Cleveland Clinic Foundation v. True Health Diagnostics LLC

United States Court of Appeals
for the Federal Circuit
______________________
THE CLEVELAND CLINIC FOUNDATION,
CLEVELAND HEARTLAB, INC.,
Plaintiffs-Appellants
v.
TRUE HEALTH DIAGNOSTICS LLC,
Defendant-Appellee
______________________
2016-1766
______________________
Appeal from the United States District Court for the
Northern District of Ohio in No. 1:15-cv-02331-PAG,
Judge Patricia A. Gaughan.
______________________
Decided: June 16, 2017
______________________
LAWRENCE D. ROSENBERG, Jones Day, Washington,
DC, argued for plaintiffs-appellants. Also represented by
SUSAN M. GERBER, Cleveland, OH.
ADAM LOUIS MARCHUK, Perkins Coie LLP, Chicago,
IL, argued for defendant-appellee. Also represented by
MICHAEL ROBERT OSTERHOFF, MARK T. SMITH, CAROLINE
AYRES TEICHNER; DAN L. BAGATELL, Hanover, NH.
______________________
Before LOURIE, REYNA, and WALLACH, Circuit Judges.
2 THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC
REYNA, Circuit Judge.
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 Cleve-
land Clinic failed to state a claim of contributory or in-
duced infringement of the fourth patent. For the reasons
explained below, we affirm.
BACKGROUND
In 2003, researchers at the Cleveland Clinic Founda-
tion developed methods for detecting the risk of cardio-
vascular disease in a patient. When an artery is damaged
or inflamed, the body releases the enzyme myeloperoxi-
dase, or MPO, in response. MPO is an early symptom of
cardiovascular disease, and it can thus serve as an indica-
tor 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.
The patents disclose methods for detecting MPO and
correlating the results to cardiovascular risk. 1 The pa-
1 The testing patents are U.S. Patent No. 7,223,552,
U.S. Patent No. 7,459,286, and U.S. Patent No. 8,349,581.
THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC 3
tents disclose that “[m]yeloperoxidase activity may be
determined by any of a variety of standard methods
known in the art.” E.g., J.A. 39 at col. 8 ll. 32–33. These
methods include colorimetric-based assay, flow cytometry,
and enzyme-linked immunosorbent assay (“ELISA”).
Additionally, the patents disclose MPO detection kits
modified from commercially available kits “by including,
for example, different cut-offs, different sensitivities at
particular cut-offs, as well as instructions or other printed
material for characterizing risk based upon the outcome
of the assay.” E.g., J.A. 38 at col. 6 ll. 21–24.
In addition to ways to “see” MPO, the inventors devel-
oped a way to correlate MPO with risk of developing
cardiovascular disease. To do this, the inventors compiled
MPO data from a population to create a “predetermined”
or “control” value. Then, using statistical methods, the
inventors analyzed the data based on whether the person
was “apparently healthy” or had some cardiovascular
disease. E.g., J.A. 45 at col. 20 ll. 32–43. Diagnosers
could then use this data to determine whether a patient
presents a risk of cardiovascular disease:
If the level of the present risk predictor in the test
subject’s bodily sample is greater than the prede-
termined value or range of predetermined values,
the test subject is at greater risk of developing or
having [cardiovascular disease] than individuals
with levels comparable to or below the predeter-
mined value or predetermined range of values.
J.A. 46 at col. 21 ll. 37–42.
The fourth patent, which relates to a method for treating
a patient, is U.S. Patent No. 9,170,260. The ’552 patent
and ’260 patent share a specification, as do the ’286
patent and ’581 patent.
4 THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC
The ’552 patent claims methods for characterizing a
test subject’s risk for cardiovascular disease by determin-
ing levels of MPO in a bodily sample and comparing that
with the MPO levels in persons not having cardiovascular
disease. The dependent claims limit the way MPO is
detected and how the MPO values in the control subjects
are evaluated. The district court analyzed claims 11, 14,
and 15, which provide:
11. A method of assessing a test subject’s risk of
having atherosclerotic cardiovascular disease,
comprising
comparing levels of myeloperoxidase in a bodily
sample from the test subject with levels of
myeloperoxidase in comparable bodily samples
from control subjects diagnosed as not having the
disease, said bodily sample being blood, serum,
plasma, blood leukocytes selected from the group
consisting of neutrophils, monocytes, sub-
populations of neutrophils, and sub-populations of
monocytes, or any combination thereo[f];
wherein the levels of myeloperoxidase in the bodi-
ly from the test subject relative to the levels of
[m]yeloperoxidase in the comparable bodily sam-
ples from control subjects is indicative of the ex-
tent of the test subject’s risk of having
atherosclerotic cardiovascular disease.
