Following the Federal Circuit’s decisions in Berkheimer, AATRIX, and ATS, the role of evidence and factual conclusions in the eligibility analysis is in a somewhat confused state. That setup makes Cleveland Clinic’s recent petition for writ of certiorari quite timely.
Cleveland Clinic Foundation v. True Health Diagnostics LLC, Supreme Court Docket No. 17-997 (2018) questions presented:
In this case, the patents were fully examined by the PTO and found to be novel and not obvious, including for one of the patents, confirmation after two ex parte reexaminations. The PTO further found that the prior art taught away from the claimed inventions. Notwithstanding …, the district court declared [the patents] invalid at the pleading stage. It gave the patents a cursory review, and refused to construe any claim terms. It took 55 separate claims – each claiming a distinct invention with many different limitations – and analyzed them as if all of the claimed inventions were a single method with two simplistic steps. The court did not permit evidentiary submissions or development of the record, and while the district court purported to take judicial notice of the prosecution history, it ignored the PTO record in its analysis. The Federal Circuit affirmed the lower court, invalidating valuable patent rights in a new and nonobvious diagnostic method using known techniques to detect an element in blood, but where the inventors had discovered that adapting known techniques for an entirely new purpose yielded medically-relevant data not known in the prior art and, in fact, taught away from by the prior art.
The questions presented are:
1. Whether the court below erred in holding, contrary to Mayo, that a method involving natural phenomena is ineligible for patent protection if it claims known techniques that have been adapted for a new use and purpose not previously known in the art.
2. Whether Mayo authorizes a district court to invalidate valuable patent rights on the pleadings when there are disputed questions of fact, a disputed question of claim construction or scope, and/or an undeveloped evidentiary record, notwithstanding the presumption of patent validity and settled procedural and Seventh Amendment safeguards that ordinarily prevent the resolution of such disputed questions on the pleadings.
The petition was filed in January and was supported by an Amicus brief filed by Raymond Mercado. In the wake of Berkheimer and AATRIX the petitioner then filed a supplemental brief setting up the conflict between Judges Moore and Stoll on the one hand and Judge Reyna on the other (Judge Reyna was also author of the Cleveland Clinic decision).
- Patents At Issue: U.S. Patent Nos. 7,223,552, 7,459,286, and 8,349,581.
- Petition for Writ of Certiorari
- Appendix that includes the Federal Circuit Decision and Other Material
- Mercado Amicus Brief
- Supplemental Brief
The defendant in this case, True Health Diagnostics, has waived its right to respond to the petition. If the Supreme Court has any interest in the case, the most likely next step would be to ask True Health for responsive briefing — likely followed by a request for the views of the Solicitor General.