Analyzing the Impact of the USPTO’s Berkheimer Memorandum

“…it would seem that, going forward, applicants would be wise to remove (or at least rethink) certain statements in their application specification that could be interpreted as indicating that certain features and/or elements of a claimed invention are well-understood, routine, and/or conventional in the art.”

 

 by: Adam Saxon, Senior Vice President, Licensing | May 15, 2018

As is now well known by those who make a living by working with U.S. patents, last month the USPTO issued what is now known as the Berkheimer memorandum to its Examiner corps, to implement the Federal Circuit’s Berkheimer decision regarding the inquiry of whether a claim limitation represents well-understood, routine, conventional activities (or elements) to a skilled artisan in the relevant field.

A major takeaway from the Berkheimer memorandum is that the USPTO has instructed its Examiners that a conclusion of well-understood, routine, conventional activities must be based upon an actual factual determination, and the analysis to be applied to this inquiry is the same as that 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.  To better understand the implications of the Berkheimer memorandum’s guidance and how it is to be applied in practice, it is helpful to review MPEP 2106.05(d) which covers the analysis of whether a claim recites Well-Understood, Routine, Conventional Activity (this is done in the context of Step 2B of the Mayo/Alice framework for analyzing subject matter eligibility under MPEP 2105.05).  As the Berkheimer memorandum points out, Examiners have a few specific means available on which to base a factual conclusion that an additional element (or combination of elements) is well-understood, routine or conventional, such that a subject matter eligibility rejection can be supported (i.e. the claim does not amount of significantly more under Mayo/Alice Step 2B).

First, and perhaps the easiest to implement, is that an Examiner may support a subject matter eligibility rejection by 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) to the extent necessary to satisfy 35 U.S.C. 112(a).  Given that an Examiner need only review the pending application disclosure and monitor applicant responses during prosecution for such a statement, it is likely that most if not all Examiners will attempt to utilize this type of citation support, when available, when making a subject matter eligibility rejection under Mayo/Alice Step 2B based on a pending claim representing well-understood, routine, conventional activities (or elements) to a skilled artisan in the relevant field.

Second, an Examiner my cite 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).  Under the most recently updated version of the MPEP (revised in January 2018), § 2106.05(d)(II) identifies a total of twenty-one areas of well‐understood, routine, conventional activities across three separate categories—seven activities are recognized under the computer functions category (including but not limited to: receiving or transmitting data over a network, performing repetitive calculations, and electronic record keeping), eight activities are recognized under the laboratory techniques category (including but not limited to: detecting DNA or enzymes in a sample, and immunizing a patient against a disease), and seven activities are recognized under the “other types of activity” category (including but not limited to: recording a customer’s order; presenting offers and gathering statistics; and arranging a hierarchy of groups, sorting information, eliminating less restrictive pricing information and determining the price).  Examiners are also likely to utilize this case citation means to support a subject matter eligibility rejection under Mayo/Alice Step 2B given that Examiners routinely cite to relevant cases, under USPTO guidance, to support rejections based on eligibility or validity, thus the Berkheimer memorandum allows Examiners to continue this practice with respect to formulating and supporting rejections based on an additional claim element (or combination of elements) being well-understood, routine or conventional.

Third, Examiners may cite to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s).  Though more experienced Examiners (those being more familiar with the scientific and technical literature in a given field) may make use of this means of rejection under the Berkheimer memorandum, it is likely that Examiners will try for the first or second means discussed above, to the extent possible,  before turning to this third means due to the manual effort that in many cases may be required to locate and review candidate publications that include disclosure that can be cited in support of a rejection that an additional claim element (or combination of elements) is well-understood, routine or conventional.

Fourth, and lastly, an Examiner may support a rejection under the Berkheimer memorandum based on a statement that the Examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s). As the Berkheimer memorandum instructs, 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).”  Given the rather strict procedures for taking official notice (see MPEP § 2144.03), the applicant’s ability to traverse such a rejection and the skepticism with which applicants may view the taking of official notice, and the other means available to Examiners to formulate rejections under the Berkheimer memorandum, it is likely that Examiners will look to one of the other means of rejection under the Berkheimer memorandum prior to resorting to the taking of official notice in support of a rejection that an additional claim element (or combination of elements) is well-understood, routine or conventional.

Based on a review of the means available to Examiners under the Berkheimer memorandum to support a rejection that an additional claim element (or combination of elements) is well-understood, routine or conventional, it would appear that most Examiners will try to utilize the first means (citation to an express statement in the specification or to a statement made by an applicant during prosecution) or the second means (citation to relevant decision) before attempting to utilize the third means (citation to a publication) or fourth means (taking of official notice).

Thus it would seem that, going forward, applicants would be wise to remove (or at least rethink) certain statements in their application specification that could be interpreted as indicating that certain features and/or elements of a claimed invention are well-understood, routine, and/or conventional in the art.  Furthermore, prosecution counsel for applicants should continue to closely monitor decisions out of the Federal Circuit that involve a holding of well-understood, routine, and/or conventional activity in the art such that prosecution counsel is readily able to distinguish such a holding (and the facts of the underlying case) from the applicant’s pending claims should an Examiner cite to a case holding as a basis for rejecting applicant’s claims under Mayo/Alice Step 2B because a claim limitation represents well-understood, routine, conventional activities (or elements) to a skilled artisan in the relevant field.

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