DCT

1:25-cv-00832

Ceribell Inc v. Natus Medical Inc

I. Executive Summary and Procedural Information

Parties & Counsel:
- Plaintiff: Ceribell, Inc. (Delaware)
- Defendant: Natus Medical Incorporated (Delaware), Excel-Tech Ltd. (Canada), and Natus Neurology Incorporated (Delaware)
- Plaintiff’s Counsel: Quinn Emanuel Urquhart & Sullivan, LLP
Case Identification: 1:25-cv-00832, D. Del., 07/07/2025
Venue Allegations: Venue is asserted on the basis that Defendants Natus Medical and Natus Neurology are Delaware corporations that reside in the district. Defendant Excel-Tech is a foreign corporation, and venue is alleged to be proper where it is subject to personal jurisdiction. All Defendants are alleged to have committed acts of infringement in the district.
Core Dispute: Plaintiff alleges that Defendants’ BrainWatch point-of-care electroencephalogram (EEG) system infringes six patents related to wearable EEG technology, including electrode assemblies and integrated headbands.
Technical Context: The technology relates to rapid, point-of-care EEG monitoring systems designed to allow non-specialist clinicians to quickly detect seizures in acute care settings.
Key Procedural History: The complaint alleges that Defendant Natus was found by a federal jury in 2018 to have willfully infringed another company’s patents related to neurological diagnostic technology. It further alleges that Natus, in its FDA 510(k) submission for the accused BrainWatch system, identified Plaintiff’s products as the “predicate devices,” a fact Plaintiff presents as evidence of intentional copying.

Case Timeline

Date	Event
2014-01-01	Plaintiff Ceribell founded
2016-03-29	Earliest Priority Date for ’0670, ’769, ’4670, ’826 Patents
2017-11-21	U.S. Patent No. 9,820,670 issues
2018-01-01	Ceribell System commercially launched
2018-04-01	Jury finds Natus willfully infringed in prior D. Del. case
2018-05-31	Earliest Priority Date for ’756 and ’434 Patents
2019-10-08	U.S. Patent No. 10,433,756 issues
2022-06-14	U.S. Patent No. 11,357,434 issues
2024-10-10	Natus publicizes submission of FDA 510(k) for Accused Product
2024-11-19	Natus receives FDA 510(k) clearance for Accused Product
2024-11-26	U.S. Patent No. 12,150,769 issues
2025-05-20	Accused Product (BrainWatch System) commercially launched
2025-06-10	U.S. Patent No. 12,324,670 issues
2025-06-24	U.S. Patent No. 12,336,826 issues
2025-07-07	Complaint filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,820,670 - Methods and Apparatus for Electrode Placement and Tracking

Patent Identification: U.S. Patent No. 9,820,670, titled “Methods and Apparatus for Electrode Placement and Tracking,” issued November 21, 2017 (Compl. ¶55).

The Invention Explained

Problem Addressed: Conventional EEG systems require a specially trained technician to manually apply 20 or more individual electrodes to a patient's scalp, a process that is time-consuming, prone to failure, and often unavailable on-demand in critical care settings like ICUs and emergency rooms (Compl. ¶20). This can delay the diagnosis of urgent neurological conditions, such as non-convulsive seizures, for hours or days (Compl. ¶21). The complaint includes an image of a conventional EEG system being applied, highlighting the complexity of the wiring and electrode placement (Compl. Fig. 2, p. 10).
The Patented Solution: The invention provides an integrated electrode carrier system, such as a headband, containing multiple electrode assemblies (Compl. ¶¶27, 55). The complaint shows an image of Plaintiff's commercial embodiment, the Ceribell System, which features a wearable headband connected to a pocket-sized recorder (Compl. Fig. 1, p. 4). These assemblies are designed with features like tubular members that can part a patient's hair and channels to distribute conductive gel, ensuring a reliable electrical connection to the scalp can be established quickly by a non-specialist (Compl. ¶¶29, 55).
Technical Importance: This technology aims to reduce the time for EEG setup from over an hour to under 10 minutes, making rapid, point-of-care seizure detection feasible in acute care environments (Compl. ¶1, 25).

