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Single Species Does Not Provide Written Description Support For Genus


In In re Kenneth Alonso (No. 2008-1079; October 30, 2008), the Federal Circuit affirms a final decision of the USPTO Board of Patent Appeals and Interferences ("the Board") holding that appellant's method claim, which is directed to treating a neurofibrosarcoma in a patient by administering a monoclonal antibody targeted to the patient's tumor, is enabled but invalid for lack of written description.

The Board reversed the Examiner's rejection of appellant's method claim for lack of enablement but sustained the rejection based on lack of adequate written description. The Board determined that the single antibody described in appellant's specification is insufficiently representative to provide adequate written descriptive support for the genus of antibodies required to practice the claimed method. The Court agrees, stating that in addition to the "representative number of species" test applied by the Board, adequate written description may also be found where the disclosure specifies relevant identifying characteristics such as complete or partial structure or other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Although appellant argues that there is a well known correlation between the structure and function of the antibodies generated by his disclosed method, the Federal Circuit states that appellant did not raise the structure-function correlation argument during proceedings before the Board and therefore refuses to consider appellant's "newly minted" argument on appeal.

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