On April 19, 2018, the United States Patent & Trademark Office (USPTO) issued a memorandum that explains the circumstances under which an examiner can conclude that technology is “well-understood, routine, and conventional,” a consideration used in assessing subject matter eligibility in accordance with the Court of Appeals for the Federal Circuit’s decision in Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018).i The memorandum notes that “unless careful consideration is given to the particular contours of subject matter eligibility (35 U.S.C. §101), it could swallow all of patent law.’"ii

In Berkheimer, the Federal Circuit established that allegations of a claim reciting well-understood, routine and conventional steps must be accompanied by concrete evidence that the steps are indeed "well-understood, routine, and conventional to a skilled artisan."iii Further, the Federal Circuit also recognized that the evidence proving that a technology is well-understood must go beyond what was simply known in the prior art because "the mere fact that something is disclosed in a piece of prior art, for example, does not mean it was well-understood, routine, and conventional."

The memorandum notes that while the Berkheimer decision did not change the basic subject matter eligibility framework, it did provide clarification that the examiner should conclude that an element represents well-understood, routine and conventional activity only when the examiner can readily conclude that the element is "widely prevalent or in common use in the relevant industry." Accordingly, the memo notes that the examiners, when formulating rejections, must provide express written support when alleging that additional element(s) are indeed well-understood, routine, and conventional.

The memorandum explains the impact of such analysis on examination procedure in formulating rejections and evaluating the applicant's response. For illustrative purposes, the memorandum provides four examples of proper express written support for rejecting a claim where one or more claim elements are well-understood, routine and conventional. First, the memorandum encourages the examiners to cite to "an express statement in the specification" or "a statement made by [the] applicant" that demonstrates the well-understood nature of a claimed element. The memorandum warns examiners that such allegation cannot be solely based on the fact that the specification is silent with respect to describing that particular element. Second, the memorandum allows the examiners to rely on previous court decisions that have discussed the well-understood, conventional or routine nature of the additional elements. The USPTO maintains a listing of such cases on its website. Third, the memorandum requires the examiners to cite to a publication that demonstrates the well-understood, routine or conventional nature of the additional elements. For example, an appropriate publication could include a book, manual, article or other source that describes the state of the art and discusses what is well known. However, the memorandum warns examiners that, to avoid gamesmanship, "merely finding the additional elements in a single patent or published application would not be sufficient to demonstrate that the additional element is well-understood understood, routine, conventional, unless the patent or published application demonstrates that the additional element are widely prevalent or in common use in the relevant field."iv Fourth, the memorandum allows examiners to take official notice of the well-understood, conventional or routine nature of the additional elements. However, the USPTO cautions the examiners that "this option should be used only when an examiner is certain, based on upon his or her personal knowledge, that additional element(s) represent well-understood, routine, or conventional activity engaged in by those in the relevant art."v

With respect to evaluating the applicant's response, the memorandum requires the examiners to reevaluate their rejections for patent ineligibility when the applicants challenge those rejections on the grounds that the additional element(s) are not well-understood, routine and conventional activity. For example, if the applicant challenges the examiner's official notice that an element or elements are not well-understood, routine and conventional activities, then the examiner must provide (i) a citation to "an express statement in the specification" or "a statement made by [the] applicant" that demonstrates the well-understood nature of a claimed element, (ii) a citation to previous court decisions that have discussed the well-understood, conventional or routine nature of the additional elements, (iii) a citation to a publication that demonstrates the well-understood, routine or conventional nature of the additional elements, or (iv) an affidavit or declaration under 37 CFR 1.104(d)(2) setting forth specific factual statements and explanation to support the applicant's position. If the examiner is unable to provide any of these responses, then the additional element(s) should be deemed as not well-understood, routine and conventional activity.

The memorandum appears to shift a burden in the patent eligibility analysis such that examiners can no longer reach a conclusion that elements are well-understood, routine and conventional without any evidentiary support. Examiners now need to demonstrate exactly how certain elements are well known, routine and conventional in order to sustain the patent eligibility rejections, rather than merely reciting that principle in a conclusory fashion or relying on a prior art without further explanation.

The USPTO republished the memorandum in the Federal Register on April 20, 2018. This publication serves as a notice and request for public comments on the USPTO's subject matter eligibility guidance, and specifically the guidance in the memorandum explained above. If you are interested in submitting such comments, please reach out to the authors.