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).

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).

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