Affirming a broad claim construction for claims directed to a nucleic acid molecule, the U.S. Court of Appeals for the Federal Circuit upheld a rejection by the U.S. Patent and Trademark Office (USPTO) that the claims were anticipated by earlier publications, which disclosed an uncharacterized form of the nucleic acid. In re Crish, Case No. 04-1075 (Fed. Cir., Dec. 21, 2004) (Lourie, J.).

Inventors Crish and Eckert (Crish) discovered the promoter region for the human involucrin gene (hINV). Their patent application claims purified DNA molecules having a specific nucleotide sequence and exhibiting promoter activity for hINV. The Board of Patent Appeals and Interferences (Board) affirmed the USPTO’s rejection that the application claims were anticipated by Crish’s earlier publications describing a molecule containing the hINV promoter region. The Board concluded that, although unsequenced, the prior art molecule necessarily possessed the same sequence as the molecules claimed in the application.

On appeal, Crish argued that the claims cannot be anticipated because the prior art references did not provide any information about the hINV promoter nucleotide sequence. Crish additionally argued, inter alia, that the prior art molecules do not necessarily contain the claimed nucleotide sequence because others have arrived at different sequences when using the same starting materials.

Affirming the USPTO’s claim construction that the claims can include hINV gene sequence additional to the recited promoter region fragments, the Federal Circuit held that the claims encompass the hINV promoter region plus other hINV gene nucleotides and are anticipated by the earlier publications describing the hINV gene which included its promoter region. Rejecting Crish’s argument based on lack of sequence information for the promoter region of the hINV gene, the Court pointed to a long line of precedent holding that the discovery of a new property for a known material does not make claims to a material reciting that property novel. The Court reasoned that the nucleotide sequence of the hINV gene is the identity of the gene’s structure, not merely one of its properties. The promoter region was not new because it had been known and used in the prior art publications, and the identification and characterization of the hINV promoter region similarly did not make it novel. The Court further rejected Crish’s argument that the molecules claimed in the application did not necessarily claim the sequences of the prior art molecules because the application claimed molecules that Crish previously disclosed. Crish was presumed to have sequenced his material correctly and evidence that others may have arrived at different results should not be relied on in lieu of his own work.

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