3. Scope of enablement
The examiner also rejected claims 158, 159, and 164-185 under 35 U.S.C.
§ 112, first paragraph, on the basis that “the specification does not enable any person
skilled in the art to make and use the invention commensurate in scope with these
claims.” Examiner’s Answer, page 8. The examiner noted that these claims
“encompass polynucleotides encoding polypeptide variants of the polypeptide of SEQ
ID NO:8[;] i.e., substitutions, deletions or insertions.” Id., pages 8-9. The examiner
reasoned “the specification has failed to teach one of ordinary skill in the art which
amino acid substitutions, deletions or insertions to make that will preserve the structure
and function of the protein, that “no particular ligand has been disclosed to bind and
activate the protein, so the artisan would not know how to test variants for functionality,”
that the specification provides no working examples of T2R61 variants, and that the
prior art (including Chandrashekar) “recognizes the complexity, unpredictability, and
non-routine nature of the work involved in trying to assay functional T2R receptors. Id.,
pages 9-11. The examiner concluded that undue experimentation would be required to
make and use the claimed variants.
Appellant argues that the claimed genera are limited to nucleic acids with a high
degree of similarity to SEQ ID NO:7 or encoding a protein very similar to SEQ ID NO:8,
that such can be made or isolated routinely, and that the specification “provides
substantial information relating to T2R assays that would enable one skilled in the art to
screen these variant hT2R61 nucleic acid sequences and identi[f]y those variants that
are functional, i.e., bind the same bitter ligands which specifically interact with wild-type
hT2R61 polypeptide.” Appeal Brief, pages 25-27.
“[T]o be enabling, the specification of a patent must teach those skilled in the art
how to make and use the full scope of the claimed invention without ‘undue
experimentation.’” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed.
Cir. 1993). “That some experimentation may be required is not fatal; the issue is
whether the amount of experimentation required is ‘undue.’” In re Vaeck, 947 F.2d 488,
495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991). Whether the amount of experimentation
required is undue is determined by reference to the well-known Wands factors. See In
re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
In this case, we agree with Appellant that the examiner has not shown, by a
preponderance of the evidence, that practicing the full scope of the claims would have
required undue experimentation. The examiner’s position rests in part on the lack of
guidance in the specification regarding amino acids in T2R61 can be altered or deleted
without affecting its function.
It is true that the specification does not teach, in so many words, which amino
acids are critical to T2R61 function. However, the specification does provide substantial
guidance to those skilled in the art. The specification provides the nucleotide and amino
acid sequences shown in SEQ ID Nos:7 and 8, which correspond to human T2R61.
The specification also incorporates by reference the sequence comparison disclosed by
Adler.2 Adler provides a sequence comparison of twenty-three human, mouse, and rat
T2R amino acid sequences. The comparison does not include human T2R61 but the
examiner has given us no reason to think that a person skilled in the art could not apply
the same techniques used by Adler to the T2R61 sequence disclosed in the instant
specification.
Adler’s sequence comparison identifies each of the seven transmembrane (TM)
domains, and shows conserved regions between TM1 and TM2, between TM3 and
TM4, and between TM5 and TM6. By comparison, the regions between TM2 and TM3,
between TM4 and TM5, and between TM6 and TM7 are much less conserved. Such
2 Adler et al., “A novel family of mammalian taste receptors,” Cell, Vol. 100, pp. 693-702 (2000). Adler
was incorporated by reference into the specification. See page 8, lines 13-15.
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