Actual Reduction To Practice Is Not Required For Inherent Anticipation Of A Therapeutic Method

This article previously appeared in Last Month at the Federal Circuit, June 2012

Judges: Lourie (dissenting), Dyk (author), Prost

[Appealed from Board]

In In re Montgomery, No. 11-1376 (Fed. Cir. May 8, 2012), the Federal Circuit affirmed the Board's decision that certain claims of U.S. Patent Application Serial No. 11/118,824 ("the '824 application") are invalid for anticipation.

The claims at issue are directed to methods of treating or preventing stroke with known renin-angiotensin system ("RAS") inhibitors. The examiner rejected these claims as anticipated by four prior art references, and Montgomery appealed to the Board.

The Board construed the independent claim as having two elements: (1) to administer an RAS inhibitor, and (2) "the patient population receiving the inhibitor . . . encompasses patients diagnosed as required stroke treatment or prevention." Slip op. at 6 (alteration in original) (citation omitted). The Board concluded that all four references taught administration of ramipril to stroke-prone patients, and that the claims were anticipated. The Board rejected Montgomery's argument that none of the references demonstrated actually treating or preventing stroke, finding that ramipril inherently treats or prevents stroke regardless of whether the authors recognized this inherent characteristic. Montgomery appealed to the Federal Circuit.

On appeal, the Federal Circuit focused on the HOPE reference ("HOPE"), noting that because it disclosed both elements, it need not address the other three references. The Court found no error in the Board's uncontested conclusion that HOPE disclosed the administration of ramipril to patients diagnosed as in need of stroke treatment or prevention.

The Court then turned to the requirement that the method be "for the treatment or prevention of stroke or its recurrence." The Court stated that it need not resolve whether the claim required efficacy, because it agreed with the Board that even if the claim had such a requirement, it was inherent in carrying out the claim steps. The Court found that HOPE inherently anticipated the claims, because it disclosed a protocol for administering ramipril to stroke-prone patients, and further disclosed that doing so inevitably treats or prevents stroke. The Court stated that it "agree[d] with the dissent that a result is only inherent if it inevitably flows from the prior art disclosure, but there is no question here that treating stroke-prone patients with...