1995) (en banc) ................................................................... 45, 50
`
`Seachange Int’l, Inc. v. C-Cor, Inc.,
`413 F.3d 1361 (Fed. Cir. 2005) ..................................................................................... 41
`
`SmithKline Beecham Corp. v. Apotex Corp.,
`403 F.3d 1331 (Fed. Cir. 2005) ..................................................................................... 27
`
`Soverain Software LLC, v. Newegg, Inc.,
`705 F.3d 1333 (Fed. Cir. 2013) ..................................................................................... 32
`
`TI Group Auto. Sys., Inc. v. VDO North Am., L.L.C.,
`375 F.3d 1126 (Fed. Cir. 2004) ..................................................................................... 27
`
`Trading Techs. Int’l, Inc. v. eSpeed, Inc.,
`595 F.3d 1340 (Fed. Cir. 2010) ..................................................................................... 42
`
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998) ..................................................................................... 43
`
`United Carbon Co. v. Bitney & Smith Co.,
`317 U.S. 228 (1942) ........................................................................................................ 38
`
`Verizon Servs. Corp. v. Vonage Holdings Corp.,
`503 F.3d 1295 (Fed. Cir. 2007) ..................................................................................... 51
`
`viii
`
`
`
`
` 9
`
`

`

`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 10 Filed: 02/03/2014
`
`TABLE OF AUTHORITIES (continued)
`
`Page(s)
`
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) ........................................................................................ 61
`
`STATUTES
`
`35 U.S.C. § 112(b) ................................................................................................................. 38
`
`ix
`
`
`
`
`10
`
`

`

`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 11 Filed: 02/03/2014
`
`
`
`STATEMENT OF RELATED CASES
`
`Pursuant to Fed. R. App. P. 47.5, counsel for NuVasive states that there was an
`
`earlier appeal and cross-appeal in this case, which a motions panel of this Court,
`
`consisting of Judges Lourie, Schall, and Dyk, dismissed as premature on August 2,
`
`2012, because the ongoing royalty rate had not yet been set by the district court. See
`
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., Appeal Nos. 2012-1263, -1266. There have
`
`been no other appeals in or from the same civil action or proceeding in the lower
`
`court previously before this or any other appellate court.
`
`There is no case known to counsel to be pending in this court that will directly
`
`affect or be directly affected by this Court’s decision. There is one other district court
`
`case between these parties—Warsaw Orthopedic, Inc. et al. v. NuVasive, Inc., Case No. 12-
`
`cv-02738-CAB (MDD) (S.D. Cal.)—that may be impacted by the Court’s decision in
`
`this appeal
`
`Moreover, there are two pending inter partes reviews in the PTO regarding
`
`Warsaw’s U.S. Patent 8,251,997, which is related to Warsaw’s ’973 patent in this case.
`
`The PTO’s opinion granting review of the ’997 patent rejected the interpretation of a
`
`prior art reference (the Brantigan ’327 patent) that Warsaw has advanced in this case,
`
`and found that Brantigan ’327 teaches an implant that is capable of lateral insertion.
`
`x
`
`
`
`
`11
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`

`

`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 12 Filed: 02/03/2014
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`
`
`STATEMENT OF JURISDICTION
`
`The district court had jurisdiction over this patent infringement case under 28
`
`U.S.C. §§ 1331 and 1338. The district court entered a final judgment on August 20,
`
`2013. (A78-79.)
`
`NuVasive filed its Notice of Appeal on August 20, 2013, and Warsaw filed its
`
`Notice of Appeal on August 20, 2013. (A5885-88, A5889-91.) Both Notices of
`
`Appeal were filed within 30 days of the final judgment, making them timely under
`
`Federal Rule of Appellate Procedure 4(a)(1)(A). This Court thus has jurisdiction over
`
`the appeal and the cross-appeal pursuant to 28 U.S.C. § 1295(a)(1).
`
`xi
`
`
`
`
`12
`
`

