Minnesota Min. and Mfg. Co. v. Research Medical

• Decision Date: 22 October 1987
• Docket Number: No. 84-C-0728S.,84-C-0728S.
• Citation: 679 F. Supp. 1037
• Parties: MINNESOTA MINING AND MANUFACTURING CO., Plaintiff, v. RESEARCH MEDICAL, INC.; Peter Von Berg; and Peter Von Berg, a corporation, GmbH, Defendants.
• Court: U.S. District Court — District of Utah

679 F. Supp. 1037

MINNESOTA MINING AND MANUFACTURING CO., Plaintiff, v. RESEARCH MEDICAL, INC.; Peter Von Berg; and Peter Von Berg, a corporation, GmbH, Defendants.

No. 84-C-0728S.

United States District Court, D. Utah, C.D.

October 22, 1987.

COPYRIGHT MATERIAL OMITTED

Laurence H. Pretty, Gary A. Clark, Los Angeles, Cal., David A. Greenwood, Van Cott, Bagley, Cornwall & McCarthy, Salt Lake City, Utah, Walker N. Kirn, Robert W. Hoke, Minnesota Min. & Mfg. Co., St. Paul, Minn., for plaintiff.

H. Ross Workman, David O. Seeley, Workman, Nydegger & Jensen, Louis M. Haynie, Research Medical, Inc., Salt Lake City, Utah, for defendants.

REVISED MEMORANDUM DECISION

SAM, District Judge.

This action arises from the alleged inducement to infringe and infringement, by defendant Research Medical, Inc. (RMI), of all claims of U.S. Patent No. 4,129,129, entitled "Venous Return Catheter and a Method of Using the Same," (the '129 patent) held by plaintiff Minnesota Mining and Manufacturing Co. (3M). RMI asserts the invalidity and unenforceability of the patent, and denies infringement. It further asserts patent misuse by 3M. Trial was before the court without a jury.

I. THE PARTIES

3M is a Delaware Corporation having its principal place of business in St. Paul, Minnesota. RMI is a Utah corporation having its principal place of business in Salt Lake City, Utah. Named defendants Peter Von Berg and Peter Von Berg GmbH are, respectively, a German businessman residing in Munich, Germany and a West German corporation that he owns and controls. The Von Berg defendants will not be considered in this opinion as they entered into a Consent Judgment with 3M.

II. JURISDICTION

3M brings this civil action for patent infringement under Title 35, United States Code, particularly sections 271, 281 and 283-85. This court has jurisdiction over the parties and the subject matter of this action pursuant to 28 U.S.C. § 1338(a). Venue properly lies in this judicial district pursuant to 28 U.S.C. § 1400(b).

III. FACTUAL BACKGROUND

This case involves catheters used to drain blood from the heart chambers for treatment in a heart-lung machine during surgery requiring cardiopulmonary bypass. While the heart is stopped, the heart-lung machine performs the functions normally conducted by the heart and lungs. Blood depleted in oxygen and rich in carbon dioxide is mechanically drained from the patient, and pumped to equipment that restores oxygen to the blood and removes excess carbon dioxide. This drainage is referred to as "venous return" or "venous drainage." The '129 patent is a two-stage venous return catheter used to drain blood from the right atrium and the vena cavae by a process known as dual cannulation.

During a bypass operation, it is extremely important that adequate amounts of blood be drained to allow for proper oxygenation and decarbonation. Insufficient oxygen can result in serious tissue damage, and inadequate removal of carbon dioxide can alter the metabolic functions of critical enzymes. Two of the most important factors in regulating the flow of blood are the design and placement of the drainage catheter. Various methods have been used by surgeons, including the insertion of one catheter in the superior vena cava (SVC) and another in the inferior vena cava (IVC) in order to collect venous blood returned to the patient's right atrium. Although reliable, the dual cannulation procedure using separate catheters requires two incisions through the atrial wall as well as sutures of both insertion points. Use of two catheters also reduces the space in which a surgeon may operate. Many surgeons prefer the single catheter because the cannulation process is shortened, the risk of infection lessened and the surgical site cleared. A single catheter known as a "dual drainage" catheter may be positioned so the leading tip rests in the right atrium, the SVC or the IVC.

A. The Amrine two-stage venous return catheter (the '129 patent)

The '129 patent is a dual drainage catheter having two diameters of tubes connected by a molded reducer (Fig. 1).¹ Six horizontal drainage slots (Fig. 1a) are evenly spaced on the rounded tip (Fig. 1b) of the smaller, first-diameter, pilot tube (Fig. 1c). The first-diameter tube tapers into the larger second-diameter tube (Fig. 1d) by means of a molded juncture (Fig. 1e) that has elongated slots (Fig. 1f) to allow blood to drain from the right atrium where the juncture rests. A tubular obturator (Fig. 1g) is placed in the catheter to the first drainage openings to block the second drainage openings during the initial insertion of the catheter.

