Todd G. Miller (SBN 163200), miller@fr.com
`Michael A. Amon (SBN 226221), amon@fr.com
`Craig E. Countryman (SBN 244601), countryman@fr.com
`Fish & Richardson P.C.
`12390 El Camino Real
`San Diego, CA 92130
`Phone: 858-678-5070/Fax: 858-678-5099
`
`Frank E. Scherkenbach (SBN 142549), scherkenbach@fr.com
`Fish & Richardson P.C.
`One Marina Park Drive
`Boston, MA 02210-1878
`Phone: 617-542-5070/Fax: 617-542-8906
`
`Jonathan J. Lamberson (SBN 239107), lamberson@fr.com
`Keeley I. Vega (SBN 259928), kvega@fr.com
`Neil A. Warren (SBN 272770), warren@fr.com
`Fish & Richardson P.C.
`500 Arguello St., Ste. 500
`Redwood City, CA 94063
`Telephone: 650-839-5070/Fax: 650-839-5071
`
`Attorneys for Defendant/Counterclaimant NUVASIVE, INC.
`
`
`UNITED STATES DISTRICT COURT
`
`SOUTHERN DISTRICT OF CALIFORNIA
`
`
`WARSAW ORTHOPEDIC, INC.;
`MEDTRONIC SOFAMOR DANEK
`U.S.A., INC.; MEDTRONIC PUERTO
`RICO OPERATIONS CO.; and
`OSTEOTECH, INC.
`
`Case No. 3:12-cv-02738 CAB (MDD)
`
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`
`NUVASIVE, INC.’S OBJECTIONS
`AND RESPONSES TO PLAINTIFFS’
`SECOND SET OF
`INTERROGATORIES (NOS. 11-13)
`
`
`
`Plaintiffs,
`
`v.
`
`
`
`NUVASIVE, INC.,
`
`
`Case No. 3:12-cv-02738 CAB (MDD)
`
`
`
`Defendant.
`AND RELATED COUNTERCLAIMS.
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`Pursuant to Rule 33 of the Federal Rules of Civil Procedure, Defendant and
`Counterclaimant NuVasive, Inc. (“NuVasive”) hereby responds to Plaintiffs and
`Counterclaim Defendants Warsaw Orthopedic, Inc., Medtronic Sofamor Danek USA,
`Inc.; Medtronic Puerto Rico Operations Co.; and Osteotech, Inc., and Counterclaim
`Defendants Medtronic, Inc. and Medtronic Sofamor Danek Deggendorf, GmbH,
`(collectively “Medtronic”) Second Set of Interrogatories to NuVasive as follows:
`RESERVATION OF RIGHTS
`This response is made in accordance with the Federal Rules of Civil Procedure
`and is based upon information currently available to NuVasive. This response is made
`without prejudice to NuVasive’s right to amend and/or supplement its responses and
`to use or rely upon subsequently discovered information in any future proceedings.
`NuVasive reserves the right to later object to the admissibility into evidence of any of
`this information on any permissible grounds, including grounds not identified below.
`GENERAL OBJECTIONS
`1.
`NuVasive objects to these interrogatories, including the Instructions and
`Definitions, on the ground and to the extent that they are inconsistent with, enlarge
`upon, or exceed the scope of discovery authorized by the Federal Rules of Civil
`Procedure, the Local Rules of the Southern District of California, any applicable orders
`of this Court, or any stipulation or agreement between the parties. In responding to
`these interrogatories, NuVasive will only comply with the obligations imposed on it by
`the Federal Rules of Civil Procedure, the Local Rules of the United States District
`Court for the Southern District of California, any applicable orders of this Court, and
`any stipulation or agreement between the parties.
`2.
`NuVasive objects to these interrogatories on the ground and to the extent
`that they call for information subject to attorney-client privilege, attorney work product
`protection, community of interest protection, joint defense protection, or that is
`otherwise immune from discovery. For convenience, NuVasive uses the terms
`
`
`NuVasive’s Responses to 2nd Set of Interrogatories
`(Nos. 11-13)
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`“privilege” or “privileged” herein to refer to information subject to attorney-client
`privilege, attorney work product protection, community of interest protection, joint
`defense protection, or that is otherwise immune from discovery. Any disclosure
`NuVasive makes of such information is inadvertent and shall not constitute a waiver of
`the applicable privilege or immunity as to such information.
`3.
