Invalidity dossier

US 11844943

Method and apparatus for transdermal stimulation over the palmar and plantar surfaces

Current assignee: EMKinetics Inc

Added 6/15/2026, 12:01:45 AM

IndustryMedical (M)
At a glanceNo PTAB challengesNo litigation on fileMedical (M)

Active provider: Google · gemini-2.5-flash

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Patent summary

Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.

✓ Generated

US Patent 11844943, titled "Method and apparatus for transdermal stimulation over the palmar and plantar surfaces," was issued to EMKinetics Inc. on December 19, 2023, following a filing date of January 4, 2022. The inventors are Amit Rajguru, Daniel R. BURNETT, Alexander Vergara, and Michael HEMATI.

Abstract:
The patent describes methods and apparatus for providing transdermal electrical stimulation therapy to a patient, particularly over glabrous (hairless) skin surfaces like the palms and soles, which overlie target nerves. The methods involve positioning a stimulator electrode over such a surface and delivering electrical stimulation through it to stimulate the target nerve, aiming to be safe and tolerable even at frequencies that might be painful on non-glabrous skin. The therapy is applicable for various conditions, including urinary incontinence and overactive bladder. The apparatus can be an ergonomic applicator, such as a glove or brace, designed to precisely position the electrode.

Independent Claims Overview:

  • Independent Claim 1: This claim describes a method for providing transdermal electrical stimulation. It involves placing a stimulator electrode on a glabrous skin surface (like the palm of a hand) that covers a target nerve or tissue. Electrical stimulation is then delivered through this skin surface via a pulse generator to the target nerve/tissue, aiming to reduce the subject's pain while being safe and tolerable. The electrical pulses can have one or more magnitudes and are delivered at a frequency between about 5 Hz and 60 Hz. The method also includes sensing nerve stimulation, providing feedback for therapy adjustment, and positioning a return electrode to aid current penetration. The stimulator electrode can be attached with an adhesive or positioned with an ergonomic applicator like a glove or brace.

  • Independent Claim 13: This claim outlines a method for delivering energy-based stimulation therapy. It involves positioning an energy-emitting device near a glabrous skin surface that overlies a target tissue. Energy is then delivered through this glabrous surface to stimulate the target tissue. The energy is delivered at a frequency of about 1 Hz to 30 Hz to generate motor and/or sensory nerve conduction, ensuring it remains safe and tolerable.

  • Independent Claim 22: This claim describes an apparatus for providing transdermal electrical stimulation therapy. The apparatus includes a stimulator electrode designed to be placed over a glabrous skin surface, such as the palm of a hand, that overlies a target nerve or tissue. A pulse generator is connected to the electrode to deliver electrical stimulation through the glabrous skin to the target nerve/tissue, which then mitigates pain in the subject. The stimulation pulses can have one or more magnitudes and are delivered at a frequency of about 5 Hz to 60 Hz, while remaining safe and tolerable. The apparatus also features a sensor (which can be a surface electrode) for detecting nerve stimulation and providing feedback for adjusting the therapy. A return electrode is also included. The stimulator electrode can be affixed with an adhesive or positioned using an ergonomic applicator like a glove or brace.

  • Independent Claim 30: This claim describes an apparatus for delivering energy-based stimulation therapy. It consists of an energy-emitting device configured to be placed near a glabrous skin surface overlying a target tissue. The device delivers energy through the glabrous skin surface to stimulate the target tissue. The energy is delivered at a frequency of about 1 Hz to 30 Hz to generate motor and/or sensory nerve conduction, while remaining safe and tolerable for the subject.

Litigation:
The patent family is currently involved in litigation. A PTAB case, PGR2024-00043, has been filed (Final Written Decision). Additionally, a US case related to this patent has been filed in the California Northern District Court (case number 3:24-cv-01702). The legal status is noted as "Active," with an estimated expiration date of April 10, 2028. The patent was granted on December 19, 2023.

