DCT
1:24-cv-00250
EMKinetics Inc v. Cala Health Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: EMKinetics, Inc. (Delaware)
- Defendant: Cala Health, Inc. (Delaware)
- Plaintiff’s Counsel: Farnan LLP
- Case Identification: 1:24-cv-00250, D. Del., 02/23/2024
- Venue Allegations: Venue is asserted in the District of Delaware on the basis that Defendant Cala Health is a Delaware corporation and therefore resides in the district.
- Core Dispute: Plaintiff alleges that Defendant’s wearable tremor-relief devices infringe two patents related to methods and apparatuses for transdermal electrical stimulation.
- Technical Context: The technology involves non-invasive, wearable neuromodulation devices that use electrical pulses and sensor feedback to treat medical conditions like essential tremor.
- Key Procedural History: The complaint alleges that the parties engaged in "licensing discussions" that commenced in 2020, which may be relevant to the allegations of pre-suit knowledge and willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2006-10-02 | ’669 and ’300 Patents Earliest Priority Date |
| 2020-01-01 | Approximate commencement of licensing discussions |
| 2020-09-29 | U.S. Patent No. 10,786,669 Issued |
| 2021-10-04 | Cala Trio device described in 510(k) Summary |
| 2022-07-22 | Cala kIQ device described in 510(k) Summary |
| 2023-04-18 | U.S. Patent No. 11,628,300 Issued |
| 2024-02-23 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,786,669 - "Method and Apparatus for Transdermal Stimulation Over the Palmar and Plantar Surfaces"
- Patent Identification: U.S. Patent No. 10,786,669, "Method and Apparatus for Transdermal Stimulation Over the Palmar and Plantar Surfaces," issued September 29, 2020. (Compl. ¶7).
The Invention Explained
- Problem Addressed: The patent describes existing treatments for conditions like overactive bladder and urinary incontinence, such as pharmacological therapies and surgical nerve stimulation, as having significant drawbacks, including side effects, high costs, and invasiveness. (’669 Patent, col. 2:13-64).
- The Patented Solution: The invention provides a non-invasive method for treating conditions like tremors by positioning an electrode on the skin (e.g., over the hand) to deliver electrical stimulation to a target nerve. (’669 Patent, Abstract). A key aspect is the use of at least one sensor to detect motion from the subject, creating a system that can monitor the condition being treated. (’669 Patent, col. 69:58-70:12).
- Technical Importance: This approach provided a method for non-invasive neuromodulation that incorporated patient monitoring, suggesting a path away from more burdensome surgical implants or systemic drugs. (cf. ’669 Patent, col. 3:1-14).
Key Claims at a Glance
- The complaint asserts independent Claim 1. (Compl. ¶13).
- The essential elements of Claim 1 are:
- A method for providing transdermal electrical stimulation therapy to a subject for treating tremors, comprising:
- positioning a stimulator electrode over a skin surface overlying a target nerve or tissue which extends through a hand of the subject;
- delivering electrical stimulation via a pulse generator transdermally through the skin surface and to the target nerve or tissue to stimulate the target nerve or tissue so that tremors experienced by the subject are mitigated; and
- detecting a motion from the subject via at least one sensor positioned on the subject.
U.S. Patent No. 11,628,300 - "Method and Apparatus for Transdermal Stimulation Over the Palmar and Plantar Surfaces"
- Patent Identification: U.S. Patent No. 11,628,300, "Method and Apparatus for Transdermal Stimulation Over the Palmar and Plantar Surfaces," issued April 18, 2023. (Compl. ¶8).
The Invention Explained
- Problem Addressed: Like its related predecessor, the ’300 Patent addresses the limitations of conventional therapies for neurological conditions, which can be invasive, have side effects, or require surgical procedures. (’300 Patent, col. 2:13-64).
- The Patented Solution: The patent claims an apparatus that embodies a closed-loop feedback system for tremor treatment. The apparatus includes an applicator (e.g., a wrist-worn band), an electrode, a controller, and a sensor. (’300 Patent, Abstract). The sensor detects the patient's motion (tremor) and sends a "feedback signal" to the controller, which in turn "adjusting or optimizing the electrical stimulation" to mitigate the tremor. (’300 Patent, col. 70:17-21).
