Becton Dickinson and Co. v. CR Bard, Inc.
| Decision Date | 21 September 1989 |
| Docket Number | Civ. A. No. 86-1684. |
| Citation | 719 F. Supp. 1228 |
| Parties | BECTON DICKINSON AND COMPANY, Plaintiff, v. C.R. BARD, INC., Defendant. |
| Court | U.S. District Court — District of New Jersey |
COPYRIGHT MATERIAL OMITTED
Elliot M. Olstein, John N. Bain, Michael S. Miller, Carella, Byrne, Bain & Gilfillan, Roseland, N.J., for plaintiff.
Frank L. Bate, Shanley & Fisher, Morristown, N.J., and John D. Foley, Warren H. Rotert, Christopher E. Chalsen, Karl M. Zielaznicki, Morgan & Finnegan, New York City, for defendant.
Plaintiff Becton Dickinson and Company ("Becton Dickinson" or "B-D") brings this patent infringement suit against defendant C.R. Bard, Inc. ("Bard") for alleged infringement of United States Patent No. 3,789,841 ("the '841 patent"). The subject matter of the '841 patent is a disposable guide wire used in the catheterization of blood vessels. Bard has moved for summary judgment on three grounds: (1) that the patent is unenforceable because of allegedly inequitable conduct on the part of B-D in the patent prosecution process; (2) that the patent is invalid for obviousness over the prior art pursuant to 35 U.S.C. § 103; and (3) that Bard has not infringed the patent as a matter of law. The Court will grant the motion.
In 1953 Sven Ivar Seldinger first described an alternative to heart bypass surgery for the treatment of blocked coronary arteries. In performing a Seldinger technique, formally known as Percutaneous Transluminal Coronary Angioplasty (PTCA), a physician directs a guide wire into the occluded artery or arterial branch. The physician then directs a balloon catheter over the guide wire to the site of the blockage, withdraws the guide wire and expands the balloon in order to expand the artery. PTCA procedures have proven so effective that today over 160,000 such procedures are performed annually.1
In 1970 William T. Antoshkiw, a Becton Dickinson employee, developed a spring guide wire that he thought was an improvement over the prior art. Based upon an application filed on September 15, 1971, the Patent and Trademark Office granted the '841 patent to Antoshkiw as assignor to B-D on February 5, 1974. The disposable guide wire of the patent is depicted in Figures 1 and 2 of the patent, which are reprinted in Appendix A. The guide wire of the '841 patent comprises a stainless steel inner wire 10 having a portion 12 of uniform diameter and a gradually tapered portion 14. The portion of the core 12 having the uniform diameter is called the "proximal portion" and is enclosed and engaged by a plastic jacket 16; the tapered portion 14 of the core is called the "distal portion" and is covered by a coil spring 18. The terms "proximal" and "distal," as used in the prior art and in the '841 patent, refer to the physician during use, so that the proximal portion is closest to the physician (and furthest from the patient) during use and the distal portion is furthest from the physician (and closest to the patient) during use.
The patent recites that the steel spring enclosing the distal portion of the invention "provides flexibility and resiliency while permitting the introduction of the guide wire through a stainless steel cannula without the danger of skiving during introduction of the wire." At the same time, the patent purports to reduce the danger of spring breakage by shortening the spring and attaching it to the inner core at both ends. The use of a tapered core wire in the distal portion, according to the patent, provides for a uniform increase in flexibility from the proximal portion to the distal tip.
The patent cites several advantages of the use of a plastic jacket around the proximal portion of the center of the core wire, namely (1) reducing the length of spring coil required and thereby greatly reducing the cost of the guide wire; (2) providing a smooth, low friction surface and thereby easing the movement of the guide wire through a blood vessel; (3) providing an outer surface that is easier to clean than the spring coil; (4) preventing blood clotting between the coils of the spring; (5) providing support to the wire and therefore reducing the chance of wire breakage; (6) providing excellent torque transmission to the distal portion, thus facilitating manipulation of the guide wire; and (7) serving as an insulator and thus eliminating the electrical hazard present during the use of devices based on the prior art.
As the general advantages of the claimed invention, the patent lists the following: (1) disposability of the guide wire and the lack of a need to clean and sterilize it after each use; (2) maneuverability; (3) a low coefficient of friction; (4) good torque transmitting ability; (5) prevention of clot formation; and (6) low chance of breakage.
The claims of the patent are as follows:
Only claims 1, 6 and 7 are independent claims; the remaining claims are dependent on other claims.
During the prosecution of the application by Antoshkiw, the Patent Examiner rejected the original claims under 35 U.S.C. § 103 as obvious over the prior art references of Muller (U.S.P. 3,452,740; Foley Unenforceability Affidavit Exh. 3), Cook (U.S.P. 3,547,103; Foley Unenforceability Affidavit Exh. 4) and Ackerman (U.S.P. 3,612,058; Foley Unenforceability Affidavit Exh. 5). The Muller patent disclosed a manipulable spring guide including a continuous coil and a slidable tensioning wire. The Cook patent disclosed a coil spring guide, including a coil spring surrounding a fine wire, a plastic needle sheath for inserting the guide wire, and a mandrel for stiffness and rigidity. The Ackerman patent disclosed a wire outer casing surrounding an inner core at the distal end and an inner reinforcing tube along the proximal end. Neither the Muller, Cook nor Ackerman patents disclosed the B-D claim features of either a plastic jacket enclosing the proximal portion of the inner core or an elongated inner core having a tapered distal end surrounded by a coil spring.
In response to this office action, Antoshkiw filed an amended application dated December 5, 1972, in which he emphasized that the claimed invention taught the use of a plastic jacket enclosing and engaging the proximal portion of the inner core wire and that this "structural distinction" was not found in the prior art. Foley Unenforceability Affidavit Exh. 2, at 22. The applicant further remarked:
The most important advantages of the present invention are derived through the use of a plastic jacket enclosing the proximal portion of the guide wire. The plastic jacket provides a smooth surface and thereby facilitates ease of insertion which results in less damage to the patient and to the catheter. The smooth surface is easier to clean and eliminates the tendency for clotting to result between the coils of the springs used in the prior art. The plastic jacket provides excellent torque transmission for greater maneuverability of the distal tip and at the same time eliminates the electrical hazard which was present during cardiovascular catheterization when devices of the prior arts were used.
In support of claim 2 of the original application, which was dependent on the original claim 1, the applicant emphasized that claim 2 taught the use of a tapered distal portion of the inner core wire. The applicant remarked:
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Becton Dickinson and Co. v. C.R. Bard, Inc.
...(BD), appeals the final decision of the United States District Court for the District of New Jersey, Becton Dickinson and Co. v. C.R. Bard, Inc., 719 F.Supp. 1228, 12 USPQ2d 1678 (D.N.J.1989), (Wolin, J.), granting summary judgment in favor of C.R. Bard, Inc. on a charge of infringement of ......