DNA . . . ‘requires a precise definition, such as by structure, formula, chemical name, or
physical properties.’”. 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997).
Where a genus of DNAs was claimed, as here, the Lilly court noted that those skilled in
the art can “visualize or recognize the identity of the members of [a fully described]
genus” and held that “[a] description of a genus of DNAs may be achieved by means of
a recitation of a representative number of DNAs, defined by nucleotide sequence, falling
within the scope of the genus or of a recitation of structural features common to the
members of the genus, which features constitute a substantial portion of the genus.” Id.
at 1568, 43 USPQ2d at 1406.
The court clarified the Eli Lilly standard in Enzo Biochem, Inc. v. Gen-Probe Inc.,
323 F.3d 956, 964, 63 USPQ2d 1609, 1613 (Fed. Cir. 2002). The Enzo court adopted
the standard that “the written description requirement can be met by ‘show[ing] that an
invention is complete by disclosure of sufficiently detailed, relevant identifying
characteristics . . . i.e., complete or partial structure, other physical and/or chemical
properties, functional characteristics when coupled with a known or disclosed correlation
between function and structure, or some combination of such characteristics.’” Id. at
964, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
Finally, the court has made clear that other factors, including the level of skill in
the art, are relevant to whether a description satisfies § 112. See Capon v. Eshhar,
418 F.3d 1349, 1358-59, 76 USPQ2d 1078, 1085 (Fed. Cir. 2005) (“Precedent
illustrates that the determination of what is needed to support generic claims to
biological subject matter depends on a variety of factors, such as the existing
knowledge in the particular field, the extent and content of the prior art, the maturity of
the science or technology, the predictability of the aspect at issue, and other
considerations appropriate to the subject matter.”).
When we apply the appropriate legal standard to the facts of this case, we
conclude that the examiner’s rejection must be reversed. The claims are limited to
nucleic acids that hybridize under stringent conditions to SEQ ID NO:7 or that encode
polypeptides at least 95% identical to SEQ ID NO:8. Thus, the claimed nucleic acids
will necessarily have a high degree of structural similarity to SEQ ID NO:7; in other
words, SEQ ID NO:7 shares something like 95% of its structure with each of the
claimed nucleic acids.
Although the specification’s disclosure does not allow those skilled in the art to
know, without testing, which of the hybridizing or 95% similar sequences will encode a
polypeptide that shares hT2R61’s bitter taste receptor function, the specification
teaches numerous assays that can be used to make that determination. See pages 50-
65. The prior art Chandrashekar reference provides evidence that carrying out such
assays was within the level of ordinary skill. See pages 703-707.
Because the claimed nucleic acids share a large proportion of their structure with
SEQ ID NO:7 and because assays that are disclosed in the specification and apparently
routine to those skilled in the art can be used to distinguish between functional and
nonfunctional embodiments, we conclude that a person of ordinary skill in the art would
have recognized from the specification’s description that the inventors were in
possession of the claimed nucleic acids. The rejection of claims 158, 159, and 164-185
for lack of adequate written description is reversed.
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