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`Todd G. Miller (SBN 163200), miller@fr.com
`Michael A. Amon (SBN 226221), amon@fr.com
`Fish & Richardson P.C.
`12390 El Camino Real
`San Diego, CA 92130
`Phone: 858-678-5070/Fax: 858-678-5099
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`Frank E. Scherkenbach (SBN 142549), scherkenbach@fr.com
`Fish & Richardson P.C.
`225 Franklin Street
`Boston, MA 02110-2804
`Phone: 617-542-5070/Fax: 617-542-8906
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`Keeley I. Vega (SBN 259928), kvega@fr.com
`Neil A. Warren (SBN 272770), warren@fr.com
`Fish & Richardson P.C.
`500 Arguello Street, Suite 500
`Redwood City, CA 94063
`Phone: 650-839-5070/Fax: 650-839-5071
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`Attorneys for Defendant/Counterclaimant NUVASIVE, INC.
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`WARSAW ORTHOPEDIC, INC.;
`MEDTRONIC SOFAMOR DANEK
`U.S.A., INC.; MEDTRONIC PUERTO
`RICO OPERATIONS CO.; AND
`OSTEOTECH, INC.
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`Plaintiff,
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`UNITED STATES DISTRICT COURT
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`SOUTHERN DISTRICT OF CALIFORNIA
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`Case No. 3:12-cv-02738-CAB-MDD
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`DEFENDANT NUVASIVE, INC.’S
`FIRST AMENDED ANSWER TO
`PLAINTIFFS’ FIRST AMENDED
`COMPLAINT FOR PATENT
`INFRINGEMENT AND FIRST
`AMENDED COUNTERCLAIMS
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`JURY TRIAL DEMANDED
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`Judge: Hon. Cathy Ann Bencivengo
`Courtroom: 4C
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`v.
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`NUVASIVE, INC.,
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`NUVASIVE, INC.,
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`WARSAW ORTHOPEDIC, INC.;
`MEDTRONIC SOFAMOR DANEK
`U.S.A., INC.; MEDTRONIC PUERTO
`RICO OPERATIONS CO.;
`OSTEOTECH, INC., MEDTRONIC,
`INC.; and MEDTRONIC SOFAMOR
`DANEK DEGGENDORF, GMBH,
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`
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`Defendant.
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`v.
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`Counterclaimant,
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`Counterclaim-Defendants.
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`Case 3:12-cv-02738-CAB-MDD Document 55 Filed 03/07/13 PageID.844 Page 2 of 23
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`Defendant NuVasive, Inc. (“NuVasive”), by and through its attorneys, hereby
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`answers the First Amended Complaint for Patent Infringement of Plaintiffs Warsaw
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`Orthopedic, Inc. (“Warsaw”), Medtronic Sofamor Danek USA, Inc. (“Sofamor Danek
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`USA”), Medtronic Puerto Rico Operations Co. (“MPROC”), and Osteotech, Inc.
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`(“Osteotech”) (collectively, “Plaintiffs”). NuVasive denies each and every allegation in
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`the First Amended Complaint that is not expressly admitted below.
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`PARTIES, JURISDICTION, AND VENUE
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`1.
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`On information and belief, NuVasive admits that Warsaw is an Indiana
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`corporation, with its principal place of business in Warsaw, Indiana. NuVasive is
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`without knowledge or information sufficient to admit or deny the remaining allegations
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`of paragraph 1 and therefore denies them.
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`2.
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`On information and belief, NuVasive admits that Sofamor Danek USA is
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`a Tennessee corporation, with its principal place of business in Memphis, Tennessee.
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`NuVasive is without knowledge or information sufficient to admit or deny the
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`remaining allegations of paragraph 2 and therefore denies them.
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`3.
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`On information and belief, NuVasive admits that MPROC is a Cayman
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`Islands corporation with its principal place of business in Humacao, Puerto Rico.
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`NuVasive is without knowledge or information sufficient to admit or deny the
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`remaining allegations of paragraph 3 and therefore denies them.
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`4.
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`On information and belief, NuVasive admits that Osteotech is a Delaware
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`corporation with its principal place of business in Eatontown, New Jersey. NuVasive is
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`without knowledge or information sufficient to admit or deny the remaining allegations
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`of paragraph 4 and therefore denies them.
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`5.
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`6.
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`NuVasive admits the allegations in paragraph 5.
