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Revision of the Materiality to Patentability Standard for the Duty To Disclose Information in Patent Applications

The United States Patent and Trademark Office (Office or PTO) is proposing to revise the standard for materiality for the duty to disclose information in patent applications and reexamination proceedings in light of the decision by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit or Court) in Therasense, Inc. v. Becton, Dickinson & Co. Specifically, the Office is proposing to revise the materiality standard for the duty to disclose to match the materiality standard, as defined in Therasense, for the inequitable conduct doctrine. While Therasense does not require the Office to harmonize the materiality standards underlying the duty of disclosure and the inequitable conduct doctrine, the Office believes that there are important reasons to do so. The materiality standard set forth in Therasense should reduce the frequency with which applicants and practitioners are being charged with inequitable conduct, consequently reducing the incentive to submit information disclosure statements containing marginally relevant information and enabling applicants to be more forthcoming and helpful to the Office. At the same time, it should also continue to prevent fraud on the Office and other egregious forms of misconduct. Additionally, harmonization of the materiality standards is simpler for the patent system as a whole.

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Legacy system
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Current entry point
www.federalregister.gov/documents/2011/07/21/2011-18408/revision-of-the-materiality-to-patentability-standard-for-the-duty-to-disclose-information-in-patent (permanent link in the Federal Register, verified 2026-09-30)
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Published
2011-07-21
Document type
Proposed Rule
Source
USPTO documents published in the Federal Register (Federal Register API)(retrieved 2026-10-06)

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