The Utility Requirement of §101 Is Specific to the Claimed Invention
In a closely-watched case, the federal circuit denied patentability to expressed sequence tags ("ESTs") that lacked "specific and substantial utility" under §101. The disclosure of utilities generic to all ESTs was insufficient, particularly where none of those utilities had been demonstrated for the actual ESTs claimed. The decision calls into question the validity of potentially hundreds of earlier-issued EST patents that lack disclosure of a specific and demonstrable utility.
In In re Fisher, No. 04-1465 (Fed. Cir. September 7, 2005), the federal circuit affirmed the district court's rejection of a single claim directed to an EST as lacking utility under §101 and for noncompliance with the enablement requirement of §112.
An EST is a short nucleotide sequence that represents a fragment of a cDNA clone. When an EST is introduced into a sample containing a mixture of DNA, the EST may hybridize with a portion of DNA. Such binding shows that the gene corresponding to the EST was being expressed at the time of mRNA extraction. Fisher's `643 application is directed to purified ESTs that encode proteins and protein fragments in maize plants. At the time of filing, Fisher did not know the precise structure or function of either the genes or the proteins encoded for by those genes. Notwithstanding, the `643 application discloses seven uses for the claimed ESTs, including (1) as molecular markers for mapping the maize genome; (2) for measuring tissue levels of mRNA; (3) as providing a source for primers; (4) as identifiers for the presence or absence of a polymorphism; (5) for isolating promoters; (6) for controlling protein expression; and (7) for locating genetic molecules of other plants and organisms. The examiner rejected Claim 1 as lacking utility under §101 because the disclosed uses were not specific to the claimed ESTs (but instead were generally applicable to any EST), and because there was no known use for the proteins produced as final products resulting from processes involving the claimed ESTs.
Relying on Brenner v. Manson, the Board affirmed the rejection under §101 because the asserted utilities were considered to "insubstantial," particularly where the claimed ESTs were asserted as useful for isolating nucleic acid molecules of other plants and organisms, which themselves had no known utility. The Board also affirmed the enablement rejection as a corollary to the utility rejection under §101.
On appeal, the federal circuit affirmed, holding that that none of Fisher's seven asserted uses met the utility requirement of § 101 (requiring a "specific and substantial utility" under Brenner), defined as providing "a significant and presently available benefit to the public." According to the court,
the claimed ESTs act as no more than research intermediates that may help scientists to isolate the particular underlying protein-encoding genes and conduct further experimentation on those genes.
Neither of the asserted uses of identifying polymorphisms or isolating promoters (emphasized by Fisher) were considered to be sufficient under §101 because Fisher presented no evidence showing that the claimed ESTs had been used in either way. Similarly, there was neither disclosure in Fisher's application nor evidence in the record showing that any of the claimed ESTs were or could have been used successfully in any of the other ways described in the application. The court cited the MPEP utility guidelines which state that "[u]tilities that require or constitute carrying out further research to identify or reasonably confirm a `real world' context of use are not substantial utilities." MPEP § 2107.01. Because specific utility of the claimed invention had not been demonstrated, the federal circuit affirmed the rejections under §§101 and 112.
Dissenting, Judge Rader argued that the claimed ESTs do have utility as research tools that enable scientists to isolate the particular underlying protein-encoding genes and, e.g., as probes used to confirm that the gene corresponding to the EST was expressed in the sample tissue at the time of mRNA extraction. He argued that the incremental nature of research requires recognition that even small steps or failed steps provide valuable scientific information beneficial to society sufficient to give a viable research tool "utility" under § 101.
Please visit http://media.aplf.org/rm/20050912-public/Issue2005-44.pdf for a copy of the case for your reference.
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