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Reissued Pacemaker Patent Did Not Violate Reissue Recapture Rule

05-1515
October 12, 2006

Decision icon Decision

Last Month at the Federal Circuit - November 2006

Judges: Michel, Schall (author), Dyk (concurringin-part and dissenting-in-part)

[Appealed from: D. Del., Chief Judge Robinson]

In Medtronic, Inc. v. Guidant Corp., No. 05-1515 (Fed. Cir. Oct. 12, 2006), the Federal Circuit affirmed the decision of the United States District Court for the District of Delaware that claims 15-26 of U.S. Reissue Patent No. 38,119 (“the ’119 patent”), a reissue of U.S. Patent No. 4,928,688 (“the ’688 patent”), did not violate the rule against recapturing surrendered subject matter in a reissue application and, thus, were not invalid.

The ’119 patent involves a method and apparatus for treating ventricular asynchrony, a condition in which a person has a defect in his or her heart ventricles. This results in the loss of effectiveness in the pumping of blood. The method of the ’119 patent works through a pacemaker device that either “conditionally” or “unconditionally” paces the two ventricles of the heart to cause simultaneous ventricular contractions. The “conditional embodiment” requires sensing a depolarization in a first ventricle, then waiting for a predetermined period of time to sense a depolarization in the second ventricle. If no depolarization is sensed in the second ventricle, the device stimulates, or “paces,” the second ventricle with an electrical pulse. In the “unconditional embodiment,” depolarization is sensed in either ventricle and, as soon as depolarization in one ventricle is sensed, both ventricles are immediately paced.

Medtronic, Inc. (“Medtronic”) filed a DJ action in the District of Delaware against Guidant Corporation and three other parties (collectively “Guidant”), alleging that claims 15-26 of the ’119 patent were invalid by reason of violation of the rule against recapturing surrendered subject matter. Following a bench trial, the district court concluded that the ’119 patent was not invalid.

On appeal, Medtronic argued that as-filed claims 1, 7, 15, and 16 of U.S. Patent Application No. 07/299,895 (“the ’895 application)—the application that later issued as the ’688 patent and was reissued as the ’119 patent—covered the unconditional embodiment and that, during prosecution, their scope was limited to the conditional embodiment.

The Federal Circuit agreed with Guidant and the district court that independent claims 1 and 7 of the ’895 application as filed did not disclose the unconditional embodiment. The Court noted that those claims as filed required the processing of signals, while in the unconditional embodiment, the device does not analyze or process any signals because it immediately and unconditionally stimulates the ventricles. Thus, the Court concluded that the recapture rule did not apply with respect to those claims.

The Court, however, agreed with Medtronic that as-filed claims 15 and 16 of the ’895 application did include the unconditional embodiment and, after an examiner’s amendment, claims 15 and 16 no longer covered the unconditional embodiment. Nevertheless, the Court concluded that there was no deliberate surrender of subject matter to obtain allowance of the claims. Specifically, the Court found that it was clear from the prosecution history that neither the examiner nor the prosecuting attorney considered the unconditional embodiment a part of the invention. Moreover, the Court found that there was no evidence that the unconditional embodiment could not have been included in the original patent. Nor was there any evidence that the unconditional embodiment was deliberately surrendered in an effort to overcome a prior art rejection. Thus, the Court concluded that because claims 15 and 16 were not amended over prior art, but made as clarifying amendments, there was no clear admission that the unconditional embodiment was not patentable. The Federal Circuit also agreed with the district court and Guidant that Dr. Mower did not clearly and unmistakably surrender the unconditional embodiment in claims 15-26 through arguments made during prosecution.

Medtronic further argued that claims 15, 16, and 22-26 of the ’119 patent were invalid because they recaptured an embodiment with only one sensing electrode that was recited in originally filed claim 7, but was amended to surrender sensing in only one ventricle. The Court, however, agreed with Guidant and the district court that as-filed claim 7 did not include an embodiment with only one sensing electrode, and thus there was no surrender of such an embodiment. In particular, the Court noted that as-filed claim 7 referred to a “biventricular pacemaker,” indicating that sensing is done in both ventricles. The claim also used the term “detecting cardiac signals,” indicating that several sensing electrodes would be used.

Thus, the Federal Circuit agreed with the district court that claims 15, 16, and 22-26 of the ’119 patent were not invalid for recapturing an embodiment with only one sensing electrode. Moreover, the Court also found that an embodiment with only one sensing electrode was not surrendered by arguments made during prosecution.

Judge Dyk, concurrring-in-part and dissenting-in-part, wrote that he believed that the ’119 patent claims 15-26 impermissibly recaptured the unconditional embodiment. In his view, the timing and content of the prosecuting attorney’s statements and the examiner’s amendments to claims 15 and 16 led to the conclusion that the unconditional embodiment was deliberately surrendered during prosecution of the original patent.