In re Brana

In 1988, Miguel Brana and others (the applicants) (plaintiffs) filed a patent application for compounds they claimed were more effective antitumor substances than structurally similar compounds. The application incorporated a particular reference that reported the efficacy of similar compounds based on tests performed on mice implanted with two specific lymphocytic leukemias, a procedure widely used by the National Cancer Institute. The examiner (defendant) rejected the claims, concluding a different prior-art reference teaching other similar compounds rendered those claims obvious. The applicants overcame that rejection with a doctor’s declaration that his tests indicated their compounds were more effective antitumor agents than those claimed in the examiner’s reference. However, the examiner issued a final rejection under the first paragraph of 35 U.S.C. § 112 (the utility requirement), concluding the applicants failed to disclose a specific disease for which the compounds could be used. Further, the examiner concluded the prior-art tests were insufficient to establish a reasonable expectation that the compounds had the practical utility of being used as antitumor agents in humans. The United States Patent and Trademark Office Board of Patent Appeals and Interferences affirmed the final rejection based entirely on the examiner’s reasoning. The applicants appealed.