Background and Objectives

The updated guidance, which takes effect on July 17, 2024, provides an overview of the USPTO’s efforts related to AI and subject matter eligibility. It includes discussions on Federal Circuit decisions pertinent to AI inventions and introduces three new examples illustrating how to apply the guidance across various technologies. This guidance aims to ensure a consistent approach to examining AI-related patents, contributing to a more predictable patent system.

Public Engagement and Implementation

The USPTO has opened the floor for public comments on the guidance update and the examples until September 16, 2024, to encourage stakeholder participation in refining the guidelines. These comments can be submitted through the regulations.gov portal. Despite being non-binding, the guidance serves as a critical resource for patent examiners and applicants, ensuring that they are well-versed in evaluating AI-related patent claims.

Inventorship and AI

In alignment with other national patent offices, the USPTO maintains that AI cannot be listed as an inventor on a patent application. The guidance clarifies that only natural persons can be recognized as inventors, even if AI systems are used during the inventive process. This approach parallels those of the United Kingdom Intellectual Property Office and the European Patent Office, ensuring a harmonized international stance on AI inventorship.

Key Areas of Focus

The guidance specifically addresses several challenging questions about AI and inventorship. It includes illustrative examples that depict various roles AI systems might play in the inventive process and outlines how inventorship should be analyzed in these scenarios. Moreover, the USPTO has updated its analysis flow charts, offering detailed procedural guidance for examiners and practitioners.

Broader Implications

This guidance is part of a broader initiative to promote innovation and clarify patent eligibility issues as AI technology evolves rapidly. The USPTO’s efforts also respond to President Biden’s Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, which underscores the importance of developing robust guidelines for AI-related patents. By establishing these updated guidelines, the USPTO aims to foster a more transparent and predictable environment for AI-related patenting, ultimately encouraging innovation and investment in this rapidly growing field.

Impact of the 2024 Guidance

The 2024 guidance issued by the United States Patent and Trademark Office (USPTO) marks a significant step towards addressing the complex issues surrounding patent eligibility for AI inventions. This update is crucial as it builds on previous guidance to provide further clarity and consistency in evaluating subject matter eligibility of claims in patent applications involving AI technologies. The guidance, which goes into effect on July 17, 2024, is particularly relevant given the rapid advancements and increasing integration of AI in various fields.

Clarification on AI Inventions

One of the key impacts of the 2024 guidance is the detailed discussion on subject matter eligibility specific to AI inventions. The update includes three new examples demonstrating the application of this guidance across a wide range of technologies, helping both the USPTO and applicants navigate the complexities involved in patenting AI-related inventions. This initiative is part of the USPTO’s ongoing efforts to adapt patent law to modern technological advancements, ensuring that innovations in AI are adequately protected under current legal frameworks.

Inventorship and AI

The guidance also provides essential clarification on the determination of inventorship for AI-assisted inventions. Following the Federal Circuit decision in Thaler v. Vidal, the guidance confirms that only natural persons can be recognized as inventors under U.S. patent law. This decision underscores the importance of human contribution in the inventive process, aligning with the principle that patents serve to incentivize and reward human ingenuity. The guidance specifies that AI-assisted inventions are not categorically unpatentable, provided that one or more natural persons have significantly contributed to the invention.

Public Participation and Further Developments

The USPTO is actively seeking comments from the public on the impact of these guidelines and the broader implications of patent eligibility jurisprudence since the Supreme Court’s decisions in Mayo v. Prometheus. This inclusive approach aims to refine the guidance further and address any emerging issues related to AI and patentability. Comments on the draft March-In Rights Guidance are due by February 6, 2024, and feedback on the inventorship guidance is accepted until July 29, 2024.

Broader Legal and Ethical Considerations

The 2024 guidance also touches on the broader ethical and legal considerations associated with AI in the legal profession. As noted in the 2023 Year-End Report on the Federal Judiciary by Chief Justice Roberts, AI holds the potential to enhance access to key information but also poses risks such as invading privacy interests and dehumanizing the law. The American Bar Association has established a task force to provide insights on the responsible use of AI, reflecting the growing need to balance innovation with ethical considerations in legal practice. By issuing this comprehensive and forward-looking guidance, the USPTO aims to foster innovation while ensuring that the legal framework for patents keeps pace with technological advancements in AI. The guidance will provide much-needed clarity for stakeholders and contribute to the consistent application of patent law in the evolving landscape of AI technology.

Implementation Challenges and Strategies

Implementing the USPTO’s 2024 guidance on patent eligibility for AI-assisted inventions presents several challenges and necessitates strategic approaches to ensure clarity and consistency in patent practices.

