DCT

5:23-cv-00626

Wave Neuroscience, Inc. v. Brain Frequency LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 5:23-cv-00626, W.D. Tex., 08/10/2023
  • Venue Allegations: Plaintiff alleges venue is proper in the Western District of Texas because Defendant's principal place of business is in New Braunfels, Texas, within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s neuromodulation system and associated treatment methods infringe four patents related to the use of transcranial magnetic stimulation, guided by electroencephalogram (EEG) data, to treat neurological disorders.
  • Technical Context: The technology involves personalized neuromodulation, where magnetic fields are used to non-invasively stimulate a patient's brain at specific frequencies to treat conditions such as depression and anxiety.
  • Key Procedural History: Plaintiff acquired the asserted patents from original assignees NeoSync, Inc. and Kosivana Holdings Limited. The complaint alleges Defendant was put on notice of the asserted patents via a letter accompanying the original complaint in this action.

Case Timeline

Date Event
2007-09-25 Earliest Priority Date ('057 Patent, '741 Patent)
2008-09-24 Earliest Priority Date ('490 Patent)
2012-04-06 Earliest Priority Date ('111 Patent)
2015-01-06 U.S. Patent No. 8,926,490 Issued
2015-04-21 U.S. Patent No. 9,015,057 Issued
2018-07-24 U.S. Patent No. 10,029,111 Issued
2019-06-12 Wave acquires assets from Kosivana
2020-02-13 Wave acquires assets from NeoSync
2022-04-26 U.S. Patent No. 11,311,741 Issued
2023-05-15 Date of letter allegedly providing notice to Defendant
2023-08-10 First Amended Complaint Filed

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

U.S. Patent No. 8,926,490 - "SYSTEMS AND METHODS FOR DEPRESSION TREATMENT USING NEURO-EEG SYNCHRONIZATION THERAPY," Issued January 6, 2015

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of treating mental disorders like depression, noting that conventional medications often have significant negative side effects and that existing Repetitive Transcranial Magnetic Stimulation (rTMS) therapies require high currents that generate significant heat ('490 Patent, col. 1:16-34).
  • The Patented Solution: The invention proposes a system for "neuro-EEG synchronization therapy" that uses alternating magnetic fields to "gently 'tune' the brain" ('490 Patent, Abstract). The system determines a subject's intrinsic EEG frequency, compares it to an average frequency from a healthy population database, and then applies a magnetic field to shift the subject's frequency toward the healthy average, allegedly to increase or decrease blood flow in specific brain regions ('490 Patent, col. 2:45-67).
  • Technical Importance: The described technology suggests a move toward personalized, data-driven neuromodulation that aims to correct specific electrophysiological biomarkers rather than applying a uniform stimulation protocol ('490 Patent, col. 2:45-51).

Key Claims at a Glance

  • The complaint asserts independent Claim 1 (Compl. ¶39).
  • Claim 1 of the ’490 Patent recites:
    • A system for treating depression comprising a magnetic field generator.
    • A non-transitory computer readable medium containing a particular data value representing an average intrinsic frequency of a healthy population.
    • A processor configured to control the magnetic field based on the data value to increase or decrease blood flow in particular regions of the brain.
  • The complaint reserves the right to assert additional claims (Compl. ¶52).

U.S. Patent No. 9,015,057 - "SYSTEMS AND METHODS FOR CONTROLLING AND BILLING NEURO-EEG SYNCHRONIZATION THERAPY," Issued April 21, 2015

The Invention Explained

  • Problem Addressed: Beyond the clinical challenges of treating mental disorders, the patent addresses the logistical and commercial problem of how to control and bill for the use of remote or patient-operated therapeutic devices ('057 Patent, col. 8:28-35).
  • The Patented Solution: The invention describes a system where a therapeutic device can download a "treatment dosage quota" from a central service ('057 Patent, col. 8:28-32). This allows a user, such as a therapist or patient, to administer a pre-paid or prescribed number of therapy sessions. The system includes logic for uploading EEG data and downloading these quotas via the internet or a phone line, creating a framework for controlled, billable, remote therapy ('057 Patent, col. 8:8-27).
  • Technical Importance: The patented solution provides a business and control method for deploying sophisticated medical devices outside of a traditional, continuously supervised clinical setting, enabling a pay-per-use or subscription-style model for medical treatment ('057 Patent, Abstract).

