IP Law Daily, PATENT—Fed. Cir.: Invalidity of AliveCor’s arrhythmia detection patents affirmed; ITC exclusion order on Apple Watches vacated, (Mar 7, 2025)

By Saurabh Kashyap, B.A., LL.B., LL.M.

PTAB correctly found all claims of AliveCor’s asserted patents unpatentable as obvious; invalidity of asserted patents leads to vacatur of ITC’s exclusion order.

The U.S. Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board’s (PTAB) determination in inter partes reviews (IPRs) filed by Apple Inc. that all claims of three patents owned by AliveCor, Inc. covering wearable arrhythmia detection technology were unpatentable as obvious. The court found that prior art sufficiently disclosed the key aspects of AliveCor’s claimed inventions and that a skilled artisan would have had a reason to combine these references to develop similar technology. In a separate ruling, the Federal Circuit vacated an International Trade Commission (ITC) exclusion order blocking imports of Apple Watches based on AliveCor’s patents. The court reasoned that because PTAB’s unpatentability findings were upheld, the ITC decision was rendered moot (AliveCor, Inc. v. Apple Inc., Nos. 2023-1512, 2023-1513, 2023-1514 (Fed. Cir. Mar. 7, 2025)); and AliveCor, Inc. v. ITC, Nos. 2023-1509, 2023-1553 (Fed. Cir. Mar. 7, 2025)).

Background. The appellant, AliveCor, Inc., is a medical technology company that develops wearable electrocardiogram (ECG) monitoring devices and software for detecting cardiac arrhythmias. The company gained recognition for pioneering AI-driven heart rate monitoring solutions, integrating them into smartwatches and standalone devices.

The appellee, Apple Inc., is a leading consumer electronics company. It designs and manufactures smart devices, including Apple Watch models that incorporate heart monitoring capabilities. Apple and AliveCor have been in long-standing competition over wearable ECG and arrhythmia detection technology, with AliveCor previously accusing Apple of anti-competitive behavior and patent infringement.

The patents at issue in the present case are U.S. Patent Nos. 9,572,499 (the ’499 patent), 10,595,731 (the ’731 patent), and 10,638,941 (the ’941 patent), which collectively describe systems and methods for detecting cardiac arrhythmias using wearable devices. AliveCor’s patents specifically cover PPG-based heart rate monitoring, machine-learning algorithms for detecting irregularities, and the confirmation of arrhythmias via ECG recording.

Apple challenged the patents through IPRs before PTAB, contending that the claimed methods and systems were obvious over prior art. Simultaneously, AliveCor filed a complaint with the ITC, seeking an exclusion order to prevent Apple from importing infringing Apple Watch models. The ITC initially ruled in favor of AliveCor, finding that Apple’s devices violated Section 337 of the Tariff Act of 1930. In October 2023, the Commission issued an exclusion order. However, the ITC stayed enforcement of the exclusion order, pending the resolution of Apple’s IPR challenges.

In 2023, PTAB issued final written decisions (here and here) invalidating all claims of the Challenged Patents. AliveCor appealed the PTAB’s rulings to the Federal Circuit, while Apple cross-appealed the ITC’s exclusion order.

PTAB’s obviousness findings. The Federal Circuit agreed with PTAB's determination that AliveCor's claims relating to machine-learning-based arrhythmia detection were obvious in light of prior art. Apple cited prior art references, including a 1997 research paper authored by Yu Hen Hu et al., titled A Patient-Adaptable ECG Beat Classifier Using a Mixture of Experts Approach, 44(9) IEEE Transactions on Biomedical Engineering 891 (1997) (“Hu”), which disclosed computerized ECG classification algorithms. Another key reference was a 2012 research paper titled Signal Quality and Data Fusion for False Alarm Reduction in the Intensive Care Unit, 45(6) Journal of Electrocardiology 596 (2012) (“Li”), authored by Qiao Li and Gari D. Clifford, which described machine-learning techniques for reducing false alarms in heart rate monitoring.

The court found that these references taught key aspects of AliveCor's claimed inventions, including the use of machine learning to analyze heart rate irregularities, integrating PPG-based sensors into wearable devices, and prompting users to confirm irregularities using additional biometric data.

AliveCor argued that its patents described a novel application of machine learning, but the court disagreed, holding that the claims did not specify any unique algorithm and instead relied on known computational techniques. Citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Federal Circuit reiterated that applying conventional machine-learning methods to a new application does not render a patent non-obvious.

ECG confirmation step. The court also upheld PTAB's finding that using ECG to confirm arrhythmia detections was obvious. Apple pointed to Shmueli et al., a reference disclosing a system that combined PPG and ECG data to assess cardiac health. The Federal Circuit found that a skilled artisan would have had reason to use ECG verification because ECG was already the gold standard for diagnosing arrhythmias, and existing research suggested combining multiple biometric inputs to improve accuracy.

AliveCor argued that Shmueli did not explicitly teach ECG-based confirmation, but the court found PTAB’s interpretation reasonable, emphasizing that Shmueli’s real-time feedback system inherently involved ECG verification.

AliveCor’s discovery challenge. AliveCor also contended that Apple withheld key evidence related to secondary considerations, such as commercial success and industry praise, that had been presented in parallel ITC proceedings. AliveCor argued that Apple’s refusal to produce certain documents prejudiced its ability to rebut the obviousness challenge before PTAB.

The Federal Circuit rejected this argument, finding that AliveCor failed to raise the discovery issue before PTAB, thereby forfeiting its right to argue it on appeal. The court ruled that Apple was under no obligation to produce ITC-related documents in PTAB proceedings unless explicitly compelled to do so. The court emphasized that procedural objections must be preserved before the agency and that AliveCor had multiple opportunities to request intervention but failed to do so.

ITC exclusion order. In a separate ruling, the Federal Circuit addressed Apple’s appeal of the ITC’s exclusion order. Because the Challenged Patents were invalidated, the court determined that the ITC’s decision was moot and vacated the exclusion order. The court relied on XY, LLC v. Trans Ova Genetics, 890 F.3d 1282 (Fed. Cir. 2018), which established that an affirmed unpatentability ruling precludes parallel enforcement actions. Since AliveCor no longer had valid patent claims, its Section 337 action at the ITC had no legal basis. Thus, the case was remanded to the ITC with instructions to dismiss the investigation.

Conclusion. Ultimately, the Federal Circuit affirmed PTAB’s determination that AliveCor’s patents were unpatentable as obvious, rejecting AliveCor’s arguments regarding secondary considerations and procedural objections. As a result, the court upheld Apple’s successful IPR challenges, rendering the asserted patent claims invalid. Separately, the Federal Circuit vacated the ITC’s exclusion order, concluding that the ITC case was moot following the invalidation of AliveCor’s patents. The ITC investigation was remanded with instructions for dismissal.

The Cases are Nos. 23-1512, 23-1513, 23-1514; and Nos. 23-1509, 23-1553.

Judge: Stark, L.

Attorneys: Sean S. Pak (Quinn Emanuel Urquhart & Sullivan, LLP) for AliveCor, Inc. Mark S. Davies (White & Case LLP) for Apple Inc. Panyin Hughes for the International Trade Commission.

Companies: AliveCor, Inc.; Apple Inc.

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