MPEP § 2001 — MPEP § 2001
Current through: 2022-07-01

2001-Duty of Disclosure, Candor, and Good Faith 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Chapter 2000 

 Section 2001 
 

 
 
 
 
 
 2001 Duty of Disclosure, Candor, and Good Faith [R-08.2017]

 
 37 CFR 1.56 Duty to disclose information material to patentability. 

 
 [Editor Note: Para. (c)(3) below is applicable only to patent
 applications filed under 35 U.S.C. 111(a) or 363 on or after September 16, 2012.]
 

 (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 withdrawn from consideration, or the application becomes abandoned.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 material to the patentability of a claim that is cancelled or withdrawn from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.

 
 

 (3) 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.
 

 
 

 
 37 CFR 1.56 (pre-AIA) Duty to disclose information material to
 patentability. 

 [Editor Note: Para. (c)(3) below is not applicable to patent
 applications filed under 35 U.S.C. 111(a) or 363 on or after Sept. 16,
 2012.] 

 *****

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

 

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

 *****

 
 

 
 

 37 CFR
 1.56 defines the duty to disclose information to the Office.
 

 
 2001.01 Who Has Duty To Disclose [R-07.2022]

 
 37 CFR 1.56 Duty to disclose information material to 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.
 

 
 

 
 *****

 

 
 37 CFR 1.56 (pre-AIA) Duty to disclose information material to 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, with the assignee or with anyone to whom there is an
 obligation to assign the application.
 

 
 

 
 *****

 

 The duty to disclose applies to matters pending before the USPTO and
 extends broadly to “[e]ach individual associated with the filing and prosecution of a
 patent application” and “[e]ach individual associated with the patent owner in a
 reexamination proceeding.” 37 CFR 1.56(c) and 1.555(a) . For
 patent applications, including reissue applications, these individuals include each
 inventor named in the application, each attorney or agent who prepares or prosecutes the
 application, and “[e]very 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.” This is intended to make clear that the duty does not extend to typists,
 clerks, and similar personnel who assist with an application. For reexamination
 proceedings, these individuals include “the patent owner, each attorney or agent who
 represents the patent owner, and every other individual who is substantively involved on
 behalf of the patent owner in a reexamination proceeding.” 37 CFR
 1.555(a) .
 

 The duty of disclosure applies only to individuals, not to
 organizations. For instance, the duty of disclosure would not apply to a corporation or
 institution as such. However, it would apply to individuals within the corporation or
 institution who were substantively involved in the preparation or prosecution of the
 application, and actions by such individuals may affect the rights of the corporation or
 institution. 
 

 

 
 2001.02 [Reserved]

 

 

 
 2001.03 To Whom Duty of Disclosure Is Owed [R-08.2017]

 37 CFR
 1.56(a) states that the “duty of candor and good faith” is owed
 “in dealing with the Office” and that all associated with the filing and prosecution of
 a patent application have a “duty to disclose to the Office” material information. This
 duty “in dealing with” and “to” the Office extends, of course, to all dealings which
 such individuals have with the Office, and is not limited to representations to or
 dealings with the examiner. For example, the duty would extend to proceedings before the
 Patent Trial and Appeal Board and the Office of the Commissioner for Patents.
 

 

 
 2001.04 Information Under 37 CFR 1.56(a) [R-07.2022]

 
 37 CFR 1.56 Duty to disclose information material to patentability. 

 
 (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.
 

 
 

 
 *****

 

 The language of 37 CFR 1.56 (and 37 CFR 1.555 )
 emphasizes that there is a duty of candor and good faith which is broader than the duty
 to disclose material information. 37 CFR 1.56 further states that “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.” Specifically, the duty of candor and good faith, and by
 extension the duty to disclose, applies to positions taken by applicants or parties
 involving the claimed subject matter.
 

