MPEP Q & A 336: Circumstances when relevant documentation should be submitted to regulatory review body.
Update: 2025-09-09
Description
Question:
When should relevant documentation submitted to a regulatory review body be submitted for the Office for review?
Answer:
Where relevant documentation is submitted to a regulatory review body, such as the U.S. Food & Drug Administration (FDA), and is material to any pending patent application or reexamination proceeding, such documentation should be submitted for Office review.
While the considerations made by the FDA for approving clinical trials are different from those made by the USPTO in determining whether a claim is patentable, submissions, particularly any assertion that is made which is contradictory to assertions made to the examiner, may be material to ongoing patent proceedings.
Chapter Details:
The answer to this question can be found in chapter 2000 of the MPEP. This chapter covers Duty of Disclosure.
The answer is from the 9th Edition, Revision 07.2022, Published February 2023. Depending on future changes to the MPEP, the question and answer may or may not be applicable in later Editions or revisions.
Section Summary:
This question and answer comes from section 2001.06(e) of the MPEP. The following is a brief summary of section 2001.06(e).
2001.06(e) Information Relating to Regulatory Review
Where relevant documentation is submitted to a regulatory review body, such as the U.S. Food & Drug Administration (FDA), and is material to any pending patent application or reexamination proceeding, such documentation should be submitted for Office review. While the considerations made by the FDA for approving clinical trials are different from those made by the USPTO in determining whether a claim is patentable, submissions, particularly any assertion that is made which is contradictory to assertions made to the examiner, may be material to ongoing patent proceedings.
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