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ADVANCED CARDIOVASCULAR v. SCIMED LIFE SYSTEMS

April 25, 2000

ADVANCED CARDIOVASCULAR SYSTEMS, INC., A CALIFORNIA CORPORATION, PLAINTIFF,
V.
SCIMED LIFE SYSTEMS, A MINNESOTA CORPORATION, DEFENDANT.



The opinion of the court was delivered by: Wilken, District Judge.

ORDER GRANTING ACS' MOTION FOR PARTIAL RECONSIDERATION OF THE COURT'S JUNE 22, 1999 ORDER

Plaintiff Advanced Cardiovascular Systems, Inc. (ACS) moves for partial reconsideration of the Court's June 22, 1999 Order denying ACS's motion for summary judgment with respect to the inequitable conduct and indefiniteness defenses raised by Defendant SciMed Life Systems (SciMed). SciMed opposes the motion. Having considered all if the papers filed by the parties, the Court grants the motion.

BACKGROUND

This case involved a patent infringement suit brought by ACS against SciMed in regard to a patent for balloon dilatation catheters. ACS and SciMed both develop, manufacture, promote, and sell catheters used to perform intravascular procedures. ACS owns U.S.Patent No. 5,496,275 (the Sirhan '275 patent), which relates to a balloon dilatation catheter used to perform percutaneous transluminal coronary angioplasty (PTCA) in patients suffering from coronary disease arising from atherosclerosis*fn1 in the coronary arteries. ACS alleges that SciMed's Bandit catheter infringes the Sirhan '275 patent.

On December 24, 1998, the Court issued its order construing the terms of the Sirhan '275 patent. In the course of construing claim one of the patent, the Court concluded that the terms "distal section" and "substantially larger" were sufficiently definite under 35 U.S.C. § 112, ¶ 2 to allow the Court to construe them. With respect to the term "distal section," the Court stated,

The Court finds that the meaning of the term "distal section" in the Sirhan '275 patent is sufficiently clear to enable a person skilled in the art to identify the distal portion of ACS' balloon dilatation catheter. First, the preferred embodiment gives not only an estimate of the length of this section, but also indicates that the distal section is situated immediately adjacent to the balloon. This is evident from the description that the distal section is the only part of the catheter, other than the balloon, to enter the patient's coronary anatomy. Figure one in the specification, depicting the reduced-profile distal section adjacent to the balloon, confirms this interpretation. Hansen Dec.Ex. 1. The specification, therefore, teaches that the distal section is between ten and forty centimeters long and is situated contiguous to the balloon.
In addition, although Mr. Corso testified that there was no industry-wide definition of distal section, he also made clear that by reference to a series of factors a person skilled in the art could generally identify the distal section on a given catheter. Mr. Corso stated that a person skilled in the art could identify the distal section by changes in the flexibility and profile of the catheter and the type of procedure for which the catheter was designed. Hansen Dec.Ex. 14 at 3-4. SciMed does not dispute that these criteria are widely known to persons skilled in the art. The Court finds that, when coupled with the description in the specification, these criteria would allow a person skilled in the art to identify with adequate precision the distal section of the Sirhan '275 patent catheter.

December 24, 1998 Order Construing Claims, Granting Defendant's Motion for Leave to Amend its Second Amended Answer, and Denying Defendant's Motion for Summary Judgment (December 24, 1998 Order) at 16-17. With respect to the term "substantially larger," the Court stated,

The Court finds that figure three, interpreted in the context of the specification as a whole, provides a sufficient indication of the breadth of the term "substantially larger" to allow a person skilled in the art to ascertain the scope of the Sirhan '275 patent. Contrary to SciMed's contention that Mr. Sirhan conceded that the figure is not accurate in its proportions, Mr. Sirhan's statement that the drawings were not to scale was made only in reference to figure one, not figure three which depicts the transverse dimensions of the distal section. Parker Dec.Ex. 18 at 28, 30. There is no evidence to suggest that figure three is not drawn to scale. Indeed, a photograph of the distal section, submitted to the PTO during the application process, confirms the proportions depicted in figure three. Sirhan Reply Dec.Ex. B at 2.
The description of the distal section in the specification provides further context with which to define the extent of the term "substantially larger." The specification clearly states that the purpose of reducing the catheter profile, which results in one transverse dimension substantially larger than the perpendicular dimension, is to increase flexibility substantially. Hansen Dec.Ex. 1 at 3:6-15. Although the specification does not provide an explicit definition, the Federal Circuit has held that terms of art that reasonably describe the claimed subject matter to a person skilled in the art need not be defined. Andrew Corp. 847 F.2d at 821 (terms "close to" and "substantially equal" not indefinite in circumstances). The Court finds that figure three, interpreted in the overall context of the specification, provides a person skilled in the art with a reasonable description, sufficient to determine the scope of the Sirhan '275 patent.

