Task: sc_issue_8

What follows is an opinion from the Supreme Court of the United States. Your task is to determine the issue of the Court's decision. Determine the issue of the case on the basis of the Court's own statements as to what the case is about. Focus on the subject matter of the controversy rather than its legal basis.

Justice Breyer
delivered the opinion of the Court.
Section 101 of the Patent Act defines patentable subject matter. It says:
“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 Court has long held that this provision contains an important implicit exception. “[Ljaws of nature, natural phenomena, and abstract ideas” are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. 593, 601 (2010); Diamond v. Chakrabarty, 447 U. S. 303, 309 (1980); Le Roy v. Tatham, 14 How. 156, 175 (1853); O’Reilly v. Morse, 15 How. 62, 112-120 (1854); cf. Neilson v. Harford, Webster’s Patent Cases 295, 371 (1841) (English case discussing same). Thus, the Court has written that “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of... nature, free to all men and reserved exclusively to none.’ ” Chakrabarty, supra, at 309 (quoting Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127, 130 (1948)).
“Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972). And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.
The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas. Thus, in Diehr the Court pointed out that “ ‘a process is not unpatentable simply because it contains a law of nature or a mathematical algorithm.’” 450 U. S., at 187 (quoting Parker v. Flook, 437 U. S. 584, 590 (1978)). It added that “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” Diehr, supra, at 187. And it emphasized Justice Stone’s similar observation in Mackay Radio & Telegraph Co. v. Radio Corp. of America, 306 U. S. 86 (1939):
“ ‘While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scien-tifie truth may be.’ ” 450 U. S., at 188 (quoting Mackay Radio, supra, at 94).
See also Funk Brothers, supra, at 130 (“If there is to be invention from [a discovery of a law of nature], it must come from the application of the law of nature to a new and useful end”).
Still, as the Court has also made clear, to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words “apply it.” See, e.g., Benson, supra, at 71-72.
The case before us lies at the intersection of these basic principles. It concerns patent claims covering processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high. The claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side effects. We must determine whether the claimed processes have transformed these unpatentable natural laws into patent-eligible applications of those laws. We conclude that they have not done so and that therefore the processes are not patentable.
Our conclusion rests upon an examination of the particular claims before us in light of the Court’s precedents. Those cases warn us against interpreting patent statutes in ways that make patent eligibility “depend simply on the draftsman’s art” without reference to the “principles underlying the prohibition against patents for [natural laws].” Flook, supra, at 593. They warn us against upholding patents that claim processes that too broadly pre-empt the use of a natural law. Morse, supra, at 112-120; Benson, supra, at 71-72. And they insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an “inventive concept,” sufficient to ensure that the patent in practice, amounts to significantly more than a patent upon the natural law itself. Flook, supra, at 594; see also Bilski, 561 U. S., at 610-611 (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant postsolution activity’ ” (quoting Diehr, supra, at 191-192)).
We find that the process claims at issue here do not satisfy these conditions. In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.
I
A
The patents before us concern the use of thiopurine drugs in the treatment of autoimmune diseases, such as Crohn’s disease and ulcerative colitis. When a patient ingests a thi-opurine compound, his body metabolizes the drug, causing metabolites to form in his bloodstream. Because the way in which people metabolize thiopurine compounds varies, the same dose of a thiopurine drug affects different people differently, and it has been difficult for doctors to determine whether for a particular patient a given dose is too high, risking harmful side effects, or too low, and so likely ineffective.
At the time the discoveries embodied in the patents were made, scientists already understood that the levels in a patient’s blood of certain metabolites, including, in particular, 6-thioguanine and its nucleotides (6-TG) and 6-methyl-mercaptopurine (6-MMP), were correlated with the likelihood that a particular dosage of a thiopurine drug could cause harm or prove ineffective. See U. S. Patent No. 6,355,623, col. 8, 11. 37-40, 2 App. 10 (“Previous studies suggested that measurement of [6-mercaptopurine (6-MP)] metabolite levels can be used to predict clinical efficacy and tolerance to azathioprine or 6-MP” (citing Cuffari, Théorét, Latour, & Seidman, 6-Mercaptopurine Metabolism in Crohn’s Disease: Correlation With Efficacy and Toxicity, 39 Gut 401 (1996))). But those in the field did not know the precise correlations between metabolite levels and likely harm or ineffectiveness. The patent claims at issue here set forth processes embodying researchers’ findings that identified these correlations with some precision.
