Cleveland Clinic Foundation "Ariosa'd" by CAFC

The Cleveland Clinic Foundation lost:



The Cleveland Clinic Foundation and Cleveland
Heartlab, Inc. accused True Health Diagnostics LLC of
infringement of three patents that claim methods for
testing for myeloperoxidase in a bodily sample and a
fourth patent that claims a method for treating a patient
that has cardiovascular disease. The United States
District Court for the Northern District of Ohio found that
the asserted claims of the three testing patents are not
directed to patent-eligible subject matter and that Cleveland
Clinic failed to state a claim of contributory or induced
infringement of the fourth patent. For the reasons
explained below, we affirm.


The background


In 2003, researchers at the Cleveland Clinic Foundation
developed methods for detecting the risk of cardiovascular
disease in a patient. When an artery is damaged
or inflamed, the body releases the enzyme myeloperoxidase,
or MPO, in response. MPO is an early symptom of
cardiovascular disease, and it can thus serve as an indicator
of a patient’s risk of cardiovascular disease.
The prior art taught that MPO could be detected in an
atherosclerotic plaque or lesion that required a surgically
invasive method. Another prior art method indirectly
detected for MPO in blood. Yet another known method
could detect MPO in blood but yielded results that were
not predictive of cardiovascular disease. The inventors
here purportedly discovered how to “see” MPO in blood
and correlate that to the risk of cardiovascular disease.



As to procedure, using 101 to dismiss is all right:



As to Cleveland Clinic’s second procedural challenge,
we have repeatedly affirmed § 101 rejections at the motion
to dismiss stage, before claim construction or significant
discovery has commenced. See, e.g., Genetic Techs.
Ltd. v. Merial L.L.C., 818 F.3d 1369, 1373–74 (Fed. Cir.
2016) (“We have repeatedly recognized that in many cases
it is possible and proper to determine patent eligibility
under 35 U.S.C. § 101 on a Rule 12(b)(6) motion.”); OIP
Techs, Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1362 (Fed.
Cir. 2015) (similar); Content Extraction, 776 F.3d at 1349
(similar); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350,
1355 (Fed. Cir. 2014) (similar).


As to 101:


To determine whether a claim is invalid under § 101,
we employ the two-step Alice framework. In step one, we
ask whether the claims are directed to ineligible subject
matter, such as a law of nature. Alice, 134 S. Ct. at 2355;
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566
U.S. 66, 75–77 (2012), McRO, 837 F.3d at 1311–12; Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375
(Fed. Cir. 2015). While method claims are generally
eligible subject matter, method claims that are directed
only to natural phenomena are directed to ineligible
subject matter. Ariosa, 788 F.3d at 1376. If the claims
are directed to eligible subject matter, the inquiry ends.
Thales Visionix Inc. v. United States, 850 F.3d 1343, 1349
(Fed. Cir. 2017).
The claims of the testing patents are directed to
multistep methods for observing the law of nature that
MPO correlates to cardiovascular disease.

(...)
This case is similar to our decision in Ariosa. In Ariosa,
the ineligible claims were directed to a method of
detecting paternally inherited cell-free fetal DNA, which
is naturally occurring in maternal blood. 788 F.3d at
1376. The inventors there did not create or alter any of
the genetic information encoded in that DNA. Id. Likewise,
here, the testing patents purport to detect MPO and
other MPO-related products, which are naturally occurring
in bodily samples. The method then employs the
natural relationship between those MPO values and
predetermined or control values to predict a patient’s risk
of developing or having cardiovascular disease. Thus, just
like Ariosa, the method starts and ends with naturally
occurring phenomena with no meaningful non-routine
steps in between—the presence of MPO in a bodily sample
is correlated to its relationship to cardiovascular disease.
The claims are therefore directed to a natural law.