 If a party to a USPTO proceeding discovers that an
 earlier position taken in a submission to the USPTO or another Government agency was
 incorrect or inconsistent with other statements made by the party, the party must
 promptly correct the record. See, e.g., In re Tendler, Proceeding No.
 D2013-17 (USPTO Jan. 1, 2014) (suspending a practitioner for four years for failure to
 correct the written record after learning of inaccuracies in a declaration the
 practitioner had filed). In the context of prosecution, an applicant must disclose to
 the USPTO any information that 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. See 37 CFR
 1.56(b)(2) . Patent owners may bring information, including prior
 art and incorrect or inconsistent positions, to the attention of the USPTO through
 supplemental examination, ex parte reexamination, reissue
 applications, or submissions under 37 CFR 1.501 . During prosecution,
 third parties may have an opportunity to disclose information to the USPTO through third
 party submissions under 37 CFR 1.290 and protests under
 37 CFR
 1.291 . After issuance, third parties may disclose information
 directed to issued patents to the USPTO via submissions under 37 CFR 1.501 , or
 in ex parte reexamination. A finding of “fraud,” “inequitable
 conduct,” or violation of duty of disclosure through bad faith or intentional misconduct
 with respect to any claim in an application or patent, renders all the claims thereof
 unpatentable or invalid. See MPEP § 2016 .
 

 The Office strives to issue valid patents. The Office has both an
 obligation not to unjustly issue patents and an obligation not to unjustly deny patents.
 Innovation and technological advancement are best served when an inventor is issued a
 patent with the scope of protection that is deserved. The rules serve to remind
 individuals associated with the preparation and prosecution of patent applications of
 their duty of candor and good faith in their dealings with the Office, and will aid the
 Office in receiving, in a timely manner, the information it needs to carry out effective
 and efficient examination of patent applications. Moreover, an incentive exists to
 submit material information to the Office because it may result in enhanced patent
 quality and may avoid later questions of materiality and intent to deceive.
 

 The definition of materiality in 37 CFR 1.56 is intended to provide
 the Office with the information it needs in order for the examiner to make a proper and
 independent determination on patentability. The patent examiner should make the
 patentability determination after considering the relevant facts properly of record in
 the particular case.
 

 37 CFR
 1.56 states that each individual associated with the filing and
 prosecution of a patent application has a duty to disclose all information known to that
 individual to be material to patentability as defined in the section. Thus, the duty
 applies to contemporaneously or presently known information. The fact that information
 was known years ago does not mean that it was recognized that the information is
 material to the present application.
 

 The term “information” as used in 37 CFR 1.56 means all of the kinds
 of information required to be disclosed and includes any information which is “material
 to patentability.” Materiality is defined in 37 CFR 1.56(b) and discussed herein
 at MPEP
 § 2001.05 . In addition to prior art such as patents and
 publications, 37 CFR
 1.56 includes, for example, information on enablement, possible
 prior public uses, sales, offers to sell, derived knowledge, prior invention by another,
 inventorship conflicts, litigation statements, and the like. “Materiality is not limited
 to prior art but embraces any information that a reasonable examiner
 would be substantially likely to consider important in deciding whether to allow an
 application to issue as a patent.” Bristol-Myers Squibb Co. v. Rhone-Poulenc
 Rorer, Inc. , 326 F.3d 1226, 1234, 66 USPQ2d 1481, 1486 (Fed. Cir. 2003)
 (emphasis in original) (finding article which was not prior art to be material to
 enablement issue).
 

 Patent examiners also have the ability to require
 submission of information that may be reasonably necessary to properly examine or treat
 a matter in a pending or abandoned application, but not necessarily “material to
 patentability.” 37
 CFR 1.105(a)(1) . The information that must be submitted to comply
 with a requirement for information under 37 CFR 1.105 may not be material to
 patentability in itself under 37 CFR 1.56 , but it is necessary to
 obtain a complete record from which a determination of patentability may be made. See
 MPEP §
 704.12(a) . Therefore, when an examiner has a reasonable basis
 to conclude that an individual identified under 37 CFR 1.56(c) or any assignee has
 information that would aid in the examination of the application or treatment of some
 matter, the examiner may require submission of information that is not necessarily
 material to patentability. This requirement could include statements made or information
 submitted to other Government agencies such as the FDA. See MPEP §
 2015 . For example, when examining a claim directed to a
 process of manufacturing a particular drug product that was effectively filed more than
 one year after FDA approval of the drug product, an examiner may appropriately require
 an applicant to submit to the USPTO information submitted to the FDA (e.g., in a New
 Drug Application or Biologics License Application) on how the drug product was
 manufactured.
 

 The term “information” is intended to be all encompassing, similar to
 the scope of the term as discussed with respect to 37 CFR 1.291(a) (see
 MPEP
 § 1901.02 ). 37 CFR 1.56(a) also states: “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.”
 

