Appeal No. 2004-1346 Page 22
Application No. 08/971,338
nervous system are the support cells, GDF-1 will likely prove to be
of therapeutic benefit in the treatment of disease processes leading
to demyelination.
Many of the members of this superfamily, including GDF-1,
are also likely to be clinically useful for tissue repair and
remodeling. For example, the remarkable capacity of the bone
morphogenetic proteins to induce new bone growth … has
suggested their utility for the treatment of bone defects caused by
trauma, surgery, or degenerative diseases like osteoporosis….
A determination of the specific clinical settings in which
GDF-1 will be used as a diagnostic or as a therapeutic tool await
further characterization of the expression patterns and biological
properties of GDF-1 both under normal physiological conditions
and during disease states.
Consistent with the cited sections of appellant’s disclosure, the examiner
points out (Answer, page 8), “[t]he specification speculates on possible activities
of GDF-1[,] [n]one 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.” Now, with
evidence from a reference published a decade after appellant’s effective filing
date, appellant asserts that their prediction was correct. Specifically, the
“prediction” that a “second potential diagnostic use for GDF-1 is as an indicator
for the presence of developmental anomalies in prenatal screens for potential
birth defects … [and] may indicate the presence of structural defects in the
developing fetus.” Specification, bridging paragraph, pages 12-13. In our
opinion, appellant’s specification cannot be stretched this far. As the examiner
explains (Answer, page 21), Rankin uses “information, materials, assays, and/or
techniques that were not known at the time of the invention and thus make clear
that one of ordinary skill in the art trying to determine what activity GDF-1 had at
the time of the invention would have been required to go beyond routine
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