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…
Read MoreWhat 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…
Read MoreHow 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…
Read MoreDo applicants need to prove that required information was not readily attainable?
No, applicants are not required to prove that the requested information was not readily attainable. However, they are expected to make a good faith effort to obtain the information and conduct a reasonable inquiry when the information is requested. According to MPEP 704.12(b): “There is no requirement for the applicant to show that the required…
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