How Aortic Innovations Lost a Patent Case Without an Adversary
Authored by Babak Akhlaghi on June 17, 2026. Aortic Innovations LLC owned four patents covering transcatheter heart valve technology. They sued Edwards Lifesciences, one of the biggest names in the space, for infringement.
They lost.
Not because Edwards found devastating prior art. Not because the technology didn’t work. Not even because the claims were poorly written at first glance.
They lost because of two words used interchangeably throughout their patent specification: “outer frame” and “self-expanding outer frame.”
The Federal Circuit ruled that Aortic had acted as its own lexicographer. By using these terms interchangeably across multiple embodiments in the specification, the court said Aortic had defined “outer frame” to mean only self-expanding frames.
Edwards’ accused product? A single balloon-expandable frame.
No self-expanding component. No infringement. Case over.
What Actually Happened in the Specification
The patent described two categories of transcatheter valve devices. One used serial frames (a self-expanding frame connected to a balloon-expandable frame at a meeting point). The other used dual frames (an inner frame sitting inside an outer frame).
The claims at issue covered the dual-frame design.
In the specification, when describing the dual-frame embodiments, the drafter referred to structure 416 in Figure 20 and structure 216 in Figure 9 using three different terms:
- “outer frame”
- “self-expanding frame”
- “self-expanding outer frame”
The specification used all three terms to describe the same structure. Multiple times. Across multiple sections.
The district court looked at this pattern and concluded that Aortic had implicitly defined “outer frame” to mean a self-expanding frame. The Federal Circuit agreed.
The court didn’t need an explicit definition. The interchangeable use across the specification was clear enough. The patent owner had narrowed its own claim scope through repetition.
The Lexicographer Trap
Patent law allows you to be your own lexicographer. You can define claim terms however you want, as long as you do it clearly in the specification.
You don’t even need to use the magic words “as used herein” or “the term X means Y.”
An implied definition works too, as long as it’s clear enough that someone skilled in the art would understand you intended to define the term narrowly.
That’s what killed Aortic’s case.
The specification didn’t just use “outer frame” and “self-expanding outer frame” interchangeably once or twice. It did so repeatedly, across multiple embodiments, in the summary section, and in the detailed description.
The court looked at the totality of the circumstances and said: you told us what “outer frame” means. Whether you meant to or not.
Why This Happens (And How to Avoid It)
Nobody sits down to draft a patent application thinking, “I’m going to limit my own claim scope today.”
It happens through what feels like good drafting. Being thorough. Describing multiple embodiments. Giving examples.
But here’s the line you can’t cross:
If you use a claim term in the claims, you need to use that exact term consistently throughout the specification.
The moment you start interchanging it with a narrower term, you’ve crossed into lexicographer territory.
The fix is simple in concept:
- Draft your claims first
- Identify the key terms in those claims
- Use those exact terms throughout the specification
- If you need to give examples or describe specific implementations, use boilerplate language: “In one embodiment…” or “In one example…” and then make it clear these are exemplary only
Add a line that says: “These examples are not limiting. The scope of the invention is defined by the claims, and one skilled in the art would understand that alternative implementations are possible.”
That language isn’t filler. It’s load-bearing.
The Summary Section Is Dangerous Territory
One of the most damaging parts of Aortic’s specification was the summary section.
It described the transcatheter valve as including “a balloon-expandable frame and a self-expanding frame secured to the balloon-expandable frame.”
Then, in the paragraphs that followed, the specification noted that “in some embodiments” other features might be present. But it never limited the self-expanding frame to “some embodiments.”
The court read this as: a transcatheter valve must have both a balloon-expandable frame and a self-expanding frame. Not sometimes. Always.
The contrast in language mattered. When the drafter wanted to indicate optionality, they used “in some embodiments.” When they didn’t use that qualifier, the court assumed the feature was required.
This is why every word in the specification matters. The absence of a qualifier can be just as limiting as the presence of one.
Edwards Didn’t Need to Prove Anything New
Edwards Lifesciences is not a small company. They have virtually unlimited legal resources. They could have fought this case on prior art, invalidity, enablement, written description.
They didn’t need to.
They just pointed at Aortic’s own specification and said: you wrote this. You used these terms interchangeably. You defined “outer frame” as self-expanding. We don’t have a self-expanding frame. We don’t infringe.
The parties stipulated to non-infringement based on claim construction. That’s how clear the language issue was.
This is the asymmetry that founders need to understand. The accused infringer doesn’t need to find a smoking gun in the prior art. They just need to find inconsistency in your own document.
What This Means for Founders
If you’re building a medical device company, or any hardware company with a patent portfolio, here’s what you need to internalize:
Every word you use in the specification can and will be used against you.
Not by the patent examiner. By the competitor you sue five years from now.
They will take your specification apart word by word. They will look for every place you used a claim term interchangeably with a narrower term. They will argue you acted as your own lexicographer. And if the pattern is clear enough, they’ll win.
This isn’t a problem you solve by filing more patents. Aortic had four patents in this case. All four had the same language issue. Volume didn’t help.
You solve it by being uncompromising about consistency.
Not careful. Not thorough. Uncompromising.
The claim term is sacred. If it says “outer frame” in the claim, it says “outer frame” in the specification. Every single time. No exceptions.
The Continuation Strategy You’re Not Using
One thing that could have helped Aortic: a pending continuation application.
If you have a continuation on file, you can tweak claim language to cover implementations you didn’t anticipate, as long as the specification supports it.
More importantly, a pending continuation changes the negotiation dynamic. The competitor sitting across the table knows you can still adjust your claims. They know their design-around might not work. That uncertainty has value.
In medtech especially, where regulatory timelines stretch for years and the competitive landscape shifts constantly, a continuation strategy isn’t optional. It’s foundational.
The Real Lesson
Aortic Innovations didn’t lose because they had bad lawyers or bad technology.
They lost because somewhere in the drafting process, someone used “outer frame” and “self-expanding outer frame” interchangeably. Probably without thinking about it. Probably because it felt like good, thorough drafting.
And that small inconsistency, repeated across multiple embodiments, became the entire case.
This is the part that doesn’t show up in CLE courses or patent prosecution guides. The failure wasn’t dramatic. It was quiet. Incremental. A word here, a phrase there.
But in patent litigation, quiet failures are the most expensive kind.
If you’re filing a patent application, or reviewing one before it goes out the door, ask yourself one question:
Did I use every claim term consistently throughout the specification?
If the answer is no, fix it before you file. Because five years from now, when you’re facing a competitor with unlimited resources, that inconsistency will be the entire case.
Work With a Patent Strategist Who Sees This Coming
The difference between a good patent attorney and a great patent attorney isn’t how many applications they file. It’s whether they catch unintentional lexicography before it becomes a Federal Circuit opinion.
If you’re building something that matters, your patent strategy should reflect that. Not volume. Not speed. Precision.
