In both concurring and dissenting opinions to an en banc review, four of the twelve judges articulated concern that the test newly articulated by the Supreme Court in recent decisions on subject matter eligibility went too far in excluding novel and non-obvious inventions.  While affirming the prior ruling of a three-judge panel, the decision highlights defects in the test as now being applied.

The case at issue involves novel use of a naturally occurring phenomenon.  In pregnant women, cell-free fetal DNA (“cffDNA”) – that is, DNA of the fetus – will naturally be found within the mother’s blood.  Discarded as medical waste by other researchers, the inventors determined that cffDNA could be extracted (“fractionated”) from a blood sample taken from the mother, isolated and amplified, and used for various purposes including diagnosis of potential birth defects and establishing paternity.  The inventors proved the viability of a more efficient, faster, less expensive, more reliable, less invasive, and lower risk process for achieving those ends prior to the birth of the child.

Because cffDNA is naturally occurring and the processes employed were not novel, the Supreme Court’s new test for subject matter eligibility required that the claims be held non-patentable, as being directed to subject matter that may not be patented.  The Supreme Court decisions in Mayo and Alice articulate a hybrid. two-part test for determining subject matter eligibility:  First, the gist or “inventive concept” is analyzed to determine if it is exempt from patenting as being directed to a law of nature, an abstract idea, etc.  Second, the remainder of the claimed invention is then analyzed to determine if the claims recite “something more” than the determined gist of the invention – a hybrid analysis that involves discounting anything that is not novel or non-obvious.  Since cffDNA occurs naturally, and is not manufactured or transformed, the gist of the invention falls within a judicial exception to patentable subject matter.  Known techniques applied – albeit to achieve a novel, non-obvious result – were discounted as insufficient to add the vague “something more” required for patentability.  As a result, the breadth of the test required the trial court to hold the claim unpatentable.

The result mandated by the Supreme Court’s new test was first criticized by one member of the three-judge panel that initially heard the appeal from the lower court ruling, Circuit Judge Linn.  Noting that the Supreme Court decisions were unnecessarily restrictive of what subject matter could be patented, the panel member concurred with the outcome on appeal only because he was bound by precedent: 

I join the court’s opinion invalidating the claims of the ’540 patent only because I am bound by the sweeping language of the test set out in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012). In my view, the breadth of the second part of the test was unnecessary to the decision reached in Mayo. This case represents the consequence—perhaps unintended—of that broad language in excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain.

Judge Linn left no doubt that he believed the claimed invention to be deserving of patent protection:

The Supreme Court’s blanket dismissal of conventional post-solution steps leaves no room to distinguish Mayo from this case, even though here no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers. Indeed, the maternal plasma used to be “routinely discarded,” ’540 patent col.1 ll.50–53, because, as Dr. Evans testified, “nobody thought that fetal cell-free DNA would be present.”

It is hard to deny that Sequenom’s invention is truly meritorious. Prior to the ’540 patent, prenatal diagnoses required invasive methods, which “present[ed] a degree of risk to the mother and to the pregnancy.” Id. at col.1 ll.16–17. The available “techniques [we]re time consuming or require[d] expensive equipment.” Id. At col.1 ll.17–37. Dr. Mark Evans testified that “despite years of trying by multiple methods, no one was ever able to achieve acceptable success and accuracy.” In a groundbreaking invention, Drs. Lo and Wainscoat discovered that there was cell-free fetal DNA in the maternal plasma. The Royal Society lauded this discovery as “a paradigm shift in non-invasive prenatal diagnosis,” and the inventors’ article describing this invention has been cited well over a thousand times. The commercial embodiment of the invention, the MaterniT21 test, was the first marketed non-invasive prenatal diagnostic test for fetal aneuploidies, such as Down’s syndrome, and presented fewer risks and a more dependable rate of abnormality detection than other tests. Unlike in Mayo, the ’540 patent claims a new method that should be patent eligible. While the instructions in the claims at issue in Mayo had been widely used by doctors—they had been measuring metabolites and recalculating dosages based on toxicity/inefficacy limits for years—here, the amplification and detection of cffDNA had never before been done. The new use of the previously discarded maternal plasma to achieve such an advantageous result is deserving of patent protection.

During rehearing of the appeal en banc, four additional members of the Federal Circuit Court of Appeals likewise expressed concerns similar to those of Judge Linn, in two concurring and one dissenting opinion.  Two concurring judges, Circuit Judges Lourie and Moore, noted that the claims as a whole – without exclusion of the patent-exempt “inventive concept” – were both admittedly novel and non-obvious and self-evidently worthy of patent protection:

[T]he claims here are directed to an actual use of the natural material of cffDNA. They recite innovative and practical uses for it, particularly for diagnostic testing: blood typing, sex typing, and screening for genetic abnormalities. And it is undisputed that before this invention, the amplification and detection of cffDNA from maternal blood, and use of these methods for prenatal diagnoses, were not routine and conventional. But applying Mayo, 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.

