2000.01 Introduction [R-07.2022]

This Chapter deals with the duties owed toward the U.S. Patent and Trademark Office by each individual who is associated with the preparation or prosecution of the application. Each individual associated with the filing and prosecution of a patent application, supplemental examination, or patent reexamination has a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section. These duties, of candor and good faith and disclosure, have been codified in 37 CFR 1.56 and 37 CFR 1.555, as promulgated pursuant to carrying out the duties of the Director under Sections 2, 3, 131, and 132 of Title 35 of the United States Code.

In some instances, the duty to disclose may constitute correcting erroneous material information in the record. Effective September 16, 2012, the America Invents Act (AIA) amended the patent laws to modify notable aspects of the duty of disclosure. Specifically, the AIA eliminated the requirement that applicants disclose that an error in a patent (e.g., change in inventorship) was made without any deceptive intent before correction is permitted. See 35 U.S.C. 116, 35 U.S.C. 251, and 35 U.S.C. 256. This does not negate, however, the continuing obligation to practice candor and good faith in all dealings before the Office.

On October 28, 2016, the Office issued a Notice of Proposed Rulemaking proposing revisions to the materiality standard for the duty to disclose information in patent applications and reexamination proceedings (duty of disclosure) in light of the decision by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) in Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1288, 99 USPQ2d 1065 (Fed. Cir. 2011)(en banc). Specifically, the Office is considering harmonizing the materiality standard for the duty of disclosure to adopt the “but-for” materiality standard for inequitable conduct as set forth in Therasense and adopted in subsequent inequitable conduct cases, which will result in revisions to 37 CFR 1.56 and 37 CFR 1.555. While these proposed rule changes have not yet been finalized, it is still important for Office stakeholders to recognize the split in how materiality may be considered within the Office and in the courts. Some of the more instructive recent cases on inequitable conduct have been incorporated in the discussion below to provide guidance on compliance with the duty of disclosure regardless of the materiality standard.

On July 29, 2022, the Office issued a Federal Register Notice reinforcing the importance of “duty of disclosure” and “duty of reasonable inquiry”, and clarifying the scope of these duties as they relate to information and statements material to patentability including, but not limited to, those received from or submitted to the Food and Drug Administration (FDA) and other governmental agencies. These duties apply during examination of patent applications, including continuation applications, and after issuance during any post-grant examination or proceeding to review the issued patent. See Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board, 87 FR 45764 (July 29, 2022).