California Medical Products v. Tecnol Med. Prod., Civil A. No. 91-620-LON.

Decision Date29 December 1995
Docket NumberCivil A. No. 91-620-LON.
Citation921 F. Supp. 1219
CourtU.S. District Court — District of Delaware
PartiesCALIFORNIA MEDICAL PRODUCTS, INC., Plaintiff, v. TECNOL MEDICAL PRODUCTS, INC., Defendant.

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Josy W. Ingersoll, of Young, Conaway, Stargatt & Taylor, Wilmington, Delaware; Of Counsel: Albert J. Breneisen, and Frank Pietrantonio, of Kenyon & Kenyon, Washington, D.C., for Plaintiff California Medical Products, Inc.

Donald F. Parsons, Jr., Mary B. Graham, and Julia Heaney, of Morris Nichols Arsht & Tunnell, Wilmington, Delaware; Of Counsel: Barbara M.G. Lynn, of Carrington, Coleman, Sloman & Blumenthal, L.L.P., Dallas, Texas, for Defendant Tecnol Medical Products, Inc.

LONGOBARDI, Chief Judge.

I. NATURE AND STAGE OF THE PROCEEDINGS

Plaintiff California Medical Products, Inc. ("CalMed"), also known as Laerdal California, commenced this action for patent infringement on November 18, 1991. CalMed alleges that defendant Tecnol Medical Products ("Tecnol") manufactures and sells a cervical collar, the 911 First Response Collar (the "911 collar"), which infringes U.S. Patent Re. 32,219 (the '219 patent) both literally and under the doctrine of equivalents. Through its answer and counterclaim for declaratory relief, Tecnol denies that it infringes the '219 patent and alleges as affirmative defenses that the '219 patent is invalid and unenforceable on various grounds.

Tecnol has also counterclaimed alleging that CalMed violated 35 U.S.C. § 292 by falsely marking its own cervical collars as patented using the label "Patent No. RE 32,219" between November 8, 1987 and February 22, 1991 while the patent had lapsed. CalMed denies Tecnol's false marking allegations. Tecnol also seeks a declaratory judgment that a new version of the 911 collar (the "modified 911 collar") does not infringe the '219 patent either literally or under the doctrine of equivalents. CalMed contends that the modified 911 collar infringes the '219 patent under the doctrine of equivalents.

On November 8, 1983, U.S. Patent No. 4,413,619 (the '619 patent), entitled "Portable Cervical Collar" was issued to Geoffrey C. Garth. The application for the '619 patent was filed on October 16, 1981. On February 10, 1984, Garth filed an application for reissue of the '619 patent. On August 5, 1986, the '219 reissue patent, also entitled "Portable Cervical Collar," was issued to Garth based upon the reissue application. Garth was the sole inventor of and applicant for the '619 and '219 patents. The '219 patent lapsed in November, 1987 following Garth's failure to pay the required maintenance fee. On or about May 17, 1989, Garth executed an assignment of the '219 patent to CalMed. Following Garth's petition for reinstatement, the Patent and Trademark Office ("PTO") reinstated the patent on February 22, 1991.

Following oral argument on motions for summary judgment, the Court found that pursuant to 35 U.S.C. § 41(c)(2) CalMed was precluded as a matter of law from recovering any damages for any infringement by Tecnol occurring during the time period that the '219 patent had lapsed. In addition to these mandatory statutory intervening rights, Tecnol contends that it is entitled to equitable intervening rights allowing it to continue to make, use, or sell the 911 collar even after the reinstatement of the '219 patent. CalMed disputes that such equitable relief is appropriate.

A nine day non-jury trial yielded a transcript of 2,223 pages. In addition, the parties designated over 1,660 pages of deposition testimony and approximately 300 exhibits were received into evidence. The parties have submitted post-trial briefing and proposed findings of fact and conclusions of law.1

This Court has jurisdiction over the subject matter of the claims and counterclaims of this action pursuant to 28 U.S.C. § 1331, § 1338(a), § 2201, and § 2202.

This Memorandum Opinion represents the Court's findings of fact and conclusions of law with respect to all issues.

