Properly Presenting Prophetic and Working Examples in a Patent Application, 35074-35075 [2021-14034]

Download as PDF 35074 Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices meeting will begin on July 21, 2021, at 9 a.m. AST, and will end on July 21, 2021, at 4 p.m. AST. Other than the start time on the first day of the meeting, interested parties should be aware that discussions may start earlier or later than indicated in the agenda, at the discretion of the Chair. SUPPLEMENTARY INFORMATION: Special Accommodations Prophetic Versus Working Examples Prophetic examples, also called paper examples, are typically used in a patent application to describe reasonably expected future or anticipated results. Prophetic examples describe experiments that have not in fact been performed. Rather, they are presented in a manner that forecasts simulated or predicted results. In contrast, working examples correspond to work performed or experiments conducted that yielded actual results. The Manual of Patent Examining Procedure (MPEP) states that prophetic examples should not be described using the past tense. MPEP 608.01(p), subsection II. Prophetic examples may be written in future or present tense. This drafting technique assists readers in differentiating between actual working examples and prophetic examples. Simultaneous interpretation will be provided. For simultaneous interpretation English-Spanish-English follow your Zoom screen instructions. You will be asked which language you prefer when you join the meeting. For any additional information on this public virtual meeting, please contact Diana Martino, Caribbean Fishery Management Council, 270 Mun˜oz Rivera Avenue, Suite 401, San Juan, Puerto Rico, 00918–1903, telephone: (787) 226–8849. Authority: 16 U.S.C. 1801 et seq. Dated: June 25, 2021. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 2021–14005 Filed 6–30–21; 8:45 am] BILLING CODE 3510–22–P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No.: PTO–P–2021–0020] Properly Presenting Prophetic and Working Examples in a Patent Application United States Patent and Trademark Office, Department of Commerce. ACTION: Notice. AGENCY: The United States Patent and Trademark Office (USPTO) is reminding applicants that patent applications must properly present examples in a manner that clearly distinguishes between prophetic examples that describe predicted experimental results and working examples that report actual experimental results. The distinction must be clear to satisfy the written description and enablement requirements and comply with the applicant’s duty of disclosure. FOR FURTHER INFORMATION CONTACT: Ali Salimi, Senior Legal Advisor, at 571– 272–0909, and Raul Tamayo, Senior Legal Advisor, at 571–272–7728, both with the Office of Patent Legal Administration, Office of the Deputy Commissioner for Patents, USPTO. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:45 Jun 30, 2021 Jkt 253001 The USPTO is reminding patent applicants of their duty to ensure that patent applications are written in a manner that clearly distinguishes prophetic examples with predicted experimental results from working examples with actual experimental results. Written Description and Enablement Requirements To be complete, the contents of a patent application must include a specification containing a written description of the invention that enables any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date. See 35 U.S.C. 112(a). At least one specific operative embodiment or example of the invention must be set forth. The example(s) and description should be sufficient to justify the scope of the claims. MPEP 608.01(p). The specification need not contain an example if the invention is otherwise disclosed in such a manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970). See MPEP 2164.02. The courts have sanctioned the use of prophetic examples to meet the written description and enablement requirements for a patent application. See, e.g., Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1310 (Fed. Cir. 2015) (‘‘efficacy data are generally not required in a patent application’’ and ‘‘a patentee is not required to provide actual working examples’’). A patent application does not need to provide a guarantee that a prophetic example actually works. Id. at 1310. ‘‘Only a sufficient description enabling a person PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 of ordinary skill in the art to carry out an invention is needed.’’ Id. The courts have further cautioned that the presence of prophetic examples alone should not be the basis for asserting that a specification is not enabling; rather, a lack of operative embodiments and undue experimentation should be determinative. Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984). Disclosed results of tests and examples, whether working or prophetic examples, in a patent application are not normally questioned unless there is a reasonable basis for doing so. However, when prophetic examples are described in a manner that is ambiguous or that implies that the results are actual, the adequacy and accuracy of the disclosure may come into question. If the characterization of the results, when taken in light of the disclosure as a whole, reasonably raises any questions as to whether the results from the examples are actual, the examiner will determine whether to reject the appropriate claims based on an insufficient disclosure under the enablement and/or written description requirements of 35 U.S.C. 112(a) following the guidance in MPEP 2164 and 2163, respectively. When such a rejection(s) is made, the applicant may reply with the results of an actual test or example that has been conducted, or by providing relevant arguments and/or declaration evidence that there is strong reason to believe that the result would be as predicted, being