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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
`
`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
`
`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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`
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`UNITED STATES DISTRICT COURT
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`SOUTHERN DISTRICT OF CALIFORNIA
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`
`WARSAW ORTHOPEDIC, INC.;
`MEDTRONIC SOFAMOR DANEK U.S.A.,
`INC.; MEDTRONIC PUERTO RICO
`OPERATIONS CO.; AND OSTEOTECH, INC.
`
`
`Plaintiff
`
`v.
`
`NUVASIVE, INC.,
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`
`
`Defendant
`
`Case No. 3:12-cv-02738-CAB-MDD
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`DEFENDANT NUVASIVE, INC.’S
`ANSWER TO PLAINTIFFS’ FIRST
`AMENDED COMPLAINT FOR PATENT
`INFRINGEMENT AND
`COUNTERCLAIMS
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`JURY TRIAL DEMANDED
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`Judge: Hon. Cathy Ann Bencivengo
`Courtroom: 2
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`Defendant NuVasive, Inc. (“NuVasive”), by and through its attorneys, hereby answers the
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`First Amended Complaint for Patent Infringement of Plaintiffs Warsaw Orthopedic, Inc.
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`(“Warsaw”), Medtronic Sofamor Danek USA, Inc. (“Sofamor Danek USA”), Medtronic Puerto
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`Rico Operations Co. (“MPROC”), and Osteotech, Inc. (“Osteotech”) (collectively, “Plaintiffs”).
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`Case 3:12-cv-02738-CAB-MDD Document 43 Filed 11/30/12 PageID.785 Page 2 of 10
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`NuVasive denies each and every allegation in the First Amended Complaint that is not expressly
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`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 corporation,
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`with its principal place of business in Warsaw, Indiana. NuVasive is without knowledge or
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`information sufficient to admit or deny the remaining allegations of paragraph 1 and therefore
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`denies them.
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`2.
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`On information and belief, NuVasive admits that Sofamor Danek USA is a
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`Tennessee corporation, with its principal place of business in Memphis, Tennessee. NuVasive is
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`without knowledge or information sufficient to admit or deny the remaining allegations of
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`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 Islands
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`corporation with its principal place of business in Humacao, Puerto Rico. NuVasive is without
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`knowledge or information sufficient to admit or deny the remaining allegations of paragraph 3 and
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`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 without
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`knowledge or information sufficient to admit or deny the remaining allegations of paragraph 4 and
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`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 the
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`patent laws of the United States, Title 35 of the United States Code.
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`7.
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`8.
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`NuVasive admits the allegations in paragraph 7.
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`NuVasive admits that it transacts business in the United States Federal Judicial
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`District for the Southern District of California. NuVasive denies the remaining allegations of
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`paragraph 8.
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`9.
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`NuVasive admits the allegations in paragraph 9.
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`Case 3:12-cv-02738-CAB-MDD Document 43 Filed 11/30/12 PageID.786 Page 3 of 10
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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 paragraphs 1-9
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`as if fully set forth herein.
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`11.
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`NuVasive admits that U.S. Patent No. 8,021,430 (the “’430 patent”) is entitled
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`“Anatomic Spinal Implant Having Anatomic Bearing Surfaces” and that it issued on September
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`20, 2011. NuVasive is without knowledge or information sufficient to admit or deny the
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`remaining allegations of paragraph 11 and therefore denies them.
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`12.
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`NuVasive denies the allegation in paragraph 12.
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`13.
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`NuVasive denies the allegation in paragraph 13.
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`14.
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`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 paragraphs 1-9
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`as if fully set forth herein.
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`16.
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`NuVasive admits that U.S. Patent No. 5,676,146 C2 (the “’146 patent”) is entitled
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`“Surgical Implant Containing A Resorbable Radiopaque Marker And Method Of Locating Such
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`Within A Body,” and that it issued on December 25, 2007. NuVasive further admits that the
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`original application to the ’146 patent initially issued as a patent on October 14, 1997, and that
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`reexamination certificates for the ’146 patent were issued on April 18, 2000 and December 25,
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`2007. NuVasive is without knowledge or information sufficient to admit or deny the remaining
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`allegations of paragraph 16 and therefore denies them.
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`17.
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`NuVasive is without knowledge or information sufficient to admit or deny the
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`allegations of paragraph 17 and therefore denies them.