More specifically, the patents — U. S. Patent No. 6,355,623 (’623 patent) and U. S. Patent No. 6,680,302 (’302 patent)— embody findings that concentrations in a patient’s blood of 6-TG or of 6-MMP metabolite beyond a certain level (400 and 7,000 picomoles (pmol) per 8xl08 red blood cells, respectively) indicate that the dosage is likely too high for the patient, while concentrations in the blood of 6-TG metabolite lower than a certain level (about 230 pmol per 8xl08 red blood cells) indicate that the dosage is likely too low to be effective.
The patent claims seek to embody this research in a set of processes. Like the Federal Circuit we take as typical claim 1 of the ’623 patent, which describes one of the claimed processes as follows:
“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
“(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
“(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
“wherein the level of 6-thioguanine less than about 230 pmol per 8xl08 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
“wherein the level of 6-thioguanine greater than about 400 pmol per 8xl08 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.” ’623 patent, col. 20,11. 10-25, 2 App. 16.
For present purposes we may assume that the other claims in the patents do not differ significantly from claim 1.
B
Respondent, Prometheus Laboratories, Inc. (Prometheus), is the sole and exclusive licensee of the ’623 and ’302 patents. It sells diagnostic tests that embody the processes the patents describe. For some time petitioners, Mayo Clinic Rochester and Mayo Collaborative Services (collectively Mayo), bought and used those tests. But in 2004 Mayo announced that it intended to begin using and selling its own test — a test using somewhat higher metabolite levels to determine toxicity (450 pmol per 8xl08 for 6-TG and 5,700 pmol per 8x108 for 6-MMP). Prometheus then brought this action claiming patent infringement.
The District Court found that Mayo’s test infringed claim 7 of the ’623 patent. App. to Pet. for Cert. 110a-115a. In interpreting the claim, the court accepted Prometheus’ view that the toxicity-risk-level numbers in Mayo’s test and the claim were too similar to render the tests significantly different. The number Mayo used (450) was too close to the number the claim used (400) to matter given appropriate margins of error. Id., at 98a-107a. The District Court also accepted Prometheus’ view that a doctor using Mayo’s test could violate the patent even if he did not actually alter his treatment decision in the light of the test. In doing so, the court construed the claim’s language, “indicates a need to decrease” (or “to increase”), as not limited to instances in which the doctor actually decreases (or increases) the dosage level where the test results suggest that such an adjustment is advisable. Id., at 107a-109a; see also Brief for Respondent i (describing claimed processes as methods “for improving... treatment... by using individualized metabolite measurements to inform the calibration of... dosages of... thiopurines” (emphasis added)).
Nonetheless the District Court ultimately granted summary judgment in Mayo’s favor. The court reasoned that the patents effectively claim natural laws or natural phenomena — namely, the correlations between thiopurine metabolite levels and the toxicity and efficacy of thiopurine drug dosages — and so are not patentable. App. to Pet. for Cert. 50a-83a.
On appeal, the Federal Circuit reversed. It pointed out that in addition to these natural correlations, the claimed processes specify the steps of (1) “administering a [thiopu-rine] drug” to a patient, and (2) “determining the [resulting metabolite] level.” These steps, it explained, involve the transformation of the human body or of blood taken from the body. Thus, the patents satisfied the Circuit’s “machine or transformation test,” which the court thought sufficient to “confine the patent monopoly within rather definite bounds,” thereby bringing the claims into compliance with § 101. Prometheus Labs., Inc. v. Mayo Collaborative Services, 581 F. 3d 1336, 1345, 1346-1347 (2009) (internal quotation marks omitted).
Mayo filed a petition for certiorari. We granted the petition, vacated the judgment, and remanded the case for reconsideration in light of Bilski, 561 U. S. 593, which clarified that the “machine-or-transformation test” is not a definitive test of patent eligibility, but only an important and useful clue, id., at 603-604. On remand the Federal Circuit reaffirmed its earlier conclusion. It thought that the “machine- or-transformation test,” understood merely as an important and useful clue, nonetheless led to the “clear and compelling conclusion... that the... claims... do not encompass laws of nature or preempt natural correlations.” 628 F. 3d 1347, 1355 (2010). Mayo again filed a petition for certiorari, which we granted.
II
Prometheus’ patents set forth laws of nature — namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. Claim 1, for example, states that if the levels of 6-TG in the blood (of a patient who has taken a dose of a thiopurine drug) exceed about 400 pmol per 8x108 red blood cells, then the administered dose is likely to produce toxic side effects. While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The relation is a consequence of the ways in which thiopurine compounds are metabolized by the body — entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.
The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? We believe that the answer to this question is no.
A
If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction “apply the law.” Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa). Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float.
