Overcoming § 101 in Medical Device Applications

Medical devices such as wearable monitoring devices, surgical robotics, smart diagnostic devices, and 3D printed prosthetics are on the cutting edge of medical technology. Companies producing these technologies must navigate the patent examination process to secure strong patent rights to block competitors, attract investment, and provide leverage for licensing agreements.

While medical device innovations often have structural components, innovations that rely in whole or in part on software or that incorporate machine learning and artificial intelligence may open up these seemingly mechanical technologies to patentable subject matter eligibility rejections under 35 U.S.C § 101.

Being prepared with an effective strategy to anticipate a § 101 challenge can help to avoid costly examination and delayed issuance of a patent, and can help to insulate the patent from § 101 attacks in litigation after grant. Addressing § 101 rejections begins at the application drafting phase, and applicants who have not drafted their application with a well-developed § 101 strategy may face an uphill battle during examination.

A key strategy for overcoming rejections under § 101 for inventions relating to medical devices incorporating software or machine learning limitations is for the applicant to show that the claimed invention provides an improvement to the functioning of a computer “or to other technology or technical field.” MPEP § 2106.04(d)(1). In order to show an improvement, the disclosure should provide sufficient details such that one skilled in the art would recognize the claimed invention as providing an improvement.

To provide a foundation to make a strong argument that the claimed invention provides a practical application, it is important to understand not only the invention but also the technological problem that the invention overcomes or the improvement that the invention provides over existing technologies. The specification should clearly explain the problem in the art that is overcome by the key features of the invention or an explanation of how the invention provides an improvement relative to existing systems. In doing so, applicants should bear in mind that courts have held that improvements providing an improved end-user experience, e.g., making a process or system faster, simpler, or easier to understand, generally do not provide an improvement to the technology. IBM Corp. v. Zillow Group, Inc., No. 2022-1861 (Fed. Cir. Jan. 9, 2024). Further, a more accurate or improved calculation is likely not sufficient to provide a practical application and can be considered to be an improvement to the abstract idea itself rather than to the underlying technology. See In re: Board of Trustees of the Leland Stanford Junior University.

Understanding the improvement to the technology also helps to determine the claim scope, as the claims should reflect the disclosed improvement to the technology. A claim recited at a high level of generality, for example, a claim that relates to analyzing data to determine a result and that concludes with a step of displaying or outputting the result is unlikely to satisfy § 101. Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353–54 (Fed. Cir. 2016). Instead, applicants should consider how the result is then used to improve the system, such as by changing the system’s operation, causing additional processes to be performed, or by causing administration of treatment, among other concrete or tangible effects.

The USPTO has recently re-emphasized the importance of identifying the improvement provided by the invention and ensuring that the claims reflect the improvement in the now precedential decision in Ex Parte Desjardins and the related updated MPEP guidance in §§ 2106.04-2106.05. In finding claims related to training a machine learning model to be patent eligible, the Appeals Review Panel in Ex Parte Desjardins relied on the Specification’s disclosure that the invention addressed the technical problem of “catastrophic forgetting” to allow the model to learn new tasks while protecting knowledge of previous tasks. The Appeals Review Panel found that the claims embodied the improvement even though the improvement (e.g., addressing catastrophic forgetting) was not expressly recited in the claims.

Applicants should be cautious that while the USPTO may be gradually embracing a more lenient approach to §101, the case law is ultimately controlling and it is not clear the courts are similarly aligned with pursuing a softer approach. See Recentive Analytics Inc. v. Fox Corp., Case No. 2023-2437 (Fed. Cir. 2025).

Until patent eligibility reform legislation, such as PERA, finally passes, or the Supreme Court intervenes, an applicant’s best approach to combatting § 101 is to work closely with their inventors and experienced IP counsel to prepare a well-drafted specification that lays the groundwork for overcoming patent eligibility challenges.

If you would like further information about drafting patent applications to insulate against § 101 rejections, please contact the authors listed above.