- Technical Importance: This claimed apparatus represents a concrete implementation of adaptive neuromodulation, where the therapy can be tailored to a patient's specific symptoms as measured by a sensor. (cf. ’300 Patent, col. 4:24-28).
Key Claims at a Glance
- The complaint asserts independent Claim 7. (Compl. ¶35).
- The essential elements of Claim 7 are:
- An apparatus for treating tremor in a subject, comprising: an applicator, an electrode, a controller, and a sensor.
- The controller transmits an electrical stimulation with an adjustable frequency.
- The sensor detects a motion of the subject and provides a feedback signal to the controller.
- This feedback signal is used to mitigate the tremor by adjusting or optimizing the electrical stimulation.
III. The Accused Instrumentality
Product Identification
The Cala Trio and Cala kIQ systems. (Compl. ¶14).
Functionality and Market Context
The accused products are described as "small, lightweight, wrist-worn stimulator device[s]" intended to provide relief from essential tremor. (Compl. ¶¶ 16, 17). They function by applying what Defendant calls "Transcutaneous Afferent Patterned Stimulation (TAPS)" to the median and radial nerves at the patient's wrist via electrodes in a wrist-worn band. (Compl. ¶¶ 16, 19, 22). The devices incorporate sensors, such as a "triaxial accelerometer," to "measure tremor motion" or "tremor frequency." (Compl. ¶¶ 25, 26). The complaint alleges this sensor data is then used to "customize the TAPS output pattern" to deliver "patient-specific, optimal stimulation." (Compl. ¶¶ 26, 54). The complaint includes a diagram from Defendant's materials, "Figure 1 Wrist-worn TAPS device," which identifies the "stimulator" and "electrode (median nerve)" components. (Compl. p. 5).
IV. Analysis of Infringement Allegations
'669 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| positioning a stimulator electrode over a skin surface overlying a target nerve or tissue which extends through a hand of the subject | The accused products include a wrist-worn band with embedded electrodes that is positioned on the inner wrist to target the median and radial nerves. | ¶¶18-19 | col. 4:50-54 |
| delivering electrical stimulation via a pulse generator transdermally through the skin surface and to the target nerve or tissue to stimulate the target nerve or tissue so that tremors experienced by the subject are mitigated | The products' stimulator allegedly delivers "Transcutaneous Afferent Patterned Stimulation (TAPS)" to the targeted nerves for "essential tremor symptom relief." | ¶¶16, 21-22 | col. 4:54-58 |
| detecting a motion from the subject via at least one sensor positioned on the subject | The accused products are alleged to contain "device sensors (triaxial accelerometer)" or "onboard sensors" that "measure tremor motion" or "tremor frequency." | ¶¶25-26 | col. 4:58-60 |
'300 Patent Infringement Allegations
| Claim Element (from Independent Claim 7) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an applicator configured for application to a region of the subject | The accused products include a "wrist-worn electrode band" that acts as the applicator. | ¶¶41-42 | col. 70:8-9 |
| an electrode located along the applicator so as to contact a skin surface of the subject when the applicator is worn by the subject | The wrist-worn band contains "multi-use, conductive electrodes" or "embedded electrodes" that contact the wrist. A photo shows the "cala kIQ" product, a wrist-worn device. | ¶¶42, 44, p. 12 | col. 70:10-12 |
| a controller in communication with the electrode; and a sensor positionable on the subject and in communication with the controller | The products include a "stimulator" containing "electronics" (the controller) and "on-board motion sensors" (the sensor). | ¶¶47-48, 50-51 | col. 70:13-16 |
| wherein the controller transmits via the electrode an electrical stimulation having an adjustable frequency... | The stimulation is allegedly "tremor-customized" and delivered at a "patient-specific, optimal stimulation frequency" based on sensor measurements. | ¶¶50-51, 54 | col. 70:17-19 |
| wherein the sensor detects a motion of the subject and provides a feedback signal to the controller so as to mitigate the tremor by adjusting or optimizing the electrical stimulation | The complaint alleges the devices "learn about your tremor and personalizes therapy" and that the "TAPS output pattern is calibrated to the individual patient's tremor frequency" based on what the onboard sensors measure. | ¶¶53-54 | col. 70:17-21 |
Identified Points of Contention:
- Scope Questions: For both patents, the claims require stimulation of a nerve that "extends through a hand." The complaint alleges stimulation of the median and radial nerves at the wrist. While these nerves do extend through the hand, a question for the court may be whether stimulation confined to the wrist area meets this limitation as construed in light of the patent's specification.