II. TECHNOLOGICAL BACKGROUND

The technology at issue in this case involves cervical collars which are utilized to restrict the motion of a patient's head and neck. Cervical collars are utilized both before ("pre-hospitalization" or "extrication" collars) and after ("post-hospitalization" collars) a patient is hospitalized. At an accident scene it is not possible for emergency personnel to fully evaluate the condition of a patient's neck and spine. It is necessary, therefore, to immobilize the patient's neck to prevent further injury. Extrication collars are used by paramedics to minimize the motion of a patient's neck while administering initial treatment, extricating the patient from, for example, automobile wreckage, and transporting the patient to the hospital.

The 911 collar, the modified 911 collar, the Stifneck collar (the extrication collar marketed by CalMed), and the collar claimed in the '219 patent all accomplish significant immobilization of the patient's neck. Without preempting or prejudicing the Court's claim construction and infringement analysis, neither side could disagree that there are some obvious similarities between these collars. All obtain the desired immobilization by utilizing a structure which encircles the patients neck and an attached structure which supports the patients chin. These structures are comprised of material which can be described as stiff yet flexible.2 The Court will refer in this Memorandum Opinion to the portion of a cervical collar which encircles the patient's neck as the "band," and the portion of the collar which supports the patients chin as the "chin support brace."

Post-hospitalization collars differ from extrication collars in that they are often constructed out of softer materials, such as foam rubber and thus do not provide the same degree of immobilization as extrication collars. While the distinction between extrication collars and post-hospitalization collars is useful in obtaining an understanding of the cervical collar industry it is not a distinction that is of significance in resolving infringement and validity issues, because the claims of the '219 patent do not explicitly distinguish between these two categories of cervical collars. The accused collars do not infringe simply because they can be characterized as extrication collars, and relevant prior art does not become irrelevant simply because it can be characterized as a post-hospitalization collar.

The 911 collar, Plaintiff's Trial Exhibit ("PX") 3 is comprised of three main structural pieces: two band sections, which the Court will refer to as the front band section and the back band section, and a chin support brace. The front band section is comprised of three layers of material. The top layer is a gray, stiff flexible material. The middle layer is a thin layer of plastic which is a lighter shade of grey. The middle layer is the same shape and size as the top layer. The bottom layer is a soft white foam which extends beyond the bottom edge of the first two layers, thus providing additional padding for the comfort of the patient. The front band section has a hole in the middle, referred to as a "trach hole," which allows medical personnel to perform a surgical procedure to provide an airway through the trachea while the patient is wearing the collar.

The back band section and the chin support brace lack the middle plastic layer found in the front band section. The grey material and the white foam are the same shape and size in the chin support brace. The white foam material extends beyond the top and bottom edges of the grey material in the back band section, again to provide additional padding for the comfort of the patient.

The chin support brace is permanently attached to the front band section by plastic "rivets" located at each end of the chin support brace. A small tab extends upward from the center of the top edge of the front band section and this tab is permanently attached to the center of the chin support brace with a rivet. The tab is formed from the same three layers of material as the front band section and is in fact part of the front band section.

A strip of blue velcro-like fabric is permanently attached to the back band section by two rivets. This strip extends several inches beyond each end of the back band section. The front band section has mutually cooperative velcro strips which are attached to the front band section by some sort of adhesive and by rivets.

One side of the front band section has a slot approximately one and three-quarters of an inch long and one-quarter inch wide cut through the velcro strip and the three layers of the front band section. A rivet extends through this slot and permanently attaches the front band section to the back band section. Plastic washers are used at either end of this rivet, apparently to provide additional support for this connection and to make it more difficult for the snap fastener to be accidentally pulled through the slot. This particular snap fastener is referred to by Tecnol as the "sizing post." The construction of the 911 collar is such that after the release of the velcro fasteners the back band section may be rotated around the sizing post, thereby allowing the back band section to be positioned directly behind the front band section, providing for compact storage.

The 911 collar is applied to the patient by first rotating the back band section out of its compact storage alignment. After checking to ensure that the sizing post is centered and the velcro is fastened over the sizing post, the chin support brace is positioned underneath the patient's chin, and the back band section is then slid behind the patient's neck. The ends of the front band piece and the back band piece are positioned so that they overlap. The circumference of the collar may be adjusted at this side by varying the amount of the overlap. The velcro retention means...

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