Key Claims at a Glance

  • The complaint asserts independent Claim 14 (Compl. ¶41).
  • Claim 14 of the ’057 Patent recites:
    • A device comprising a permanent magnet and a controller subunit that moves the magnet to apply a magnetic field.
    • The controller subunit is configured to move a Q-factor of an intrinsic frequency of the brain within a specified EEG band up, down, or toward a pre-selected Q-factor.
  • The complaint reserves the right to assert additional claims (Compl. ¶59).

U.S. Patent No. 10,029,111 - "RTMS AT HARMONICS OF BIOLOGICAL SIGNALS," Issued July 24, 2018 (Multi-Patent Capsule)

Technology Synopsis

The patent describes a method of administering rTMS at a pulse rate that is a harmonic of a non-EEG biological metric, such as a patient's heart rate ('111 Patent, Abstract). The purpose is to establish "frequency coupling" between different organs (e.g., heart and brain) by selecting the harmonic closest to a desired EEG frequency associated with the targeted cognitive symptom ('111 Patent, col. 4:35-58).

Asserted Claims

Independent Claim 1 (Compl. ¶43).

Accused Features

The complaint alleges that the general methods employed by the Brain Frequency™ system infringe this patent (Compl. ¶44).

U.S. Patent No. 11,311,741 - "SYSTEMS AND METHODS FOR ANXIETY TREATMENT USING NEURO-EEG SYNCHRONIZATION THERAPY," Issued April 26, 2022 (Multi-Patent Capsule)

Technology Synopsis

This patent describes a method for treating anxiety by adjusting the output of a magnetic field to influence a "Q-factor"—a measure of frequency selectivity—of a specified EEG band in a subject's brain ('741 Patent, Abstract). The system aims to move the subject's Q-factor toward a pre-selected target Q-factor, often derived from a healthy population, to "tune" the brain and affect anxiety symptoms ('741 Patent, col. 2:2-6).

Asserted Claims

Independent Claim 1 (Compl. ¶45).

Accused Features

The complaint alleges that the general methods employed by the Brain Frequency™ system for treating anxiety infringe this patent (Compl. ¶46).

III. The Accused Instrumentality

Product Identification

"The Brain Frequency™ system" and its associated treatment procedures (Compl. ¶36).

Functionality and Market Context

The complaint alleges the accused system induces neuromodulation by first performing an EEG to measure electrical patterns in the brain (Compl. ¶36). The system then allegedly uses "gentle, short, magnetic pulses" to treat symptoms such as depression and anxiety (Compl. ¶36). The complaint further alleges that Defendant does not directly administer treatments but rather develops and commercializes the technology by licensing it to third-party medical providers (Compl. ¶38).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint references claim charts in an "Exhibit 5," which was not provided. The following analysis is based on the narrative infringement allegations in the complaint.

'490 Patent Infringement Allegations (Prose Summary)

The complaint alleges that Defendant infringes at least Claim 1 of the ’490 Patent by making, using, or selling systems for treating depression (Compl. ¶¶ 39, 52). The alleged infringement is based on disclosures on Defendant's website, which purportedly show the Brain Frequency™ system comprises a magnetic field generator, uses data (analogous to the claimed "particular data value"), and has a processor to control the magnetic field to treat depression, which the patent links to increasing or decreasing blood flow in the brain (Compl. ¶¶ 39, 40).

'057 Patent Infringement Allegations (Prose Summary)

The complaint alleges that Defendant infringes at least Claim 14 of the ’057 Patent by making, using, or selling devices for neuromodulation (Compl. ¶¶ 41, 59). The infringement theory appears to map the accused system's functionality—using a magnetic field generator to treat conditions like anxiety and depression by altering brainwave characteristics—onto the claim's requirement of a device with a magnetic field generator and a controller that moves a Q-factor of an intrinsic frequency (Compl. ¶41). The allegations are based on disclosures from Defendant's website (Compl. ¶42).

