MPEP § 2004 — MPEP § 2004
Current through: 2022-07-01

2004-Aids to Compliance With Duty of Disclosure 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Chapter 2000 

 Section 2004 
 

 
 
 
 
 
 2004 Aids to Compliance With Duty of Disclosure [R-07.2022]

 While it is not appropriate to attempt to set forth procedures by which
 attorneys, agents, and other individuals may ensure compliance with the duty of disclosure,
 the items listed below are offered as examples of possible procedures which could help
 avoid problems with the duty of disclosure. Though compliance with these procedures may not
 be required, they are presented as helpful suggestions or best practices to avoid duty of
 disclosure problems.
 

 1. Many attorneys, both corporate and private, are using letters and
 questionnaires for applicants and others involved with the filing and prosecution of the
 application and checklists for themselves and applicants to ensure compliance with the duty
 of disclosure. The letter generally explains the duty of disclosure and what it means to
 the inventor and assignee. The questionnaire asks the inventor and assignee questions
 about:
 

 __ the origin of the invention and its point of departure from
 what was previously known and in the prior art,
 

 __ possible public uses and sales (See GS Cleantech
 Corp. v. Adkins Energy LLC , 951 F.3d 1310, 2020 USPQ2d 10092 (Fed. Cir.
 2020)),
 

 __ prior publication, knowledge, patents, foreign patents,
 etc.
 

 The checklist is used by the attorney to ensure that the applicant has
 been informed of the duty of disclosure and that the attorney has inquired of and cited
 material prior art.
 

 The use of these types of aids would appear to be most helpful, though not
 required, in identifying prior art and may well help the attorney and the client avoid or
 more easily explain a potentially embarrassing and harmful “fraud” allegation.
 

 2. It is desirable to ask questions about inventorship. Who is the proper
 inventor? Are there disputes or possible disputes about inventorship? If there are
 questions, call them to the attention of the U.S. Patent and Trademark Office.
 

 3. It is desirable to ask questions of the inventor about the disclosure
 of the best mode. Make sure that the best mode is described. See MPEP §§ 2165 -
 2165.04 .
 

 4. It is desirable for an attorney or agent to make certain that the
 inventor, especially a foreign inventor, recognizes his or her responsibilities in signing
 the oath or declaration. See 37 CFR 1.69(a) .
 

 
 37 CFR 1.69 Foreign language oaths and declarations. 

 
 (a) Whenever an individual making an oath or declaration cannot
 understand English, the oath or declaration must be in a language that such
 individual can understand and shall state that such individual understands the
 content of any documents to which the oath or declaration relates.
 

 
 *****

 

 Note MPEP § 602.06 for a more detailed
 discussion.
 

 5. It is desirable for an attorney or agent to carefully evaluate and
 explain to the applicant and others involved the scope of the claims, particularly the
 broadest claims. Ask specific questions about possible prior art which might be material in
 reference to the broadest claim or claims. There is some tendency to mistakenly evaluate
 prior art in the light of the gist of what is regarded as the invention or narrower
 interpretations of the claims, rather than measuring the art against the broadest claim
 with all of its reasonable interpretations. It is desirable to pick out the broadest claim
 or claims and measure the materiality of prior art against a reasonably broad
 interpretation of these claims.
 

 6. It may be useful to evaluate the materiality of prior art or other
 information from the viewpoint of whether it is the closest prior art or other information.
 This will tend to put the prior art or other information in better perspective. See
 Semiconductor Energy Laboratory Co. v. Samsung Electronics Co., 204
 F.3d 1368, 1374, 54 USPQ2d 1001, 1005 (Fed. Cir. 2000) (“A withheld reference may be highly
 material when it discloses a more complete combination of relevant features, even if those
 features are before the patent examiner in other references.” (citations omitted)).
 However, 37 CFR
 1.56 may still require the submission of prior art or other
 information which is not as close as that of record.
 

