On March 7, 2025, the Federal Circuit issued its decision in AliveCor, Inc. v. Apple Inc., upholding the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruling that invalidated AliveCor’s patents on heart rate monitoring technology. The case has significant implications for the wearable technology industry, particularly in the areas of patentability, obviousness, and the interplay between patent litigation and administrative patent challenges.

Background of the Case

AliveCor, a medical technology company, held patents covering systems and methods for detecting cardiac arrhythmias using wearable devices. The key patents in dispute—U.S. Patent Nos. 9,572,499, 10,595,731, and 10,638,941—described a technology involving smartwatches equipped with photoplethysmography (PPG) sensors to monitor heart rate, notify users of irregularities, and prompt them to conduct electrocardiogram (ECG) recordings for further analysis.

Apple challenged these patents through inter partes review (IPR) at the PTAB, arguing that the claims were obvious in light of prior art references. The Board ruled in Apple’s favor, finding that the claims lacked novelty. AliveCor appealed to the Federal Circuit, arguing that the PTAB’s conclusions on obviousness were incorrect and that Apple had withheld evidence relevant to secondary considerations of non-obviousness.

Key Legal Issues

1. Obviousness of Machine Learning-Based Arrhythmia Detection

AliveCor’s patents included claims requiring the use of machine learning algorithms to detect arrhythmias based on heart rate data. The court affirmed the PTAB’s determination that this approach was obvious in view of prior art references, particularly:

• Hu 1997: A study describing a patient-adaptable ECG classifier that employed machine learning to detect cardiac conditions.
• Li 2012: A research paper discussing the use of machine learning to reduce false arrhythmia alarms by integrating multiple physiological signals.
• Shmueli Patent Application (2012): A prior patent application disclosing a wrist-mounted heart monitoring device that used both PPG and ECG data to detect and confirm irregular heart activity.

The Federal Circuit concluded that a person of ordinary skill in the art would have been motivated to combine these techniques, reinforcing the Board’s finding that AliveCor’s claimed use of machine learning was not sufficiently novel.

2. “Confirmation” Step in Arrhythmia Detection

Another key issue was whether the requirement to confirm an arrhythmia using ECG data was patentable. AliveCor argued that its method—detecting arrhythmia using PPG data and then confirming it using an ECG—was unique. However, Apple successfully argued that Shmueli already disclosed this concept. The PTAB and the Federal Circuit both found that a skilled artisan would have found it obvious to confirm PPG-based arrhythmia detection with ECG, leading to the invalidation of the relevant claims.

3. Failure to Produce Secondary Consideration Evidence

AliveCor also contended that Apple failed to disclose evidence from a parallel International Trade Commission (ITC) investigation, which had considered secondary indicators of non-obviousness, such as commercial success and industry praise. AliveCor claimed that Apple’s withholding of this evidence violated discovery obligations.

However, the Federal Circuit found that AliveCor had forfeited this argument by failing to raise the issue before the PTAB. The court emphasized that procedural diligence is essential in IPR proceedings and that issues must be timely presented to be considered on appeal.

Implications for Intellectual Property Law

This decision underscores several critical points in patent law and intellectual property strategy:

• Obviousness in Emerging Technologies: Courts and the PTAB continue to scrutinize patents in fast-evolving fields like machine learning and wearable tech, often finding that incremental improvements fail to meet the non-obviousness requirement.
• Interplay Between Patent Litigation and IPRs: The case highlights the increasing role of inter partes reviews in invalidating patents that might otherwise survive district court litigation.
• Procedural Rigor in Patent Challenges: Parties must be meticulous in raising all relevant issues during PTAB proceedings; failure to do so may result in forfeiture on appeal.

Conclusion

The Federal Circuit’s decision in AliveCor v. Apple represents a significant win for Apple and a cautionary tale for patent holders in the medical technology space. As courts and administrative bodies continue to apply strict standards for patent validity, companies seeking to protect their innovations must ensure their patents contain clear, non-obvious advancements over existing technology. Moreover, maintaining procedural diligence in parallel patent litigation and administrative proceedings is crucial to avoiding unfavorable rulings on appeal.

As wearable health technology continues to advance, the legal battles over patentability will shape the competitive landscape, influencing which companies can dominate the market with their innovations.

By Charles Gideon Korrell