I could not find specific dockets for US patent 11844943 in the CAFC 2026 dockets via the search query. The provided patent information does, however, include details of ongoing litigation at the PTAB and a District Court in California, which are relevant to the patent's legal status.## US Patent 11844943: Transdermal Stimulation Over Palmar and Plantar Surfaces

Title: Method and apparatus for transdermal stimulation over the palmar and plantar surfaces
Assignee: EMKinetics Inc
Inventors: Amit Rajguru, Daniel R. BURNETT, Alexander Vergara, Michael HEMATI
Filing Date: 2022-01-04
Issue Date: 2023-12-19

Abstract:
The patent discloses methods and apparatus for providing transdermal electrical stimulation therapy, particularly by positioning a stimulator electrode over glabrous (hairless) skin surfaces, such as the palms of the hands or soles of the feet, which overlie a target nerve. This approach aims to deliver electrical stimulation safely and tolerably to the target nerve, even at frequencies that might be uncomfortable on other skin areas. The technology is presented as a treatment for various conditions, including urinary incontinence and overactive bladder, and can utilize ergonomic applicators like gloves or braces to accurately position the electrodes.

Plain-Language Overview of Independent Claims:

  • Independent Claim 1: This claim describes a method for providing transdermal electrical stimulation therapy by placing a stimulator electrode on a glabrous skin surface (e.g., the palm of a hand) that is located over a target nerve or tissue. Electrical pulses are then delivered through this skin surface to stimulate the underlying nerve or tissue, with the goal of reducing pain in the subject. The pulses can vary in magnitude and are delivered at a frequency between approximately 5 Hz and 60 Hz, ensuring the therapy remains safe and tolerable. The method further involves using a sensor to detect nerve stimulation, which provides feedback to adjust the therapy. A return electrode is also positioned on the subject to facilitate the electrical current's penetration. The stimulator electrode can be attached using an adhesive or held in place by an ergonomic device like a glove or brace.

  • Independent Claim 13: This claim outlines a method for delivering energy-based stimulation therapy. It involves positioning an energy-emitting device close to a glabrous skin surface that covers a target tissue. The device then delivers energy through this skin surface to stimulate the target tissue. The energy is specifically delivered at a frequency ranging from about 1 Hz to 30 Hz, designed to generate motor and/or sensory nerve conduction while ensuring the process is safe and tolerable for the subject.

  • Independent Claim 22: This claim pertains to an apparatus designed for transdermal electrical stimulation therapy. The apparatus comprises a stimulator electrode intended for placement on a glabrous skin surface (such as the palm of a hand) overlying a target nerve or tissue. It also includes a pulse generator connected to this electrode, which delivers electrical stimulation through the glabrous skin to the target nerve or tissue to alleviate pain in the subject. The stimulation consists of pulses, which may have one or more different magnitudes, delivered at a frequency of about 5 Hz to 60 Hz, all while maintaining safety and tolerability. The apparatus further incorporates a sensor (potentially a surface electrode) to detect nerve stimulation, providing feedback for therapy adjustments, and includes a return electrode. The stimulator electrode can be secured with an adhesive or an ergonomic applicator like a glove or brace.

  • Independent Claim 30: This claim describes an apparatus for delivering energy-based stimulation therapy. It features an energy-emitting device configured to be positioned near a glabrous skin surface that covers a target tissue. The apparatus is designed to deliver energy through this glabrous skin surface to stimulate the target tissue. The energy delivery occurs at a frequency of about 1 Hz to 30 Hz, generating motor and/or sensory nerve conduction in a manner that is safe and tolerable for the subject.

Legal Status and Litigation:
US Patent 11844943 is currently active and is estimated to expire on April 10, 2028. The patent family is subject to litigation, including a PTAB case identified as PGR2024-00043, which has had a Final Written Decision. Additionally, a related US district court case (3:24-cv-01702) has been filed in the California Northern District Court. While specific 2026 dockets for this patent number were not found directly in the CAFC database via search, the existing litigation at the PTAB and District Court indicates ongoing legal challenges to the patent.

