User:HanyuBao/sandbox

The Mayo two-step test
The court devised a two-step test to examine the patent eligibility of a concept according to the case Mayo Collaborative v. Prometheus Labs. The first part asks if the claim is directed to a patent ineligible concept. "Phenomena of nature, mental processes and abstract, intellectual concepts are not patentable because they are basic tools of scientific and technological work." The second part askes whether the concept contains any conventional steps that would not deem it sufficiently "inventive." Therefore, a patent focusing on natural phenomenon must contain additional components so that it is not merely replicating a law of nature.

Panel decision
A three-judge panel affirmed the judgment of the district court. The majority concluded that the patent fails the two-step test that the Supreme Court developed in Mayo for determining whether a method patent impermissibly claims a natural law or phenomenon.

First, the court said, the claims "are directed to a patent-ineligible concept" because the "method begins and ends with a natural phenomenon" (i.e., cffDNA). Second, it said, the claimed method did not "'transform' the claimed naturally occurring phenomenon into a patent-eligible application"of the phenomenon.

The court reasoned that, "[f]or process claims that encompass natural phenomen[a], the process steps . . . must be new and useful." But researchers already knew how to accomplish the individual steps of (1) fractionating blood; (2) amplifying DNA; and (3) detecting characteristics in amplified DNA. Therefore, the claimed method impermissibly added only "well-understood, routine, and conventional activity" to the natural phenomenon that the doctor inventors had discovered. That made the claimed subject matter patent-ineligible as a matter of law.

The court said that it rejected Sequenom's argument that "implies that the inventive concept lies in the discovery of cffDNA in plasma or serum." That discovery is the discovery of a natural phenomenon. The court also rejected the argument that the patent did not preempt the entire use of cffDNA and that some uses were unpreempted. While total preemption "may signal patent ineligible subject matter," under Parker v. Flook and other cases "the absence of complete preemption does not demonstrate patent eligibility." The fact that once a court concludes that the claims involve only natural phenomena and "conventional" techniques, "preemption concerns are fully addressed and made moot."

Commentary
Senior Judge Linn commented on the decision that "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." Linn claimed even though he personally did not agree with the decision of this particular case, he still made his judgement in accordance with the Mayo. Furthermore, Judge Lourie states that "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." Agreed by Judge Dyk, they proposed that the Mayo does identify clear language of the standardization of the test, but they question the credibility and rationality of this standardization applying to diagnostic methods.

Professor Robert Cook‑Deegan and Professor Subhashini Chandrasekharan pointed out in their article that "we believe that some of the angst about this case is misplaced. The central problem is with the patent language and breadth of claims, not the invention." They agreed that the decision might discourage the innovation for more complex gene diagnostics, but they stated that the reason why the court denied the patent eligibility in this case is because the scope of patents applied for by this company exceeds their research results in the laboratory.

The researcher Alexa Johnson claimed that "by adopting a test such as this one, courts would be taking steps to clarify which uses of natural principles are acceptable and which overstep their bounds into areas of undue preemption. Courts would be returning patent law to its roots in rewarding the creation of innovative technologies for the benefit of the public." Johnson confirmed the rationality of the Mayo and articulated that the court aimed to make restrictions on inventors who tend to apply patents beyond their inventions. However, Johnson also stated that terms in the test need further clarifications, specifically in medical fields, to both protect the rights of researchers and patients.