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`NuVasive admits that the Complaint purports to state claims arising under
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`the patent laws of the United States, Title 35 of the United States Code.
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`7.
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`NuVasive admits the allegations in paragraph 7.
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`8.
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`NuVasive admits that it transacts business in the United States Federal
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`Judicial District for the Southern District of California. NuVasive denies the remaining
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`allegations of paragraph 8.
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`9.
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`NuVasive admits the allegations in paragraph 9.
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`PLAINTIFFS’ COUNT I
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`10.
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`In response to paragraph 10, NuVasive incorporates its responses to
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`paragraphs 1-9 as if fully set forth herein.
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`11. NuVasive admits that U.S. Patent No. 8,021,430 (the “’430 patent”) is
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`entitled
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`“Anatomic Spinal Implant Having Anatomic Bearing Surfaces” and that it issued on
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`September 20, 2011. NuVasive is without knowledge or information sufficient to
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`admit or deny the remaining allegations of paragraph 11 and therefore denies them.
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`12. NuVasive denies the allegation in paragraph 12.
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`13. NuVasive denies the allegation in paragraph 13.
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`14. NuVasive denies the allegation in paragraph 14.
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`PLAINTIFFS’ COUNT II
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`15.
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`In response to paragraph 15, NuVasive incorporates its responses to
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`paragraphs 1-9 as if fully set forth herein.
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`16. NuVasive admits that U.S. Patent No. 5,676,146 C2 (the “’146 patent”) is
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`entitled “Surgical Implant Containing A Resorbable Radiopaque Marker And Method
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`Of Locating Such Within A Body,” and that it issued on December 25, 2007.
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`NuVasive further admits that the original application to the ’146 patent initially issued
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`as a patent on October 14, 1997, and that reexamination certificates for the ’146 patent
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`were issued on April 18, 2000 and December 25, 2007. NuVasive is without
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`knowledge or information sufficient to admit or deny the remaining allegations of
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`paragraph 16 and therefore denies them.
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`17. NuVasive is without knowledge or information sufficient to admit or
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`deny the allegations of paragraph 17 and therefore denies them.
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`18. NuVasive is without knowledge or information sufficient to admit or
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`deny the allegations of paragraph 18 and therefore denies them.
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`19. NuVasive is without knowledge or information sufficient to admit or
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`deny the allegations of paragraph 19 and therefore denies them.
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`20. NuVasive denies the allegation in paragraph 20.
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`21. NuVasive denies the allegation in paragraph 21.
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`22. NuVasive denies the allegation in paragraph 22.
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`23. NuVasive denies the allegation in paragraph 23.
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`24. NuVasive admits that it was served with Plaintiffs’ original Complaint for
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`Patent Infringement and Jury Demand on or about August 21, 2012. NuVasive is
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`without knowledge or information sufficient to admit or deny the remaining allegations
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`in paragraph 24 and therefore denies them.
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`25. NuVasive denies the allegation in paragraph 25.
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`26. NuVasive denies the allegations in paragraph 26.
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`27. NuVasive denies the allegation in paragraph 27.
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`28. NuVasive denies the allegation in paragraph 28.
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`PLAINTIFFS’ COUNT III
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`29.
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`In response to paragraph 29, NuVasive incorporates its responses to
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`paragraphs 1-12 as if fully set forth herein.
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`30. NuVasive admits that U.S. Patent No. 8,251,997 (the “’997 patent”) is
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`entitled “A Method For Inserting An Artificial Implant Between Two Adjacent
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`Vertebrae Along A Coronal Plane” and that it issued on August 28, 2012 from U.S.
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`Application No. 13/306,586 (“the ’583 application”). NuVasive is without knowledge
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`or information sufficient to admit or deny the remaining allegations of paragraph 30
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`and therefore denies them.
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`31. NuVasive denies the allegation of paragraph 31.
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`32. NuVasive denies the allegation of paragraph 32.
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`33. NuVasive denies the allegation of paragraph 33.
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`34. NuVasive admits that an Opposition and Petition Under 37 C.F.R. §
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`1.183 was filed with the United States Patent & Trademark Office in the inter partes
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`reexamination of U.S. Patent No. 7,207,949. The Opposition and Petition stated in a
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`footnote that the claims of the ’583 application were allowed and the patent would
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`issue shortly. NuVasive denies the remaining allegations in paragraph 34.
