Executive Summary

On October 27, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed that “outer frame” in patents covering transcatheter aortic valve replacement devices means a “self-expanding frame.” In Aortic Innovations LLC v. Edwards Lifesciences Corp., No. 24-1145 (Fed. Cir. 2025), the court concluded that the patents’ language effectively equated “outer frame” with “self-expanding frame,” narrowing the scope of the claims. For device companies, this decision is a clear reminder that the words used in a patent can lock in a particular design, with direct consequences for competitive positioning, freedom to operate, and infringement risk.

What Happened

The patents at issue describe dual frame transcatheter valves, with an inner and an outer frame. The specifications repeatedly referred to the “outer frame” as “self expanding,” using those terms interchangeably. The accused product used a balloon expandable frame. The district court read “outer frame” to mean “self expanding frame,” and the Federal Circuit agreed. Because the accused device was balloon expandable, it fell outside the claims as construed, resulting in non infringement.

Why It Matters for Device Developers

This decision turns on how the patents described the technology—not on arcane legal doctrine. By treating “outer frame” and “self expanding frame” as synonymous throughout the specification, the patents effectively limited its own scope. If your patents do not explicitly account for alternative design paths—such as balloon expandable versus self expanding architectures—you may unintentionally exclude future variations of your own products and give competitors room to design around.

For companies investing in transcatheter platforms, the distinction between frame modalities is not just an engineering choice; it can be outcome determinative in litigation and in negotiations. Courts look to how your specification speaks about your device. If it consistently links a core component with a single modality, expect competitors to press for a narrow reading—and expect courts to credit the patent’s own language.

Implications for Product Strategy and Risk

The ruling underscores three practical points for R&D and IP strategy teams:

• Design Modality Drives Claim Scope: If your patent text consistently describes a component (e.g., an outer frame) in terms of a specific mechanism (e.g., self expanding), courts may treat that mechanism as part of the claim. That narrows your coverage to that modality.
• Specification Discipline Is Strategic: Interchangeable terminology can be interpreted as a definition. If the specification uses “outer frame” and “self expanding frame” interchangeably, you risk baking the modality into the claim—whether or not the claim language says so.
• Freedom to Operate Depends on Alternatives: Competitors can avoid infringement by choosing a different, non disclosed modality. Conversely, if your patents expressly and clearly describe both self expanding and balloon expandable options, you preserve broader protection and reduce design around pathways.

What Companies Should Do Now

Align your engineering and IP narratives early and deliberately. When drafting or updating disclosures, ensure the specification separates component identity from actuation modality unless you intend to lock in that modality. Name and describe viable alternatives with sufficient detail to support claims and to avoid an unintended equivalence between a component and a single mechanism.

For ongoing product development and portfolio reviews:

• Verify that key components (e.g., frames, anchors, sealing skirts) are described independently of specific mechanisms unless intentionally limited.
• Document and include alternative implementations you might commercialize or want to block, for example: balloon expandable, self expanding, hybrid, or staged expansion configurations.
• Audit legacy filings for interchangeable terminology that could narrow scope and prioritize continuation applications that clarify distinctions where commercially important.
• In freedom to operate analyses, scrutinize competitor specifications for modality linking language; opportunities to avoid infringement may hinge on choosing a different, disclosed or undisclosed modality.

Bottom Line

Courts take companies at their word. If a patent treats an “outer frame” as a “self expanding frame,” that wording can control the outcome. Medtech innovators should ensure their patents clearly articulate design alternatives and avoid language that unintentionally equates a component with a single modality. The result is stronger protection for current products, more leverage against competitors, and lower risk of being boxed into one design path.