DCT

1:26-cv-00011

Cognito Therap Inc v. Optoceutics Inc

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-00011, D. Del., 01/06/2026
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant OptoCeutics, Inc. is a Delaware corporation and is therefore subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s EVY product line, a multi-sensory platform for cognitive support, infringes seven patents related to the use of non-invasive light and sound stimulation to induce gamma brain wave oscillations for treating neurodegenerative diseases.
  • Technical Context: The technology involves using precisely modulated sensory stimuli, particularly light and sound at approximately 40 Hz, to non-invasively entrain the brain's gamma wave activity, which is often deficient in patients with conditions like Alzheimer's disease.
  • Key Procedural History: The Massachusetts Institute of Technology (MIT), the original assignee of several of the asserted patents, exclusively licensed the patents to co-plaintiff Cognito Therapeutics, Inc. Cognito developed its own commercial product, Spectris™, based on the patented technology, which received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation in 2020.

**Case Timeline**

Date Event
2015-11-24 Earliest Priority Date for ’497, ’816, and ’490 Patents
2016-07-11 MIT exclusively licenses ’490, ’497, and ’816 Patents to Cognito
2016-11-17 Earliest Priority Date for ’759 and ’072 Patents
2017-10-10 Earliest Priority Date for ’586 and ’225 Patents
2018-12-25 U.S. Patent No. 10,159,816 Issues
2019-01-14 MIT exclusively licenses ’586 and ’225 Patents to Cognito
2019-04-23 U.S. Patent No. 10,265,497 Issues
2020-06-16 U.S. Patent No. 10,682,490 Issues
2021-03-30 U.S. Patent No. 10,960,225 Issues
2022-02-08 U.S. Patent No. 11,241,586 Issues
2025-08-12 U.S. Patent No. 12,383,759 Issues
2025-10-07 U.S. Patent No. 12,434,072 Issues
2026-01-06 Complaint Filing Date

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

U.S. Patent No. 10,682,490 - *“Methods and Devices for Providing a Stimulus to a Subject to Induce Gamma Oscillations”*

The Invention Explained

  • Problem Addressed: The patent background describes Alzheimer's disease as a progressive neurodegenerative disorder characterized by memory decline and the accumulation of amyloid plaques. It notes that gamma wave oscillations (about 20 Hz to 100 Hz), which are critical for cognitive functions, are deficient in AD patients ('490 Patent, col. 1:40-52, col. 2:1-5).
  • The Patented Solution: The invention proposes a method and system for treating or mitigating such disorders by administering a non-invasive stimulus to a subject at a frequency of approximately 35 Hz to 45 Hz. This stimulation is designed to induce, enhance, or restore synchronized gamma oscillations in at least one brain region, thereby addressing the deficiency observed in AD patients ('490 Patent, Abstract; col. 2:32-44).
  • Technical Importance: The invention provides a non-pharmacological and non-invasive therapeutic strategy to address a key neuropathological hallmark of Alzheimer's disease (Compl. ¶12).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 ('490 Patent, Claim 1; Compl. ¶49).
  • The essential elements of independent claim 1 are:
    • A method, comprising:
    • A) administering a non-invasive stimulus to a subject having a frequency of about 35 Hz to about 45 Hz
    • to induce synchronized gamma oscillations in at least one brain region of the subject.
  • The complaint does not explicitly reserve the right to assert dependent claims for the ’490 Patent.

