Trilateral Project 24.1-Biotechnology 192

The assessment of the existence of an inventive step involving the selection of specific listed members of a genus does not turn solely on the number of members of the genus, but must be assessed in light of the remainder of the art. In any instance in which a prima facie case is made out that the claimed invention lacks an inventive step, this position may be overcome by a showing of unexpected results. An analysis must be conducted as to the reasonable, expected variation before a decision can be made as to whether any parameter, such as amount of material produced, is unexpected.