DCT
4:24-cv-01702
Avation Medical Inc v. EMKinetics Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Avation Medical, Inc. (Delaware)
- Defendant: EMKinetics, Inc. (Delaware)
- Plaintiff’s Counsel: Calfee, Halter & Griswold LLP; Rutan & Tucker, LLP
- Case Identification: 4:24-cv-01702, N.D. Cal., 03/19/2024
- Venue Allegations: Venue is alleged to be proper as Defendant’s principal place of business is in San Francisco, within the Northern District of California.
- Core Dispute: Plaintiff Avation Medical seeks a declaratory judgment that its Vivally® System for treating overactive bladder does not infringe three patents owned by Defendant EMKinetics related to electrical neuromodulation therapy.
- Technical Context: The technology involves non-invasive neuromodulation, specifically the application of electrical or magnetic stimulation to peripheral nerves like the posterior tibial nerve to treat medical conditions.
- Key Procedural History: The complaint alleges that a justiciable controversy exists based on a series of communications from Defendant, including an October 2023 letter initiating licensing discussions, a December 2023 phone call communicating a belief that a license was required, and a February 2024 "settlement offer." The complaint also notes that on the same day as the settlement offer, Defendant filed a patent infringement lawsuit against a third-party, Cala Health, in the neuromodulation field.
Case Timeline
| Date | Event |
|---|---|
| 2006-10-02 | Earliest Priority Date for ’477, ’742, and ’943 Patents |
| 2015-04-07 | U.S. Patent No. 9,002,477 Issues |
| 2022-01-18 | U.S. Patent No. 11,224,742 Issues |
| 2023-10-23 | Defendant sends letter to Plaintiff to "initiate licensing discussions" |
| 2023-12-19 | Defendant's counsel communicates belief that Plaintiff requires a license |
| 2023-12-19 | U.S. Patent No. 11,844,943 Issues |
| 2024-02-23 | Defendant sends Plaintiff a "settlement offer" |
| 2024-02-23 | Defendant files patent infringement suit against third-party Cala Health |
| 2024-03-19 | Complaint for Declaratory Judgment Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,002,477 - "Methods and Devices for Performing Electrical Stimulation to Treat Various Conditions"
The Invention Explained
- Problem Addressed: The patent's background describes prior art pulsed electromagnetic stimulation devices as often requiring a trained technician for hand-held operation, resulting in inconsistent therapy, and being generally unsuitable for portable or home use (’477 Patent, col. 3:17-24, 4:56-62).
- The Patented Solution: The invention proposes a system for electromagnetic induction therapy that includes an applicator (e.g., a body-worn wrap) with conductive coils, one or more sensors to detect the resulting nerve or muscle stimulation, and a controller. The controller receives feedback from the sensor about the efficacy of the therapy and adjusts the current through the coils to optimize treatment, enabling consistent and repeatable at-home application (’477 Patent, Abstract; col. 6:5-24).
- Technical Importance: The claimed feedback loop between a remote sensor and a controller for adjusting stimulation was aimed at transforming neuromodulation from a clinician-administered procedure to a reliable, automated, at-home therapy.
Key Claims at a Glance
- The complaint identifies Claim 1 as the sole asserted independent claim (Compl. ¶29).
- Essential elements of Claim 1 (a method) include:
- non-invasively positioning a first portion of a patient's body relative to an electrical stimulator such that a posterior tibial nerve is in proximity;
- passing a current through the stimulator to deliver an electrical stimulus to the nerve;
- detecting electrical conduction or a muscular response via at least one sensor positioned along a second portion of the body;
- receiving a signal from the sensor providing feedback about the therapy's efficacy; and
- adjusting the current via a controller based on the feedback.
- The complaint asserts non-infringement of any dependent claims as well (Compl. ¶30).