U.S. Patent No. 10,265,497 - *“Systems and Methods for Treating Dementia”*

The Invention Explained

  • Problem Addressed: The patent addresses the technical problem of dementia, including Alzheimer's disease, which is characterized by cognitive decline and pathological hallmarks such as amyloid plaques. The background links these pathologies to deficits in gamma frequency oscillations in the brain ('497 Patent, col. 1:38-64).
  • The Patented Solution: The patented solution is a method for treating dementia by administering a non-invasive stimulus to a subject. The purpose of this stimulus is to induce synchronized gamma oscillations in at least one brain region, thereby providing a therapeutic effect ('497 Patent, Abstract; col. 2:32-44).
  • Technical Importance: This technology offers a non-invasive approach to potentially mitigate dementia by targeting the underlying neural oscillation deficits associated with the disease (Compl. ¶12).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 ('497 Patent, Claim 1; Compl. ¶64).
  • The essential elements of independent claim 1 are:
    • A method for treating dementia in a subject in need thereof, the method comprising:
    • administering a non-invasive stimulus to the subject to induce synchronized gamma oscillations in at least one brain region of the subject to treat dementia in the subject.
  • The complaint does not explicitly reserve the right to assert dependent claims for the ’497 Patent.

Other Patents-in-Suit

  • Multi-Patent Capsule:

    • Patent Identification: U.S. Patent No. 10,159,816, “Systems and Methods for Preventing, Mitigating, and/or Treating Dementia,” issued December 25, 2018 (Compl. ¶15).
    • Technology Synopsis: This patent describes a method for treating Alzheimer's disease by inducing synchronized gamma oscillations in the brain. The method comprises non-invasively delivering a visual or auditory signal with a frequency of approximately 35 Hz to 45 Hz to a subject ('816 Patent, Abstract; Compl. ¶76).
    • Asserted Claims: At least independent claim 1 (Compl. ¶77).
    • Accused Features: The accused EVY system’s light and sound stimulation, which is marketed as operating at 40 Hz, is alleged to practice the claimed method (Compl. ¶¶34, 77).

  • Multi-Patent Capsule:

    • Patent Identification: U.S. Patent No. 10,960,225, “Systems and Methods for Preventing, Mitigating, and/or Treating Dementia Via Visual Stimulation that Binds Higher Order Brain Regions, Reduces Neurodegeneration and Neuroinflammation, and Improves Cognitive Function,” issued March 30, 2021 (Compl. ¶18).
    • Technology Synopsis: The patent claims a method for treating dementia or Alzheimer's disease by delivering chronic visual stimuli at a frequency of about 30 Hz to 50 Hz. This is intended to entrain synchronized gamma oscillations in multiple brain regions, specifically including the prefrontal cortex and the hippocampus, to achieve various therapeutic effects like reducing neurodegeneration and enhancing memory ('225 Patent, Abstract; Compl. ¶89).
    • Asserted Claims: At least independent claim 46 (Compl. ¶90).
    • Accused Features: The EVY system's 40 Hz light and sound therapy is alleged to entrain synchronized gamma oscillations in the prefrontal cortex and hippocampus, thereby practicing the claimed method (Compl. ¶¶38-39, 90).

  • Multi-Patent Capsule:

    • Patent Identification: U.S. Patent No. 11,241,586, “Systems and Methods for Preventing, Mitigating, and/or Treating Dementia,” issued February 8, 2022 (Compl. ¶17).
    • Technology Synopsis: This patent discloses a method for treating dementia or Alzheimer's disease by non-invasively delivering combined and synchronously aligned auditory and visual stimuli. The stimuli have a frequency of about 20 Hz to 60 Hz and are intended to induce synchronized gamma oscillations in at least one brain region ('586 Patent, Abstract; Compl. ¶102).
    • Asserted Claims: At least independent claim 1 (Compl. ¶103).
    • Accused Features: The accused EVY product, described as a "multi-sensory platform" of light and sound that aims to "synchronize[] to 40Hz," is alleged to practice the claimed method (Compl. ¶¶37, 103).

  • Multi-Patent Capsule:

    • Patent Identification: U.S. Patent No. 12,383,759, “Methods and Systems for Neural Stimulation Via Visual, Auditory and Peripheral Nerve Stimulations,” issued August 12, 2025 (Compl. ¶21).
    • Technology Synopsis: The patent claims a system for treating Alzheimer's or dementia. The system comprises a stimulus-emitting component for providing a non-invasive auditory or visual stimulus (30-60 Hz), one or more processors, a memory device, and a feedback sensor ('759 Patent, Abstract; Compl. ¶29).
    • Asserted Claims: At least independent claim 1 (Compl. ¶116).
    • Accused Features: The entire EVY product suite—including the light device, sound stimulation headphones, and mobile application with tracking features—is alleged to constitute the claimed system (Compl. ¶¶34-36, 116).