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`18.
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`NuVasive is without knowledge or information sufficient to admit or deny the
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`allegations of paragraph 18 and therefore denies them.
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`19.
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`NuVasive is without knowledge or information sufficient to admit or deny the
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`allegations of paragraph 19 and therefore denies them.
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`20.
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`NuVasive denies the allegation in paragraph 20.
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`21.
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`NuVasive denies the allegation in paragraph 21.
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`Case 3:12-cv-02738-CAB-MDD Document 43 Filed 11/30/12 PageID.787 Page 4 of 10
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`22.
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`NuVasive denies the allegation in paragraph 22.
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`23.
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`NuVasive denies the allegation in paragraph 23.
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`24.
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`NuVasive admits that it was served with Plaintiffs’ original Complaint for Patent
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`Infringement and Jury Demand on or about August 21, 2012. NuVasive is without knowledge or
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`information sufficient to admit or deny the remaining allegations in paragraph 24 and therefore
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`denies them.
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`25.
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`NuVasive denies the allegation in paragraph 25.
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`26.
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`NuVasive denies the allegations in paragraph 26.
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`27.
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`NuVasive denies the allegation in paragraph 27.
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`28.
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`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 paragraphs 1-
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`12 as if fully set forth herein.
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`30.
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`NuVasive admits that U.S. Patent No. 8,251,997 (the “’997 patent”) is entitled “A
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`Method For Inserting An Artificial Implant Between Two Adjacent Vertebrae Along A Coronal
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`Plane” and that it issued on August 28, 2012 from U.S. Application No. 13/306,586 (“the ’583
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`application”). NuVasive is without knowledge or information sufficient to admit or deny the
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`remaining allegations of paragraph 30 and therefore denies them.
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`31.
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`NuVasive denies the allegation of paragraph 31.
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`32.
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`NuVasive denies the allegation of paragraph 32.
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`33.
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`NuVasive denies the allegation of paragraph 33.
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`34.
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`NuVasive admits that an Opposition and Petition Under 37 C.F.R. § 1.183 was
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`filed with the United States Patent & Trademark Office in the inter partes reexamination of U.S.
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`Patent No. 7,207,949. The Opposition and Petition stated in a footnote that the claims of the ’583
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`application were allowed and the patent would issue shortly. NuVasive denies the remaining
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`allegations in paragraph 34.
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`35.
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`NuVasive denies the allegation in paragraph 35
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`36.
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`NuVasive denies the allegation in paragraph 26.
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`Case 3:12-cv-02738-CAB-MDD Document 43 Filed 11/30/12 PageID.788 Page 5 of 10
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`37.
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`NuVasive denies the allegations of paragraph 37.
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`38.
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`NuVasive admits that some of its marketing materials read “the CoRoent XL
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`family of implants. Designed specifically for the eXtreme Lateral Interbody Fusion (XLIF)
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`procedure,” among other things. NuVasive denies the remaining allegations in paragraph 38.
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`39.
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`NuVasive admits that some of its marketing materials read “fourth generation XLIF
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`access system” and “designed to deliver safe and reproducible XLIF outcomes by combining
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`Strength, Precision, Fluoro-visibility, and Integrated Neuromonitoring,” among other things.
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`NuVasive denies the remaining allegations of paragraph 39.
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`40.
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`NuVasive denies the allegations in paragraph 40.
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`41.
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`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 entitled to
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`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’ First
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`Amended Complaint. NuVasive reserves the right to assert additional affirmative defenses as they
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`become known through discovery and the course of the litigation.
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`First Affirmative Defense
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`42.
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`NuVasive has not infringed and does not currently infringe, either directly or
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`indirectly, any valid, enforceable claim of the ’430, ’146, and ’997 patents.
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`Second Affirmative Defense
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`43.
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`The ’430, ’146, and ’997 patents are invalid for failure to satisfy the requirements
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`of 35 U.S.C. § 101 et seq., including, without limitation, sections 101, 102, 103, and 112.
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`Third Affirmative Defense
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`44.
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`One or more of the plaintiffs lack standing to assert infringement of the ’430, ’146,
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`and ’997 patents.
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`NuVasive, for its counterclaims against Plaintiffs, states and alleges as follows:
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`COUNTERCLAIMS
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`Case 3:12-cv-02738-CAB-MDD Document 43 Filed 11/30/12 PageID.789 Page 6 of 10
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`45.
