Title: Breaking Down the 2025 USPTO § 101 Guidance Update: What It Means for Patent Eligibility
Published by Patent 360 | June 30, 2025
Navigating Section 101 of the U.S. Patent Law — which determines subject matter eligibility — has long been one of the most challenging parts of obtaining a patent, especially for software, diagnostic methods, and biotechnology. But in early 2025, the USPTO issued new guidance that narrows the interpretation of "abstract ideas" and provides more predictability for patent applicants.
Here's what you need to know — and how Patent 360 can help you take advantage of these changes.
What Is 35 U.S.C. § 101?
Section 101 governs what types of inventions can be patented. To be eligible, an invention must fall within the statutory categories (process, machine, manufacture, or composition of matter) and not fall into a "judicial exception" (laws of nature, natural phenomena, or abstract ideas).
For years, vague interpretations of "abstract ideas" — especially in software and diagnostic methods — led to high rejection rates, unpredictable outcomes, and examiner inconsistency.
2025 USPTO Guidance: Key Updates
In January 2025, the USPTO released updated guidance that offers greater clarity and narrower application of the judicial exceptions.
1. Clarified "Significantly More" Test (Step 2A, Prong Two & Step 2B)
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The new framework emphasizes real-world technical improvements or transformations as a basis for eligibility.
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Examiners are now instructed to consider practical applications, even when the claims involve some abstraction.
2. Software & AI Patent Applications Get a Boost
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Claims related to machine learning models, data classification, and system performance enhancements are more likely to clear § 101 if tied to a specific technical solution.
3. Diagnostic Methods Are No Longer Automatically Excluded
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If the method includes a novel detection step or a data transformation process, it may now be eligible — a significant departure from post-Mayo precedent.
4. Examiner Training and Internal Appeals
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Examiners must document and cite specific reasons when rejecting under § 101.
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Applicants can request subject matter eligibility interviews or appeal based on misapplication of the new guidance.