 7. Care should be taken to see that prior art or other information cited
 in a specification or in an information disclosure statement is properly described and that
 the information is not incorrectly or incompletely characterized. See Apotex v.
 UCB, Inc., 763 F.3d 1354, 1361-62, 112 USPQ2d 1081, 1087-88 (Fed. Cir.
 2014)(finding that the patent specification omitted material information was among the
 facts that supported a conclusion that the patent is unenforceable due to inequitable
 conduct). It is particularly important for an attorney or agent to review, before filing,
 an application which was prepared by someone else, e.g., a foreign applicant or
 practitioner. It is also important that an attorney or agent make sure that foreign
 clients, including foreign applicants, attorneys, and agents understand the requirements of
 the duty of disclosure, and that the U.S. attorney or agent review any information
 disclosure statements or citations to ensure that compliance with 37 CFR 1.56 is
 present. See Semiconductor Energy Laboratory Co. v. Samsung Electronics
 Co., 204 F.3d 1368, 54 USPQ2d 1001 (Fed. Cir. 2000). In this case, during
 prosecution the patentee submitted an untranslated 29-page Japanese reference as well as a
 concise explanation of its relevance and an existing one-page partial English translation,
 both of which were directed to less material portions of the reference. The untranslated
 portions of the Japanese reference “contained a more complete combination of the elements
 claimed [in the patent] than anything else before the PTO.” 204 F.3d at 1374, 54 USPQ2d at
 1005. The patentee, whose native language was Japanese, was held to have understood the
 materiality of the reference. “The duty of candor does not require that the applicant
 translate every foreign reference, but only that the applicant refrain from submitting
 partial translations and concise explanations that it knows will misdirect the examiner’s
 attention from the reference’s relevant teaching.” 204 F.3d at 1378, 54 USPQ2d at 1008. See
 also 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.
 

 
 8. Care should be taken to see that inaccurate statements, inaccurate
 evidence or inaccurate experiments are not introduced into the record, either inadvertently
 or intentionally. For example, stating that an experiment “was run” or “was conducted”
 when, in fact, the experiment was not run or conducted is a misrepresentation of the facts.
 See Apotex v. UCB, Inc., 763 F.3d 1359, 112 USPQ2d 1085 (Fed. Cir.
 2014). No results should be represented as actual results unless they have actually been
 achieved. Paper or prophetic examples should not be described using the past tense.
 Hoffman-La Roche, Inc. v. Promega Corp., 323 F.3d 1354, 1367, 66
 USPQ2d 1385, 1394 (Fed. Cir. 2003); see also MPEP § 608.01(p), subsection II and
 §
 707.07(l) . Also, misrepresentations can occur when experiments
 which were run or conducted are inaccurately reported in the specification, e.g., an
 experiment is changed by leaving out one or more ingredients. See Steierman v.
 Connelly, 192 USPQ 433 (Bd. Pat. Int. 1975); 192 USPQ 446 (Bd. Pat. Int.
 1976). Misrepresentations can also occur in declarations submitted to the Office. See
 Intellect Wireless v. HTC Corp., 732 F. 3d 1339, 1342, 108 USPQ2d
 1563, 1565 (Fed. Cir. 2013) wherein applicants submitted a declaration under
 37 CFR
 1.131 containing false statements regarding reduction to practice of
 the claimed invention.
 

 When drafting a patent application, it is a best practice to
 take care to ensure the proper tense is employed to describe experiments and test results
 so readers can readily distinguish between actual results and predicted results. Any
 ambiguities should be resolved so a person having ordinary skill in the art reading the
 disclosure, including those who may not have the level of skill of the inventor, can rely
 on the disclosure as an accurate description of experiments that support the patent claim
 coverage. It is a best practice to label examples as prophetic or otherwise separate them
 from working examples to avoid ambiguities. Such presentation will help a reader easily
 distinguish prophetic examples from working examples with actual experimental results and
 will enhance the public’s ability to rely on the patent disclosure. See Properly
 Presenting Prophetic and Working Examples in a Patent Application , 86 Fed.
 Reg. 35074, 5 (July 1, 2021). 
 