J.A. 50 at col. 30 ll. 48–62.
14. A method of assessing a test subject’s risk of
developing a complication of atherosclerotic cardi-
ovascular disease comprising:
determining levels of myeloperoxidase (MPO) ac-
tivity, myeloperoxidase (MPO) mass, or both in a
bodily sample of the test subject, said bodily sam-
ple being blood, serum, plasma, blood leukocytes
THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC 5
selected from the group consisting of neutrophils
and monocytes, or any combination thereof;
wherein elevated levels of MPO activity or MPO
mass or both in the test subject’s bodily sample as
compared to levels of MPO activity, MPO mass, or
both, respectively in comparable bodily samples
obtained from control subjects diagnosed as not
having the disease indicates that the test subject
is at risk of developing a complication of athero-
sclerotic cardiovascular disease.
J.A. 51 at col. 31 ll. 8–23.
15. The method of claim 14, wherein the test sub-
ject’s risk of developing a complication of athero-
sclerotic cardiovascular disease is determined by
comparing levels of my[elo]peroxidase mass in the
test subject’s bodily sample to levels of myelop-
eroxidase mass in comparable samples obtained
from the control subjects.
J.A. 51 at col. 31 ll. 24–29.
The ’286 patent and ’581 patent further claim ways of
detecting MPO. The dependent claims of the ’286 patent
limit MPO detection by flow cytometry and further re-
quire detection of another compound, troponin. Other
dependent claims of the ’286 patent and ’581 patent
require detection of MPO byproducts. The district court
analyzed claims 21 and 22 of the ’286 patent and claim 5
of the ’581 patent, which provide:
21. A method of assessing the risk of requiring
medical intervention in a patient who is present-
ing with chest pain, comprising
characterizing the levels of myeloperoxidase activ-
ity, myeloperoxidase mass, or both, respectively in
the bodily sample from the human patient, where-
6 THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC
in said bodily sample is blood or a blood deriva-
tive,
wherein a patient whose levels of myeloperoxidase
activity, myeloperoxidase mass, or both is charac-
terized as being elevated in comparison to levels
of myeloperoxidase activity, myeloperoxidase
mass or both in a comparable bodily samples ob-
tained from individuals in a control population is
at risk of requiring medical intervention to pre-
vent the occurrence of an adverse cardiac event
within the next six months.
J.A. 71 at col. 23 l. 45–col. 24 l. 10.
22. A method of determining whether a patient
who presents with chest pain is at risk of requir-
ing medical intervention to prevent an adverse
cardiac event within the next six months compris-
ing:
comparing the level of a risk predictor in a bodily
sample from the subject with a value that is based
on the level of said risk predictor in comparable
samples from a control population, wherein said
risk predictor is myeloperoxidase activity,
myeloperoxidase mass, a myeloperoxidase-
generated oxidation product, or any combination
thereof, and wherein said bodily sample is blood,
serum, plasma, or urine,
wherein a subject whose bodily sample contains
elevated levels of said risk predictor as compared
to the control value is at risk of requiring medical
intervention to prevent an adverse cardiac event
within 6 months of presenting with chest pain,
and
wherein the difference between the level of the
risk predictor in the patient’s bodily sample and
the level of the risk predictor in a comparable bod-
THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC 7
ily sample from the control population establishes
the extent of the risk to the subject of requiring
medical intervention to prevent an adverse cardi-
ac event within the next six months.
J.A. 71 at col. 24 ll. 11–33.
