Medical Diagnostic Patent Ineligible Under Section 101 

April 10, 2019

On January 7, 2019, the U.S. Patent and Trademark Office issued its 2019 Revised Patent Subject Matter Eligibility Guidance. The 2019 Guidance revises the PTO’s procedures for determining whether a claim is directed to a judicial exception to patent subject matter eligibility.

Prior to the 2019 Guidance, the PTO had issued Examples 1-36 to provide guidance on eligible subject matter. All claims identified as patent eligible in these examples continued to be eligible under the 2019 Guidance.

However, on April 1, 2019, the Federal Circuit in Cleveland Clinic Foundation v. True Health Diagnostics LLC, declined to follow the PTO’s “Example 29-Claim 1,” and concluded that the district court did not err in finding the medical diagnostic claims at issue ineligible under 35 U.S.C. § 101, noting that the claims were strikingly similar to those found to be patent ineligible in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).

Claim 1 in Ariosa states:

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.

In Ariosa, the Federal Circuit held that this medical diagnostic claim was ineligible under § 101 because it was directed to the discovery that paternally inherited cell-free fetal DNA exists in maternal blood plasma, and the amplification and detection techniques were known in the art.

After the decision in Ariosa, on May 4, 2016, the PTO issued Example 29–Claim 1, an example of a medical diagnostic claim, directed to the detection of a hypothetical protein, JUL-1. Claim 1 of Example 29 states:

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.

The PTO stated that Example 29-Claim 1 does not recite or describe any ineligible concept and is therefore eligible under § 101.

In Cleveland Clinic, however, the Federal Circuit reasoned that like the claims in Ariosa, Example 29–Claim 1, is directed to using techniques to detect JUL-1 that were conventionally applied to detect any protein of interest, and the only remaining non-conventional element of the claim is the discovery that the JUL-1 protein is present in a bodily sample. The Federal Circuit concluded that to the extent that Example 29–Claim 1 is analogous to the claims at issue in Cleveland Clinic, Ariosa controls.

In Cleveland Clinic, claim 1 of U.S. Patent No. 9,575,065 is representative:

1. A method of detecting elevated MPO [myeloperoxidase, a naturally occurring protein] mass in a patient sample comprising:

a) obtaining a plasma sample from a human patient having atherosclerotic cardiovascular disease (CVD); and

b) detecting elevated MPO mass in said plasma sample, as compared to a control MPO mass level from the general population or apparently healthy subjects, by contacting said plasma sample with anti-MPO antibodies and detecting binding between MPO in said plasma sample and said anti-MPO antibodies.

The Federal Circuit in Cleveland Clinic held that claim 1 (and other claims like it) were “directed to the natural law that blood MPO levels correlate with atherosclerotic CVD” and “contain no additional inventive concept,” because the “claimed method uses a known technique in a standard way to observe a natural law.”

Some commentators have questioned whether 35 U.S.C. § 101 should be amended to provide broader patent eligibility for medical diagnostic patents. On March 13, 2019, Chairman Tillis and Senator Coons of the Subcommittee on Intellectual Property of the Senate Judiciary Committee discussed the “mess” of § 101 patent eligibility and the “disincentive” to invent in medical diagnostics. They explained that they are working together on a legislative solution to § 101, which they expect to present by early summer. Stay tuned.



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