Medtronic, Inc. v. Daig Corp.

• Decision Date: 30 April 1986
• Docket Number: No. 85-2645,85-2645
• Parties: MEDTRONIC, INC. and Medtronic Puerto Rico, Inc., Appellees, v. DAIG CORPORATION, Appellant. Appeal
• Court: U.S. Court of Appeals — Federal Circuit

Page 903

789 F.2d 903

229 U.S.P.Q. 664

MEDTRONIC, INC. and Medtronic Puerto Rico, Inc., Appellees, v. DAIG CORPORATION, Appellant.

Appeal No. 85-2645.

United States Court of Appeals, Federal Circuit.

April 30, 1986.

Malcolm L. Moore, Williamson, Bains, Moore & Hansen, Minneapolis, Minn., argued for appellant Daig Corp.

Robert T. Edell, Merchant, Gould, Smith, Edell, Welter & Schmidt, Minneapolis, Minn., argued for appellees. With him on brief was Albert L. Underhill. Joseph F. Breimeyer, Medtronic, Inc., Minneapolis, Minn., of counsel.

Before BISSELL and ARCHER, Circuit Judges, RE, Judge. ^*

BISSELL, Circuit Judge.

Daig Corporation (Daig) appeals from a judgment of the United States District Court for the District of Minnesota, ¹ which found U.S. Patent No. 3,902,501 ('501) not proved invalid under 35 U.S.C. Sec. 103 and infringed in a patent infringement action instituted by the assignee of the '501 patent, Medtronic, Inc. and its wholly-owned subsidiary, Medtronic Puerto Rico, Inc. (collectively called Medtronic). We affirm.

BACKGROUND

A. The Invention

A pacemaker is a device comprised of a pulse generator, a lead and a power source which is used to provide electrical stimulation to the heart in order to restore an acceptable heart rate in a patient whose rate is too low or erratic.

The two major types of pacemaker leads are myocardial leads and endocardial (or transvenous) leads. Myocardial pacemaker leads are either sutured or screwed into the tissue of the outside of the heart. The surgery necessary for myocardial lead fixation is disadvantageous because of the attendant trauma to the patient, the risks associated with major surgery, and the extended recuperation time. Endocardial An endocardial lead is inserted inside the heart through a vein. This requires a minor surgical procedure under local anesthesia, requiring a small incision in the vein through which the lead is passed to the desired location in the heart.

leads were developed to alleviate the problems that accompany myocardial lead implantation.

The invention of the '501 patent is directed to an endocardial pacemaker lead structure for transvenous implantation having a pacing electrode at its distal tip. ² This endocardial electrode, or tined lead, provides a means of passively fixing a medical electrode to heart tissue, particularly the trabeculae ³ of the ventricles ⁴ and the right atrial appendage. ⁵ The patented structure is a lead having a plurality of pliant, nonconducting tines which extend away from an exposed metal electrode tip and cooperate within the heart to hold the exposed electrode tip against the heart wall. This provides a suitable electrical relationship for transmitting pulses from a pacemaker pulse generator to the heart to properly time, or pace, the patient's heart beats. The tines provide this fixation without damaging or penetrating the heart tissue.

B. Proceedings and the District Court Opinion

Medtronic charged Daig with infringement of claim 1 of the '501 patent and U.S. Patent No. 3,737,579. Daig answered denying infringement and counterclaimed for a declaration of invalidity, and asserted antitrust violations. Daig later charged Medtronic with infringement of U.S. Patent 4,236,529 assigned to it. Medtronic defended by asserting patent invalidity and sought a declaratory judgment to that effect. The two actions were consolidated for trial. The trial judge ordered the trial trifurcated with the issues of patent validity and infringement to be tried first, the issues of damages relating to patent infringement to be tried second, and the issues of liability and damages relating to the antitrust and unfair competition claims to be tried to a jury last. When the trial commenced the court heard and received evidence with respect to claim 1 of the '501 patent only. The remaining issues were severed for a later, separate trial.

After a bench trial, the trial judge prepared a 107 page discussion of findings of fact and conclusions of law and adjudged the '501 not proved invalid and the accused devices used by Daig infringing claim 1 of the '501 patent.

ISSUE

Whether the trial judge erred in finding that claim 1 of the '501 patent was not obvious in view of the prior art.

