In a latest determination with essential implications for synthetic intelligence (AI) pushed innovation, the Patent Trial and Enchantment Board (PTAB) denied a patent for an AI-based medical software.[1] The refusal was not as a result of the invention was not new or creative. Slightly, the refusal was as a result of the invention didn’t meet a basic rule of U.S. patent regulation. In Ex parte Michalek, the PTAB particularly acknowledged that the patent claims at subject recited new details about the nexus between sure biomarkers and the event of lung most cancers as facilitated by machine studying. In reality, previous to enchantment, the applicant had efficiently refuted all arguments raised by the patent examiner that the invention was not new or nonobvious. That mentioned, based mostly on U.S. Patent Workplace steerage and a associated instance from that steerage, the PTAB nonetheless decided the claims had been flawed based mostly on the authorized precept of material eligibility. Though the information on this determination concern medical well being innovation, the choice is useful to tell patent technique for AI-enabled innovations throughout numerous disciplines and industries.
In its patent software, the applicant submitted patent claims masking a machine studying enabled functionality to foretell a illness state of a human based mostly on sure biomarkers. Throughout prosecution, the applicant had overcome all prior artwork rejections. Thus, the problem of novelty and nonobviousness of the claims had been particularly raised, thought of, and resolved within the applicant’s favor. Patentability rested on the one remaining subject of material eligibility.
Material eligibility refers as to whether an invention is of the required kind to qualify for patent safety underneath U.S. patent regulation. Processes, machines, manufactures, and compositions of matter are patentable however pure legal guidelines, mathematical ideas, and summary concepts, for instance, usually are not. In apply, distinguishing between the 2 classes has confirmed tough. Due to this issue and the distinctive complexities posed by AI pushed innovation, the U.S. Patent Workplace has issued particular steerage on material eligibility of AI-related innovations. The steerage units forth ideas that inform how patent examiners ought to assess whether or not AI-driven improvements meet material eligibility necessities. For example these ideas, the USPTO has supplied numerous particular “examples” demonstrating when AI-related innovations are patent-eligible and when they aren’t.
Though it acknowledged that the invention concerned a brand new thought, the PTAB in Michalek discovered that the invention was a pure regulation and a mathematical idea. The PTAB relied on an instance from Patent Workplace steerage that characterizes an invention regarding willpower of affected person danger for a medical situation as ineligible as a result of it concerned an enchancment to an summary thought, to not the functioning of a pc or different know-how. Based on the cited instance, the recital of a therapy for the medical situation in principle may have helped the applicant to show the subject material eligibility of the invention. Nevertheless, the PTAB didn’t focus on this feature and, in any occasion, no proof indicated {that a} therapy had been described within the patent software. As maybe extra related, the PTAB didn’t focus on different examples from Patent Workplace steerage which may have higher utilized to save lots of the invention.
Whereas this case concerned medical well being know-how, the implicated points inform patent methods for AI-enabled innovations throughout all industries. Patent candidates working with AI ought to be ready for the Patent Workplace to use related reasoning to their functions. Patent candidates ought to be ready to deal with strained reliance on sure examples from Patent Workplace steerage or, higher but, spotlight extra analogous examples. It’s essential for patent candidates on the preparation stage to proactively devise an software drafting technique supported by the steerage and examples to ask smoother prosecution.
FOOTNOTES
[1] Ex parte Michalek, Enchantment No. 2023-004204 (PTAB Dec. 27, 2024).
