Cleveland Clinic

By Eli Mazour

After the 2014 Supreme Court Alice decision, the judges of the Federal Circuit failed to reach a meaningful consensus regarding how the subject matter eligibility test set out in Alice should be applied.  As a result, new USPTO Director Andrei Iancu recognized that there was no practical way for examiners to navigate all of the patent eligibility decisions for each individual patent application.  To address this problem, the USPTO released the “2019 Revised Patent Subject Matter Eligibility Guidance.”

In the recent Cleveland Clinic Foundation v. True Health Diagnostics decision, a panel of the Federal Circuit invalidated claims related to cardiovascular testing under § 101 and stated that “[w]hile we greatly respect the PTO’s expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance” (Fed. Cir. 2019).  The decision caused consternation among some practitioners regarding the value of relying on USPTO guidance.

Director Iancu’s comments regarding Cleveland Clinic

This past Thursday, at the ABA’s annual IP conference, Iancu addressed those concerns.  First, he pointed out that Cleveland Clinic did not even mention the 2019 revised guidance.  Instead, Cleveland Clinic discussed Example 29 from guidance that was published by the PTO on May 4, 2016, which is almost two years before Iancu became the director.  Second, Iancu noted that Cleveland Clinic just stated that to the extent that Example 29 contradicts a court decision, the court decision controls.  In other words, Cleveland Clinic pointed out facts that were clear before the 2019 revised guidance was even released: 1) courts are not bound by guidance released by the USPTO and 2) incorrect guidance released by the USPTO would not override previous court decisions.  Cleveland Clinic did not in any way directly undermine the 2019 revised guidance.

Moreover, Iancu indicated a change in approach by the USPTO: instead of reacting to each new Federal Circuit decision that deals with § 101, the USPTO is now taking a look at the § 101 issue holistically.  And, Iancu argued that the Federal Circuit should address the § 101 problem through en banc decisions by the full Federal Circuit.  In totality, this suggests that a single Federal Circuit decision by a panel of three judges is unlikely to significantly change the USPTO’s approach set out by the 2019 revised guidance.

Practical tips for drafting & prosecution

As it stands now, USPTO examiners and PTAB judges are expected to apply the 2019 revised guidance for § 101 analysis.  In fact, ex parte appeal decisions that deal with § 101 are currently being reviewed at the PTAB to make sure that the 2019 revised guidance is being applied by PTAB judges.  Therefore, in order to ensure efficient prosecution and positive appeal results, practitioners should primarily rely on the 2019 revised guidance to overcome § 101 rejections.

However, when drafting new patent applications, practitioners should plan for the possibility of the Federal Circuit, the Supreme Court, or even possibly Congress taking a narrower view of patent eligibility.  Therefore, to the extent possible, patent applications should be drafted with all of the relevant court decisions in mind.  The goal should be for an eventual patent to be able to withstand – or even better yet avoid – the most stringent § 101 scrutiny during litigation.