Diagnostic and therapeutic method claims that combine routine and conventional physical implementation of a law of nature with a simple mental process step are not patent eligible. Here, for example, analyzing non-coding regions of a person’s genome to detect coding regions based on a natural relationship between the two was found to be patent-ineligible because the novel feature of the analysis could be performed mentally once the natural relationship was discovered. “[A] mental process step … does not create the requisite inventive concept, because it merely sets forth a routine comparison that can be performed by the human mind.” It may therefore be best to more specifically claim how a law of nature—even a newly discovered one—is being exploited beyond merely applying it mentally to otherwise conventional analysis techniques.
Background / Facts: The patent being asserted here is directed to methods of detecting a coding region of a person’s genome by amplifying and analyzing a linked non-coding region of that person’s genome. The link between coding and non-coding regions (linkage disequilibrium) was surprising and discovered by the inventor. The detection uses a well-known amplification process and an analysis of the results based on the linking relationship.
Issue(s): Whether the claims are eligible for patenting under 35 U.S.C. § 101.
Holding(s): No. “Claim 1 broadly covers essentially all applications, via standard experimental techniques, of the law of linkage disequilibrium to the problem of detecting coding sequences of DNA.” Further, “[t]he term ‘to detect the allele’ (in the sense of examining the non-coding region to detect an allele in the coding region) is a mental process step, one that provides claim 1 with a purpose but does not create the requisite inventive concept, because it merely sets forth a routine comparison that can be performed by the human mind. … [It] also merely informs the relevant audience—e.g., doctors or others seeking to make a genetic diagnosis—to apply a law of nature for a purpose—detecting a polymorphism within a coding region of an allele of interest.” Finally, although “[c]laim 1 was found by the patent examiner to be novel over the prior art, … the novelty of looking to non-coding DNA to detect a coding region allele of interest resides in the novelty of the newly discovered natural law of linkage disequilibrium between coding and non-coding regions and adds little more than a restatement of the natural law itself.”