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Alice Comes For Medical Devices

Rejections under 35 U.S.C. § 101 are a fact of life for patent attorneys practicing in software. The recent CardioNet, LLC v. InfoBionic, Inc. decision shows that Alice and 101 issues are increasingly bleeding into the medical device arts.

Judge Talwani of the District of Massachusetts dismissed CardioNet's suit against InfoBionic on U.S. Patent No. 7,941,207 ("the '207 Patent") for "Cardiac Monitoring," which covers systems and techniques for monitoring cardiac activity, finding that the claims at issue were directed to patent-ineligible subject matter under 35 U.S.C. § 101. The complete Order is available here.

Claims 1, 2, 3, 7, 10, 11, 12, and 22 were at issue. Claim 1 of the '207 Patent recites:

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.

​To determine whether claims are patent-eligible under 35 U.S.C. § 101, the Court must apply the 2-Step test set forth in Alice. Specifically, the Court queries whether (1) the claims are directed to laws of nature, natural phenomena, or abstract ideas, and (2) if the claims at issue were found to be directed to laws of nature, natural phenomena, or abstract ideas, whether the elements of each claim both “individually and as an ordered combination transform the nature of the claim into a patent-eligible application.”

Applying the Alice 2-Step, the Court first noted that "the claims add conventional computer components to the abstract idea that AF can be distinguished by focusing on the variability of the irregular heartbeat." Under step two, the Court found that the inventiveness of the claim elements do not make them patent eligible. Specifically, the Court distinguished this case from others noting that "unlike in Bascom, Andocs, or the previous CardioNet litigation, the asserted claims of the ’207 patent are broadly described, with no meaningful limitation, so as to preempt other technological systems directed to the abstract idea of monitoring and analyzing ventricular beats to identify AF events."

One of the interesting takeaways of this decision is the Court's discussion of the term "determination logic" by the Patentee, noting that it is "undefined and unspecified." Terms such as "determination logic" are uncommon in medical device patents. A close reading of the decision shows that the various dependent claims and examples in the specification include several potential permutations that could have been used to frame the device in a better light for an Alice inquiry. For example, the use of a transformation function in the "weight" step of dependent claim 2 may have saved this claim from Alice. It would be unfair to Monday-Morning-Quarterback the Patentee's mistakes, especially because examination of the '207 Patent precedes both Alice and Mayo.

Reactions to this case were as expected. Many attorneys chimed in that this case ought to have been decided on obviousness and anticipation grounds, and not Alice. Nevertheless, it is a data point that should be considered when drafting claims. Thus, it is incumbent upon Patentees to strategically use dependent claims to rebut potential 101 concerns by adding multiple layers of specificity. Additionally, intentional inclusion of claim elements that cannot be performed by the human mind is helpful so as to tie the claims to a machine and meet the machine-or-transformation test.

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