1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
Appeal from the United States District Court for the Northern District of California. The district court found that the asserted claims were not directed to patent eligible subject matter and granted Ariosa’s motion for summary judgment.
Exception Category: Natural Phenomenon
Neither of the inventors “created or altered any of the genetic information encoded in the cffDNA, and it is undisputed that the location of the nucleic acids existed in nature before [the inventors] found them.”
“The method  begins and ends with a natural phenomenon. Thus, the claims are directed to matter that is naturally occurring.”
“[T]he claims of the ‘540 patent are directed to a naturally occurring thing or natural phenomenon.”
Significantly More: No
No, the appended steps in the process were conventional and routine
The court examined the elements of the claim to determine whether the claim contains an inventive concept sufficient to “transform” the claimed naturally occurring phenomenon into a patent-eligible application. “We conclude that the practice of the method claims does not result in an inventive concept that transforms the natural phenomenon of cffDNA into a patentable invention.”
“A claim that recites an abstract idea, law of nature, or natural phenomenon must include ‘additional features’ to ensure “that the [claim] is more than a drafting effort designed to monopolize the [abstract idea, law of nature, or natural phenomenon].”
“For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful.”
“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.” “The claims of the ‘540 patent at issue in this appeal are not directed to patent eligible subject matter and are, therefore, invalid.”
Affirmed the district court’s determination that the claims are based on the natural phenomenon of paternally inherited cffDNA (cell-free fetal DNA) and that the claims did not add enough to the natural phenomenon to make the claims patent eligible under § 101.