Judicial and Executive Branches split over Subject Matter, New Legislation may be Coming

April 10, 2019
Post by Oliver P. Couture, Ph.D.

Earlier this month the U.S. Court of Appeals for the Federal Circuit (CAFC) heard another appeal in the Cleveland Clinic v. True Health cases. In their appeal, one of Cleveland Clinic’s arguments that their claims were valid was because Skidmore deference should apply to the Examiner’s decision to allow the application to issue in light of the Julitis example (Example 29) of the subject matter guidelines. True Health argued that the guidelines were not relevant because they did not claim the link between the test and the disease and were just a method of detection. The CAFC, siding with True Health, unsurprisingly held the claims invalid. The CAFC further stated that while they recognize the PTO’s expertise, they are not bound by the guidelines, but are bound by the court’s precedence, such as Ariosa.

This puts the administrative and judicial on seemingly opposite ends of the subject matter issue, even more so under the new PTO subject matter guidelines. Under the new guidelines, if a claim recites a judicial exception, it must integrate the exception into a practical application to be subject matter eligible. However, currently, even if a patent is deemed valid by the PTO, it may not be enforceable in the courts due to the different approaches.

However, there does appear to be new legislation that may be out as early as this summer which may reform Section 101. Senators Thom Tillis and Chris Coons have organized roundtable meetings to address this issue and may have a skeletal outline as soon as next week. The roundtables have already outlined what they have deemed to be four guiding principles, including:

  1. Subject matter eligibility should not turn on if the technology is old, conventional, known, or any other factors relevant to obviousness or anticipation;
  2. The claims must be construed as a whole and it will be impermissible to dissect a claim and assess each part separately;
  3. Diagnostic and life science technologies should be eligible for patent protection per se, subject to meeting the other statutory requirements; and
  4. There will no longer be judicial exceptions, only statutory exceptions codified in Section 101 which would be the sole and exclusive basis for excluding subject matter.

It would be a welcomed boon to the entire biotechnology field if the guiding principles became codified.

Oliver P. Couture is an Intellectual Property Attorney in the Biotechnology & Chemical Patent Practice Group at McKee, Voorhees & Sease, PLC. For additional information please visit the MVS website or contact Oliver directly via email at

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