sequence comparisons provide guidance to those skilled in the art regarding what
regions of the T2R proteins are likely to be required for function: changes in conserved
regions are more likely to disrupt function of the protein than changes in non-conserved
regions. Thus, Adler guides a skilled worker to areas of T2R61 that are likely to be
tolerant of amino acid changes.
The specification also discloses assays for determining whether a T2R61 variant
retains the activity of the wild-type protein. See pages 50-65 (discussing numerous
assays to test for binding of a T2R receptor to putative taste modifiers). Chandrashekar
provides evidence that such assays identify functional bitter taste receptors. See the
abstract: “[W]e use a heterologous expression system to show that specific T2Rs
function as bitter taste receptors. A mouse T2R (mT2R-5) responds to the bitter tastant
cycloheximide, and a human and a mouse receptor (hT2R-4 and mT2R-8) responded to
denatonium and 6-n-propyl-2-thiouracil.”
Finally, Appellant has presented post-filing evidence, which the examiner has
considered (Examiner’s Answer, page 17), that confirm that the methods disclosed in
the specification demonstrate that hT2R61 intereacts with several compounds that elicit
a bitter taste. See the evidence attached to the Appeal Brief as Exhibit 3.
On the facts of this case, we must agree with Appellant that the examiner has not
adequately explained why practicing the full scope of the claims would have required
undue experimentation. The prior art, which was incorporated by reference into the
specification, provides substantial guidance with respect to the direction the
experimentation should proceed. The process of making and assaying mutated
proteins would appear to be routine, if tedious, experimentation. The claims are limited
to variants having 5% or less variation compared to SEQ ID NO:8 and those hybridizing
to SEQ ID NO:7 under stringent conditions. In view of these factors, we cannot say that
the examiner has shown nonenablement by a proponderance of the evidence. The
rejection of claims 158, 159, and 164-185 for lack of enablement is reversed.
4. Written description
The examiner also rejected claims 158, 159, and 164-185 under 35 U.S.C.
§ 112, first paragraph, on the basis that “the claims encompass polynucleotides not
described in the specification, e.g., mutated sequences, allelic variants, or sequences
that have a recited degree of identity. None of these sequences meet the written
description provision of 35 U.S.C. § 112, first paragraph.” Examiner’s Answer, page 12.
The examiner reasoned that
[t]he specification has not provided a particular essential feature, either a
functional or structural feature, that the claimed genus of polynucleotides
possess. The recitation of the property of hybridization does not, alone,
provide sufficient information regarding the structure of the claimed
polynucleotide variants. Further, most of these variants are expected to
encode polypeptides having an amino acid sequence different than that of
SEQ ID NO:8 and thus having different structural and functional
properties.
The examiner “‘bears the initial burden . . . of presenting a prima facie case of
unpatentability.’ In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir.
1992). Insofar as the written description requirement is concerned, that burden is
discharged by ‘presenting evidence or reasons why persons skilled in the art would not
recognize in the disclosure a description of the invention defined by the claims.’” In re
Alton, 76 F.3d 1168, 1175, 37 USPQ2d 1578, 1583 (Fed. Cir. 1996).
Several recent decisions of the U.S. Court of Appeals for the Federal Circuit have
addressed the written description of inventions involving DNA. In University of
California v. Eli Lilly and Co., the court held that “[a]n adequate written description of a
Page: Previous 1 2 3 4 5 6 7 8 Next
Last modified: November 3, 2007