What sources of information are covered by the duty of disclosure under 37 CFR 1.56?

The duty of disclosure under 37 CFR 1.56 covers all material information that individuals are aware of, regardless of the source. This includes information from: Co-workers Trade shows Communications with competitors or potential infringers Related foreign applications Prior or copending U.S. patent applications Related litigation and post-grant proceedings Preliminary examination searches Information related to regulatory…

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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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What information from copending U.S. patent applications needs to be disclosed?

Individuals covered by 37 CFR 1.56 must disclose information about copending U.S. patent applications that are “material to patentability” of the application in question. This includes: Identification of pending or abandoned applications filed by at least one of the inventors or assigned to the same assignee Applications that disclose similar subject matter Prior art references…

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