Extrinsic Evidence and Abstract Ideas in Patent-Eligibility: CardioNet, LLC v. InfoBionic, Inc.

What if any limits are there on the extrinsic evidence (prior art) that can be considered in determining whether a patent claim is drawn to an abstract idea under step one of the Alice/Mayo 35 U.S.C. § 101 patent-eligibility test? And to what extent does the answer to this question matter; is it merely academic?

In CardioNet, LLC v. InfoBionic, Inc., No. 2019-1149 (Fed. Cir. April 17, 2020), a three-judge panel (Judges Stoll, Plager, and Dyk) reversed the district court’s grant of a Rule 12(b)(6) motion because claims  of U.S. Patent No. 7,941,207 “are directed to a patent-eligible improvement to cardiac monitoring technology and are not directed to an abstract idea.” The panel unanimously agreed that the ‘207patent’s claims were patent-eligible – and that a remand was not needed for a “review of the prior art or facts outside of the intrinsic record regarding the state of the art at the time of the invention.” Judge Dyk nonetheless vigorously dissented from what he characterized as dicta in Judge Stoll’s majority opinion suggesting that review of “extrinsic evidence to establish that a practice is longstanding” can be limited.

Claims 1–3, 7, 10–12, and 22 of the ’207 patent were at issue; independent claim 1 recites:

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.

The district court had concluded that the ’207 patent claims are directed to the abstract idea of distinguishing atrial fibrillation and flutter “by focusing on the variability of the irregular heartbeat,” and that there was no improvement to cardiac monitoring devices or “any particular computerized technology.” Accordingly, the district court granted InfoBionic’s Rule 12(b)(6) motion.

The Federal Circuit, in contrast, concluded under Alice step one that “claim 1 of the ’207 patent is directed to an improved cardiac monitoring device and not to an abstract idea,” citing McRO, Inc. v. Bandai Namco Games America Inc. (Fed. Cir. 2016). The court found that the claim recites specific steps to detect cardiac activity. Moreover, the specification explained how the claimed steps led to improved results.

The court specifically identified district court error in its “incorrect assumption that the claims are directed to automating known techniques.” There was no evidence that doctors had previously used the claimed technique for diagnosing atrial fibrillation or flutter. The district court similarly “erred by disregarding the written description’s recitation of the advantages of the claimed invention.” In addition, Berkheimer v. HP Inc. (Fed. Cir. 2018), and Fairwarning IP, LLC v. Iatric Systems, Inc. (Fed. Cir. 2016), relied on by the district court, in fact dealt with claims “[i]n stark contrast” to the claims here, which “do not merely collect electronic information, display information, or embody mental processes.”

Having determined that the claims of the ’207 patent are not directed to an abstract idea, and that analysis under Alice step two was not necessary, the majority opinion (in Part II.C) then went on to address a dispute raised by the parties concerning whether the court could “resolve this Alice step one issue at the Rule 12(b)(6) stage without” a remand for the district court “to assess the state of the art as of the invention date” for a determination as to “whether the asserted claims are directed to automating a practice long used by doctors.”

The majority opinion acknowledged that both Alice and Bilski v. Kappos equated abstract ideas with fundamental and long-standing economic practices. However, neither case relied “on an examination of the prior art as part of its step one inquiry.” Enfish, LLC v. Microsoft Corp. (Fed. Cir. 2016), and other cases demonstrate that the Alice step one inquiry begins and ends “with the patent itself.” This is not to say that looking to extrinsic evidence “is impermissible” or would be irrelevant here. The trial court has “discretion whether to take judicial notice of a long-standing practice where there is no evidence of such practice in the intrinsic record.” The majority opinion “simply clarif[ied]” that evaluation of extrinsic evidence is not required under Alice step one.

Judge Dyk wrote in dissent because he thought that the majority went too far after properly determining “that the record does not support the defendant’s contentions” that the ’207 patent claims embodied a long-standing practice. According to Judge Dyk:

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. I agree that the § 101 inquiry is different from § 102/103 analysis, and the mere fact that a prior art reference discloses an idea does not make it longstanding. But limiting the use of extrinsic evidence to establish that a practice is longstanding would be inconsistent with authority. No case has ever said that the nature of a longstanding practice cannot be determined by looking at the prior art

Judge Dyk cited numerous cases in which the Federal Circuit had gone outside the intrinsic record to determine whether a practice was fundamental and long-standing. He concluded that:

The panel does not purport to overrule prior cases, nor could it. But the language of the panel opinion is likely to sow confusion for both the district court and the bar.

Will the majority’s opinion sow confusion? I am not so sure. One thing that may be more likely is that this case manifests a recent trend away from Rule 12(b)(6) dismissals based on patent-ineligibility.