Appeal No. 2004-1369 Page 17
Application No. 08/966,233
biological properties of GDF-1 both under normal physiological conditions and
during disease states.” See also, Answer, page 20, wherein the examiner points
out that Akhurst teach that “it is essential that more functional studies are carried
out” to manipulate TGF-β isoform expression or isoform function. See Akhurst
page 165. Accordingly, we agree with the examiner that, at best, Akhurst
“supports the examiner’s position that further research would be required to
reasonably determine or confirm any activity or involvement of GDF-1 in
embryogenesis.” Answer, page 20.
In addition, we note that Akhurst identify several activities in which TGF-β
may be involved in mammalian embryogenesis. By way of example we note the
following activities taught by Akhurst, and the respective transforming growth
factor isoforms associated with each activity:
1. Haematopoiesis: Akhurst, page 157, endnotes omitted, wherein
Akhurst point out that “[s]ince TGFβ1 is known to be a potent
inhibitor of haematopoiesis…, it is likely that this growth factor acts
as an autocrine negative regulator of cell growth. … Neither
TGFβ2 or β3 RNAs have been detected in haematopoietic tissue of
mouse or man….”
Appellant has not identified on this record whether GDF-1 exhibits
TGFβ1, TGFβ2 or TGFβ3 activity.
2. Vascularization and Angiogenesis: Akhurst, page 157, endnote
omitted, wherein Akhurst point out that “[t]he endothelial cell
response to TGFβ is clearly isoform-specific in vitro. Though
TGFβ1 is a potent growth inhibitor of this cell type, at physiological
concentrations, TGFβ2 shows no such activity.
Appellant has not identified on this record whether GDF-1 exhibits
TGFβ1 or TGFβ2 activity.
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