EMKinetics Inc v. Avation Medical Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: EMKinetics, Inc. (Delaware)
  • Defendant: Avation Medical, Inc. (Delaware)
  • Plaintiff’s Counsel: Standley Law Group LLP; The Law Offices of David A. Gerasimow, P.C.
• Case Identification: 2:25-cv-00207, S.D. Ohio, 03/04/2025
• Venue Allegations: Plaintiff alleges venue is proper in the Southern District of Ohio because Defendant's principal place of business is located in the district, where it maintains a regular and established place of business.
• Core Dispute: Plaintiff alleges that Defendant’s Vivally® neuromodulation system infringes a patent related to methods for transdermal electrical stimulation to treat overactive bladder and incontinence.
• Technical Context: The technology involves non-invasive neuromodulation, a field focused on treating medical conditions by applying electrical or magnetic energy to targeted nerves, offering an alternative to pharmaceutical or surgical interventions.
• Key Procedural History: The patent-in-suit claims priority back to a provisional application filed in 2006. The complaint alleges that the Defendant has been aware of the patent since its issuance.

Case Timeline

Date	Event
2006-10-02	Earliest Priority Date for U.S. Patent 12,226,632
2025-02-18	U.S. Patent 12,226,632 Issues
2025-03-04	Complaint Filed

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

U.S. Patent No. 12,226,632 - "Methods and Apparatus for Transdermal Stimulation over the Palmar and Plantar Surfaces"

The Invention Explained

• Problem Addressed: The patent addresses the limitations of existing treatments for overactive bladder (OAB) and urinary incontinence (UI), such as the side effects of pharmacological therapies and the high cost and invasive nature of surgical options like sacral nerve stimulation (SNS) (’632 Patent, col. 2:46-64).
• The Patented Solution: The invention provides methods and systems for non-invasive electrical stimulation of nerves, such as the tibial nerve, to treat conditions like OAB (’632 Patent, col. 2:33-40). A key aspect is a closed-loop feedback system where a sensor detects electrical conduction in the target nerve, and a controller adjusts the stimulation based on this feedback to ensure proper and effective therapy (’632 Patent, col. 4:1-14). The patent describes, for example, a wrap-around device for the ankle that targets the tibial nerve (’632 Patent, Fig. 1).
• Technical Importance: This technology presents a non-invasive method for neuromodulation that could improve patient compliance and accessibility compared to prior art needle-based or permanently implanted systems (’632 Patent, col. 3:7-19).

Key Claims at a Glance

• The complaint asserts independent claim 25 (’632 Patent, col. 72:25-50).
• The essential elements of independent claim 25 are:
  • A method of treating overactive bladder or incontinence comprising:
  • Non-invasively positioning an electrical stimulator near a subject's ankle to target the tibial nerve;
  • Passing a current through the electrical stimulator;
  • Delivering an electrical stimulus to the tibial nerve to treat the condition;
  • Detecting for electrical conduction in the tibial nerve using a sensor and controller, specifically by detecting a lack of presence of the electrical conduction at a distant body part as an indicator of proper electrode placement; and
  • Adjusting the electrical stimulus via the controller in response to the detected electrical conduction.
• The complaint alleges infringement of "one or more claims of the ‘632 Patent... including without limitation Claim 25," which may suggest an intent to reserve the right to assert other claims (Compl. ¶20).

III. The Accused Instrumentality

Product Identification

• The accused product is the Avation Vivally® neuromodulation system, which includes the "Vivally Wrap" ankle brace, the "CliQ" controller, and the "MyVivally Mobile App" (Compl. ¶10-11).

Functionality and Market Context

• The Vivally system is described as a "wearable therapeutic" for treating overactive bladder symptoms using "physiologic closed-loop controlled transcutaneous tibial nerve stimulation (PCLC-TTNS)" (Compl. ¶13). The system uses an electrical stimulator within an ankle brace to non-invasively target the tibial nerve (Compl. ¶12-13). A marketing image from the complaint displays the three primary components of the accused system: the Vivally Wrap, the CliQ controller, and the Vivally App (Compl. p. 3). The system allegedly utilizes "continuous EMG [electromyogram] sensing" via a sensor and a "proprietary algorithm" which "not only confirms successful nerve stimulation but also individualizes therapy by continuously adjusting the stimulatory output" (Compl. ¶15-16).

