Appeal 2006-2945
Application 10/041,958
of the evidence favors the Examiner’s conclusion that it “would have been
further obvious to select antibodies against a single α or β subunit in view of
Perera[’s] . . . and Williams[’] demonstration of neutralizing monoclonal
antibodies against these specific subunits” (Answer 6).
Secondary evidence of non-obviousness:
Appellants direct our attention to several Declarations to demonstrate
that:
1. “neonatal gnotobiotic colostrum deprived piglets have a unique
potential as a model to evaluate prophylactic or therapeutic approaches
offering new advantages to prevent or lessen systemic complications of
EHEC (enterohemorrhagic E. coli)[ ] 3 infection in humans” (Gunzer
Declaration ¶ 5);
2. “the gnotobiotic piglet is the best model for evaluating therapies for
the prevention or treatment of tissue damage by STEC infection . . .” (Leong
Declaration ¶ 4); and
3. “piglets are the only model which can be used to determine the
therapeutic dose against the systemic effect of the Stx” (Tzipori Declaration
¶ 4). Nevertheless, Tzipiri declares that “[t]he exact injectable dose required
to establish this amount of antibody in the blood stream of human individual
[to be fully protected against the development of HUS] will be determined in
a dose-response study during phase I clinical trials” (Tzipori Declaration ¶
5).
3 According to Appellants’ Specification “enterohemorrhagic Escherichia
coli (EHEC), [are] now more commonly referred to as Shiga toxin
producing E. coli (STEC). . .” (Specification 2).
19
Page: Previous 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Next
Last modified: September 9, 2013