Generated 6/16/2026, 12:46:32 PM

Cases on file (0)

Specific litigation cases in our database that name US patent 11844943. The free-form analysis below may also discuss cases beyond this list.

No cases on file mention this patent. Upload a CSV or add a case manually in Admin → Manage litigation cases.

Litigation summary

Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.

✓ Generated

As of April 26, 2026, the following litigation is known involving US patent 11844943:

1. Post-Grant Review (PGR) at the USPTO

  • Case Number: PGR2024-00043
  • Plaintiff(s): AVATION MEDICAL, INC. (Petitioner)
  • Defendant(s): EMKinetics Inc (Patent Owner)
  • Jurisdiction: United States Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB)
  • Filing Date: July 1, 2024
  • Current Status: Active. The Patent Owner may file a preliminary response to the petition no later than three months from the filing date of July 1, 2024. This response should outline why the requested review should not be instituted. The Patent Owner also has the option to waive the preliminary response to expedite the proceeding.

2. District Court Litigation

  • Jurisdiction: California Northern District Court
  • Case Number: 3:24-cv-01702
  • Current Status: Litigation filed.
  • Plaintiff(s): Not specified in the provided information.
  • Defendant(s): Not specified in the provided information.
  • Filing Date: Not specified in the provided information.

3. First Worldwide Family Litigation

  • Current Status: Litigation filed.
  • Jurisdiction: Not specified, but noted as "First worldwide family litigation."
  • Case Number: Not specified in the provided information.
  • Plaintiff(s): Not specified in the provided information.
  • Defendant(s): Not specified in the provided information.
  • Filing Date: Not specified in the provided information.

Generated 6/16/2026, 12:46:27 PM

Proceedings on file (0)

All PTAB activity →

AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.

No PTAB proceedings on file. This patent has not been challenged via IPR, PGR, or CBM. The absence is itself a signal — well-asserted patents eventually attract IPRs. The LLM analysis below may surface filings the ODP feed hasn’t indexed yet.

PTAB challenges

AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.

✓ Generated

The search results provide some information about PGR2024-00043.
Specifically:

  • Filing Date: July 1, 2024 (from the "PTAB proceedings on file" and search result).
  • Petitioner: Avation Medical, Inc. (from "PTAB proceedings on file" and search result).
  • Patent Owner: EMKinetics, Inc. (from "PTAB proceedings on file").
  • Status: Final Written Decision (from "PTAB proceedings on file"), last modified 2026-04-02.
  • Patent Number: US11844943B2 (from search result).

However, the search results do not provide the following crucial details for PGR2024-00043:

  • Judge panel: Not found in the snippets.
  • Petition grounds: Which claims, what art, what statutory basis (§ 102 / § 103 / § 112). The snippets only mention general aspects of PGRs.
  • Institution decision: Instituted/denied/partially instituted, date, and reasoning. The snippets from only mention the petition was "accorded the filing date" and discusses the preliminary response, not the institution decision itself.
  • Final Written Decision (FWD) verdict at claim-level granularity: Which independent/dependent claims were canceled/patentable, and the panel's reasoning. The snippets indicate a FWD was issued, but no details about the outcome of the claims are provided.
  • Settlement/termination: No specific information about settlement for this particular PGR, although general information about PTAB settlements is mentioned in.
  • Appeal: No information about an appeal to the Federal Circuit for PGR2024-00043.

Given the status "Final Written Decision" and last modified date of 2026-04-02, the decision should be public. I need to find the actual FWD document. The USPTO PTAB Decisions portal or P-TACTS would be the best source.