Identified Points of Contention

  • Functional Questions: The patents claim specific functional outcomes, such as "increas[ing] or decreas[ing] blood flow" ('490 Patent) or moving a "Q-factor" ('057 and '741 Patents). A central question will be what evidence demonstrates that the accused Brain Frequency™ system, which is described as using "gentle, short, magnetic pulses," actually performs these specific, claimed functions.
  • Scope Questions: For the ’490 Patent, a question may arise as to whether the data used by the accused system constitutes the claimed "particular data value" representative of a "healthy population database." For the ’057 Patent, a question may be whether the accused system's alleged "controller" performs all the steps of moving a "Q-factor," a specific technical metric whose construction will be key.

V. Key Claim Terms for Construction

Term 1 ('490 Patent, Claim 1): "processor configured to control said magnetic field based on said particular data value... to increase or decrease blood flow"

  • Context and Importance: This functional language is central to the claimed invention. The dispute may turn on whether the accused system's general treatment of depression symptoms is sufficient to meet this specific functional requirement of modulating blood flow.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the invention more generally as using magnetic fields to gently "tune" the brain and affect symptoms of depression, which may support a broader reading where any effective depression treatment inherently involves the claimed function (’490 Patent, Abstract).
    • Evidence for a Narrower Interpretation: The detailed description links the therapy directly to physiological changes, stating that "shifting down the intrinsic frequency" can correspond to "increasing blood flow in the cortex" (’490 Patent, col. 18:7-12). This could support a narrower construction requiring proof of this specific mechanism of action.

Term 2 ('057 Patent, Claim 14): "controller subunit that... moves a Q-factor of an intrinsic frequency... toward a pre-selected Q-factor"

  • Context and Importance: The term "Q-factor" is a specific technical metric for the frequency selectivity of an EEG signal. Infringement will depend on whether the accused system's controller is shown to measure and actively "move" this specific metric toward a target value.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The abstract describes the invention as using alternating magnetic fields to "gently 'tunes' the brain and affects mood, focus, and cognition," which might suggest that "mov[ing] a Q-factor" is one way of describing this general tuning process (’057 Patent, Abstract).
    • Evidence for a Narrower Interpretation: The patent explicitly defines "Q-factor" with reference to a figure illustrating peak energy and bandwidth (fo/Δf), indicating it is a precise, calculated value (’057 Patent, col. 15:7-14; Fig. 12). This suggests a narrow construction requiring evidence of a system that calculates and manipulates this specific ratio.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement against all four patents. It asserts Defendant intentionally promotes, aids, and instructs its customers (third-party medical providers) to purchase and use the accused systems in an infringing manner (Compl. ¶¶ 53, 60, 66, 72). The complaint states that direct infringement by these customers is evidenced by statements on the customers' websites (Compl. ¶¶ 54, 61, 67, 73).
  • Willful Infringement: The complaint alleges that Defendant has had actual knowledge of the asserted patents "since at least as early as the receipt of the letter dated May 15, 2023, that accompanied the original Complaint filed in this action" (Compl. ¶47). Based on this allegation of knowledge, the complaint seeks treble damages for willful infringement (Compl. p. 14, ¶4).

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

  • A core issue will be one of evidentiary proof: The complaint bases its infringement allegations on marketing claims from Defendant's website. A key question will be what technical evidence can be presented to demonstrate that the accused "Brain Frequency™ system" actually performs the specific technical functions required by the patent claims, such as modulating cerebral blood flow ('490 Patent) or manipulating a calculated "Q-factor" ('741 Patent).
  • A central dispute will likely involve indirect liability: Given the allegation that Defendant licenses its technology to third-party providers, the case will likely focus on whether Plaintiff can prove acts of direct infringement by those third parties and, critically, whether Defendant's actions in promoting and supporting its system establish the specific intent required to prove inducement of that infringement.
  • The case may also turn on claim construction: The viability of the infringement claims will depend on the scope assigned to functional terms like "control said magnetic field... to increase or decrease blood flow" ('490 Patent) and "moves a Q-factor... toward a pre-selected Q-factor" ('057 Patent). The court's interpretation of these terms will determine the level of technical proof required to show infringement.