Key Claims at a Glance

The complaint asserts at least independent claim 1 (Compl. ¶57, 59).
The complaint references an exemplary claim chart exhibit that was not attached to the filing; therefore, the specific elements of the asserted claims are not detailed in the pleading (Compl. ¶57). Based on the complaint's narrative, the claim is directed to electrode assemblies for EEG measurement that comprise tubular members with distribution channels for conductive fluid or gel (Compl. ¶55).
The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 12,150,769 - Methods and Apparatus for Electrode Placement and Tracking

Patent Identification: U.S. Patent No. 12,150,769, titled “Methods and Apparatus for Electrode Placement and Tracking,” issued November 26, 2024 (Compl. ¶67).

The Invention Explained

Problem Addressed: The patent addresses the same technical problem as the related ’0670 Patent: the difficulty and delay associated with conventional EEG setup, particularly in the presence of hair, which can impede a good electrical connection with the scalp (’769 Patent, col. 1:26-38).
The Patented Solution: The patent claims a method for measuring electrical signals that integrates skin preparation and electrode application. The method involves using an electrode assembly that has at least one "prong" to prepare the skin surface (e.g., part hair) before or during the dispensing of conductive gel from a reservoir through a defined fluid path within the prong itself (’769 Patent, Abstract; Claim 1). This allows a user to establish a reliable connection in a single, streamlined process (Compl. ¶67).
Technical Importance: This claimed method simplifies the complete EEG setup workflow, further reducing the time and specialized skill needed to acquire diagnostic-quality brain activity data in urgent medical situations (Compl. ¶28).

Key Claims at a Glance

The complaint asserts at least independent claim 1 (Compl. ¶69, 71).
The essential elements of independent claim 1 include:
- positioning an electrode assembly comprising a reservoir and at least one prong having a channel or slot;
- preparing a surface of the skin with the electrode assembly;
- dispensing a conductive fluid or gel from the reservoir through a series of defined passageways to the skin surface; and
- measuring electrical signals from the skin with the assembly (’769 Patent, col. 22:1-21).
The complaint reserves the right to identify additional infringing activities during discovery (Compl. ¶68).

U.S. Patent No. 12,324,670 - Methods and Apparatus for Electrode Placement and Tracking

Patent Identification: U.S. Patent No. 12,324,670, "Methods and Apparatus for Electrode Placement and Tracking," issued June 10, 2025 (Compl. ¶79).
Technology Synopsis: This patent, from the same family as the '0670 and '769 patents, is directed to electrode carrier systems and assemblies for EEG measurement. The technology facilitates rapid setup by integrating electrodes and a conductive gel reservoir into a single apparatus (’4670 Patent, Abstract).
Asserted Claims: At least independent claim 1 (Compl. ¶81).
Accused Features: The Natus BrainWatch Point-of-Care EEG System and its components (Compl. ¶¶79-80).

U.S. Patent No. 12,336,826 - Methods and Apparatus for Electrode Placement and Tracking

Patent Identification: U.S. Patent No. 12,336,826, "Methods and Apparatus for Electrode Placement and Tracking," issued June 24, 2025 (Compl. ¶91).
Technology Synopsis: This patent, also from the '0670 family, is directed to a headband containing electrode assemblies that can be used in EEG measurement devices (Compl. ¶91).
Asserted Claims: At least independent claim 1 (Compl. ¶93).
Accused Features: The Natus BrainWatch Point-of-Care EEG System and its components (Compl. ¶¶91-92).

U.S. Patent No. 10,433,756 - Adjustable Geometry Wearable Electrodes

Patent Identification: U.S. Patent No. 10,433,756, "Adjustable Geometry Wearable Electrodes," issued October 8, 2019 (Compl. ¶103).
Technology Synopsis: This patent describes wearable electrode assemblies designed to improve patient comfort, particularly during extended use or when a patient is resting their head against a surface. The invention features an electrode body that is at least partially collapsible or compressible, which serves to decrease the direct force and pressure applied to the skin (’756 Patent, Abstract; col. 2:1-12).
Asserted Claims: At least independent claims 1 and 22 (Compl. ¶105).
Accused Features: The electrode assemblies of the Natus BrainWatch system (Compl. ¶¶104, 107).

