Free Answer to Complaint - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE VENETEC INTERNATIONAL, INC., Plaintiff, vs. NEXUS MEDICAL, LLC, Defendant. NEXUS MEDICAL, LLC'S FIRST AMENDED ANSWER AND COUNTERCLAIM TO VENETEC INTERNATIONAL, INC.'S SECOND SUPPLEMENTAL COMPLAINT AND COUNTERCLAIM Pursuant to the Memorandum and Order dated March 28, 2008 (D.I. 135), Defendant Nexus Medical, LLC ("Nexus"), for its First Amended Answer and Counterclaim to Venetec International, Inc.'s ("Venetec") Second Supplemental Complaint, hereby states as follows, with each numbered answer corresponding to the numbered paragraph of the Second Supplemental Complaint: Parties 1. Nexus lacks sufficient knowledge or information to form a belief as to the truth of C.A. NO. 07-57 (MPT)

the allegations of this paragraph and, on that basis, denies them. 2. Admitted. Jurisdiction and Venue 3. Nexus admits this paragraph identifies the title and section of the United States

Code under which Plaintiff's claims are based and that this Court has subject matter jurisdiction. To the extent that any further response is required, Nexus denies that it has infringed any valid claim of the asserted patents.

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4.

Nexus denies that it sells products within this judicial district, but admits that this

paragraph accurately states the statutes on which Plaintiff's venue allegations are based and that venue is proper. Count I Patent Infringement ­ U.S Patent No. 6,213,979 5. Nexus incorporates by reference its responses to paragraphs 1 through 4 above as

if fully set forth herein. 6. Nexus admits that the face of U.S. Patent No. 6,213,979 ("the `979 Patent")

indicates the `979 Patent is entitled "Medical Line Anchoring System," indicates it was issued on April 10, 2001, and that a copy of the `979 Patent is attached to the Second Supplemental Complaint as Exhibit A. Nexus denies the `979 Patent was duly and legally issued and Nexus lacks sufficient knowledge or information to form a belief as to the truth of the remaining allegations of this paragraph and, on that basis, denies them. 7. 8. 9. Denied. Denied. Denied. Count II Patent Infringement ­ U.S. Patent No. 6,447,485 10. Nexus incorporates by reference its responses to paragraphs 1 through 9 above as

if fully set forth herein. 11. Nexus admits that the face of U.S. Patent No. 6,447,485 ("the `485 Patent")

indicates the `485 Patent is entitled "Medical Line Anchoring System," indicates it was issued on September 10, 2002, and that a copy of the `485 Patent is attached to the Second Supplemental Complaint as Exhibit B. Nexus denies the `485 Patent was duly and legally issued and Nexus

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lacks sufficient knowledge or information to form a belief as to the truth of the remaining allegations of this paragraph and, on that basis, denies them. 12. 13. 14. Denied. Denied. Denied. Count III Patent Infringement ­ U.S. Patent No. 7,247,150 15. Nexus incorporates by reference its responses to paragraphs 1 through 14 above

as if fully set forth herein. 16. Nexus admits that the face of U.S. Patent No. 7,247,150 ("the `150 Patent")

indicates the `150 Patent is entitled "Medical Line Anchoring System," indicates it was issued on July 24, 2007, and that a copy of the `150 Patent is attached to the Second Supplemental Complaint as Exhibit C. Nexus denies the `150 Patent was duly and legally issued and Nexus lacks sufficient knowledge or information to form a belief as to the truth of the remaining allegations of this paragraph and, on that basis, denies them. 17. 18. 19. Denied. Denied. Denied. Count IV False Marking As To The `396 Patent 20. Nexus incorporates by reference its responses to paragraphs 1 through 19 above

as if fully set forth herein. 21. Nexus admits that paragraph 21 is a summary of an excerpt of 35 U.S.C. § 292(a).