`

`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 13 Filed: 02/03/2014
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`
`
`STATEMENT OF THE ISSUES FOR NUVASIVE’S CROSS-APPEAL
`
`1. Whether the judgment of no invalidity on the ’973 patent can stand where:
`
`
`(i) Each element of the asserted claims is present in the prior art commercial
`Brantigan implants;
`
`
`(ii) The Brantigan ’327 patent anticipated or rendered obvious each asserted
`claim; and
`
`(iii) Warsaw distinguished this prior art by relying only on limitations that are
`not part of the claims as properly construed by the district court.
`
`2. Whether the asserted ’973 claims are indefinite because they purport to cover an
`apparatus yet implicitly require method steps because they define the implant’s
`dimensions relative to the vertebrae between which it is inserted.
`
`3. Whether the infringement judgment on the ’933 patent should be reversed where:
`
`
`(i) Warsaw’s theory of equivalence vitiated the numerical and structural
`limitations recited in the claims; and
`
`
`(ii) Warsaw relied on different structures to meet the “first and second
`portions” requirement in different parts of the claims, even though the
`claims require the same structure to meet this requirement throughout.
`
`
`4. Whether the entire “lost profits” award should be set aside because Warsaw
`sought to recover money that other Medtronic entities supposedly would have
`transferred to Warsaw, rather than its own lost sales revenue.
`
`5. Whether the “lost profits” award should be vacated because Warsaw included
`hundreds of unpatented items in its calculations.
`
`xii
`
`
`
`13
`
`

`

`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 14 Filed: 02/03/2014
`
`
`
`STATEMENT OF THE ISSUES FOR WARSAW’S APPEAL
`
`1. If this Court affirms the liability judgment on the ’973 or ’933 patent, whether the
`district court abused its discretion when denying Warsaw’s supplemental damages
`request.
`
`2. If this Court affirms the liability judgment on the ’973 or ’933 patent, whether the
`district court abused its discretion in setting an ongoing royalty at a rate higher
`than the jury’s but consistent with the public interest in continued availability of
`the accused products.
`
`3. Whether the district court correctly construed the claims of the ’236 patent, and, if
`so, whether substantial evidence supports the jury’s infringement determination.
`
`
`
`
`
`
`
`xiii
`
`
`
`
`14
`
`

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`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 15 Filed: 02/03/2014
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`
`
`STATEMENT OF THE FACTS
`
`I.
`
`Technology Background on Spinal Fusion Surgery.
`
`The patents-in-suit relate to various spinal surgery components. The spine
`
`includes a vertebral column that is composed of a series of bony vertebral bodies
`
`separated by spongy discs. (A1998-99.)
`
`
`
`The discs can deteriorate, bulging into surrounding tissue or irritating nearby
`
`nerves. One treatment is fusion surgery, in which all or part of the disc is removed
`
`and replaced with an implant (which maintains proper separation between the
`
`vertebrae) and bone growth material (which promotes fusion between vertebrae).
`
`(A10131-32.) Surgeons can optionally install fixation equipment (e.g., rods and
`
`screws) separately in patients to further stabilize the spine. (A11186-87.)
`
`There are multiple ways to access the disc space to perform a fusion, including
`
`through the patient’s front (anterior), back (posterior), or side (lateral). Several
`
`references in the 1980s and early 1990s disclosed lateral insertion, (A17429-41 at
`
`1
`
`
`
`15
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`

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`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 16 Filed: 02/03/2014
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`
`
`A17436, A17438, A17440; A11835-37; A12186-87; A17450-59 at 2:55-59), and the
`
`lateral approach had the known benefit of avoiding the aorta or the spinal cord.
`
`(A252-53.) But the lateral approach had a major challenge that prevented its
`
`widespread use, particularly for the lower, lumbar, spine. (A10367-70, A10470-72.)
`
`The lumbar spine is surrounded by the psoas, a nerve-packed muscle:
`
`
`
`(A17546.) A surgeon trying to access the disc space through the psoas without
`
`guidance has an 80-90% chance of hitting a nerve. (A17634-35, A10472-73.)
`
`
`
`NuVasive solved this problem by introducing eXtreme Lateral Interbody
`
`Fusion (XLIF) in 2003—the first safe and reproducible lateral procedure that included
`
`a nerve-monitoring system. (A10403-04, A10413, A10470-72.) Nerve-monitoring
`
`made lateral procedures accessible to all properly trained spine surgeons, not just the
`
`few, highly skilled ones who had successfully performed a lateral fusion in the past.
`
`(Id.) NuVasive’s U.S. Patent 7,470,236 covers its first nerve-monitoring algorithm.
`
`(A279-300, A10468-71.) NuVasive has other patents on various aspects of XLIF,
`
`several of which it currently asserts against Medtronic in another suit.
`
`2
`
`
`
`
`16
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`