 It should be noted that the rules are not intended
 to require information favorable to patentability such as, for
 example, evidence of commercial success of the invention. Similarly, the rules are not
 intended to require, for example, disclosure of information concerning the level of
 skill in the art for purposes of determining obviousness.
 

 37 CFR
 1.56(a) states that the duty to disclose information exists until
 the application becomes abandoned. The duty to disclose information, however, does not
 end when an application becomes allowed but extends until a patent is granted on that
 application. The rules provide for information being considered after a notice of
 allowance is mailed and before the issue fee is paid ( 37 CFR 1.97(d) )
 (see MPEP § 609.04(b),
 subsection III ). The rules also provide for an application to
 be withdrawn from issue:
 

 
 (A) because one or more claims are unpatentable ( 37 CFR
 1.313(c)(1) );
 

 (B) for express abandonment so that information may be considered in
 a continuing application before a patent issues ( 37 CFR
 1.313(c)(3) ); or 
 

 (C) for consideration of a request for continued examination (RCE)
 under 37 CFR
 1.114 ( 37 CFR 1.313(a) and
 (c)(2) ). Note that RCE practice does not apply to utility
 or plant applications filed before June 8, 1995 or to design applications. See
 MPEP §
 706.07(h) .
 

 
 See MPEP
 § 1308 for additional information pertaining to withdrawal of
 an application from issue.
 

 In a continuation-in-part application, individuals covered by
 37 CFR
 1.56 have a duty to disclose to the Office all information known
 to be material to patentability 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. See 37 CFR 1.56(e) .
 

 37 CFR
 1.56 provides that the duty of disclosure can be met by submitting
 information to the Office in the manner prescribed by 37 CFR 1.97 and
 1.98 . See MPEP § 609 et seq . Applicants are provided certainty as to when information will
 be considered, and applicants will be informed when information is not considered. Note,
 however, if even a document was cited to or considered in a prior examination or related
 Office proceeding, the Office may order reexamination based on the document if it raises
 a substantial new question of patentability. See MPEP § 2242 and MPEP § 2258.01 .
 

 37 CFR 1.555 provides for the duty
 of disclosure in reexamination proceedings. For a discussion of information material to
 patentability in a reexamination proceeding, see MPEP § 2280 or MPEP § 2684 . For
 supplemental examination and any ex parte reexamination proceeding
 ordered under 35 U.S.C. 257 , information material
 to patentability is defined by 37 CFR 1.56 . See 37 CFR
 1.625(d)(4) and MPEP §
 2820 .
 

 

 
 2001.05 Materiality Under 37 CFR 1.56(b) [R-07.2022]

 
 37 CFR 1.56 Duty to disclose information material to patent ability. 

 *****

 
 (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.
 

 *****

 

 Under the rule, information is not material unless it comes within the
 definition of 37
 CFR 1.56(b)(1) or (2) . Generally, when information is
 clearly cumulative or not material, there is no duty to disclose the information to the
 Office. “[I]nformation 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.” 37
 CFR 1.56(b) . In close cases where the materiality or consistency
 of the information is in question, the applicant should consider submitting this
 information to the USPTO. The Office believes that most applicants will wish to submit
 the information even though they may not be required to do so, to strengthen the patent
 and avoid the risks of an incorrect judgment on their part on materiality. The USPTO
 holds those individuals subject to this duty to the highest standards.
 

 

 
 2001.06 Sources of Information under 37 CFR 1.56 [R-07.2022]

 All individuals covered by 37 CFR 1.56 (reproduced in
 MPEP §
 2001.01 ) have a duty to disclose to the U.S. Patent and
 Trademark Office all material information they are aware of
 regardless of the source of or how they become aware of the information. See
 Brasseler, U.S.A. I, L.P. v. Stryker Sales Corp ., 267 F.3d 1370,
 1383, 60 USPQ2d 1482, 1490 (Fed. Cir. 2001) (“Once an attorney, or an applicant has
 notice that information exists that appears material and questionable, that person
 cannot ignore that notice in an effort to avoid his or her duty to disclose.”).
 Materiality controls whether information must be disclosed to the Office, not the
 circumstances under which or the source from which the information is obtained. If
 material, the information must be disclosed to the Office. The duty to disclose material
 information extends to information such individuals are aware of prior to or at the time
 of filing the application or become aware of during the prosecution thereof before the
 application is granted.
 