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`NuVasive, Inc. is a Delaware corporation with its principal place of business in San
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`The Parties
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`Diego, California.
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`46.
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`On information and belief, Warsaw is an Indiana corporation, with its principal
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`place of business in Warsaw, Indiana.
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`47.
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`On information and belief, Medtronic USA is a Tennessee corporation with its
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`principal place of business in Memphis, Tennessee.
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`48.
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`On information and belief, MPROC is a Cayman Islands corporation with its
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`principal place of business in Humacao, Puerto Rico.
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`49.
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`On information and belief, Osteotech is a Delaware corporation with its principal
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`place of business in Eatontown, New Jersey.
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`Jurisdiction and Venue
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`50.
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`These counterclaims arise under the patent laws of the United States, Title 35 of the
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`United States Code, and the Federal Declaratory Judgment Act, Title 28 of the United States
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`Code.
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`51.
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`This Court has subject matter jurisdiction over these counterclaims pursuant to 28
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`U.S.C. §§ 1331, 1338, 2201, and 2202.
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`52.
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`Plaintiffs have consented to personal jurisdiction by commencing an action alleging
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`infringement of the patents-in-suit in this judicial district, as set forth in Plaintiffs’ Complaint and
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`First Amended Complaint.1
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`53.
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`Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and 1400.
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`NUVASIVE’S COUNT I
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`54.
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`NuVasive incorporates by reference the allegations of the preceding paragraphs of
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`its Counterclaims as if fully set forth herein.
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`55.
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`An actual and justiciable controversy exists between NuVasive and Plaintiffs as to
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`the infringement of the ’430 patent, as evidenced by Plaintiffs’ First Amended Complaint and
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`NuVasive’s Answer thereto, as set forth above.
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`1 See Third Affirmative Defense, supra.
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`56.
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`NuVasive has not infringed and does not currently infringe, either directly or
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`indirectly, any valid claim of the ’430 patent.
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`57.
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`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.,
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`NuVasive requests the declaration of the Court that NuVasive has not infringed and does not
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`currently infringe, either directly or indirectly, any valid claim of the ’430 patent.
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`NUVASIVE’S COUNT II
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`58.
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`NuVasive incorporates by reference the allegations of the preceding paragraphs of
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`its Counterclaims as if fully set forth herein.
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`59.
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`An actual and justiciable controversy exists between NuVasive and Plaintiffs as to
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`the validity of the ’430 patent, as evidenced by Plaintiffs’ First Amended Complaint and
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`NuVasive’s Answer thereto, as set forth above.
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`60.
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`The ’430 patent is invalid for failure to satisfy the requirements of 35 U.S.C. § 101
`
`et seq., including, without limitation, sections 101, 102, 103, and 112.
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`61.
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`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.,
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`NuVasive requests the declaration of the Court that the ’430 patent is invalid for failure to satisfy
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`the requirements of 35 U.S.C. § 101 et seq., including, without limitation, sections 102, 103, and
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`112.
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`NUVASIVE’S COUNT III
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`62.
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`NuVasive incorporates by reference the allegations of the preceding paragraphs of
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`its Counterclaims as if fully set forth herein.
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`63.
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`An actual and justiciable controversy exists between NuVasive and Plaintiffs as to
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`the infringement of the ’146 patent, as evidenced by Plaintiffs’ First Amended Complaint and
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`NuVasive’s Answer thereto, as set forth above.
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`64.
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`NuVasive has not infringed and does not currently infringe, either directly or
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`indirectly, any valid claim of the ’146 patent.
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`65.
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`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.,
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`NuVasive requests the declaration of the Court that NuVasive has not infringed and does not
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`currently infringe, either directly or indirectly, any valid claim of the ’146 patent.
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`NUVASIVE’S COUNT IV
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`66.
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`NuVasive incorporates by reference the allegations of the preceding paragraphs of
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`its Counterclaims as if fully set forth herein.
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`67.
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`An actual and justiciable controversy exists between NuVasive and Plaintiffs as to
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`the validity of the ’146 patent, as evidenced by Plaintiffs’ First Amended Complaint and
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`NuVasive’s Answer thereto, as set forth above.
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`68.
