In an interesting decision in the biotechnology area, the Court of Appeals for the Federal Circuit recently held that certain nucleic acid sequences had no utility and were not enabled. In re Fisher (Fed. Cir., September 7, 2005).
The owner of the patent at issue is the biotechnology giant, The Monsanto Company. The patent application claimed five purified nucleic acid sequences known as expressed sequence tags (ESTs) that encode certain proteins in maize plants. Although the inventors identified the ESTs, they did not know the function of the genes or the proteins. The application described several uses for the ESTs, including gene mapping in maize, providing primers to use in polymerase chain reaction processes to duplicate genes, determining the presence of polymorphisms, isolating promoters, controlling gene expression, and locating genes in other plants.
The examiner rejected the claim under 35 U.S.C. ��101 on the grounds the ESTs had no specific and substantial utility. The examiner found that the uses described by Monsanto were not specific as they were no different from the uses of any EST, and were not substantial as the proteins encoded by the ESTs had no identifiable function. The examiner also rejected the claim on the grounds that it was not enabled under 35 U.S.C. ��112, first paragraph, finding that the application could not teach how to use the ESTs because they had no specific and substantial utility. Continue Reading How Useful is Useful