 Individuals covered by 37 CFR 1.56 may be or become aware
 of material information from various sources such as, for example, co-workers, trade
 shows, communications from or with competitors, potential infringers, or other third
 parties, related foreign applications (see MPEP § 2001.06(a) ), prior or copending
 United States patent applications (see MPEP § 2001.06(b) ), related litigation
 and/or post-grant proceedings (see MPEP § 2001.06(c) ), preliminary
 examination searches and supporting information related to regulatory review (see
 MPEP §
 2001.06(e) ).
 

 
 2001.06(a) Prior Art Cited in Related Foreign Applications [R-08.2012]

 Applicants and other individuals, as set forth in 37 CFR 1.56 ,
 have a duty to bring to the attention of the Office any material prior art or other
 information cited or brought to their attention in any related foreign application.
 The inference that such prior art or other information is material is especially
 strong where it has been used in rejecting the same or similar claims in the foreign
 application or where it has been identified in some manner as particularly relevant.
 See Gemveto Jewelry Co. v. Lambert Bros., Inc. , 542 F. Supp. 933,
 216 USPQ 976 (S.D. N.Y. 1982) wherein a patent was held invalid or unenforceable
 because patentee’s foreign counsel did not disclose to patentee’s United States
 counsel or to the Office prior art cited by the Dutch Patent Office in connection
 with the patentee’s corresponding Dutch application. The court stated, 542 F. Supp.
 at 943, 216 USPQ at 985:
 

 
 Foreign patent attorneys representing applicants for U.S. patents
 through local correspondent firms surely must be held to the same standards of
 conduct which apply to their American counterparts; a double standard of
 accountability would allow foreign attorneys and their clients to escape
 responsibility for fraud or inequitable conduct merely by withholding from the
 local correspondent information unfavorable to patentability and claiming
 ignorance of United States disclosure requirements.
 

 
 

 
 2001.06(b) Information Relating to or From Copending United States
 Patent Applications [R-08.2017]
 

 The individuals covered by 37 CFR 1.56 have a duty to bring
 to the attention of the examiner, or other Office official involved with the
 examination of a particular application, information within their knowledge as to
 other copending United States applications which are “material to patentability” of
 the application in question. This may include providing the identification of pending
 or abandoned applications filed by at least one of the inventors or assigned to the
 same assignee as the current application that disclose similar subject matter that
 are not otherwise identified in the current application. As set forth by the court in
 Armour & Co. v. Swift & Co. , 466 F.2d 767, 779, 175
 USPQ 70, 79 (7th Cir. 1972):
 

 
 [W]e think that it is unfair to the busy examiner, no matter how
 diligent and well informed he may be, to assume that he retains details of every
 pending file in his mind when he is reviewing a particular application . . . [T]he
 applicant has the burden of presenting the examiner with a complete and accurate
 record to support the allowance of letters patent.
 

 
 See also MPEP § 2004 , paragraph 9.
 

 Accordingly, the individuals covered by 37 CFR 1.56 
 cannot assume that the examiner of a particular application is necessarily aware of
 other applications which are “material to patentability” of the application in
 question, but must instead bring such other applications to the attention of the
 examiner. See Regeneron Pharm., Inc. v. Merus B.V. , 144 F. Supp.
 3d 530, 560 (S.D.N.Y. 2015), and Dayco Prod., Inc. v. Total Containment,
 Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
 For example, if a particular inventor has different applications pending which
 disclose similar subject matter but claim patentably indistinct inventions, the
 existence of other applications must be disclosed to the examiner of each of the
 involved applications. Similarly, the prior art references from one application must
 be made of record in another subsequent application if such prior art references are
 “material to patentability” of the subsequent application. See Dayco
 Prod., 329 F.3d at 1369, 66 USPQ2d at 1808.
 

 If the application under examination is identified as a
 continuation, divisional, or continuation-in-part of an earlier application, the
 examiner will consider the prior art properly cited in the earlier application. See
 MPEP §
 609 and MPEP § 719.05 , subsection (II)(A),
 example J. The examiner must indicate in the first Office action whether the prior
 art in a related earlier application has been reviewed. Accordingly, no separate
 citation of the same prior art need be made in the later application, unless
 applicant wants a listing of the prior art printed on the face of the patent.
 