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`The ’146 patent is invalid for failure to satisfy the requirements of 35 U.S.C. § 101
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`et seq., including, without limitation, sections 102, 103, and 112.
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`69.
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`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.,
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`NuVasive requests the declaration of the Court that the ’146 patent is invalid for failure to satisfy
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`the requirements of 35 U.S.C. § 101 et seq., including, without limitation, sections 102, 103, and
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`112.
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`NUVASIVE’S COUNT V
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`70.
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`NuVasive incorporates by reference the allegations of the preceding paragraphs of
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`its Counterclaims as if fully set forth herein.
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`71.
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`An actual and justiciable controversy exists between NuVasive and Plaintiffs as to
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`the infringement of the ’997 patent, as evidenced by Plaintiffs’ First Amended Complaint and
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`NuVasive’s Answer thereto, as set forth above.
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`72.
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`NuVasive has not infringed and does not currently infringe, either directly or
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`indirectly, any valid claim of the ’997 patent.
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`73.
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`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.,
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`NuVasive requests the declaration of the Court that NuVasive has not infringed and does not
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`currently infringe, either directly or indirectly, any valid claim of the ’997 patent.
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`NUVASIVE’S COUNT VI
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`74.
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`NuVasive incorporates by reference the allegations of the preceding paragraphs of
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`its Counterclaims as if fully set forth herein.
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`75.
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`An actual and justiciable controversy exists between NuVasive and Plaintiffs as to
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`the validity of the ’997 patent, as evidenced by Plaintiffs’ First Amended Complaint and
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`Case 3:12-cv-02738-CAB-MDD Document 43 Filed 11/30/12 PageID.792 Page 9 of 10
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`NuVasive’s Answer thereto, as set forth above.
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`76.
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`The ’997 patent is invalid for failure to satisfy the requirements of 35 U.S.C. § 101
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`et seq., including, without limitation, sections 102, 103, and 112.
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`77.
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`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.,
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`NuVasive requests the declaration of the Court that the ’997 patent is invalid for failure to satisfy
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`the requirements of 35 U.S.C. § 101 et seq., including, without limitation, sections 102, 103, and
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`112.
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`NUVASIVE’S PRAYER FOR RELIEF
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`WHEREFORE, NuVasive respectfully requests that the Court enter judgment in
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`NuVasive’s favor and against Plaintiffs as follows:
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`1.
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`2.
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`3.
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`That Plaintiffs’ First Amended Complaint be dismissed with prejudice;
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`That Plaintiffs take nothing by reason of their First Amended Complaint;
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`Declaring that NuVasive has not infringed and does not currently infringe, either
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`directly or indirectly, any valid, enforceable claim of the ’430, ’146, and ’997 patents;
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`4.
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`That Plaintiffs and their officers, employees, agents, licensees, successors, and
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`assigns, and all persons acting in concert or participation with them, be permanently enjoined from
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`charging that NuVasive has infringed or is infringing the ’430, ’146, and ’997 patents;
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`5.
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`7.
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`8.
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`9.
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`Declaring that the ’430, ’146, and ’997 patents are invalid;
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`That this is an exceptional case under 35 U.S.C. § 285;
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`Awarding NuVasive its costs and reasonable attorneys’ fees for this litigation; and
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`Awarding NuVasive any further relief that the Court deems just and proper.
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`JURY DEMAND
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`NuVasive hereby demands a trial by jury on all issues so triable.
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`Dated: November 30, 2012
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`FISH & RICHARDSON P.C.
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`By: s/ Michael A. Amon
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`Michael A. Amon
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`Attorneys for Defendant/Counterclaimant
`NUVASIVE, INC.
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`Case 3:12-cv-02738-CAB-MDD Document 43 Filed 11/30/12 PageID.793 Page 10 of 10
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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 foregoing
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`document has been served on November 30, 2012 to all counsel of record who are deemed to have
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`consented to electronic service via the Court’s CM/ECF system per Civ LR 5.4(d). Any other
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`counsel of record will be served by U.S. mail or hand delivery.
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`I declare under penalty of perjury under the laws of the United States of America that the
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`above is true and correct. Executed on November 30, 2012, at San Diego, California.
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` s/ Michael A. Amon
`Michael A. Amon
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`9
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`Case No. 3:12-cv-02738-CAB-MDD
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