AI Risks With the Patent Office: What Life Science Companies Should Be Asking Now
Robert J. Hilton, Ph.D. & Justin Culbertson, Ph.D.
AI tools are reshaping patent preparation and prosecution, but statements made to the USPTO are permanent, and AI-generated inaccuracies don’t come with warning labels. Efficiency gains are real, but so is the need for proper oversight to protect your portfolio.
Federal Circuit Confirms Patent Eligibility of Gene Therapy Patent in Regenexbio Inc. v. Sarepta Therapeutics
Agnes Juang, Ph.D. & Ashley C. Morales
Genetically engineered cultured host cells containing recombinant nucleic acids useful for gene therapy are patent-eligible for being markedly different from anything occurring in nature.
USPTO Launches PIER Pilot Program Creating New Pre-Examination Decision Point for PCT National Stage Applications
The USPTO’s new PIER Pilot Program requires applicants in selected PCT national stage applications to affirmatively decide whether to proceed with, delay, or abandon U.S. patent examination. Participation is mandatory for selected applications, and failure to respond to the USPTO’s Requirement for Information will result in abandonment. Patent owners and applicants with active or pending 35 U.S.C. § 371 filings should prepare internal workflows now to evaluate and respond to selection quickly.
SMEDs Are Working: What the USPTO’s Updated § 101 Patent Eligibility Guidance Means for Innovators
Philip M. Nelson & Jarom D. Kesler
The U.S. Patent and Trademark Office’s April 30, 2026 memorandum encourages patent applicants to submit separate declarations supporting “subject matter eligibility” (SMEDs) in response to § 101 rejections. The USPTO first encouraged this approach in December 2025, and confirms in this latest guidance that such declarations have been helpful in facilitating patent allowance. SMED declarations should explain how the claimed invention is “better, cheaper, faster, and/or more efficient” and provides “real-world technological application, effect and benefit.”
Knobbe Martens Named Life Sciences Prosecution Firm of the Year at Life Sciences Patent Network Awards
Knobbe Martens is proud to share the firm received the “Life Sciences Prosecution Firm of the Year” award at the 2026 Life Sciences Patent Network (LSPN) Awards ceremony, held yesterday in Boston.
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