In Genetic Technologies Limited v. Merial LLC. [2015-1202, -1203] (April 8, 2016) the Federal Circuit affirmed the\u00a0district court\u00a0dismissal for failure to state a claim and entry of final\u00a0judgment that claims 1\u201325 and 33\u201336 of U.S. Patent No. 5,612,179\u00a0are ineligible for patenting under 35 U.S.C. \u00a7101. \u00a0The method of the ‘179 patent involved looking in the introns or non-coding regions (aka the junk DNA) for alleles in the exons or coding regions. \u00a0No one had previously appreciated that alleles in the exons could be identified by looking in the introns.<\/p>\n
The Federal Circuit began by noting that\u00a0it has\u00a0repeatedly recognized that in many cases it\u00a0is possible and proper to determine patent eligibility\u00a0under 35 U.S.C. \u00a7 101 on a Rule 12(b)(6) motion. \u00a0The Federal Circuit added that\u00a0In many cases evaluation\u00a0of a patent claim\u2019s subject matter eligibility under\u00a0\u00a7101 can proceed even before a formal claim construction, quoting:\u00a0\u201c[C]laim construction is not an inviolable prerequisite to a
\nvalidity determination under \u00a7101.\u201d \u00a0The Federal Circuit concluded\u00a0Here, there is no claim construction\u00a0dispute relevant to the eligibility issue.<\/p>\n
Beginning with Step 1 of the Mayo\/Alice test, the Federal Circuit found that the claims were directed to\u00a0to the relationship between\u00a0non-coding and coding sequences in linkage disequilibrium\u00a0and the tendency of such non-coding DNA sequences\u00a0to be representative of the linked coding sequences which it characterized as a law\u00a0of nature. \u00a0The Court explained the claimed invention:\u00a0a method of detecting\u00a0a coding region of a person\u2019s genome by amplifying and\u00a0analyzing a linked non-coding region of that person\u2019s\u00a0genome. \u00a0The Court observed that the claim was broad, covering\u00a0any comparison, for any purpose, of\u00a0any non-coding region sequence known to be linked with a\u00a0coding region allele at a multi-allelic locus, concludign the claims broadly cover “essentially all\u00a0applications, via standard experimental techniques, of the\u00a0law of linkage disequilibrium to the problem of detecting\u00a0coding sequences of DNA.”<\/p>\n
The Federal Circuit found this “quite similar” to the claims invalidated in Mayo<\/em> itself. The Federal Circuit also found the claims “remarkably similar” to the claims in Ariosa,<\/em> which were found in step 1 to be directed to unpatentable subject matter. \u00a0The Court said “[t]he similarity of claim 1 to the claims evaluated in\u00a0Mayo and Ariosa requires the conclusion that claim 1 is\u00a0directed to a law of nature.<\/p>\n At step two of Mayo\/Alice the Federal Circuit\u00a0examined the\u00a0elements of the claim to determine whether it contains an\u00a0inventive concept sufficient to transform the claimed The Mayo\/Alice two step completely discounts new, and even surprising discoveries of natural phenomenon, in considering whether there is patentable subject matter. \u00a0This makes unpatentable many important diagnostic advances as in Ariosa and now in Genetic Technologies. \u00a0The more appropriate question is, once the naturally occurring phenomenon is known, is particular application of that phenomenon obvious. \u00a0Maybe the results would be similar, but important, valuable advances would not simply be discounted as they are under the current Mayo\/Alice test.<\/strong><\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" In Genetic Technologies Limited v. Merial LLC. [2015-1202, -1203] (April 8, 2016) the Federal Circuit affirmed the\u00a0district court\u00a0dismissal for failure to state a claim and entry of final\u00a0judgment that claims 1\u201325 and 33\u201336 of U.S. Patent No. 5,612,179\u00a0are ineligible for … Continue reading
\nabstract idea or law of nature into a patent-eligible\u00a0application. \u00a0The Federal Circuit concluded that the additional elements of claim 1\u00a0are insufficient to provide the inventive concept necessary\u00a0to render the claim patent-eligible. \u00a0The Federal Circuit found the added physical steps of DNA amplification and\u00a0analysis of the amplified DNA to provide a user with the\u00a0sequence of the non-coding region do not, individually or\u00a0in combination, provide sufficient inventive concept to\u00a0render claim 1 patent eligible. \u00a0A result the Court found directly comparable to Ariosa. \u00a0<\/em>The Federal Circuit was not impressed that the analysis was performed on amplified, i.e. manmade DNA, because it was the genetic sequence that was important, and it was identical, \u00a0Finally the Federal Circuit was not impressed that no one had befor analyzed man-made non-coding DNA in order to detal a coding region allele, finding that\u00a0\u201cto detect the allele\u201d was a mental process step of the type discounted in Mayo.<\/p>\n