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`35. NuVasive denies the allegation in paragraph 35
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`36. NuVasive denies the allegation in paragraph 26.
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`37. NuVasive denies the allegations of paragraph 37.
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`38. NuVasive admits that some of its marketing materials read “the CoRoent
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`XL family of implants. Designed specifically for the eXtreme Lateral Interbody Fusion
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`(XLIF) procedure,” among other things. NuVasive denies the remaining allegations in
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`paragraph 38.
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`39. NuVasive admits that some of its marketing materials read “fourth
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`generation XLIF access system” and “designed to deliver safe and reproducible XLIF
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`outcomes by combining Strength, Precision, Fluoro-visibility, and Integrated Neuromonitoring,”
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`among other things. NuVasive denies the remaining allegations of paragraph 39.
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`40. NuVasive denies the allegations in paragraph 40.
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`41. NuVasive denies the allegations in paragraph 41.
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`PLAINTIFFS’ PRAYER FOR RELIEF
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`In response to Plaintiffs’ Prayer for Relief, NuVasive denies that Plaintiffs are
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`entitled to the relief requested or any other relief.
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`AFFIRMATIVE DEFENSES
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`NuVasive asserts the following affirmative defenses in response to Plaintiffs’
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`First Amended Complaint. NuVasive reserves the right to assert additional affirmative
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`defenses as they become known through discovery and the course of the litigation.
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`First Affirmative Defense
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`42. NuVasive has not infringed and does not currently infringe, either directly
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`or indirectly, any valid, enforceable claim of the ’430, ’146, and ’997 patents.
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`Second Affirmative Defense
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`43. The ’430, ’146, and ’997 patents are invalid for failure to satisfy the
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`requirements of 35 U.S.C. § 101 et seq., including, without limitation, sections 101, 102,
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`103, and 112.
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`Third Affirmative Defense
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`44. One or more of the plaintiffs lack standing to assert infringement of the
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`’430, ’146, and ’997 patents.
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`COUNTERCLAIMS
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`NuVasive, for its counterclaims against Plaintiffs, states and alleges as follows:
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`The Parties
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`45. NuVasive, Inc. is a Delaware corporation with its principal place of
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`business in San Diego, California. NuVasive owns intellectual property, and designs,
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`manufactures, offers for sale, sells, and otherwise distributes medical devices and
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`instruments for use in connection with spine surgery.
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`46. On information and belief, Warsaw is an Indiana corporation, with its
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`principal place of business in Warsaw, Indiana.
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`47. On information and belief, Medtronic, Inc. (“Medtronic”), is a Minnesota
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`corporation, with its principal place of business in Minneapolis, Minnesota. On
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`information and belief, Medtronic makes and/or has made, offers for sale, sells and/or
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`has sold, and/or otherwise distributes medical devices and instruments for use in
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`connection with spine surgery, including but not limited to the MAST Quadrant
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`retractor and system, the NIM-Eclipse Spinal System (including the NIM X-PAK
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`Probe and NIM Eclipse Direct Lateral Dilators), the Clydesdale Spinal System, and the
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`Capstone-L products, and promotes, teaches, and/or provides training on the Direct
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`Lateral Interbody Fusion (“DLIF”) procedure.
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`48. On information and belief, Sofamor Danek USA (a.k.a. “Medtronic
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`USA”) is a Tennessee corporation with its principal place of business in Memphis,
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`Tennessee. On information and belief, Medtronic USA makes, offers for sale, sells,
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`and/or otherwise distributes medical devices and instruments for use in connection
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`with spine surgery, including but not limited to the MAST Quadrant retractor and
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`system, the NIM-Eclipse Spinal System (including the NIM X-PAK Probe and NIM
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`Eclipse Direct Lateral Dilators), the Clydesdale Spinal System, and the Capstone-L
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`products, and promotes, teaches, and/or provides training on the DLIF procedure.
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`49. On information and belief, MPROC is a Cayman Islands corporation with
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`its principal place of business in Humacao, Puerto Rico.
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`50. On information and belief, Medtronic Sofamor Danek Deggendorf,
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`GmbH (“Medtronic Germany”) is a German corporation, with its principal place of
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`business in Deggendorf, Germany. On information and belief, Medtronic Germany
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`makes, offers for sale, sells, imports and/or otherwise distributes medical devices and
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`instruments for use in connection with spine surgery, including but not limited to the
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`Clydesdale Spinal System and the Capstone-L products.
