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: WIPO published a Patent Landscape Report on GenAI. The Patent Landscape Report discusses trends in GenAI, including trends in: GenAI scientific publications, GenAI patents, GenAI models, types of data used in GenAI, and GenAI application areas.Continue Reading WIPO Issues a Patent Landscape Report on Generative Artificial Intelligence (GenAI)
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)
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)
To date, the Federal Circuit has not reviewed many cases involving artificial intelligence (AI). However, in a recent case, the Federal Circuit found that a “machine learning” claim element lacked sufficient enablement because both the claim itself and the written description of the patent to which it belonged failed to describe “how” the claimed invention implemented this element. In view of this ruling, patent practitioners should endeavor to explain sufficiently in the written description the specific aspects of how machine learning features (and other computer-implemented invention features) operate in order to demonstrate sufficient enablement.Continue Reading The Federal Circuit hints at Enablement requirements for Artificial Intelligence (AI) Inventions
I am excited to announce the publication of the American Intellectual Property Law Association (AIPLA)’s article on “IP Aspects of Augmented Reality and Virtual Reality Technologies.” Continue Reading Announcing AIPLA article on Augmented Reality(AR) / Virtual Reality(VR): IP Aspects of Augmented Reality and Virtual Reality Technologies
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. Continue Reading Announcing IPO white paper on a Global Perspective on Software and Medical Device Guidance
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 Takeaway: The concept of the “Metaverse,” while decades old, is just starting to gain traction today. Early efforts to establish the Metaverse came from the video game industry. That is, as video games have become more modern, they are increasingly designed to have interactive virtual worlds, which is a hallmark of the Metaverse. Because of this, we can expect the U.S. Patent and Trademark Office (USPTO) and courts to look to prior art and previous cases involving video game technology to decide Metaverse-related issues in the future. For the same reason, we can also use best practices for patenting software-related technologies (upon which video game technology relies) to prepare Metaverse-related patents.
Continue Reading Exploring the Metaverse and Patent-related topics