OPINION

Daig presented this court with the same analysis of the prior art and testimony that was presented to the trial judge. It is not the role of this court to review de novo proceedings of a district court. Daig bears the burden of showing that the trial judge, in deciding the question of obviousness, committed reversible legal error, or that its probative findings underlying the legal conclusion were clearly erroneous in light of the record made at trial. Carl Schenck, A.G. v. Norton Corp., 713 F.2d 782, 785, 218 USPQ 698, 700 (Fed.Cir.1983); see also, Fromson v. Advance Offset Plate, Inc., 755 F.2d 1549, 1555, 225 USPQ 26, 30 (Fed.Cir.1985); Atlas Powder Co. v. E.I. DuPont DeNemours & Co., 750 F.2d 1569, 1573, 224 USPQ 409, 411 (Fed.Cir.1984). The "clearly erroneous" standard is satisfied when this court is left with the firm conviction that error has been committed. See, e.g., Raytheon Co. v. Roper Corp., 724 F.2d 951, 956, 220 USPQ 592, 596 (Fed.Cir.1983), cert. denied, --- U.S. ----, 105 S.Ct. 127, 83 L.Ed.2d 69 (1984).

Daig argues that the trial judge erred in that he misunderstood the problem that the '501 invention overcame, misinterpreted the teachings and disclosures of the prior art, failed to understand the differences between certain prior art and the claimed invention and failed to consider the prior art as a whole in determining obviousness. Daig further argued that the record evidence does not establish commercial success attributable to the claimed tined lead.

OBVIOUSNESS

In assessing nonobviousness the following factual inquiries must be made: (1) the scope and content of the prior art; (2) the level of ordinary skill in the art; (3) the differences between the claimed invention and the prior art; and (4) objective evidence of secondary considerations such as long-felt need, unexpected results, or commercial success. Graham v. John Deere Co., 383 U.S. 1, 17, 86 S.Ct. 684, 693, 15 L.Ed.2d 545, 148 USPQ 459, 467 (1966); see, e.g., Simmons Fastener Corp. v. Illinois Tool Works, Inc., 739 F.2d 1573, 1575, 222 USPQ 744, 746 (Fed.Cir.1984), cert. denied, --- U.S. ----, 105 S.Ct. 2138, 85 L.Ed.2d 496 (1985).

The trial judge, Judge Larson, recognized the requisite Graham inquiries. He properly stated that prior art references "include pacemaker leads and catheter-like devices in general." A person of ordinary skill in this art in 1972 was determined to "have had a master's degree in electrical or mechanical engineering coupled with a basic knowledge of the physiology and anatomy of the heart and vascular system." Judge Larson proceeded to articulate a detailed analysis of the prior art cited to the U.S. Patent and Trademark Office and the additional references that were introduced at trial, with each reference reviewed for what it taught and disclosed. ⁶

No contest is had with the scope of the prior art or the level of ordinary skill in the art determinations. Instead, Daig's challenge with the trial's outcome begins with the premise that the problem solved by the '501 invention was incorrectly identified as the:

development of an endocardial pacemaker lead with a means of passive fixation to reduce the incidence of lead dislodgement in the ventricles and right atrial appendage and to lessen the risk of tissue penetration or damage in the veins and heart chambers.

Nevertheless, Daig offers no alternative articulation of the problem and merely urges this court to find error in "undue emphasis" being placed on the lead dislodgement aspect of the problem. Daig continues by asserting that errors occurred in the discussion of the Schaldach article and the Rasor patent and that by analyzing the prior art references individually, the trial court failed to consider the references as a whole. However, the alleged errors in the trial judge's understanding of the Schaldach article and Rasor patent amount to nothing more than argument. Judge Larson's interpretation of the references is amply supported by the record; it is not clearly erroneous.

We now turn our attention to the trial judge's discussion of the prior art teachings "as a whole." Under Rule 52(a) of the Federal Rules of Civil Procedure, in a non-jury trial, "the court shall find the facts specially and state separately its conclusions of law thereon ...." This court has recognized that failure to make specific factual findings is an abuse of discretion. See, e.g., Seattle Box Co., Inc. v. Industrial Crating & Packing, 756 F.2d 1574, 1578, 225 USPQ 357, 360 (Fed.Cir.1985) (it was error for the court to limit its statements on the equitable components of intervening rights to a mere ultimate conclusion, without any explanation of the particular factors and facts it considered); Jones v. Hardy, 727 F.2d 1524, 1529, 220 USPQ 1021, 1025 (Fed.Cir.1984) (failure to make specific Graham findings constituted error). Such a failure has not occurred in this case.

While Rule 52(a) does require specific fact findings to be stated, the rule is not so severe as to require the trial judge to articulate every imaginable permutation and combination of prior art teachings. "The ultimate test of the adequacy of findings is whether they are sufficiently comprehensive and pertinent to the issue to form a basis for the decision (and whether they are supported by the evidence)." Loctite Corporation v. Ultraseal Ltd., 781 F.2d 861, 862, 872, 228 USPQ 90, 98 (Fed.Cir.1985). While a complete discussion of all possible permutations and combinations of the prior art would remove all doubt about whether the trial court properly reviewed the prior art for its total teachings, we are convinced by the "express[ed] and necessarily implied findings" that Judge Larson properly viewed the prior art as...