On April 19, 2018, the United States Patent and Trademark Office (USPTO) issued a Memorandum to the Patent Examining Corps with guidance for determining whether a claim element is “well-understood, routine or conventional” when making a determination of subject matter eligibility under 35 U.S.C. §101.

A two-part test for determining subject matter eligibility was set forth by the Supreme Court in Mayo1 and Alice 2 and can be found in the Manual of Patent Examining Procedure (M.P.E.P.) §2106. Step 1 determines whether the claims are directed to one of the four categories of patentable subject matter: a process, a machine, an article of manufacture, or a composition of matter. Step 2 has two parts. In part 2A, a determination is made as to whether the claim is directed to a judicial exception: a law of nature, a natural phenomenon (product of nature) or an abstract idea. If the invention is directed towards a judicial exception, part 2B requires determining whether the claims recite additional elements that amount to significantly more than the judicial exception. One consideration for determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine or conventional.

The USPTO Memorandum was prompted by the decision of the Federal Circuit in Berkheimer3 and relates to the analysis under Part 2B, i.e., whether the additional element(s) recited by the claims represent “well-understood, routine or conventional” activity.

The USPTO Memorandum clarifies that an Examiner can only conclude that an element represents well-understood, routine or conventional activity when the element is “widely prevalent or common in use in the relevant industry.” The memorandum clarifies that this is a factual determination that must be supported by one or more of the following:

 

1. A citation to an express statement in the specification or a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional elements(s)4;

2. A citation to one or more court decisions listed in the M.P.E.P.5 noting the well-understood, routine or conventional nature of the additional element(s);

3. A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s)6; or

4. A statement that the Examiner is taking official notice of the well-understood, routine and conventional nature of the additional element(s).

The Memorandum notes that the M.P.E.P. will be updated to incorporate the changes to the patent eligibility analysis under 35 U.S.C. §101 laid out in the Memorandum.

Mayo v. Prometheus, 132 S.Ct 1289 (2012)
Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 134 S.Ct. 2347 (2014)
Berkheimer v. HP, Inc., 881 F.3d 1360 (Fed. Cir. 2018)
For an Examiner to conclude that a claim element is well-understood, routine or conventional, the specification must describe the element 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).” (See, Memorandum, p. 3)
M.P.E.P. §2106.05(d)(II)
The Memorandum notes that this does not includes all items that might otherwise qualify as a printed publication such that a document may be a printed publication and still not establish that something is well known, routine or conventional. (See, Memorandum, p. 4)

See Berkheimer v. HP, Inc. here.
See the Opinion here.

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