On April 1, 2019, the Court of Appeals for the Federal Circuit (CAFC) issued an opinion affirming a dismissal under Federal Rule of Civil Procedure 12(b)(6) by the United States District Court for the Eastern District of Virginia. Cleveland Clinic Foundation et al. v. True Health Diagnostics
, —F. App’x—, (Fed. Cir. Apr. 1, 2019). The CAFC ruled that the district court had correctly decided that the asserted claims are invalid as patent ineligible abstract ideas under 35 U.S.C. § 101.
Section 101 of the United States patent laws prescribes the categories of inventions and discoveries that can properly be the subject of a patent: “any new and useful process, machine, manufacture, or composition of matter.” These categories are limited by judicially-created proscriptions against patenting abstract ideas, laws of nature, and natural phenomena.
The Supreme Court has set out a two-step framework for determining patent eligibility:
Alice Corp. v. CLS Bank Int’l
- determine whether the claims at issue are directed to one of the patent-ineligible concepts (such as a law of nature); and, if so, then:
- determine whether the elements of the claim, considered both individually and as an ordered combination, recite an “‘inventive concept’ – i.e., an element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.’”
, 573 U.S. 208, 217 (2014) (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc.
, 566 U.S. 66, 72–73 (2012)).
The patents involved in this case are related to patents that were the subject of an earlier CAFC appeal. In that earlier appeal, the CAFC decided that claims directed to measuring the level of blood myeloperoxidase (MPO) and using that measurement to diagnose cardiovascular disease (CVD) were unpatentable because they merely described the natural law associating MPO with CVD.
In this case, the patent claims in question recited particular methods for measuring MPO blood levels, such as use of an enzyme-linked immunosorbent assay. The district court considered those patent claims and granted a motion to dismiss, holding that, like the earlier claims, these claims were directed to a natural law, and did not contain any inventive concept sufficient to render them patentable.
The CAFC affirmed. Despite the fact that the claims were on their face directed to measuring MPO levels in patients with CVD, the Court held that the claims were directed to the natural law associating MPO and CVD, and further held that the patent documents themselves admitted that the particular measurement methods claimed were known in the art, so those methods could not be an inventive concept. The Court therefore held the claims unpatentable.
Interestingly, the claims very closely paralleled the claim used in an example contained in official Patent Office guidance issued on May 4, 2016. In that guidance, the Patent Office explained that such claims are patentable. The CAFC held that while it respects the Office’s views concerning the patent laws, it is not bound by the Office’s guidance examples, and is instead bound by the Court’s own precedent holding such claims unpatentable. The case illustrates that while Patent Office guidance can be helpful in arguing for patentability in the Office, it is no guarantee that the resulting issued claims will be enforceable.