Patent No. US12194289 (titled "Transcutaneous Electrical Muscle Stimulation Device For The Treatment Of Premature Ejaculation Or Erectile Dysfunction, And Methods Of Use Thereof") was filed by Virility Medical Ltd on Sep 14, 2020.
’289 is related to the field of devices and methods for treating sexual dysfunction, specifically premature ejaculation and erectile dysfunction. Current treatments for premature ejaculation include SSRIs, botulinum neurotoxin, and desensitization, which can have systemic side effects or limited efficacy. The patent addresses the need for a localized, on-demand solution that avoids systemic drug effects.
The underlying idea behind ’289 is to use a transcutaneous electrical muscle stimulation (TEMS) device, specifically a skin patch with integrated electrodes and circuitry, to deliver electrical impulses to the bulbospongiosus muscle (also referred to as bulbocavernosus muscle) in the perineum. The electrical stimulation is intended to modulate the muscle's activity during sexual intercourse, thereby delaying ejaculation or improving erectile function.
The claims of ’289 focus on a skin patch device with at least two electrodes and electronic circuitry configured to deliver electrical impulses to the bulbospongiosus muscle during sexual intercourse. The key feature is the ability to delay ejaculation through specific electrical impulse parameters (intensity, frequency, current, pulse width). The device is also configured to receive signals from a remote device to initiate the electrical stimulation.
The device works by attaching the skin patch to the perineum, positioning the electrodes to target the bulbospongiosus muscle. Upon activation, either manually or remotely, the electronic circuitry generates and delivers electrical impulses transcutaneously. These impulses induce a continuous contraction of the bulbospongiosus muscle, which interferes with the rhythmic contractions normally associated with ejaculation, thus delaying it. The device can also be used to stimulate the ischiocavernosus muscles to treat erectile dysfunction.
Unlike systemic drug treatments, this approach provides localized and immediate control over the muscle activity involved in ejaculation. The device is designed to be disposable and easy to use, allowing for on-demand treatment without the need for long-term medication. The ability to remotely activate the device adds a layer of convenience and spontaneity, allowing the user to initiate the stimulation discreetly.
In the mid-2010s when ’289 was filed, electrical stimulation was an established method for therapeutic intervention, at a time when transcutaneous electrical nerve stimulation (TENS) was typically implemented using commercially available stimulators and electrodes. At this time, applying electrical stimulation to specific muscle groups for rehabilitation or pain management was a common practice, when systems commonly relied on pre-programmed stimulation patterns or user-defined parameters.
The examiner allowed the claims because the applicant successfully addressed prior rejections. Specifically, amendments to claims 27 and 28 overcame prior art rejections under 35 U.S.C. 112. The examiner was persuaded by the applicant's arguments against rejections based on 35 U.S.C. 103, and the applicant's terminal disclaimer overcame rejections based on non-statutory double patenting. The examiner stated that the claims now define over the closest prior art (Tippey, Lavoisier, Kolb, and Bogie) for the reasons argued by the applicant, and no proper rejection of the independent claims could be made using any single reference or combination of references.
This patent contains 23 claims, with independent claims 1 and 13. Independent claim 1 focuses on a device comprising a skin patch with electrodes and circuitry for delivering electrical impulses to the bulbospongiosus muscle to delay ejaculation, while independent claim 13 focuses on a method of using such a device. The dependent claims generally elaborate on the specific features, configurations, and parameters of the device and method described in the independent claims.
Definitions of key terms used in the patent claims.

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