`
`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
`
`
`
`
`
`Case: 13-1576 Document: 33 Page: 15 Filed: 02/03/2014
`
`
`
`STATEMENT OF THE FACTS
`
`I.
`
`Technology Background on Spinal Fusion Surgery.
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`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
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`separated by spongy discs. (A1998-99.)
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`
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`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
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`and replaced with an implant (which maintains proper separation between the
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`vertebrae) and bone growth material (which promotes fusion between vertebrae).
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`(A10131-32.) Surgeons can optionally install fixation equipment (e.g., rods and
`
`screws) separately in patients to further stabilize the spine. (A11186-87.)
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`There are multiple ways to access the disc space to perform a fusion, including
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`through the patient’s front (anterior), back (posterior), or side (lateral). Several
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`references in the 1980s and early 1990s disclosed lateral insertion, (A17429-41 at
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`1
`
`
`
`Case: 13-1576 Document: 33 Page: 16 Filed: 02/03/2014
`
`
`
`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
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`widespread use, particularly for the lower, lumbar, spine. (A10367-70, A10470-72.)
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`The lumbar spine is surrounded by the psoas, a nerve-packed muscle:
`
`
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`(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
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`a nerve-monitoring system. (A10403-04, A10413, A10470-72.) Nerve-monitoring
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`made lateral procedures accessible to all properly trained spine surgeons, not just the
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`few, highly skilled ones who had successfully performed a lateral fusion in the past.
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`(Id.) NuVasive’s U.S. Patent 7,470,236 covers its first nerve-monitoring algorithm.
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`(A279-300, A10468-71.) NuVasive has other patents on various aspects of XLIF,
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`several of which it currently asserts against Medtronic in another suit.
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`2
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