Trilateral Project 24.1-Biotechnology 086

With respect to derivatives obtained by way of addition/deletion/substitution of the original nucleotide sequence clearly specified in a working example, where the term "addition/deletion/substitution" is clearly defined in the specification as implying that the derivatives have high identity (homology) with the original sequence, the enablement requirement is generally satisfied without concrete disclosure such as a working example, provided that the application is filed after common technical knowledge was established with regard to the method of making an addition, deletion and substitution to a nucleotide sequence coding a natural-occurring protein without losing the proteins functions and properties.

When the claimed invention is related to derivatives of a short sequence, it is very likely that the function would be lost through a modification of nucleotides. In such a case, the enablement requirement could not be generally satisfied.