Challenges

Determining Inventorship

One of the primary challenges lies in determining inventorship when AI systems are involved in the innovation process. The guidance emphasizes that AI-assisted inventions are not categorically unpatentable but stipulates that the inventorship analysis should focus on human contributions. This necessitates clear criteria for evaluating the extent and significance of human input versus AI assistance. The requirement that only natural persons can be listed as inventors, in alignment with existing legal frameworks, adds another layer of complexity, particularly in collaborative environments where AI plays a substantial role.

Legal and Policy Consistency

Ensuring consistency in the application of these guidelines across various departments within the USPTO, such as the Central Reexamination Unit and the Patent Trial and Appeal Board (PTAB), is crucial. This involves standardizing the interpretation and application of the guidance to avoid discrepancies and ensure fair treatment of all patent applications involving AI technologies. Moreover, aligning this guidance with international standards and practices, especially given the global nature of AI innovation, poses a significant challenge.

Strategies

Training and Education

To address these challenges, the USPTO has initiated extensive training programs for its personnel, including examiners and other stakeholders. These training sessions focus on the nuances of AI-assisted inventions and provide practical examples to illustrate the application of the guidance. Additionally, webinars and Q&A sessions have been scheduled to disseminate knowledge and clarify doubts regarding the new guidelines.

Public Engagement and Feedback

The USPTO actively seeks public comments on the inventorship guidance for AI-assisted inventions, reflecting its commitment to transparency and stakeholder engagement. This feedback mechanism allows for the identification and resolution of potential issues before they become widespread. By incorporating diverse viewpoints from the innovation ecosystem, the USPTO aims to refine and enhance its guidance, ensuring it meets the needs of all stakeholders.

Continuous Updates and Adaptation

Recognizing the rapid evolution of AI technologies, the USPTO plans to regularly update its guidance to reflect new developments and emerging challenges. This includes adding new case examples and providing further clarity on subject matter eligibility and other pertinent issues. The guidance update set to take effect in July 2024 exemplifies this adaptive approach, with new examples and detailed discussions aimed at maintaining relevance and effectiveness in a dynamic technological landscape. Through these strategic initiatives, the USPTO aims to mitigate the challenges associated with implementing the 2024 guidance on patent eligibility for AI-assisted inventions, ensuring robust and consistent patent practices that support innovation and protect intellectual property rights.

Case Studies and Examples

In re Starrett

The case of In re Starrett is notable not only for its specific subject matter but also for its departure from life sciences technology. According to the Federal Circuit decision, it pertained to “a gadget-free extension of human senses”. The court’s endorsement of the Wands factors in this case supports the guidance instructing USPTO personnel to apply the Wands factors regardless of the technology. While there has been much discussion on whether the Supreme Court decision in Amgen would impact how claims are analyzed for enablement under 35 USC § 112, the USPTO maintains adherence to the Wands factors across various technologies when examining patent applications and reviewing granted patents.

AI-Related Patent Inventions Post-Alice

Following the Supreme Court’s Alice decision, courts have routinely applied the two-part Alice test to analyze general software-related inventions, including those involving artificial intelligence (AI). AI-related patent inventions continue to be scrutinized under this test, and the USPTO’s guidance update provides further clarity on this matter. This update includes examples and discussions of Federal Circuit decisions that are particularly relevant to AI inventions.

Thaler v. Vidal

In the landmark case of Thaler v. Vidal, Stephen Thaler petitioned the U.S. Supreme Court to review an appeals court’s decision that patents can only be issued to human inventors and that his AI system cannot be the legal creator of inventions it generated. This case underscores the ongoing debate over the role of AI in inventorship and the legal recognition of AI-generated inventions.

Medical Device Litigation

Litigation relating to medical devices is expected to increase, leading to greater clarity regarding the scope of medical diagnostic patents. The uncertainties in the laws on patent-eligible subject matter, especially in life sciences and medical diagnostics, have been significant. With the Supreme Court declining to take another Section 101 case, companies in this field are left to navigate existing case law and guidance. The USPTO’s updated guidance aims to address these uncertainties and provide a more consistent framework for evaluating AI-related medical inventions.

Examples of AI in Medical Diagnostics

One example provided in the updated guidance involves a deep learning model used for automated image recognition of a medical condition in image data. This model identifies characteristics of the medical condition and modifies, updates, or prioritizes an electronic workflow for diagnostic evaluation based on the recognized characteristics. These systems and methods for processing electronic imaging data obtained from medical procedures highlight the practical applications of AI in medical diagnostics.

