In Ariosa Diagnostics, Inc. v. Sequenom, Inc., 2013 U.S. Dist. LEXUS 156554, the U.S. District Ct. for N.D. Cal., granted summary judgment to Ariosa that the claims of U.S. Patent No. 6,258,540 were invalid as directed to patent-ineligible natural phenomena in combination with conventional sampling and detection techniques. The claim were directed to methods for detecting paternally inherited nucleic acid of fetal origin by amplifying a paternally inherited nucleic acid of fetal origin from a serum or plasma sample from a pregnant female and detecting the presence of this type of “cffDNA”. Claims 21 and25 recite that they are directed to “A method of performing a prenatal diagnosis” by obtaining a non-cellular fraction of the blood sample, amplifying the cffDNA in the fraction, detecting its presence and “providing a diagnosis based on the presence, quantity and/ or sequence of the DNA.”  Some conditions can be diagnosed by just measuring the absolute level of the bffDNA.  No specific diagnostic conclusions were recited in the claims. In fact, during oral argument, Sequenom had admitted: “I don’t disagree that if you go through all the elements in the claim you could put a check as either a conventional item or a natural phenomenon.”

Read the rest of this entry »