April 27, 2020

Federal Circuit Revives Cardiac Monitoring Patent, Not Directed to an Abstract Idea

Holland & Knight Section 101 Blog
Anthony J. Fuga
Section 101 Blog

CardioNet asserted its patent directed to cardiac monitoring against InfoBionic in the U.S. District Court for the District of Massachusetts. The defendant moved to dismiss the complaint, arguing that the patent was ineligible under Section 101 because the patent claims are directed to the abstract idea that atrial fibrillation and atrial flutter can be determined by looking at the variability of an irregular heartbeat. The district court agreed with InfoBionic and granted the motion to dismiss, holding that the asserted claims are invalid. CardioNet appealed to the U.S. Court of Appeals for the Federal Circuit.

The Asserted Patent

The asserted patent, titled "Cardiac Monitoring," teaches that its systems and techniques determine the beat-to-beat variability in heart rate over a series of successive heartbeats. Specifically, they determine the variability in heart rate "over a series of between 20 and 200 of the recent R to R intervals," or the timing between "R-waves."

The patent claims on appeal were drawn to a device for detecting and reporting the presence of atrial fibrillation or atrial flutter in the patient – specifically detecting beat-to-beat timing of cardiac activity, detecting premature ventricular beats and determining the relevance of the beat-to-beat timing to atrial fibrillation or atrial flutter while taking into account the variability in the beat-to-beat timing caused by premature ventricular beats.

The Federal Circuit noted that the patent describes certain advantages of the claimed device, including "by analyzing the beat-to-beat timing for atrial fibrillation or atrial flutter while also taking into account the variability in the beat-to-beat timing caused by premature ventricular beats, the device can more accurately distinguish atrial fibrillation and atrial flutter from other types of arrhythmias."

The Federal Circuit's Section 101 Analysis

The Federal Circuit disagreed with the district court's assessment and instead, found that the claims were "directed to an improved cardiac monitoring device and not to an abstract idea." Looking at claim 1, the court determined that the language indicated that it focuses "on a specific means or method that improves" cardiac monitoring technology as opposed to being directed to a result or effect that itself is the abstract idea while merely invoking generic processes and machinery. The written description agreed with this assessment, the court said:

the written description identifies a number of advantages gained by the elements recited in the claimed cardiac monitoring device. By analyzing the "variability in the beat-to-beat timing" for "atrial fibrillation and atrial flutter in light of the variability in the beat-to-beat timing caused by ventricular beats identified by the ventricular beat detector," the claimed invention more accurately detects the occurrence of atrial fibrillation and atrial flutter, as distinct from V-TACH and other arrhythmias.

The appellate court determined that there was nothing in the record to suggest that the claims "merely computerize pre-existing techniques for diagnosing atrial fibrillation and atrial flutter." This, the Federal Circuit said, is "the heart of the district court's erroneous step one analysis" – an assumption that the claims are directed to automating known techniques.

Because the Federal Circuit concluded under Alice step one that the asserted claims are not directed to an abstract idea, the court did not reach Alice step two.

Assessing the State of the Art

The Federal Circuit also addressed a dispute over whether the court could resolve Alice step one at the Rule 12 stage without remanding to assess the state of the art as of the invention date. The court concluded that remand was unnecessary. "Alice step one presents a legal question that can be answered based on the intrinsic evidence . . . regardless of whether the prior art demonstrates that the idea or other aspects of the claim are known, unknown, conventional, unconventional, routine, or not routine."

Addressing the dissent (discussed below), the majority stated that "we do not hold today that it is impermissible for courts to look outside the intrinsic evidence as part of their Alice step one inquiry . . . It is within the trial court's discretion to take judicial notice of a longstanding practice where there is no evidence of such practice."

The majority went on to "clarify that step one of the Alice framework does not require an evaluation of the prior art or facts outside the intrinsic record regarding the state of the art at the time of the invention."

Judge Dyk's Dissent in Part

Judge Timothy B. Dyk agreed with the majority that the asserted patent claims had not been shown to be patent ineligible. His problem with the majority opinion is what he calls "confusing dicta."

"On the one hand, the majority recognizes that establishing that a practice is longstanding is clearly relevant, but on the other hand seems to suggest undefined limits on the use of extrinsic evidence to determine whether a practice was longstanding in the prior art at the time of the invention . . . But limiting the use of extrinsic evidence to establish that a practice is longstanding would be inconsistent with authority."

Dyk points to a number of the Federal Circuit's own cases, which looked to extrinsic evidence. For example, in Capital One Bank, the court found that claims directed to customizing marketing were ineligible and relied on the fact that "newspaper inserts had often been tailored based on information known about the customer—for example, a newspaper might advertise based on the customer's location." Dyk concludes by stating that to determine whether something is a longstanding practice "necessarily requires an analysis of whether the practice is part of a well-established state of the art at the time of the invention."

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