Dow Corning Corp. v. Surgitek, Inc.

378 F. Supp. 1128, 182 U.S.P.Q. (BNA) 688, 1974 U.S. Dist. LEXIS 7936
CourtDistrict Court, E.D. Wisconsin
DecidedJune 25, 1974
DocketNo. 71-C-75
StatusPublished

This text of 378 F. Supp. 1128 (Dow Corning Corp. v. Surgitek, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Wisconsin primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Dow Corning Corp. v. Surgitek, Inc., 378 F. Supp. 1128, 182 U.S.P.Q. (BNA) 688, 1974 U.S. Dist. LEXIS 7936 (E.D. Wis. 1974).

Opinion

DECISION AND ORDER

MYRON L. GORDON, District Judge.

This is a suit by Dow Corning Corporation against the Medical Engineering Corporation and its marketing subsidiary, Surgitek, Inc., for patent infringement of claims 1 through 5 of patent number 3,293,663. That patent, entitled “Surgically Implantable Human Breast Prosthesis”, and invented by Dr. Thomas D. Cronin, was issued to the plaintiff on December 27, 1966. The defendants have manufactured and sold the accused device since late in 1970.

The complaint, filed on February 2, 1971, alleged infringement of the Cronin patent and also of patent number 3,257,668. The latter patent is no longer involved; a consent decree was entered holding it valid and infringed.

In their amended answer and counterclaim, the defendants claim that the Cronin patent is not infringed and that it is invalid. In addition, they charge the plaintiff with misuse and unclean hands, based upon fraud on the patent office, as well as violation of the antitrust laws. The fraud, misuse and antitrust issues were severed in an order dated September 20, 1973. 61 F.R.D. 578. Evidence was received with respect to the validity and infringement issues alone at a court trial on March 25-27, 1974, and the parties have submitted post-trial briefs.

The defendants contend that the Cronin patent is invalid and that the accused device is non-infringing. First, pointing to a number of “prior art” patents and publications, they urge that the subject matter of the Cronin patent was obvious at the time of filing. 35 U.S.C. § 103. The defendants also charge the plaintiff with having deliberately withheld such information from the patent office.

Secondly, the defendants claim that the Cronin patent is invalid because Dr. Cronin did not himself invent the patented subject matter. 35 U.S.C. § 102(f). That the Cronin patent allegedly failed to disclose the best mode known to Dr. Cronin at the time the application was filed is advanced as the third challenge to its validity. 35 U.S.C. § 112, j[ 1. Fourthly, the presumption of validity which would otherwise attach to the Cronin patent has been undermined, according to the defendants, to the extent that certain patent office rules of practice were allegedly violated. Rules of Practice of the United States Patent Office, Rule 133(b); 35 U.S.C. § 112. .Finally, while insisting that the accused device does not infringe the Cronin patent the defendants suggest that the doctrine of file wrapper estoppel is applicable under the circumstances of this case.

[1130]*1130The prosthesis shown in the Cronin patent consists of a two-piece container; it is made of silicone rubber and filled with silicone gel, which is provided with a tissue attaching means on its back. Described in the patent and shown in the drawing is a corrugated piece of dacron mesh fabric cemented in spots to the entire back of the container. The dacron mesh is described as a material through which body tissue can grow in order to anchor the prosthesis to the chest wall after implantation. The patent states that such material should be porous for the purpose indicated, and states also that other “sponge-like material” can be used.

I. PRIOR ART IMPLANTS

In the 1950's, surgeons began to use synthetic materials for purposes of mammary augmentation, including ivalon, etheron, dicora, polyurethane and silicone rubber, all of which were in the form of open cell sponges. The sponges were supplied in solid block form, carved by the surgeon to the desired shape, and then placed in a pocket formed over the chest wall in the patient. The open cell nature of the sponge materials permitted the entire surface of the implant to be invaded by fibrous body tissue; such tissue would grow into or through the sponge cell structure and become interwoven with the sponge, thereby increasing the amount of sear tissue formation.

The record indicates that the long term results of such grafts proved unsatisfactory to the extent that the implants, invaded by scar tissue, shrunk and became hard, sometimes rock-like; asymmetry also occurred.

Prior to 1961, several preformed prostheses were designed to obviate the shrinkage problem by limiting the depth of the tissue penetration. These devices were known as compound prostheses, having an inner core to provide the desired softness and a separate outer envelope of tissue permeable material functioning as the tissue anchoring means.

The Pangman patent, number 2,842,775, which issued July 15, 1958, together with the Edwards prosthesis, which was first made in 1959 by Dr. Ben Edwards, are representative compound prostheses. Each reduced the amount of the scar tissue invasion; but with time, the record shows that the tissue intrusion of the outer sponge cover produced the same type of shrinkage and hardening problems that had previously existed with the carved sponge blocks.

Dr. Edwards indicated that the reason why the entire surface of his prosthesis was covered with sponge-like, tissue permeable material was so that there would be “no unsatisfied tissue” which might cause an unnatural response in the body. He acknowledged his reluctance, until 1964, to use the Cronin prosthesis; the primary feature of that device is its limited use of a tissue fixation means. Indeed, the record indicates that at the time that the Cronin patent was issued, it had long been accepted by the medical profession that, as Dr. Edwards stated, mammary prostheses had to have a tissue anchoring means around their entire periphery in order to satisfy the surrounding body tissues.

Dr. Cronin’s approach was contrary to this concept. He did not want the entire prosthesis firmly attached to tissue. Rather, he wanted his device to have only a limited amount of material on the back to anchor it to the chest wall; the rest of the prosthesis was to move freely.

II. VALIDITY

A. Obviousness

The defendants’ defense of obviousness is founded upon 24 patents and publications. Of the 12 patents relied upon by the defendants, five were cited by the patent office in the prosecution of the Cronin patent and another is set out in the Cronin specifications. In the court’s opinion, the other patents are no more pertinent than the art which was before the patent office; the publications are even less relevant than the patents.

[1131]*1131The Nelson patent number 3,020,260 is cited in the specifications of the patent. Of the five patents cited by the patent office, four relate to external or bra-type prostheses which are not implantable. These breast shaped forms include the Heuchan patent number 1,250,875; the Bernhardt patent number 2,542,619; the Freedman patent number 2,636,182; and, the Kausch patent number 2,543,499. Hollow and filled only with air, or containing at least a section having air, these devices are not implantable in the human body; they have some fabric on the back, but it is merely a flat fabric designed to shield the wearer from the generally toxic, rubbery material of the prostheses.

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378 F. Supp. 1128, 182 U.S.P.Q. (BNA) 688, 1974 U.S. Dist. LEXIS 7936, Counsel Stack Legal Research, https://law.counselstack.com/opinion/dow-corning-corp-v-surgitek-inc-wied-1974.