 9. Do not rely on the examiner of a particular application to be aware of
 other applications belonging to the same applicant or assignee. It is desirable to call
 such applications to the attention of the examiner even if there is only a question that
 they might be “material to patentability” of the application the examiner is considering.
 See Dayco Prod., Inc. v. Total Containment, Inc. , 329 F.3d 1358,
 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003) (contrary decision of another examiner
 reviewing substantially similar claims is ‘material’; copending application may be
 ‘material’ even though it cannot result in a shorter patent term, when it could affect the
 rights of the patentee to assign the issued patents). It is desirable to be particularly
 careful that prior art or other information in one application is cited to the examiner in
 other applications to which it would be material. Do not assume that an examiner will
 necessarily remember, when examining a particular application, other applications which the
 examiner is examining, or has examined. A “lapse on the part of the examiner does not
 excuse the applicant.” KangaROOS U.S.A., Inc. v. Caldor, Inc. , 778 F.2d
 1571, 1576, 228 USPQ 32, 35 (Fed. Cir. 1985); see also MPEP § 2001.06(b). 

 10. When in doubt, it is desirable and safest to submit information. Even
 though the attorney, agent, or applicant does not consider it necessarily material, someone
 else may see it differently and embarrassing questions can be avoided. The court in
 U.S. Industries v. Norton Co. , 210 USPQ 94, 107 (N.D. N.Y. 1980)
 stated “[i]n short, the question of relevancy in close cases, should be left to the
 examiner and not the applicant.” See also LaBounty Mfg., Inc. v. U.S. Int’l Trade
 Comm’n , 958 F.2d 1066, 22 USPQ2d 1025 (Fed. Cir. 1992).
 

 11. It is desirable to submit material information about prior uses and
 sales even if it appears that they may have been experimental, not involve the specifically
 claimed invention, or not encompass a completed invention. See TransWeb v.
 3M , 812 F.3d 1295, 1300, 117 USPQ2d 1617, 1619-20 (Fed. Cir. 2016). See also
 Hycor Corp. v. The Schlueter Co., 740 F.2d 1529, 1534-37, 222 USPQ
 553, 557-59 (Fed. Cir. 1984), LaBounty Mfg., Inc. v. U.S. Int’l Trade
 Comm’n , 958 F.2d 1066, 22 USPQ2d 1025 (Fed. Cir. 1992), and GS
 Cleantech Corp. v. Adkins Energy LLC , 951 F.3d 1310, 2020 USPQ2d 10092 (Fed.
 Cir. 2020). 
 

 12. Submit information promptly. An applicant, attorney, or agent who is
 aware of prior art or other information and its significance should submit the same early
 in prosecution, e.g., before the first action by the examiner, and not wait until after
 allowance. Potentially material information discovered late in the prosecution should be
 immediately submitted. That the issue fee has been paid is no reason or excuse for failing
 to submit information. See Elmwood Liquid Products, Inc. v. Singleton Packing Corp ., 328 F. Supp. 974, 170 USPQ 398 (M.D. Fla.
 1971).
 

 13. It is desirable to avoid the submission of long lists of documents if
 it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative
 information. If a long list is submitted, highlight those documents which have been
 specifically brought to applicant’s attention and/or are known to be of most significance.
 See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc ., 359 F. Supp. 948, 175
 USPQ 260 (S.D. Fla. 1972), aff’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir.
 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC
 v. Textron Inc. , 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
 

 14. Watch out for continuation-in-part (CIP) applications where
 intervening material information or documents may exist; particularly watch out for foreign
 patents and publications related to the parent application and dated more than 1 year
 before the filing date of the CIP. These and other intervening documents may be material
 information. See In re Ruscetta , 255 F.2d 687, 690-91, 118 USPQ 101, 104
 (CCPA 1958); In re van Langenhoven , 458 F.2d 132, 173 USPQ 426 (CCPA
 1972); Chromalloy American Corp. v. Alloy Surfaces Co. , 339 F. Supp.
 859, 173 USPQ 295 (D. Del. 1972).
 

