Https Ecf - Casd.uscourts - Gov Cgi-Bin Show Temp - PL File 2893695-0 - 25679

Case 3:08-cv-01512-MMA -AJB Document 12 Filed 10/13/08 Page 1 of 27
1 Frank E. Scherkenbach (SBN 142549)

FISH & RICHARDSON P.C.
2 225 Franklin Street
Boston, MA 02110-2804
3
Telephone: (617) 542-5070
4 Facsimile: (617) 542-8906
5 John E. Gartman (SBN 152300)

Juanita R. Brooks (SBN 75934)
6 Kimberly I. Kennedy (SBN 253828)
FISH & RICHARDSON P.C.
7
12390 El Camino Real
8 San Diego, California 92130
Telephone: (858) 678-5070
9 Facsimile: (858) 678-5099
10 Michael E. Florey (pro hac vice application to be submitted)
11 FISH & RICHARDSON P.C.
60 South Sixth Street
12 3300 RBC Plaza
Minneapolis, MN 55402
13 Telephone: (612) 335-5070
Facsimile: (612) 288-9696
14
15 Attorneys for Defendant

NUVASIVE, INC.
16
UNITED STATES DISTRICT COURT
17
SOUTHERN DISTRICT OF CALIFORNIA
18
19
MEDTRONIC SOFAMOR DANEK USA, INC.; Case No. 08 CV 1512 LAB (AJB)
20 WARSAW ORTHOPEDIC, INC.;
MEDTRONIC PUERTO RICO OPERATIONS DEFENDANT NUVASIVE, INC.’S
21 CO.; and MEDTRONIC SOFAMOR DANEK ANSWER TO PLAINTIFFS’ FIRST
DEGGENDORF, GmbH, AMENDED COMPLAINT FOR PATENT
22 INFRINGEMENT AND
Plaintiffs, COUNTERCLAIMS
23
24 v. JURY TRIAL DEMANDED
25 NUVASIVE, INC.,
26 Defendant.
27
28
Case No. 08 CV 1512 LAB (AJB)

1 NUVASIVE, INC.,
2 Counterclaimant,
3
v.
4
MEDTRONIC SOFAMOR DANEK USA, INC.;
5 WARSAW ORTHOPEDIC, INC.;
MEDTRONIC PUERTO RICO OPERATIONS
6 CO.; and MEDTRONIC SOFAMOR DANEK
7 DEGGENDORF, GmbH,
8 Counterclaim Defendants.
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28

1 Defendant NuVasive, Inc. (“NuVasive”), by and through its attorneys, hereby answers the
2 First Amended Complaint for Patent Infringement of Plaintiffs Medtronic Sofamor Danek USA,
3 Inc. (“Medtronic USA”), Warsaw Orthopedic, Inc. (“Warsaw”), Medtronic Puerto Rico
4 Operations Co. (“Medtronic Puerto Rico”), and Medtronic Sofamor Danek Deggendorf, GmbH
5 (“Medtronic Deggendorf”) (collectively, “Plaintiffs”). NuVasive denies each and every allegation
6 in the First Amended Complaint that is not expressly admitted below.
7 PARTIES, JURISDICTION, AND VENUE

8 1. NuVasive is without knowledge or information sufficient to admit or deny the
9 allegations of paragraph 1 and therefore denies them.
16 5. NuVasive admits the allegations in paragraph 5.
17 6. NuVasive admits that the Complaint purports to state claims arising under the
18 patent laws of the United States, Title 35 of the United States Code. NuVasive denies that there is
19 any merit to the claims.

21 8. NuVasive admits that it transacts business in this judicial district. NuVasive denies
22 the remaining allegations of paragraph 8.

24 PLAINTIFFS’ COUNT I
25 10. In response to paragraph 10, NuVasive incorporates its responses to paragraphs 1-9
26 as if fully set forth herein.