I will try to directly search for the Final Written Decision document for PGR2024-00043.## Proceedings overview
There is one AIA trial proceeding on file for US patent 11844943. This proceeding, PGR2024-00043, has reached a Final Written Decision, but the specific claim-level outcomes are not publicly detailed in the provided search results. Therefore, the defensive posture for a defendant is currently unclear regarding which claims, if any, have been canceled or sustained.

PGR2024-00043 — Avation Medical, Inc. v. EMKinetics, Inc.

  • Type: Post-Grant Review
  • Filed: 2024-07-01
  • Status: Final Written Decision, last modified 2026-04-02. This means the PTAB has issued its final determination on the patentability of the challenged claims.
  • Judge panel: Information regarding the specific judge panel is not available in the provided search results.
  • Petition grounds: The specific claims challenged, prior art asserted, and statutory bases (§ 102 / § 103 / § 112) are not detailed in the provided search results. The petition for post-grant review was filed in the proceeding.
  • Institution decision: The outcome and date of the institution decision are not available in the provided search results. The petition was accorded a filing date of July 1, 2024, and the patent owner was given three months to file a preliminary response.
  • Final Written Decision (if issued): A Final Written Decision was issued, with the last modification on 2026-04-02. However, the specific verdict at a claim-level granularity (i.e., which claims were canceled or held patentable, and the reasoning) is not available in the provided search results.
  • Settlement / termination: There is no specific information in the provided search results indicating a settlement for this particular proceeding.
  • Appeal: There is no information in the provided search results indicating that the Final Written Decision for PGR2024-00043 has been appealed to the Federal Circuit.
  • Defensive value: Without the specific claim-level outcomes of the Final Written Decision, the immediate defensive value of this proceeding is uncertain. To understand its impact, the full text of the Final Written Decision would need to be reviewed to determine which claims, if any, were invalidated.

Strategic summary

Only one PTAB proceeding, PGR2024-00043, has been identified for US patent 11844943. While this proceeding has reached a "Final Written Decision," the precise outcome regarding the patentability of individual claims (i.e., which claims were canceled, sustained, or left untested) is not available from the provided data. Therefore, it is impossible to currently state which claims of 11844943 are now CANCELED versus SUSTAINED versus UNTESTED. The patent owner, EMKinetics, Inc., prevailed to the extent that a final decision was reached, but the details of that decision are crucial to understand the patent's current scope and strength.

Regarding the estoppel landscape, if any claims were found unpatentable in the Final Written Decision, Avation Medical, Inc. (the petitioner) and its privies would be estopped under 35 U.S.C. § 325(e)(2) from asserting in future civil actions or other USPTO proceedings any ground of unpatentability that they raised or reasonably could have raised during this PGR. However, without knowing the specific grounds asserted and the claims addressed, the exact scope of estoppel remains unclear for other potential defendants. There are no pattern signals indicating multiple proceedings by the same petitioner or aggressive PTAB appeal strategies by the patent owner based on the single identified proceeding.

Recommended next steps

As a defendant facing assertion of US patent 11844943, the critical next step is to obtain and thoroughly review the Final Written Decision for PGR2024-00043. This document will explicitly state which claims, if any, were found unpatentable. The USPTO PTAB Decisions portal is the authoritative source for these documents. A direct link to the decision for PGR2024-00043 should be sought on the USPTO website (e.g., https://www.uspto.gov/patents/ptab/decisions). Once the FWD is obtained, the disposition regarding each challenged claim should be analyzed immediately. If claims central to an infringement theory have been canceled, this significantly weakens any assertion based on those claims.

Generated 6/16/2026, 12:46:30 PM

Assignment history

Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.

✓ Generated

Inventors

  • Amit Rajguru (EMKinetics Inc.)
  • Daniel R. BURNETT (EMKinetics Inc.)
  • Alexander Vergara (EMKinetics Inc.)
  • Michael HEMATI (EMKinetics Inc.)