Moreover, the claims here are not abstract. There is nothing abstract about performing actual physical steps on a physical material. And if the concern is preemption of a natural phenomenon, this is, apparently, a novel process and that is what patents are intended to incentivize and be awarded for. The panel here also noted that there were other uses for cffDNA and other methods of prenatal diagnostic testing using cffDNA that do not involve the steps recited in the various claims. That fact should sufficiently address the concern of improperly tying up future use of natural phenomena and laws.

In sum, it is unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility on grounds that they only claim a natural phenomenon plus conventional steps, or that they claim abstract concepts.

A third judge, Circuit Judge Dyk, concurred separately because he believed the claims under review were, in fact, too broadly written to warrant patent protection.  Nonetheless, he implored the Supreme Court to revise or clarify the new subject matter eligibility test:

I share the concerns of some of my colleagues that a too restrictive test for patent eligibility under 35 U.S.C. § 101 with respect to laws of nature (reflected in some of the language in Mayo) may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences, which are often driven by discovery of new natural laws and phenomena. This leads me to think that some further illumination as to the scope of Mayo would be beneficial in one limited aspect. At the same time I think that we are bound by the language of Mayo, and any further guidance must come from the Supreme Court, not this court.

Judge Dyk went on to identify the specific manner in which he found the Supreme Court’s test wanting:

The Mayo/Alice framework works well when the abstract idea or law of nature in question is well known and longstanding, as was the situation in Mayo itself (as discussed below), earlier Supreme Court cases, and in many of our own recent cases where we have found claims patent ineligible under § 101. Where the abstract idea or law of nature is well known and longstanding, there is no basis for attributing novelty to that aspect of the claimed invention.

Also, it seems to me that the Mayo/Alice framework works well with respect to abstract ideas. In my view, claims to business methods and other processes that merely organize human activity should not be patent eligible under any circumstances. See Alice, 134 S. Ct. at 2360 (Sotomayor, J., concurring); In re Bilski, 545 F.3d 943, 972 (Fed. Cir. 2008) (en banc) (Dyk, J., concurring).  In any event, departing from the Mayo/Alice framework with respect to abstract ideas (as opposed to discoveries of natural laws and phenomena) would create serious risks of undue preemption because of the difficulty in distinguishing between new and established abstract ideas.

But, as I see it, there is a problem with Mayo insofar as it concludes that inventive concept cannot come from discovering something new in nature—e.g., identification of a previously unknown natural relationship or property. In my view, Mayo did not fully take into account the fact that an inventive concept can come not just from creative, unconventional application of a natural law, but also from the creativity and novelty of the discovery of the law itself. This is especially true in the life sciences, where development of useful new diagnostic and therapeutic methods is driven by investigation of complex biological systems. I worry that method claims that apply newly discovered natural laws and phenomena in somewhat conventional ways are screened out by the Mayo test. In this regard I think that Mayo may not be entirely consistent with the Supreme Court’s decision in Myriad.

The sole dissent, Circuit Judge Newman, disputed whether the Supreme Court’s prior decisions actually required the outcome reached, as asserted by the prior critics in the Federal Circuit.  She argued that over-generalization, against which prior Supreme Court decisions specifically cautioned, led to a decision that should have been different under an individual, detailed, fact-specific analysis:

In the case at bar, 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. As the panel recognized, this is a “breakthrough,” for this information can now be learned not only earlier in the gestation period than was previously available, but without the risks of the previously required invasive procedures of penetrating the amniotic sac.

Precedent does not require that all discoveries of natural phenomena or their application in new ways or for new uses are ineligible for patenting; the Court has cautioned against such generalizations. Such caution takes hold for the case at bar. The new diagnostic method here is novel and unforeseen, and is of profound public benefit—“a significant contribution to the medical field,” Panel Maj. Op. at 16—a “breakthrough,” Panel Conc. Op. at 5. The panel’s decision to withhold access to patenting, now endorsed by the en banc court’s refusal to rehear the case, is devoid of support.

Nor does patenting of this new diagnostic method preempt further study of this science, nor the development of additional applications. Patenting does, however, facilitate the public benefit of provision of this method through medical diagnostic commerce, rather than remaining a laboratory curiosity.

The December 2, 2015 decision to refuse rehearing en banc now opens the way for the patent owner to seek petition for writ of certiorari to the Supreme Court for further reconsideration of its much-criticized test for patent subject matter eligibility.