Appeal No. 2005-0410
Application No. 09/902,461
skill in the art with knowledge of the invention in suit, when no prior art reference or
references of record convey or suggest that knowledge, is to fall victim to the insidious
effect of a hindsight syndrome wherein that which only the inventor taught is used
against its teacher”).
Third, although we find no motivation to combine the teachings of Fuller and
Bijvoet to arrive at the claimed invention, we also point out that the assays disclosed in
the applied prior art, do not appear to provide one of ordinary skill in the art a
reasonable expectation of success in treating human GSD-II patients. Fuller only
discloses in vitro studies with cultured fibroblasts and skeletal muscle cells taken from
GSD-II patients. Although the studies look promising, no follow-up testing using art-
recognized animal models is reported. Bijvoet, on the other hand, tests the
recombinant enzymes produced in transgenic mice and CHO cells in what is said to be
an art-recognized animal model for the severe infantile form of human GSD-II (viz.,
GSD-II knock-out mice). Bijvoet, p. 1819, col. 2, lines 3-8. However, Bijvoet only
administers a single intravenous dosage of the enzymes to 8- and 16- week old mice.
The mice were sacrificed two days later. Bijvoet reports finding increased levels of
human acid "-glucosidase in the liver and spleen, as well as “significant” levels in
heart, skeletal muscle and other organs. Id., lines 11-15. However, Bijvoet did not
continue the studies to ascertain whether the treatment had any beneficial effects on the
mice. Thus, given the limited results from Bijvoet’s experiments, we cannot conclude
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