Trilateral Project 24.1-Biotechnology 158

(Case a)

Generally, novelty cannot be denied due to the fact that an amino acid sequence of polypeptide utilized as an epitope is one part of amino acid sequence of antigenic protein described in prior art document.

In this case, however, there is probability of lack of inventive step.

(Case b)

Similarly to the above-mentioned case a, an amino acid sequence of a polypeptide, which is useful as an epitope and has the same partial amino acid sequence with an antigenic protein described in the specification of a prior application, is not directly considered substantially identical.

However, when the entire amino acid sequence of viral antigen protein which is closely related to human diseases (for instance, the hepatitis virus) is described in the specification of a prior application, one can self-evidently infer that an epitope which can be used for diagnosis and detection of infections with the virus would exist in some part of this amino acid sequence even if there is no concrete description of the fragment representing a useful epitope for this antigen protein. Therefore, if an invention in a later application is defined in a comprehensive claim which includes any polypeptide fragment useful as an epitope for these amino acid sequences and has no concrete confirmation by way of a working example, etc., it is substantially identical to the sequence described in the specification of a prior application, in general.

However, since it would be difficult to provide an epitope useful for real detection and diagnosis, even on the current state of the art, a claimed polypeptide which is concretely confirmed useful as an epitope by way of a working example, etc. in the later application is not considered substantially identical unless there is concrete description of the polypeptide in the specification of a prior application.