Nevada Patent of the Month – January 2026

Patent Provenance

Patent Identification and the Nevada Distinction

In the increasingly convergent domains of interactive media and clinical medicine, U.S. Patent No. 12,525,344 has emerged as a foundational document, signaling a shift from theoretical digital health applications to scalable, industrial-grade therapeutic infrastructure. Formally titled “Immersive medicine translational engine for development and repurposing of non-verified and validated code,” this intellectual property was officially applied for on March 4, 2024, and subsequently granted by the United States Patent and Trademark Office (USPTO) on January 13, 2026. The patent is assigned to DeepWell DTx, with inventorship credited to Ryan J. Douglas and Matthew J. Douglas, whose work focuses on the intersection of neurological activation and immersive gameplay mechanics.

The significance of this patent extends beyond its technical claims; it has been distinguished as the Nevada Patent of the Month, a prestigious accolade bestowed by the specialist R&D tax advisory firm Swanson Reed. This recognition was not the result of subjective editorial selection but rather the output of a rigorous, data-driven analysis utilizing proprietary Artificial Intelligence (AI) technology. The AI system screened over 1,000 potential patents filed within the jurisdiction, evaluating them against a matrix of technical complexity, novelty, and commercial viability. The selection of Patent No. 12,525,344 from such a voluminous dataset underscores its status as a statistical outlier in terms of innovation and utility.

The Imperative of Real-World Impact

The Swanson Reed AI algorithms selected this specific patent for the Nevada Patent of the Month award primarily due to its profound real-world impact. Unlike many patents in the software sector which are defensive in nature—filed to blockade competitors rather than to be deployed—U.S. Patent No. 12,525,344 addresses a critical, tangible failure in the current healthcare market: the “engagement gap” in digital therapeutics (DTx).

The current healthcare ecosystem is burdened by a mental health crisis of global proportions, exacerbated by a shortage of clinicians and the high cost of pharmacological interventions. While digital therapeutics have long promised a scalable solution, early iterations failed to achieve mass adoption due to poor user retention. Patients frequently abandon “gamified” medical apps because they lack the intrinsic entertainment value of commercial media. Patent No. 12,525,344 was chosen because it provides a “translational engine” capable of taking Non-Medical Digital Assets (NMDAs)—mainstream video games that consumers already play voluntarily—and repurposing them into Therapeutic Digital Assets (TDAs). By unlocking the therapeutic potential of billions of dollars of existing software assets, this patent offers a pathway to immediate, scalable, and high-adherence mental health treatment, justifying its recognition as a high-impact innovation by the Swanson Reed AI analysis.

Technological Architecture and Innovation Analysis

To fully appreciate the superiority of the invention described in U.S. Patent No. 12,525,344, one must dissect the technical architecture of the “Translational Engine.” The patent describes a system that fundamentally alters the relationship between software inputs and physiological outputs.

The “Black Box” Wrapping Mechanism

The core innovation lies in the system’s ability to handle “Non-Verified and Validated Code”. In traditional medical device software development (Software as a Medical Device, or SaMD), regulatory bodies like the FDA typically require a “White Box” approach, where every line of code is inspected, verified, and validated to ensure it does not pose a risk to the patient. This requirement has historically made it impossible to use complex, commercial video games (which may contain millions of lines of code and proprietary third-party engines) as medical treatments.

The DeepWell patent circumvents this by treating the game as a “Black Box.” The Translational Engine does not need to access or alter the source code of the video game (the NMDA). Instead, it acts as a middleware or wrapper layer that monitors:

1. Inputs: The user’s controller commands, voice data, and biometric signals (heart rate, galvanic skin response).
2. Outputs: The game’s audio-visual stream and haptic feedback.

By monitoring these distinct signals, the engine can infer the user’s physiological state and the game’s intensity level. It can then intervene—not by rewriting the game code, but by overlaying therapeutic prompts (e.g., “Breathe”) or modulating the input sensitivity to force physiological regulation. This architecture allows for the medicinalization of high-quality entertainment assets without the prohibitive cost of re-engineering them.

Vagus Nerve Stimulation (VNS) via Immersive Media

The patent details the use of “immersive media” to stimulate the Vagus Nerve, the primary component of the parasympathetic nervous system. Traditional VNS requires surgical implants or external electrical stimulation devices. DeepWell’s approach utilizes “bio-behavioral” stimulation.

