The claim at issue in Genetic Technologies Limited v. Merial LLC  Fed. Cir. 2016, was the following:

1. A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising:

(a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to proudce an amplified DNA sequence characteristic of said allele; and b) analyzing the amplified DNA sequence to detect the allele. 

In holding the claim a directed to a law of nature, the Court said the case was similar to Mayo where the Supreme Court considered method claims that likewise required analysis of a biological sample (the blood fo a patient being treated with a thiopurine drug) and in which the focus of the claimed advance over the prior art was allegedly newly discovered information about human biolgy: the likelihood that a pateint could suffer toxic side effeccts from particular doses of the drug (Claim 1, for example, states that if the levels of 6-TG in the blood exceed about 400 pmol per 8×108 red blood cells, then the adminsitered dose is likely to produce toxic side effects) and Ariosa v. Sequenom which covered a method of detecting fetal DNA by amplifying and analyzing cell-free fetal DNA (“cffDNA:) samples from a pregnant woman’s blood. 

The Court then proceeding to step two of the Mayo/Alice anlysis to examine the elements of the claim to determine whether they contain an inventive concept sufficient to transform the claimed abstract idea (or law of nature) into a patent-eligible application. Alice, 134 S. Ct at 2357. The question is whether the claims do significantly more than describe a natural relation. The inventive concept necessary at step two fo the Mayo/Alice anlysis cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself. Instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity”. Simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable.  

The Court found that the additional elements of claim 1 were insufficient to provide the inventive concept necessary to render the claim patent eligible. The first claimed step of “ampliyfing” genomic DNA with a primer pair was indisputably well known, routine, and conventional in the filed of molecular biology as of 1989. The second physical implementation step “analyzing” amplified DNA to provide a user with information about the amplified DNA, including its sequence was also well knonw, routine, and conventional at the time the patent was filed because techniques to analyze amplified DNA were known. 

In dismissing GTG’s argument that once the noncoding DNa has been amplified and sequenced, an instruction to users to analyze the amplified ANA sequence to detect the coding region allele provided a sufficient inventive concept, the Court held that the term “to detect the allele” is a mental process step that does not create the requisite inventive concept, because it merely sets forth a routine comparison that can be performed by the human mind. As held in Cybersource, 64 F3d 1366, 1373 (Fed. Cir. 2011), “methods which can be performed entirely in the human mind are unpatentable not because there is anything wrong with claiming metnal method steps as part of a process containing non-mental steps, but rather because computational methods which can be performed entirely in the human mind are the types of methods that embody the basic tools of scientific and technology work that are free to all men and reserved exclusively to none.”  The Court further pointed to Mayo which considered and rejected diagnostic and therapeutic method claims that combined routine and conventional physical implementation of a law of nature with a simple mental process step. An exemplary claim in Mayo recited “a method of optimzing therapeutic efficacy for treatment of a gastrointestinal disorder, comprising (a) adminstiering a thiopurine drug and (b) determining the level of a metabolite wherein a certain low metabolite level indicated a need to increase drug dosage and a certain high metabolite level indicated a need to decrease drug dosage. Mayo held that the “wherein” clauses simply tell a doctor about the relevant natural laws, at most adding a suggestion that he should take htose laws into account when treating his patient. Here, the phrase “to detect the allele” in claim 1 of the ‘179 patent also merely informs the relvant audience to apply a law of nature of a purpose of detecting a polymorphism within a coding region fo an allele of itnerest. The limtiation “to detect the allele” merely asks the user to compare the non-coding sequence he has amplified and anlyzed with a library of non-coing sequences known to be in linkage disequilibrium with certain coding reigon alleles. 

The Court further pointed out that the case is also simliar to In re BRCA1 & BRCA2 based hereditary Cancer Test, 774 F.3d 755 (Fed. Cir. 2014) wehre claim 8 of US Patent No. 5,753,441 recited a method of screening for alternations of the BRCA1 gene that included the steps of amplifying all or part of a BRCA1 gene form a sample using a set of primers to produce amplified nucleic acids and sequencing the amplified nucleic acids and comparing the sequence with wild type BRCA1. The calims was invalid because it was directed to an abstract idea and did not add enough to distinguish it from a claim to the abstract idea.