The Supreme Court extended the prohibition that laws of nature, combined with “well-understand, routine [and] conventional” method steps are not patent eligible subject matter under 35 U.S.C. Sec. 101. Mayo Collaborative Serv. v. Prometheus Labs., Inc., Case No. 10-1150 (U.S., March 20, 2012) (available here). The Patent Statute provides: “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 held that this provision contains an important implicit exceptions on patentable subject matter. “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Prometheus Opn. 1; citing Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. ___, ___ (2010) (slip op., at 5); 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).
“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.” p. 2; Gottschalk v. Benson, 409 U. S. 63, 67 (1972). The exclusion of laws of nature was extended in Parker v. Flook, 437 U.S. 584, 590 (1978) (adjusting alarm limits in catalytic conversion of hydro carbons not patentable subject mater) and Gottschalk v. Benson, 409 U.S. 63, 67 (1972) (mathematical process for converting binary-coded decimal numerals into pure binary numbers). In Bilski, the Court considered claims covering a process for hedging risks of price changes by, for example, contracting to purchase commodities from sellers at a fixed price, reflecting the desire of sellers to hedge against a drop in prices, while selling commodities to consumers at a fixed price, reflecting the desire of consumers to hedge against a price increase. p. 5; Bilski v. Kappos, 561 U.S. – (2010). This hedging risk method was also not patentable subject matter.
Is “Inventive Concept” a New Requirement For Process Patents?
The Court in Prometheus stated that Flook and Benson “insist[ed] 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.” p. 3, citing O’Reilly v. Morse, 15 How. 62, 112-120 (1854)(Morse’s telegraph case).
“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.” P. 4. “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 8×108 red blood cells, then the administered dose is likely to produce toxic side effects.” P. 8.
Laws of Nature: Process Plus What
“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.’ P. 8-9.
In the Promotheus case, first, the “administering” step refered to the relevant audience, namely doctors who treat patients with certain diseases with thiopurine drugs. 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. 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. 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.
“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.” P. 10.
Like Flook, the instructions “add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field. And since they are steps that must be taken in order to apply the laws in question, the effect is simply to tell doctors to apply the law somehow when treating their patients.” “The ‘determining’ step too is set forth in highly general language covering all processes that make use of the correlations after measuring metabolites, including later discovered processes that measure metabolite levels in new ways.” P. 18.
In a cautionary statement, the Court stated “We need not, and do not, now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them. For here, as we have said, the steps add nothing of significance to the natural laws themselves.” P. 18.
The Supreme Court confirmed that the Bilski, machine or transformation (MOT) test for patentable subject matter, is a useful clue, but stated the MOT test does not trump the law of nature exclusion. P. 19. Also, the Court indicated that the law of nature exclusion under § 101 is independent of the novelty requirements of § 102, non-obvious requirements of § 103 and the requirement to clearly and exactly describe the invention under § 112.
The Claim
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 8×108 red blood cells indicates a need tincrease the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. See U.S.P.N. 6,355,623.
In conclusion, with respect to method or process claims, the transformation of blood chemistry coupled with only a “determining” step, is not patentable statutory subject matter under § 101. Such “chemical transformation” with a “determining step” is now held to fall within the “conventional post solution” category as does issuing an alarm (Flook) or printing or displaying a result. These are “well understood, routine, conventional activity, previously engaged in by those in the field.” P. 13. Further, the sequence of the steps was not unique.
