To address the legal issues presented by artificial intelligence ("AI"), the U.S. Copyright Office ("Office") launched a multi-part Copyright and Artificial Intelligence Report ("Report") (see our Commentaries on Part One and...more
5/27/2025
/ Algorithms ,
Artificial Intelligence ,
Copyright ,
Copyright Infringement ,
Copyright Litigation ,
Copyright Office ,
Fair Use ,
Government Agencies ,
Innovative Technology ,
Intellectual Property Protection ,
Machine Learning ,
New Guidance
The Office of Management and Budget releases highly anticipated guidance to federal agencies on the use and deployment of artificial intelligence and how to manage its risks....more
5/7/2025
/ Artificial Intelligence ,
Executive Orders ,
Federal Contractors ,
Government Agencies ,
Machine Learning ,
National Security ,
New Guidance ,
OMB ,
Regulatory Requirements ,
Risk Management ,
Technology Sector ,
Trump Administration
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
12/27/2024
/ Artificial Intelligence ,
FDA Approval ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Post-Market Approval ,
Regulatory Agenda
The Situation: Concerns that uncertain and unpredictable patent subject matter eligibility jurisprudence thwarts U.S. economic and technological advancements are especially acute in the fast advancing AI space. Stakeholders...more
The USPTO's April 11, 2024, guidance clarifies how existing USPTO rules apply to the use of AI by practitioners when interacting with the USPTO....more
The Background: In response to the Biden administration's "Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence" on October 30, 2023, the U.S. Patent and Trademark Office...more
2/19/2024
/ Artificial Intelligence ,
Biden Administration ,
Executive Orders ,
Intellectual Property Protection ,
Inventions ,
Inventors ,
Joint Inventors ,
New Guidance ,
Patent Act ,
Patent-Eligible Subject Matter ,
Patents ,
Popular ,
Public Comment ,
USPTO
USPTO Director Katherine K. Vidal issued guidance on February 6, 2024 regarding the use of AI in drafting materials submitted to the USPTO’s administrative boards, including the PTAB. Of biggest concern in the guidance is...more
The U.S. Copyright Office published new guidance on the registration of works containing artificial intelligence ("AI")-generated material and announced public roundtables on the intersection of AI and copyright....more
On August 18, 2020, the USPTO issued guidance regarding the reliance on Applicant Admitted prior art (AAPA). Under 35 U.S.C. § 311(b), IPRs may be instituted only “on the basis of prior art consisting of patents or printed...more
Patent procurement activity is increasing to protect embedded artificial intelligence ("AI") technologies in a variety of digital healthcare solutions. The United States Patent and Trademark Office ("USPTO") has issued the...more
8/19/2019
/ Artificial Intelligence ,
CLS Bank v Alice Corp ,
Digital Health ,
Healthcare ,
Life Sciences ,
Medical Devices ,
New Guidance ,
Patent Applications ,
Patent-Eligible Subject Matter ,
Patents ,
Section 101 ,
Technology ,
USPTO
The Situation The legal uncertainty surrounding patent subject matter eligibility under Section 101 of the United States Code ("35 U.S.C. § 101") has been the subject of much attention, as it has become difficult for...more
1/11/2019
/ Abstract Ideas ,
CLS Bank v Alice Corp ,
Mayo v. Prometheus ,
New Guidance ,
Patent Applications ,
Patent Examinations ,
Patent Prosecution ,
Patent-Eligible Subject Matter ,
Patents ,
Section 101 ,
USPTO