 15. Watch out for information that might be deemed to be prior art under
 pre-AIA 35 U.S.C.
 102(f) and (g).
 

 Prior art under pre-AIA 35 U.S.C. 102(f) may be
 available under pre-AIA
 35 U.S.C. 103 . See OddzOn Products, Inc. v. Just
 Toys , Inc., 122 F.3d 1396, 1401, 43 USPQ2d 1641, 1644 (Fed.
 Cir. 1997)(35 U.S.C. “102(f) is a prior art provision for purposes of § 103”);
 Dale Electronics v. R.C.L. Electronics , 488 F.2d 382, 386, 180 USPQ
 225, 227 (1st. Cir. 1973); and Ex parte Andresen , 212 USPQ 100, 102 (Bd.
 App. 1981).
 

 Note also that evidence of prior invention under pre-AIA 35 U.S.C.
 102(g) may be available under pre-AIA 35 U.S.C. 103 , such as in
 In re Bass , 474 F.2d 1276, 177 USPQ 178 (CCPA 1973). In addition, the
 AIA provides that the provisions of pre-AIA 35 U.S.C. 102(g) apply to each
 claim of an AIA application for patent if the patent application: (1) contains or contained
 at any time a claim to a claimed invention having an effective filing date as defined in
 35 U.S.C.
 100(i) that occurs before March 16, 2013; or (2) is ever designated
 as a continuation, divisional, or continuation-in-part of an application that contains or
 contained at any time a claim to a claimed invention that has an effective filing date
 before March 16, 2013.
 

 Note pre-AIA 35 U.S.C. 103(c) disqualifies pre-AIA 35 U.S.C.
 102(f) / 103 or 102(g) / 103 prior art which was, at the time
 the second invention was made, owned by or subject to an obligation of assignment to, the
 person who owned the first invention. Further note that pre-AIA 35 U.S.C. 103(c) disqualifies
 pre-AIA 35 U.S.C.
 102(e)/103 prior art for applications filed on or after November 29,
 1999. See MPEP §§
 2146 - 2146.02 .
 

 16. Watch out for information picked up or disclosed by the inventors and
 others at conventions, plant visits, in-house reviews, etc. See, for example, Dale
 Electronics v. R.C.L. Electronics , 488 F.2d 382, 386-87, 180 USPQ 225, 228
 (1st Cir. 1973).
 

 17. Make sure that all of the individuals who are subject to the duty of
 disclosure, such as spelled out in 37 CFR 1.56 , are informed of and
 fulfill their duty.
 

 18. If information was specifically considered and discarded as not
 material, this fact might be recorded in an attorney’s file or applicant’s file, including
 the reason for discarding it. If judgment might have been bad or something might have been
 overlooked inadvertently, a note made at the time of evaluation might be an invaluable aid
 in explaining that the mistake was honest and excusable. Though such records are not
 required, they could be helpful in recalling and explaining actions in the event of a
 question of “fraud” or “inequitable conduct” raised at a later time. 
 

 19. Finally, where relevant documentation is submitted to a
 regulatory review body, such as the Food & Drug Administration (FDA), and is material
 to a pending patent application, such documentation should be submitted for examiner
 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 opposing arguments, may be material to ongoing patent
 prosecution. Belcher Pharmaceuticals, LLC v. Hospira, Inc. , 11 F.4th
 1345, 1353-54, 2021 USPQ2d 909 (Fed. Cir. 2021). 
 

 [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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 Last Modified: 
 
 03/09/2026 20:50:38