In Berkheimer, the Federal Circuit held that “[w]hether something is well-understood, routine, and conventional to a skilled artisan at the time of the patent is a factual determination.” Id. at 1369. The USPTO interpreted this to apply to § 101 rejections based on an element (or combination of elements) representing well-understood, routine, conventional activity. This change will be formally applied in a modification to MPEP procedures regarding subject matter eligibility.
One change impacts formulating rejections. Under the new guidance, an examiner must cite express support that an additional element (or combination of elements) is well-understood, routine or conventional. Support can come from a citation to an express statement in the specification or to a statement made by an applicant during prosecution; a citation to one or more of the court decisions discussed in the MPEP; a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); or a statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s). Additional support and requirements are needed for an examiner to use the latter category.
When evaluating an applicant's response, the examiner should reevaluate whether it is readily apparent that the additional elements are in actuality well understood, routine, conventional activities to those who work in the relevant field. If the examiner has taken official notice, the examiner must provide one of the other basis for support noted above, or provide an affidavit or declaration under 37 CFR 1.104(d)(2) setting forth specific factual statements and explanation to support the position. To learn more click here.
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