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`51. On information and belief, Osteotech is a Delaware corporation with its
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`principal place of business in Eatontown, New Jersey.
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`Jurisdiction and Venue
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`52. These counterclaims arise under the patent laws of the United States, Title
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`35 of the United States Code, and the Federal Declaratory Judgment Act, Title 28 of
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`the United States Code.
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`53. This Court has subject matter jurisdiction over these counterclaims
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`pursuant to 28 U.S.C. §§ 1331, 1338, 2201, and 2202.
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`54.
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`Plaintiffs have consented to personal jurisdiction by commencing an
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`action alleging infringement of the patents-in-suit in this judicial district, as set forth in
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`Plaintiffs’ Complaint and First Amended Complaint.1
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`55. Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and
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`1400.
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`1 See Third Affirmative Defense, supra.
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`NUVASIVE’S COUNT I
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`56. NuVasive incorporates by reference the allegations of the preceding
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`paragraphs of its Counterclaims as if fully set forth herein.
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`57. An actual and justiciable controversy exists between NuVasive and
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`Plaintiffs as to the infringement of the ’430 patent, as evidenced by Plaintiffs’ First
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`Amended Complaint and NuVasive’s Answer thereto, as set forth above.
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`58. NuVasive has not infringed and does not currently infringe, either directly
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`or indirectly, any valid claim of the ’430 patent.
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`59.
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`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et
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`seq., NuVasive requests the declaration of the Court that NuVasive has not infringed
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`and does not currently infringe, either directly or indirectly, any valid claim of the ’430
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`patent.
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`NUVASIVE’S COUNT II
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`60. NuVasive incorporates by reference the allegations of the preceding
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`paragraphs of its Counterclaims as if fully set forth herein.
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`61. An actual and justiciable controversy exists between NuVasive and
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`Plaintiffs as to the validity of the ’430 patent, as evidenced by Plaintiffs’ First Amended
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`Complaint and NuVasive’s Answer thereto, as set forth above.
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`62. The ’430 patent is invalid for failure to satisfy the requirements of 35
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`U.S.C. § 101 et seq., including, without limitation, sections 101, 102, 103, and 112.
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`63.
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`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et
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`seq., NuVasive requests the declaration of the Court that the ’430 patent is invalid for
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`failure to satisfy the requirements of 35 U.S.C. § 101 et seq., including, without
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`limitation, sections 102, 103, and 112.
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`NUVASIVE’S COUNT III
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`64. NuVasive incorporates by reference the allegations of the preceding
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`paragraphs of its Counterclaims as if fully set forth herein.
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`65. An actual and justiciable controversy exists between NuVasive and
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`Plaintiffs as to the infringement of the ’146 patent, as evidenced by Plaintiffs’ First
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`Amended Complaint and NuVasive’s Answer thereto, as set forth above.
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`66. NuVasive has not infringed and does not currently infringe, either directly
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`or indirectly, any valid claim of the ’146 patent.
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`67.
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`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et
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`seq., NuVasive requests the declaration of the Court that NuVasive has not infringed
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`and does not currently infringe, either directly or indirectly, any valid claim of the ’146
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`patent.
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`NUVASIVE’S COUNT IV
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`68. NuVasive incorporates by reference the allegations of the preceding
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`paragraphs of its Counterclaims as if fully set forth herein.
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`69. An actual and justiciable controversy exists between NuVasive and
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`Plaintiffs as to the validity of the ’146 patent, as evidenced by Plaintiffs’ First Amended
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`Complaint and NuVasive’s Answer thereto, as set forth above.
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`70. The ’146 patent is invalid for failure to satisfy the requirements of 35
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`U.S.C. § 101 et seq., including, without limitation, sections 102, 103, and 112.
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`71.
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`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et
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`seq., NuVasive requests the declaration of the Court that the ’146 patent is invalid for
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`failure to satisfy the requirements of 35 U.S.C. § 101 et seq., including, without
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`limitation, sections 102, 103, and 112.
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`NUVASIVE’S COUNT V
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`72. NuVasive incorporates by reference the allegations of the preceding
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`paragraphs of its Counterclaims as if fully set forth herein.
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`73. An actual and justiciable controversy exists between NuVasive and
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`Plaintiffs as to the infringement of the ’997 patent, as evidenced by Plaintiffs’ First
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`Amended Complaint and NuVasive’s Answer thereto, as set forth above.
