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It’s seven years since the Supreme Court decided Mayo v. Prometheus, 566 U.S. 66 (2012).
My takeaway from a three year-old conversation with Gavin Bogle (below) was “diagnostic devices aren’t patentable.”
Of course, it’s more nuanced than that, says guest contributor, medical device IP practitioner Peter Sleman.
Thank you, Joe, for the opportunity to address the Group this way.
There is a growing sense among inventors the patent system has become too complex, inconsistent, and unpredictable. A client recently shared a story of how he invented an orthopedic device, filed an application, and was granted a patent. The device was a success.
Almost a decade later, he filed suit against an infringer in a district court. Weeks before his decision, the Supreme Court decided an unrelated case known as Nautilus that “clarified” the law on indefiniteness. The District Court, taking Nautilus into consideration, deemed his claims indefinite and invalid. He lost.
It is a bitter pill to swallow. His patent claims were valid when he filed them, valid during examination, and valid when he brought suit.
But it all changed when the Supreme Court waded into patent claim construction.
Patent attorneys have become accustomed to following court decisions closely to spot trends and adjust their prosecution strategies. This is why the recent CardioNet decision in the District of Massachusetts has gotten some attention from practitioners focused on medical devices.
What happened in CardioNet?
The CardioNet suit revolved around a system and technique for monitoring cardiac activity in U.S. Patent No. 7,941,207. The patent claims relate to a heart monitor with a beat detector, a ventricular beat detector, and certain logic components that determine variabilities.
In this case, the District Court deemed the claims not patent-eligible under 35 U.S.C. § 101. This statute bars a person from attempting to patent laws of nature, natural phenomena, or abstract ideas, and over the past few years the § 101 inquiry has been informed by what is known as the Alice-test.
What exactly is Alice?
Like Nautilus, Alice was a Supreme Court decision. The Supreme Court does not look at patents often, but seismic shifts occur when it does pick up a patent case such as 2014’s Alice. To determine whether claims are patent-eligible under 35 U.S.C. § 101, the Supreme Court articulated a two-step test.
In CardioNet, the Court applied the Alice two-step and decided the claims to the heart monitor at issue were not patent-eligible. This is more common in software cases, but rare when the underlying technology is a medical device.
CardioNet decision will probably be appealed, and its reach is limited. Additionally, the specific wording in the claims of the CardioNet patent left much to be desired. Medical device innovators and manufacturers should not panic and can learn a few lessons from this case as to how to articulate a claim with enough specificity to avoid invalidation by Alice.
Will this affect me?
It depends on your field. CardioNet has almost no bearing on traditional mechanical medical devices (think orthopedics), but the same reasoning may be used to invalidate other, more complex medical devices with electronics components. As more medical devices employ sensors and processors, you can be sure that Alice will become more relevant. Look no further than the new Apple Watch heart rate monitor to see this in action.
In fact, Apple was recently granted U.S. Patent No. 1,007,6257 on a similar “seamlessly embedded heart rate monitor.” Would the claims in Apple’s patent survive Alice? That’s an interesting conversation for another time, but when you view the claims side-by-side with CardioNet claims you will see a difference in approach.
What are the implications for my business?
Patent claims are fences around your invention. It’s tempting to push those boundaries and pursue a claim as broad as possible to expand your territory; yet, the broadest claims are usually the easiest to invalidate and most susceptible to an Alice challenge.
Instead, when software is involved, present claims with varying scope including general claims, intermediate claims and more narrowly-tailored claims. Presenting claims that are specific and have multiple “meaningful limitations,” will ensure that at least some of the claims will survive an Alice challenge.
Applicants can file a number of linked applications. We refer to those as “patent families.” Typically, when a patent nears allowance, the Applicant may choose to file a “continuation” application to pursue additional claims, but this must be filed before the original patent issues.
By keeping a continuation application pending, Applicants retain the opportunity to pursue adjusted claim language and scope as needed. Continuations also present a hurdle to your competitors because they may know what is protected by granted claims, but they are left with a degree of uncertainty as to what else you may be able to cover in the future.
Postscript: Alice was the progeny of Mayo and relied heavily on it to frame how one should judge whether software is patent-eligible. While Gavin’s thoughts were more focused on diagnostics and attempting to claim the relationship between analyte and disease, the CardioNet decision relates to hardware/software and attempting to capture algorithms, such as those for beat detection. Alice may only be an issue for certain classes of medical devices, and steps can be taken to frame the invention as one relating to a machine, not just an algorithm or a scientific principle or relationship.
Editor’s note: That was great, Peter, thank you – and I encourage other group members to contribute so meaningfully.
A “Medically Accurate Webinar” next Wednesday
If you aid in the design, development, engineering, or manufacturing of devices for home-based patient monitoring, you’ll want to attend a free session I’m co-hosting with Group member Walt Maclay.
What: “What You Need to Know Before Manufacturing a Wearable Device.”
When: Live on Wednesday, January 23 at noon Eastern Standard Time and Replay on Demand shortly thereafter.
Where: Online! And it’s free.
Why: Education = good. Join us! 😊
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