5. A method of determining whether a patient
who presents with chest pain is at risk of requir-
ing medical intervention to prevent an adverse
cardiac event within the next six months compris-
ing:
determining the level of risk predictor in a bodily
sample from the subject, wherein said risk predic-
tor is myeloperoxidase activity, myeloperoxidase
mass, a myeloperoxidase (MPO)-generated oxida-
tion product or any combination thereof,
wherein said bodily sample is blood, serum, plas-
ma or urine,
wherein said myeloperoxidase-generated oxida-
tion product is nitrotyrosine or a myeloperoxidase-
generated lipid peroxidation product selected from
[list of products] or any combination thereof, and
comparing the level of said risk predictor in the
bodily sample of the patient to the level of said
risk predictor in comparable samples obtained
from a control population,
wherein a subject whose bodily sample contains
elevated levels of said risk predictor as compared
to the control value is at risk of requiring medical
intervention to prevent an adverse cardiac event
within 6 months of presenting with chest pain.
J.A. 86 at col. 20 ll. 12–50.
The ’260 patent builds on these patents and requires
administration of a lipid lowering drug to a patient at risk
8 THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC
of cardiovascular disease. Claim 1 of the ’260 patent
recites:
1. A method for administering a lipid lowering
agent to a human patient based on elevated levels
of myeloperoxidase (MPO) mass and/or activity
comprising:
(a) performing an enzyme linked immunosorbent
assay (ELISA) comprising contacting a serum or
plasma sample with an anti-MPO antibody and a
peroxidase activity assay to determine MPO activ-
ity in the serum or plasma sample;
(b) selecting a patient who has elevated levels of
MPO mass and/or activity compared to levels of
MPO mass and/or activity in apparently healthy
control subjects; and
(c) administering a lipid lowering agent to the se-
lected human patient.
J.A. 117 at col. 30 ll. 10–23.
True Health is a diagnostic laboratory. It purchased
the assets of Health Diagnostics Lab, which had contract-
ed with the Cleveland Clinic to perform MPO testing.
Rather than continue the relationship with Cleveland
Clinic, True Health opted to perform its own MPO testing.
In November 2015, Cleveland Clinic sued True Health,
asserting infringement of the testing patents. Cleveland
Clinic moved for a temporary restraining order and pre-
liminary injunction, which the district court denied.
Cleveland Clinic Found. v. True Health Diagnostics, LLC,
No. 1:15 CV 2331, 2015 WL 7430082, at *6 (N.D. Ohio
Nov. 18, 2015).
After the district court denied the motion for tempo-
rary restraining order and preliminary injunction, Cleve-
land Clinic amended its complaint to add allegations of
infringement of the ’260 patent. True Health moved to
THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC 9
dismiss the amended complaint, arguing that the testing
patents were directed to patent-ineligible subject matter
and that Cleveland Clinic failed to state a claim for indi-
rect infringement of the ’260 patent.
The district court granted True Health’s motion.
Cleveland Clinic Found. v. True Health Diagnostics, LLC,
No. 1:15 CV 2331, 2016 WL 705244, at *9 (N.D. Ohio Feb.
23, 2016). The district court found all the claims of the
testing patents patent ineligible under 35 U.S.C. § 101
(2012). Id. at *5–7. The district court also dismissed the
contributory and induced infringement claims of the ’260
patent, and denied leave to amend the complaint. Id. at
*7–9.
Procedurally, the district court found that it was
proper to consider § 101 at the motion to dismiss stage.
Although Cleveland Clinic argued that the district court
should first conduct formal claim construction on some
identified terms, the district court reasoned that “plaintiff
offer[ed] no proposed construction for these terms.” Id. at
*3. And though Cleveland Clinic objected to treating any
claims as representative of others, the district court found
it appropriate to consider the above asserted claims
representative because “plaintiff fail[ed] to point out any
claim that is not represented by the aforementioned
claims.” Id.
The district court next found the testing patents pa-
tent ineligible under the two-step framework for analyz-
ing patent subject matter eligibility under § 101
articulated in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134
S. Ct. 2347, 2355 (2014). See Cleveland Clinic, 2016 WL
705244, at *7. The district court found that the testing
patents’ claims were directed to a law of nature under
Alice step one because the claims were directed to “the
correlation between MPO in the blood and the risk of
[cardiovascular disease].” Id. at *6. Under Alice step two,
the district court found there was no saving inventive
10 THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC
concept. First, the patents employ well-known methods to
detect MPO. Id. Second, comparing MPO levels with a
control value could be a bare mental process. Id. Finally,
even looking at the claims as a whole, the steps in combi-
nation “simply instruct a user to apply a natural law, i.e.,
that an increase in MPO mass or MPO activity in a blood
sample correlates to an increase in [cardiovascular dis-
ease] risk.” Id.
