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Insufficient Written Description Under Representative Number of Species Test Where Only One Species Was Identified

October 30, 2008

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Last Month at the Federal Circuit - November 2008

Judges: Michel, Mayer, Stearns (author and District Judge sitting by designation)

[Appealed from: Board]

In In re Alonso, No. 08-1079 (Fed. Cir. Oct. 30, 2008), the Federal Circuit affirmed the Board’s decision sustaining the examiner’s rejection of claim 92 of U.S. Patent Application No. 08/469,749 (“the ’749 application”) for lack of adequate written description.

Claim 92 of the ’749 application was directed to a method of treating neurofibrosarcoma, a rare cancer of the sheath of a peripheral nerve, using human monoclonal antibodies targeted to a patient’s tumor. In Example 1, the ’749 application described preparing a tumor cell suspension from a tumor sample, sensitizing human spleen cells with the tumor cells, fusing the sensitized spleen cells with a cell line to create hybridomas, and screening for hybridomas that secrete monoclonal antibodies specifically reactive to the tumor cells. Example 2 of the ’749 application further described treating a patient with neurofibrosarcoma using monoclonal antibodies obtained by this method using cells isolated from the patient’s own tumor.

The examiner rejected claim 92 as lacking adequate written description support for the broad genus of antibodies encompassed by the claim language. The Board affirmed the rejection, finding the single antibody described in the specification to be insufficiently representative to provide adequate written description support for the genus of antibodies claimed. The Court also noted that the Board relied on two scientific articles that confirmed the hypothesis that the antibodies required to perform Alonso’s claimed method vary substantially in their composition.

The Court found that the Board’s factual findings for lack of written description were supported by substantial evidence. The Court relied on its previous holding in Noelle v. Lederman, 355 F.3d 1343, 1350 (Fed. Cir. 2004), 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.” Slip op. at 7. The Court also found that Alonso failed to distinguish the facts of University of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2002), by arguing that he had reduced his method to practice and identified the resulting compound. The Court stated 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.” Slip op. at 8. The Court also dismissed Alonso’s argument that the Board’s findings as to the sufficiency of description and enablement were at odds since the Board had reversed the examiner’s rejection of claim 92 for lack of enablement. The Court restated that, while the written description and enablement requirements usually rise and fall together, each serves discrete legal requirements, and that an invention may be enabled even though it has not been described.

The Court also noted that the specification of the ’749 application does not characterize the antigens to which the monoclonal antibodies must bind, and only discloses the molecular weight of the one antigen identified in the specification. The Court further stated that the specification taught nothing about the structure, epitope characterization, binding affinity, specificity, or pharmacological properties common to the large family of antibodies implicated by the method. Relying on prior written description case law, the Federal Circuit held that this was insufficient.

Alonso also argued that there was a well-known correlation between the structure and function of the antibodies generated by the treatment method described in the ’749 application. However, since Alonso did not raise the structure-function correlation argument in the proceedings before the Board, the Federal Circuit did not consider the argument on appeal.