The mechanism relies on the concept of “Hard Fun” or high-arousal gameplay. When a player is engaged in an intense video game, their Sympathetic Nervous System (fight-or-flight) is activated. The Translational Engine detects this arousal and introduces specific challenges—such as vocalizing (humming/chanting) or controlled breathing—that mechanically stimulate the Vagus Nerve. This forces the player to activate their Parasympathetic Nervous System (rest-and-digest) while under stress. This concurrent activation trains the user’s nervous system to self-regulate in high-pressure situations, a skill that translates directly to real-world anxiety management.

Competitive Landscape and Benchmarking

The digital health sector is crowded, yet distinct stratifications exist. To demonstrate the superiority of Patent No. 12,525,344, we must benchmark it against the three incumbent categories: Traditional Pharmacotherapy, First-Generation Digital Therapeutics, and Consumer Wellness Applications.

Competitor Cluster A: First-Generation DTx (e.g., Akili Interactive, Pear Therapeutics)

• Operational Model: These companies adopt a “De Novo” development model, building therapeutic games from scratch with clinical efficacy as the primary goal and entertainment value as a secondary consideration.
• Technological Limitation: The “Chocolate-Covered Broccoli” problem. Developing a video game that competes with AAA titles (like Call of Duty or Zelda) costs hundreds of millions of dollars. DTx companies, operating on healthcare R&D budgets, produce games with lower graphical fidelity and shallower mechanics. This results in low engagement and high churn rates.
• DeepWell Superiority: The DeepWell patent allows for the utilization of Sunk Costs. By repurposing existing games, the Translational Engine leverages the hundreds of millions of dollars already spent by game publishers on graphics, physics engines, and narrative design. The cost of goods sold (COGS) for the “entertainment” portion of the therapy is effectively zero for the therapeutic provider, providing an insurmountable economic moat.

Competitor Cluster B: Consumer Wellness Apps (e.g., Calm, Headspace)

• Operational Model: These platforms rely on passive content delivery—guided meditations, sleep stories, and ambient music.
• Technological Limitation: Low Arousal Interaction. These apps operate primarily on the “top-down” cognitive level, asking users to relax in a low-stress environment. They struggle to treat acute anxiety or PTSD because they do not simulate the stress conditions under which these pathologies manifest. They lack the biofeedback loops necessary to confirm physiological change.
• DeepWell Superiority: The patent introduces Dynamic Biofeedback Loops. Unlike a meditation app that plays a track regardless of the user’s state, the Translational Engine monitors the user’s biometrics in real-time. If the user does not regulate their heart rate, they may fail the level in the game. This gamified consequence creates a potent learning reinforcement loop that passive apps cannot replicate.

Competitor Cluster C: Traditional Pharmacotherapy (SSRI/SNRI)

• Operational Model: Chemical intervention to modulate neurotransmitter levels.
• Technological Limitation: Systemic Side Effects and Lack of Skills Acquisition. Pharmaceuticals affect the entire biological system, often leading to weight gain, lethargy, or sexual dysfunction. Furthermore, drugs treat the symptoms but do not teach the patient behavioral skills to manage their condition once the drug is withdrawn.
• DeepWell Superiority: The technology offers a Non-Invasive, Skills-Based Intervention. The patent facilitates “endogenous” medicine—teaching the body to produce its own neurochemicals (e.g., dopamine, nitric oxide) through controlled behavior. There are no systemic side effects, and the user acquires a transferable skill (self-regulation).

Benchmarking Matrix

The following table benchmarks the DeepWell Translational Engine against these competitor classes across key performance indicators (KPIs).

Real-World Impact and Future Potential

The “Real-World Impact” criteria used by the Swanson Reed AI to select this patent is rooted in the immediate and future applicability of the technology to solve systemic health challenges.

Immediate Impact: The Mental Health Triage

The most immediate application of Patent No. 12,525,344 is in the triage of mental health conditions.

• Accessibility: By embedding therapeutic engines into consumer gaming consoles (Xbox, PlayStation), the patent allows for the delivery of care to populations that are geographically or economically isolated from clinical centers.
• Adolescent Male Demographic: This demographic is statistically the least likely to seek talk therapy but the most likely to engage in hardcore gaming. The Translational Engine meets this patient population “where they are,” delivering therapy through a medium they trust and enjoy.
• Reduction of Opioid Reliance: For chronic pain management, “immersive distraction” is a proven analgesic. The DeepWell engine can enhance this by coupling distraction with active pain-management breathing techniques, potentially reducing the need for opioid prescriptions in pain clinics.

