I am excited to announce the publication of the Intellectual Property Owner (IPO)’s white paper on “Software and Medical Device Guidance: A Global Perspective.”
The paper was authored by the IPO’s Software and Medical Device Subcommittee, which I had the honor and pleasure of leading in 2022. The Subcommittee reports to the IPO’s Software Committee.
PatentNext Summary: Artificial Intelligence (AI) typically involves certain common aspects such as training data and AI models trained from that training data. Nonetheless, a recent Patent Trial and Appeal Board (PTAB) decision found that it is not always obvious to combine these common aspects to render an AI-based medical device invention unpatentable.
Continue Reading PTAB finds Artificial Intelligence (AI) Medical Device Patent not so Obvious
PatentNext Summary: Software-based medical devices that focus on “data processing” can be patented. However, a patent practitioner should exercise care when drafting such claims. Otherwise, patent eligibility issues can arise. This article demonstrates countervailing Federal Circuit decisions that reached opposite patent eligibility conclusions for a pair of “data processing” medical device patents asserted by Cardionet, LLC against Infobionic, Inc.
The below article provides additional details. This article forms the second part of a multi-part series. The first part, focusing on patent-eligible software-based medical devices (i.e., “particular machines” and those having “underlying improvements”), may be found here: Patenting Software-based Medical Devices (Part 1).
Continue Reading Patenting Software-based Medical Devices (Part 2)
PatentNext Summary: The development of modern medical devices increasingly includes the use of software for performing sophisticated diagnostic or treatment-related functions. In fact, the U.S. Food and Drug Administration (FDA) now defines specific categories of software-based medical devices that include “Software as a Medical Device (SaMD)” and “Software in a Medical Device (SiMD).” In a similar way, courts review patents directed to software-based medical devices across several categories, which include inventions having “particular machines” (e.g., SiMD) and inventions purely involving software only (e.g., SaMD).
Continue Reading Patenting Software-based Medical Devices (Part 1)