`NuVasive objects to these interrogatories on the ground and to the extent
`that they seek to obtain information not within NuVasive’s possession, custody, or
`control.
`4.
`NuVasive objects to these interrogatories on the ground and to the extent
`that they seek information already in Plaintiffs’ possession, information that is a matter
`of public record or information that is otherwise equally available to Plaintiffs.
`5.
`NuVasive objects to these interrogatories on the ground and to the extent
`that they call for information which is confidential or proprietary to, or the trade secrets
`of, a third party, and which NuVasive is under an obligation and duty to a third party to
`not disclose. NuVasive will not disclose such information without the third parties’
`consent, unless required by court order or law.
`6.
`NuVasive objects to these interrogatories on the ground and to the extent
`that they contain discrete subparts. Each subpart should count as a separate
`interrogatory toward the limit on interrogatories imposed by the Federal Rules of Civil
`Procedure or by Order of the Court.
`7.
`NuVasive objects to these interrogatories on the ground and to the extent
`that they are vague and ambiguous. NuVasive will make every effort to construe these
`interrogatories in good faith consistent with its obligations under the Federal Rules of
`Civil Procedure and applicable local rules.
`8.
`NuVasive objects to these interrogatories on the ground and to the extent
`that they purport to define a term or phrase used in any of the claims of the patents-in-
`suit.
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`NuVasive’s Objections and Responses to 2nd Set
`of Interrogatories (Nos. 11-13)
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`9.
`NuVasive objects to these interrogatories to the extent they call for a legal
`conclusion. For example, the Court has not yet construed the patent claim language.
`NuVasive’s responses should not be construed as admissions of any particular legal
`characterization made by these interrogatories.
`10. NuVasive objects to these interrogatories on the ground and to the extent
`that they are overly broad and unduly burdensome.
`11. NuVasive objects to these interrogatories on the ground and to the extent
`that they seek information not relevant to any claim or defense in this litigation and are
`not reasonably calculated to lead to the discovery of admissible evidence.
`12. NuVasive objects to these interrogatories as impermissibly premature to
`the extent that they call for expert opinion or testimony. Expert discovery has not yet
`started in this case.
`13. NuVasive objects to these interrogatories to the extent they are premature
`in light of the sequenced disclosures called for by the Patent Local Rules of the
`Southern District of California or any applicable scheduling order entered in this case.
`14. NuVasive objects to the various requirements for identification of a
`person, a business, a communication, a document, and information withheld under any
`claim of privilege or any other basis on the grounds that they are vague, ambiguous,
`overly broad, and unduly burdensome. Plaintiffs’ requirements are unreasonable and
`exceed the requirements under the Federal Rules of Civil Procedure and the Local
`Rules.
`15. NuVasive objects to the definitions of “NuVasive,” “Defendant,” “you,”
`or “your” to the extent they include persons or entities that are separate and distinct
`from NuVasive and over which NuVasive has no control.
`16. NuVasive objects to the definitions of “NuVasive,” “Defendant,” “you,”
`or “your” as overly broad and unduly burdensome to the extent they encompass
`persons or entities having no relevance to this action.
`
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`NuVasive’s Objections and Responses to 2nd Set
`of Interrogatories (Nos. 11-13)
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`17. NuVasive objects to the definitions of “Accused NuVasive Products” and
`“Alleged Invention” as vague, ambiguous, and overbroad.
`18. NuVasive objects to these interrogatories as premature to the extent they
`seek information relating to United States Patent Nos. 8,251,997 or 8,444,696.
`NuVasive will provide such information after entry by the Court of any applicable
`schedule.
`19. NuVasive objects to these interrogatories as overly broad, unduly
`burdensome, and harassing to the extent they seek information regarding products not
`accused of infringement in this case.
`20.
`Subject to all its General and Specific Objections and limitations,
`NuVasive will respond to these interrogatories based on information available to it after
`a reasonable investigation. NuVasive’s investigation is ongoing, and NuVasive reserves
`the right to supplement its responses. NuVasive also reserves the right to produce or
`use any information disclosed and/or discovered after service of this response in
`support of or in opposition to any motion, in depositions, or at trial.
`21. NuVasive incorporates by reference the foregoing General Objections in
`its Specific Response to each interrogatory. NuVasive may repeat a General Objection
`for emphasis or some other reason. The failure to repeat any such objection with
`respect to a particular interrogatory does not waive that objection. Moreover,
`NuVasive does not waive its right to amend its objections. Any specific objections to
`the following requests are in addition to, and not in lieu of, the foregoing objections.
