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. 

Special Accommodations 

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 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices 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 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 

AGENCY: Department of the Air Force, 

Department of Defense (DoD). 

ACTION: 30-Day information collection 

notice. 

SUMMARY: 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. 

ADDRESSES: 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. 

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 

AGENCY: Defense Acquisition 

Regulations System, Department of 

Defense (DoD). 

ACTION: Notice. 

SUMMARY: 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. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES