Settling an unresolved issue in biotechnology patent law, the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. Patent and Trademark Office Board of Patent Appeals and Interferences (the Board) and denied a patent to expressed sequence tags (ESTs) for failure to meet the statutory requirements of utility and enablement. In re Fisher, Case No. 04-1465 (Fed. Cir. Sept. 9, 2005) (Michel, J.) (Rader, J., dissenting).
Fisher appealed a U.S. Patent and Trademark Office (UPSTO) final rejection based on lack of utility and lack of enablement of a claim directed to ESTs (which are short nucleotide sequences representing a cloned DNA fragment) to the Board. The claim at issue recites five ESTs, each corresponding to a maize gene for which neither the precise structure, the function nor the encoded proteins were known at the time of filing. Citing Brenner v. Mason, a U.S. Supreme Court case that affirmed the utility rejection for a claimed process of making a compound having no known use, the Board found a lack of either a specific or a substantial utility for each of the asserted uses and affirmed the final rejection.
Noting that Brenner v. Mason does not define the terms "specific" and "substantial," the Federal Circuit took the opportunity to clarify the two-pronged test for utility under 35 U.S.C. §101. The Court indicated that, to satisfy the "substantial" utility requirement, an asserted use must show that the claimed invention has a significant and presently available public benefit. Turning to the "specific" utility requirement, the Court explained an application must disclose a use which is not so vague as to be meaningless. Thus, in addition to providing a "substantial" utility, an asserted use must also show the claimed invention can provide a well-defined and particular benefit to the public. Applying these principles, the Court found the asserted utilities for ESTs met neither the substantial nor the specific test but were merely a starting point for further research, providing no presently available benefit. With regard to the "specific" utility requirement, the Court found Fisher had failed to assert any utilities distinguishing the claimed ESTs from the more than 32,000 ESTs disclosed in the application or any EST derived from any organism. The Court held that, absent identification of a function for the underlying protein-encoding genes, the claimed ESTs had not been researched and understood to the point of providing an immediate, well-defined, real-world benefit to the public meriting the grant of a patent.
In dissent, Judge Rader indicated ESTs are research tools that provide a cognizable benefit to society and "only the final step of a lengthy incremental research inquiry gets protection" under the majority holding.
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