Appeal No. 1999-1433
Application 08/453,852
the abstract. Bachwich further discloses that TNF and LPS act in an additive manner to
stimulate macrophages to produce more IL-1 than either substance alone. Id., p. 100,
lines 11-12.
The examiner argues that it would have been obvious to one of ordinary skill in
the art to “administer TNF to cause the release of IL-1 to elicit an immune adjuvant
response in mice against an antigen” because Staruch discloses that the adjuvant
effects of LPS are mediated through IL-1 and Bachwich discloses that TNF (and LPS)
stimulate the release of IL-1. Answer, p. 7. We disagree.
As we discussed above, in this case the burden is on the examiner to establish
that the applied prior art teaches or suggests that (i) TNF-" is an adjuvant, and
(ii) TNF-" exerts its adjuvant effect in an antigen-specific manner.
To that end, we find that (i) Staruch discloses that when IL-1 is administered to an
animal host in conjunction with BSA, IL-1 acts as an adjuvant to enhance the antibody
response to BSA, and (ii) Bachwich discloses that TNF stimulates IL-1 (and PGE2)
production by macrophages, in vitro. However, Bachwich does not characterize the
TNF-induced IL-1 release. Thus, what is missing from the applied prior art is a teaching
or suggestion that when TNF is administered to an animal host in conjunction with an
antigen, that TNF will act as an adjuvant and stimulate an enhanced immune response
to said antigen. Again, we find that the examiner has tried to compensate for this
deficiency in the teachings of references by shoving those components which are taught
therein and which are required to arrive at the claimed method into a black box. Answer,
12
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