`22. NuVasive is willing to discuss its objections in a good faith attempt to
`resolve or narrow any differences between the parties.
`SPECIFIC OBJECTIONS AND RESPONSES
`INTERROGATORY NO. 11:
`State whether NuVasive contends that any item of prior art identified in
`Plaintiffs’ Disclosure of Invalidity Contentions, or in any amendments thereto, does not
`
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`NuVasive’s Objections and Responses to 2nd Set
`of Interrogatories (Nos. 11-13)
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`render invalid all asserted claims of the Asserted NuVasive Patents for which the prior
`art was identified, including state with particularity all bases for this contention,
`including for each such item of prior art, an identification of all claim limitations
`NuVasive contends are missing from the prior art, an explanation of why it was not
`obvious to modify or combine the prior art as disclosed to achieve the claimed
`invention, an identification of all facts and documents that NuVasive contends supports
`its position, and an identification of each person with knowledge of the facts that
`support NuVasive’s position, along with a summary of the supporting facts known to
`each such person.
`RESPONSE TO INTERROGATORY NO. 11:
`NuVasive incorporates by reference each of the General Objections and further
`objects to this interrogatory to the extent it seeks information protected from discovery
`by the attorney client privilege, work product immunity, or any other applicable
`privilege or immunity. NuVasive further objects to this interrogatory’s use of the terms
`and phrases “prior art,” “claim limitations,” “obvious to modify or combine,” and
`“claimed invention” to the extent this interrogatory and those terms and phrases seeks a
`legal conclusion. NuVasive objects to this interrogatory as calling for expert opinion,
`and therefore premature as the time for expert disclosures has not yet occurred.
`NuVasive further objects to this interrogatory as unduly burdensome in that it seeks
`“an identification of all facts and documents,” and “an identification of each person
`with knowledge of the facts that support NuVasive’s positions, along with a summary
`of the supporting facts known to each such person.” NuVasive also objects to this
`interrogatory to the extent that the sought after information is publicly available, or is
`otherwise in Medtronic’s possession and control, and therefore is equally accessible to
`Medtronic as to NuVasive.
`
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`NuVasive’s Objections and Responses to 2nd Set
`of Interrogatories (Nos. 11-13)
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`INTERROGATORY NO. 12:
`State whether NuVasive contends there is objective evidence of non-obviousness
`for each asserted claim of the Asserted NuVasive Patents, and if so, identify the nexus
`between each alleged secondary factor and the claimed invention, including on a claim-
`by-claim basis all facts that You contend support or evidence such alleged objective
`evidence of non-obviousness or secondary considerations (Including commercial
`success, long-felt need, failure of others, commercial acquiescence, unexpected results,
`improved results, and/or new results) that should be considered in determining
`whether the claim is invalid for obviousness.
`RESPONSE TO INTERROGATORY NO. 12:
`NuVasive incorporates by reference each of the General Objections and further
`objects to this interrogatory to the extent it seeks information protected from discovery
`by the attorney client privilege, work product immunity, or any other applicable
`privilege or immunity. NuVasive further objects to this interrogatory’s use of the terms
`and phrases “objective evidence of non-obviousness,” “nexus,” “secondary factor,”
`“evidence of non-obviousness,” “secondary considerations,” “commercial success,”
`“long-felt need,” “failure of others,” “commercial acquiescence,” “unexpected results,”
`“improved results,” and “new results” to the extent this interrogatory and those terms
`and phrases seeks a legal conclusion. NuVasive objects to this interrogatory as calling
`for expert opinion, and therefore premature as the time for expert disclosures has not
`yet occurred. NuVasive further objects to this interrogatory as unduly burdensome to
`the extent it asks NuVasive to “identify the nexus between each alleged secondary
`factor and the claimed invention, including on a claim- by-claim basis all facts that You
`contend support or evidence such alleged objective evidence of non-obviousness or
`secondary considerations.” NuVasive also objects to this interrogatory to the extent the
`requested information is publicly available, or is otherwise in Medtronic’s possession
`and control, and therefore is equally accessible to Medtronic as to NuVasive.
