Datascope Corp. v. SMEC, Inc.

• Decision Date: 01 November 1985
• Docket Number: Nos. 85-812,85-837,s. 85-812
• Citation: 227 USPQ 838,776 F.2d 320
• Parties: DATASCOPE CORP., Appellee/Cross Appellant, v. SMEC, INC., Appellant/Cross Appellee. Appeal
• Court: U.S. Court of Appeals — Federal Circuit

Page 320

776 F.2d 320

227 U.S.P.Q. 838

DATASCOPE CORP., Appellee/Cross Appellant, v. SMEC, INC., Appellant/Cross Appellee.

Appeal Nos. 85-812, 85-837.

United States Court of Appeals Federal Circuit.

Nov. 1, 1985.

Ezra Sutton, Woodbridge, N.J., for appellant.

Stevan J. Bosses, Fitzpatrick, Cella, Harper & Scinto, New York City, for appellee. With him on brief were Sidney P. Bresnick and Leonard P. Diana, New York City.

Before MARKEY, Chief Judge, DAVIS, Circuit Judge, and HARVEY, Senior District Judge. ^*

MARKEY, Chief Judge.

Consolidated appeal from a September 24, 1984 judgment of the United States District Court for the District of New Jersey, 594 F.Supp. 1306, 224 USPQ 694 (D.N.J.1984), holding claims 1-8, 18, 19, 21, 22, and 24-27 of Datascope Corporation's (Datascope's) U.S. Patent No. 4,261,339 ('339 patent) valid and infringed, and all claims of Datascope's U.S. Patent No. 4,327,709 ('709 patent) invalid for obviousness, 35 U.S.C. Sec. 103 (1985). ¹ We affirm in part and reverse in part.

Background

(1) Proceedings in the District Court

Datascope sued SMEC, Inc. (SMEC) on December 23, 1981, alleging infringement of certain claims of its '339 patent and requesting treble damages, interest, costs, and attorney fees. On January 14, 1982, SMEC denied infringement, alleged invalidity of all claims of the patent under 35 U.S.C. Secs. 101, 102, 103, and 112, and alleged unenforceability for acts of inequitable conduct during prosecution. SMEC also counterclaimed for damages and an injunction, alleging various acts of unfair competition and antitrust violations. On February 16, 1982 Datascope answered SMEC's counterclaim.

On January 1, 1983, Datascope amended its complaint, alleging infringement of certain claims of its '709 patent. On April 4, 1983, SMEC responded as described above. Datascope answered SMEC's counterclaim on April 20, 1984. ²

Trial without jury was held on January 9-11, 13, 16-18, February 8-10, and July 10-12, 1984.

On July 12, the district court ordered that proposed Findings and Conclusions be submitted by August 1, 1984, and that closing argument be heard on August 13, 1984. The record does not reflect that either party submitted Findings and Conclusions. Following closing argument on August 13, the district court reserved its decision.

The district court's opinion was filed on September 24, 1984. SMEC filed notice of appeal on October 24, 1984. On October 30, 1984 the district court entered a final judgment order.

SMEC filed a supplemental notice of appeal on November 19, 1985. Datascope filed notice of appeal on November 30, 1984.

(1) The '339 Patent

Datascope filed an application for "Balloon Catheter with Rotatable Support" on March 6, 1978. The invention related particularly to "inflatable balloon catheters" used in intra-aortic pumping.

Intra-aortic balloon (IAB) pumping was, at the time of the invention, a recognized method of cardiac assistance for a failing heart and of treating cardiogenic shock. It had been used to help wean a patient away from cardiopulmonary bypass, to support a patient during a difficult postoperative period, and to provide pulsation to the linear flow supplied by a cardiopulmonary bypass device. IAB pumping had also been used following myocardial infarction to limit the extension of necrosis and as therapy for angina pectoris.

In the IAB catheter disclosed in the '339 patent, an inflatable balloon chamber ³ portion of a catheter is "tightly twisted into a small cross-sectional diameter", i.e., a diameter generally no greater than that of the inflating gas supply tube of the catheter. That is achieved by supporting the balloon chamber about "support means" of small diameter (described in the specification as a "support wire"), one end of which is "rotatable relative to the chamber wherein the chamber is adapted to being compactly wrapped, rolled or twisted about the support means upon rotation of the chamber which causes swiveling of the support means." The small cross-sectional diameter of the resulting IAB catheter permitted insertion of that device "through small incisions or even by percutaneous insertion," and enabled the catheter to be "guided through smaller and more tortuous canals and passageways."