U.S. Patent No. 11,224,742 - "Methods and Devices for Performing Electrical Stimulation to Treat Various Conditions"
The Invention Explained
- Problem Addressed: Similar to its parent '477 patent, the background of the '742 patent details the limitations of prior art electrical stimulation devices, noting they can be difficult to use, inconsistent in application, and require skilled medical personnel (’742 Patent, col. 3:1-4:67).
- The Patented Solution: The patent describes a method for treating overactive bladder by non-invasively positioning an electrical stimulator so that a branch of the posterior tibial nerve is "directly targeted." The method requires delivering an electrical stimulus such that the nerve branch "directly receives" the stimulation to treat the condition (’742 Patent, col. 46:46-54). This language suggests an emphasis on the precision and directness of the stimulation.
- Technical Importance: The invention purports to improve the efficacy of non-invasive overactive bladder treatment by focusing on the directness of the nerve targeting and stimulus delivery.
Key Claims at a Glance
- The complaint identifies Claim 1 as the sole asserted independent claim (Compl. ¶39).
- Essential elements of Claim 1 (a method) include:
- non-invasively positioning a first body portion relative to a stimulator such that a branch of a posterior tibial nerve is directly targeted;
- passing a current through the stimulator; and
- delivering an electrical stimulus to the nerve branch such that the branch directly receives the stimulation to treat overactive bladder or incontinence.
- The complaint asserts non-infringement of any dependent claims as well (Compl. ¶40).
U.S. Patent No. 11,844,943 - "Methods and Apparatus for Transdermal Stimulation Over the Palmar and Plantar Surfaces"
Technology Synopsis
- The patent addresses the challenge of delivering electrical stimulation through glabrous (non-hairy) skin, such as the sole of the foot, which can be painful (’943 Patent, col. 50:62-51:3). The invention describes methods and apparatus, such as a stimulator positioned within a sock or on a strap, for providing transdermal electrical stimulation over these surfaces to treat conditions like overactive bladder, while remaining safe and tolerable for the patient (’943 Patent, col. 4:26-30).
Asserted Claims
- Independent Claims 1, 14, and 27 (Compl. ¶49).
Accused Features
- The complaint's non-infringement theory focuses on the claim limitation "near an ankle," arguing that the patent's own disclosure characterizes stimulation at the ankle as painful and intolerable, thereby disclaiming effective stimulation at that location (Compl. ¶50).
III. The Accused Instrumentality
Product Identification
- The Avation Vivally® System (Compl. ¶1).
Functionality and Market Context
- The complaint describes the Vivally System as an FDA-cleared, wearable, at-home neuromodulation device for treating urge urinary incontinence and urgency from overactive bladder syndrome (Compl. ¶5). From a technical standpoint, the complaint alleges the system "uses pulse-width modulation to apply stimulation energy, in which the electrical signal supplied via the stimulation electrodes is at a constant current" (Compl. ¶30). It is further alleged to provide "stimulation energy to a site overlying a nerve at the ankle" (Compl. ¶50). The complaint notes that Vivally is the "first and only such device that is cleared by FDA to be marketed in the United States that applies closed-loop, adaptive and non-invasive at-home neuromodulation" for these conditions (Compl. ¶5).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
U.S. Patent No. 9,002,477 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| ...adjusting the current via a controller in communication with the electrical stimulator based on the feedback. | The Vivally system does not adjust the current based on feedback. It applies stimulation energy using pulse-width modulation, where the electrical signal is supplied at a constant current. | ¶30 | col. 6:18-19 |
Identified Points of Contention
- Scope Question: A central issue will be the construction of "adjusting the current." The dispute raises the question of whether this phrase is limited to adjusting the amplitude of the current (amperage), or if it can be read more broadly to include other methods of adjusting the total delivered energy, such as the pulse-width modulation allegedly used by the Vivally system while maintaining a constant current amplitude.