`
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`NuVasive’s Objections and Responses to 2nd Set
`of Interrogatories (Nos. 11-13)
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`Subject to and without waiving any of the foregoing General and Specific
`Objections, NuVasive responds that discovery is in its early stages, NuVasive’s
`investigation is ongoing, and NuVasive reserves its right to and will supplement its
`response to this interrogatory as the evidence develops. NuVasive further responds
`that it intends to provide expert testimony regarding “objective evidence of non-
`obviousness” for the asserted claims, including “the nexus between each alleged
`secondary factor and the claimed invention,” to the extent that NuVasive understands
`those terms. NuVasive further responds that it pioneered a safe and reproducible
`lateral trans-psoas retroperitoneal fusion surgical procedure that uses NuVasive’s
`pioneering systems and instruments to allow surgeons to safely navigate through the
`patient’s nerve dense psoas muscle. NuVasive markets this procedure and the specially
`designed instruments, implants and systems needed to safely and reproducibly perform
`the procedure as eXtreme Lateral Interbody Fusion (“XLIF”). For example, NuVasive
`has developed and offers the NeuroVision nerve monitoring system, MaXcess line of
`retractors and the CoRoent XL implants that are used for the XLIF procedure. The
`safety and efficacy of these products as used during an XLIF procedure have caused the
`procedure to become widely adopted and commercially successful. NuVasive further
`responds that the commercial success of XLIF and the associated systems, instruments
`and implants is presumptively due to the patented invention, and Medtronic has
`presented no evidence to rebut this presumption. See, e.g., J.T. Eaton & Co., Inc. v.
`Atlantic Paste & Clue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997). NuVasive further
`responds that its asserted patents and the asserted claims in this case relate generally to
`XLIF. By way of example only, the asserted claims of U.S. Patent No. 8,000,782 relate
`to, among other things, having a stimulation electrode being arranged in a fixed
`position relative to a longitudinal axis of at least one dilating cannula such that the
`stimulation electrode rotates with the at least one dilating cannula when the dilating
`cannula is rotated about the longitudinal axis, thereby providing an indication of nerve
`
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`NuVasive’s Objections and Responses to 2nd Set
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`direction, among other things, when a stimulation signal is emitted by the dilating
`cannula. This feature of U.S. Patent No. 8,000,782, among others, allows the
`stimulated dilators of NuVasive’s MaXcess and NeuroVision, which form part of the
`XLIF methods and tools, to provide information to the surgeon regarding the relative
`direction of nerve tissue, making it possible for the surgeon to safely and reproducibly
`traverse the psoas muscle during the XLIF procedure. The ability to safely and
`reproducibly traverse the psoas muscle to perform a minimally invasive lumbar spine
`fusion from a direct lateral approach is one of the factors that has contributed to
`XLIF’s commercial success.
`By way of additional example only, the asserted claims of U.S. Patent Nos.
`8,005,535; 8,016,767; and 8,192,356 relate to, among other things, systems and methods
`for using a distraction assembly in combination with nerve monitoring to create a
`distraction corridor, and a retraction assembly that includes a blade holder apparatus
`that releasably locks with a plurality of retractor blades that enlarge a distraction
`corridor to form an operative corridor to pass an implant to the lumbar spine. These
`features of U.S. Patent Nos. 8,005,535; 8,016,767; and 8,192,356, among others, allow
`the stimulated dilators and retractor of NuVasive’s MaXcess and NeuroVision, which
`form part of the XLIF methods and tools, to create and provide a safe operative
`corridor to the lumbar spine, making it possible for the surgeon to safely and
`reproducibly traverse the psoas muscle and perform a lateral fusion procedure during
`the XLIF procedure. The ability to safely and reproducibly traverse the psoas muscle to
`perform a minimally invasive lumbar spine fusion from a direct lateral approach is one
`of the factors that has contributed to XLIF’s commercial success.
`By way of additional example only, the asserted claims of U.S. Patent Nos.
`8,187,334 and 8,361,156 relate, to among other things, spinal fusion implants of non-
`bone, radiolucent construction, that include at least a predefined number radiopaque
`markers located in specific areas of the implants, anti-migration features, and at least
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`one fusion aperture. These features of U.S. Patent Nos. 8,187,334 and 8,361,156,
`among others, allow NuVasive’s CoRoent implants, used in NuVasive’s XLIF
`procedure, to promote bone growth and fusion when osteoinductive material is placed
`in the fusion aperture and the implant implanted in the interbody space of a patient,
`and for the implant’s location to be determined relative to the vertebral bodies under
`fluoroscopy. This allows surgeons to safely and reproducibly place the CoRoent
`implants in the best position within the interbody space, which increases the success of
`the fusion procedure, and is one of the factors that has contributed to XLIF’s
`commercial success.
