Appeal No. 1999-1413
Application 08/176,024
The state of the art to which the invention pertains is such that as of
this date passive immunization has not been used to prevent malaria in
humans and that there are no vaccines for active or passive immunization
that are accepted as being effective for prevention of P. vivax malaria.
Charoenvit et al. (Science 251) states that it has never been definitively
established in humans that circulating antibodies to the sporozoite of
Plasmodium can prevent infection. Furthermore, Harris et al. establishes
the use of monoclonal antibodies for in vivo human therapy is art-recognized
to be highly experimental and unpredictable to those of skill in the art. The
record contains no working examples relating to the use of the NVS3
antibody for treatment of P. vivax malaria in humans....
The invention has been exemplified using the monkey model.
However, the evidence obtained using the monkey model is not sufficient to
allow one of ordinary skill in the art to predict the ability to practice the
claimed invention for treatment of humans given that the monkey model used
to exemplify the claimed invention is not an art-accepted model which is
recognized as having a clear correlation with human efficacy for the
evaluation of agents for passive immunotherapy of malaria.
On the other hand, the appellants argue that proof of efficacy in humans is not
required, and that the monkey animal model tests disclosed in the specification are
accepted by experts in the field. Substitute Brief, pages 13-15.
The specification provides a working example demonstrating efficacy of the
claimed formulation in a nonhuman primate, the Saimiri monkey. Example 3, pages 13-
15. In addition, the Hoffman Declaration of record provides an expert opinion that “most
experts in the field consider this monkey model to be the most reliable system for
predicting what will occur in humans.” Hoffman Declaration, page 6. The Hoffman
Declaration also cites long-held knowledge in the art of passive immunotherapy for acute
malaria in human children. Hoffman Declaration, pages 4-5.
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