On April 19, the USPTO released a Memorandum from Robert Bahr, The Deputy Commissioner for Patent Examination Policy, that summarized the support required for a finding if a claim directed to a judicial exception to s. 101 eligibility under Step 2A of the Mayo/Alice analysis chart of MPEP 2106 – a natural phenomenon, an abstract idea or a product of nature [ ed. note “PAIN’]– contains an additional inventive concept that, taken alone or in combination, would not represent well-understood, routine, or conventional [“WRC”] activity. The Memorandum was prompted by the recent decision in Berkheimer v. HP, 881 F.3d 1360 (Fed. Cir. 2018).

At virtually the same time, Director Iancu released a Request for Comments on Determining Whether a claim element is [WRC] for the Purposes of Subject Matter Eligibility, and it pretty much repeats the factors listed in the Bahr Memorandum. For a detailed summary of the factual underpinnings that an examiner must make in order to support a rejection on the basis that a claim directed to a PAIN does not meet the inventive concept requirement because it is WRC, please refer to my post of April 20^th.

I criticized the four factors outlined in the Memorandum/Request for using the s. 112 standard that that which is known to the art need not be set forth fully in the specification, as a blaze mark to guide examiners in determining whether the additional elements(s) in the claim are WRC. In other words, if the specification does not give the details of how to measure a biomarker, the examiner can use such facts to support a WRC finding. This relying on material not present in the specification is repeated in Factors 1, 3 and 4. I also criticized Factor 2 as permitting examiners to simply cite to “one or more court decisions discussed in MPEP 2106(5)(d)(2)” as noting the WRC nature of the additional element(s) in the claim, primarily due to the breadth of the summaries of the cases in this section of the MPEP.

The Revised Guidance in the May 8^th Presentation (which is available as a slideshow from the PTO) takes these two criticisms to heart. It drops the reference to the value of a s. 112 analysis in Factors relating to the evidence of WRC provided by the specification, the disclosures in the prior art and the ability of the examiner to take official notice of the WRC, which usually will be based upon disclosures in the prior art.

The Revised Guidelines start out by stating that the examiner should conclude that a claim element(s) represents only WRC activity only if he/she can conclude that the element(s) is “widely prevalent or in common use in the relevant industry,” a conclusion that must be supported by factual determinations. Here is a quick run-down of the four “Options” that the examiner can use to demonstrate that a claim directed to PAIN does not contain more than elements that are WRC (These are mostly my words):

1. Applicant makes a “statement against interest” in the specification or during prosecution that a claim element(s) is conventional, widely prevalent or in common use, or is a commercially available product.

2. The examiner can cite to one or more court decisions as noting the WRC nature of the additional elements, as reported in MPEP 2106(d)(II). I criticized this as overly broad, especially in view of the fact that there is almost no case law involving diagnostic testing or methods of medical treatment. Interestingly, in Vanda v. West-Ward, the Fed. Cir. stated that the Mayo claims were diagnostic claims. This is a stretch – What condition did they diagnose? The recited patient had been treated with the drug before any sample testing was carried out. However, the revised guidelines make it clear that the additional element in the claim must be the same as the element addressed in the court case, as well as the fact that the case must be on the MPEP list. Vanda v. West-Ward should be added to this list.

3. The examiner finds prior art publication(s) that demonstrate that the element(s) in questions are WRC, not just in existence at some point in the past. This should come from the prior art located in the search done by the Examiner or disclosed by Applicant.

4. The examiner is permitted to take official notice of the WRC of the additional element(s) but only to be used when the examiner is certain thereof based upon his/her personal knowledge. For all but the most indisputable WRC, the examiner may be required to provide a declaration under 37 CFR 1.104(d)(2).

If more than one element is present, the examiner must show that the combination of the elements is WRC in the pertinent art. If the examiner cited to a publication not previously of record in response to an argument by applicant, the office action should not be made final.

Comments must be received by Aug. 20, 2018 by submitting them to Eligibilty2018@USPTO.gov.