Regarding infringement of the ’260 patent, the district
court found that True Health’s testing service was not a
“material or apparatus” that could form the basis for
contributory infringement. Id. at *7–8 (citing In re Bill of
Lading Transmission & Processing Sys. Patent Litig., 681
F.3d 1323, 1337 (Fed. Cir. 2012) (“Contributory infringe-
ment occurs if a party sells or offers to sell, a material or
apparatus for use in practicing a patented process, and
that ‘material or apparatus’ is material to practicing the
invention, has no substantial non-infringing uses, and is
known by the party to be especially made or especially
adapted for use in an infringement of such patent.”)
(internal quotation marks and citation omitted)).
Regarding induced infringement, the district court
found that Cleveland Clinic did not allege facts sufficient
to show the specific intent to induce a third party to
infringe. The district court reasoned that, “in generic
terms, the third-party direct infringer must administer a
lipid lowering agent based on elevated levels of MPO in
order to infringe the ’260 patent.” Id. at *9. Hence, the
“plaintiff must sufficiently allege that defendant specifi-
cally intends to induce doctors to administer a lipid lower-
ing agent based on elevated levels of MPO. The complaint
is completely devoid of any factual allegations supporting
this theory.” Id.
In response to the motion to dismiss, Cleveland Clinic
sought leave to amend its complaint in the event the
claim was dismissed. Id. The district court denied Cleve-
THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC 11
land Clinic’s request. Id. (citing PR Diamonds, Inc. v.
Chandler, 364 F.3d 671, 699 (6th Cir. 2004)).
Cleveland Clinic timely appealed. We have jurisdic-
tion under 28 U.S.C. § 1295(a)(1).
DISCUSSION
We first address whether the testing patents are pa-
tent ineligible under § 101 and conclude that they are.
We next address whether the district court properly
dismissed the ’260 patent infringement claims and con-
clude that it did.
1. § 101 Subject Mater Eligibility
A. Standard of Review
For procedural questions not unique to patent law, we
review a grant of a motion to dismiss according to the law
of the regional circuit, which in this case is the Sixth
Circuit. See, e.g., Univ. of Utah v. Max-Planck-
Gesellschaft zur Forderung der Wissenschaften E.V., 734
F.3d 1315, 1319 (Fed. Cir. 2013). The Sixth Circuit
reviews de novo dismissals for failure to state a claim.
Bovee v. Coopers & Lybrand C.P.A., 272 F.3d 356, 360
(6th Cir. 2001). We also review de novo whether a claim is
patent-ineligible under the judicially created exceptions to
§ 101. McRO, Inc. v. Bandai Namco Games Am. Inc., 837
F.3d 1299, 1311 (Fed. Cir. 2016).
B. Procedural Challenges
As a preliminary matter, we address Cleveland Clin-
ic’s procedural challenges to the district court’s patentable
subject matter eligibility analysis. Cleveland Clinic
argues that the district court erred by analyzing only
certain claims from each of the testing patents as repre-
sentative. Cleveland Clinic also argues that the district
court should have undertaken claim construction and
developed the factual and expert record before analyzing
12 THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC
whether the claims were eligible under § 101. We do not
find these arguments persuasive.
As to Cleveland Clinic’s first procedural challenge, we
find no error in the district court addressing claims 11, 14,
and 15 of the ’552 patent, claims 21 and 22 of the ’286
patent, and claim 5 of the ’581 patent as representative.