`The success of the XLIF procedure, the MaXcess line of retractors and the
`NeuroVision nerve monitoring system (which relate to U.S. Patent Nos. D652,922;
`D666,294; 8,000,782; 8,005,535; 8,016767; and 8,192,356), and the CoRoent XL line of
`implants (which relate to U.S. Patent Nos. 8,187,334 and 8,361,156) is exemplified by
`the phenomenal growth of NuVasive from a small start-up company in 1997 to a
`company that today provides products, training and support to doctors who perform
`thousands of XLIF procedures per year. Since its introduction in 2003, more than
`100,000 spinal levels have been treated using the XLIF methods and systems,
`improving the lives of patients, many of whom could not be safely or effectively treated
`with other surgical approaches and procedures.
`Equally important, is the widespread adoption of XLIF by surgeons and the
`positive reviews surgeons give the pioneering XLIF procedure. For example, in the
`December 15, 2010 issue of SPINE – one of the preeminent peer reviewed journals for
`spine surgeons – several articles discuss the many advantages of XLIF over
`conventional surgical approaches for lumbar fusion. Conventional surgical approaches
`“have been associated with high morbidities that can often offset the benefits of
`intervention. Approach-related morbidities include vascular complications in anterior
`lumbar
`interbody fusion
`[ALIF], and neural complications
`in posterior and
`
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`transforaminal lumbar interbody fusion (PLIF and TLIF). … Open posterior
`approaches for fusion and supplemental internal fixation that require extensive
`dissection of paraspinal musculature can result in permanent erector spinae denervation
`and loss of function. Open lumbar spine surgeries are often accompanied by incisional
`pain, with increased rates of postoperative infection compared to minimally invasive
`surgical techniques.” Youssef, Jim A. et al., “Minimally Invasive Surgery: Lateral
`Approach Interbody Fusion”, Spine, Vol. 35, No. 26S, Supplement to December 15,
`2010, S302 By comparison to the ALIF and PLIF conventional procedures, the benefits
`of XLIF include “the avoidance of vascular, visceral, and sexual dysfunction
`complications sometimes experienced in open anterior procedures, and paraspinal
`denervation, dural tear, and neural injuries in posterior approaches, while also allowing
`for broad discectomy and placement of a large footprint graft.” Id. at S303. In other
`words, all the benefits associated with open conventional spinal surgery with fewer
`negative side-effects. The study went on to find that the XLIF “does not require a
`general access surgeon, does not retract or violate the peritoneum, eliminates the need
`for mobilization of the great vessels and preserves the anterior and posterior
`longitudinal ligaments”, which result in “decreased hospital stay” and reduced “residual
`care events after surgery, such as intensive care unit usage, physical therapy, emergency
`room visits, etc…” Id. at S309. Moreover, XLIF procedures result in shorter operating
`times, lower blood loss, reduced or eliminated need for blood transfusions, and lower
`morbidity rates compared to conventional open procedures. Id. at S307-S309. As an
`added feature, XLIF appears to reduce the overall cost of lumbar interbody fusion by
`about 10% compared to conventional open procedures. Id. at S309. Many of these
`benefits over the prior modalities were unexpected by surgeons and others in the
`industry.
`Moreover, the XLIF procedure, and NuVasive’s tools for performing the XLIF
`procedure, including the MaXcess Retractor, the CoRoent XL line of implants, and the
`
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`NeuroVision nerve monitoring system are being copied by NuVasive’s competitors,
`including at least Medtronic, Globus and others.
`Pursuant to Fed. R. Civ. P. 26(e), NuVasive reserves its right to supplement its
`response to this interrogatory, as necessary, as the evidence develops.
`INTERROGATORY NO. 13:
`Identify specifically, by page, column, line, and Bates Number, where each
`element of each asserted claim of the Asserted NuVasive Patents is disclosed within
`each earlier application to which the Asserted NuVasive Patents claim priority.