27 11. NuVasive admits that U.S. Patent No. 5,860,973 (the “ ’973 patent” ) is entitled
28 ///
1
1 “ Translateral Spinal Implant” and that it issued on January 19, 1999. NuVasive is without
2 knowledge or information sufficient to admit or deny the remaining allegations of paragraph 11
3 and therefore denies them.
4 12. NuVasive denies the allegations in paragraph 12.
6 PLAINTIFFS’ COUNT II
7 14. In response to paragraph 14, NuVasive incorporates its responses to paragraphs 1-
8 13 as if fully set forth herein.
9 15. NuVasive admits that U.S. Patent No. 5,772,661 (the “ ’661 patent” ) is entitled
10 “ Methods and Instrumentation for the Surgical Correction of Human Thoracic and Lumbar Spinal
11 Disease from the Antero-Lateral Aspect of the Spine” and that it issued on June 30, 1998.
12 NuVasive is without knowledge or information sufficient to admit or deny the remaining
17 PLAINTIFFS’ COUNT III

20 20. NuVasive admits that U.S. Patent No. 6,936,051 B2 (the “ ’051 patent” ) is entitled
21 “ Multilock Anterior Cervical Plating System” and that it issued on August 30, 2005. NuVasive is
22 without knowledge or information sufficient to admit or deny the remaining allegations of
23 paragraph 20 and therefore denies them.

26 ///
27 ///
28 ///
2
1 PLAINTIFFS’ COUNT IV
5 “ Multilock Anterior Cervical Plating System” and that it issued on August 30, 2005. NuVasive is
10 PLAINTIFFS’ COUNT V
14 “ Anterior Cervical Plate System” and that it issued on July 12, 2005. NuVasive is without
19 PLAINTIFFS’ COUNT VI

23 “ Instruments and Methods for Minimally Invasive Tissue Retraction and Surgery” and that it
24 issued on September 20, 2005. NuVasive is without knowledge or information sufficient to admit
25 or deny the remaining allegations of paragraph 32 and therefore denies them.

28 ///
3
1 PLAINTIFFS’ COUNT VII

5 “ Anterior Cervical Plating System and Bone Screw” and that it issued on November 29, 2005.
6 NuVasive is without knowledge or information sufficient to admit or deny the remaining
10 PLAINTIFFS’ COUNT VIII
14 “ Single-Lock Anterior Cervical Plate” and that it issued on August 6, 2002. NuVasive is without
19 PLAINTIFFS’ COUNT IX

23 “ Single-Lock Anterior Cervical Plating System” and that it issued on July 15, 2003. NuVasive is

28 ///
4
1 PLAINTIFFS’ PRAYER FOR RELIEF

2 In response to Plaintiffs’ Prayer for Relief, NuVasive denies that Plaintiffs are entitled to
3 the relief requested or any other relief.
4 AFFIRMATIVE DEFENSES
5 NuVasive asserts the following affirmative defenses in response to Plaintiffs’ First
6 Amended Complaint. NuVasive reserves the right to assert additional affirmative defenses as they
7 become known through discovery and the course of the litigation.
8 First Affirmative Defense
9 47. NuVasive has not infringed and does not currently infringe, either directly or
10 indirectly, any valid claim of the ’973, ’661, ’051, ’050, ’320, ’933, ’390, ’542, and ’586 patents.
11 Second Affirmative Defense
12 48. The ’973, ’661, ’051, ’050, ’320, ’933, ’390, ’542, and ’586 patents are invalid for
13 failure to satisfy the requirements of 35 U.S.C. § 101 et seq., including, without limitation,
14 sections 101, 102, 103, and 112.
15 Third Affirmative Defense

16 49. The alleged inventor named on the ’973 patent, Gary Karlin Michelson, his
17 attorneys, agents, and/or others owing a duty of candor to the United States Patent & Trademark
18 Office (collectively, the “ ’973 applicants” ) committed acts constituting inequitable conduct during
19 prosecution of the ’973 patent.