Although Cleveland Clinic argues that the unexamined
dependent claims provide sufficient inventive concepts
over the representative claims, our examination reveals
the opposite. For example, Cleveland Clinic argues that
the district court failed to take into consideration claims
that require specific analytical techniques, claims that
limit the predetermined comparison values to a single
value or representative value or ranges, or claims that
measure the presence of specific MPO-generated oxida-
tion products. Each limitation Cleveland Clinic raises,
however, merely recites known methods of detecting MPO
or MPO derivatives and applies the correlation between
these biomarkers and cardiovascular health. Where, as
here, the claims “are substantially similar and linked to
the same” law of nature, analyzing representative claims
is proper. Content Extraction & Transmission LLC v.
Wells Fargo Bank, N.A., 776 F.3d 1343, 1348 (Fed. Cir.
2014).
As to Cleveland Clinic’s second procedural challenge,
we have repeatedly affirmed § 101 rejections at the mo-
tion to dismiss stage, before claim construction or signifi-
cant 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). In any event, Cleveland
Clinic provided no proposed construction of any terms or
THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC 13
proposed expert testimony that would change the § 101
analysis. Accordingly, it was appropriate for the district
court to determine that the testing patents were ineligible
under § 101 at the motion to dismiss stage.
C. Alice Step One
Section 101 of the Patent Act defines patent eligible
subject matter:
Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of
matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to
the conditions and requirements of this title.
35 U.S.C. § 101. The Supreme Court has long held that
there are certain exceptions to this provision: laws of
nature, natural phenomena, and abstract ideas. Alice,
134 S. Ct. at 2354 (collecting cases).
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. E.g., J.A. 50 at
col. 30 ll. 47–52; J.A. 71 at col. 24 ll. 11–18; J.A. 86 at
col. 20 ll. 12–44. Moreover, the testing patents’ specifica-
14 THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC
tions similarly instruct that the inventions are “based on
the discovery that patients with cardiovascular disease
have significantly greater levels of leukocyte and [MPO],”
J.A. 36 at col. 2 ll. 33–36; see J.A. 67 at col. 16 ll. 56–67
(describing the study’s results as to MPO levels), 68 at
col. 17 ll. 30–39 (same), and they do not purport to alter
MPO levels in any way, see Genetic Technologies, 818 F.3d
at 1376 (evaluating the asserted patents’ specification in
support of its conclusion that the claims were focused on a
patent-ineligible law of nature because, inter alia, they
“involved[d] no creation or alteration of DNA sequences”).
Cleveland Clinic’s invention thus involves “seeing” MPO
already present in a bodily sample and correlating that to
cardiovascular disease. Because the testing patents are
based on “the relation [between cardiovascular disease
and heightened MPO levels that] exists in principle apart
from human action,” they are directed to a patent-
ineligible law of nature. Mayo, 566 U.S. at 77.
This case is similar to our decision in Ariosa. In Ari-
osa, 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. Like-
wise, here, the testing patents purport to detect MPO and
other MPO-related products, which are naturally occur-
ring 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. Id.
Cleveland Clinic argues that its invention is similar to
the patent-eligible invention described in Rapid Litigation
THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC 15
Management Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed.
Cir. 2016). In CellzDirect, the inventors developed cryo-
preservation techniques to preserve liver cells for later
use. Id. at 1045. We held that the claims were not di-
rected to a natural law because they were “simply not
directed to the ability of [liver cells] to survive multiple
freeze-thaw cycles. Rather, the claims of the [asserted
patent were] directed to a new and useful laboratory
technique for preserving [liver cells].” Id. at 1048. Unlike
CellzDirect, the asserted claims of the testing patents are
directed to the natural existence of MPO in a bodily
sample and its correlation to cardiovascular risk rather
than to “a new and useful laboratory technique” for de-
tecting this relationship. Indeed, Cleveland Clinic has not
created a new laboratory technique; rather, it uses well-
known techniques to execute the claimed method. The
specifications of the testing patents confirm that known
testing methods could be used to detect MPO, and that
there were commercially available testing kits for MPO
detection. E.g., J.A. 39 at col. 8 ll. 32–33; J.A. 38 at col. 6
ll. 21–24.
Because the claims of the testing patents are directed
to a natural law, we turn to the second step of the Alice
framework.
D. Alice Step Two
In Alice step two, we examine the elements of the
claims to determine whether they contain an inventive
concept sufficient to transform the claimed naturally
occurring phenomena into a patent-eligible application.