To the extent that any further response is required, Nexus denies that it has violated any

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provision of 35 U.S.C. § 292. 22. Nexus admits that a purported image of the packaging of "The Bone" is attached

to the Second Supplemental Complaint as Exhibit D. Nexus denies the remaining allegations of the paragraph. 23. Nexus admits that the face of U.S. Patent No. 5,356,396 ("the `396 Patent")

indicates the `396 Patent is entitled "Infusion Apparatus," indicates it was issued on October 18, 1994, and indicates it was assigned to Medical Associates Network, Inc. from an application filed by the named inventors Philip Wyatt, Gary Schaeffer, and Freddy Zinger. Nexus further admits that a copy of the `396 Patent is attached to the Second Supplemental Complaint as Exhibit E. 24. 25. Denied. Denied. Count V False Marking As To The `413 Patent 26. Nexus incorporates by reference its responses to paragraphs 1 through 25 above

as if fully set forth herein. 27. Nexus admits that paragraph 27 is a summary of an excerpt of 35 U.S.C. § 292(a).

To the extent that any further response is required, Nexus denies that it has violated any provision of 35 U.S.C. § 292. 28. Nexus admits that a purported image of the packaging of "The Bone" is attached

to the Second Supplemental Complaint as Exhibit D. Nexus denies the remaining allegations of the paragraph. 29. Nexus admits that the face of U.S. Patent No. 5,360,413 ("the `413 Patent")

indicates the `413 Patent is entitled "Needleless Access Device," indicates it was issued on

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November 1, 1994, and indicates it was assigned to Filtertek, Inc. from an application filed by the named inventors Michael H. Leason, Rick R. Ruschke, and Ralph L. Davis. Nexus further admits that a copy of the `413 Patent is attached to the Second Supplemental Complaint as Exhibit F. 30. 31. Denied. Denied. Count VI False Marking As To The `426 Patent 32. Nexus incorporates by reference its responses to paragraphs 1 through 31 above

as if fully set forth herein. 33. Nexus admits that paragraph 33 is a summary of an excerpt of 35 U.S.C. § 292(a).

To the extent that any further response is required, Nexus denies that it has violated any provision of 35 U.S.C. § 292. 34. Nexus admits that a purported image of the packaging of "The Bone" is attached

to the Second Supplemental Complaint as Exhibit D. Nexus denies the remaining allegations of the paragraph. 35. Nexus admits that the face of U.S. Patent No. 5,501,426 ("the `426 Patent")

indicates the `426 Patent is entitled "Medical Coupling Site Valve Body," indicates it was issued on March 26, 1996, and indicates it was assigned to Vernay Laboratories, Inc. from an application filed by the named inventors Gordon E. Atkinson and Dennis A. Boehmer. Nexus further admits that a copy of the `426 Patent is attached to the Second Supplemental Complaint as Exhibit G. 36. 37. Denied. Denied.

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Count VII False Marking As To The `708 Patent 38. Nexus incorporates by reference its responses to paragraphs 1 through 37 above

as if fully set forth herein. 39. Nexus admits that paragraph 39 is a summary of an excerpt of 35 U.S.C. § 292(a).

To the extent that any further response is required, Nexus denies that it has violated any provision of 35 U.S.C. § 292. 40. Nexus admits that a purported image of the packaging of "The Bone" is attached

to the Second Supplemental Complaint as Exhibit D. Nexus denies the remaining allegations of the paragraph. 41. Nexus admits that the face of U.S. Patent No. 5,533,708 ("the `708 Patent")

indicates the `708 Patent is entitled "Medical Coupling Site Valve Body," indicates it was issued on July 9, 1996, and indicates it was assigned to Vernay Laboratories, Inc. from an application filed by the named inventors Gordon E. Atkinson and Thomas J. Solomon. Nexus further admits that a copy of the `708 Patent is attached to the Second Supplemental Complaint as Exhibit H. 42. 43. Denied. Denied. Count VIII False Marking As To The `735 Patent 44. Nexus incorporates by reference its responses to paragraphs 1 through 43 above

as if fully set forth herein. 45. Nexus admits that paragraph 45 is a summary of an excerpt of 35 U.S.C. § 292(a).

To the extent that any further response is required, Nexus denies that it has violated any provision of 35 U.S.C. § 292.