 

 
 2001.06(c) Information From Related Litigation and/or Trial
 Proceedings [R-08.2017]
 

 The America Invents Act (AIA) added trial proceedings to be
 conducted by the Patent Trial and Appeal Board (PTAB) including inter
 partes review proceedings, post-grant review, covered business method
 reviews, and derivation. In many instances, these trial proceedings yield information
 that may be considered material to pending related patent applications. Where the
 subject matter for which a patent is being sought is or has been involved in
 litigation and/or a trial proceeding, or the litigation and/or trial proceeding
 yields information material to currently pending applications, the existence of such
 litigation and any other material information arising therefrom must be brought to
 the attention of the examiner or other appropriate official at the U.S. Patent and
 Trademark Office. In particular, material information that is raised in trial
 proceedings that is relevant to related applications undergoing examination should be
 submitted on an Information Disclosure Statement for the examiner’s consideration.
 Examples of such material information include evidence of possible prior public use
 or sales, questions of inventorship, prior art, allegations of “fraud,” “inequitable
 conduct,” and “violation of duty of disclosure.” Another example of such material
 information is any assertion that is made during litigation and/or trial proceeding
 which is contradictory to assertions made to the examiner. Environ Prods.,
 Inc. v. Total Containment, Inc. , 43 USPQ2d 1288, 1291 (E.D. Pa. 1997).
 Such information might arise during litigation and/or trial proceeding in, for
 example, pleadings, admissions, discovery including interrogatories, depositions, and
 other documents and testimony.
 

 Where a patent for which reissue is being sought is, or has been,
 involved in litigation and/or trial proceeding which raised a question material to
 examination of the reissue application, such as the validity of the patent, or any
 allegation of “fraud,” “inequitable conduct,” or “violation of duty of disclosure,”
 the existence of such litigation and/or trial proceeding must be brought to the
 attention of the examiner by the applicant at the time of, or shortly after, filing
 the application. Such information can be disclosed either in the reissue oath or
 declaration, or in a separate paper, preferably accompanying the application, as
 filed. Litigation and/or trial proceedings that begin after filing of the reissue
 application should be promptly brought to the attention of the Office. The details
 and documents from the litigation and/or trial proceedings, insofar as they are
 “material to patentability” of the reissue application as defined in
 37 CFR
 1.56 , should accompany the application as filed, or be
 submitted as promptly thereafter as possible. See Critikon, Inc. v. Becton
 Dickinson Vascular Access, Inc. , 120 F.3d 1253, 1258-59, 43 USPQ2d 1666,
 1670-71 (Fed. Cir. 1997) (patent held unenforceable due to inequitable conduct based
 on patentee's failure to disclose a relevant reference and for failing to disclose
 ongoing litigation).
 

 For example, the defenses raised against validity of the patent, or
 charges of “fraud” or “inequitable conduct” in the litigation, would normally be
 “material to the examination” of the reissue application. It would, in most
 situations, be appropriate to bring such defenses to the attention of the Office by
 filing in the reissue application a copy of the court papers raising such defenses.
 At a minimum, the applicant should call the attention of the Office to the
 litigation, the existence and the nature of any allegations relating to validity
 and/or “fraud,” or “inequitable conduct” relating to the original patent, and the
 nature of litigation materials relating to these issues. Enough information should be
 submitted to clearly inform the Office of the nature of these issues so that the
 Office can intelligently evaluate the need for asking for further materials in the
 litigation. See MPEP §
 1442.04 .
 

 If litigation papers of a live litigation relating to a pending
 reissue application are filed with the Office, the Solicitor’s Office should be
 notified of the filing of the litigation papers in the application file. If the
 litigation is not live, the litigation papers are processed by the Technology Center
 assigned the reissue application.
 

 

 
 2001.06(d) Information Relating to Claims Copied From a
 Patent [R-08.2017]
 

 Where claims are copied or substantially copied from a patent,
 37 CFR
 41.202(a) requires the applicant, at the time he or she
 presents the claim(s), to identify the patent and the numbers of the patent claims.
 Clearly, the information required by 37 CFR 41.202(a) as to the source
 of copied claims is material information under 37 CFR 1.56 and failure to inform
 the USPTO of such information may violate the duty of disclosure.
 

