Appeal No. 1999-1433
Application 08/453,852
Here, we find that the examiner has not provided any explanation as to why it
would have required undue experimentation for one skilled in the art to make and use
the claimed invention. Nor does the examiner make any mention of the Wands factors.
Rather, we find that the examiner’s rejection consists only of an unsupported assertion
that the technique of inducing an immune response by administering a native
substance is not art-recognized. Answer, p. 5.
Accordingly, we reverse Rejection III.
III. The § 103 rejections
A. The rejection of claims 1, 2, 4 and 14 over Kato and Beutler or Kornbluth.
The examiner has premised her conclusion of obviousness on the teachings of
either Kato and Beutler, or Kato and Kornbluth. To that end we find:
1. Kato discloses that lipopolysaccharide (LPS) derived from
Klebsiella O3 is a strong adjuvant. Kato, p. 31, col. 1, lines 1-6. Kato .....
2. Beutler discloses that mice which are passively immunized with
anti-TNF antibody are protected against the lethal effect of the LPS endotoxin produced
by Escherichia coli. Beutler, p. 869, the abstract. Beutler reports that
These data give evidence for the role of cachectin/TNF in mediating the lethal
effects of LPS. Cachectin/TNF is clearly only one of the mediators responsible
for the numerous pathological effects evoked by LPS, since the passively
immunized mice become febrile, and continue to appear ill and distressed. It is
possible, for example that cachectin/TNF acts in concert with other mediators
(for example, interleukin-1, interferons, and lymphotoxin) in order to elicit the
lethal effect of LPS).
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