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46.

Nexus admits that a purported image of the packaging of "The Bone" is attached

to the Second Supplemental Complaint as Exhibit D. Nexus denies the remaining allegations of the paragraph. 47. Nexus admits that the face of U.S. Patent No. 5,632,735 ("the `735 Patent")

indicates the `735 Patent is entitled "Infusion Apparatus" and indicates it was issued on May 27, 1997, to named inventors Philip Wyatt and Gary Schaeffer. Nexus further admits that a copy of the `735 Patent is attached to the Second Supplemental Complaint as Exhibit I. 48. 49. Denied. Denied. Count IX False Marking As To The `215 Patent 50. Nexus incorporates by reference its responses to paragraphs 1 through 49 above

as if fully set forth herein. 51. Nexus admits that paragraph 51 is a summary of an excerpt of 35 U.S.C. § 292(a).

To the extent that any further response is required, Nexus denies that it has violated any provision of 35 U.S.C. § 292. 52. Nexus admits that a purported image of the packaging of "The Bone" is attached

to the Second Supplemental Complaint as Exhibit D. Nexus denies the remaining allegations of the paragraph. 53. Nexus admits that the face of U.S. Patent No. 6,991,215 ("the `215 Patent")

indicates the `215 Patent is entitled "Valve For Use With A Syringe And Which Prevents Backflow," indicates it was issued on January 31, 2006, and indicates it was assigned to Occupational & Medical Innovations, Ltd., from an application filed by the named inventor Bruce Leigh Kiehne. Nexus further admits that a copy of the `215 Patent is attached to the

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Second Supplemental Complaint as Exhibit J. 54. 55. Denied. Denied. Affirmative Defenses 1. Plaintiffs Second Supplemental Complaint fails to state a claim for which relief

may be granted. 2. 3. Nexus has not infringed any valid claim of the Patents-in-Suit. One or more of the asserted claims of each of the Patents-in-Suit is invalid and

void under 35 U.S.C. §§ 102, 103, and/or 112. 4. The `150 Patent is unenforceable for inequitable conduct, as more fully set forth

in Nexus's Count III of its counterclaim. WHEREFORE, Nexus prays that Plaintiff take nothing by way of its Second Supplemental Complaint, that Plaintiff's claims be dismissed with prejudice, that Nexus be awarded its costs, expenses, and attorneys' fees in defending the matter, and such other and further relief as the Court deems just and proper.

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Counterclaim COMES NOW Nexus Medical, LLC ("Nexus"), and for its Counterclaim against Plaintiff, alleges as follows: Parties 1. Nexus is a Delaware limited liability company with its principal place of business

at 11315 Strang Line Road, Lenexa, Kansas 66215. 2. Upon information and belief, Venetec International, Inc. ("Venetec") is a

Delaware corporation with its principal place of business in San Diego, California, 66215. Jurisdiction and Venue 3. This is an action for Declaratory Judgment under 28 U.S.C. §§ 2201 and 2202

seeking adjudication that U.S. Patent No. 6,213,979 (the "`979 patent"), U.S. Patent No. 6,447,485 (the "`485 Patent"), and U.S. Patent No. 7,247,150 (the "`150 Patent") (collectively the "Patents-in-Suit") are not infringed and are invalid and void, and that the `150 Patent is unenforceable. 4. This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.

§§ 1331 and 1338 in that this action arises under the patent laws of the United States and an actual controversy exists between the parties. 5. 139l(b). Count I Noninfringement of the Patents-in-Suit 6. Nexus incorporates by reference and re-alleges paragraphs 1 through 5 of its Venue is proper in this judicial district and division pursuant to 28 U.S.C. §

counterclaim as if fully set forth herein. 7. Venetec has alleged that it is the owner of the Patents-in-Suit.

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8.

