(b) the problem with the software inventions (such as “mathematical algorithms, including those executed on a generic computer,... [and] some fundamental economic and conventional business practices")[8] is that the scope of such claims is incommensurably broad compared to their contribution to "the Progress of Science" (quid pro quo), the US Courts rejected early attempts to develop different set of rules for the two challenges and instead tried to find a common approach to these, as well to potential other subject matter eligibility challenges in the future.
The unified Alice-Mayo approach to subject matter eligibility requires (1) the newly discovered Law of Nature or mathematical formula to be assumed as known, (2) an additional "inventive concept", that limits the application of (1) to a specific and non-trivial use.
[10] Although the details are discussed below, the net result as of year 2023 can be summarized as follows: Things (including living organisms and nucleic acids) found in nature are not patent-eligible (Funk Bros.
[12] The legislative and judicial history of the later is illustrated in the figure below: The subject-matter exception to patenting mathematical formulas and algorithms arose out of three Supreme Court cases commonly referred to as the "patent-eligibility trilogy" between 1972 and 1981: Gottschalk v. Benson, Parker v. Flook, and Diamond v. Diehr.
"[17] Similar judicial philosophy was adopted by Federal Circuit Judge Pauline Newman in Ariosa v. Sequenom, but this approach was firmly rejected by the SCOTUS in Mayo Collaborative Services v. Prometheus Laboratories, Inc. and it is not the controlling law in the USA.
In this case, Samuel Morse applied for a patent with a claim on "the use of the motive power of the electric or galvanic current, which I call electro-magnetism, however developed for marking or printing intelligible characters, signs, or letters, at any distances".
Although, the method was previously unknown and non-obvious, the Supreme Court found that the process in Benson was unpatentable since the invention, an algorithm, was no more than abstract mathematics.
[5] More generally, the Court noted that phenomena of nature, mental processes and abstract intellectual concepts were not patentable, since they were the basic tools of scientific and technological work.
The Court further noted that validating this type of patent would foreclose all future use of the algorithm in question, which is undesirable from the public policy viewpoint and the constitutional requirement "to promote the progress of science".
The US government and several legal scholars advised the Supreme Court to adopt machine-or-transformation test for subject matter eligibility, because it is fair and easy to apply.
The invention in this case was a method of calculating alarm limits by using a "smoothing algorithm" to make the system responsive to trends but not momentary fluctuations in process variables (such as temperature).
"The fact that the algorithm may not have actually been known previously and that, when taken in combination with other claim elements, it might produce an invention that is novel and nonobvious, plays no part in the analysis" of patentable subject matter.
[citation needed] The United States Supreme Court ruled in Diamond v. Chakrabarty that a living non-naturally genetically modified bacterium is patent eligible under 35 U.S.C.
"[24][25] As a result of the ruling, the patented invention included claims drawn to a non-naturally occurring bacterium that was genetically modified to be capable of degrading hydrocarbons.
[27] In this case the United States Supreme Court backed away from the analytic dissection approach, and insisted that patent-eligibility must be decided on the basis of the claim (or invention) considered as a whole.
In 2007 the Federal Circuit has ruled, in In re Nuijten,[34] that signals (such as electromagnetic waves) are not statutory subject matter, because articles of manufacture (the only plausible category under 35 U.S.C.
Allowing the signal to be patented will only lead to abusive lawsuits against Internet Service Providers and other third parties, not to the {constitutional goal of} promotion of and advancement of science.
"[35] In 2008 Federal Circuit en banc affirmed in In re Bilski the rejection of the patent claims involving a method of hedging risks in commodities trading.
The court held that the "useful, concrete, and tangible" test for patent-eligibility of a process is incorrect, and that State Street Bank v. Signature Financial Group is no longer valid legal authority on this point.
The court reasoned "the steps in the claimed processes (aside from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field."
[41][42] Others, such as the American Medical Association (AMA), praised the decision for invalidating patents that would have hampered the ability of physicians to provide quality patient care.
[48] The appeal court reversed the ruling deciding that isolated DNA had a "markedly different chemical structure" from other human genetic material.
On June 13, 2013, in Association for Molecular Pathology v. Myriad Genetics the US Supreme Court partly reversed the decision again deciding, that isolated DNA even after removal of introns was not patentable.
[51] In October 2015, the High Court of Australia ruled against Myriad Genetics, holding that a mutated gene associated with susceptibility to breast cancer cannot give rise to a patentable invention under Australian law.
In May 2013, the Federal Circuit handed down an en banc decision in CLS Bank v. Alice[55] applying the various concepts in the "Supreme Court Trilogy".
[57] Subsequently Federal Circuit court applied the Mayo v. Prometheus test to invalidate as patent-ineligible a patent said to "solve ... a very practical problem accessing fetal DNA without creating a major health risk for the unborn child.
"[58] The rational for denying patent-eligibility in this case allegedly stems from claims being directed toward non-eligible subject matter (Law of Nature), "if the APPLICATION [of this discovery] merely relies upon elements already known in the art.
She criticized the Federal Circuit's position on patent-eligible subject matter (claims preempting the use of the laws of nature), following the SCOTUS decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc..
[63] To quote the Federal Circuit: The first claimed step of ‘‘amplifying’’ genomic DNA with a primer pair was indisputably well known, routine, and conventional in the field of molecular biology as of 1989, when the first precursor application to the ’179 patent was filed.
[67] More specifically, the proposed sections read:[68] The Biden's administration has been very supportive of the US congressmen, who try to pass clear guidelines on patentable subject matter.