20 50. In particular, during prosecution of the ’973 patent, the ’973 applicants were aware
21 of an article by H. V. Crock titled “ Anterior Lumbar Interbody Fusion—Indications for its Use
22 and Notes on Surgical Technique,” Clinical Orthopedics, vol. 165, p. 157-163 (1982) (the “ Crock
23 article” ). The Crock article was discussed in the Background of the Invention section of U.S.
24 Patent Application No. 08/074,781, to which the application that issued as the ’973 patent
25 originally claimed priority.
26 51. The Crock article was not discussed in the application that issued as the ’973 patent
27 and was not cited by the ’973 applicants during prosecution of the ’973 patent.
28 ///
5
1 52. The Crock article was material to the patentability of the ’ 973 patent.
2 53. On information and belief, the ’ 973 applicants withheld the Crock article from the
3 United States Patent & Trademark Office with the intent to deceive the United States Patent &
4 Trademark Office, rendering the ’ 973 patent unenforceable for inequitable conduct.
5 54. The application that issued as the ’ 973 patent originally claimed priority to multiple
6 applications, the earliest of which was U.S. Patent Application No. 07/205,935, filed June 13,
7 1988 (the “ 1988 application” ).
8 55. During prosecution of the application that issued as the ’ 973 patent, the ’ 973
9 applicants filed an information disclosure statement (“ IDS” ) citing more than forty patents,
10 including U.S. Patent No. 5,192,327 to Brantigan (the “ Brantigan patent” ). The Brantigan patent
11 was filed on March 22, 1991, and issued on March 9, 1993. As such, neither the filing date nor
12 the issue date of the Brantigan patent was earlier than the originally-claimed priority date of the
13 application that issued as the ’ 973 patent.
14 56. The examiner signed and dated the IDS which included the Brantigan patent on
15 July 28, 1997, and issued a notice of allowance on August 6, 1997.
16 57. After the claims were allowed and prosecution on the merits was closed, the ’ 973
17 applicants amended the priority claim so that the application that issued as the ’ 973 patent no
18 longer claimed priority back to the 1988 application. The application as amended claimed priority
19 to an application filed on February 27, 1995, which is later than both the filing date and the issue
20 date of the Brantigan patent.
21 58. The Brantigan patent was material to the patentability of the ’ 973 patent.
22 59. On information and belief, the ’ 973 applicants originally claimed priority to the
23 1988 application and later amended the priority claim after the claims were allowed over the
24 Brantigan patent with the intent to deceive the United States Patent & Trademark Office,
25 rendering the ’ 973 patent unenforceable for inequitable conduct.
26 60. In the Background of the Invention section of the ’ 973 patent, the ’ 973 applicants
27 stated that “ In the past, Cloward, Wilterberger, Crock, Viche, Bagby, Brantigan, and others have
28 ///
6
1 taught various methods involving the drilling of holes across the disc space between two adjacent
2 vertebrae of the spine for the purpose of causing interbody spinal fusion.” The applicants further
3 stated that “ However, all of the prior implants have been inserted from either the front or the back
4 of the patient.”
5 61. The Crock article discloses an implant inserted from a lateral aspect of the spine.
6 62. The Brantigan patent also discloses an implant inserted from a lateral aspect of the
7 spine.
8 63. The ’ 973 applicants’ statement that “ all of the prior implants have been inserted
9 from either the front or the back of the patient” was false.
10 64. The statement was material to the patentability of the ’ 973 patent.
11 65. On information and belief, the ’ 973 applicants made the statement, knowing it to be
12 false, with the intent to deceive the United States Patent & Trademark Office, rendering the ’ 973
13 patent unenforceable for inequitable conduct.
14 Fourth Affirmative Defense