Venetec has charged Nexus with infringement of the Patents-in-Suit, and Nexus

has denied that allegation. 9. 10. Nexus has not infringed any valid claim of the Patents-in-Suit. There is a substantial, justiciable, and continuing controversy between Nexus and

Venetec as to Venetec's suit for infringement of the Patents-in-Suit and whether Nexus has infringed or is infringing any valid claim of the Patents-in-Suit. 11. Nexus will be damaged in its business by the charges of infringement by Venetec

in its Second Supplemental Complaint and will be irreparably harmed if the existing controversy between the parties is not promptly adjudicated. 12. Nexus. Count II Invalidity of the Patents-in-Suit 13. Nexus incorporates by reference and re-alleges paragraphs 1 through 12 of its As a result, Nexus seeks a declaration that the Patents-in-Suit are not infringed by

counterclaim as if fully set forth herein. 14. 15. Venetec has alleged that it is the owner of the Patents-in-Suit. Venetec has charged Nexus with infringement of the Patents-in-Suit, and Nexus

has denied that allegation. 16. Upon information and belief, one or more of the claims of the Patents-in-Suit are

invalid and void under 35 U.S.C. §§ 102, 103, and/or 112. 17. There is a substantial, justiciable, and continuing controversy between Nexus and

Venetec as to Venetec's suit for infringement of the Patents-in-Suit and the validity and scope of the Patents-in-Suit. 18. Nexus will be damaged in its business by the charges of infringement by Venetec

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in its Second Supplemental Complaint and will be irreparably harmed if the existing controversy between the parties is not promptly adjudicated. 19. void. Count III Unenforceability of the `150 Patent 20. Nexus incorporates by reference and re-alleges paragraphs 1 through 19 of its As a result, Nexus seeks a declaration that the Patents-in-Suit are invalid and

counterclaim as if fully set forth herein. 21. 22. Venetec has alleged that it is the owner of the `150 Patent. Venetec has charged Nexus with infringement of the `150 Patent and Nexus has

denied that allegation. 23. As used in Count III of Nexus's Counterclaim, "Venetec" is defined to

specifically include one or more members of the group of individuals owing a duty of candor to the Patent Office, pursuant to 37 C.F.R. § 1.56(a). 24. The `150 Patent is a continuation of the `485 Patent, and therefore, the `150 Patent

is related to and claims priority to the `485 Patent. 25. The `485 Patent is a divisional of the `979 Patent, and therefore, the `485 Patent is

related to and claims priority benefit to the `979 Patent. 26. 27. The `150, `485, and `979 patents are related and disclose the same subject matter. The present litigation was filed on January 29, 2007, and asserted only the `485

and `979 Patents. (D.I. 1). 28. Per MPEP § 2001.06(c), the Patent Office requires proper citation of the existence

of this litigation and material information arising therefrom. 29. The existence of this litigation is per se material to patentability of the `150 Patent

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Application. 30. On January 3, 2007, Venetec filed with the U.S. Patent Office an Amendment in

the `150 Patent Application, attached as Exhibit A. 31. On February 7, 2007, Venetec held an in-person interview with the patent

examiner for the `150 Patent Application. A copy of the Interview Summary filed by the Patent Office is attached as Exhibit B. 32. During the interview, Venetec's representative and the patent examiner discussed

Venetec's amendments to the claims submitted in the Amendment filed on January 3, 2007, in the `150 Patent Application. (See Exhibit B). 33. Subsequent to the in-person interview, the patent examiner issued a Notice of

Allowability and Examiner's Amendment, attached as Exhibit C, on March 16, 2007, for the `150 Patent Application. 34. From January 3, 2007, through March 15, 2007, Venetec was actively prosecuting

the `150 Patent Application to obtain allowance of claims, some of which have been asserted in the present litigation as infringing. 35. Venetec paid the issue fee for the `150 Patent Application on March 15, 2007, a

day prior to the Patent Office's mailing of the Notice of Allowance. A copy of the Issue Fee Transmittal filed by Venetec is attached as Exhibit D. 36. Venetec had from January 29, 2007, the date of filing of the present litigation, up

to March 15, 2007, the date of payment of the issue fee in the `150 Patent Application, to inform the Patent Office of the existence of the present litigation, but failed to do so. 37. Per MPEP § 2001.04 and 37 C.F.R. § § 1.56(a) and 1.97, after payment of the

issue fee, information will only be considered if (1) the application is withdrawn from issue, a