What else is there in the claims before us? The process that each claim recites tells doctors interested in the subject about the correlations that the researchers discovered. In doing so, it recites an “administering” step, a “determining” step, and a “wherein” step. These additional steps are not themselves natural laws but neither are they sufficient to transform the nature of the claim.
First, the “administering” step simply refers to the relevant audience, namely, doctors who treat patients with certain diseases with thiopurine drugs. That audience is a preexisting audience; doctors used thiopurine drugs to treat patients suffering from autoimmune disorders long before anyone asserted these claims. In any event, the “prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.’” Bilski, supra, at 610-611 (quoting Diehr, 450 U. S., at 191-192).
Second, the “wherein” clauses simply tell a doctor about the relevant natural laws, at most adding a suggestion that he should take those laws into account when treating his patient. That is to say, these clauses tell the relevant audience about the laws while trusting them to use those laws appropriately where they are relevant to their decision-making (rather like Einstein telling linear accelerator operators about his basic law and then trusting them to use it where relevant).
Third, the “determining” step tells the doctor to determine the level of the relevant metabolites in the blood, through whatever process the doctor or the laboratory wishes to use. As the patents state, methods for determining metabolite levels were well known in the art. ’628 patent, col. 9,11. 12-65, 2 Ápp. 11. Indeed, scientists routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds. ’623 patent, col. 8,11. 37-40, id., at 10. Thus, this step tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field. Purely “conventional or obvious” “[pre]-solution activity” is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law. Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at 610-611 (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’... adding ‘insignificant postsolution activity’” (quoting Diehr, 450 U. S., at 191-192)).
Fourth, to consider the three steps as an ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately. See id., at 188 (“[A] new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made”). Anyone who wants to make use of these laws must first administer a thiopurine drug and measure the resulting metabolite concentrations, and so the combination amounts to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients.
The upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations. To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.
pq
r-⅜
A more detailed consideration of the controlling precedents reinforces our conclusion. The cases most directly on point are Diehr and Flook, two cases in which the Court reached opposite conclusions about the patent eligibility of processes that embodied the equivalent of natural laws. The Diehr process (held patent eligible) set forth a method for molding raw, uncured rubber into various cured, molded products. The process used a known mathematical equation, the Arrhenius equation, to determine when (depending upon the temperature inside the mold, the time the rubber had been in the mold, and the thickness of the rubber) to open the press. It consisted in effect of the steps of: (1) continuously monitoring the temperature on the inside of the mold, (2) feeding the resulting numbers into a computer, which would use the Arrhenius equation to continuously recalculate

Question: What is the issue of the decision?
年. involuntary confession
数. habeas corpus
日. plea bargaining: the constitutionality of and/or the circumstances of its exercise
的. retroactivity (of newly announced or newly enacted constitutional or statutory rights)
月. search and seizure (other than as pertains to vehicles or Crime Control Act)
用. search and seizure, vehicles
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回. subconstitutional fair procedure: entrapment
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区. Voting Rights Act of 1965, plus amendments
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正. liability, punitive damages
说. Employee Retirement Income Security Act (cf. union trust funds)
意. state or local government tax
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已. federal or state regulation of securities
结. natural resources - environmental protection (cf. national supremacy: natural resources, national supremacy: pollution)
会. corruption, governmental or governmental regulation of other than as in campaign spending
段. zoning: constitutionality of such ordinances, or restrictions on owners' or lessors' use of real property
计. arbitration (other than as pertains to labor-management or employer-employee relations (cf. union arbitration)
源. federal or state consumer protection: typically under the Truth in Lending; Food, Drug and Cosmetic; and Consumer Protection Credit Acts
色. patents and copyrights: patent
時. patents and copyrights: copyright
交. patents and copyrights: trademark
系. patents and copyrights: patentability of computer processes
过. federal or state regulation of transportation regulation: railroad
电. federal and some few state regulations of transportation regulation: boat
询. federal and some few state regulation of transportation regulation:truck, or motor carrier
符. federal and some few state regulation of transportation regulation: pipeline (cf. federal public utilities regulation: gas pipeline)
未. federal and some few state regulation of transportation regulation: airline
程. federal and some few state regulation of public utilities regulation: electric power
常. federal and some few state regulation of public utilities regulation: nuclear power