Mayo, 566 U.S. at 71–72; McRO, 837 F.3d at 1312 (quot-
ing Alice, 134 S. Ct. at 2355). We must consider the
elements of the claims both individually and as an or-
dered combination to determine whether additional
elements transform the nature of the claims into a patent-
eligible concept. Ariosa, 788 F.3d at 1375 (citations
omitted). “To save a patent at step two, an inventive
16 THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC
concept must be evident in the claims.” RecogniCorp,
LLC v. Nintendo Co., 855 F.3d 1322, 1327 (Fed. Cir.
2017).
We conclude that the practice of the method claims
does not result in an inventive concept that transforms
the natural phenomena of MPO being associated with
cardiovascular risk into a patentable invention. Mayo
and Ariosa make clear that transforming claims that are
directed to a law of nature requires more than simply
stating the law of nature while adding the words “apply
it.” Mayo, 566 U.S. at 72; Ariosa, 788 F.3d at 1377.
In Ariosa, the challenged claims involved a method
that was a general instruction to doctors to apply routine,
conventional techniques when seeking to detect paternal-
ly inherited cell-free fetal DNA in the blood serum of a
pregnant woman. Ariosa, 788 F.3d at 1377. The same is
true here. The ’552 patent and ’581 patent contain a
“determining” step that requires analyzing MPO levels.
Cleveland Clinic does not purport to have invented color-
imetric-based assay, flow cytometry, or ELISA, or any of
the claimed methods to “see” MPO and its derivatives in
bodily samples. Rather, the claims here instruct that
MPO levels be detected or determined using any of these
known techniques. The claims of the testing patents also
contain a “comparing” step where MPO levels are com-
pared to statistically derived control or predetermined
values. Here too, Cleveland Clinic does not purport to
derive new statistical methods to arrive at the predeter-
mined or control levels of MPO that would indicate a
patient’s risk of cardiovascular disease. Known statistical
models can be employed, as described, for example, in the
specification of the ’552 patent:
Predetermined values of MPO activity or MPO
mass, such as for example, mean levels, median
levels, or “cut-off” levels, are established by assay-
ing a large sample of individuals in the general
THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC 17
population or the select population and using a
statistical model such as the predictive value
method for selecting a positivity criterion or re-
ceiver operator characteristic curve that defines
optimum specificity (highest true negative rate)
and sensitivity (highest true positive rate) as de-
scribed in Knapp, R.G., and Miller, M.C.
(1992) . . . .
J.A. 46 at col. 21 ll. 12–20.
The claims, whether considered limitation-by-
limitation or as a whole, do not sufficiently transform the
natural existence of MPO in a bodily sample and its
correlation to cardiovascular risk into a patentable inven-
tion. The process steps here merely tell those “interested
in the subject about the correlations that the researchers
discovered.” Mayo, 566 U.S. at 78.
Cleveland Clinic’s invention here is distinct from the
CellzDirect invention when examining Alice step two. In
CellzDirect, the inventors took the discovery that certain
liver cells will survive multiple freeze-thaw cycles and
applied that to improve existing methods for preserving
liver cells. CellzDirect, 827 F.3d at 1051. Here, the
testing patents here do not extend their discovery that
MPO correlates to cardiovascular risk to a patentable
method. They require only conventional MPO detection
methods and compare those values to predetermined or
control values derived from conventional statistical meth-
ods. 2
Cleveland Clinic argues that its invention is narrowly
preemptive and thus should be patent eligible. However,
“[w]here a patent’s claims are deemed only to disclose
2 The ’260 patent, which claims a method of treat-
ing a patient that is determined to have a risk of cardio-
vascular disease, is not challenged under § 101.
18 THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC
patent ineligible subject matter under the Mayo frame-
work, as they are in this case, preemption concerns are
fully addressed and made moot.” Ariosa, 788 F.3d at
1379. Likewise, while Cleveland Clinic argues that its
discovery of the relationship between MPO and cardiovas-
cular health was groundbreaking, “even such valuable
contributions can fall short of statutory patentable subject
matter, as it does here.” Id. at 1380.
Accordingly, we affirm the district court’s determina-
tion that the testing patents are directed to patent-
ineligible subject matter.
