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USPTO Director Signals Continued Pro-Patent Discretionary Denial Policy at the Patent Trial and Appeal Board Ted M. Cannon In a precedential decision in Magnolia Medical Technologies, Inc. v. Kurin, Inc.,...

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,...

In the Law360 article “How Patent Eligibility Declarations Can Stave Off Rejection,” Knobbe Martens partner Philip Nelson discussed the practical impacts of the U.S. Patent and Trademark Office’s recent update...

Key Takeaway: 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....

Available Now: Federal Circuit Year in Review Report Knobbe Martens’ 2025 Federal Circuit Year in Review report, covering over 50 of the most noteworthy patent-related Federal Circuit decisions issued last...

In a recent Law360 article, Knobbe Martens partners Rosaleen Chou, Ted Cannon, and Philip Nelson highlight significant policy developments at the U.S. Patent and Trademark Office (USPTO) expected to shape...

A Music Album with an Unusual Journey PleasrDAO (“Pleasr”) is a decentralized autonomous organization[i] that acquires culturally significant digital art and artifacts. One such work is Once Upon a Time...

USPTO Proposes Rule and Director Implements Policy Likely to Limit Multiple Patent Validity Challenges Ted M. Cannon On Friday, October 17, the USPTO published a proposed rule that, if implemented, would likely...

On October 31, 2025, Director Squires spoke to the American Intellectual Property Law Association and provided a forceful statement on his view for the direction of patent law. Of particular...

The United States Patent and Trademark Office recently announced two new pilot programs available at the early stages of patent prosecution in original applications. The Automated Search Pilot Program allows...

On August 7, 2025, the Office of the Inspector General (“OIG”) issued Advisory Opinion 25-09 (“Advisory Opinion”) providing a favorable opinion regarding remuneration to physicians with an ownership interest in a medical device manufacturer....

Medical imaging is one of the most promising fields for use of AI tools, as pattern recognition and large data sets can enhance human diagnosis (e.g., by radiologists) or even compete...

In the article “Capitalizing on Medical Device IP Opportunities in a Changing Environment,” published in Intellectual Asset Management’s latest special report on life sciences IP, partners Philip Nelson, Sabing Lee,...

In the article “Legislative Developments in Patents: Prospects for the PREVAIL and RESTORE Acts and PERA in 2025,” published by IP Watchdog, partner Philip Nelson discusses three significant bills that...

In the Law360 article “How 2 Proposed Bills Could Transform Patent Law,” partner Philip Nelson writes about the potential impact of two pieces of legislation that could affect patent law:...

Today Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA) introduced the Patent Eligibility Restoration Act (PERA), bipartisan legislation mirroring a proposed law introduced last year by Senators Thom Tillis (R-NC) and Chris Coons (D-DE). The proposed law seeks to restore patent eligibility to inventions across many fields and affirms the basic principle that the patent system is central to promoting technology-based innovation.

In recent years, Congress has considered potential new laws for patent reform, typically changes to the system supported by patent owners. Two main areas of focus are “Section 101” and the “PTAB.” Below is a summary of two such efforts currently being considered by Congress.

On October 5, 2023, the World Intellectual Property Organization published Cast21’s PCT application related to its alternative cast device – a 3D-printed exoskeleton created from a medical-grade resin. Cast21’s device seeks to address limitations in one of orthopedic care’s fundamental treatment methods: the cast. A soggy cast can lead to infections, reduced support, skin infections, and more. But as discussed in Cast21’s white paper, Cast321’s FDA-approved product touts a waterproof and breathable design, allowing patients to shower, swim, or wash their limbs.

Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve “indications for use” of their products–for use selling them in the U.S. Those same companies often seek U.S. patent protection so that they can profit from their inventions underlying those same products. In both cases, the companies seek to persuade federal government agencies to approve their requests.

Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B to the Federal Food, Drug, and Cosmetic Act (FD&C Act) at the end of 2022, addressing concerns over the cybersecurity of medical devices. Risks from cybersecurity incidents involving medical devices may include “Health Insurance Portability and Accountability Act (HIPAA) violations, improper patient health assessments, miscalculated medication dosages, and other potentially fatal outcomes,” according to Lifesciences Intelligence.

Introduction The Mayo/Alice subject-matter eligibility test has been a controversial topic since its creation. Many have argued that it leaves innovators, particularly in the software field, with uncertainty as to whether their advances are patentable. In American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, the Federal Circuit extended this uncertainty into the mechanical field.