careful not to introduce new matter into the application. MPEP 707.07(l) and 2161– 2164.08(c). Applicant’s Duty of Disclosure Care should be taken to see that inaccurate or misleading statements, inaccurate evidence, or inaccurate experiments are not introduced into the record. MPEP 2004 sets forth best practices to avoid duty of disclosure problems (see, in particular, MPEP 2004, item 8). As noted above, prophetic examples should not be described using the past tense. Hoffmann-La Roche, Inc. v. Promega Corp., 323 F.3d. 1354, 1367 (Fed. Cir. 2003) (improperly identifying a prophetic example in the past tense validly raises an inequitable conduct issue based on the intent of the inventors in drafting the example in the past tense, when the example, in fact, is prophetic). Knowingly asserting in a patent application that a certain result ‘‘was run’’ or an experiment ‘‘was conducted’’ when, in fact, the experiment was not conducted or the result was not obtained is fraud. Apotex Inc. v. UCB, Inc., 763 F.3d 1354, 1362 E:\FR\FM\01JYN1.SGM 01JYN1 Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices (Fed. Cir. 2014) (the inventor ‘‘admitted that he never performed the experiments described in the . . . patent, and yet he drafted the examples in the specification entirely in pasttense language.’’). No results should be represented as actual results unless they have actually been achieved. Distinguishing prophetic examples from working examples in a clear manner will avoid raising issues relating to the applicant’s duty of disclosure. Best Practices When drafting a patent application, care must be taken 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. Andrew Hirshfeld, Commissioner for Patents, Performing the Functions and Duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. [FR Doc. 2021–14034 Filed 6–30–21; 8:45 am] BILLING CODE 3510–16–P DEPARTMENT OF DEFENSE Department of the Air Force [Docket ID: USAF–2021–HQ–0003] Submission for OMB Review; Comment Request Department of the Air Force, Department of Defense (DoD). ACTION: 30-Day information collection notice. khammond on DSKJM1Z7X2PROD with NOTICES AGENCY: The DoD has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act. DATES: Consideration will be given to all comments received by August 2, 2021. SUMMARY: VerDate Sep<11>2014 16:45 Jun 30, 2021 Jkt 253001 Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: Angela Duncan, 571–372–7574, or whs.mc-alex.esd.mbx.dd-dodinformation-collections@mail.mil. SUPPLEMENTARY INFORMATION: Title; Associated Form; and OMB Number: Aircraft and Personnel Automated Clearance System (APACS); OMB Control Number 0701–0160. Type of Request: Extension. Number of Respondents: 492,000. Responses per Respondent: 1. Annual Responses: 492,000. Average Burden per Response: 30 minutes. Annual Burden Hours: 246,000. Needs and Uses: The information collection requirement is necessary to obtain PII which is used by in-country U.S. Embassy approvers to grant country travel clearances, Geographical Combatant Commands approvers to grant theater travel clearances, and by the Office of Secretary of Defense for Policy approvers to grant special area travel clearances. Aircrew PII is used for verification, identification and authentication of travelers for aircraft and personnel travel clearances, as required by DoDD 4500.54E, DoD Foreign Clearance Program. Affected Public: Individuals or households. Frequency: On occasion. Respondent’s Obligation: Voluntary. OMB Desk Officer: Ms. Jasmeet Seehra. You may also submit comments and recommendations, identified by Docket ID number and title, by the following method: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http:// www.regulations.gov as they are received without change, including any personal identifiers or contact information. DOD Clearance Officer: Ms. Angela Duncan. ADDRESSES: PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 35075 Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dddod-information-collections@mail.mil. Dated: June 28, 2021. Kayyonne T. Marston, Alternate OSD Federal Register, Liaison Officer, Department of Defense. [FR Doc. 2021–14073 Filed 6–30–21; 8:45 am] BILLING CODE 5001–06–P DEPARTMENT OF DEFENSE Defense Acquisition Regulations System Early Engagement Opportunity: Implementation of National Defense Authorization Act for Fiscal Year 2021 Defense Acquisition Regulations System, Department of Defense (DoD). ACTION: Notice. AGENCY: DoD announces an early engagement opportunity regarding implementation of the National Defense Authorization Act for Fiscal Year 2021 within the acquisition regulations. DATES: Early inputs should be submitted in writing via the Defense Acquisition Regulations System (DARS) website shown below. The website will be updated when early inputs will no longer be accepted. ADDRESSES: Submit early inputs via the DARS website at https:// www.acq.osd.mil/dpap/dars/early_ engagement.html. SUMMARY: FOR FURTHER INFORMATION CONTACT: Jennifer Johnson, Tel: 703–717–8226. Send inquiries via email to osd.dfars@ mail.mil and reference ‘‘Early Engagement Opportunity: Implementation of NDAA for FY 2021’’ in the subject line. SUPPLEMENTARY INFORMATION: DoD is providing an opportunity for the public to provide early inputs on implementation of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2021 within the acquisition regulations. The public is invited to submit early inputs on sections of the NDAA for FY 2021 via the DARS website at https://www.acq.osd.mil/ dpap/dars/early_engagement.html. The website will be updated when early inputs will no longer be accepted. Please note, this venue does not replace or circumvent the rulemaking process. DARS will engage in formal rulemaking, in accordance with 41 U.S.C. 1707, when it has been determined that rulemaking is required to implement a E:\FR\FM\01JYN1.SGM 01JYN1

