Arthrocare Corp. v. Smith & Nephew, Inc.
| Decision Date | 10 March 2004 |
| Docket Number | No. CIV.01-504-SLR.,CIV.01-504-SLR. |
| Citation | 310 F.Supp.2d 637 |
| Parties | ARTHROCARE CORPORATION, Plaintiff, v. SMITH & NEPHEW, INC., Defendant. |
| Court | U.S. District Court — District of Delaware |
Jack B. Blumenfeld, Karen Jacobs Louden, James W. Parrett, Jr., of Morris, Nichols, Arsht & Tunnell, Wilmington, DE, Weil, Gotshal & Manges LLP, Redwood Shores, CA, (Matthew D. Powers, Jared Bobrow, Perry Clark, of counsel), for plaintiff.
William J. Marsden, Jr., Keith A. Walter, Jr., Fish & Richardson P.C., Wilmington, DE, Fish & Richardson P.C., Boston, MA (Mark J. Hebert, Kurtis D. MacFerrin, of counsel), for defendants.
On July 25, 2001, plaintiff Arthrocare Corporation ("Arthrocare") filed this action against defendant Smith & Nephew, Inc. ("Smith & Nephew") alleging willful direct, contributory, and inducing infringement of certain claims of U.S. Patent Nos. 5,697,536 (the " '536 patent"), 5,697,882 (the " '882 patent") and 6,224,592 (the " '592 patent"). (D.I.1) Smith & Nephew answered the complaint on September 13, 2001 denying the infringement allegations and asserting five affirmative defenses including noninfringement, invalidity, misuse, unenforceability based upon inequitable conduct, and unclean hands. (Id.) Smith & Nephew also asserted counterclaims for a declaratory judgment that the patents in suit are invalid and not infringed by any act of Smith & Nephew and that the '592 patent is unenforceable due to inequitable conduct. (D.I.10) On September 26, 2001, Arthrocare denied Smith & Nephew's counterclaims. (D.I.20) With the court's permission, Smith & Nephew amended their answer on November 27, 2002 to add counterclaims for antitrust violations under 15 U.S.C. § 1 of the Sherman Act. (D.I.219)
ArthroCare is organized under the laws of the State of Delaware with its principal place of business in California. (D.I. 1 at ¶ 2) Smith & Nephew is also organized under the laws of State of Delaware with its principal place of business in Massachusetts. (Id. at ¶ 3) The court has jurisdiction over this case pursuant to 28 U.S.C. §§ 1331, 1338(a), and 2201(a).
The court separated the issues raised by the parties into two phases, the first phase to include the issues of infringement, validity, and inequitable conduct and the second phase to include the issues of damages, willfulness, and antitrust counterclaims. From April 30, 2003 through May 9, 2003, the parties tried the issues of infringement and invalidity before a jury. The court ruled on May 12, 2003 that the parties could submit their inequitable conduct cases on the briefs limited to the record created at trial. (See D.I. 418 at 1071-02) Currently before the court are the parties' post-trial motions on the issues of infringement, invalidity, and inequitable conduct.1 (D.I.424, 427, 432, 437, 455, 458)
The patents in suit generally relate to electrosurgery and to surgical devices and methods that employ high frequency voltage to cut and ablate tissue. These devices are of either a monopolar or a bipolar nature. A monopolar device, as the name suggests, consists of only a single electrode. It directs an electric current from the exposed or active electrode through a patient's body to a return electrode externally attached to the patient's body. In contrast, a bipolar device consists of two electrodes. An active electrode in contact with the patient's tissue transmits an electric current through the patient's tissue to a return electrode also in contact with the patient's tissue. When using either type of device, the target region must be treated with isotonic saline to maintain an isotonic environment around the tissue and to keep the area in clear view.
Electrosurgical techniques are advantageous because they reduce patient bleeding and the trauma associated with operations involving cutting. At the same time, a diverse range of risks may be implicated. With monopolar devices, electric current may flow in undefined paths through a patient's body. Also, high voltages typically must be applied to generate a current suitable for cutting or ablation using either monopolar or bipolar devices. Such high voltage may damage or destroy surrounding tissue.