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`Case: 13-1576 CASE PARTICIPANTS ONLY Document: 32 Page: 17 Filed: 02/03/2014
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`
`
`Contrary to Warsaw’s accusations at p. 10-11, XLIF was developed in-house at
`
`NuVasive. (A10445-50, A10523, A10569.) NuVasive’s efforts had nothing to do
`
`with Medtronic’s ELIF (Endoscopic Lateral Interbody Fusion)—a procedure that
`
`Medtronic abandoned before ever trying it on a live human, because it was unsafe.
`
`(A10397, A10445-47, A10472-73.) When Medtronic did introduce a lateral procedure
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`several years later—Direct Lateral Interbody Fusion (DLIF)—surgeons described it as
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`“inferior” and called NuVasive’s XLIF procedure “irreplaceable.” (A16572-76.)
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`Medtronic responded to NuVasive’s success with XLIF in two ways. It
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`updated DLIF to include better nerve-monitoring technology—technology that
`
`infringes NuVasive’s ’236 patent. (A240.) And a Medtronic-related holding company
`
`(Warsaw) filed this suit targeting the implants and retractors used in XLIF.
`
`II. Warsaw’s ’973 Patent.
`
`A. The ’973 Patent Tries to Distinguish Its Implant Based on the
`“Oversized” Dimensions.
`
`Warsaw’s U.S. Patent 5,860,973 is part of a family that includes patents to
`
`implants of various sizes and shapes and to various surgical methods. The technology
`
`was not developed by Medtronic—it was licensed from Dr. Gary Michelson, who has
`
`never performed a lateral fusion on a live human patient. (A10236.) The ’973 patent
`
`is directed to an implant with a length, width, and height that are defined relative to
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`the dimensions of the space between two adjacent vertebrae. (A243-59.) Its earliest
`
`possible priority date is in 1995. (A18873.)
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`The ’973 patent distinguished its implant from the prior art based on size. The
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`patent is directed to an “oversized spinal implant” intended “for insertion from the
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`side of a patient (translateral).” (A243-52 at Abstract, 1:15-18.) The specification
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`contrasts the size of the “translateral spinal fusion implant of the present invention”
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`with prior implants that were inserted from the front or back because “such implants
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`are necessarily limited by the depth, measured from front to back of the vertebrae.”
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`(A253 at 3:11-17; see also A252 at 2:3-8.) The specification criticizes these prior
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`implants as too small to provide adequate stability for the spine, stressing that the
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`advantage of the “translateral spinal fusion implant of the present invention” is that it
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`“has more surface area of contact” with the vertebrae “and thus permits greater
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`stability so as to withstand torque.” (A253 at 3:50-53.)
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`The prosecution history likewise contrasted prior implants based on size.
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`Responding to an anticipation rejection, the Applicant argued that “[n]one of the
`
`implants of the past teach, disclose, or suggest a translateral spinal implant having a
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`length that is substantially greater than one half the transverse width of the vertebrae
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`and the length being substantially greater than the width of the vertebrae.” (A31009.)
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`After distinguishing one prior art implant in detail based on size, (A31011), the
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`Applicant concluded that his oversized implant was patentable because it was “being
`
`sized to maximize the surface area of contact of the claimed implant between the two