 

 
 2001.06(e) Information Relating to Regulatory Review [R-07.2022]

 Where relevant documentation is submitted to a
 regulatory review body, such as the U.S. Food & Drug Administration (FDA), and is
 material to any pending patent application or reexamination proceeding, such
 documentation should be submitted for Office review. While the considerations made by
 the FDA for approving clinical trials are different from those made by the USPTO in
 determining whether a claim is patentable, submissions, particularly any assertion
 that is made which is contradictory to assertions made to the examiner, may be
 material to ongoing patent proceedings. Belcher Pharmaceuticals, LLC v.
 Hospira, Inc. , 11 F.4th 1345, 1353-54, 2021 USPQ2d 909 (Fed. Cir. 2021).
 See also MPEP §
 2164.05 . Duty of disclosure may require that if the actual
 filing date of an application is after the date of the applicant’s date of marketing
 approval by FDA, and the applicant intends to list any resulting patent in the orange
 book for that product, informing the USPTO during examination of the application of
 that intent and applicant should consider providing the Paragraph IV “factual and
 legal basis” notice to USPTO. 
 

 Accordingly, each party presenting a paper to the
 USPTO, whether a practitioner or non-practitioner, has a duty to perform an inquiry
 that is reasonable under the circumstances. This reasonable inquiry may comprise
 reviewing documents that are submitted to or received from other Government agencies,
 including the FDA. If any reviewed document is material to the patentability of a
 pending matter before the Office, such as a patent application (including a reissue
 application), or a reexamination proceeding, the party has a duty to submit the
 information to the USPTO. 37 CFR 1.56 , 1.555 , and
 11.18(b)(2) . A duty of reasonable inquiry may exist based on
 circumstances known to the party presenting the paper to the USPTO. Failing to
 inquire when the circumstances warrant it could result in sanctions or other action
 under 37 CFR
 11.18(c) , which may include: (1) striking the offending paper;
 (2) referring a practitioner’s conduct to the Director of Enrollment and Discipline
 for appropriate action; (3) precluding a party or practitioner from submitting a
 paper, or presenting or contesting an issue; (4) affecting the weight given to the
 offending paper; or (5) terminating the proceedings in the Office. See, e.g.,
 In re Hao, Proceeding No. D2021-14 (USPTO Apr. 27, 2022)
 (involving disciplinary sanctions predicated on non-compliance with 37 CFR 11.18 ).
 See also MPEP § 2015 .
 

 

 

 [top] 

 

 

 
 

 
 

 

 

 

 
 
 
 2000-Duty of Disclosure 
 2000.01-Introduction 

 
 

 2001-Duty of Disclosure, Candor, and Good Faith 
 2001.01-Who Has Duty To Disclose 

 2001.02-[Reserved] 

 2001.03-To Whom Duty of Disclosure Is Owed 

 2001.04-Information Under 37 CFR 1.56(a) 

 2001.05-Materiality Under 37 CFR 1.56(b) 

 2001.06-Sources of Information under 37 CFR 1.56 
 2001.06(a)-Prior Art Cited in Related Foreign Applications 

 2001.06(b)-Information Relating to or From Copending United States Patent Applications 

 2001.06(c)-Information From Related Litigation and/or Trial Proceedings 

 2001.06(d)-Information Relating to Claims Copied From a Patent 

 2001.06(e)-Information Relating to Regulatory Review 

 
 

 
 

 2002-Disclosure — By Whom and How Made 
 2002.01-By Whom Made 

 2002.02-Must be in Writing 

 
 

 2003-Disclosure __ When Made 
 2003.01-Disclosure After Patent Is Granted 

 
 

 2004-Aids to Compliance With Duty of Disclosure 

 2005-Comparison to Requirements for Information 

 2006‑2009-[Reserved] 

 2010-Office Handling of Duty of Disclosure/Inequitable Conduct Issues 

 2011-Correction of Errors in Application 

 2012-Reissue Applications Involving Issues of Fraud, Inequitable Conduct, and/or Violation of Duty of Disclosure 
 2012.01-Collateral Estoppel 

 
 

 2013-Protests Involving Issues of Fraud, Inequitable Conduct, and/or Violation of Duty of Disclosure 

 2014-Duty of Disclosure in Reexamination Proceedings and Supplemental Examination 

 2015-Duties of Disclosure and Reasonable Inquiry Arise in Dealings With Other Government Agencies 

 2016-Fraud, Inequitable Conduct, or Violation of Duty of Disclosure Affects All Claims 

 2017‑2022-[Reserved] 

 

 

 
 

 
 
 

 
 

 

 
 
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 03/09/2026 20:50:38