15 66. The alleged inventor named on the ’ 661 patent, Gary Karlin Michelson, his
17 Office (collectively, the “ ’ 661 applicants” ) committed acts constituting inequitable conduct during
18 prosecution of the ’ 661 patent.
19 67. In particular, during prosecution of the ’ 661 patent, the ’ 661 applicants were aware
20 of the Crock article. The Crock article was discussed in the Background of the Invention section
21 of U.S. Patent Application No. 08/074,781, to which the ’ 661 patent claims priority.
22 68. The Crock article was not discussed in the application that issued as the ’ 661 patent
23 and was not cited by the ’ 661 applicants during prosecution of the ’ 661 patent.
28 ///
7
1 COUNTERCLAIMS
2 NuVasive, for its counterclaims against Plaintiffs, states and alleges as follows:
3 The Parties
4 71. NuVasive, Inc. is a Delaware corporation with its principal place of business in San
5 Diego, California.
6 72. On information and belief, Medtronic USA is a Tennessee corporation with its
7 principal place of business in Memphis, Tennessee.
8 73. On information and belief, Warsaw is an Indiana corporation with its principal
9 place of business in Winona Lake, Indiana.
10 74. On information and belief, Medtronic Puerto Rico is a Cayman Islands corporation
11 with its principal place of business in Villalba, Puerto Rico.
12 75. On information and belief, Medtronic Deggendorf is a German corporation with its
13 principal place of business in Deggendorf, Germany.
14 Jurisdiction and Venue
15 76. These counterclaims arise under the patent laws of the United States, Title 35 of the
16 United States Code, and the Federal Declaratory Judgment Act, Title 28 of the United States
17 Code.
18 77. This Court has subject matter jurisdiction over these counterclaims pursuant to 28
19 U.S.C. §§ 1331, 1338, 2201, and 2202.

20 78. Plaintiffs have consented to personal jurisdiction by commencing an action alleging
21 infringement of the patents-in-suit in this judicial district, as set forth in Plaintiffs’ Complaint and
22 First Amended Complaint.
23 79. Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and 1400.
24 NUVASIVE’S COUNT I
25 80. NuVasive incorporates by reference the allegations of the preceding paragraphs of
26 its Counterclaims as if fully set forth herein.

27 ///
28 ///
8
1 81. An actual and justiciable controversy exists between NuVasive and Plaintiffs as to
2 the infringement of the ’ 973 patent, as evidenced by Plaintiffs’ First Amended Complaint and
3 NuVasive’ s Answer thereto, as set forth above.
5 indirectly, any valid claim of the ’ 973 patent.
6 83. Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.,
7 NuVasive requests the declaration of the Court that NuVasive has not infringed and does not
8 currently infringe, either directly or indirectly, any valid claim of the ’ 973 patent.
9 NUVASIVE’S COUNT II
13 the validity of the ’ 973 patent, as evidenced by Plaintiffs’ First Amended Complaint and
15 86. The ’ 973 patent is invalid for failure to satisfy the requirements of 35 U.S.C. § 101
16 et seq., including, without limitation, sections 101, 102, 103, and 112.
18 NuVasive requests the declaration of the Court that the ’ 973 patent is invalid for failure to satisfy
19 the requirements of 35 U.S.C. § 101 et seq., including, without limitation, sections 102, 103, and
20 112.
21 NUVASIVE’S COUNT III

25 the enforceability of the ’ 973 patent, as evidenced by Plaintiffs’ First Amended Complaint and

28 ///
9
5 of an article by H. V. Crock titled “ Anterior Lumbar Interbody Fusion—Indications for its Use
6 and Notes on Surgical Technique,” Clinical Orthopedics, vol. 165, p. 157-163 (1982) (the “ Crock
7 article” ). The Crock article was discussed in the Background of the Invention section of U.S.
8 Patent Application No. 08/074,781, to which the application that issued as the ’ 973 patent
9 originally claimed priority.
16 95. The application that issued as the ’ 973 patent originally claimed priority to multiple
17 applications, the earliest of which was U.S. Patent Application No. 07/205,935, filed June 13,
18 1988 (the “ 1988 application” ).
19 96. During prosecution of the application that issued as the ’ 973 patent, the ’ 973
20 applicants filed an information disclosure statement (“ IDS” ) citing more than forty patents,
21 including U.S. Patent No. 5,192,327 to Brantigan (the “ Brantigan patent” ). The Brantigan patent
22 was filed on March 22, 1991, and issued on March 9, 1993. As such, neither the filing date nor
23 the issue date of the Brantigan patent was earlier than the originally-claimed priority date of the
24 application that issued as the ’ 973 patent.
25 97. The examiner signed and dated the IDS which included the Brantigan patent on
26 July 28, 1997, and issued a notice of allowance on August 6, 1997.