- Technical Questions: A primary technical question for the '300 Patent revolves around the "feedback signal" that "adjusting or optimizing" the stimulation. The complaint alleges the accused products perform this function during a "device setup" phase where a "postural hold" is used to "customize" or "calibrate" the therapy. (Compl. ¶¶ 51, 54). This raises the question of whether a one-time calibration at setup satisfies the claim limitation, or if the patent requires a more dynamic, iterative adjustment during the course of the therapy session itself.
V. Key Claim Terms for Construction
Term 1: "feedback signal ... so as to mitigate the tremor by adjusting or optimizing the electrical stimulation" (’300 Patent, Claim 7)
- Context and Importance: This phrase defines the closed-loop functionality that is central to the '300 Patent's apparatus claim. The definition of this process—specifically, what constitutes "adjusting or optimizing"—will be critical. Practitioners may focus on this term because the defendant's alleged activity (a one-time calibration) may not align with a potentially narrower construction requiring dynamic, ongoing adjustment during therapy.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of the claim does not specify the timing, frequency, or duration of the adjustment. An initial "optimization" based on a "feedback signal" from a sensor during setup could arguably fall within this language. The specification describes a healthcare provider fine-tuning the device during an "initial therapy session." (’300 Patent, col. 11:35-41).
- Evidence for a Narrower Interpretation: The specification also describes a system where "the level of stimulation is fine-tuned" during "successive therapy sessions" and where feedback is used to "automatically adjust the stimulation level." (’300 Patent, col. 11:32-38, col. 43:35-39). This language may support an interpretation that the "adjusting or optimizing" is an ongoing or iterative process, not a single pre-therapy calibration event.
Term 2: "detecting a motion from the subject" (’669 Patent, Claim 1)
- Context and Importance: This element introduces the sensor component into the claimed method. Its interpretation is important because while the '669 Patent's independent claim does not require using the detected motion for feedback, its presence is a required step of the method.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language is facially broad and does not qualify the type of "motion" to be detected. Any detection of patient movement, including the general tremor itself as allegedly performed by the accused products' accelerometers, would meet this plain reading. (Compl. ¶25).
- Evidence for a Narrower Interpretation: The summary of the invention in the specification describes this step more specifically as "detecting a muscular response caused by an electrical conduction in the target nerve or muscle." (’669 Patent, col. 4:58-60). A defendant could argue this context narrows the claim term to require detection of a response to the stimulation, rather than simply detecting the underlying tremor motion that the therapy is intended to treat.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for both patents. Inducement is based on allegations that Cala Health provides users with detailed instructions and online help-center articles that encourage use of the Accused Products in an infringing manner. (Compl. ¶¶ 27, 55). Contributory infringement is based on allegations that the products are especially made for this use and are not staple articles of commerce with substantial non-infringing uses. (Compl. ¶¶ 28, 56).
- Willful Infringement: Willfulness is alleged for both patents. The allegations are predicated on pre-suit knowledge stemming from "licensing discussions among the parties that commenced in 2020." (Compl. ¶¶ 32, 60). The complaint alleges Cala Health knew of the '669 Patent no later than its issue date (September 29, 2020) and of the '300 Patent no later than its issue date (April 18, 2023). (Compl. ¶¶ 27, 55).
VII. Analyst’s Conclusion: Key Questions for the Case
- A key functional question will be one of temporal scope: does the accused products' alleged one-time calibration of therapy during a setup phase constitute the "adjusting or optimizing" of stimulation via a "feedback signal" as required by Claim 7 of the '300 patent, or does the claim, in light of the specification, require a more dynamic, iterative adjustment during the therapy itself?
- A central evidentiary issue will concern pre-suit knowledge: the complaint's allegation of "licensing discussions" beginning in 2020 puts Defendant’s state of mind at the forefront. The discovery process will likely focus on the substance of these communications to determine whether Defendant’s actions following these discussions give rise to liability for willful and indirect infringement.