In a non-precedential decision, a three-judge panel of the Federal Circuit made clear that it would not give deference to USPTO patent eligibility guidance that it finds inconsistent with Supreme Court and Federal Circuit decisions. In the case before it, the patent owner (The Cleveland Clinic Foundation) argued that its claims should be found to satisfy 35 USC § 101 by analogy to Julitis Claim 1 of the USPTO guidance, but the panel found that example to be inconsistent with its decisions.

Julitis Claim 1

As summarized by the Federal Circuit panel, Example 29 of the USPTO patent eligibility examples published May 5, 2016 relates to “a hypothetical protein, ‘JUL-1,’ which naturally occurs in people with an autoimmune disease, ‘julitis,’ but not in others.” According to the example, the application “discloses ‘routine and conventional’ techniques, including an immunoassay and  spectroscopy, to detect the presence of the protein in a patient’s plasma sample.”

Claim 1 of the Julitis example recites:

1. A method of detecting JUL-1 in a patient, said method comprising:
a. obtaining a plasma sample from a human patient; and
b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

As explained in this article, the USPTO guidance cites the Supreme Court’s finding in Mayo that the “recited steps of administering a drug to a patient and determining the resultant level of 6-thioguanine in the patient “are not themselves natural laws” to reach the conclusion that this claim satisfies § 101.

However, the Federal Circuit panel (made up of Judges Lourie, Moore, and Wallach) found Julitis Claim 1 to be “strikingly similar” to claim 1 of the patent the Federal Circuit invalidated in Sequenom before the Julitis example was promulgated:

1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
amplifying a paternally inherited nucleic acid from the serum or plasma sample and
detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

As the panel recalls, “we held this claim ineligible because it was directed to the discovery that paternally inherited cffDNA exists in maternal blood plasma, … and the amplification and detection techniques were concededly known in the art.” As noted by the panel, the USPTO’s Example 29 similarly “stipulates that the techniques used to detect JUL-1 were conventionally applied to detect any protein of interest.” The panel explained further:

The only remaining non-conventional element of each claim is the discovery that the protein is present in the bodily sample, and the discovery of a natural law cannot by itself provide the requisite inventive concept.

The panel concludes:

[T]o the extent that Example 29–Claim 1 is analogous to the claims at issue, [Sequenom] must control. Accordingly, we decline to follow the PTO’s Example 29–Claim 1 and conclude that the district court did not err in its consideration of the PTO’s subject matter eligibility

Who Got It Wrong First?

If the USPTO’s guidance on Julitis Claim 1 is based on the Supreme Court decision in Mayo, is it the  USPTO who got it wrong, or did the Federal Circuit go too far with Sequenom?