  • Multi-Patent Capsule:

    • Patent Identification: U.S. Patent No. 12,434,072, “Methods and Systems for Neural Stimulation Via Visual, Auditory and Peripheral Nerve Stimulations,” issued October 7, 2025 (Compl. ¶22).
    • Technology Synopsis: The patent covers a method for treating cognitive impairment using a system with light sources and a feedback sensor. The method includes emitting light pulses at 40 Hz while determining the subject's attention level by performing eye tracking or determining head/body orientation via the feedback sensor ('072 Patent, Abstract; Compl. ¶29).
    • Asserted Claims: At least independent claim 1 (Compl. ¶129).
    • Accused Features: The EVY system, which includes a light device and a mobile app for tracking user progress, is alleged to practice the claimed method (Compl. ¶¶34-36, 129).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant’s “EVY” product, which includes a light therapy device, headphones, and a companion mobile application called the "EVY INSIGHT App" (Compl. ¶¶34, 36).

Functionality and Market Context

  • The EVY product is marketed as a “40 Hz multi-sensory platform of light, sound and tech” designed to support individuals with Alzheimer's disease or dementia (Compl. ¶¶34, 37). The platform combines "40 Hz Light Therapy" with "40 Hz Sound Stimulation" to provide "brainwave entrainment" (Compl. ¶¶34, 36). An image from OptoCeutics's website shows the EVY components, including a light-emitting box and headphones (Compl. p. 11). The mobile application is described as tying the components together and allowing users to track progress in areas like mood, sleep, and memory (Compl. p. 12, ¶36).
  • The complaint alleges that OptoCeutics's own marketing materials state that the therapy aims to "stimulate the brain's gamma wave activity so that it synchronizes to 40Hz" to improve cognitive functions (Compl. p. 14, ¶37). The complaint further alleges, on information and belief, that the EVY system treats Alzheimer's disease by entraining synchronized gamma oscillations in the hippocampus and the prefrontal cortex (Compl. ¶¶38-39).

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,682,490 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method, comprising: A) administering a non-invasive stimulus to a subject... The EVY product is a non-invasive system that administers both light and sound stimuli to a user (Compl. ¶¶34, 36). ¶49 col. 2:32-35
...having a frequency of about 35 Hz to about 45 Hz... The EVY product is explicitly marketed as a "40 Hz Light Therapy" and "40 Hz Sound Stimulation" platform, which falls within the claimed frequency range (Compl. ¶¶34, 37). ¶49 col. 2:40-42
...to induce synchronized gamma oscillations in at least one brain region of the subject. Defendant’s website is cited as stating that its therapy aims to "stimulate the brain's gamma wave activity so that it synchronizes to 40Hz" (Compl. p. 14, ¶37). ¶49 col. 2:32-36

U.S. Patent No. 10,265,497 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating dementia in a subject in need thereof, the method comprising: administering a non-invasive stimulus to the subject... The EVY product is marketed to "support those living with Alzheimer's [disease] or dementia" and administers non-invasive light and sound stimuli (Compl. ¶¶34, 64). ¶64 col. 2:32-35
...to induce synchronized gamma oscillations in at least one brain region of the subject to treat dementia in the subject. Defendant's marketing materials allegedly state the therapy's purpose is to synchronize gamma wave activity to 40 Hz to improve cognitive functions in this patient population (Compl. p. 14, ¶¶37, 64). ¶64 col. 2:42-44

Identified Points of Contention

  • Scope Questions: A potential point of contention may be whether the Defendant's marketing of the EVY product to "support" cognitive health for those with dementia meets the "treating dementia" limitation of the '497 Patent. The complaint's infringement theory for the asserted method claims rests on the allegation that OptoCeutics itself "uses the methods" (Compl. ¶65), raising the question of what specific actions by the defendant constitute performance of the claimed method steps.
  • Technical Questions: The infringement allegations rely on Defendant's marketing statements that the EVY product "synchronizes to 40Hz" to meet the "induce synchronized gamma oscillations" limitation. A key technical question will be what evidentiary proof is required to show that the accused product, particularly its "Invisible Spectral Flicker technology" (Compl. p. 11), actually causes the claimed neurophysiological effect in one or more brain regions as required by the claims.

