In re Kao -- A Ray of Hope in a Post-KSR World

In this Commentary, Robert T. Burns and Laurie A. Axford focus on the Federal Circuit's holding and rationale in In re Huai-Hung Kao, 2011 U.S. App. LEXIS 9729 (Fed. Cir. May 13, 2011) [enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law] and how they provide a "ray of hope" for responding to obviousness rejections in a post-KSR world (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (U.S. 2007) [enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law]). The authors discuss the ruling and its implications. They write:

In Kao, the court reversed the Board and remanded the case for further consideration, holding that (1) the Board improperly relied on its own factual assertions in the face of evidence presented by the assignee, and that (2) the Board improperly considered evidence of secondary considerations presented on appeal.

II. Background

A. Overview of the claimed subject matter and the issues on appeal

     Kao is a consolidation of three appeals of decisions from the USPTO Board of Patent Appeals and Interferences: United States Patent Application Nos. 11/680,432 ("the '432 application"), 12/167,859 ("the '859 application"), and 11/766,740 ("the '740 application"). The '432 application relates to controlled-release tablets containing oxymorphone, an opioid narcotic used to manage chronic pain. The claims on appeal are for a controlled-release formulation having a dissolution rate allowing pain relief for twelve to twenty-four hours, compared to previous tablets that only relieve pair for up to six hours. The claims were rejected as obvious, using WO 01/08661 ("Maloney") as the primary reference allegedly teaching everything except the claimed dissolution rate.

     The assignee challenged these rejections by submitting declarations and arguing that Maloney did not teach the claimed dissolution rate, and by submitting declarations presenting evidence of secondary considerations to rebut a conclusion of obviousness. The USPTO was unconvinced, and actually used portions of the assignee's declarations to support its finding of obviousness Kao, 2011 Fed. Cir. LEXIS 9729 at *7-8. The USPTO also dismissed the evidence of secondary considerations, concluding that the evidence failed to overcome the rejections because it was not commensurate with the scope of the claims. Id. at *8.

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