The US Court of Appeals for teh Federal Circuit  on Dcember 2, 2015 denied the petition for rehearing en banc for Ariosa Diagnostics. The conurring opinions and dissenting opinions are, however, illustrative of important take home points and perhaps also of things to come, likely at the US Supreme Court level.

The en banc decision is worth studying for two reasons. First, the concurring and dissenting opinions set forth a new review of the current test for patent eligibility. Second, these opinions note the large concern of the Justices that the current Mayo/Alice framework for determining patent eligibility needs to be revisited by the US Supreme Court or perhaps (as noted in the dissenting opinion) that claims such as those in Ariosa are patent eligible under the current framework and that the en banc decision was incorrectly decided. No matter which is right, the Ariosa deicision to deny en ban review appears likely to be the ideal case to provide the US Supreme Court with a further opportunity to further define the Mayo decision. In other words, we could finally have arrived to the time where more guidance will be provided by the US Supreme Court. 

The Ariosa case has been earlier discussed in this blog. As a reminder, the claims are directed to an actual use of the natural material of cffDNA. It was undisputed that before the invention, the amplification and detection of cffDNA from maternal blood and the use of these methods for prenatal diagnoses, were not routine and conventional. But applying Mayo, Justices Lourie and Moore state that “we are unfortunately obliged to divorce the additional steps from the asserted natural phenomenon to arrive at a conclusion that they add nothing innovative to the process.”

Perhaps key here is the use of the word “unfortunately” which signifies their view that the current Mayo/Alice framework is not a good one. The Justices go on to state “Moreover, the claims here are not abstract. There is nothing abstract about performing actual physical steps on a physical material”. 

Circuit Judge DYK restated the courrent test for patent ineligibility under the Mayo decision. First, we determine whether the claims at issue are directed to a patent ineligible conecpt. Second, one looks to determine whether the method amounts to a general instruction to apply routine, conventional techniques. This two step test was confirmed in Alice Corp to distinguishing patents that claims laws of nature, natural phenomena, and abstract ideas from those that claim patent eligible applications of those concepts. First, we determine whether the claims at issue are directed to one of those patent ineligible concepts and if so, we then ask, what else is there in the claims? The process is described as a two step analysis as a search for an inventive concept –an element or combination of elements that is sufficient to ensure that the patent in practice aomunts to significantly more than a patent upon the ineligible concept itself. Applying the test to Ariosa, DYK stated that the Court had no other alternative but to find the claims ineligible. For, the claims are generally directed to detecting the presence of a naturally occuring thing or a natural phenomenon, cffDNA in materanl plasma or serum. Second, the method amounted to a general instruction to apply routine, conventional techniques when seeking to detect cffDNA. 

However, DYK noted that the Mayo/Alic fraemwork words well when the law of nature in question is well known and longstanding, as was the situation in Mayo. or in respect to abstract ideas such as claims to business methods and other processes that merely organize human activity asin Alice. But DYK stated that Mayo is problematic insofar as it concludes that inventive concept cannot come from discovering something new in nature (e.g., identificaiton of a previously unkown natural relationship or property). DYK stated that in his view, Mayo did not fully take into account the fact that an inventive concept can come not just from creative, unconventional applicaiton of a natural law, but also from the creativity and novelty of the discovery of the law itself. DYK further stated that the Mayo decision may not be entirely consistent with the Supreme Court’s decision in Myriad wehre the patent applicant discovered a previously unkown natural phenomenon: the sequences of the BRCA1 and BRCA2 genes and their connection with cancer. While the Court found ineligible Myraid’s claims to naturally occurring gDNA sequences, it suggested that new applications of knowledge about the BRCA1 and BRCA2 genes could generally be eligible with reference to claim 21 of the US Patent No. 5,753,441. Myriad thus appeared to recognize that an inventive concept can sometimes come from discovery of an unkown natural phenomenon, not just from unconventional application of a phenomenon. As Myriad emphasized, the first party with knowledge of a law of nature, natural phenomenon, or abstract idea should be in an excellent position to claim applications of that knowledge.

Finally, the dissenting opinion from Justic Newman points to a second possibility which may occur in the future with the Supreme Court –that in fact the claims to Ariosa Diagnostics are entirely consistent with the current framework of Mayo. Newman noted that Mayo recognized the principle that patent eligibility is not disabled when science is put to practical use, stating that “a new way of using an existing drug” is patent eligible. Similarly in Myriad Genetics, the Court stated that “this case does not involve patents on new applicaitons of knowledge about BRCA1 and BRCA2 genes” and further explained with respect to its holding “we merely hold that genes and the information they encode are not patent eligible under seciton 101 simply because they have been isolated from the surrounding genetic material”. Newman pointed out that in Ariosa, the inventors are not claiming the scientific fact of the discovery of paternal DNA in the blood of a pregnant woman; they are claiming the discovery and development of a new diagnostic method of using this information which all recognized as a “breakthrough”.