Before Lourie, Moore, and Reyna. Modified opinion following Ariosa rehearing petition.
Summary: The Federal Circuit modified its earlier decision and clarified the difference between a natural phenomenon and human engineering.
Illumina sued Ariosa Diagnostics for patent infringement on methods of extracting fetal DNA from blood, based on the size difference between fetal DNA and maternal DNA. The Northern District of California held that Illumina’s patents were invalid under 35 U.S.C. § 101 as being directed to a natural phenomenon. The Federal Circuit reversed, finding that Illumina’s patents were directed to patent-eligible subject matter. Ariosa petitioned for rehearing. In this modified opinion, the Federal Circuit acknowledged the natural phenomenon that fetal DNA is generally shorter than maternal DNA. But the court explained that Illumina’s claimed size thresholds that assist in differentiating the two are human-engineered. The claims at issue did not cover a method that analyzes the natural size disparity between fetal and maternal DNA, but rather exploit this disparity to separate the two.