Appeal No. 2005-2121 Page 3
Application No. 09/745,605
and immune disorders” (id., page 54). Thus, according to appellants, detection of
APEX-1 or its RNA transcripts in abnormal amounts can be used to diagnose or monitor
the course of “a disease associated with the presence or absence of the [APEX-1]
protein” (id., pages 47 and 48). Similarly, the specification discloses that the present
invention can be used to treat disorders associated with abnormally decreased or
increased APEX-1 activity or expression (id., pages 54 and 55).
DISCUSSION
Utility
The examiner rejected claims 1-5 and 53-65 under 35 U.S.C. § “because the
claimed invention is not supported by either a specific and/or substantial utility or a well
established utility.” Answer, page 3. The claims stand or fall together. Appeal Brief,
page 4. We will focus on claim 1, which reads as follows:
1. An isolated nucleic acid molecule encoding APEX-1.
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) (“Only after the PTO provides evidence showing that one of ordinary skill in
the art would reasonably doubt the asserted utility does the burden shift to the applicant
to provide rebuttal evidence sufficient to convince such a person of the invention’s
asserted utility.”).
The U.S. Court of Appeals for the Federal Circuit recently addressed the utility
requirement in the context of a claim to an expressed sequence tag – a short nucleotide
sequence encoding a fragment of a protein expressed in a particular tissue, at a
particular point in time. See In re Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir.
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