Yesterday the USPTO issued subject matter eligibility guidance to its examining corps in a memorandum that changes how examiners approach their Alice Step 2B analysis. Specifically, the memo recognizes the Federal Circuit’s recent decision in Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018) and instructs examiners to abide by its holding. Berkheimer itself held that the question of whether certain claim limitations represent well-understood, routine, or conventional activity under Alice Step 2B is a factual issue, with Berkheimer precluding summary judgment that all of the claims at issue were not patent eligible. This principle was then reaffirmed by the Federal Circuit a week later in Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121 (Fed. Cir. 2018) in the context of a judgment on the pleadings and judgment as a matter of law.
As for the memo itself, it indicates that while Berkheimer does not change the basic subject matter eligibility framework set forth in MPEP § 2106, the case does provide clarification for the Alice Step 2B inquiry in that whether something is well-understood, routine, and conventional to a skilled artisan at the time of the patent is a factual determination. “[A]n examiner should conclude that an element (or combination of elements) represents well-understood, routine, conventional activity only when the examiner can readily conclude that the element(s) is widely prevalent or in common use in the relevant industry…[and] such a conclusion must be based upon a factual determination…This memorandum further clarifies that the analysis as to whether an element (or combination of elements) is widely prevalent or in common use is the same as the analysis under 35 U.S.C. § 112(a) as to whether an element is so well-known that it need not be described in detail in the patent specification [emphasis original].”
Then, before getting into the types of evidence that will suffice for such a factual determination, the memo reiterates that “[t]he question of whether additional elements represent well-understood, routine, conventional activity is distinct from patentability over the prior art under 35 U.S.C. §§ 102 and 103. This is because a showing that additional elements are obvious under 35 U.S.C. § 103, or even that they lack novelty under 35 U.S.C. § 102, is not by itself sufficient to establish that the additional elements are well-understood, routine, conventional activities or elements to those in the relevant field.”
The memo then provides four types of “evidence” that examiners can use in a Step 2B analysis, with any one of the following being sufficient.
First, “[a] citation to an express statement in the specification or to a statement made by an applicant during prosecution [may suffice] that demonstrates the well-understood, routine, conventional nature of the additional element(s). A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a). A finding that an element is well-understood, routine, or conventional cannot be based only on the fact that the specification is silent with respect to describing such element [emphasis added]”.
Second, a citation to one or more of the court decisions discussed in MPEP § 2106.05(d)(II) will suffice if the decision notes the well-understood, routine, or conventional nature of the additional element(s) of a given claim that is being examined. Providing a few examples, MPEP § 2106.05(d)(II) indicates that the following items are well-understood, routine, or conventional activity: receiving or transmitting data over a network, performing repetitive calculations, electronic recordkeeping, storing and retrieving information in memory, determining the level of a biomarker in blood, detecting DNA or enzymes in a sample, immunizing a patient against a disease, restricting public access to media by requiring a consumer to view an advertisement, and presenting offers and gathering statistics.
Third, a citation to a publication can be used that demonstrates the well-understood, routine, conventional nature of the additional element(s). “An appropriate publication could include a book, manual, review article, or other source that describes the state of the art and discusses what is well-known and in common use in the relevant industry. It does not include all items that might otherwise qualify as a ‘printed publication’ as used in 35 U.S.C. § 102. Whether something is disclosed in a document that is considered a ‘printed publication’ under 35 U.S. C § 102 is a distinct inquiry from whether something is well-known, routine, conventional activity. A document may be a printed publication but still fail to establish that something it describes is well-understood, routine, conventional activity…The nature of the publication and the description of the additional elements in the publication would need to demonstrate that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).”
Last, the examiner may take official notice of the well-understood, routine, or conventional nature of the additional element(s). However, the memo notes that the standards for official notice in this capacity are the same as for supporting a rejection under 35 U.S.C. § 103, as discussed in MPEP § 2144.03.
The memo then concludes by discussing how to evaluate a patent applicant’s response to the examiner’s use of one or more of the four types of evidence discussed above by stating that “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… that an element(s) is well-understood, routine, conventional activity, and the applicant challenges the examiner’s position, specifically stating that such element(s) is not well-understood, routine, conventional activity, the examiner must then provide one of the [three other types of evidence above], or an affidavit or declaration under 37 CFR 1.104(d)(2) setting forth specific factual statements and explanation to support his or her position.”