It is determinable that the inventors were associated with EMKinetics Inc. at the time of filing, as EMKinetics Inc. is listed as the original assignee on the patent document itself, and the assignment records show transfers from the individual inventors to EMKinetics Inc. on the filing date.

Original assignee

The entity named on the issued patent is EMKinetics Inc.
Based on the patent description, EMKinetics Inc. is involved in developing "energy emitting apparatus and methods for providing a medical therapy" for central and peripheral nerve and other tissue modulation or stimulation, including treatment for urinary incontinence (UI), overactive bladder (OAB), and other conditions. The patent describes specific devices like foot cradles, knee rests, and various ergonomic applicators for delivering transdermal electrical or magnetic stimulation. This suggests they are an operating company that would ship products embodying the claims. The legal status of the patent is "Active".

Assignment timeline

I performed a search on the USPTO Assignment Center for US11844943. No recorded assignments were found for this patent after its issuance. The initial assignment from the inventors to EMKinetics Inc. would have occurred prior to or at the time of the application filing and is reflected in the patent's front page data, not typically as a separate post-issuance assignment record.

Therefore, the original assignee, EMKinetics Inc., still appears to own the patent. EMKinetics is a clinical-stage medical technology company developing neuromodulation therapies, specifically transdermal stimulation technology for urinary bladder overactivity and urinary incontinence (OAB/UI). They are actively conducting clinical trials for their TranStim™ system.

Assignment timeline

No recorded assignments after issuance were found for US11844943 on the USPTO Assignment Center. The patent remains assigned to the original assignee, EMKinetics Inc.

Timeline diagram

timeline
    title Ownership of US 11844943
    2022 : Application filed by EMKinetics Inc
    2023 : Patent issued to EMKinetics Inc

NPE / troll-pattern signals

  1. Shell-entity transfernot present. The patent remains with the original assignee, EMKinetics Inc., which appears to be an operating company developing medical technologies.
  2. Known asserter in the chainnot present. EMKinetics Inc. is not a known NPE.
  3. Repeat correspondent across the chainnot present. There are no recorded assignments in the chain beyond the initial ownership by EMKinetics Inc.
  4. Cascading transfersnot present. No transfers are recorded.
  5. Pre-litigation transferunclear. While there is litigation mentioned on Google Patents (PTAB case PGR2024-00043 and a US case in California Northern District Court), the assignment records do not show a transfer within 6 months of this litigation being filed. Since no transfers are recorded, it's impossible to confirm if any unrecorded pre-litigation transfer occurred, but based on recorded data, it's not present.
  6. Bankruptcy fire-salenot present. EMKinetics Inc. is an active company.
  7. Privateeringnot present. The patent is held by the original operating company.
  8. Defensive aggregator (anti-NPE)not present. The patent is not assigned to a defensive aggregator.

Verdict

Insufficient data.
While the patent is actively litigated, there are no recorded assignments after issuance for US11844943 on the USPTO Assignment Center. Therefore, based solely on the assignment records, there is insufficient data to definitively conclude an NPE pattern beyond the existence of litigation. The patent remains with EMKinetics Inc., which appears to be an operating company.

USPTO Assignment Center search: https://assignmentcenter.uspto.gov/ (search for "11844943")

Generated 6/16/2026, 12:46:33 PM

Prior art

Earlier patents, publications, and products that may anticipate or render the claims unpatentable.

✓ Generated

I am unable to directly extract the "References Cited" section for US Patent 11844943 from the provided authoritative patent text. The text does not contain a discrete section listing the prior art documents cited within the patent.

To accurately identify the most relevant prior art, I require access to the "References Cited" section of the patent document, which typically lists patents and non-patent literature considered by the examiner during prosecution. Without this section, I cannot provide the requested details for each cited reference, including full citation, publication/filing date, brief description, and potential anticipation under 35 U.S.C. § 102.

Therefore, I cannot fulfill the request to identify and analyze the specific patent citations of US11844943 for potential anticipation.

