Trilateral Project 24.1-Biotechnology 105

In U.S. practice, no working example is required for enablement. The specification must contain a written description of the invention in clear, concise terms to allow one skilled in the art to make and use the claimed invention without an undue amount of experimentation. The question here would be whether or not one skilled in the art could reproducibly make the claimed monoclonal antibody without undue experimentation. The applicant in the specification must set forth the procedures for making such monoclonal antibody, and the Examiner in the PTO must accept the disclosure of the invention unless he or she has reason to doubt the objective truth of the statements contained in the specification. In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971). The PTO bears the initial burden of setting forth a reasonable explanation of why the scope of protection provided by the claim is not enabled by the specification's description of the invention. This burden includes providing reasons for doubting any assertions in the specification as to the scope of enablement. In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).

There is no general rule, and each application must be separately considered based on the disclosure provided and the particular antibody claimed. A generic monoclonal which specifically binds to a particular protein would be, in most cases, more easily enabled with the description of the antigen, enablement of the availability of antigen, and a description of the immunization procedures. Specific antibodies, however, with a particular binding pattern are more difficult to reproducibly manufacture. Because the mere description of their production may not allow one to follow the procedures as set forth in the specification and produce the exact monoclonal antibody being claimed, deposit of the hybridoma in an acceptable depository may be required for enablement.

A mere recognition of immunogenicity of a particular protein is not itself sufficient to provide enablement. It depends upon the fact of the case and the antibody being claimed, that is, whether it is a generic or specific antibody. The facts disclosed here, that the protein has a molecular weight greater than 10kDa, that the protein is not human, and that an antibody has been made successfully to another, very similar protein, would provide an expectation that antibodies could be made to this protein in the absence of evidence to the contrary. The exact antibody being claimed and it properties would have to be evaluated with this disclosure in order to determine whether or not it is enabled. A very specific antibody may not be enabled without a deposit of the hybridoma.