On his first day in office, USPTO Director John Squires signed patents for distributed ledger technology and medical diagnostics—two areas that have faced significant eligibility challenges under Section 101. The message was unmistakable: the USPTO is committed to a "strong, robust, expansive, and resilient intellectual property system." For life science and diagnostics companies, this signals a window of opportunity to build IP portfolios that might have been impossible just months ago.

The Shift in Patent Eligibility Standards

The precedential In re Desjardins decision marked a turning point. The USPTO's Appeals Review Panel clarified that improvements to machine learning models can constitute "practical applications" under the Alice/Mayo framework—directly contradicting the overly restrictive interpretations that had plagued AI patent applications.

As the decision noted: "Categorically excluding AI innovations from patent protection in the United States jeopardizes America's leadership in this critical emerging technology." The panel explicitly rejected evaluating claims "at such a high level of generality" that would equate any machine learning with an unpatentable "algorithm."

New Guidance for Examiners

The August 2025 memorandum to Technology Centers 2100, 2600, and 3600 provides critical reminders that favor applicants:

• Mental process limitations: Examiners must not expand the "mental process" grouping to encompass claim limitations that cannot practically be performed in the human mind. AI-specific processes often fall outside this grouping.
• Recites vs. involves: Claims that merely "involve" a judicial exception (but don't explicitly recite one) are eligible and don't require further eligibility analysis.
• Improvements consideration: Technical improvements to AI systems—even using generic computer components—can integrate a judicial exception into a practical application.
• Close calls favor applicants: Examiners should only reject when it's "more likely than not" (greater than 50%) that a claim is ineligible. Uncertainty should not result in rejection.

Why Diagnostics Companies Should Act Now

Diagnostic inventions have faced particular challenges under Mayo v. Prometheus, which held that claims directed to laws of nature require something "significantly more" to be patent-eligible. But the new guidance creates pathways for diagnostics companies:

• AI-assisted diagnostic methods that improve the technical process of diagnosis—not just apply known correlations—may qualify as practical applications
• Novel data processing techniques, even when the underlying biological correlation is known, can provide the technical improvement needed for eligibility
• Hardware-software combinations that improve diagnostic accuracy or speed represent patentable technical solutions

Building Your Portfolio During the Window

Policy at the USPTO can shift with administrations. The current favorable environment may not last indefinitely. Life science companies should:

• Audit existing innovations: Review AI-assisted discoveries and diagnostic methods that may now be patentable under the expanded guidance
• Emphasize technical improvements: Frame patent applications around specific technical problems solved, not just the abstract concept
• Document human contribution: Maintain clear records of human involvement in AI-assisted invention to address inventorship requirements
• File continuation applications: For previously rejected applications, consider continuations with claims crafted to align with the new guidance
• Prioritize filing speed: File provisional applications quickly to establish priority dates while the favorable guidance is in effect

The Competitive Imperative

Companies that build strong patent portfolios during this window will have significant advantages: defensive protection against competitors, leverage in partnership and acquisition negotiations, and assets that can attract investment. Those who wait may find the window has closed—and their competitors have already secured the key patents in their space.