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`74. NuVasive has not infringed and does not currently infringe, either directly
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`or indirectly, any valid claim of the ’997 patent.
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`75.
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`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et
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`seq., NuVasive requests the declaration of the Court that NuVasive has not infringed
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`and does not currently infringe, either directly or indirectly, any valid claim of the ’997
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`patent.
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`NUVASIVE’S COUNT VI
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`76. NuVasive incorporates by reference the allegations of the preceding
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`paragraphs of its Counterclaims as if fully set forth herein.
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`77. An actual and justiciable controversy exists between NuVasive and
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`Plaintiffs as to the validity of the ’997 patent, as evidenced by Plaintiffs’ First Amended
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`Complaint and NuVasive’s Answer thereto, as set forth above.
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`78. The ’997 patent is invalid for failure to satisfy the requirements of 35
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`U.S.C. § 101 et seq., including, without limitation, sections 102, 103, and 112.
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`79.
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`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et
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`seq., NuVasive requests the declaration of the Court that the ’997 patent is invalid for
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`failure to satisfy the requirements of 35 U.S.C. § 101 et seq., including, without
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`limitation, sections 102, 103, and 112.
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`NUVASIVE’S COUNT VII
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`80. NuVasive incorporates by reference the allegations set forth in paragraphs
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`45-50 and 52-55 as if fully set forth herein.
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`81. United States Patent No. 8,000,782 (“the ’782 patent”, a copy of which is
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`attached as Exhibit A to this pleading), titled “Systems and Methods for Performing
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`Surgical Procedures and Assessments,” issued on August 16, 2011. NuVasive is the
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`owner by assignment of the ’782 patent.
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`82. Medtronic and Medtronic USA have infringed and continue to infringe
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`the ’782 patent by making, using, offering for sale, selling, and/or otherwise
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`distributing infringing products, including but not limited to the NIM-Eclipse Spinal
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`System, including the NIM Eclipse Direct Lateral Dilators.
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`83. Medtronic’s and Medtronic USA’s infringement of the ’782 patent has
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`been without permission, consent, authorization, or license of NuVasive.
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`84. Medtronic’s and Medtronic USA’s infringement of the ’782 patent has
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`caused and will continue to cause NuVasive substantial damage, and has caused and
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`will continue to cause NuVasive irreparable harm for which there is no remedy at law.
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`NUVASIVE’S COUNT VIII
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`85. NuVasive incorporates by reference the allegations set forth in paragraphs
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`45-50 and 52-55 as if fully set forth herein.
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`86. United States Patent No. 8,005,535 (“the ’535 patent”, a copy of which is
`
`attached as Exhibit B to this pleading), titled “Systems and Methods for Performing
`
`Surgical Procedures and Assessments,” issued on August 23, 2011. NuVasive is the
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`owner by assignment of the ’535 patent.
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`87. Medtronic, Medtronic USA, and Medtronic Germany (collectively “the
`
`Medtronic Counterclaim Defendants”) have induced and continue to induce direct
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`infringement of the ’535 patent by surgeons in violation of 35 U.S.C. § 271(b) by
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`actively taking steps to facilitate the purchase and/or distribution of at least their
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`MAST Quadrant retractor and system, NIM-Eclipse Spinal System (including the NIM
`
`X-PAK Probe and NIM Eclipse Direct Lateral Dilators), the Clydesdale Spinal System,
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`and the Capstone-L products for use in the Medtronic Counterclaim Defendants’
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`DLIF spinal procedure, which is performed through the side of a patient’s body, with
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`knowledge that such use infringes one or more claims of the ’535 patent, and with the
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`specific intent to induce infringement.
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`88. The Medtronic Counterclaim Defendants have and continue to promote,
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`teach, instruct, and/or train surgeons to use their MAST Quadrant retractor and
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`system, NIM-Eclipse Spinal System (including the NIM X-PAK Probe and NIM
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`Eclipse Direct Lateral Dilators), the Clydesdale Spinal System, and/or Capstone-L
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`products in their DLIF surgical procedure. The Medtronic Counterclaim Defendants
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`include such instruction in, for example, published surgical techniques, marketing
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`literature, on its website, available at http://www.medtronic.com/for-healthcare-
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`professionals/products-therapies/spinal/therapies/minimally-invasive-spinal-
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`surgery/index.htm, and on videos posted on the internet explaining the DLIF
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`procedure, among other places. The Medtronic Counterclaim Defendants also
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`promote, teach, instruct and provide additional information regarding these products
`
`through courses offered to surgeons on how to perform DLIF.