Future Potential: The Therapeutic Metaverse and Spatial Computing

As the technology sector pivots toward Spatial Computing (e.g., Apple Vision Pro, Meta Quest), the relevance of Patent 12,525,344 expands.

• VR Exposure Therapy: The engine is perfectly suited for Virtual Reality (VR) exposure therapy (for PTSD or phobias). The “Risk Mitigation” layer described in the patent ensures that the immersive experience does not re-traumatize the patient. If the biometric sensors detect that the user’s heart rate has exceeded a safety threshold, the engine can automatically “dampen” the intensity of the VR experience (e.g., reducing color saturation, muting audio, or slowing down time) to bring the patient back to a safe window of tolerance.
• Generative AI Integration: In the near future, the “Non-Verified Code” described in the patent could be generated in real-time by AI. The Translational Engine would act as the “Safety Rails” for Generative AI games, ensuring that the AI does not generate content that is psychologically harmful, while steering the procedural generation toward therapeutic outcomes (e.g., generating a level that induces a specific rhythmic breathing pattern).
• The “Video Game Pharmacy”: The patent lays the legal and technical groundwork for a “formulary” of video games. Insurance companies could eventually reimburse “Game Pass” subscriptions if the user logs a certain number of therapeutic hours via the DeepWell Engine. This creates a new economic model for the gaming industry, opening up the $4 trillion healthcare market to game publishers.

Regulatory Strategy and Compliance

A critical component of the patent’s superiority is its approach to regulation. The FDA regulates “Software as a Medical Device” (SaMD).

• The Predicate Problem: To get FDA clearance, a device usually needs a “predicate”—a similar device that is already legal. DeepWell’s patent likely positions the system to use traditional biofeedback devices as predicates, but innovates on the delivery mechanism.
• General Wellness vs. Medical Device: The patent allows for a bifurcated market strategy. The engine can be deployed immediately as a “General Wellness” product (low regulation) for stress reduction, while simultaneously gathering Real-World Data (RWD) to support a full FDA submission for treating specific pathologies like Major Depressive Disorder (MDD). The “Risk Mitigation” layer is the key feature that assures regulators that the system is safe, even if the underlying game code is unknown.

The R&D Tax Credit Analysis (IRC Section 41)

The development of the “Immersive medicine translational engine” represents a significant investment in high-risk, high-technical-uncertainty engineering. Consequently, it is a prime candidate for the Research and Development (R&D) Tax Credit under Internal Revenue Code (IRC) Section 41.

Swanson Reed, as a specialist firm focusing exclusively on R&D tax claims, utilizes the “4-Part Test” to substantiate eligibility. Below is a detailed analysis of how a project utilizing Patent No. 12,525,344 meets these statutory requirements, and how Swanson Reed facilitates the claim process.

Part 1: Permitted Purpose

Definition: The activity must relate to a new or improved business component (product, process, computer software, technique, formula, or invention) regarding its function, performance, reliability, or quality. Activities related to style, taste, or cosmetic design are explicitly excluded.

• Application to Patent 12,525,344: The “Business Component” is the Translational Engine software platform. The development aimed to create a new capability: the ability to ingest non-medical code and output a therapeutic asset. This function did not previously exist. Furthermore, the project sought to improve the reliability of digital therapeutic delivery (ensuring consistent dosage via software algorithms) and the performance of the biofeedback loop (reducing latency between biometric input and game response).
• Swanson Reed’s Role: Swanson Reed works with the development team to isolate the “functional” improvements from the “artistic” ones. While the creation of the video game art is likely not eligible (as it relates to style), the engineering of the engine that renders that art for therapeutic effect is eligible. Swanson Reed’s documentation strategies ensure this distinction is clear to the IRS.

Part 2: Technological in Nature

Definition: The process of experimentation must rely on principles of the “hard sciences”—physical or biological sciences, engineering, or computer science.

