Patent eligibility under 35 U.S.C. § 101 should be a straightforward threshold question: any “new and useful process, machine, manufacture, or composition of matter” is eligible for protection. Yet over time, this once-clear principle has become anything but.

Although the statute itself has remained unchanged for two centuries, its interpretation has evolved dramatically through judicial decisions. And it is this common law precedent that has shaped the approach to the determination of patent subject matter eligibility.

In April, the Federal Circuit issued a significant patent law ruling involving artificial intelligence. In Recentive Analytics, Inc. v. Fox Corp, the Court addressed a core question facing many AI-driven businesses: When are solutions applying machine learning to real-world problems inventive and patentable? The Federal Circuit affirmed the trial court’s dismissal of the underlying case at the pleading stage under § 101 and held that applying generic machine learning models to scheduling and programming tasks—without disclosing any technological advances to the underlying machine learning techniques—failed to meet the eligibility standards under 35 U.S.C. § 101.

Nearly seven years after the landmark Supreme Court decision in Alice Corp. v. CLS Bank Int’l, subject matter eligibility for patent claims under 35 U.S.C § 101 remains a moving target. In Alice, the Court found claims for a computerized escrow arrangement ineligible for patenting because they were directed to the abstract idea of “intermediated settlement” and did not recite an inventive concept that could impart eligibility under Section 101. While the Alice case focused on a software invention, a few recent lower court decisions suggest that, in certain circumstances, medical device patents may not be immune from similar patent eligibility challenges.