Trilateral Project 24.1-Biotechnology 191

In this case, to create experimentally an optimal or suitable combination from promoters P1, P2, P3, P4, P5 ... , PM and hosts H1, H2, H3, H4, H5 ... HN would be normally considered lack of inventive step, as long as those combinations are within the range of ordinary creative ability which is commonly displayed by a person skilled in the art.

However, if the advantageous effect, which is achieved with the transformant obtained through this combination, is either qualitatively different from that of prior art, or quantitatively superior, even if the quality is the same, and when this effect cannot be expected by a person skilled in the art on the basis of the state of the art, inventive step is present.

In addition, this judgement does not usually depend on the number of M or N, but if the number of M or N is extremely small so that the number of the alternatives is very small, and if there is uncontestable reasoning that a person skilled in the art could have easily arrived at a claimed invention based on a cause or a motivation, inventive step is denied regardless of advantageous effects of a claimed invention.

On the other hand, depending on the extent of disclosure in said prior art, there would be a case that the optimal or suitable selection would be beyond the range of ordinary creative ability of a person skilled in the art.