Patenting Activity for AI in Medicine

Contrary to fears that AI-related inventions in the medical field might face significant eligibility challenges, patent office data show robust and rising patenting activity in this area. The annual patenting activity for medical machine learning technologies indicates a healthy trend of innovation and legal recognition in the field. This trend reflects the increasing implementation of AI-related technologies in society and their subsequent impact on various technical fields.

Japanese Patent Office (JPO) Data

The Japanese Patent Office (JPO) has updated its data based on patent applications until 2021, revealing a steady increase in domestic applications for AI-related inventions since 2014, with approximately 9,000 applications filed in 2021.

Critical Perspectives

The release of the USPTO’s 2024 guidance on patent eligibility for AI-assisted inventions has sparked significant discussion among legal experts, industry stakeholders, and academics. One of the primary points of contention revolves around the USPTO’s steadfast reliance on the Wands factors for assessing enablement, regardless of the technology involved. The Federal Circuit’s endorsement of the Wands factors in cases outside of life sciences, such as In re Starrett, has reinforced this approach, suggesting a broad applicability across various technological domains. However, some critics argue that the Wands factors, developed in the context of biotechnology, may not be entirely suitable for the nuanced challenges presented by AI and software inventions. Furthermore, the USPTO’s stance that AI systems cannot be named as inventors, as upheld in the Federal Circuit’s decision in Thaler v. Vidal, continues to be a contentious issue. Critics point out that this position might stifle innovation by not fully recognizing the integral role AI systems play in the inventive process. The guidance asserts that patents should reward human ingenuity, thus focusing the inventorship analysis on human contributions, which some argue overlooks the collaborative nature of AI-human interactions in modern invention processes. The interpretation of “intellectual domination” over AI systems also presents a gray area. While the USPTO provides hypothetical examples to clarify this, principles such as maintaining control over an AI system do not automatically qualify a person as an inventor, leading to potential ambiguity in real-world applications. Critics worry that this might result in inconsistent rulings, thereby creating uncertainty for patent applicants and holders. Moreover, the international landscape of AI-related patent laws presents additional complexities. The differing approaches between jurisdictions, such as the recent Federal Court of Canada ruling striking down the “problem-solution” approach for software patent eligibility, highlight the lack of harmonization in patent laws concerning AI technologies. This divergence underscores the need for a more unified global framework to address the patentability of AI-assisted inventions effectively. Despite these concerns, the USPTO’s guidance aims to bring clarity and consistency to the evaluation of AI-assisted inventions, promoting innovation while adhering to the principles of patent law. However, the ongoing debates suggest that further refinements and possibly legislative action may be necessary to fully address the challenges posed by the integration of AI into the inventive process.

Summary

The United States Patent and Trademark Office (USPTO) issued the 2024 Guidance on Patent Eligibility for AI Inventions to provide clarity and consistency in determining the subject matter eligibility of AI inventions under patent law (35 U.S.C. § 101). This update, effective from July 17, 2024, builds on previous guidance by offering detailed instructions for evaluating AI-related patent claims, reflecting the USPTO’s commitment to adapting patent law to accommodate rapid advancements in AI technology. The guidance aims to foster a more predictable patent system, benefiting both examiners and applicants. A key aspect of the 2024 guidance is its detailed discussion on subject matter eligibility specific to AI inventions, including three new examples illustrating how the guidance applies across various technologies. This initiative helps navigate the complexities involved in patenting AI-related innovations, ensuring that such inventions are adequately protected under current legal frameworks. The guidance also addresses the determination of inventorship, confirming that only natural persons can be recognized as inventors, even if AI systems are used during the inventive process, following the Federal Circuit decision in Thaler v. Vidal. This approach aligns with international standards and reinforces the principle that patents incentivize human ingenuity. Public engagement is a critical component of the 2024 guidance, with the USPTO actively seeking stakeholder comments until September 16, 2024. This inclusive approach aims to refine the guidelines further and address emerging issues related to AI and patentability. The guidance is part of a broader initiative to promote innovation and respond to President Biden’s Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, emphasizing the need for robust guidelines for AI-related patents. The release of this guidance has sparked significant discussion among legal experts, industry stakeholders, and academics, particularly regarding the determination of inventorship and the application of the Wands factors for assessing enablement across various technological domains. Despite some criticism, the USPTO’s efforts aim to provide much-needed clarity and consistency in the evolving landscape of AI technology, encouraging innovation and investment in this rapidly growing field.

2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence
https://www.federalregister.gov/documents/2024/07/17/2024-15377/2024-guidance-update-on-patent-subject-matter-eligibility-including-on-artificial-intelligence

USPTO issues AI subject matter eligibility guidance
https://www.uspto.gov/about-us/news-updates/uspto-issues-ai-subject-matter-eligibility-guidance