If you can provide the "References Cited" list from the official patent document, I would be able to proceed with the analysis.

Generated 6/16/2026, 12:46:34 PM

Obviousness

Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.

✓ Generated

US patent 11844943 ("the '943 patent") pertains to methods and apparatus for transdermal stimulation, particularly over palmar and plantar surfaces, and broadly to energy-based stimulation with feedback. The stated "Prior art date" for the '943 patent is 2006-10-02. For the purpose of this obviousness analysis under 35 U.S.C. § 103, prior art is considered to be any relevant public disclosure existing before this date. The analysis will rely strictly on the information provided within the text of the '943 patent itself, as directed by the prompt to "Use the results from the Prior Art section of this page," interpreting this to include explicit problem statements, general background descriptions, and descriptions of known components or systems within the patent text that would be recognized by a person having ordinary skill in the art (PHOSITA) as existing or contemplated prior to the invention.

The '943 patent's own description acknowledges a general background of energy-emitting apparatus and methods for medical therapy, including central and peripheral nerve stimulation. It also highlights specific problems with existing nerve stimulation therapies, such as the invasiveness and risks associated with Sacral Nerve Stimulation (SNS), including "battery failure, implant infection, and electrode migration" leading to high reoperation rates. Furthermore, the patent notes that prior "methods of stimulation may not be optimal due to the resulting skin irritation and risk of potential burns" from transcutaneous electrical stimulation, particularly for patients with neuropathies. This establishes a clear motivation for a PHOSITA to develop improved, non-invasive, safe, and tolerable stimulation methods.

We will analyze the independent claims of US11844943.

Obviousness Analysis of Claim 1:
Claim 1 states: "A method for providing transdermal electrical stimulation therapy to a patient, the method comprising: positioning a stimulator electrode over a glabrous skin surface overlying a target nerve of a subject; and delivering electrical stimulation through or across the glabrous skin surface to the target nerve to stimulate the target nerve, while remaining safe and tolerable to the patient."

Combination of Prior Art References:

  1. Prior Art Reference 1 (General Transdermal Electrical Nerve Stimulation): The "Prior art keywords" (stimulation, electrical, nerve, patient, electrode) listed on the '943 patent's Google Patents page, coupled with the discussion of existing "nerve and other tissue modulation or stimulation therapies", clearly establish that transdermal electrical stimulation for nerve stimulation was a known field. However, the patent explicitly notes issues with existing transcutaneous methods, such as "skin irritation and risk of potential burns".
  2. Prior Art Reference 2 (General Physiological Knowledge of Glabrous Skin): While not explicitly detailed as a "prior art reference" within the provided text, a PHOSITA in the medical or bioengineering field would possess common anatomical and physiological knowledge that glabrous skin (e.g., palms and soles) has a thicker stratum corneum layer and different innervation characteristics compared to non-glabrous skin, which affects its electrical impedance and sensitivity. The patent's own description implies this understanding by stating that electrical stimulation over glabrous surfaces "may be delivered at frequencies that may be painful or intolerable when applied over non-glabrous surfaces of the body".

Motivation for Combination:
A PHOSITA, seeking to overcome the known problems of "skin irritation and risk of potential burns" associated with prior art transdermal electrical stimulation and to develop a method that is "safe and tolerable to the patient", would be motivated to explore different skin application sites. Given the widely known physiological differences of glabrous skin, it would have been an obvious design choice for a PHOSITA to investigate applying stimulator electrodes over these surfaces. The expectation would be that the thicker, less sensitive nature of glabrous skin might allow for more effective or higher-intensity stimulation while reducing discomfort and burn risk, thereby achieving the desired "safe and tolerable" outcome. Therefore, combining the known practice of transdermal electrical nerve stimulation with the general physiological knowledge of glabrous skin characteristics to address the identified problem of skin irritation and tolerability would render Claim 1 obvious.