27 ///
28 ///
10
1 98. After the claims were allowed and prosecution on the merits was closed, the ’ 973
2 applicants amended the priority claim so that the application that issued as the ’ 973 patent no
3 longer claimed priority back to the 1988 application. The application as amended claimed priority
4 to an application filed on February 27, 1995, which is later than both the filing date and the issue
5 date of the Brantigan patent.
6 99. The Brantigan patent was material to the patentability of the ’ 973 patent.
7 100. On information and belief, the ’ 973 applicants originally claimed priority to the
8 1988 application and later amended the priority claim after the claims were allowed over the
9 Brantigan patent with the intent to deceive the United States Patent & Trademark Office,
10 rendering the ’ 973 patent unenforceable for inequitable conduct.
11 101. In the Background of the Invention section of the ’ 973 patent, the ’ 973 applicants
12 stated that “ In the past, Cloward, Wilterberger, Crock, Viche, Bagby, Brantigan, and others have
13 taught various methods involving the drilling of holes across the disc space between two adjacent
14 vertebrae of the spine for the purpose of causing interbody spinal fusion.” The applicants further
15 stated that “ However, all of the prior implants have been inserted from either the front or the back
16 of the patient.”
17 102. The Crock article discloses an implant inserted from a lateral aspect of the spine.
18 103. The Brantigan patent also discloses an implant inserted from a lateral aspect of the
19 spine.
20 104. The ’ 973 applicants’ statement that “ all of the prior implants have been inserted
21 from either the front or the back of the patient” was false.
22 105. The statement was material to the patentability of the ’ 973 patent.
23 106. On information and belief, the ’ 973 applicants made the statement, knowing it to be
24 false, with the intent to deceive the United States Patent & Trademark Office, rendering the ’ 973
25 patent unenforceable for inequitable conduct.
27 NuVasive requests the declaration of the Court that the ’ 973 patent is unenforceable due to
28 inequitable conduct.
11
1 NUVASIVE’S COUNT IV
12 NUVASIVE’S COUNT V
19 et seq., including, without limitation, sections 102, 103, and 112.

23 112.
24 NUVASIVE’S COUNT VI

27 ///
28 ///
12
2 the enforceability of the ’ 661 patent, as evidenced by Plaintiffs’ First Amended Complaint and
9 of the Crock article. The Crock article was discussed in the Background of the Invention section
10 of U.S. Patent Application No. 08/074,781, to which the ’ 661 patent claims priority.
18 NuVasive requests the declaration of the Court that the ’ 661 patent is unenforceable due to
19 inequitable conduct.
20 NUVASIVE’S COUNT VII

28 ///
13
4 NUVASIVE’S COUNT VIII

15 112.
16 NUVASIVE’S COUNT IX


27 ///
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14
1 NUVASIVE’S COUNT X
12 112.
13 NUVASIVE’S COUNT XI
24 NUVASIVE’S COUNT XII

27 ///
28 ///
15
9 112.
10 NUVASIVE’S COUNT XIII

21 NUVASIVE’S COUNT XIV


27 ///
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16
6 112.
7 NUVASIVE’S COUNT XV
18 NUVASIVE’S COUNT XVI

26 ///
27 ///
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17
4 112.
5 NUVASIVE’S COUNT XVII

