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Disclosure of single antibody insufficient to describe genus of related antibodies

By McKee, Voorhees & Sease, P.L.C.

In a recent decision, the Federal Circuit affirmed the decision of the Board of Patent Appeals and Interferences sustaining in part the examiner's final rejection of the broadest claim in an application, directed to methods of treating neurofibrosarcoma using monoclonal antibodies.  The Board reversed the examiner's rejection of the claim for lack of enablement, but sustained the rejection for lack of adequate written description.  The Board agreed with the examiner that the single example provided of a functional monoclonal antibody for use in treatment and the method of its production did not provide sufficient support for the genus encompassing all such antibodies.

The Federal Circuit affirmed, finding the Board's conclusion supported by substantial evidence.  The question turned on the level of variability within the claimed genus.  There was evidence in the record that the species in the genus "would be expected to vary substantially," based on statements made in scientific literature (including one paper authored by the inventor).  As described by the court:

The specification of the '749 Application does not characterize the antigens to which the monoclonal antibodies must bind; it discloses only the molecular weight of the one antigen identified in Example 2. This is clearly insufficient.  The specification teaches nothing about the structure, epitope characterization, binding affinity, specificity, or pharmacological properties common to the large family of antibodies implicated by the method. While Alonso's claim is written as a method, the antibodies themselves are described in purely structural language – "a monoclonal antibody idiotypic to the neurofibrosarcoma of said human." This sparse description of antibody structure in the claim stands in stark contrast to the detailed method of making the antibodies found in the specification.

Accordingly, the court affirmed the rejection on written description grounds.

More detail of In re Alonso after the jump.

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Full post as published by FileWrapper on November 06, 2008 (boomark / email).