Appeal No. 1997-4275
Application No. 08/253,217
and an antibody to lipopolysaccharide (LPS) which is useful for treating and preventing
sepsis in patients with bacterial infections.
The rejection under 35 U.S.C. § 103(a)
The appealed claims stand rejected under 35 U.S.C. § 103(a) as being obvious
over the combined teachings of Ziegler and Beutler.
The examiner relies on Ziegler as describing the use of anti-LPS antibody for the
treatment of gram negative bacteremia and shock, which is sepsis. (Answer, page 3).
Appellants do not dispute the examiner’s interpretation of the Ziegler reference.
The examiner relies on Beutler as teaching (Answer, page 5):
that anti-TNF antibody protects mice from the lethal effects of
endotoxin LPS produced by E.coli. Beutler et al. teach that
TNF is produced in vivo and in vitro in response to LPS
challenge (page 869, col. 3). Therefore, they passively
immunized mice with anti-TNF antibody and challenged the
mice with lethal doses of LPS. They were able to demonstrate
that the LD of LPS in mice treated with the immune serum
50
was significantly higher than the LD for the control mice (Fig.
50
3) and this shift was dose dependent (Table 1). Beutler et al.
concluded that a role of TNF was to mediate the lethal effects
of LPS because mice that were injected with anti-TNF
antibody prior to the administration of LPS fared better than
those passively immunized at the moment LPS injection or
thereafter (page 871, col. 1).
The examiner does not argue that either reference explicitly describes or suggests
a combination of an antibody to TNF and an antibody to bacterial LPS or the use of such a
combination to treat sepsis in a human, as presently claimed.
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