16 NUVASIVE’S COUNT XVIII


27 112.
28 ///
18
1 NUVASIVE’S COUNT XIX

12 NUVASIVE’S COUNT XX

23 112.
24 NUVASIVE’S COUNT XXI

27 ///
28 ///
19
2 the infringement of U.S. Patent No. 7,008,422 B2 (the “ ’ 422 patent” ), titled “ Instruments and
3 Methods for Stabilization of Bony Structures.” A copy of the ’ 422 patent was attached as Exhibit
4 H to Plaintiffs’ August 18, 2008 Complaint.
5 182. Plaintiffs have alleged that Warsaw is the owner of the ’ 422 patent by assignment,
6 and that Medtronic USA, Medtronic Puerto Rico, and Medtronic Deggendorf are co-exclusive
7 licensees of the ’ 422 patent and, together with Warsaw, share the exclusive right to bring suit for
8 infringement of the ’ 422 patent.
9 183. As evidenced by Plaintiffs’ August 18, 2008 Complaint, Plaintiffs have asserted
10 that NuVasive has contributed to the infringement and continues to contribute to the infringement
11 of the ’ 422 patent.
17 NUVASIVE’S COUNT XXII


21 the validity of the ’ 422 patent, as evidenced by Plaintiffs’ August 18, 2008 Complaint.

27 112.
28 ///
20
1 NUVASIVE’S COUNT XXIII

5 the infringement of the U.S. Patent No. 6,530,929 B1 (the “ ’ 929 patent” ), titled “ Instruments for
6 Stabilization of Bony Structures.” A copy of the ’ 929 patent was attached as Exhibit I to
7 Plaintiffs’ August 18, 2008 Complaint.
13 that NuVasive has infringed and continues to infringe the ’ 929 patent.
19 NUVASIVE’S COUNT XXIV


26 ///
27 ///
28 ///
21
4 112.
5 NUVASIVE’S COUNT XXV

9 the infringement of U.S. Patent No. 6,235,028 B1 (the “ ’ 028 patent” ), titled “ Surgical Guide Rod.”
10 A copy of the ’ 028 patent was attached as Exhibit J to Plaintiffs’ August 18, 2008 Complaint.
16 that NuVasive has infringed and continues to infringe the ’ 028 patent.
22 NUVASIVE’S COUNT XXVI
27 ///
28 ///
22
6 112.
7 NUVASIVE’S PRAYER FOR RELIEF

8 WHEREFORE, NuVasive respectfully requests that the Court enter judgment in
9 NuVasive’ s favor and against Plaintiffs as follows:
10 1. That Plaintiffs’ First Amended Complaint be dismissed with prejudice;
11 2. That Plaintiffs take nothing by reason of their First Amended Complaint;
12 3. Declaring that NuVasive has not infringed and does not currently infringe, either
13 directly or indirectly, any valid claim of the ’ 973, ’ 661, ’ 051, ’ 050, ’ 320, ’ 933, ’ 390, ’ 542, ’ 586,
14 ’ 422, ’ 929, and ’ 028 patents;
15 4. That Plaintiffs and their officers, employees, agents, licensees, successors, and
16 assigns, and all persons acting in concert or participation with them, be permanently enjoined from
17 charging that NuVasive has infringed or is infringing the ’ 973, ’ 661, ’ 051, ’ 050, ’ 320, ’ 933, ’ 390,
18 ’ 542, ’ 586, ’ 422, ’ 929, and ’ 028 patents;
19 5. Declaring that the ’ 973, ’ 661, ’ 051, ’ 050, ’ 320, ’ 933, ’ 390, ’ 542, ’ 586, ’ 422, ’ 929,
20 and ’ 028 patents are invalid;
21 6. Declaring that the ’ 973 and ’ 661 patent are unenforceable due to inequitable
22 conduct;
23 7. That this is an exceptional case under 35 U.S.C. § 285;

24 8. Awarding NuVasive its costs and reasonable attorneys’ fees for this litigation; and
25 9. Awarding NuVasive any further relief that the Court deems just and proper.
26 ///
27 ///
28 ///
23
1 JURY DEMAND
2 NuVasive hereby demands a trial by jury on all issues so triable.
3
5 Dated: October 13, 2008 FISH & RICHARDSON P.C.

