Appeal No. 2004-1369 Page 14
Application No. 08/966,233
characterization of the expression patterns and biological properties of GDF-1
both under normal physiological conditions and during disease states.”
After what appears to be a comprehensive review of appellant’s
disclosure, the examiner finds (Answer, page 15),
the specification does not enable using GDF-1 in any capacity
without undue experimentation. Again, the specification is an
invitation to experiment without clear direction or guidance as to the
particular biological activity to investigate. Embryogenesis and
mediation of cell differentiation are broad areas of basic research.
No tumors nor developmental defects are identified as being
associated for any screening or diagnostic methods. No normal or
abnormal levels for GDF-1 are disclosed in the specification for any
cell type or tissue. No direction or guidance as to particular known
tumors or known developmental defects to be investigated are
provided.
In response, appellant presents several different arguments. We take
each argument in turn.
I. TGF-β activity varies quite widely:
Appellant asserts (Brief, bridging paragraph, pages 7-8) that the examiner
provides no documentary evidence to support the assertion that the activities of
the members of the TGF-β superfamily “vary quite widely” and that some
members of the superfamily have diverse activities in embryonic development
while others have no role in development.
In response, the examiner finds (Answer, page 19), “[a]ppellant relies
upon Akhurst et al.” With reference to page 164-165 of Akhurst, the examiner
finds (Answer, page 20), Akhurst teach “the evidence would suggest that each
isoform of TGF-β (i.e. TGF-β1, TGF-β2, and TGF-β3) has a distinct function in
vivo.” Further, the examiner notes (Answer, page 6) that appellant’s own
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