Trilateral Project 24.1-Biotechnology 092

If the claimed DNA of this type is not characterized by function, the claim clearly includes DNAs which do not satisfy the requirement for utility. In such a case, the enablement requirement is not satisfied.

If the rate of identity (homology) is low, a very large number of sequences different from the original DNA sequence are included in the sequences characterized by the identity (homology) even when the claimed DNA is further characterized by function as mentioned in 1.1.1.2.1(1). It is unlikely that each of these DNA sequences could encode proteins having the same activity. Therefore, it would be difficult for a person skilled in the art to obtain DNA sequences which could encode proteins having the same activity as the protein encoded by the original DNA, among a very large number of sequences as mentioned above, without undue experimentation.

Judgement on the degree of identity (homology) depends on its definition.