6
7 By: s/Kimberly I. Kennedy

Frank E. Scherkenbach (SBN 142549)
8 John E. Gartman (SBN 152300)
Juanita R. Brooks (SBN 75934)
9
Michael E. Florey (pro hac vice application
10 to be submitted)
Kimberly I. Kennedy (SBN 253828)
11
Attorneys for
12 NUVASIVE, INC.
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1 CERTIFICATE OF SERVICE
2
3 The undersigned hereby certifies that a true and correct copy of the above and foregoing
4 document has been served on October 13, 2008, to all counsel of record who are deemed to have
5 consented to electronic service via the Court’ s CM/ECF system per Civil Local Rule 5.4. Any
6 other counsel of record will be served by electronic mail, facsimile and/or overnight delivery.
7
8 s/Kimberly I. Kennedy_________________
Kimberly I. Kennedy (SBN 253828)
9 kennedy@fr.com
10
Attorney for Defendant
11 NUVASIVE, INCORPORATED
60525415.doc
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Case 3:08-cv-01512-MMA -AJB Document 12 Filed 10/13/08 Page 1 of 27

1 Frank E. Scherkenbach (SBN 142549)

5 John E. Gartman (SBN 152300)

15 Attorneys for Defendant

Case No. 08 CV 1512 LAB (AJB)

Case No. 08 CV 1512 LAB (AJB)

6 in the First Amended Complaint that is not expressly admitted below.

7 PARTIES, JURISDICTION, AND VENUE

19 any merit to the claims.

23 9. NuVasive admits the allegations in paragraph 9.

26 as if fully set forth herein.

2 knowledge or information sufficient to admit or deny the remaining allegations of paragraph 11

3 and therefore denies them.

4 12. NuVasive denies the allegations in paragraph 12.

5 13. NuVasive denies the allegations in paragraph 13.

19 18 as if fully set forth herein.

23 paragraph 20 and therefore denies them.

25 22. NuVasive denies the allegations in paragraph 22.

12 26 as if fully set forth herein.

15 knowledge or information sufficient to admit or deny the remaining allegations of paragraph 28

16 and therefore denies them.

17 29. NuVasive denies the allegations in paragraph 29.

18 30. NuVasive denies the allegations in paragraph 30.

21 30 as if fully set forth herein.

25 or deny the remaining allegations of paragraph 32 and therefore denies them.

26 33. NuVasive denies the allegations in paragraph 33.

1 PLAINTIFFS’ COUNT VII

12 38 as if fully set forth herein.

15 knowledge or information sufficient to admit or deny the remaining allegations of paragraph 40

16 and therefore denies them.

17 41. NuVasive denies the allegations in paragraph 41.

18 42. NuVasive denies the allegations in paragraph 42.

21 42 as if fully set forth herein.

25 paragraph 44 and therefore denies them.

26 45. NuVasive denies the allegations in paragraph 45.

1 PLAINTIFFS’ PRAYER FOR RELIEF

14 sections 101, 102, 103, and 112.

15 Third Affirmative Defense

19 prosecution of the ’973 patent.

25 originally claimed priority.

7 1988 (the “ 1988 application” ).

13 application that issued as the ’ 973 patent.

15 July 28, 1997, and issued a notice of allowance on August 6, 1997.

20 date of the Brantigan patent.

25 rendering the ’ 973 patent unenforceable for inequitable conduct.

13 patent unenforceable for inequitable conduct.

14 Fourth Affirmative Defense

18 prosecution of the ’ 661 patent.

19 U.S.C. §§ 1331, 1338, 2201, and 2202.

26 its Counterclaims as if fully set forth herein.

3 NuVasive’ s Answer thereto, as set forth above.

5 indirectly, any valid claim of the ’ 973 patent.

21 NUVASIVE’S COUNT III

23 its Counterclaims as if fully set forth herein.

26 NuVasive’ s Answer thereto, as set forth above.

3 prosecution of the ’ 973 patent.

9 originally claimed priority.

18 1988 (the “ 1988 application” ).

24 application that issued as the ’ 973 patent.

26 July 28, 1997, and issued a notice of allowance on August 6, 1997.

5 date of the Brantigan patent.

10 rendering the ’ 973 patent unenforceable for inequitable conduct.