In a decision that appears to conflict with the Court's own precedent, the U.S. Court of Appeals for the Federal Circuit recently tightened the written description requirement of 35 U.S.C. § 112, first paragraph, as it is applied to biotechnology inventions. In Re Kenneth Alonso, Case No. 08-1079 (Fed. Cir., Oct. 30, 2008) (Stearns, D.J., sitting by designation).
The claimed invention recites a method for treating neurofibrosarcoma, a rare cancer of the sheath of a peripheral nerve, by administering an effective amount of a monoclonal antibody idiotypic to the neurofibrosarcoma and further recites that the monoclonal antibody is secreted from a human-human hybridoma derived from the neurofibrosarcoma cells. The specification exemplified the preparation of a tumor cell suspension from the sample of a tumor and the subsequent sensitization of human spleen cells. The results of treating a patient with neurofibrosarcoma with monoclonal antibodies against a 221 kD tumor surface antigen from a hybridoma obtained by sensitizing adult spleen cells from the patient's tumor. The examiner rejected the claim for lacking adequate written description support for the broad genus of antibodies encompassed by the claim language. The Board of Patent Appeals and Interferences (the Board) reversed the examiner's rejection of the claim for lack of enablement, but sustained the rejection for lack of adequate written description, agreeing with the examiner that the single antibody described in the specification is insufficiently representative to provide adequate written descriptive support for the genus of antibodies required to practice the claimed invention. Alonso appealed.
Applying a substantial evidence standard of review, the Federal Circuit agreed that "the one compound disclosed by Alonso cannot be said to be representative of a densely populated genus." The court noted that it held in Noelle that a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated. The Court also pointed to its precedent in University of Rochester, noting that it found a specification lacked written descriptive support where the inventors had neither possession nor knowledge of the claimed compound. The Federal Circuit rejected Alonso's argument that he reduced his method to practice and identified the resulting compound, stating that "while it is true that Rochester disclosed no compounds that worked with the claimed method, the one compound disclosed by Alonso cannot be said to be representative of a densely populated genus." The Court further noted that the specification discloses only the molecular weight of the one antigen identified in the example and teaches nothing about the structure, binding affinity or other properties "common to the large family of antibodies implicated by the method." Because Alonso failed to argue before the Board that there is a well-known correlation between the structure and function of the specific antibodies generated by his disclosed method, noting that the Court has found adequate written descriptive support for a claimed invention where the disclosure specifies relevant identifying characteristics, the Court refused to hear that argument on appeal. The Federal Circuit also affirmed the Board's enablement finding without elaboration, merely noting in a footnote that enablement and written description will often, but not always, stand or fall together.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