`RESPONSE TO INTERROGATORY NO. 13:
`NuVasive incorporates by reference each of the General Objections and further
`objects to this interrogatory to the extent it seeks information protected from discovery
`by the attorney client privilege, work product immunity, or any other applicable privilege
`or immunity. NuVasive further objects to this interrogatory’s use of the phrase “where
`each element of each asserted claim of the Asserted NuVasive Patents is disclosed within
`each earlier application to which the Asserted NuVasive Patents claim priority” to the
`extent this interrogatory and that phrase seek a legal conclusion. NuVasive further
`objects to this interrogatory as unduly burdensome to the extent it asks NuVasive to
`identify “where each element of each asserted claim of the Asserted NuVasive Patents is
`disclosed within each earlier application to which the Asserted NuVasive Patents claim
`priority.” NuVasive also objects to this interrogatory to the extent the sought after
`information is publicly available, or is otherwise in Medtronic’s possession and control,
`and therefore is equally accessible to Medtronic as to NuVasive.
`Subject to and without waiving any of the foregoing General and Specific
`Objections, NuVasive responds that discovery is in its early stages, NuVasive’s
`investigation is ongoing, and NuVasive reserves its right to and will supplement its
`response to this interrogatory as the evidence develops. NuVasive further responds, to
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`NuVasive’s Objections and Responses to 2nd Set
`of Interrogatories (Nos. 11-13)
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`11
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`Case No. 3:12-cv-02738 CAB (MDD)
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`FISH & RICHARDSON P.C.
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`the extent it understands this interrogatory, as provided in Exhibits A-F, attached hereto
`and incorporated into this response.
`Pursuant to Fed. R. Civ. P. 26(e), NuVasive reserves its right to supplement its
`response to this interrogatory, as necessary, as the evidence develops.
`
`Dated: July 8, 2013
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`
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`By: s/Michael A. Amon
` Michael A. Amon
`
`Attorneys for Defendant/Counterclaimant
`NUVASIVE, INC.
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`NuVasive’s Objections and Responses to 2nd Set
`of Interrogatories (Nos. 11-13)
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`12
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a true and correct copy of the above and
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`foregoing document has been served on July 8, 2013 to the following individuals via
`electronic mail.
`
`
`Luke L. Dauchot, SBN 229829
`Alexander F. MacKinnon, SBN 146883
`Nimalka R. Wickramaseker, SBN 26814
`Sharre Lotfollahi, SBN 258913
`Kirkland & Ellis LLP
`333 South Hope Street
`Los Angeles, CA 90017
`Phone: 213-680-8400
`Fax: 213-680-8500
`Service email: Medtronic-NuVasiveIII@kirkland.com
`Personal emails: ldauchot@kirkland.com;
`nimalka.wickramasekera@kirkland.com;
`alexander.mackinnon@kirkland.com; sharre.lotfollahi@kirkland.com
`
` I declare under penalty of perjury that the foregoing is true and correct.
`
`Executed this 8th day of July, 2013, at San Diego, California.
`
`
` s/Michael A. Amon
`Michael A. Amon
`
`NuVasive’s Objections and Responses to 2nd Set
`of Interrogatories (Nos. 11-13)
`
`
`13
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`Case No. 3:12-cv-02738 CAB (MDD)
`
`

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`16706, 16717, 16724, 16728, 16752, 16754.
`17:5; 29:9-32:1; NUVA0016684-NUVA0017032 at 16691-99,
`See, e.g., NUVA0015344-NUVA0015507 at FIGs. 18-19; 16:16-
`16706, 16724, 16728, 16752.
`17:5; 29:9-32:19; NUVA0016684-NUVA0017032 at 16691-99,
`See, e.g., NUVA0015344-NUVA0015507 at FIGs. 16-18; 16:16-
`
`
`
`16717, 16724, 16728, 16752, 16754.
`32:19; NUVA0016684-NUVA0017032 at 16691-99, 16706,
`See, e.g., NUVA0015344-NUVA0015507 at FIGs 1-21; 15:11-
`
`16717, 16724, 16728, 16752, 16754.
`32:19; NUVA0016684-NUVA0017032 at 16691-99, 16706,
`See, e.g., NUVA0015344-NUVA0015507 at FIGs 1-21; 15:11-
`
`16706, 16717, 16724, 16728, 16752, 16754, 16767.
`17:5; 29:9-32:19; NUVA0016684-NUVA0017032 at 16691-99,
`See, e.g., NUVA0015344-NUVA0015507 at FIGs. 16-19; 16:16-
`16854-5.
