Heart-Monitoring Ineligible under § 101 as Abstract Idea

The District of Massachusetts recently granted a motion to dismiss for ineligible subject matter under 35 U.S.C. § 101 and the Alice/Mayo test in a case involving home electrocardiogram sensors, CardioNet, LLC v. InfoBionic, Inc.—demonstrating that despite some courts’ decisions to the contrary, Rule 12 dismissals are available for ineligible subject matter notwithstanding the Federal Circuit’s decision in Berkheimer v. HP that such decisions can involve factual inquiries.

CardioNet and InfoBionic compete selling home electrocardiogram (ECG) sensors that monitor a patient’s heartbeat via the electrical activity passing through the heart muscles. In this dispute—not their first—CardioNet accuses InfoBionic’s MoMe Kardia Systems of infringing CardioNet’s U.S. Patent No. 7,941,207. The ’207 patent covers a way of detecting atrial fibrillation and atrial flutter, two types of heart arrhythmia. Here is the first claim:

1. A device, comprising:

a beat detector to identify a beat-to-beat timing of cardiac activity;

a ventricular beat detector to identify ventricular beats in the cardiac activity;

variability determination logic to determine a variability in the beat-to-beat timing of a collection of beats;

relevance determination logic to identify a relevance of the variability in the beat-to-beat timing to at least one of atrial fibrillation and atrial flutter; and

an event generator to generate an event when the variability in the beat-to-beat timing is identified as relevant to the at least one of 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.

InfoBionic responded to CardioNet’s complaint by moving to dismiss for ineligible subject matter under § 101. The court applied the two-step Alice framework, asking “Step One: Are Claims Directed to a Patent Ineligible Concept?” i.e., “laws of nature, natural phenomena, or abstract ideas”; and “Step Two: Does the Inventiveness of the Claim make it Patent Eligible?”

For Step One, the court found that the claims were directed to the patent-ineligible concept of an abstract idea, comparing this case to a line of cases about “computer-implemented claims for collecting and analyzing data.” InfoBionic chose to focus on abstract ideas, so the court did so too. An alternative path would have been to argue that the relationship between variability of beat-to-beat timing for beats and ventricular beats is a natural phenomenon or law of nature. InfoBionic may have thought that the line of abstract-idea cases about computer-implemented inventions was more definitive or developed than the line of law-of-nature cases about medical diagnoses.

For Step Two, the court found that the claims did not recite anything transforming the ineligible concept. The claims elements were all functional elements: “beat detector,” “variability determination logic,” and so on. As such, they did not provide any meaningful limitation on the concept. What’s more, the claim elements could all be performed by “conventional, off-the-shelf, cardiac monitoring equipment and conventional computer hardware and/or software.”

CardioNet pushed back on Step Two, emphasizing that, according to Berkheimer, “the second step of Aliceinvolves factual inquiries” and is thus not appropriate for a motion to dismiss. But the court replied that its decision did not rely on any disputed facts. The court ends its decision this way:

Here, there are no disputes of fact as the court accepts the Plaintiffs’ non-conclusory factual assertions in the complaint and the patent as true. On the facts as alleged, and the patent terms as construed by Plaintiffs, Plaintiffs’ asserted claims are not directed to any improvement in the computer technology itself, but rather seek to improve cardiac monitoring instead through the abstract idea of measuring the variability of heartbeats.

Lessons for Practice

This decision showcases the power of § 101 for accused infringers: they have the ability to get a complaint dismissed at the pleading stage, rather than waiting through discovery for summary judgment or trial. InfoBionic’s ineligibility argument can be reframed as an obviousness argument. A person of skill in the art in the medical-device field could have combined conventional heart-monitoring technology with the known relationship between atrial fibrillation/flutter and beat-to-beat variability of the patient’s heartbeat. But that obviousness argument would have required factual development during discovery, meaning it wouldn’t have supported a motion to dismiss—unlike § 101.

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