2. ’260 Patent Infringement
The ’260 patent is a method-of-treatment patent
whose claims require “administering a lipid lowering
agent to the selected human patient.” J.A. 117 at col. 30
ll. 22–24. Cleveland Clinic does not allege that True
Health directly infringes this patent, rather, it alleges
that True Health indirectly infringes via contributory and
induced infringement. As discussed below, we find that
the district court properly dismissed Cleveland Clinic’s
claims.
A. Standard of Review
In the Sixth Circuit, courts employ two standards of
review for denials of motions to amend complaints:
(1) abuse of discretion, the general standard when a court
denies a motion for leave to amend; or (2) de novo, the
standard when a court denies leave to amend because the
amended pleading would not withstand a motion to
dismiss. Pulte Homes, Inc. v. Laborers’ Int’l Union of N.
Am., 648 F.3d 295, 304–05 (6th Cir. 2011) (citations
omitted). Here, like in Pulte, Cleveland Clinic did not file
a motion for leave to amend, but rather “buried its re-
quest . . . in its brief opposing the motion to dismiss” and
the district court “did not explain why it withheld leave to
THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC 19
amend. The lesser standard, abuse of discretion, there-
fore applies.” Id. at 305.
B. The District Court Properly Dismissed Cleveland
Clinic’s Contributory Infringement Claims
Contributory infringement occurs if a party sells, or
offers to sell, a material or apparatus for use in practicing
a patented process, and that “material or apparatus” is
material to practicing the invention, it has no substantial
non-infringing uses, and it is known by the party “to be
especially made or especially adapted for use in an in-
fringement of such patent.” 35 U.S.C. § 271(c); Bill of
Lading, 681 F.3d at 1337. A party that provides a service,
but no “material or apparatus,” cannot be liable for con-
tributory infringement. PharmaStem Therapeutics, Inc.
v. ViaCell, Inc., 491 F.3d 1342, 1357 (Fed. Cir. 2007)
(“Under the plain language of the statute, a person who
provides a service that assists another in committing
patent infringement may be subject to liability under
§ 271(b) for active inducement of infringement, but not
under § 271(c) for contributory infringement.”).
True Health provides MPO testing services. The only
“material or apparatus” that Cleveland Clinic claims True
Health sells are lab reports documenting the results of
True Health’s testing services. We agree with the district
court that the “lab reports attached to the complaint
reflect the manner in which defendant reports the results
of the service it provides.” Cleveland Clinic, 2016 WL
705244, at *8. They are not a “material or apparatus.”
Accordingly, it was not an abuse of discretion for the
district court to dismiss Cleveland Clinic’s contributory
infringement claims and deny leave to amend.
C. The District Court Properly Dismissed Cleveland
Clinic’s Induced Infringement Claims
“Whoever actively induces infringement of a patent
shall be liable as an infringer.” 35 U.S.C. § 271(b). “How-
20 THE CLEVELAND CLINIC v. TRUE HEALTH DIAGNOSTICS LLC
ever, knowledge of the acts alleged to constitute infringe-
ment is not enough.” DSU Med. Corp. v. JMS Co., 471
F.3d 1293, 1305 (Fed. Cir. 2006) (en banc) (citations
omitted). The mere knowledge of possible infringement
by others does not amount to inducement; specific intent
and action to induce infringement must be proven. Id.
It is undisputed that True Health does not sell or pre-
scribe lipid lowering drugs to patients. Cleveland Clinic
argues that True Health’s lab reports are sufficient to
create the reasonable inference that a doctor who ordered
such a report would rely on the results and would admin-
ister a lipid lowering agent where the results indicated
the patient had a cardiovascular disease risk. Cleveland
Clinic alleges no facts that suggest any connection be-
tween True Health and doctors that may prescribe lipid
lowering drugs. Cleveland Clinic thus falls short of
showing “specific intent and action” on behalf of True
Health to induce infringement of the ’260 patent. It was
not an abuse of discretion for the district court to dismiss
Cleveland Clinic’s induced infringement claims and deny
leave to amend.
CONCLUSION
We have considered Cleveland Clinic’s other argu-
ments and do not find them persuasive. We thus affirm
the district court’s grant of True Health’s motion to dis-
miss.
AFFIRMED