条. federal and some few state regulation of public utilities regulation: oil producer
当. federal and some few state regulation of public utilities regulation: gas producer
情. federal and some few state regulation of public utilities regulation: gas pipeline (cf. federal transportation regulation: pipeline)
口. federal and some few state regulation of public utilities regulation: radio and television (cf. cable television)
合. federal and some few state regulation of public utilities regulation: cable television (cf. radio and television)
车. federal and some few state regulations of public utilities regulation: telephone or telegraph company
实. miscellaneous economic regulation
组. comity: civil rights
版. comity: criminal procedure
周. comity: First Amendment
址. comity: habeas corpus
记. comity: military
二. comity: obscenity
同. comity: privacy
业. comity: miscellaneous
权. comity primarily removal cases, civil procedure (cf. comity, criminal and First Amendment); deference to foreign judicial tribunals
其. assessment of costs or damages: as part of a court order
进. Federal Rules of Civil Procedure including Supreme Court Rules, application of the Federal Rules of Evidence, Federal Rules of Appellate Procedure in civil litigation, Circuit Court Rules, and state rules and admiralty rules
试. judicial review of administrative agency's or administrative official's actions and procedures
验. mootness (cf. standing to sue: live dispute)
料. venue
传. no merits: writ improvidently granted
述. no merits: dismissed or affirmed for want of a substantial or properly presented federal question, or a nonsuit
集. no merits: dismissed or affirmed for want of jurisdiction (cf. judicial administration: Supreme Court jurisdiction or authority on appeal from federal district courts or courts of appeals)
多. no merits: adequate non-federal grounds for decision
无. no merits: remand to determine basis of state or federal court decision (cf. judicial administration: state law)
员. no merits: miscellaneous
报. standing to sue: adversary parties
他. standing to sue: direct injury
無. standing to sue: legal injury
服. standing to sue: personal injury
线. standing to sue: justiciable question
这. standing to sue: live dispute
制. standing to sue: parens patriae standing
将. standing to sue: statutory standing
处. standing to sue: private or implied cause of action
高. standing to sue: taxpayer's suit
子. standing to sue: miscellaneous
道. judicial administration: jurisdiction or authority of federal district courts or territorial courts
章. judicial administration: jurisdiction or authority of federal courts of appeals
手. judicial administration: Supreme Court jurisdiction or authority on appeal or writ of error, from federal district courts or courts of appeals (cf. 753)
库. judicial administration: Supreme Court jurisdiction or authority on appeal or writ of error, from highest state court
三. judicial administration: jurisdiction or authority of the Court of Claims
从. judicial administration: Supreme Court's original jurisdiction
支. judicial administration: review of non-final order
家. judicial administration: change in state law (cf. no merits: remand to determine basis of state court decision)
长. judicial administration: federal question (cf. no merits: dismissed for want of a substantial or properly presented federal question)
付. judicial administration: ancillary or pendent jurisdiction
秒. judicial administration: extraordinary relief (e.g., mandamus, injunction)
路. judicial administration: certification (cf. objection to reason for denial of certiorari or appeal)
完. judicial administration: resolution of circuit conflict, or conflict between or among other courts
象. judicial administration: objection to reason for denial of certiorari or appeal
则. judicial administration: collateral estoppel or res judicata
现. judicial administration: interpleader
京. judicial administration: untimely filing
转. judicial administration: Act of State doctrine
辑. judicial administration: miscellaneous
限. Supreme Court's certiorari, writ of error, or appeals jurisdiction
力. miscellaneous judicial power, especially diversity jurisdiction
学. federal-state ownership dispute (cf. Submerged Lands Act)
外. federal pre-emption of state court jurisdiction
调. federal pre-emption of state legislation or regulation. cf. state regulation of business. rarely involves union activity. Does not involve constitutional interpretation unless the Court says it does.
项. Submerged Lands Act (cf. federal-state ownership dispute)
北. national supremacy: commodities
工. national supremacy: intergovernmental tax immunity
笑. national supremacy: marital and family relationships and property, including obligation of child support
监. national supremacy: natural resources (cf. natural resources - environmental protection)
任. national supremacy: pollution, air or water (cf. natural resources - environmental protection)
相. national supremacy: public utilities (cf. federal public utilities regulation)
微. national supremacy: state tax (cf. state tax)
册. national supremacy: miscellaneous
联. miscellaneous federalism
平. boundary dispute between states
增. non-real property dispute between states
听. miscellaneous interstate relations conflict
解. incorporation of foreign territories
等. federal taxation, typically under provisions of the Internal Revenue Code
得. federal taxation of gifts, personal, business, or professional expenses
收. priority of federal fiscal claims: over those of the states or private entities
安. miscellaneous federal taxation (cf. national supremacy: state tax)
价. legislative veto
藏. executive authority vis-a-vis congress or the states
命. miscellaneous
应. real property
看. personal property
索. contracts
资. evidence
产. civil procedure
串. torts
布. wills and trusts
原. commercial transactions
Answer:

Answer: 色