37 C.F.R. § 1.56

Duty to disclose information material to patentability

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(a) A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section. The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration, or the application becomes abandoned. Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application. There is no duty to submit information which is not material to the patentability of any existing claim. The duty to disclose all information known to be material to patentability is deemed to be satisfied if all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by §§ 1.97(b)-(d) and 1.98. However, no patent will be granted on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct. The Office encourages applicants to carefully examine:

(1) Prior art cited in search reports of a foreign patent office in a counterpart application, and

(2) The closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.

(b) Under this section, information is material to patentability when it is not cumulative to information already of record or being made of record in the application, and

(1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or

(2) It refutes, or is inconsistent with, a position the applicant takes in:

(i) Opposing an argument of unpatentability relied on by the Office, or

(ii) Asserting an argument of patentability.

A prima facie case of unpatentability is established when the information compels a conclusion that a claim is unpatentable under the preponderance of evidence, burden-of-proof standard, giving each term in the claim its broadest reasonable construction consistent with the specification, and before any consideration is given to evidence which may be submitted in an attempt to establish a contrary conclusion of patentability.

(c) Individuals associated with the filing or prosecution of a patent application within the meaning of this section are:

(1) Each inventor named in the application;

(2) Each attorney or agent who prepares or prosecutes the application; and

(3) Every other person who is substantively involved in the preparation or prosecution of the application and who is associated with the inventor, the applicant, an assignee, or anyone to whom there is an obligation to assign the application.

(d) Individuals other than the attorney, agent or inventor may comply with this section by disclosing information to the attorney, agent, or inventor.

(e) In any continuation-in-part application, the duty under this section includes the duty to disclose to the Office all information known to the person to be material to patentability, as defined in paragraph (b) of this section, which became available between the filing date of the prior application and the national or PCT international filing date of the continuation-in-part application.

[57 FR 2034, Jan. 17, 1992, as amended at 65 FR 54666, Sept. 8, 2000; 77 FR 48818, Aug. 14, 2012]
Notes of Decisions
Cited in 639 cases (66 in the last 5 years), 1974–2026 · leading case: Avid Identification Systems, Inc. v. Crystal Import Corp.
Avid Identification Systems, Inc. v. Crystal Import Corp. (2010) cafc · cites it 38× “In reviewing the district court's finding, we address which individuals are "substantively involved" in the preparation or prosecution of a patent application and thus owe a duty of candor and good faith to the Patent and Trademark Office under 37 C.F.R. § 1.56 . We affirm the…”
Therasense, Inc. v. Becton, Dickinson and Co. (2011) cafc · cites it 18× “1984); see also 37 C.F.R. § 1.56 (1977) (a reference is material if "there is a substantial likelihood that a reasonable examiner would consider it important in deciding whether to allow the application to issue as a patent").”
Abbott Laboratories v. Sandoz, Inc. (2008) cafc · cites it 8× “The district court declined to hold the '616 patent unenforceable based on a withdrawn claim, citing 37 C.F.R. § 1.56 (a): Rule 56(a). The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration, or the…”
Dayco Products, Inc. v. Total Containment, Inc. (2003) cafc · cites it 6× “This interpretation of materiality was based, in part, on 37 C.F.R. § 1.56 (a) (1991), 1 which defined materiality using a “reasonable examiner” standard.”
Exergen Corp. v. Wal-Mart Stores, Inc. (2009) cafc · cites it 4× “See 37 C.F.R. § 1.56 (a) (“Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the [PTO] .”
Bruno Independent Living Aids, Inc. v. Acorn Mobility Services, Ltd., and Acorn Stairlifts, Inc., Defendants-Cross (2005) cafc · cites it 6× “In response, Acorn conditionally cross-appeals from the ruling denying additional discovery on that issue. We have jurisdiction pursuant to 28 U.”
Cargill, Inc. v. Sears Petroleum & Transport Corp. (2004) nynd · cites it 9× “The requirement of disclosure implicated by Cargill’s inequitable conduct claims finds its roots in 37 C.F.R. § 1.56 , which imposes a “duty of candor and good faith” in dealing with the “[Patent and Trademark] Office” on “[ejach individual associated with the filing and…”
Kimberly-Clark Corporation v. Johnson & Johnson and Personal Products Company (1984) cafc · cites it 6× “See 37 CFR 1.56. However, since it has actually happened that the axiom has been combined with the obligation to disclose--a tactic likely to be repeated--we are moved to analyze this old axiom (as we have analyzed equally venerable dogmas from the past for the purpose of…”
Therasense, Inc. v. Becton, Dickinson and Co. (2010) cafc · cites it 10× “37 C.F.R. § 1.56 (a)-(b). These rules are directly relevant to the materiality component of inequitable conduct because "if a misstatement or omission is material under the .”
Cargill, Inc. v. Canbra Foods, Ltd. (2007) cafc · cites it 4× “In that decision, we explained that the standard for materiality set forth in the current version of PTO Rule 56, see 37 C.F.R. § 1.56 (b) (2006), did not supplant the earlier “reasonable examiner” standard, see 37 C.”
In Re Kozaburo Harita, Kukiyoshi Ajisawa, Kinji Iizuke, Yukihiko Kinoshita, Tetsuhide Kamijo, and Michihiro Kobayashi (1988) cafc · cites it 13× “It is in his office that the "Special Program Examiner" is to be found and his function is to consider issues of violation of the duty of disclosure to the PTO as prescribed in 37 CFR 1.56, among other things. On June 19, 1984, he issued a final rejection of claims 8-10 4 based…”
Digital Control v. The Charles MacHine Works (Also Known as Ditchwitch) (2006) cafc · cites it 3× “; see 37 C.F.R. § 1.56 (a) (1991). However, in 1992, the PTO amended Rule 56, creating an arguably narrower standard of materiality.”
— 37 C.F.R. § 1.56(a) — 26 cases
— 37 C.F.R. § 1.56(b) — 8 cases
— 37 C.F.R. § 1.56(b)(1) — 2 cases
Exergen Corp. v. Wal-Mart Stores, Inc. (2009) cafc “See 37 C.F.R. § 1.56 (a) (“Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the [PTO] .”
— 37 C.F.R. § 1.56(b)(2) — 4 cases
— 37 C.F.R. § 1.56(b)(2)(a) — 1 case
— 37 C.F.R. § 1.56(b)(2)(h) — 1 case
— 37 C.F.R. § 1.56(b)(2)(ii) — 4 cases
— 37 C.F.R. § 1.56(b)(2000) — 1 case
— 37 C.F.R. § 1.56(b)(2003) — 1 case
— 37 C.F.R. § 1.56(c) — 3 cases
— 37 C.F.R. § 1.56(d) — 4 cases
In Re Kozaburo Harita, Kukiyoshi Ajisawa, Kinji Iizuke, Yukihiko Kinoshita, Tetsuhide Kamijo, and Michihiro Kobayashi (1988) cafc “It is in his office that the "Special Program Examiner" is to be found and his function is to consider issues of violation of the duty of disclosure to the PTO as prescribed in 37 CFR 1.56, among other things. On June 19, 1984, he issued a final rejection of claims 8-10 4 based…”
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