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`adjacent vertebrae” which “permits substantial improvement of the function of
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`Applicant’s implant” over the prior art. (A31012.)
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`The asserted claims—24, 41, 42, 57, and 61—include a non-limiting preamble
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`and a body that recites the “oversized” dimensions the Applicant thought
`
`distinguished his implant from the prior art. Claim 35 (from which 41 and 42 depend)
`
`is representative and contains the key language related to the parties’ validity dispute:
`
`35. A translateral spinal implant for insertion from the lateral aspect of
`the spine in the disc space between two adjacent vertebrae, said implant
`having
`
`
`a length that is greater than one half the transverse width of the
`vertebrae,
`
`said length being substantially greater than the depth of the vertebrae,
`
` height for contacting each of the two adjacent vertebrae, and
`
` width that is at least as great as the height.
`
` a
`
` a
`
`
`(A258 at 13:1-7.) The other claims add prior art structures (e.g., ratchetings to prevent
`
`the implant from slipping out and openings for bone growth material). (A257-58.)
`
`The claims define the implant’s dimensions relative to the size of the vertebrae
`
`between which it is inserted. Nevertheless, the specification explains that a “preferred
`
`embodiment” is 42 mm in length, 26 mm in width, and 10-12 mm in height:
`
`In the preferred embodiment, the spinal fusion implant 900 has a height in the
`range of 8 mm to 16 mm, with the preferred height being 10-12 mm; a width in
`the range of 24 mm to 32 mm, with the preferred width being 26 mm; and a
`length in the range of 32 mm to 50 mm, with 42 mm being the preferred
`length.
`
`(A256 at 10:42-47.)
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`B. The Prior Art Brantigan Commercial Implants Have the Same
`Dimensions Claimed in the ’973 Patent.
`
`There were prior implants with the same dimensions as the ’973 claims. By
`
`1990, years before the earliest possible priority date, spine surgeon Dr. John Brantigan
`
`had developed and used implants with the same dimensions and structures. (A11459-
`
`69, A11480-81, A11499-501, A11504; A15358; A15362-69; A15359-61; A15491-502;
`
`A17835-65, A17858; A18873.)
`
`For example, a June 1990 document shows Dr. Brantigan ordering four
`
`different implants that fall within the ’973 patent’s “preferred dimensions,” including
`
`one with dimensions of 42 mm x 28 mm x 14 mm. (A15367-69; A11461-67.)
`
`In addition, Dr. Brantigan inserted an implant in a patient named “JC” on July
`
`9, 1990 to address a burst facture at the L1 vertebrae. (A15493; A11467-69, A11496-
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`1504; A12222-23.) The implant’s dimensions were 35 mm x 24 mm x 15 mm. (Id.)
`
`The following post-operative CT scans, taken in 1991, show that implant: the left
`
`image is a top view of the implant (black) on the vertebrae, and the right image is a
`
`side view showing the implant with white bone growing through the holes:
`
`
`
`(A17855, A17858; A11496-501.)
`
`The Brantigan 42 mm and 35 mm implants meet all the structural limitations—
`
`i.e., the length, width, and height requirements, and the additional details regarding the
`
`ratchetings, openings for bone growth materials, and shape—in the body of the ’973
`
`claims. (See Argument Section I.A, below.) They are even within the “preferred”
`
`dimensions in the ’973 specification:
`
`
`
`Length (mm)
`Width (mm)
`Height (mm)
`
`’973 patent’s
`“preferred”
`dimensions
`32-50
`24-32
`8-16
`
`Dr. Brantigan’s 42
`mm implant
`
`Dr. Brantigan’s
`implant for JC
`
`42
`28
`14
`
`35
`24
`15
`
`
`The inventor himself admitted the Brantigan 42 mm implant is “pretty much the same
`
`size” as his preferred embodiment. (A12138-39.)
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`C. The Brantigan ’327 Patent Discloses Implants for Lateral Insertion
`With The Same Dimensions As The ’973 Patent.
`
`Dr. Brantigan obtained a 1993 patent on his commercial implants, U.S Patent
`
`5,192,327. (A17450-59.) The ’327 patent states that the implants are “suitable for
`
`anterior, posterior, or lateral placement in any area of the spine requiring replacement of
`
`disc or vertebral body.” (Id. at 2:55-59, 2:64-66, 5:30-34, 6:65-67.) Figure 6 shows the
`
`implant’s shape, the same as the implants in the