USPTO Issues Patent Eligibility Examination Guidance Under Berkheimer

23 April 2018 PharmaPatents Blog
Authors: 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 Eligibility2018@uspto.gov 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.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.