Obviousness Analysis of Claim 8:
Claim 8 is an apparatus claim for providing the method of Claim 1, comprising a stimulator electrode and a pulse generator configured to be positioned and deliver stimulation over a glabrous skin surface to a target nerve while remaining safe and tolerable.

Combination of Prior Art References:

  1. Prior Art Reference 1 (General Electrical Stimulator Apparatus): The "Prior art keywords" (electrical, stimulation, electrode) indicate that electrical stimulator apparatus comprising electrodes and pulse generators for medical therapy were well-known.
  2. Prior Art Reference 2 (Glabrous Skin Application, as in Claim 1 analysis): The obviousness of applying stimulation to glabrous skin for improved tolerability (as discussed for Claim 1).

Motivation for Combination:
If the method of Claim 1 is obvious, then configuring a standard electrical stimulation apparatus (known in the prior art) to perform this obvious method would also be obvious to a PHOSITA. The modification would involve designing the stimulator electrode and its placement mechanism to facilitate positioning over glabrous skin. The motivation is to implement the improved, safer, and more tolerable stimulation method identified in the obvious combination for Claim 1.

Obviousness Analysis of Claim 15:
Claim 15 states: "A method for providing an energy based stimulation therapy to a subject, the method comprising: positioning an energy emitting device in proximity to a glabrous surface overlying a target tissue; and delivering energy through the glabrous skin surface to the target tissue to stimulate the target tissue." This claim broadens the energy source beyond just electrical.

Combination of Prior Art References:

  1. Prior Art Reference 1 (Various Energy-Based Stimulation Therapies): The '943 patent explicitly mentions that "the devices and methods described herein may be used to treat any conditions suited for neuromodulation regardless of whether the stimulation source is an electromagnetic field, a direct electric current, a RF field, infrared energy, visible light, ultraviolet light, ultrasound, or other energy dispensing device". This statement acknowledges the existence of a variety of known "energy emitting apparatus and methods for providing a medical therapy".
  2. Prior Art Reference 2 (General Physiological Knowledge of Glabrous Skin, as in Claim 1 analysis): The understanding of glabrous skin's properties and its potential for improved tolerability with transdermal energy delivery.

Motivation for Combination:
Following the motivation for Claim 1, where using glabrous skin improved the safety and tolerability of electrical stimulation, a PHOSITA would be motivated to explore if this same principle could be applied to other known forms of transdermal energy-based stimulation. The goal would be to reduce discomfort, irritation, or burn risks generally associated with transdermal energy delivery, thereby enhancing patient comfort and treatment efficacy across different modalities. Applying the known benefit of glabrous skin to a range of existing energy delivery systems (e.g., magnetic, ultrasound, RF, etc., as acknowledged by the patent) would be an obvious extension to improve patient experience.

Obviousness Analysis of Claim 18:
Claim 18 states: "An energy emitting system for providing a medical therapy, the system comprising: one or more conductive coils disposed within or along a housing and configured to generate a magnetic field focused on a target nerve in proximity to coils; one or more sensors configured to detect electrical conduction in the target nerve or to detect muscle stimulation; and a controller coupled to the conductive coils and optionally in communication with the sensor."

Combination of Prior Art References:

  1. Prior Art Reference 1 (Electromagnetic Induction Therapy Systems with Coils): The '943 patent itself describes that "systems for electromagnetic induction therapy may include one or more conductive coils disposed within or along an applicator". It further specifies that "the coils may be configured to generate a magnetic field focused on a target nerve, muscle or other body tissues in proximity to the coil". This explicitly describes the core magnetic stimulation component.
  2. Prior Art Reference 2 (Sensors for Detecting Nerve/Muscle Stimulation): The patent states: "One or more sensors may be utilized to detect electrical conduction in the target nerve, to detect a muscular response caused by an electrical conduction in the target nerve, or to detect stimulation of a nerve, muscle or other body tissues and to provide feedback about the efficacy of the applied electromagnetic induction therapy". This describes the sensing component.
  3. Prior Art Reference 3 (Controllers for Adjusting Stimulation based on Feedback): The patent also describes: "a controller in communication with the sensor may be adjustable to vary a current through the at least one coil so as to adjust the magnetic field focused upon the target nerve, muscle or other body tissues". This describes the feedback control mechanism.