`NUVA0017032 at 16691-99, 16701, 16706, 16722, 16725,
`17:5; 29:9-32:19; 41, claims 1, 2, 3, 5, 6; NUVA0016684-
`See, e.g., NUVA0015344-NUVA0015507 at FIGs 1-21; 16:16-
`NUVA0016684-NUVA0017032 at 16693, 16757.
`See, e.g., NUVA0015344-NUVA0015507 at 28:28-29:9;
`16717, 16724, 16728, 16752, 16754.
`NUVA0016684-NUVA0017032 at NUVA0016691-99, 16706,
`7:34; 16:16-17:5; 33:26-34:2; 29:9-32:19; 41, claims 1, 2, 3, 5, 6;
`See, e.g., NUVA0015344-NUVA0015507 at FIGs 1-21; 3:30-
`
`DISCLOSURE
`
`
`
`spine;
`sequential dilator cannulas in the trans psoas path toward the
`advancing a working corridor instrument over the two or more
`
`diameter in the trans psoas path toward the spine;
`advancing two or more sequential dilator cannulas of increasing
`path toward the spine;
`when the initial dilator cannula is inserted into the trans psoas
`the control unit in response to delivery of the stimulation signal
`monitoring the neuromuscular response information displayed by
`psoas path toward the spine;
`cannula when the initial dilator cannula is inserted into the trans
`stimulation signal proximate to a distal end of the initial dilator
`activating the elongate stimulation instrument to deliver the
`initial dilator cannula;
`stimulation instrument is disposed within an inner lumen of the
`bodily tissue toward a lateral aspect of a spine while an elongate
`inserting an initial dilator cannula in a trans psoas path through
`signals from the EMG electrodes;
`to display neuromuscular response information in response to
`and including a graphical user interface to receive user input and
`activating a control unit operable to provide a stimulation signal
`muscles;
`mounting a plurality of EMG electrodes proximate to selected leg
`
`operative corridor to an intervertebral disc, comprising:
`1. A method of inserting a spinal implant through a trans psoas
`
`CLAIM
`
`U.S. Patent No. 8,005,535
`
`Exhibit A
`
`

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`Page 2 of 3
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`32:19; NUVA0016684-NUVA0017032 at 16691-99.
`See, e.g., NUVA0015344-NUVA0015507 at FIGs 1-19; 15:11-
`
`NUVA0016684-NUVA0017032 at 16991-3.
`See, e.g., NUVA0015344-NUVA0015507 at 30:23-31:12;
`
`NUVA0016684-NUVA0017032 at 16712, 16756.
`See, e.g., NUVA0015344-NUVA0015507 at FIG. 16; 29:9:30:6;
`
`17:5; 29:9-32:19; NUVA0016684-NUVA0017032 at 16692.
`See, e.g., NUVA0015344-NUVA0015507 at FIGs. 16-18; 16:16-
`
`21; NUVA0016684-NUVA0017032 at 16692.
`See, e.g., NUVA0015344-NUVA0015507 at FIG. 18-19; 30:19-
`
`NUVA0016684-NUVA0017032 at 16691.
`See, e.g., NUVA0015344-NUVA0015507 at FIG. 16; 29:9-30:6;
`16754.
`NUVA0016684-NUVA0017032 at 16717, 16724, 16728, 16752,
`See, e.g., NUVA0015344-NUVA0015507 at 33:26-34:2;
`
`NUVA0017032 at 16717, 16724, 16728, 16752, 16754.
`29:9-32:19; 41, claims 1, 2, 3, 5, 6; NUVA0016684-
`See, e.g., NUVA0015344-NUVA0015507 at FIG. 19; 16:16-17:5;
`
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`between the elongate stimulation instrument and a nerve based on
`innervated by the stimulation signal, determine a relationship
`unit that is configured to: measure the response of nerves
`control unit comprises activating a neurophysiology monitoring
`9. The method of claim 8, wherein the step of activating the
`stimulation instrument.
`one of nerve proximity and direction relative to the elongate
`information displayed by the control unit is indicative of at least
`8. The method of claim 1, wherein the neuromuscular response
`initial dilator cannula.
`instrument comprises a K-wire instrument insertable into the
`6. The method of claim 1, wherein the elongate stimulation
`a previously delivered dilator cannula.
`has an increased diameter and a decreased