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[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Notices]
[Pages 35074-35075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14034]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No.: PTO-P-2021-0020]


Properly Presenting Prophetic and Working Examples in a Patent 
Application

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The United States Patent and Trademark Office (USPTO) is 
reminding applicants that patent applications must properly present 
examples in a manner that clearly distinguishes between prophetic 
examples that describe predicted experimental results and working 
examples that report actual experimental results. The distinction must 
be clear to satisfy the written description and enablement requirements 
and comply with the applicant's duty of disclosure.

FOR FURTHER INFORMATION CONTACT: Ali Salimi, Senior Legal Advisor, at 
571-272-0909, and Raul Tamayo, Senior Legal Advisor, at 571-272-7728, 
both with the Office of Patent Legal Administration, Office of the 
Deputy Commissioner for Patents, USPTO.

SUPPLEMENTARY INFORMATION: The USPTO is reminding patent applicants of 
their duty to ensure that patent applications are written in a manner 
that clearly distinguishes prophetic examples with predicted 
experimental results from working examples with actual experimental 
results.

Prophetic Versus Working Examples

    Prophetic examples, also called paper examples, are typically used 
in a patent application to describe reasonably expected future or 
anticipated results. Prophetic examples describe experiments that have 
not in fact been performed. Rather, they are presented in a manner that 
forecasts simulated or predicted results. In contrast, working examples 
correspond to work performed or experiments conducted that yielded 
actual results. The Manual of Patent Examining Procedure (MPEP) states 
that prophetic examples should not be described using the past tense. 
MPEP 608.01(p), subsection II. Prophetic examples may be written in 
future or present tense. This drafting technique assists readers in 
differentiating between actual working examples and prophetic examples.