Id. at 18-19.

The Court also granted SciMed's motion for leave to amend its second amended answer to add a defense of inequitable conduct. The Court rejected ACS' argument that SciMed's proposed amendment would be futile, stating that ACS had failed to demonstrate that there was no set of facts on which SciMed could prevail. The Court noted that SciMed's inequitable conduct defense depended on the contention that the distal section that ACS described as "quite short" in the Sirhan application process was contained in the embodiment portrayed in figure three of the specification of U.S.Patent No. 5,040,548 (the Yock '548 patent) and in the same embodiment depicted in figure three of the specification of U.S.Patent No. 5,769,868 (the Yock '868 patent). During the Yock '868 patent application process, ACS described the distal section in the latter embodiment as being at least ten centimeters long. ACS argued that it was referring to figure ten, not figure three, when it described the embodiment in the Yock '868 specification as being at least ten centimeters in length. The Court concluded that because both parties' arguments were plausible, it could not hold, as a matter of law, that SciMed's allegation of inequitable conduct was futile.

On June 22, 1999, the Court granted ACS' motion for summary judgment of validity, finding that the Sirhan patent was not anticipated by the Frassica patent, the Coehlo invention, or the Yock '868 patent. With respect to the latter, the Court concluded that claims one, four, six, nine, ten, and eleven of the Sirhan patent are not anticipated by the Yock '868 patent because the oblong-shaped section of the Yock '868 patent is not the distal section within the meaning of the Court's construction of the Sirhan patent. The Court also concluded that the Sirhan patent is not obvious in light of the prior art. Furthermore, it granted ACS' motion for summary judgment that the Bandit catheter infringes the Sirhan patent.

However, the Court denied ACS' motion for summary judgment of enforceability, stating that none of the evidence relied upon by ACS established the actual length of the oblong-shaped section depicted in figures 3A and 3B of the Yock specification, and that SciMed had produced some evidence tending to show that figures 3A and 3B were misrepresented by ACS' counsel, Edward Lynch, during the prosecution of the Sirhan patent. Thus, the Court concluded that SciMed had presented sufficient evidence of both a material misrepresentation and an intent to deceive to preclude granting ACS' motion for summary judgment of enforceability. However, the Court noted that to prevail on its defense, SciMed would have to meet a "heavy burden" of proving by clear and convincing evidence that:

(1) during the prosecution of the Sirhan patent, ACS' counsel referred to figures 3A and 3B of the Yock specification when he described the oblong-shaped section as being quite short; (2) during the prosecution of the Yock '868 patent, ACS' counsel referred to the same figures in the Yock specification when he described the oblong-shaped section as being at least ten centimeters long; (3) the two descriptions of the length of the oblong-shaped section are wholly incompatible; (4) ACS' counsel's description, during the Sirhan prosecution, was both false and material to the PTO's decision to award the Sirhan patent; and (5) ACS misrepresented the length of the oblong-shaped section with the intent of misleading the patent examiner.

June 22, 1999 Order Granting ACS' motions for Summary Judgment of Validity and Infringement and Denying ACS' motion for Summary Judgment of Enforceability and SciMed's Motions for Summary Judgment of Invalidity and No Willful Infringement (June 22, 1999 Order) at 24.

The Court also denied SciMed's motion for summary judgment of invalidity and no willful infringement. However, it clarified that SciMed was not precluded from raising indefiniteness as a defense at trial, despite the Court's discussion of indefiniteness in the context of claims construction. The Court explained,

In its Order of December 24, 1998, the Court addressed the issue of indefiniteness as an issue of claims construction only to the extent that it found that the "distal section" and "substantially larger" claim terms of the Sirhan patent were sufficiently definite to allow the Court to construe them. The Order further denied SciMed's implicit request for summary judgment on the issue of invalidity due to indefiniteness. The Order, however, does not constitute an actual adjudication of SciMed's defense of indefiniteness.

Id. at 38.

DISCUSSION

I. Legal Standard

Summary judgment is properly granted when no genuine and disputed issues of material fact remain, and when, viewing the evidence most favorably to the non-moving party, the movant is clearly entitled to prevail as a matter of law. See Fed.R.Civ.P. 56; Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Eisenberg v. Insurance Co. of North America, 815 F.2d 1285, 1288-89 (9th Cir. 1987).

The moving party bears the burden of showing that there is no material factual dispute. Therefore, the Court must regard as true the opposing party's evidence, if supported by affidavits or other evidentiary material. See Celotex, 477 U.S. at 324, 106 S.Ct. 2548; Eisenberg, 815 F.2d at 1289. The Court must draw all reasonable inferences in favor of the party against whom summary judgment is sought. See Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 ...


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