U.S. Patent No. 11,357,434 - Adjustable Geometry Wearable Electrodes

Patent Identification: U.S. Patent No. 11,357,434, "Adjustable Geometry Wearable Electrodes," issued June 14, 2022 (Compl. ¶115).
Technology Synopsis: A continuation of the '756 patent family, this patent is also directed to electrode assemblies with adjustable geometry for comfort. It further describes structures to dispense conductive gel and facilitate the clearing of skin or hair prior to establishing an electrical connection (’434 Patent, Abstract).
Asserted Claims: At least independent claim 1 (Compl. ¶117).
Accused Features: The electrode assemblies of the Natus BrainWatch system (Compl. ¶¶116, 119).

III. The Accused Instrumentality

Product Identification

The Natus BrainWatch Point-of-Care EEG System and its components (Compl. ¶8).

Functionality and Market Context

The Accused Product is described as a "wireless, wearable point-of-care EEG system" intended for "quick setup by any ED or ICU clinician within minutes" (Compl. ¶46). The complaint alleges the system includes a disposable elastic headband with integrated electrodes and "sealed gel pods" that apply conductive gel to the patient's skin (Compl. ¶¶43, 50). The complaint includes a table from Natus's FDA 510(k) filing that compares the features of the BrainWatch system to Ceribell's products, noting identical head size ranges, the same number of recording electrodes, and a similar gel delivery mechanism (Compl. Fig. 3, p. 23). The complaint alleges Natus launched the product to compete directly with Ceribell in the point-of-care EEG market that Ceribell created (Compl. ¶43).

IV. Analysis of Infringement Allegations

As the complaint's claim chart exhibit for U.S. Patent No. 9,820,670 was not provided, the infringement allegations are summarized based on the complaint's narrative. The complaint alleges that the BrainWatch system infringes because it is an electrode assembly for EEG measurement that comprises "tubular members with distribution channels for conductive fluid or gel flow" (Compl. ¶55). The core of this infringement theory appears to be that the physical structure and gel-delivery mechanism of the BrainWatch electrodes read on the elements of the '0670 patent's claims (Compl. ¶56).

’769 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
positioning an electrode assembly adjacent skin of the subject, the electrode assembly comprising a reservoir and at least one prong having a channel or slot extending along a bottom portion of the at least one prong	The Natus BrainWatch system includes an electrode headband. Natus's user manuals allegedly instruct users to position the headband on a patient. Its electrode assemblies contain "sealed gel pods" (the alleged reservoir) and electrodes (the alleged prongs).	¶¶46, 50, 73	col. 22:2-7
preparing a surface of the skin of the subject with the electrode assembly	Natus allegedly instructs users to apply the device, which, by its nature, involves preparing the skin surface for EEG measurement by parting hair and making contact with the scalp.	¶73	col. 22:8-9
dispensing a conductive fluid or gel from the reservoir through a vertical passageway and a horizontal passageway...a lumen of the at least one prong, and the channel or slot...to the skin surface	The BrainWatch system's integrated "sealed gel pods" are alleged to dispense conductive electrolyte gel from the electrode assembly onto the patient's skin to establish an electrical connection.	¶50	col. 22:10-16
measuring one or more electrical signals of the subject from the skin of the subject with the electrical assembly	The intended and actual function of the Natus BrainWatch EEG System is to measure electrical signals from the brain via electrodes placed on the scalp.	¶46	col. 22:17-21

Identified Points of Contention

Scope Questions: The analysis of the '0670 Patent may focus on the court's construction of "tubular member" and "distribution channels." A central question will be whether the physical structures of the BrainWatch electrode and its integrated gel pod fall within the scope of these terms as defined in the patent. For the '769 Patent, a key issue may be the scope of the method step "preparing a surface of the skin." The dispute could turn on whether this term requires a specific abrasive or hair-parting action beyond what occurs during simple placement of the electrode on a patient's head.
Technical Questions: A key factual question will concern the internal mechanics of the accused BrainWatch electrode assembly. The infringement analysis for the '769 Patent will require evidence of whether the accused device's fluid path for the conductive gel maps onto the specific sequence of a "vertical passageway", "horizontal passageway", and "lumen" required by the claim.

