Trilateral Project 24.1-Biotechnology 183

The prior art shows Y, a monoclonal antibody which binds to antigen A and the invention is directed to Y', a monoclonal antibody which binds to antigen A' which is novel but may have the same epitope as A because the antigens are closely similar.

The invention monoclonal antibody Y' would be anticipated by or would have been obvious over the prior art monoclonal antibody Y because since the antigens are so similar, they would have epitopes in common and the antibodies would be expected to bind to both antigens. The claimed antibody would be the same as or not patentably distinct from that of the prior art. The burden would then shift back to applicants to show a difference between the claimed antibody and that of the prior art. Such a showing would have to be commensurate with the scope of the claims.

If A' is a modified protein of antigen A and there is nothing in the application which makes it clear that the epitope is on the modified region of the antigen and is thus not contained in A, the same analysis as above would result. The antibody would be anticipated or obvious over that of the prior art because the antigens contain regions in common and thus identical or patentably indistinct antibodies would be produced from immunization with the antigens.