Conmed Corp. v. Ludlow Corp.

• Decision Date: 09 December 2002
• Docket Number: No. 5:00-CV-633.,5:00-CV-633.
• Citation: 235 F.Supp.2d 109
• Parties: CONMED CORPORATION, and NDM, Inc., Plaintiffs, v. LUDLOW CORPORATION, and The Ludlow Company, LP, Defendants.
• Court: U.S. District Court — Northern District of New York

235 F.Supp.2d 109

CONMED CORPORATION, and NDM, Inc., Plaintiffs, v. LUDLOW CORPORATION, and The Ludlow Company, LP, Defendants.

No. 5:00-CV-633.

United States District Court, N.D. New York.

December 9, 2002.

Hancock & Estabrook LLP, Syracuse, NY (James R. Muldoon, Esq., John R. Powers, of counsel), for Plaintiffs.

Milbank, Tweed, Hadley & McCloy LLP, New York City (Jeffrey A. Barist, Esq., John M. Griem, Esq., Christopher E. Chalsen, Esq., Parker H. Bagley, Esq., Of Counsel), for Defendants.

MEMORANDUM-DECISION and ORDER

HURD, District Judge.

I. INTRODUCTION

Plaintiffs, ConMed Corporation and NDM, Inc. (collectively "ConMed"), commenced the instant action against defendants, Ludlow Corporation and Ludlow Company, LP (collectively "Ludlow"), pursuant to 35 U.S.C. §§ 271, et. seq., asserting one count of patent infringement. Specifically, plaintiffs allege continuing infringement of its U.S. Patent No. 4,674,511 by defendants' manufacture and sale of the Kendall Care 210 Resting ECG Electrode. Ludlow asserts counterclaims seeking (1) a declaratory judgment of non-infringement; and (2) a declaratory judgment that ConMed's patent is invalid. Both parties have moved for summary judgment.

Oral argument was heard on April 12, 2002 in Utica, New York. Decision was reserved.

II. FACTS

ConMed owns U.S. Patent No. 4,674,511 (" the '511 patent") entitled "Medical Electrode."¹ A medical electrode is a device placed on a patient's skin that senses electrical stimulus emitted from the body. The electrode is connected to a machine, such as an electrocardiogram, that collects and interprets the signals sensed by the electrode.

A. Prosecution History of the '511 Patent

The initial application for the '511 patent was made by James Cartmell ("Cartmell") in 1984.² Cartmell's application contained twenty-four claims. The first claim provided as follows:

In a medical electrode of the type having a conductor and electrolyte means comprising a conductive adhesive for providing an electrolyte between said conductor and the skin of the patient and for adhering said electrode to the skin, the improvement wherein said electrode further comprises patient adhesive means which is more aggressive than said conductive adhesive for adhering an electrode to the skin for a longer period of time or with greater security than is possible with said conductive adhesive alone.

The patent application disclosed ten different embodiments, or configurations, of the electrode. Each embodiment was a variation of the basic invention and was supported by separate figures depicting the features of the particular embodiment. The United States Patent and Trademark Office ("USPTO") determined that the application contained two or more independent and distinct inventions. In the initial office action, serial 06/608-188, dated October 3, 1985, the USPTO restricted the invention claims under 35 U.S.C. § 121 for (a) inclusion of both product and process claims, and (b) inclusion of five independent and distinct embodiments (i.e., separately patentable products). (See Griem Aff. Ex. 2(D) at 104.) Accordingly, Cartmell was required to restrict the proposed inventions to either the product claims (claims 1-20) or the process claims (claim 21-24). The USPTO further found that

[a]pplicant is required under 35 U.S.C. 121 to elect a single disclosed species for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, no claims are deemed to be generic.

(Id. at 105.)

In response to the USPTO, Cartmell elected to prosecute product claims 1-20. Cartmell traversed the USPTO's requirement that he elect a single disclosed species for prosecution on the merits. Specifically, Cartmell argued that it was inappropriate to elect between FIGS. 15-16 and FIGS. 17-18 of the application because the inventions "are not patentably distinct." (Id. at 108.) In response to the USPTO's requirement that a single species be elected, together with a listing of all claims readable thereon, Cartmell elected "the species contained in FIGS. 15 and 16. Claims 1, 2, 3, 4, 6 and 7 are readable thereon." (Id.)

In February 1986, the USPTO found that

Claims 5 and 8-24 stand withdrawn from further consideration ... as being drawn to a nonelected invention and species, the requirement having been traversed ... [by Cartmell]. The election requirement is deemed to be proper since the embodiments of Figures 15-16 and 17-18 are not obvious variants and therefore patentably distinct. Generic claims do not evidence obviousness. The requirement is therefore made FINAL.

(Id. at 110.)

