265 F.3d 1294 (Fed. Cir. 2001), 00-1417, Advanced Cardiovascular Systems v. Medtronic Inc

Docket Nº:00-1417
Citation:265 F.3d 1294
Party Name:ADVANCED CARDIOVASCULAR SYSTEMS, INC., Plaintiff-Appellee, v. MEDTRONIC, INC., Defendant-Appellant.
Case Date:September 10, 2001
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit

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265 F.3d 1294 (Fed. Cir. 2001)

ADVANCED CARDIOVASCULAR SYSTEMS, INC., Plaintiff-Appellee,

v.

MEDTRONIC, INC., Defendant-Appellant.

No. 00-1417

United States Court of Appeals, Federal Circuit

September 10, 2001

Appealed from: United States District Court for the Northern District of California Senior Judge D. Lowell Jensen

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[Copyrighted Material Omitted]

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[Copyrighted Material Omitted]

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Edward A. Mas, II, McAndrews, Held & Malloy, Ltd., of Chicago, Illinois, argued for plaintiff-appellee. With him on the brief were Timothy J. Malloy, Leland G. Hansen, and James M. Hafertepe.

Ernest I. Reveal, Robins, Kaplan, Miller & Ciresi L.L.P., of Minneapolis, Minnesota, argued for defendant-appellant. With him on the brief were Kevin D. Conneely, Rita Coyle DeMeules, and Susan L. Dunbar.

Before BRYSON, GAJARSA, and LINN, Circuit Judges.

LINN, Circuit Judge.

Medtronic, Inc. ("Medtronic") appeals a final judgment from the United States District Court for the Northern District of California. Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., No. C-95-3577 (N.D. Cal. May 17, 2000) (judgment). The district court decided, on summary judgment, that claim 3 of United States Patent No. 5,451,233 ("'233 patent"), owned by Advanced Cardiovascular Systems, Inc. ("ACS"), was not invalid, not unenforceable, and was infringed. Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., No. C-95-3577, slip op. at 13 (N.D. Cal. Aug. 25, 1999) ("Summary Judgment Opinion"). A jury then found that Medtronic's infringement was willful. On post-trial motion filed by ACS, the district court enhanced damages by thirty percent for a total of $7,086,311. Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., No. C-95-3577 (N.D. Cal. Mar. 31, 2000) ("Enhanced Damages Opinion").

Medtronic appeals: (1) the summary judgment, challenging the conclusion that claim 3 was not unenforceable and challenging the claim construction that resulted in infringement; (2) the enhancement of damages; and (3) the district court's denial of two of its motions. The first motion, denied before summary judgment, was for leave to assert invalidity under 35 U.S.C. § 112, paragraph 1. The second motion was for a new trial based on various evidentiary preclusions at trial. Because Medtronic has not shown any reversible error, we affirm.

BACKGROUND

A. The Technology and the Relevant Patents

The technology involved relates to rapid exchange catheters for performing coronary angioplasty. In addition to the '233 patent, ACS has three other patents on this technology that were originally part of the present lawsuit. The '233 patent and two of ACS's other patents are referred to collectively by the parties as "the Yock patents," in reference to their common inventor. The two other Yock patents are United States Patent No. 5,040,548 ("'548 patent") and United States Patent No.

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5,061,273 ("'273 patent"). The fourth ACS patent originally part of this lawsuit is United States Patent No. 5,496,346 ("'346 patent"). The last of these to issue was the '233 patent, which issued on September 19, 1995. Medtronic also has at least one patent in this field that is relevant to the present suit. That patent is United States Patent No. 5,549,556 ("'556 patent").

The '233 patent relates to rapid exchange catheters for use in coronary angioplasty. Coronary angioplasty refers to the use of a balloon to increase the blood flow through a stenosis, which is a partially blocked section of a blood vessel feeding the heart. As described in the '233 patent and the briefs, a typical coronary angioplasty consists of the following three steps. First, a physician inserts a guiding catheter, a tubular structure, into a patient's blood vessel beginning at the top of the patient's leg. The guiding catheter is advanced toward the heart through the patient's blood vessel, stopping short of the coronary arteries, and is then fixed in place. Second, the physician inserts a guidewire into the guiding catheter until the distal end of the guidewire exits the guiding catheter, which is still inside the patient's blood vessel, and enters the coronary arteries. The physician then positions the guidewire across the stenosis to be treated in the coronary arteries, and the guidewire is fixed in place. Third, the physician advances a balloon catheter along the guidewire until the balloon, which is on the end of the balloon catheter closest to the heart, exits the guiding catheter and is positioned across the stenosis. The physician then inflates the balloon to treat the stenosis, deflates the balloon, and removes the balloon catheter without disturbing the placement of either the guidewire or the guiding catheter.