• Application to Patent 12,525,344: The development of this patent sits at the convergence of Computer Science and Biomedical Engineering.
• Computer Science: The project involves complex software architecture, specifically in the areas of API integration, real-time data signal processing, and middleware development. The challenge of wrapping compiled code requires deep knowledge of memory management and instruction sets.
• Biological Science: The core claim involves the “repurposing” of code for “therapeutic modalities.” This requires the application of neuroscience and physiology principles to determine how digital stimuli affect the Vagus Nerve.
• Swanson Reed’s Role: Swanson Reed utilizes degreed engineers and scientists to prepare the claim. They can identify the specific “Qualified Research Expenses” (QREs) associated with the technical staff (engineers, data scientists, neuroscientists) while excluding non-technical staff (marketing, management). This ensures the “Technological in Nature” test is met with precision.

Part 3: Elimination of Uncertainty

Definition: At the outset of the project, there must be uncertainty regarding the capability to develop the component, the method of development, or the appropriate design.

• Application to Patent 12,525,344: The development team faced significant technical uncertainties:
• Capability Uncertainty: Is it physically possible to intercept the render pipeline of a third-party game engine (like Unreal Engine 5) and inject therapeutic overlays without causing frame-rate drops that would ruin the user experience?
• Methodological Uncertainty: How can the system synchronize a user’s breathing (detected via a standard webcam) with game logic in real-time, given the noise and lighting variables in a home environment?
• Design Uncertainty: What is the optimal system architecture to ensure the “Risk Mitigation” module works across different hardware platforms (PC vs. Console vs. Mobile)?
• Swanson Reed’s Role: Swanson Reed helps the client document these uncertainties. They do not just ask “What did you do?”; they ask “What kept you up at night?” They archive emails, JIRA tickets, and meeting minutes that demonstrate the team did not know the answers at the start of the project. This “contemporaneous documentation” is the gold standard for audit defense.

Part 4: Process of Experimentation

Definition: Substantially all (at least 80%) of the activities must constitute a process of experimentation. This involves identifying one or more alternatives, evaluating them, and refining the hypothesis through modeling, simulation, or systematic trial and error.

• Application to Patent 12,525,344: The development of the Translational Engine was not a linear process. It likely involved:
• Hypothesis: “We can use the audio-stream of the game to trigger the breathing exercise.”
• Testing: Building a prototype that analyzed audio waveforms.
• Failure Analysis: Finding that audio analysis was too slow or triggered false positives during quiet moments in the game.
• Pivot: Refactoring the system to analyze direct controller inputs instead.
• Optimization: Iterating on the code to reduce CPU overhead.
• Swanson Reed’s Role: The firm helps frame the narrative to show a scientific method. They map the version control history (Git commits) to specific experiments. They ensure that the claim captures not just the successful code, but the “dead ends” and failed experiments, which are often the strongest proof that a process of experimentation occurred.

Swanson Reed’s Value Proposition: Audit Defense and AI

Swanson Reed is one of the few firms in the U.S. that focuses exclusively on the R&D tax credit. This specialization allows them to offer distinct advantages:

• Six-Eye Review: Every claim undergoes review by a Qualified Engineer, a Scientist, and a Tax Attorney/CPA. This multidisciplinary approach mirrors the IRS’s own audit teams.
• AI-Driven Substantiation: Just as they used AI to identify Patent 12,525,344 as a winner, they use AI tools to scan a client’s general ledger and project management software to identify every potential QRE, ensuring no eligible dollar is left on the table.
• Independence: As an independent firm not affiliated with a CPA audit practice, they avoid conflicts of interest, allowing them to aggressively (yet compliantly) defend the claim during an IRS examination.

Final Thoughts

U.S. Patent No. 12,525,344 is a watershed moment in the history of digital health. It represents the maturation of the industry from “apps that track health” to “software that creates health.” By solving the dual challenges of user engagement and content creation costs, DeepWell DTx has created a technology with the potential to impact millions of lives, fully justifying its selection as the Nevada Patent of the Month by Swanson Reed’s AI.

For the innovators behind this technology, and for the industry at large, the R&D Tax Credit serves as a vital lifeline. It incentivizes the risk-taking required to bridge the gap between two disparate industries—gaming and medicine. With the guidance of specialized firms like Swanson Reed, companies can navigate the complexities of the 4-Part Test, ensuring that the tax code functions as intended: as a fuel for the engines of the future. The convergence of ludology (the study of games) and pharmacology is no longer science fiction; with Patent 12,525,344, it is a verified, validated, and patent-protected reality.