IV. Analysis of Infringement Allegations

U.S. Patent No. 12,226,632 Infringement Allegations

Claim Element (from Independent Claim 25)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
non-invasively positioning a first portion of a subject’s body near an ankle relative to an electrical stimulator such that a tibial nerve within the first portion of the body is directly targeted...	The Vivally system includes a non-invasive ankle brace ("Vivally Wrap") containing an electrical stimulator that is positioned near the user's ankle.	¶13	col. 10:28-34
passing a current through the electrical stimulator;	The system's "CliQ" controller and electrical stimulator function by passing a current to generate the therapeutic stimulus.	¶11-12	col. 69:26-28
delivering an electrical stimulus from the electrical stimulator to the tibial nerve such that the tibial nerve directly receives the electrical stimulation to treat overactive bladder or incontinence;	The ankle brace with its stimulator is alleged to directly target the tibial nerve and deliver electrical stimulation to treat overactive bladder or incontinence.	¶12	col. 69:29-31
detecting for an electrical conduction in the tibial nerve via a sensor in communication with a controller by detecting for a lack of presence of the electrical conduction... as an indicator of proper electrode placement...	The system is alleged to detect electrical conduction in the tibial nerve using a sensor and controller, interpreting a lack of presence of conduction at a distant body part as an indicator that the electrode is properly placed. The system is marketed as using "continuous EMG sensing."	¶14, ¶15	col. 69:32-46
adjusting the electrical stimulus via the controller in response to the electrical conduction detected in the tibial nerve.	The system is alleged to adjust the electrical stimulus via its controller in response to the detected nerve conduction, and is marketed as "continuously adjusting the stimulatory output."	¶16	col. 69:47-51

• Identified Points of Contention:
  • Scope Questions: The complaint alleges the accused system meets the claim limitation of "detecting for a lack of presence of the electrical conduction... as an indicator of proper electrode placement" (Compl. ¶14). However, the supporting evidence cited in the complaint describes the accused system as using EMG sensing to "confirm successful nerve stimulation" (Compl. ¶16). This raises the question of whether a system that confirms a positive signal (the presence of stimulation) literally infringes a claim that requires detecting a negative signal (the lack of presence). The defense may argue a mismatch between the claim's specific negative limitation and the accused product's positive-confirmation functionality.
  • Technical Questions: Claim 25 requires detecting conduction "at a second portion of the subject’s body distant from the first portion." The complaint does not specify the location of the sensor relative to the stimulator in the Vivally system. The resolution of this issue will depend on evidence establishing the physical configuration of the accused device and whether the sensor location qualifies as "distant" under the proper construction of that term.

V. Key Claim Terms for Construction

• The Term: "detecting for a lack of presence of the electrical conduction... as an indicator of proper electrode placement"
• Context and Importance: This limitation is central to the infringement analysis. The case may turn on whether the accused product's method of using EMG sensing to "confirm successful nerve stimulation" can be interpreted as "detecting for a lack of presence" of conduction to indicate proper placement. Practitioners may focus on this term because it appears to be a negative limitation, which can be difficult to prove is met by a system that affirms a positive condition.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A plaintiff may argue that, from a functional perspective, a system that searches for a correct signal is inherently detecting the "lack of presence" of that correct signal until it is found. The specification's general statements about using sensors to provide feedback and "report lack of stimulation of the bodily tissues" in case of malfunction could be used to argue for a broader functional meaning beyond the literal words (’632 Patent, col. 10:59-65).
  • Evidence for a Narrower Interpretation: A defendant may argue that the plain language requires a specific method: monitoring for a negative event (an absence of a signal) to determine placement. The patent repeatedly uses this "lack of presence" language for various scenarios (migration, malfunction, placement), suggesting it is a deliberately chosen and specific technical approach, not a general description of any feedback mechanism (’632 Patent, col. 69:32-46, col. 71:17-24, col. 72:38-46).

VI. Other Allegations

• Indirect Infringement: The complaint alleges Avation induces infringement by providing users with instructions, marketing materials, and a smartphone app that allegedly encourage and facilitate use of the Vivally system in a manner that performs the patented method (Compl. ¶17). It also alleges contributory infringement, stating the Vivally system is a material part of the invention, is not a staple article of commerce, and is especially made for an infringing use (Compl. ¶19).
• Willful Infringement: The complaint asserts that Avation has been aware of the '632 Patent "since at least date of its issuance" and has acted with "deliberate and intentional infringement or, alternatively, through its willfully blind disregard" of Plaintiff's patent rights (Compl. ¶18, ¶23).

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

• A core issue will be one of claim construction: Can the negative limitation "detecting for a lack of presence of the electrical conduction... as an indicator of proper electrode placement" be construed to read on the accused product's alleged function of using EMG sensing to confirm the presence of successful nerve stimulation?
• A second central question will be one of evidentiary proof: What evidence will be presented to establish that the accused Vivally system's sensor operates at a location "distant from the first portion" of the body where stimulation is applied, as required by the claim?
• Finally, a key factual dispute for damages will concern knowledge and intent: When did Avation first become aware of the '632 Patent, and what actions, if any, did it take in response? The answer will be critical to the determination of willfulness and any potential for enhanced damages.