The USPTO rejected claims 1 and 6 under 35 U.S.C. §§ 102(b)³ and 102(e)⁴ "as being clearly anticipated by" certain other patents. (Id.) The USPTO rejected claims 2 and 7 pursuant to 35 U.S.C. § 103⁵ "as being unpatentable" over certain other patents because "[t]he use of a conductive paint would have been obvious." (Id. at 111.) Finally, the USPTO rejected claims 3 and 4 pursuant to 35 U.S.C. § 103 because "[t]he particular structure of conductive adhesive overlying the paint would have been obvious over" another patent. (Id.)

Cartmell responded to the USPTO by amending his application. Cartmell's response to the USPTO action, dated August 11, 1986, amended claims 1, 6 and 7, canceled claims 2, 3, and 4 and retained claims 5 and 8 through 24 under 37 C.F.R. 1.142(b). (Id. at 114-16). In his papers amending his application, Cartmell stated that:

Claims 1, 4, 6 and 7 are presented for prosecution at this time..... [C]laim 1 is amended to recite that the conductor comprises a sheet of flexible material and conductive paint adhered to one face of said sheet, that the conductive adhesive forms a layer engaging said sheet in overlying relationship to at least a portion of said paint, and that the patient adhesive means is a layer on said one face of said sheet. This structure is in clear contrast to the prior art relied upon by the [PTO] in which, with the exception of Anderson et al '215, the patient adhesive is on a piece of tape or the like separate from the conductor.... [T]he Engel patent is most similar in appearance. However, its backing 20 and adhesive coating 22 are clearly on the side of the plate 12 opposite its skin-contacting face.

(Id. at 115).⁶

In the final office action, dated October 3, 1986, the USPTO allowed claims 1 and 6; canceled claims 2 through 4; rejected claim 7 stating that it would be allowed if amended to overcome rejection under 35 U.S.C. § 112; and withdrew from consideration claim 5 and claims 8 through 24. (Id. at 119-120.)

Cartmell's response, dated December 3, 1986, amended claim 7 and added a new claim 25 based on an interview with the patent examiner. (Id. at 121.) Additionally, Cartmell's response canceled claim 5 and claims 8 through 24, placing the application in condition for allowance. (See id.) The USPTO January 5, 1987 Notice of Allowability confirmed the allowance of claims 1, 6, 7 and 25, and renumbered these claims 1 through 4. Cartmell canceled claims 5 and 8-24 in response to USPTO's final office action.⁷ (See Id. at 123.)

B. Ludlow's Product

Ludlow manufactures and sells a diagnostic medical electrode called the Kendall Care 210 (the "210"). The 210 consists of the following components. The 210 has a substrate of flexible polymeric foam (the "backing layer"). The surface of the backing layer closest to the patient (the "patient side") is completely covered by an adhesive. A polyester layer is adhered centrally on the patient side of the adhesive. The polyester layer is smaller than the polymeric foam backing, so as to leave the adhesive exposed around the margin on three sides of polyester layer. A conductive layer of silver/silver chloride film paint is applied onto the polyester layer.⁸ A blue hydrogel is adhered to the conductive paint layer on the patient side so as to leave exposed a "tab" portion of the conductive paint layer.⁹ The "tab" portion of the conductive paint layer is used to provide electrical engagement to peripheral equipment, such as an ECG. A liner is placed over the patient side of the electrode to protect it during storage. The liner is removed from the electrode prior to being used.

C. ConMed's Claim

In it's Complaint, ConMed claims that the 210 infringes upon its '511 patent. ConMed contends that the 210 contains all the elements of the '511 patent, that is: (1) a flexible sheet of backing comprised of both foam and polyester (substrate); (2) a coating of conductive paint adhered to the face of the flexible sheet that faces the patient's skin; (3) a hydrogel conductive adhesive that overlies the conductive paint; and (4) a conductive adhesive adhered to the patient side of the flexible sheet backer that is more "aggressive" than the hydrogel adhesive. (Plaintiffs' Mem. in Opp'n, at 2).

Ludlow denies this, arguing that the '511 patent includes two elements not present in the 210. Specifically, Ludlow contends that "[t]he first element not found in the Care 210 electrode is a `sheet of flexible material' that has a layer of conductive paint adhering to the same face of the sheet as the required layer of patient adhesive." (Ludlow Mem. of Law at 1.) In this regard, Ludlow contends that its product is different because it does not contain a single layer of material that contains both the patient adhesive and the conductive paint as is required by the '511 patent, but that its product contains separate layers: (1) a polymeric foam backer containing the patient adhesive; and (2) a polyester layer to which the conductive paint layer is applied. (See Griem Aff. Ex. 2, at 20-21.)

The second element that Ludlow insists is missing from the 210 is a "conductive adhesive that `forms a layer engaging' the sheet of flexible material." (Ludlow Mem. of Law at 2.). Ludlow contends that the 210 is different from the '511 patent because its conductive adhesive (the hydrogel) is...