37 C.F.R. 1.765 Duty of disclosure in patent term extension proceedings.

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1. (d) The duty of disclosure pursuant to this section rests on the individuals identified in paragraph (a) of this section and no submission on behalf of third parties, in the form of protests or otherwise, will be considered by the Office. Any such submissions by third parties to the Office will be returned to the party making the submission, or otherwise disposed of, without consideration by the Office.

Although the statute specifically provides for public input into the determination of the regulatory review period, i.e., the filing of a due diligence petition before the regulatory agency, no such provision was made for proceedings before the Office. Since applicant already has a duty of disclosure to both the Office and the regulatory agency, and Congress expected that it would be an administratively simple proceeding, no input from third parties is permitted. Absent an invitation from the Director, any such submission would be inappropriate. Accordingly, 37 CFR 1.765(d) precludes submissions to the Office by or on behalf of third parties, thereby making patent term extension proceedings in the Office an ex parte matter between the patent owner or its agent and the Office. Submissions by third parties not requested by the Office will be returned, or otherwise disposed of, without consideration. See In re Dubno, 12 USPQ2d 1153, 1154 (Comm’r Pat. & Tm. 1989).