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Request for Continued Examination is filed, and the information is properly cited in an Information Disclosure Statement ("IDS"); or (2) the application is withdrawn from issue, the application is expressly abandoned, a continuing application is filed, and the information is properly cited in an IDS filed in the continuing application. 38. 2007. 39. In the June 20, 2007, IDS (Exhibit E), Venetec stated that it was filing the IDS "in Venetec listed this litigation on an IDS filed with the Patent Office on June 20,

accordance with M.P.E.P. § 2001.06(c)," and therefore, Venetec knew of its obligations under § 2001.06( c) to cite the existence of litigation involving the same subject matter as an examined patent application. 40. On June 25, 2007, the Patent Office responded to Venetec's filing of the IDS

("Patent Office Response"), attached hereto as Exhibit F. 41. The Patent Office Response explains that the litigation listed on the IDS was not

considered by the patent examiner in the prosecution of the `150 Patent Application because the issue fee had already been paid. 42. The Patent Office Response advises Venetec to file a petition to withdraw the

`150 Patent Application from issue to have the IDS considered by the Patent Office. 43. Although Venetec had the opportunity to petition the Patent Office to withdraw

the `150 Patent Application from issue and either (1) file a Request for Continued Examination and an IDS properly citing the existence of the litigation; or (2) expressly abandon the `150 Patent Application, file a continuing application, and file an IDS in the continuing application properly citing the existence of the litigation, Venetec failed to do so. 44. The Patent Office did not consider the existence of this litigation in determining

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patentability of the `150 Patent Application. 45. In response to Venetec's First Set of Interrogatories in this litigation, Nexus

served Venetec with invalidity contentions of the `485 Patent (the "Interrogatory Invalidity Contentions") on May 30, 2007, including invalidity claim charts. 46. The Interrogatory Invalidity Contentions arise from the present litigation and

therefore should have been properly cited to the Patent Office, pursuant to MPEP § 2001.06(c). 47. The Interrogatory Invalidity Contentions are per se material to patentability of the

`150 Patent Application. 48. Venetec listed the Interrogatory Invalidity Contentions on the IDS filed with the

Patent Office on June 20, 2007. (See Exhibit E). 49. In the June 20, 2007, IDS (Exhibit E), Venetec stated that it was filing the IDS "in

accordance with M.P.E.P. § 2001.06(c)," and therefore, Venetec knew of its obligations under § 2001.06(c) to cite material information arising from litigation involving the same subject as an examined application. 50. On June 25, 2007, the Patent Office responded to Venetec's filing of the IDS (the

afore-mentioned Patent Office Response), attached hereto as Exhibit F. 51. The Patent Office Response explains that the Interrogatory Invalidity Contentions

listed on the IDS were not considered by the patent examiner in the prosecution of the `150 Patent Application because the issue fee had already been paid. 52. The Patent Office Response advises Venetec to file a petition to withdraw the

`150 Patent Application from issue to have the IDS considered by the Patent Office. 53. Although Venetec had the opportunity to petition the Patent Office to withdraw

the `150 Patent Application from issue and either (1) file a Request for Continued Examination

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and an IDS properly citing the Interrogatory Invalidity Contentions; or (2) expressly abandon the `150 Patent Application, file a continuing application, and file an IDS in the continuing application properly citing the Interrogatory Invalidity Contentions, Venetec failed to do so. 54. The Patent Office did not consider the Interrogatory Invalidity Contentions in

determining patentability of the `150 Patent Application. 55. Nexus filed a Request for Reexamination of the `485 Patent ("the `485

Reexamination") with the Patent Office on June 25, 2007, and a copy of the `485 Reexamination was provided to Venetec at or about that time. 56. The `485 Reexamination sets forth four prior art references that invalidate claims