The catheter is introduced into the right atrium of the heart and extends into the IVC (Fig. 2d). The right atrial appendage is circumferentially sutured (Fig. 2a) and clamped (Fig. 2b), and the catheter is inserted into the atrium as the suture is released (Fig. 2c). When insertion is complete, the first drainage openings lie in and drain from the IVC (Fig. 3a), and the second drainage openings lie at the edge of and drain from the right atrium (Fig. 3b). The obturator (Fig. 1g) is removed after the second drainage openings enter the right atrium.

B. Development and prosecution history of the '129 patent

In 1970, Sarns, Inc. (Sarns),² a medical products company, hired Bruce Amrine as a design engineer, and later promoted him to sole project engineer for the entire Sarns catheter product line. Amrine alleges he drew his first sketch of the two-stage catheter on September 26, 1975 and a second on November 11, 1975. Blueprints of the catheter were drawn in December 1975 and January 1976; fourteen prototypes were made in February 1976, and sent to three or four surgeons for testing.

The application that resulted in the '129 patent was filed on March 18, 1977, with method claims 1-4 and apparatus claims 5-7. In the Office Action of the '129 application, only apparatus claim 7 was allowed. Method claims 1-4 and apparatus claims 5 and 6 were rejected as unpatentable for their failure to distinguish over prior art. Amrine successfully argued to the patent examiner that all claims should be allowed.

C. The RMI patent (Polaris catheter)

The accused product, the Polaris catheter (Fig. 4), is a unitary catheter comprised of a small-diameter tube (Fig. 4a) that gradually tapers to a large-diameter tube (Fig. 4b). The lead tip is slotted (Fig. 4c), and secondary holes (Fig. 4d) are located on the flat portion of the large-diameter tube, directly above the tapered junction. The catheter may optionally be provided with wire reinforcement to prevent kinking (Fig. 4e). Instructions included with the Polaris catheter suggest insertion into the SVC only.

In the first Office Action on the Polaris catheter, the patent examiner rejected all claims as being "anticipated by Amrine," in that every element found in the rejected RMI claim was found in the same combination in Amrine's patent. By responsive amendment, RMI added the additional limitation to claim 1 that emphasized RMI's invention was directed to the reinforcing collar in the gray areas of RMI's unitary catheter. RMI eventually obtained a patent on the amended claim 1.³

OPINION

IV. VALIDITY OF THE '129 PATENT

Several sections of Title 35 U.S.C. are relevant to RMI's challenge to the validity of the '129 patent.⁴ Under 35 U.S.C. § 102(a), public knowledge or uses by others before Amrine's invention date is prior art over which his claims must distinguish. Section 102(b) provides that irrespective of Amrine's invention date, printed publications or public uses or sales more than one year before the application filing date are prior art. Section 102(f) requires that Amrine himself be the inventor of the claimed subject matter. Section 102(g) contains rules regarding abandonment, concealment and suppression as well as conception and reduction to practice. Section 103 requires that the claimed invention be unobvious to one of ordinary skill who is presumed to have knowledge of all the relevant prior art. If RMI should successfully carry its burden under any one of these sections, the affected claims are invalid.

A. Asserted prior art

RMI contends that prior art references, not submitted to the United States Patent and Trademark Office (PTO), show lack of inventiveness and obviousness sufficient to defeat the '129 patent. The references considered by the court include the works of Dr. Charles Bailey, Dr. Michael Chiechi, Dr. John Flege and Richard Berryessa, as well as a reference to an article co-authored by Dr. Edward A. Fitch and Dr. Bailey.

1. Dr. Charles Bailey

Dr. Charles Bailey, an eminent clinical professor of and pioneer in cardiac surgery,⁵ testified that in 1959 he abandoned the dual cannulation technique that required two cannulae, and began using a single catheter venous drainage procedure. That same year, Dr. Bailey and one of his students, Dr. Blanco, contributed to an article entitled, "Single Catheter Gravity Drainage of the Right Atrium or Right Ventricle During Total Cardiac Bypass."⁶ Although the article does not specifically mention drainage from the IVC, RMI asserts the publication teaches insertion of a single-diameter catheter with several drainage openings through the right atrial appendage in a manner that facilitates drainage from the coronary sinus as well as the SVC and the IVC. Dr. Bailey also testified he followed the described method of insertion that placed the tip of the catheter into the IVC. He used the Blanco catheter in approximately one-third of his operations from 1959 until his retirement in 1977. During that time, Dr. Bailey trained approximately 75 residents in the catheter's use, and demonstrated it to numerous visiting surgeons.

Dr. Bailey discovered the Blanco catheter was too large for use on small individuals. To solve that problem, he used a tapered catheter (modified by the addition of sideholes) that fit easily into the IVC. The same methods of insertion through the...