The Fisher application was directed to ESTs that correspond to genes expressed in maize pooled leaf tissue at the time of anthesis (flower opening). The application taught that the ESTs could be used in a variety of ways, including (1) as a molecular marker for mapping the maize genome; (2) in microarray techniques to obtain information on gene expression in a tissue sample; (3) as a source of primers for PCR to duplicate the genes; (4) to identify the presence or absence of polymorphisms; (5) to isolate promoters by chromosome walking; (6) to control protein expression and (7) to locate genes of other plants and organisms.
The examiner of Fisher's patent application rejected the EST claims for lack of utility, following the rationale set forth in the Utility Guidelines. The Examiner noted that the suggested uses were applicable to any EST and that there was no known use for the encoded proteins. The Board of Patent Appeals and Interferences affirmed, finding that none of the suggested uses was specific or substantial.
The Federal Circuit upheld the Board decision, agreeing that the statute requires "a specific and substantial" utility. The court interpreted this requirement as meaning that the invention must be useful "in its current form, not that it may prove useful at some future date after further research."
Additionally, the utility must relate to "a well-defined and particular benefit to the public." The court reviewed the Patent Office's Utility Guidelines, and found that they comport with its interpretation of the statute's utility requirement.
Turning to the usefulness of Fisher's ESTs, the court noted Fisher's admission that "the underlying genes have no known functions." Although Fisher argued that should be irrelevant, the court disagreed. The court reasoned that, without knowledge of the corresponding gene's function, the ESTs are "objects upon which scientific research could be performed with no assurance that anything useful will be discovered in the end."
Although Fisher argued that the ESTs were akin to patentable research tools, such as a microscope, the court likened the ESTs to chemical compounds with no known use, which long have been held unpatentable.
The court reviewed each of Fisher's asserted uses, and found them all to be hypothetical. For example, there was no indication that the ESTs could be used to identify a polymorphism, or even that a relevant polymorphism exists. Likewise, there was no indication that the ESTs could be used to identify a corresponding gene in another plant or organism, or that such a corresponding gene exists, or has a useful function.
In sum, the court found that Fisher failed to prove that the ESTs could be successfully used in any of the seven ways suggested. The court also noted that the asserted uses were not specific, because any EST from any gene in the maize genome has the potential to perform any of the suggested uses.
The court concluded that granting Fisher a patent to the ESTs "would amount to a hunting license" because the ESTs were "only tools to be used along the way in the search for a practical utility." Simply put, without knowing the function of the corresponding genes, the ESTs do not provide "an immediate, well-defined, real world benefit to the public" that merits the grant of a patent.