Appeal 2007-2953
Application 10/175,749
2. UTILITY
Claims 25-32 and 35-37 stand rejected under 35 U.S.C. §§ 101 and
112, first paragraph, as lacking patentable utility. The Examiner finds that
“[t]he instant specification and the prior art do not teach how the polypeptide
of SEQ ID NO:74 functions or a specific and well-established utility for the
polypeptide of SEQ ID NO:74” (Answer 4).
The Examiner acknowledges the claim to priority to provisional
application 60/080,333 and the disclosure in that application that SEQ ID
NO:74 has homology to protein disulfide isomerase (PDI) proteins (id. at
4-5). The Examiner finds that “[b]ased on sequence homology to known
catalytic sites, the argument that the polypeptide of SEQ ID NO:74 is a PDI
family member and shares some function[al] characteristics with other PDI
family members is convincing” (id. at 8).
Nevertheless, the Examiner concludes that the provisional application
did not disclose any specific and substantial utility for the polypeptide of
SEQ ID NO:74. The Examiner summarizes the disclosed utilities as (1)
using the claimed polypeptide to treat “unspecified human disorders,” (2)
using the claimed polypeptide to identify molecules that will bind to it, and
(3) using the claimed polypeptide to raise antibodies for use in detecting or
purifying the polypeptide of SEQ ID NO:74 or as “therapeutics for
unspecified disorders” (Answer 8). The Examiner concludes that “[w]ithout
identifying a specific disorder, use of the claimed polypeptides . . . as a
therapeutic or diagnostic for an unspecified disorder characterized by protein
misfolding is not a specific or substantial use” (id. at 9).
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