USPTO Subject Matter Eligibility Guidance Does Not Carry the Day in Court

In Cleveland Clinic Foundation v. True Health Diagnostics LLC (nonprecedential), the Federal Circuit affirmed the district court’s order granting defendant’s Rule 12(b)(6) motion to dismiss because the asserted patent claims are invalid under Section 101. The two asserted patents issued from applications that claimed priority to a patent that the Federal Circuit had found invalid because it was directed to ineligible subject matter under Section 101.

After the claims of the parent patent were invalidated, the Cleveland Clinic obtained claims that were directed to techniques for detecting elevated levels of myeloperoxidase in the blood of patients having cardiovascular disease. The new claims, however, did not survive the Section 101 challenge.

The Federal Circuit rejected the argument that the new claims were not directed to a natural law finding that merely rephrasing the claims does not make them less directed to a natural law. The court also rejected the argument that the claims are not directed to a natural law because only certain techniques can be used to observe the natural law. Natural laws exist regardless of the methods used by humans to observe them.

Under the second prong of the Mayo test, the Federal Circuit found that the new claims contained no additional inventive step. Here, the court relied on its earlier cases to reject the argument that using a known technique in a standard way to observe a natural law can confer an inventive concept. Thus, it is not enough dress up a natural law with known techniques used in a standard way to show an inventive step.

The Cleveland Clinic argued that the district court failed to give the appropriate deference to the USPTO’s subject matter eligibility guidance, namely, Example 29 of the guidance. The Federal Circuit explicitly stated that it is not bound by the USPTO’s guidance. This is a strong reminder that the USPTO’s guidance does not have the force of law.

The Federal Circuit analyzed the hypothetical claim of Example 29 and concluded that it was indistinguishable to the claims that were found invalid under Section 101 in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). The court considered Example 29, however, it declined to follow the hypothetical claim of Example 29 because the claim is invalid under Ariosa, which is the controlling law.

Although the USPTO’s subject matter eligibility guidance is a good tool for prosecuting claims, practitioners should make sure that the claims conform with case law regarding subject matter eligibility by the Federal Circuit and the Supreme Court.

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