The Federal Circuit decision in Cleveland Clinic Foundation confirms that controlling case law supersedes any guidance from the US Patent and Trademark Office on subject matter eligibility. Practitioners drafting patent claims should ensure their claims conform to both PTO guidance regarding subject matter eligibility and Federal Circuit Section 101 case law.
Many hoped the US Court of Appeals for the Federal Circuit’s decision in Cleveland Clinic Foundation v. True Health Diagnostics, LLC would clarify when method claims post-Vanda implicate a patent-ineligible natural law under 35 USC § 101. Instead, the Federal Circuit issued a nonprecedential opinion tracking its previous decisions, and ultimately holding the claims invalid under Section 101 as (1) directed to a patent-ineligible natural law and (2) reciting no other inventive concept.
Although the Federal Circuit’s holding did not articulate any bright-line rules or further advance the jurisprudence surrounding method claims relating to natural laws, the court did address subject matter eligibility guidance by the US Patent and Trademark Office (PTO). In particular, it rejected Example 29 of a May 4, 2016, PTO guidance as inconsistent with the Federal Circuit’s holding in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).
This rejection may affect how practitioners view and apply the post-Vanda PTO guidance regarding subject matter eligibility. Cleveland Clinic II’s confirmation that controlling case law supersedes any PTO guidance counsels that practitioners drafting patent claims should ensure their claims conform with not only the PTO guidance regarding subject matter eligibility but also Federal Circuit case law.
In Cleveland Clinic Foundation v. True Health Diagnostics LLC, the Federal Circuit held that Cleveland Clinic’s US Patent 7,223,552 (the ‘552 Patent) was “directed to the ineligible natural law that blood MPO [myeloperoxidase] levels correlate with atherosclerotic CVD.” In this case, Cleveland Clinic asserted method claims from patents issuing from continuations of the ‘552 Patent—US Patent 9,575,065 and US Patent 9,581,597. The Federal Circuit found Claim 1 of the ‘597 patent to be illustrative:
1. A method for identifying an elevated myeloperoxidase (MPO) concentration in a plasma sample from a human subject with atherosclerotic cardiovascular disease comprising:
a) contacting a sample with an anti-MPO antibody, wherein said sample is a plasma sample from a human subject having atherosclerotic cardiovascular disease;
b) spectrophotometrically detecting MPO levels in said plasma sample;
c) comparing said MPO levels in said plasma sample to a standard curve generated with known amounts of MPO to determine the MPO concentration in said sample; and
d) comparing said MPO concentration in said plasma sample from said human subject to a control MPO concentration from apparently healthy human subjects, and identifying said MPO concentration in said plasma sample from said human subject as being elevated compared to said control MPO concentration.
The Federal Circuit acknowledged the difference between the continuation claims and the original, ineligible method in Cleveland Clinic I—specifically that the continuation claims “recite methods of identifying and detecting MPO, in contrast to the ‘552 patent’s claimed method of assessing atherosclerotic CVD risk from blood MPO levels.”
Relying on the immunoassay identification and detection technique, Cleveland Clinic argued that (1) the claims are directed to this specific technique for detecting blood MPO levels; (2) the correlation between blood MPO and atherosclerotic CVD is not a natural law because it could only be detected using certain techniques; and (3) applying an immunoassay to blood MPO levels supplies an inventive concept. Conversely, True Health argued that (1) the correlation between blood MPO and atherosclerotic CVD is a natural law, regardless of any detection difficulty; and (2) using “known techniques in a standard way to observe the natural law neither renders the claims directed to something other than this natural law nor supplies an additional inventive concept.”
The Federal Circuit agreed with True Health, finding that the continuation claims—like the parent claims in Cleveland Clinic I—recited a patent-ineligible natural law:
The claims are not directed to new techniques for performing an immunoassay to detect a patient’s blood MPO levels. They only recite applying known methods to detect MPO levels in plasma, comparing them to standard MPO levels, and reaching a conclusion: that the patient’s blood MPO levels are elevated in comparison to a control group. This conclusion is simply another articulation of the natural law that blood MPO levels correlate with atherosclerotic CVD.
It explained that “laws of nature exist regardless of the methods used by humans to observe them,” and noted that Ariosa’s patent-ineligible claim for detecting cffDNA in maternal blood plasma was similarly situated to blood MPO levels here.
The Federal Circuit also held the claims contained no additional inventive concept to make the claims patent eligible. It rejected Cleveland Clinic’s argument that “using a known technique in a standard way to observe a natural law can confer an inventive concept,” noting that this argument “has been consistently rejected by this court in circumstances nearly identical to this case.” It further rejected Cleveland Clinic’s assertion that remand was warranted due to the district court improperly resolving factual disputes against it at the pleadings stage, observing that the patents’ “specification and prosecution history plainly concede that each of the process steps was well-known in the art.”
Cleveland Clinic additionally argued that the district court failed to give appropriate deference to the PTO’s guidance regarding subject matter eligibility. Cleveland Clinic specifically relied on Example 29–Claim 1 from the PTO’s May 4, 2016, guidance, which it argued was comparable to the asserted claims and deemed patent eligible by the PTO:
Example 29–Claim 1
1. A method of detecting JUL-1 in a patient, said method comprising:
a. obtaining a plasma sample from a human
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 Federal Circuit, however, found that “Example 29–Claim 1 is strikingly similar to claim 1 of U.S. Patent 6,258,540” at issue in Ariosa:
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.
Although it explained that it “greatly respect[ed] the PTO’s expertise on all matters relating to patentability, including patent eligibility,” the Federal Circuit made clear that it is “not bound by its guidance.” Moreover, it noted the importance, “especially regarding the issue of patent eligibility and the efforts of the courts to determine the distinction between claims directed to natural laws and those directed to patent-eligible applications of those laws,” for “the need for consistent application of [its] case law.” Thus, the court explained, “to the extent that Example 29–Claim 1 is analogous to the claims at issue, Ariosa must control.”
The Federal Circuit’s nonprecedential decision in Cleveland Clinic II reaffirmed that conformance with the court’s Section 101 case law will continue to control future decisions. Cleveland Clinic II also may influence how practitioners appearing before the PTO will approach claim drafting to ensure that their claims not only conform with PTO guidance regarding subject matter eligibility, but also current case law. Indeed, the court’s statement that “to the extent that Example 29–Claim 1 [of PTO guidance] is analogous to the claims at issue, Ariosa must control” demonstrates the importance of following Federal Circuit case law, as PTO guidance deems this claim patent eligible in contravention to Ariosa’s holding.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact the authors, Michael J. Abernathy, Maria E. Doukas, or Michael T. Sikora, in our Chicago office, or any of the following lawyers from Morgan Lewis’s IP life sciences practice:
Olga Berson, Ph.D.
Jeffry S. Mann, Ph.D.
 No. 2018-1218, slip op. at 2, 9-12 (Fed. Cir. April 1, 2019) (Cleveland Clinic II).
 Id. at 12-15.
 Id. at 13.
 859 F.3d 1352, 1360-61 (Fed. Cir. 2017) (Cleveland Clinic I).
 Cleveland Clinic II, slip op. at 5.
 Id. at 6.
 Id. at 7.
 Id. at 9.
 Id. at 10.
 Id. at 11.
 Id. at 11-12.
 Id. at 12.
 Id. at 13.
 Id. at 14 (citing Ariosa, 788 F.3d at 1373-74).
 Id. at 13 (emphasis added).