The patents in suit involve improvements over the monopolar and bipolar devices of the prior art. Specifically, the post-trial motions.
The '536 patent, entitled "System and Method for Electrosurgical Cutting and Ablation," was issued on December 16, 1997 with Philip E. Eggers and Hira V. Thapliyal as inventors. It was originally filed on November 18, 1996. The '536 patent traces priority to the now abandoned U.S. Application No. 817,575. It was granted with sixty-four claims on December 16, 1997. On December 23, 1999, a third party filed a request for an ex parte reexamination based solely upon prior art. The United States Patent and Trademark Office ("PTO") granted this request and, after reexam, issued a "Notice of Intent to Issue an Ex Parte Reexamination Certificate" as to all original claims.
Claims 46, 47, and 56 are presently asserted and are apparatus type claims. Claims 46 and 56 depend from claim 45. Claim 47 depends from claim 46. These claims read as follows:
45. An electrosurgical system for applying electrical energy to a target site on a structure within or on a patient's body, the system comprising:
a high frequency power supply;
an electrosurgical probe comprising a shaft having a proximal end and a distal end, and a connector near the proximal end of the shaft electrically coupling the electrode terminal to the electrosurgical power supply;
a return electrode electrically coupled to the electrosurgical power supply; and
an electrically conducting fluid supply for directing electrically conducting fluid to the target site such that the electrically conducting fluid generates a current flow path between the return electrode and the electrode terminal.
46. An electrosurgical system as in claim 45, wherein the return electrode forms a portion of the shaft of the electrosurgical probe.
47. An electrosurgical system as in claim 46 further including an insulating member circumscribing the return electrode, the return electrode being sufficiently spaced from the electrode terminal to minimize direct contact between the return electrode and the patient's tissue.
56. The electrosurgical system of claim 45 wherein the target site is selected from the group consisting essentially of the abdominal cavity, thoracic cavity, knee, shoulder, hip, hand, foot, elbow, mouth, spine, ear, nose, throat, epidermis and dermis of the patient's body.
('536 patent, col. 18 at 11. 13-36; col. 19 at 11. 11-15)
The court construed disputed terms of the post-trial motions are as follows:
1. The term "electrosurgical system" shall be given its "ordinary definition" and construed to mean "an assemblage or combination of things or parts forming a unitary whole."
2. The term "return electrode" shall be construed to mean "an electrode having a larger area of contact than an active electrode, thus affording a lower current density."
3. The term "connector" shall be construed to mean "a structure that electrically links the electrode terminal to the high frequency power supply."
4. The phrases "spacing a return electrode away from the body structure" and "the return electrode is not in contact with the body structure" shall be construed to mean that the return electrode is not to contact the body at all during the performance of the claimed method.2
5. The term "electrically conducting fluid" and "electrically conductive fluid" shall be construed to mean "any fluid that facilitates the passage of electrical current."
The '882 patent, entitled "System and Method for Electrosurgical Cutting and Ablation," was issued on December 16, 1997 with Philip E. Eggers and Hira V. Thapliyal as inventors. It was originally filed on November 22, 1995 and traces priority to the same original application as the '536 patent, namely U.S. Application No. 817,575. The '882 patent was granted with fifty-six claims on December 16, 1997. Claims 13, 17, and 54 are presently asserted. All are method type claims. Claims 13 and 17 depend from claim 1 and claim 54 depends from both claim 1 and claim 28. These claims recite:
1. A method for applying energy to a target site on a patient body structure comprising:
providing an electrode terminal and a return electrode, electrically coupled to a high frequency voltage source;
positioning the active electrode in close proximity to the target site in the presence of an electrically conducting fluid; and
applying a high frequency voltage between the electrode terminal and the return electrode, the high frequency voltage being sufficient to vaporize the fluid in a thin layer over at least a portion of the electrode terminal and to induce the discharge of energy to the target site in contact with the vapor layer.
13. The method of claim 1 wherein at least a portion of the energy induced is in the form of photons having a wavelength in the ultraviolet spectrum.
17. The method of claim 1 wherein the high frequency voltage is at...
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