For process claims that encompass natural phenomenon, the process steps themselves are the additional features that must be new and useful. Here, for example, using a newly discovered source of cell-free fetal DNA (“cffDNA”) to conduct fetal screening was found to be patent ineligible because the screening steps themselves were otherwise well-understood, routine, and conventional. “Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art.” It may therefore be best to avoid framing the description of an invention in a bottom-up fashion around the discovery and subsequent application of a natural phenomenon, but instead, to frame it in a top-down fashion around the steps of a new procedure (that happens to be predicated on an unspecified natural phenomenon).
Background / Facts: The patent being asserted here relates to the scientific discovery that cell-free fetal DNA (“cffDNA”) is present in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste. The parties agree that the patent does not claim cffDNA. Instead, the patent claims certain methods of using cffDNA for non-invasive prenatal screening by amplifying the cffDNA contained in a sample of a plasma or serum from a pregnant female and detecting a portion that is paternally inherited. Using methods like polymerase chain reaction (“PCR”) to amplify and detect cffDNA was well-understood, routine, and conventional activity at the time of the invention.
Issue(s): Whether the claimed methods are patent eligible applications of a natural phenomenon, specifically a method for detecting paternally inherited cffDNA.
Holding(s): No. After noting that “the claimed method begins and ends with a naturally occurring phenomenon,” the court turned to step two of the Alice framework. “The method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA. Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful. The only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum. … [A]ppending routine, conventional steps to a natural phenomenon, specified at a high level of generality, is not enough to supply an inventive concept.”