When is a regulatory review period determination considered final?

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

A regulatory review period determination is not considered final until all due diligence petitions and informal hearings, if any, have been resolved. This is important because the USPTO cannot issue a certificate for extension of the term of a patent until the regulatory review period determination is final, unless an interim extension is warranted under specific circumstances.

MPEP 2757 clearly states: “The regulatory review period determination is not final until due diligence petitions and informal hearings, if any, have been resolved. A certificate for extension of the term of a patent may not issue from the Office until the regulatory review period determination is final unless an interim extension appears warranted under 35 U.S.C. 156(d)(5) and (e)(2).“