What are the duties of disclosure and reasonable inquiry in dealings with other government agencies?

Individuals with a duty to disclose or parties with a duty of reasonable inquiry must ensure consistency in statements made to the USPTO and other government agencies regarding claimed subject matter. The MPEP 2015 states: “Each individual with a duty to disclose, or party with a duty of reasonable inquiry, should ensure that the statements…

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What are the disclosure requirements for information related to regulatory review, such as FDA submissions?

Information submitted to regulatory review bodies, such as the U.S. Food & Drug Administration (FDA), may be material to pending patent applications or reexamination proceedings and should be disclosed to the USPTO. The MPEP states: “Where relevant documentation is submitted to a regulatory review body, such as the U.S. Food & Drug Administration (FDA), and…

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How should applicants respond if information remains unknown after a reasonable inquiry?

If information remains unknown after a reasonable inquiry, applicants can simply state that the requested information is either unknown or not readily available. There’s no need to distinguish between these two scenarios. MPEP 704.12(b) states: “Thus, if information remains unknown after a reasonable inquiry is made, applicant may simply reply that the requested information is…

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