1-3, 5-8, 11-13, 15-18, and 21-22 ("the Reexamined Claims") of the `485 Patent. 57. The `485 Reexamination contains no less than twenty-four arguments for

invalidity (the "Reexamination Invalidity Contentions") of the Reexamined Claims that are detailed in no less than twenty-four claim charts. 58. The Reexamination Invalidity Contentions include, but are not limited to,

assertions that the Reexamined Claims of the `485 Patent are invalid as anticipated and/or obvious in view of, and in combination with, certain prior art references. 59. Because the `485 Patent is related to the `150 Patent, the Request for

Reexamination of the `485 Patent and the Reexamination Invalidity Contentions in the `485 Reexamination are material to patentability of the `150 Patent Application. 60. The Request for Reexamination of the `485 Patent and the Reexamination

Invalidity Contentions in the `485 Reexamination arise from the present litigation and therefore should be properly cited to the Patent Office, pursuant to MPEP § 2001.06(c). 61. The Request for Reexamination of the `485 Patent and the Reexamination

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Invalidity Contentions in the `485 Reexamination are per se material to patentability of the `150 Patent Application. 62. The claim charts and Reexamination Invalidity Contentions set forth in the `485

Reexamination were neither cited by Venetec in the `150 Patent Application nor considered by the Patent Office during prosecution of the `150 Patent. 63. Upon information and belief, Venetec's failure to cite for consideration by the

Patent Office the existence of this litigation, the Interrogatory Invalidity Contentions, the Request for Reexamination of the `485 Patent, and/or the Reexamination Invalidity Contentions, was with bad faith and an intent to deceive the Patent Office. 64. Venetec breached its duty of candor before the Patent Office, as prescribed in 37

C.F.R. § 1.56, for failing to cite for consideration by the Patent Office with an intent to deceive the Patent Office, the existence of this litigation, the Interrogatory Invalidity Contentions, the Request for Reexamination of the `485 Patent, and/or the Reexamination Invalidity Contentions, and such breach resulted in inequitable conduct of the `150 Patent Application. 65. There is a substantial, justiciable, and continuing controversy between Nexus and

Venetec as to Venetec's suit for infringement of the `150 Patent and whether the `150 Patent is unenforceable. 66. Nexus will be damaged in its business by the charges of infringement by Venetec

in its Second Supplemental Complaint and will be irreparably harmed if the existing controversy between the parties is not promptly adjudicated. 67. As a result, Nexus seeks a declaration that the `150 Patent is unenforceable.

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Prayer for Relief WHEREFORE, Nexus prays for the following relief: 1. 2. 3. 4. That the Patents-in-Suit be declared not infringed by Nexus; That the Patents-in-Suit be declared invalid and void; That the `150 Patent be declared unenforceable; That judgment on Plaintiff's Second Supplemental Complaint be rendered for

Nexus, with costs of litigation awarded to Nexus; 5. That the Court find this case to be exceptional and award Nexus its reasonable

attorneys' fees and costs pursuant to 35 U.S.C. § 285; 6. That the Court grant to Nexus such other, further, and different relief as the Court

may deem just and proper.

Date: March 10, 2008

/s/ Richard K. Herrmann Richard K. Herrmann #405 Mary B. Matterer #2696 Amy Arnott Quinlan #3021 MORRIS JAMES LLP 500 Delaware Avenue, Suite 1500 Wilmington, Delaware 19801-1494 302-888-6800 [email protected] Patrick A. Lujin (Admitted Pro Hac Vice) Robert T. Adams (Admitted Pro Hac Vice) SHOOK HARDY & BACON L.L.P 2555 Grand Boulevard Kansas City, MO 64108 816-474-6550

_

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Peter A. Strand (Admitted Pro Hac Vice) SHOOK HARDY & BACON L.L.P. Hamilton Square 600 14th Square, NW, Suite 800 Washington, D.C. 20005-2004 202-783-8400 Robert H. Reckers (Admitted Pro Hac Vice) SHOOK HARDY & BACON L.L.P. JPMorgan Chase Tower 600 Travis Street, Suite 1600 Houston, Texas 77002-2911 713-227-8008 ATTORNEYS FOR DEFENDANT AND COUNTERCLAIM PLAINTIFF NEXUS MEDICAL, LLC

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