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Genetic Technologies Limited v. LabCorp

Representative Claim(s)

1. A method to predict potential sprinting, strength, or power performance in a human comprising:

a) analyzing a sample obtained from the human for the presence of one or more genetic variations in α–actinin–3 (ACTN3) gene;

b) detecting the presence of two 577R alleles at the loci encoding amino acid number 577 of the α–actinin–3 (ACTN3) protein; and

c) predicting the potential sprinting, strength, or power performance of the human, wherein the presence of two copies of the 577R allele is positively associated with potential sprinting, strength, or power performance.

Posture:

Motion to Dismiss

Exception Category: Law of Nature

“Claim 1 of the ′342 Patent sets out the correlation between a particular genetic variation and sprinting, strength or power performance… Thus, according to the claim, if a person has two copies of the 577R allele, he is likely to be a better sprinter than if he did not….  The correlation is the handiwork of nature—man did not do anything to bring about this relationship.”

Significantly More: No

“The claimed method consists of three steps: an ‘analyzing’ step, a ‘detecting’ step, and a ‘predicting’ step…”

“First, the ‘analyzing’ step is insufficient to make the claim patent eligible.  It merely tells the users of the method to analyze a sample obtained from a person for the presence of genetic variations in the ACTN3 gene, without further specification as to how the sample should be analyzed.”  The court noted that the specification provided that any number of well-known methods could be used to analyze the sample.

“Second, the ‘detecting’ step fares no better. It simply tells users of the process to detect the presence of two 577R alleles in the sample, again without specifying any particular method for doing so.”  As with the analyzing step, the court noted that the specification taught that users could choose from several well-known detection methods.

Citing Prometheus, the court found that, “Third, the ‘predicting’ step, which tells users of the process to predict the athletic performance of the person based on the presence of two 577R alleles in the sample, amounts to no more than an ‘instruction [to] apply the [natural] law.’”

The court also looked at three steps as a whole, finding, “Lastly, looking to claim 1 as a whole, the steps in combination do not make the natural law and insignificant post-solution activity into patent-eligible subject matter.”