Kingsdown Medical Consultants, Ltd. v. Hollister Inc.

Decision Date21 December 1988
Docket NumberNo. 88-1265,88-1265
Citation9 U.S.P.Q.2d 1384,863 F.2d 867
PartiesKINGSDOWN MEDICAL CONSULTANTS, LTD. and E.R. Squibb & Sons, Inc., Plaintiffs-Appellants, v. HOLLISTER INCORPORATED, Defendant-Appellee. Appeal
CourtU.S. Court of Appeals — Federal Circuit

Garland P. Andrews, Richards, Harris, Medlock & Andrews, Dallas, Tex., argued for plaintiffs-appellants. With him on the brief were David L. Hitchcock and Eugenia S. Hansen.

James T. Fitzgibbon, Lockwood, Alex, Fitzgibbon & Cummings, Chicago, Ill., argued for defendant-appellee. With him on the brief was Angelo J. Bufalino. Also on the brief were Richard T. Zwirner and Judith L. Borden, Schuyler, Roche & Zwirner, Chicago, Ill.

Before MARKEY, Chief Judge, SMITH and ARCHER, Circuit Judges.

MARKEY, Chief Judge.

Kingsdown Medical Consultants, Ltd. and E.R. Squibb & Sons, Inc., (Kingsdown) appeal from a judgment of the United States District Court for the Northern District of Illinois, No. 84 C 6113, holding U.S. Patent No. 4,460,363 ('363) unenforceable because of inequitable conduct before the United States Patent and Trademark Office (PTO). We reverse and remand.

BACKGROUND

Kingsdown sued Hollister Incorporated (Hollister) for infringement of claims 2, 4, 5, 9, 10, 12, 13, 14, 16, 17, 18, 27, 28, and 29 of Kingsdown's '363 patent. 1 The district court held the patent unenforceable because of Kingsdown's conduct in respect of claim 9 and reached no other issue.

The invention claimed in the '363 patent is a two-piece ostomy appliance for use by patients with openings in their abdominal walls for release of waste.

The two pieces of the appliance are a pad and a detachable pouch. The pad is secured to the patient's body encircling the abdominal wall opening. Matching coupling rings are attached to the pad and to the pouch. When engaged, the rings provide a water tight seal. Disengaging the rings allows for removal of the pouch.

A. The Prosecution History

Kingsdown filed its original patent application in February 1978. The '363 patent issued July 17, 1984. The intervening period of more than six-and-a-half years saw a complex prosecution, involving the submission, rejection, amendment, re-numbering, etc., of 118 claims, a continuation application, an appeal, a petition to make special, and citation and discussion of 44 references.

After a series of office actions and amendments, Kingsdown submitted claim 50. With our emphasis on the language of interest here, claim 50 read:

A coupling for an ostomy appliance comprising a pad or dressing having a generally circular aperture for passage of the stoma, said pad or dressing aperture encircled by a coupling member and an ostomy bag also having a generally circular aperture for passage of the stoma, said bag aperture encircled by a second coupling member, one of said coupling members being two opposed walls of closed looped annular channel form and the other coupling member of closed loop form having a rib or projection dimensioned to be gripped between the mutaully (sic) opposed channel walls when said coupling members are connected, said rib or projection having a thin resilient deflectible seal strip extending therefrom, which, when said rib or projection is disposed between said walls, springs away therefrom to sealingly engage one of said walls, and in which each coupling member is formed of resilient synthetic plastics material.

The examiner found that claim 50 contained allowable subject matter, but rejected the claim for indefiniteness under 35 U.S.C. Sec. 112, second paragraph, objecting to "encircled", because the coupling ring could not, in the examiner's view, "encircle" the aperture in the pad, the ring and aperture not being "coplanar." The examiner had not in earlier actions objected to "encircled" to describe similar relationships in other claims. Nor had the examiner found the identical "encircled" language indefinite in original claims 1 and 6 which were combined to form claim 50.

