USPTO Issues Patent Eligibility Examination Guidance Under Berkheimer

23 April 2018 PharmaPatents Blog
Author(s): Courtenay C. Brinckerhoff

As announced in a Federal Register Notice dated April 20, 2018, the USPTO has issued a new memorandum to the Examining Corps providing supplemental patent eligibility examination guidance under Berkheimer, a Federal Circuit decision that addressed the evidentiary requirements for establishing that something is “well-understood, routine, or conventional.”

The Berkheimer Decision

In Berkheimer v. HP Inc. the Federal Circuit emphasized the factual nature of the second step of the Alice/Mayo patent eligibility analysis:

The question of whether a claim element or combination of elements is well-understood, routine and conventional to a skilled artisan in the relevant field is a question of fact. Any fact, such as this one, that is pertinent to the invalidity conclusion must be proven by clear and convincing evidence.

The court confirmed that “not every § 101 determination contains genuine disputes over the underlying facts material to the § 101 inquiry,” but held that when it does, summary judgment is not appropriate. The court also reiterated the principles that “[w]hether a particular technology is well-understood, routine, and conventional goes beyond what was simply known in the prior art,” and that “the mere fact that something is disclosed in a piece of prior art … does not mean it was well-understood, routine, and conventional.”

Noting that the patent specification at issue included a detailed description of features recited in certain dependent claims, the court vacated and remanded the lack of eligibility finding as to those claims.

The Berkheimer Memo Updates MPEP § 2106

The Federal Register Notice discusses the Berkheimer memorandum, which is a memorandum to the Examining Corps explaining how the USPTO should be determining subject matter eligibility. Neither the Federal Circuit decision nor the memorandum alter the substantive requirements for patent eligibility. Rather, they focus on the evidence required to reach a finding of ineligibility under step two of the Alice/Mayo analysis.

As set forth in the Federal Register Notice “[t]he Berkheimer memorandum revises the procedures set forth in MPEP § 2106.07(a) (Formulating a Rejection For Lack of Subject Matter Eligibility) and MPEP § 2106.07(b) (Evaluating Applicant’s Response).”

As to “Formulating Rejections,” the Berkheimer revisions provide that “an additional element (or combination of elements) is not well-understood, routine or conventional unless the examiner finds, and expressly supports a rejection in writing with, one or more of the following:

  1. A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s).
  2. A citation to one or more of the court decisions discussed in MPEP § 2106.05(d)(II) as noting the well-understood, routine, 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).
  4. A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s).

With regard to the first option, the Federal Register Notice provides the following additional guidance:

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.

With regard to the fourth option, the Federal Register Notice references MPEP § 2144.03 and states:

This option should be used only when the examiner is certain, based upon his or her personal knowledge, that  the additional element(s) represents well-understood, routine, conventional activity engaged in by those in the relevant art, in 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).

If an applicant challenges such an assertion, the examiner must provide evidence in accordance with options 1-3, 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.”

Public Comment Period

The USPTO is seeking public comments on these proposed revisions to the MPEP. Written comments should be sent by email to by August 20, 2018.

Incentive For More Robust Specifications

Both the Berkheimer Federal Circuit decision and the Berkheimer memorandum make clear that whether a feature is described in detail in the specification is not dispositive on the issue of whether that feature is “well-understood, routine, or conventional.” However, the Berkheimer decision indicates that patent owners may be able to at least prevent summary judgment by describing in detail features that may be considered under step two of the Alice/Mayo eligibility analysis. While inventors may not consider such features to be at the core of their inventions, if features that integrate a natural product, natural phenomenon, or abstract idea into specific applications of the invention are not well-routine, understood, and conventional, the Berkheimer guidance provides even more incentive to elaborate on those features in the specification.

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