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The Cleveland Clinic Foundation v. True Health Diagnostics, LLC

Representative Claim(s)

U.S. Patent No. 7,223,552
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 bodily from the test subject relative to the levels of [m]yeloperoxidase in the comparable bodily samples from control subjects is indicative of the extent of the test subject’s risk of having atherosclerotic cardiovascular disease.

14. A method of assessing a test subject’s risk of developing a complication of atherosclerotic cardiovascular disease comprising:
determining levels of myeloperoxidase (MPO) activity, myeloperoxidase (MPO) mass, or both in a bodily sample of the test subject, said bodily sample being blood, serum, plasma, blood leukocytes 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 atherosclerotic cardiovascular disease.

15. The method of claim 14,
wherein the test subject’s risk of developing a complication of atherosclerotic cardiovascular disease is determined by comparing levels of my[elo]peroxidase mass in the test subject’s bodily sample to levels of myeloperoxidase mass in comparable samples obtained from the control subjects.

 

U.S. Patent No. 7,459,286
21. A method of assessing the risk of requiring medical intervention in a patient who is presenting with chest pain, comprising
characterizing the levels of myeloperoxidase activity, myeloperoxidase mass, or both, respectively in the bodily sample from the human patient, wherein said bodily sample is blood or a blood derivative,
wherein a patient whose levels of myeloperoxidase activity, myeloperoxidase mass, or both is characterized as being elevated in comparison to levels of myeloperoxidase activity, myeloperoxidase mass or both in a comparable bodily samples obtained from individuals in a control population is at risk of requiring medical intervention to prevent the occurrence of an adverse cardiac event within the next six months.

22. A method of determining whether a patient who presents with chest pain is at risk of requiring medical intervention to prevent an adverse cardiac event within the next six months comprising:
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 bodily sample from the control population establishes the extent of the risk to the subject of requiring medical intervention to prevent an adverse cardiac event within the next six months.

 

U.S. Patent No. 8,349,581
5. A method of determining whether a patient who presents with chest pain is at risk of requiring medical intervention to prevent an adverse cardiac event within the next six months comprising:
determining the level of risk predictor in a bodily sample from the subject, wherein said risk predictor is myeloperoxidase activity, myeloperoxidase mass, a myeloperoxidase (MPO)-generated oxidation product or any combination thereof,
wherein said bodily sample is blood, serum, plasma or urine,
wherein said myeloperoxidase-generated oxidation product is nitrotyrosine or a myeloperoxidasegenerated 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.

 

U.S. Patent No. 9,170,260
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 activity 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 selected human patient.

Posture:

Appeal from United States District Court for the Northern District of Ohio. The District Court granted True Health’s motion to dismiss for failure to state a claim, finding that the asserted claims were not directed to patent-eligible subject matter.

Exception Categories: Law of Nature, Natural Phenomenon

“The claims of the testing patents are directed to multistep methods for observing the law of nature that MPO correlates to cardiovascular disease.”

“Cleveland Clinic’s invention [] 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 direct to a patent-ineligible law of nature.”

“[J]ust like in Ariosa, the method starts and ends with naturally occurring phenomena with no meaningful non-routine steps between – the presence of MPO in a bodily sample is correlated to its relationship to cardiovascular disease.”

“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 detecting this relationship.”

Significantly More: No

“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.”

“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 invention.”

“[T]he 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 methods.”