V. Key Claim Terms for Construction

  • The Term: "administering a non-invasive stimulus" (asserted in Claim 1 of both the ’490 and ’497 patents)

    • Context and Importance: This term defines the core action of the asserted method claims. Its construction is critical because the infringement allegation is against the manufacturer (OptoCeutics), not just the end-user. Practitioners may focus on whether "administering" can be construed to mean "providing a device and instructions for use," which would support a direct infringement theory against the manufacturer, or if it is limited to the end-user's physical act of using the device.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification of the '497 Patent discusses an embodiment including "a stimulus-emitting device to emit the stimulus and/or administering the stimulus to the subject," which may suggest that providing the device is part of the "administering" step ('497 Patent, col. 2:53-55).
      • Evidence for a Narrower Interpretation: The claims are drafted as methods ("A method...comprising: administering..."), which could be interpreted to require the performance of the action itself, an act carried out by the user of the device rather than the seller.

  • The Term: "to induce synchronized gamma oscillations" (asserted in Claim 1 of both the ’490 and ’497 patents)

    • Context and Importance: This is a functional limitation that describes the intended result of the claimed method. The dispute may center on the required level of proof to show that the accused product achieves this result.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patents teach that a stimulus at a specific frequency (e.g., 40 Hz) is the mechanism that induces the oscillation. Language in the '490 Patent states that the method comprises "administering a non-invasive stimulus...having a frequency of about 35 Hz to about 45 Hz to induce" the oscillations, potentially suggesting that applying a stimulus in the claimed frequency range inherently satisfies the "to induce" requirement ('490 Patent, Claim 1).
      • Evidence for a Narrower Interpretation: The patents include extensive "Experimental Data" sections with neurophysiological measurements demonstrating that the inventive method produces the claimed effect ('497 Patent, col. 22:23-75:51). This may support an argument that infringement requires empirical proof that the accused device actually causes the claimed neurological result, not merely that it is designed to do so.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on the allegation that OptoCeutics actively encourages its customers to use the EVY products in a manner that directly infringes the method claims (Compl. ¶¶52, 67). Contributory infringement is based on the allegation that the EVY products are a material part of the patented methods and are especially adapted for infringing use (Compl. ¶¶51, 66).
  • Willful Infringement: Willfulness is alleged based on OptoCeutics's alleged full knowledge of the patents and their scope. The complaint provides evidence suggesting pre-suit knowledge, including a screenshot of a competitive comparison chart from OptoCeutics's website that explicitly names "Cognito Therapeutics" (Compl. p. 20, ¶55). The complaint also alleges that OptoCeutics's website and marketing materials reference the foundational scientific research of Dr. Tsai, an inventor of the asserted patents, and link to an MIT webpage describing that research (Compl. ¶¶41-44, 56).

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

  • A core issue will be one of functional proof: What level of evidence will be required to demonstrate that the accused EVY product, with its "Invisible Spectral Flicker" technology, actually performs the claimed function of "induc[ing] synchronized gamma oscillations" in specific brain regions, beyond what is claimed in Defendant's marketing materials?
  • A key question will be one of definitional scope: Can Plaintiffs establish that OptoCeutics's act of selling a product marketed to "support" individuals with dementia constitutes "treating dementia" as required by the method claims of the '497 Patent, and does selling the device constitute "administering" the stimulus for purposes of direct infringement?
  • The case may also turn on the strength of the willfulness allegations, as the complaint presents specific evidence—including a competitive chart naming Cognito and marketing materials linking to the inventor's research—that raises the question of whether any infringement was intentional and knowing.