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).
[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.]
[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.]
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37 CFR 1.56 defines the duty to disclose information to the Office.
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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.
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.
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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:
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.
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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.
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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.
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)).
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.
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.
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.
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.
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.