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`89.
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`Following the Medtronic Counterclaim Defendants’ instructions,
`
`surgeons have and continue to implant Clydesdale Spinal System products and/or
`
`Capstone-L products into human bodies using at least the MAST Quadrant retractor
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`and system and NIM-Eclipse Spinal System (including the NIM X-PAK Probe and
`
`NIM Eclipse Direct Lateral Dilators) while performing the DLIF surgical procedure,
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`which constitutes direct infringement of at least one claim of the ’535 patent.
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`90. Upon information and belief, the Medtronic Counterclaim Defendants
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`have and continue to monitor NuVasive’s patent portfolio, including monitoring the
`
`’535 patent’s issuance.
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`91. At a minimum, the Medtronic Counterclaim Defendants had knowledge
`
`of the claims of the ’535 patent by at least March 7, 2013.
`
`92. The Medtronic Counterclaim Defendants have and continue to act with
`
`the specific intent to induce direct infringement of the ’535 patent by, among other
`
`things, actively marketing, selling, supporting, and warranting the MAST Quadrant
`
`retractor and system, NIM-Eclipse Spinal System (including the NIM X-PAK Probe
`
`and NIM Eclipse Direct Lateral Dilators), the Clydesdale Spinal System, and/or the
`
`Capstone-L products, and actively continuing to instruct surgeons to use the MAST
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`Quadrant retractor and system, NIM-Eclipse Spinal System (including the NIM X-
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`PAK Probe and NIM Eclipse Direct Lateral Dilators), the Clydesdale Spinal System,
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`and/or Capstone-L products while performing the Medtronic Counterclaim
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`Defendants’ DLIF surgical technique as alleged with knowledge of the ’535 patent.
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`93. The Medtronic Counterclaim Defendants are also contributing to the
`
`infringement of the ’535 patent in violation of 35 U.S.C. § 271(c) by offering for sale,
`
`selling, promoting, teaching, and encouraging the use of their MAST Quadrant
`
`retractor and system, NIM-Eclipse Spinal System (including the NIM X-PAK Probe
`
`and NIM Eclipse Direct Lateral Dilators), the Clydesdale Spinal System, and/or
`
`Capstone-L products in their DLIF surgical technique. The Medtronic Counterclaim
`
`Defendants market their MAST Quadrant retractor and system, NIM-Eclipse Spinal
`
`System (including the NIM X-PAK Probe and NIM Eclipse Direct Lateral Dilators),
`
`the Clydesdale Spinal System, and/or Capstone-L products as especially made or
`
`especially adapted for use in their DLIF surgical technique.
`
`94. The MAST Quadrant retractor and system is not a staple article of
`
`commerce suitable for substantial non-infringing use. The MAST Quadrant retractor
`
`and system is especially designed for use in the Medtronic Counterclaim Defendants’
`
`DLIF surgical procedure, a procedure performed from the lateral aspect of the spine.
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`For example, the blade length of the MAST Quadrant is especially adapted for use in
`
`lateral spine surgery.
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`95. The NIM-Eclipse Spinal System (including the NIM X-PAK Probe and
`
`NIM Eclipse Direct Lateral Dilators) is not a staple article of commerce suitable for
`
`substantial non-infringing use. The NIM-Eclipse Spinal System (including the NIM X-
`
`PAK Probe and NIM Eclipse Direct Lateral Dilators) is especially designed for use in
`
`the Medtronic Counterclaim Defendants’ DLIF surgical procedure. For example, the
`
`Medtronic Counterclaim Defendants’ NIM-Eclipse Direct Lateral Dilators are designed
`
`specifically to detect the presence and relative direction of nerves in the psoas muscle
`
`during the DLIF surgical procedure.
`
`96. The Clydesdale Spinal System and Capstone-L products are not staple
`
`articles of commerce suitable for substantial non-infringing use. The Clydesdale Spinal
`
`
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`System is especially designed for use in the Medtronic Counterclaim Defendants’ DLIF
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`surgical procedure. For example, the 510K application for the Clydesdale filed with the
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`U.S. Food and Drug Administration indicates that the Clydesdale Spinal System
`
`implants are designed to “be implanted via a minimally invasive lateral approach.” See
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`e.g., http://www.accessdata.fda.gov/cdrh_docs/pdf12/K122591.pdf. Similarly, the
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`Capstone-L products are designed for use in the Medtronic Counterclaim Defendants’
`
`DLIF surgical procedure to be implanted through a lateral approach. The Clydesdale
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`Spinal System and Capstone-L products include at least dimensions, surface
`
`configurations, and insertion mechanisms for use in a minimally invasive, lateral
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`approach to the human spine.
