Appeal No. 1999-1413
Application 08/176,024
antibody in the context of an analytical tool. Harlow, the secondary reference, states that
when preparing a PBS solution of monoclonal antibodies in the laboratory, “[i]f there is no
reason to avoid the use of sodium azide, add to 0.02%”. Harlow, page 287. In our view,
neither reference, however, provides any reason for one of ordinary skill in the art to avoid
the use of sodium azide in preparing a monoclonal antibody solution, such as for preparing
a composition for use in vivo.
The diagnostic use of a monoclonal antibody as described by McCutchan 1 and 2,
in view of Harlow, would reasonably appear to have suggested that sodium azide be used
in preparing such monoclonal antibody solutions. Therefore, taking the teachings of the
references in their entirety, the references as a whole would have suggested to one of
ordinary skill in the art a composition comprising a monoclonal antibody, PBS and sodium
azide in an antibody solution, leading to a solution which is not a pharmaceutically
acceptable formulation, as claimed. Moreover, we find no evidence of record suggesting
the use of, or supporting a reasonable expectation of success for the use of the
monoclonal antibody for preparation of a pharmaceutical formulation for passive
immunization against P. vivax. Therefore, we will not sustain the rejection of the claims for
obviousness.
CONCLUSION
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