Appeal No. 2005-2385
Application No. 09/485,045
conditions with which the protein is associated are disclosed; thus, there is
no "specific benefit in currently available form" to be derived from
detection of GDF-16 or inhibition of its activity.
With respect to enablement, the examiner argues that “one skilled in the art
clearly would not know how to use the claimed invention” “since the claimed invention is
not supported by either a specific or substantial utility.” Id., page 4. As evidence of lack
of utility and enablement, the examiner puts forth Massagué. The examiner argues,
Massagué (Ann. Rev. Biochem., 1998, vol. 67, pp. 753-791) teaches that
‘this family comprises a large number of.. . factors, each capable of
regulating a fascinating array of cellular processes.. .’ (p. 745). Even
those family members identified as GDFs have functions as varied as the
promotion of chondrogenesis and the inhibition of muscle growth (p. 755).
There is therefore no well-established utility for members of this family;
they are involved in many different processes and utility is specific to the
individual protein.
Answer, page 4.
On the other hand, appellants argue the utility for the claimed polynucleotide and
polypeptide sequence is present in the specification, as filed. Appellants argue (Brief,
page 5)
[t]he specification discloses that GDF-16 is a TGF-beta family member.
Based on this fact and the known activities of various TGF-beta family
members, a number of utilities were asserted for GDF-16 encoding
polynucleotides, [and] ... are supported by published literature. ... More
specifically, the specification discloses that a GDF-16 polynucleotide can
be utilized in detecting and diagnosing a cell proliferative disorder by
detecting an altered level of expression compared with that of a normal
cell (page 19, lines 3-10). Furthermore, the specification discloses that a
GDF-16 polynucleotide can be used to detect a close family member of
GDF-16 (page 7, lines 18-23).
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