Mind Your Examples

06 July 2021 PharmaPatents Blog
Authors: Courtenay C. Brinckerhoff

In an unusual Federal Register Notice, the USPTO “reminded” 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.” According to the USPTO, “The distinction must be clear to satisfy the written description and enablement requirements and comply with the applicant's duty of disclosure.”

Prophetic Examples versus Working Examples

In the Federal Register Notice, the USPTO distinguishes between “prophetic examples” which “describe experiments that have not in fact been performed,” and “working examples” which “correspond to work performed or experiments conducted that yielded actual results.” The Notice refers to MPEP guidance to the effect that “prophetic examples should not be described using the past tense,” but “may be written in future or present tense.”

Written Description and Enablement

The Federal Register Notice discusses the relationship between the presentation of examples and satisfaction of the written description and enablement requirements, while acknowledging that examples are not always required and that prophetic examples may be sufficient. However, the Notice warns:

[W]hen 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 ….

Duty of Disclosure

The Federal Register Notice refers to two Federal Circuit decisions indicating that describing  examples that have not been carried out in a manner that suggests they were actually conducted raises inequitable conduct issues. The USPTO advises:

Distinguishing prophetic examples from working examples in a clear manner will avoid raising issues relating to the applicant's duty of disclosure.

Best Practices?

The Federal Register Notice outlines “best practices” that may go beyond the cited MPEP guidance. In addition to ensuring “the proper tense is employed to describe experiments and test results so readers can readily distinguish between actual results and predicted results,” the USPTO suggests:

It is a best practice to label examples as prophetic or otherwise separate them from working examples to avoid ambiguities.

Interestingly, the USPTO suggests making the distinction clear not just to the examiner, but also to “a person having ordinary skill in the art … including those who may not have the level of skill of the inventor” and to “the public.”

Changing Practices?

This Federal Register Notice is unusual, because the USPTO does not often publish “practice tips” in the Federal Register. It makes one wonder if the USPTO has seen an increase in prophetic examples not presented as such, or if a particular case has raised concerns. 

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