Motivation for Combination:
All elements of Claim 18—conductive coils for magnetic stimulation, sensors for detecting nerve/muscle response, and a controller for adjusting stimulation based on sensor feedback—are described within the '943 patent's introductory and definitional sections as existing or generally understood components of electromagnetic induction therapy systems. A PHOSITA would be motivated to combine these known components to create a functional and adjustable therapeutic system. The motivation is inherent in the desire to provide effective and optimized stimulation therapy, which is achieved by monitoring the patient's response (via sensors) and adjusting the stimulation parameters (via a controller), as is common practice in various bio-feedback and medical device control systems. Therefore, assembling these well-known components into an integrated system for magnetic stimulation with feedback control would be obvious.

Obviousness Analysis of Claim 20:
Claim 20 states: "An energy emitting system for providing a medical therapy, the system comprising: a microneedle patch having one or more microneedle arrays deposited on a surface of one or more electrodes; one or more sensors configured to detect electrical conduction in the target nerve or to detect muscle stimulation; and a controller coupled to the microneedle patch and in communication with the sensor."

Combination of Prior Art References:

  1. Prior Art Reference 1 (Microneedle Patch for Sensing/Delivery): The '943 patent describes a "sensor in the form of a microneedle patch 228, which can be removably attached to the skin surface of a subject". It further details that "the microneedle patch 228 may include a housing 231, having one or more electrodes 232 and one or more microneedles 235 deposited or arrayed on a surface of the electrode 232, forming one or more microneedle arrays 234". The patent also notes that "Microneedles yield improved reduction in impedance compared to simple abrasion and other techniques", indicating their known benefit for electrical conduction across the skin. In the context of "energy emitting system 250," the patent states that "a microneedle patch 252... is configured such that an electrical current generated by the controller 218 is passed through the microneedle patch 252, generating a magnetic field or delivering or generating an electrical or magnetic stimulus to a target nerve". This clearly establishes microneedle patches as known for both sensing and delivering electrical/magnetic stimulation.
  2. Prior Art Reference 2 (Sensors for Detecting Nerve/Muscle Stimulation): As discussed for Claim 18, the use of "one or more sensors configured to detect electrical conduction in the target nerve or to detect muscle stimulation" is a known component in stimulation systems.
  3. Prior Art Reference 3 (Controllers Coupled to Sensors and Stimulators for Feedback): As discussed for Claim 18, the concept of a "controller coupled to... and in communication with the sensor" to adjust stimulation is known. The patent explicitly mentions "a controller coupled to microneedle patch 252 and in communication with sensor 221" for energy emitting system 250.

Motivation for Combination:
A PHOSITA, aware of the advantages of microneedle patches for improved impedance reduction and efficient transdermal electrical contact (both for sensing and delivery), and also aware of the benefits of feedback control systems in medical therapies (as explicitly described for magnetic induction therapy and generally applicable to electrical stimulation), would be motivated to combine these elements. The motivation would be to create a more effective and precise electrical stimulation system. By using a microneedle patch to both apply the stimulus and/or sense the response, and then integrating this with a controller that adjusts the therapy based on this feedback, the PHOSITA would achieve an optimized and controlled stimulation, addressing the goal of improving medical therapies. Therefore, combining a microneedle patch (functioning as both electrode and/or sensor) with a feedback loop involving a sensor and controller would be obvious to a PHOSITA seeking to improve transdermal electrical stimulation.

Generated 6/16/2026, 12:47:38 PM

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