Claim 1 is representative:

1. A catheter comprising an inflatable and deflatable chamber having a proximal end and a distal end, said chamber in use being adapted to have substantially the same surface area when inflated and when deflated, a catheter tube portion connected at or adjacent an end thereof to the proximal end of said chamber and having a passage communicating with the interior of said chamber for admitting fluid into and withdrawing fluid from said chamber, support means for supporting said chamber extending in said chamber from the distal end thereof to said catheter tube portion and terminating in said catheter tube portion, said support means being non-rotatably connected to one of said ends of said chamber and rotatably coupled to the other of said ends of said chamber to permit relative angular motion between said support means and said chamber when said chamber is twisted about its longitudinal axis such that a configuration of said catheter may be obtained in which said chamber is wrapped about said support means, whereby insertion of said catheter into a body passageway or the like is aided.

(3) The '709 Patent

The '709 patent, which resulted from a continuation in part of the application that resulted in the '339 patent, claims apparatus and a method for the percutaneous insertion of an intra-aortic balloon into an artery through a sheath. Claim 1 is representative:

1. A system for percutaneous insertion of an intra-aortic balloon comprising in combination:

a flexible hollow sheath having an end adapted to be inserted into an artery of a subject through a puncture,

a balloon catheter comprising

a catheter tube,

a balloon envelope having one end connected to one end of said catheter tube,

an elongated flexible support member within said envelope having one end coupled to the other end of said envelope which is remote from said catheter tube, said envelope folding generally longitudinally along the axis of said support member to have a reduced diameter sufficiently small to be inserted through said sheath into the artery. ⁴

Issues Presented

(1) Whether the district court erred in refusing to hold claims of the '339 patent invalid.

(2) Whether the district court's finding that SMEC's device infringed certain claims of the '339 patent under the doctrine of equivalents was clearly erroneous.

(3) Whether the district court erred in holding the claims of the '709 patent invalid for obviousness.

Opinion

I. Validity of the '339 Patent

SMEC says the issue on appeal is "whether the trial court erred in finding [sic, holding] the '339 patent valid in view of the prior art." That is not the issue. Nor, under the statute, 35 U.S.C. Sec. 282, can it ever as stated be the issue. This court has spoken of the misconception that there exists some need for courts to hold or declare patents valid: "Patents are born valid." Panduit Corp. v. Dennison Mfg. Co., 774 F.2d 1082, 1096 (Fed.Cir.1985), Roper Corp. v. Litton Systems, Inc., 757 F.2d 1266, 1270, 225 USPQ 345, 347 (Fed.Cir.1985). The presumption that the patent is valid, 35 U.S.C. Sec. 282, continues until the validity-challenger has "so carried his burden as to have persuaded the decisionmaker that the patent can no longer be accepted as valid." Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1534, 218 USPQ 871, 875 (Fed.Cir.1984).

SMEC says: (1) claim limitations inserted to obtain allowance "do not in themselves distinguish over the prior art," because the prior art teaches rotatability between the support means and one end of the balloon chamber; and (2) "it is clear that these claims are obvious," ⁵ because the prior art "clearly teaches the alleged differences."

(1) The Prior Art

(a) Grayzel Patent

SMEC says a juncture between two elements in Figure 2 of Grayzel would have represented a ball and socket joint to one of ordinary skill in the art, and that Datascope's witness Wolvek (one of the inventors) "admitted" on cross examination that Figure 2 depicted a ball-joint. ⁶

What SMEC calls an "admission" is a Wolvek statement made with respect to a freehand blackboard sketch by SMEC's counsel at trial, not with respect to Figure 2. Counsel's trial tactic substituted a distortion of the prior art for the real thing, an attempt to manipulate the prior art we have found thoroughly improper. See Panduit Corp. v. Dennison Mfg. Co., 774 F.2d 1082, 1095. At no time did Wolvek "admit" that Grayzel's disclosure of a rod "attached to" a hollow tube disclosed a ball-joint.

Grayzel's specification neither teaches nor suggests a "ball-joint" or its like. As the district court cogently observed, had Grayzel intended to disclose a rotatable support member, "one would have expected express reference to such a feature, as it would have represented a significant departure from the prior art." 594 F.Supp. at 1311, 224 USPQ at 698. Moreover, SMEC does not and cannot reconcile its present assertions with the statement of its own expert witness, Marzullo, that if Figure 2 had been intended to disclose a ball-joint, it was improperly drawn.

(b) Other Prior Art

SMEC says United States Patent Nos. 3,585,983 to Kantrowitz and 3,671,979 to Moulopoulos taught rotation of the balloon chamber with respect to a support member. As the district court properly found, however, Kantrowitz does not teach rotation as that term is taught in the '339 patent. As Dr. Kantrowitz testified at trial, moreover, twisting the wire "braid" disclosed in the Kantrowitz reference tended to damage and eventually destroy the IAB device. Moulopoulos discloses an artificial heart valve having a flexible folding membrane. That reference neither taught nor suggested rotatability as disclosed in the '339 patent, and...