Trilateral Project 24.1-Biotechnology 068

With respect to the enablement requirement, the initial burden of pointing out the reason of rejection is on the examiner, but the burden of proof (the burden of persuasion) is finally on the applicant throughout the prosecution.

Where the examiner gets convinced that it is more probable than not that an application constitutes a violation of enablement requirement, the examiner should send a notice for rejection by showing concrete reasons.

Against the reason for rejection, the applicant may argue or clarify by putting forth written arguments or certificates on the result of experiment, etc. The reason for rejection shall be overcome if the applicant's argument is confirmed to be adequate. Where the applicant's argument does not change the examiner's conviction at all or where it succeeds in denying the examiner's conviction only to the extent that truth or falsity becomes unclear, the examiner may make a decision of rejection on the ground of the notice for rejection which was earlier notified. (Implementing Guidelines I-1-3.2.3(4))