PatentNext Takeaway: This post highlights the FDA’s increasing regulatory efforts for artificial intelligence (AI) and machine learning (ML)-enabled medical devices (MLMDs), with a focus on managing device AI/ML updates through Predetermined Change Control Plans (PCCPs). The FDA emphasizes five guiding principles for PCCPs to ensure safety, risk management, and transparency for MLMDs throughout their lifecycle.
PatentNext Takeaway: The USPTO announced its 2024 Guidance Update on Patent Subject Matter Eligibility, particularly focusing on Artificial Intelligence (AI). Effective July 17, 2024, this guidance aims to address examination procedures for U.S. patent applications under 35 U.S.C. § 101, following President Biden’s executive order on the safe development and use of AI. The 2024 AI Guidance is designed to help USPTO personnel apply existing subject matter eligibility rules to AI-related inventions during patent examination, appeal, and post-grant proceedings. It includes case examples from the Federal Circuit, which, although not AI-specific, are relevant for understanding software-related arts. Additionally, it introduces hypothetical examples (new example claims 47-49) illustrating how AI-related patent claims will be analyzed for eligibility. These examples suggest that examiners will scrutinize AI-related claims more rigorously, emphasizing the need for detailed descriptions of how AI features improve technology or technical fields and/or provide a specific medical treatment. While the guidance does not constitute new law, it replaces previous guidance and is expected to be integrated into the MPEP eventually.Continue Reading The USPTO Issues Guidance on Patenting Artificial Intelligence (AI)-related Inventions per 35 U.S.C. § 101 (Subject Matter Eligibility)
PatentNext Takeaway: Can text generated by artificial intelligence (AI) (e.g., an “AI-generated text”) constitute “prior art” pursuant to U.S. patent law? The answer to that question will impact whether AI-generated text can be used to preclude human inventions from issuing as patents in the United States. Third-party entities currently publish AI-generated text for the express purpose of preventing patent inventions from issuing. But this seems to run afoul of U.S. law requiring human “conception,” not to mention the U.S. Constitution, which seeks “[t]o promote the Progress of Science and useful Arts ….” Accordingly, it is possible that Congress or the courts will look not only the to related statutory text, but also to existing court decisions to preclude AI-generated text from constituting “prior art.”Continue Reading Can Artificial Intelligence (AI) Generate Prior Art (e.g., a “Printed Publication”) pursuant to U.S. Patent Law?
I am excited to announce the publication of the Intellectual Property Owner (IPO)’s paper on Patent Marking regarding Software Medical Devices.
The paper provides an in-depth analysis of patent marking laws as they apply to software and medical devices. It covers multiple jurisdictions, including the United States, the United Kingdom, France, and Germany. The paper addresses various types of medical devices and software platforms, such as external, implantable, cloud-based devices, and third-party devices. Continue Reading Patent Marking And Software Medical Devices (IPO Paper Announcement)
I am excited to announce the publication of the Intellectual Property Owner (IPO)’s Artificial Intelligence (AI) Patenting Handbook (the “AI Patenting Handbook”). This is a second, updated version of the AI patenting handbook. Continue Reading Artificial Intelligence (AI) Patenting Handbook: Version 2.0
PatentNext Takeaway: The U.S. Patent and Trademark Office (USPTO) recently issued examination guidance regarding patentability for artificial intelligence (AI)-assisted inventions. The guidance states that AI-assisted inventions are not “category unpatentable.” Instead, when a natural person provides a “significant contribution” to an invention, such an invention can be patentable even if an AI system contributed to the invention. While the guidance does not constitute law, it is grounded in law, i.e., the Federal Circuit’s so-called Pannu factors, which serve as a test for ensuring that a natural person contributed, at least in part, to the conception of the invention as required in the Federal Circuit’s Thaler decision on AI inventorship. The guidance also provides several useful guidelines and examples to help patent practitioners determine what constitutes a “significant contribution” for purposes of establishing natural person inventorship and, thus, patentability for AI-assisted inventions. Continue Reading The U.S. Patent Office provides Inventorship Guidance for AI-Assisted Inventions
Demonstrating that a claimed invention provides an “improvement” to an underlying computing device is one of the best ways to achieve patent eligibility pursuant to Section 101 of U.S. Patent Law. However, the Federal Circuit has repeatedly held that an improvement to a “User Experience” (UX) alone is insufficient. The Federal Circuit recently issued yet another case, further cementing its position that improving a UX, without more, fails to demonstrate a technical improvement for satisfying Section 101 per the Alice two-part test.
The President’s recent Executive Order (EO) regarding artificial intelligence (AI) addresses, among other things, intellectual property (IP). The EO directs the U.S. Patent and Trademark Office (USPTO) and U.S. Copyright Office to provide guidance and recommendations on IP issues of patent inventorship, patent eligibility, and copyright authorship in view of Artificial Intelligence (AI). While the guidance and recommendations will not have the force of law, they are nonetheless expected to include data and insights from stakeholders that could form a basis for future legislation and/or provide persuasive information as AI-related cases find their way into U.S. courts. Continue Reading Intellectual Property (IP) impacts from President Biden’s Executive Order on Artificial Intelligence (AI)
PatentNext Takeaway: Companies have increased access to artificial intelligence (AI) tools, such as ChatGPT and Github Copilot, which promise to improve the efficiency and work product output of employees. However, the adoption of such AI tools is not without risks, including the risk of loss of intellectual property (IP) rights. Accordingly, companies should proceed with caution by considering developing an AI policy to help eliminate or mitigate such risks. An AI policy can look similar to, and in many cases be a supplement to, a company’s open-source software policy. Continue Reading Artificial Intelligence (AI) Policy Considerations
According to a recent district court decision, an artificial intelligence (AI) cannot be an “author” as that term is defined by U.S. copyright law. This decision follows the U.S. Ninth Circuit Court of Appeal’s precedent regarding a “monkey selfie” photograph, where that court found that non-humans (e.g., monkeys) lack standing to sue under U.S. copyright law. The U.S. Copyright Office has since used such rulings to deny copyright registration of works that identify non-humans (i.e., AI systems) as the sole author. Continue Reading How U.S. Copyright Law on Artificial Intelligence (AI) Authorship Has Gone the Way of the Monkey