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`97. The use of MAST Quadrant retractor and system, NIM-Eclipse Spinal
`
`System (including the NIM X-PAK Probe and NIM Eclipse Direct Lateral Dilators),
`
`the Clydesdale Spinal System products, and/or the Capstone-L products in the
`
`Medtronic Counterclaim Defendants’ DLIF surgical procedure necessarily and directly
`
`infringe at least one claim of the ’535 patent.
`
`98. The Medtronic Counterclaim Defendants’ infringement of the ’535 patent
`
`has been without permission, consent, authorization, or license of NuVasive.
`
`99. The Medtronic Counterclaim Defendants’ infringement of the ’535 patent
`
`has caused and will continue to cause NuVasive substantial damage, and has caused
`
`and will continue to cause NuVasive irreparable harm for which there is no remedy at
`
`law.
`
`NUVASIVE’S CLAIM IX
`
`100. NuVasive incorporates by reference the allegations set forth in paragraphs
`
`45-50 and 52-55 as if fully set forth herein.
`
`101. United States Patent No. 8,016,767 (“the ’767 patent”, a copy of which is
`
`attached as Exhibit C to this pleading), titled “Surgical Access System and Related
`
`Methods,” issued on September 13, 2011. NuVasive is the owner by assignment of the
`
`’767 patent.
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`102. The Medtronic Counterclaim Defendants have induced and continue to
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`induce direct infringement of the ’767 patent by surgeons in violation of 35 U.S.C. §
`
`271(b) by actively taking steps to facilitate the purchase and/or distribution of at least
`
`its MAST Quadrant retractor and system, NIM-Eclipse Spinal System (including the
`
`NIM X-PAK Probe and NIM Eclipse Direct Lateral Dilators), the Clydesdale Spinal
`
`System, and the Capstone-L products in the Medtronic Counterclaim Defendants’
`
`DLIF spinal procedure, which is performed through the side of a patient’s body, with
`
`knowledge that such use infringes one or more claims of the ’767 patent, and with the
`
`specific intent to induce infringement.
`
`103. The Medtronic Counterclaim Defendants have and continue to promote,
`
`teach, instruct, and/or train surgeons to use its MAST Quadrant retractor and system,
`
`NIM-Eclipse Spinal System (including the NIM X-PAK Probe and NIM Eclipse
`
`Direct Lateral Dilators), the Clydesdale Spinal System, and/or the Capstone-L products
`
`in their DLIF surgical procedure. The Medtronic Counterclaim Defendants include
`
`such instruction in, for example, published surgical techniques, marketing literature, on
`
`its website, available at http://www.medtronic.com/for-healthcare-
`
`professionals/products-therapies/spinal/therapies/minimally-invasive-spinal-
`
`surgery/index.htm, and on videos posted on the internet explaining the DLIF
`
`procedure, among other places. The Medtronic Counterclaim Defendants also
`
`promote, teach, instruct and provide additional information regarding these products
`
`through courses offered to surgeons on how to perform DLIF.
`
`104. Following the Medtronic Counterclaim Defendants’ instructions,
`
`surgeons have and continue to implant Clydesdale Spinal System products and/or
`
`Capstone-L products into human bodies using at least the MAST Quadrant retractor
`
`and system and NIM-Eclipse Spinal System (including the NIM X-PAK Probe and
`
`NIM Eclipse Direct Lateral Dilators) while performing the DLIF surgical procedure,
`
`which constitutes direct infringement of at least one claim of the ’767 patent.
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`105. Upon information and belief, the Medtronic Counterclaim Defendants
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`have and continue to monitor NuVasive’s patent portfolio, including monitoring the
`
`’767 patent’s issuance.
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`106. At a minimum, the Medtronic Counterclaim Defendants had knowledge
`
`of the claims of the ’767 patent by at least March 7, 2013.
`
`107. The Medtronic Counterclaim Defendants have and continue to act with
`
`the specific intent to