activate or inhibit the polypeptides,” but concluded that “[t]hese proposed uses lack a
substantial utility, because each of the proposed uses are of a general nature.” Id.,
page 5.
Appellant argues that the evidence of record supports the specification’s
assertion that SEQ ID NO:8 is a bitter taste receptor. See the Appeal Brief, pages 11-
15. Appellant also argues that “most significantly, and as correctly disclosed in the as-
filed application, the subject T2R nucleic acid sequences, based in their reasonably
anticipated . . . functionality as bitter taste receptors can be used in high throughput
screens to identi[f]y compounds which modulate the activity of this receptor.” Id., page
20.
The U.S. Court of Appeals for the Federal Circuit recently addressed the utility
requirement in the context of a claim to DNA. See In re Fisher, 421 F.3d 1365, 1371,
76 USPQ2d 1225, 1229 (Fed. Cir. 2005). The Fisher court held that § 101 requires a
utility that is both substantial and specific. Id. at 1371, 76 USPQ2d at 1229. A
substantial utility is one that “show[s] that an invention is useful to the public as
disclosed in its current form, not that it may be useful at some future date after further
research. Simply put, to satisfy the ‘substantial’ utility requirement, an asserted use
must show that that claimed invention has a significant and presently available benefit
to the public.” Id., 76 USPQ2d at 1230.
A specific utility is one “ which is not so vague as to be meaningless.” Id. In
other words, “in addition to providing a ‘substantial’ utility, an asserted use must show
that that claimed invention can be used to provide a well-defined and particular benefit
to the public.” Id.
When we apply the standards set out in Fisher to the facts of this case, we
conclude that the examiner’s rejection must be reversed. As we understand it, the
examiner does not dispute that the protein encoded by the claimed nucleic acids is a
bitter taste receptor, but contends that those skilled in the art could not use the protein
for any specific and substantial way without first knowing what compounds were bound
by it.
We find this position untenable. The specification discloses that the T2R61
protein can be used in screening assays to identify compounds that bind the protein.
Given the undisputed characterization of the protein as a bitter taste receptor, it seems
reasonable to expect that some of those compounds would be antagonists that would
block the perception of bitter taste by the receptor. As Chandrashekar1 put it, “the
identification of human bitter taste receptors makes it possible to use high-throughput
screening strategies to identify bitter taste antagonists, and in a small but significant
way, eliminate bitterness from the world.” Page 710.
This utility is disclosed in the specification (see page 9) and relied on in the
Appeal Brief (see page 20). It also seems to us to be a “substantial” and “specific”
utility, as defined by the Fisher court: identifying compounds that can block the bitter
taste of foods or medicines would seem to provide a significant, presently available, and
well-defined benefit to the public.
The examiner bears the initial burden of showing that a claimed invention lacks
patentable utility. See In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed.
Cir. 1995). In this case, however, the examiner’s explanation of the rejection
(Examiner’s Answer, pages 4-8) does not address this asserted utility. The examiner’s
reasoning does not persuade us that the disclosed utility is inadequate to meet the
requirements of 35 U.S.C. § 101. We therefore reverse the rejections under 35 U.S.C.
§§ 101 and 112, first paragraph, based on lack of utility.
1 Chandrashekar et al., “T2Rs function as bitter taste receptors,” Cell, Vol. 100, pp. 703-711 (2000).
Chandrashekar was incorporated by reference into the specification. See page 8, lines 14-15.
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