[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.

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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]
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