Physicians frequently need to exchange balloon catheters during a single coronary angioplasty. For example, if a stenosis blocks most of the blood flow through a vessel, the physician may first need to use a small balloon to increase the size of the opening through the stenosis, and then use a larger balloon to further increase the opening.

The physical connection between the balloon catheter and the guidewire is central to the present dispute. In the relevant prior art systems, the balloon catheter contained an internal channel, referred to as a guidewire lumen, along its entire length and an opening to the lumen at each end of the catheter. The balloon catheter also contained an inflating lumen that connected to, and provided the channel for inflating, the balloon. The guidewire lumen enabled the balloon catheter to travel over the guidewire, completely enclosing the guidewire, as the balloon catheter was inserted into the guiding catheter positioned in the blood vessel. The drawback of this design was that it was cumbersome to exchange balloon catheters because the guidewire was approximately ten feet long and, thus, changing the balloon catheter that rode along the guidewire was a two-person job.

The '233 patent describes a solution to this problem, providing a design that allows one person to exchange balloon catheters. The guidewire lumen in the balloon catheter is shortened considerably so that it no longer runs the entire length of the balloon catheter. Rather, the guidewire lumen begins at the far end of the balloon catheter, that is, the end near the balloon, but extends back through the balloon catheter only about 10-15 cm. This length is selected so as to ensure that the proximal end of the guidewire lumen, that is, the end nearer the physician, is retained within the guiding catheter when the balloon catheter is in place across a stenosis. This

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retention is important because if the guidewire lumen of the balloon catheter protrudes entirely from the guiding catheter, problems can occur in positioning, moving, or withdrawing the balloon catheter.

A preferred embodiment of the '233 patent has the guidewire lumen running through the inside of the balloon, giving the balloon a cylindrical shape. This is termed a coaxial design and is illustrated in the figures below from the '233 patent.

[Tabular or Graphical Material Omitted]

Figures 3A and 3B show a transition region at the proximal end of the guidewire lumen, that is, the end nearer the physician and away from the heart. The transition region also, therefore, shows the proximal guidewire lumen opening. The left-hand portion of Figure 3A shows the configuration for the majority of the length of the catheter; the transition region does not occur until approximately 10-15 cm from the distal end of the catheter, which is the end nearer the heart. The distal end of the catheter is shown in Figures 4A and 4B.

Figures 4A and 4B show the coaxial design, with the guidewire 27 positioned in guidewire lumen 37, with balloon 33 surrounding both of them. Figures 3A and 3B show the transition region where the guidewire 27 enters the guidewire lumen 37, through the proximal guidewire lumen opening 43, and becomes surrounded by the inflation lumen 41 that eventually opens up into the balloon 33.

Although five patents are relevant to the present suit, only claim 3 of the '233 patent is at issue, as explained below in the section describing the procedural history. Claim 3 recites:

3. An elongated balloon dilatation catheter for performing an angioplasty procedure within a human patient's coronary artery which has means for the rapid exchange of the catheter over a guidewire without the utilization of an exchange wire or an extension wire, comprising:

a) an elongated catheter shaft having proximal and distal ends and being configured for percutaneous introduction into the patient's femoral artery;

b) a distal guidewire opening in the distal end of the catheter shaft;

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c) a proximal guidewire opening in the catheter shaft spaced a short distance of at least 10 cm proximally from the distal guidewire opening and a substantial distance from the proximal end of the catheter shaft;

d) a flexible distal shaft section configured to be advanceable within the patient's coronary arteries having a guidewire-receiving lumen extending proximally from the distal guidewire opening to the proximal guidewire opening and having an inflation lumen coextensive at least in part with the guidewire-receiving lumen,

e) an inflatable dilatation balloon on the distal shaft section having proximal and distal ends, having an interior which is in fluid communication with the inflation lumen and being spaced closer to the distal end of the catheter shaft than the proximal guidewire opening; and

f) a proximal shaft section much longer than the distal shaft section which is an elongated tubular member with an inner lumen extending therein in fluid communication with the inflation lumen in the distal section and which is suitable to advance the distal shaft section within a patient's coronary artery over a guidewire slidably disposed within the guidewire...

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