[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]
-----------------------------------------------------------------------
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