Trilateral Project 24.1-Biotechnology 179

When the whole amino acid sequence of the viral antigenic protein is publicly known, obtaining any partial polypeptide fragment of the whole antigenic protein is within the range of ordinary creative ability which is commonly displayed by a person skilled in the art, because it can be easily prepared by using genetic engineering method or peptide synthesis.

Also, if there is well-founded reason that some parts of the viral antigenic protein would be useful as an epitope for analysis and diagnosis of the infection by the infectious virus with immunoassay, the search for the effective sites as the epitope on the viral antigenic protein is a problem which can be easily come up with by a person skilled in the art. The inventive step generally cannot be recognized for an invention which merely provides a polypeptide fragment useful for an epitope, because the advantageous effect of the fragment is no more than what can be expected by a person skilled in the art.

However, when the specification discloses that a specific claimed partial polypeptide fragment is suitable in particular for an epitope or has different effect, and the effect is either qualitatively different from that of prior art or qualitatively homogeneous but quantitatively superior, and a person skilled in the art cannot expect this effect on the basis of the state of the art as of the filing, inventive step is present.