Written Description and Enablement Requirements

    To be complete, the contents of a patent application must include a 
specification containing a written description of the invention that 
enables any person skilled in the art or science to which the invention 
pertains to make and use the invention as of its filing date. See 35 
U.S.C. 112(a). At least one specific operative embodiment or example of 
the invention must be set forth. The example(s) and description should 
be sufficient to justify the scope of the claims. MPEP 608.01(p). The 
specification need not contain an example if the invention is otherwise 
disclosed in such a manner that one skilled in the art will be able to 
practice it without an undue amount of experimentation. In re 
Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970). See MPEP 
2164.02.
    The courts have sanctioned the use of prophetic examples to meet 
the written description and enablement requirements for a patent 
application. See, e.g., Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 
1310 (Fed. Cir. 2015) (``efficacy data are generally not required in a 
patent application'' and ``a patentee is not required to provide actual 
working examples''). A patent application does not need to provide a 
guarantee that a prophetic example actually works. Id. at 1310. ``Only 
a sufficient description enabling a person of ordinary skill in the art 
to carry out an invention is needed.'' Id. The courts have further 
cautioned that the presence of prophetic examples alone should not be 
the basis for asserting that a specification is not enabling; rather, a 
lack of operative embodiments and undue experimentation should be 
determinative. Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 
F.2d 1569, 1577 (Fed. Cir. 1984).
    Disclosed results of tests and examples, whether working or 
prophetic examples, in a patent application are not normally questioned 
unless there is a reasonable basis for doing so. However, when 
prophetic examples are described in a manner that is ambiguous or that 
implies that the results are actual, the adequacy and accuracy of the 
disclosure may come into question. If the characterization of the 
results, when taken in light of the disclosure as a whole, reasonably 
raises any questions as to whether the results from the examples are 
actual, the examiner will determine whether to reject the appropriate 
claims based on an insufficient disclosure under the enablement and/or 
written description requirements of 35 U.S.C. 112(a) following the 
guidance in MPEP 2164 and 2163, respectively. When such a rejection(s) 
is made, the applicant may reply with the results of an actual test or 
example that has been conducted, or by providing relevant arguments 
and/or declaration evidence that there is strong reason to believe that 
the result would be as predicted, being careful not to introduce new 
matter into the application. MPEP 707.07(l) and 2161-2164.08(c).

Applicant's Duty of Disclosure

    Care should be taken to see that inaccurate or misleading 
statements, inaccurate evidence, or inaccurate experiments are not 
introduced into the record. MPEP 2004 sets forth best practices to 
avoid duty of disclosure problems (see, in particular, MPEP 2004, item 
8). As noted above, prophetic examples should not be described using 
the past tense. Hoffmann-La Roche, Inc. v. Promega Corp., 323 F.3d. 
1354, 1367 (Fed. Cir. 2003) (improperly identifying a prophetic example 
in the past tense validly raises an inequitable conduct issue based on 
the intent of the inventors in drafting the example in the past tense, 
when the example, in fact, is prophetic). Knowingly asserting in a 
patent application that a certain result ``was run'' or an experiment 
``was conducted'' when, in fact, the experiment was not conducted or 
the result was not obtained is fraud. Apotex Inc. v. UCB, Inc., 763 
F.3d 1354, 1362

[[Page 35075]]

(Fed. Cir. 2014) (the inventor ``admitted that he never performed the 
experiments described in the . . . patent, and yet he drafted the 
examples in the specification entirely in past-tense language.''). No 
results should be represented as actual results unless they have 
actually been achieved. Distinguishing prophetic examples from working 
examples in a clear manner will avoid raising issues relating to the 
applicant's duty of disclosure.

Best Practices

    When drafting a patent application, care must be taken 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.

Andrew Hirshfeld,
Commissioner for Patents, Performing the Functions and Duties of the 
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2021-14034 Filed 6-30-21; 8:45 am]
BILLING CODE 3510-16-P