Appeal No. 2005-2121 Page 5
Application No. 09/745,605
the alleged uses. . . . Nothing about Fisher’s seven alleged uses set the five claimed
ESTs apart from the more than 32,000 ESTs disclosed in the ‘643 application or indeed
from any EST derived from any organism. Accordingly, we conclude that Fisher has only
disclosed general uses for its claimed ESTs, not specific ones that satisfy § 101.” Id.
The examiner notes that “the specification fails to disclose any particular function
or biological significance” for APEX-1. Answer, page 4. Appellants argue that APEX-1 “is
homologous to the CD2 subfamily, which is well-characterized as having utility with
respect to leukocyte proliferation, differentiation, migration and activation, and diseases
associated therewith” (Brief, pages 7-8), and “homology to a molecule with known utility is
acceptable for establishing Section 101 utility” (id., page 8). Nevertheless, the examiner
argues that the specification does not disclose the degree of homology between APEX-1
and any particular member of the CD2 subfamily, and in any case, “[a]ssignment to this
family does not support an inference of utility because the members are not known to
share a common utility” (Answer, page 16). That is, “no activit[ies] [are] known to be
common to all members of the CD2 subfamily[,]” and “there is no evidence that the . . .
APEX-1 polypeptide would share any one of those different activities” (id., page 15). The
examiner concludes that “[t]he instant claims are drawn to a nucleic acid encoding a
polypeptide of as yet undetermined function or biological significance” (id., page 5),
without an “immediately apparent or ‘real world’ utility as of the filing date” (id.).
With respect to appellants’ assertion that APEX-1 is useful “for diagnosing . . . a
disease associated with the presence or absence of the APEX protein” (Specification,
page 47), the examiner notes that “the specification does not disclose a nexus between
any specific disease states and a change in the amount or form of APEX genes” (Answer,
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