1234 F.3d 567 (Fed. Cir. 2023)
In re Application of H. S.
Does the use of naturally occurring proteins in a biotechnological process, when significantly altered by human intervention, qualify as patentable subject matter under current patent law?
Under 35 U.S.C. § 101, patentable subject matter includes any new and useful process, machine, manufacture, or composition of matter. However, laws of nature, natural phenomena, and abstract ideas are not patentable. The court applies the Alice/Mayo framework to determine patent eligibility, focusing on whether the claimed process amounts to significantly more than a patent on the ineligible concept itself.
The court reversed the PTO's decision, holding that the method described by H. S. constitutes patentable subject matter. The court found that the procedure involved an inventive application of natural principles, thus meeting the requirements for patent eligibility.
This case is significant for law students and practitioners because it clarifies the application of the Alice/Mayo test in the biosciences. The decision underscores how biotechnological innovations, even when utilizing natural phenomena, can qualify for protection if they exhibit significant human-engineered modifications. It presents an important precedent for determining the limits of patent eligibility in a field where the line between natural and human-made inventions often blurs.