U.S. Patent No. 11,224,742 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| ...non-invasively positioning a first portion of a patient's body relative to an electrical stimulator such that a branch of a posterior tibial nerve within the first portion of the body is directly targeted by the electrical stimulator... | The complaint alleges that the Vivally system does not "directly target" a branch of a posterior tibial nerve as the term is used in the patent. | ¶40 | col. 46:46-51 |
| ...delivering an electrical stimulus from the electrical stimulator to the branch of the posterior tibial nerve such that the branch directly receives the electrical stimulation... | The complaint alleges the Vivally system does not deliver a stimulus such that the branch "directly receives" it as required by the claim. | ¶40 | col. 46:51-54 |
Identified Points of Contention
- Technical Question: The dispute will likely focus on the technical meaning of the adverbs "directly targeted" and "directly receives." The question for the court will be what specific level of precision, focus, or method of energy delivery is required by this language and whether the complaint provides evidence that the Vivally system's operation falls outside that scope.
V. Key Claim Terms for Construction
The Term: "adjusting the current" (from ’477 Patent, Claim 1)
Context and Importance
- This term is the foundation of Avation’s non-infringement argument for the ’477 Patent. Avation contends its system holds the current constant and uses pulse-width modulation, which it argues is distinct from "adjusting the current." The case may turn on whether "current" is construed narrowly as amplitude or broadly as the overall electrical energy delivered.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent's abstract states a controller may be adjustable "to vary a current through a coil to adjust the magnetic field." One might argue that "vary a current" in this context refers to any change that alters the resulting therapeutic field, which could include pulse-width modulation (’477 Patent, Abstract).
- Evidence for a Narrower Interpretation: The plain and ordinary meaning of "current" in electrical engineering refers to amperage. The claim language does not mention adjusting other electrical parameters like pulse width or frequency. The complaint's explicit contrast between "adjusting the current" and using "pulse-width modulation" at a "constant current" suggests this narrow interpretation will be Avation's primary position (Compl. ¶30).
The Term: "directly targeted" (from ’742 Patent, Claim 1)
Context and Importance
- This adverb qualifies the "positioning" step and is a potential scope-limiting term. Avation's non-infringement defense for the ’742 Patent depends on this term requiring a specific action or result that its Vivally system does not perform.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification does not appear to provide an explicit definition for "directly targeted." A party could argue it simply means the stimulator is aimed at the nerve's anatomical location, as opposed to an indirect or systemic application of energy.
- Evidence for a Narrower Interpretation: Practitioners may focus on this term because its inclusion suggests a distinction from prior art that may have targeted the nerve more generally. The specification's frequent discussion of overcoming the limitations of inconsistent, hand-held prior art devices could be used to argue that "directly targeted" implies a repeatable, precise, and focused application of energy that general placement in the vicinity of a nerve would not achieve (’742 Patent, col. 3:1-4:67).
VI. Other Allegations
- Indirect Infringement: The complaint does not contain specific factual allegations regarding indirect infringement but requests a declaratory judgment that Avation has not and is not indirectly infringing any claims of the Challenged Patents (Compl., Prayer for Relief ¶1).
VII. Analyst’s Conclusion: Key Questions for the Case
This declaratory judgment action presents several focused questions of claim construction that will be central to resolving the non-infringement dispute.
- A core issue will be one of definitional scope: can the term "adjusting the current," as used in the ’477 Patent, be construed to encompass the practice of pulse-width modulation while maintaining a constant current amplitude, or is its meaning restricted to the adjustment of amplitude alone?
- A second key question will be one of qualifying scope: what technical standard is imposed by the terms "directly targeted" and "directly receives" in the ’742 Patent? The resolution will depend on whether this language requires a specific degree of focus and energy delivery that distinguishes it from a more general application of stimulation in the anatomical vicinity of the nerve.
- A third issue will be one of claim construction via specification disclaimer: does the ’943 Patent's characterization of stimulation "near the medial malleolus [i.e., ankle]" as "painful and intolerable" operate to limit the scope of the claimed phrase "near an ankle," potentially excluding systems that provide effective, non-painful stimulation at that same location?