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DOC/PTO RIN: 0651-AC58 Publication ID: Fall 2019 
Title: Revision of the Duty to Disclose Information in Patent Applications and Reexamination Proceedings 
Abstract: The United States Patent and Trademark Office (Office or PTO) is revising 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) in Therasense, Inc. v. Becton, Dickinson & Co, 649 F.3d 1276 (Fed. Cir. 2011) (en banc). Specifically, the Office is revising the materiality standard for the duty to disclose information to match the "but-for" materiality standard for inequitable conduct as set forth in Therasense. The Office is also incorporating an explicit reference to "affirmative egregious misconduct." The materiality standard set forth in Therasense should reduce the frequency with which applicants and practitioners are being charged with inequitable conduct, consequently improving the disclosure practice before the Office by reducing the incentive to submit information disclosure statements containing marginally relevant information and enabling applicants to be more forthcoming and helpful to the Office. Additionally, harmonization of the materiality standards is simpler for the patent system as a whole. 
Agency: Department of Commerce(DOC)  Priority: Info./Admin./Other 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Not subject to, not significant 
CFR Citation: 37 CFR 1.555    37 CFR 1.56   
Legal Authority: 35 U.S.C. 2(b)(2)   
Legal Deadline:  None
Action Date FR Cite
NPRM  07/21/2011  76 FR 43631   
NPRM Comment Period End  09/19/2011 
Second NPRM  10/28/2016  81 FR 74987   
Second NPRM Comment Period End  12/27/2016 
Final Rule  06/00/2020 
Final Rule Effective  08/00/2020 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Raul Tamayo
Department of Commerce
Patent and Trademark Office
600 Dulany Street, P.O. Box 1450,
Alexandria, VA 22313
Phone:571 272-7728
Fax:571 273-7728