V. Key Claim Terms for Construction

The Term: "prong" (’769 Patent)

Context and Importance: This term is central to the physical structure of the claimed electrode assembly. The determination of whether the electrode structures on the accused BrainWatch headband constitute "prongs" will be critical to the infringement analysis. Practitioners may focus on this term because the complaint alleges Natus copied Ceribell's electrode configuration (Compl. ¶43).
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The '769 patent is part of a larger family, and the specifications may use terms like "tubular member" and "prong" interchangeably. The specification of the related '4670 patent describes "prongs" as potentially having "a relatively broad tissue-contacting region" (’4670 Patent, col. 6:40-42), which may support a construction not limited to a narrow, pointed shape.
- Evidence for a Narrower Interpretation: The specification discloses numerous specific embodiments of "prongs," showing detailed geometries with channels, recesses, and crescent shapes (’4670 Patent, Figs. 17-27). A defendant could argue that the term "prong" is implicitly limited by these detailed examples to structures more complex than a simple electrode contact.

The Term: "preparing a surface of the skin" (’769 Patent)

Context and Importance: This active method step is a key limitation in asserted claim 1 of the '769 patent. The construction of this term will define the specific actions that constitute infringement of the claimed method.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification of the related '434 patent states that electrode assemblies may "facilitate the clearing of skin and/or hair prior to establishing an electrical connection" (’434 Patent, col. 1:15-18). This could support a broader interpretation where "preparing" includes any action by the device that helps part hair or improve contact.
- Evidence for a Narrower Interpretation: The specification also uses more specific, active language, describing the potential for "abrading the skin" and using "abrasive elements" or an "abrasive material" (’769 Patent, col. 14:10-15; ’434 Patent, col. 1:63-65). A defendant may argue that "preparing" requires an affirmative abrasive or exfoliating action, rather than just incidental contact during placement.

VI. Other Allegations

Indirect Infringement

The complaint alleges inducement of infringement, stating that Natus provides user manuals, advertisements, and other instructions that actively encourage and teach its customers (e.g., hospitals, clinicians) to use the Accused Products in an infringing manner (Compl. ¶¶61, 73, 97, 109, 121). The complaint also pleads contributory infringement, alleging Natus sells the BrainWatch system knowing it is especially made for use in an infringement of the patents and is not a staple article of commerce (Compl. ¶¶62, 74, 98, 110, 122).

Willful Infringement

Willfulness is alleged based on Natus's alleged knowledge of the patents since at least the filing of the complaint (Compl. ¶¶63, 75). The complaint further supports its request for enhanced damages by asserting that Natus is a "serial copycat" with a prior jury finding of willful infringement against it, and by alleging that Natus intentionally copied Ceribell’s technology, as evidenced by its reliance on Ceribell's products as predicate devices in its FDA 510(k) submission (Compl. ¶¶2, 8, 41-42, 48).

VII. Analyst’s Conclusion: Key Questions for the Case

A central issue will be one of definitional scope: can the patent terms "tubular member," "prong," and "distribution channel," which are described with specific geometries in the patents, be construed to cover the physical structures of the electrode contacts and "sealed gel pods" in the accused BrainWatch system?
A key evidentiary question will be one of functional operation: does the use of the BrainWatch system, as instructed by Natus, perform the specific, multi-part method steps required by claim 1 of the '769 patent, particularly the step of "preparing a surface of the skin"?
The case may also turn on a question of intent: does the evidence cited in the complaint—including Natus's prior history of infringement and its use of Ceribell’s products as FDA predicate devices—support a finding of willful infringement and justify an award of enhanced damages?