Federal Circuit Snubs Extrinsic Evidence in Reversing Ruling on 12(b)(6) Motion Arguing Invalidity Under § 101

May 4, 2020

Reading Time : 3 min

For background, the asserted claims of the patent-at-issue (U.S. Patent No. 7,941,207) are directed to a device or system that implements a particular method of detecting and distinguishing troublesome, irregular heartbeats (i.e., “atrial fibrillation or atrial flutter”) from non-troublesome heartbeats. The method measures beat-to-beat variability in heart rates and generates an event for relevant variability.

In district court proceedings, the defendant filed an early Rule 12(b)(6) motion to dismiss for failure to state a claim, arguing that the asserted claims are directed to patent-ineligible subject matter under § 101. Ruling on the motion, the district court determined that, under step one of the Alice test, the asserted claims are directed to the patent-ineligible abstract idea that certain troublesome heartbeats “can be distinguished by focusing on the variability of the irregular heartbeat,” and that the claims simply automate known techniques. Plaintiff appealed.

On appeal, citing its ruling in Berkheimer v. HP Inc., 881 F.3d 1360, 1365 (Fed. Cir. 2018), the Federal Circuit maintained that a determination that a claim is directed to patent-in-eligible subject matter is a question-of-law, potentially containing underlying issues of fact, that is reviewed de novo. Applying First Circuit procedural law for a dismissal for failure to state a claim, the Federal Circuit also maintained that such dismissals are reviewed de novo, accepting as true all well-pleaded facts alleged in the complaint and drawing all reasonable inferences in favor of the non-moving party.

Turning to step one of Alice, the Federal Circuit framed the issue on appeal as “whether the claims ‘focus on a specific means or method that improves the relevant technology or are instead directed to a result or effect that itself is the abstract idea and merely invoke generic processes and machinery.’” Ultimately, the court ruled that the claims are patent-eligible because they are “directed to an improved cardiac monitoring device and not to an abstract idea.”

The court relied heavily on the written description of the asserted patent, which according to the court “identifie[d] a number of advantages gained by the elements recited in the claimed cardiac monitoring device.” Given the practice, at stage 12(b)(6), of construing all facts and drawing all reasonable inferences in favor of the non-moving party, the court accepted statements of advantage in the specification as true and “consider[ed] them important in [its] determination that the claims are drawn to a technological improvement.” The court further noted that nothing in the record “suggests that the claims merely computerize pre-existing techniques for diagnosing atrial fibrillation and atrial flutter.”

Moreover, the court ruled that it was unnecessary—for the purpose of informing a determination of whether the asserted claims are directed to automating a practice long used by doctors—to remand to the district court the issue of the state-of-the-art as of the invention date. According to the court, Alice step one presents a legal question that can be answered based on the intrinsic evidence. In particular, the court reasoned, “the analysis under Alice step one is whether the claims as a whole are ‘directed to’ an abstract idea, regardless of whether the prior art demonstrates that the idea or other aspects of the claim are known, unknown, conventional, unconventional, routine, or not routine.” The court continued that it “need not consult the prior art to see if, in fact, the assertions of improvement in the patent’s written description are true,” given the stage of the motion.

Further, the court opined that courts are free to “consult the plain claim language, written description, and prosecution history and, from these sources, conclude that the claims are directed to automating a longstanding or fundamental practice.” Nevertheless, the court stated that “[i]f the extrinsic evidence is overwhelming to the point of being indisputable, then a court could take [judicial] notice of that and find the claims directed to the abstract idea of automating a fundamental practice, [] but the court is not required to engage in such an inquiry in every case.”

Practice Tip:

This case suggests that a patent’s written description is paramount in determining whether the claims are patent eligible at the 12(b)(6) stage. To that end, patent practitioners may consider providing ample descriptions of advantages that a claimed invention may have over prior art alternatives. Such descriptions could be dispositive in defending against early motions based on § 101.

Share This Insight

Previous Entries

IP Newsflash

November 17,2025

The district of Delaware recently denied a defendant’s partial motion to dismiss pre-suit willful infringement from the litigation, finding instead that the allegations taken as a whole were sufficient to support pre-suit willfulness at the pleading stage. Specifically, the court found that the allegations as to the defendant’s involvement in a related foreign opposition proceeding and participation in the relevant industry were accompanied by detailed factual support that sufficiently pleaded willful infringement for the pre-suit period.

...

Read More

IP Newsflash

November 14, 2025

The Ninth Circuit recently reversed a district court’s decision to strike a plaintiff’s trade secret claims under the Defend Trade Secrets Act (DTSA) at the discovery stage. In doing so, the Ninth Circuit made clear that under the DTSA, whether a party defined their trade secret with sufficient particularity is a question of fact that generally does not lend itself to resolution in the absence of at least some discovery. This ruling contrasts with the California Uniform Trade Secrets Act (CUTSA), which requires a party to define their trade secrets with reasonable particularity before commencing discovery.

...

Read More

IP Newsflash

November 11, 2025

The Federal Circuit recently vacated a summary judgment ruling of invalidity, holding that the district court erred in applying preclusive effect to the Patent Trial and Appeal Board’s unpatentability findings regarding other claims in the same patent. In doing so, the Federal Circuit reiterated that issue preclusion does not apply where the prior factual determinations were made under a lower standard of proof.

...

Read More

IP Newsflash

November 3, 2025

The Federal Circuit recently clarified the requirement for work disclosed in a reference to qualify as “by another” under pre-AIA Sections 102(a) and (e), holding that there must be complete inventive identity between the information disclosed in the asserted reference and the inventors named on the relevant patent. 

...

Read More

© 2025 Akin Gump Strauss Hauer & Feld LLP. All rights reserved. Attorney advertising. This document is distributed for informational use only; it does not constitute legal advice and should not be used as such. Prior results do not guarantee a similar outcome. Akin is the practicing name of Akin Gump LLP, a New York limited liability partnership authorized and regulated by the Solicitors Regulation Authority under number 267321. A list of the partners is available for inspection at Eighth Floor, Ten Bishops Square, London E1 6EG. For more information about Akin Gump LLP, Akin Gump Strauss Hauer & Feld LLP and other associated entities under which the Akin Gump network operates worldwide, please see our Legal Notices page.