To render claim 50 definite, and thereby overcome the Sec. 112 rejection, Kingsdown amended the claim. With our emphasis on the changed language, amended claim 50 read:

A coupling for an ostomy appliance comprising a pad or dressing having a body contacting surface and an outer surface with a generally circular aperture for passage of the stoma extending through said pad or dressing, a coupling member extending outwardly from said outer pad or dressing surface and encircling the intersection of said aperture and said outer pad or dressing surface, and an ostomy bag also having a generally circular aperture in one bag wall for passage of the stoma with a second coupling member affixed to said bag wall around the periphery of said bag wall aperture and extending outwardly from said bag wall, one of said coupling members being two opposed walls of closed looped annular channel form and the other coupling member of closed loop form having a rib or projection dimensioned to be gripped between the mutually opposed channel walls when said coupling members are connected, said rib or projection having a thin resilient deflectible seal strip extending therefrom, which, when said rib or projection is disposed between said walls, springs away therefrom to sealingly engage one of said walls, and in which each coupling member is formed of resilient synthetic plastic material.

To avoid the Sec. 112 rejection, Kingsdown had thus added the pad's two surfaces, replaced "aperture encircled", first occurrence, with "encircling the intersection of said aperture and said outer pad or dressing surface", and deleted "encircled", second occurrence. In an advisory action, the examiner said the changes in claim language overcame the Sec. 112 rejection and that amended claim 50 would be allowable.

While Kingsdown's appeal of other rejected claims was pending, Kingsdown's patent attorney saw a two-piece ostomy appliance manufactured by Hollister. Kingsdown engaged an outside counsel to file a continuation application and withdrew the appeal.

Thirty-four claims were filed with the continuation application, including new and never-before-examined claims and 22 claims indicated as corresponding to claims allowed in the parent application. In prosecuting the continuation, a total of 44 references, including 14 new references, were cited and 29 claims were substituted for the 34 earlier filed, making a total of 63 claims presented. Kingsdown submitted a two-column list, one column containing the claim numbers of 22 previously allowed claims, the other column containing the claim numbers of the 21 claims in the continuation application that corresponded to those previously allowed claims. 2 That list indicated, incorrectly, that claim 43 in the continuation application corresponded to allowed claim 50 in the parent application. Claim 43 actually corresponded to the unamended claim 50 that had been rejected for indefiniteness under Sec. 112. Claim 43 was renumbered as the present claim 9 in the '363 patent.

There was another claim 43. It was in the parent application and was combined with claim 55 of the parent application to form claim 61 in the continuation. Claim 55 contained the language of amended claim 50 relating to "encircled." It was allowed as submitted and was not involved in any discussion of indefiniteness. Claim 61 became claim 27 of the patent. Claim 27 reads as follows:

An ostomy appliance comprising a pad or dressing having a body contacting surface and an outer surface with an aperture for passage of the stoma extending through said pad or dressing, a coupling member extending outwardly from said pad or dressing and encircling the intersection of said aperture and the outer surface of said pad or dressing and an ostomy bag also having an aperture in one bag wall for passage of the stoma with a second coupling member affixed to said bag wall around the periphery of said bag wall aperture and extending outwardly from said bag wall, said bag coupling member being two opposed walls of closed loop channel form and said pad or dressing coupling member being a closed loop form having a rib or projection dimensioned to be gripped between the opposed channel walls when said coupling members are connected, and a thin resilient seal strip extending at an angle radially inward from an inner surface of said rib or projection which engages the outer surface of said inner channel wall and wherein said rib or projection has a peripheral bead extending therefrom in a direction opposite said deflectible seal strip and said outer channel wall has a complementary bead on its inner surface, each of said two beads having an annular surface inclined to the common axis of said coupling members when connected, the arrangement being such that said two annular surfaces are in face-to-face contact when said two members are in their mutually coupled positions. (emphasis provided)

B. The District Court

The district court rendered its opinion and announced its decision orally from the bench.

Having examined the prosecution history, the district court found that the examiner could have relied on the representation that claim 43 corresponded to allowable claim 50 and rejected Kingsdown's suggestion that the examiner must have made an independent examination of claim 43, because: (1) in the Notice of Allowance, the examiner said the claims were allowed "in view of applicant's communication of 2 July 83"; 3 (2) there was no evidence that the examiner had compared the language of amended claim 50 with that of claim 43; and (3) the examiner could justifiably rely on the representation because of an applicant's duty of candor.

The district court found the materiality element of inequitable conduct, because allowability of claim 50 turned on the amendment overcoming the Sec. 112 rejection in the parent application. Kingsdown's knowledge of materiality was inferred from claim 50's having been deemed allowable in the parent application only after...

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