Appeal No. 2004-1369 Page 13
Application No. 08/966,233
[t]he protein products lack patentable utility for the reasons set forth
below; therefore, the methods of producing the protein and vectors
and hosts used therefore to make these protein products must also
lack patentable utility.
The specification and claims disclose using the nucleic acid
sequence encoding GDF-1 to produce GDF-1 proteins.
According to the examiner (Answer, page 8),
[t]he specification speculates on possible activities of GDF-1. None
of the particular activities disclosed for other TGF-β superfamily
members have been demonstrated for this protein in the
specification and none were known at the time of the invention.
None of the uses set forth in the specification could be practiced at
the time of the invention without undue experimentation. Providing
a laundry list of potential uses [as set forth in appellant’s
specification], some of which are diametrically opposed to each
other, is not deemed to be enabling.
To emphasize the “laundry list” of potential uses set forth in appellant’s
specification the examiner reproduces portions of appellant’s disclosure found at
pages 1, 2, 12-15, and 20 into the answer. See Answer, pages 9-14. For
example, the portions of appellant’s specification reproduced by the examiner
identify several potential uses for GDF-1 including, inter alia, “as a specific
marker for the presence of tumors arising from cell types that normally express
GDF-1” (specification, page 12; Answer, page 11); “as an indicator for the
presence of developmental anomalies in prenatal screens for potential birth
defects” (id.); and “in prenatal screens for genetic diseases that either directly
correlate with the expression or function of GDF-1 or are closely linked to the
GDF-1 gene” (specification, page 13; Answer, page 12). Nevertheless, despite
the assertion of “potential uses for GDF-1” appellant admits (specification, page
14; Answer, page 13), “[a] determination of the specific clinical settings in which
GDF-1 will be used as a diagnostic or as a therapeutic tool await further
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