Minnesota Patent of the Month – February 2026

Comprehensive Research Report on U.S. Patent No. 12,516,964

“Method and Apparatus for Breath-Hold Monitoring in Diagnostic and Therapeutic Procedures”

Assignee: EmpNia Inc.

Inventor: Manojeet Bhattacharya

Award Designation: Minnesota Patent of the Month, February 2026

Selection Methodology: AI-Driven Comparative Analysis (Selected from >1,000 Candidates)

Executive Introduction: The Zenith of Minnesota Innovation

In the densely populated landscape of medical technology intellectual property, where thousands of filings vie for attention annually, the distinction of “Patent of the Month” serves as a definitive bellwether for transformative innovation. For February 2026, this prestigious accolade has been awarded to U.S. Patent No. 12,516,964, titled “Method and apparatus for breath-hold monitoring in diagnostic and therapeutic procedures.” The patent, which details a novel application of fiber optic sensing for physiological monitoring, was applied for on January 27, 2025, and officially granted on January 6, 2026. Assigned to EmpNia Inc., a Minneapolis-based medical device innovator, and invented by the visionary engineer Manojeet Bhattacharya, this intellectual property represents a fundamental paradigm shift in the field of oncology and radiation therapy.

The selection of this specific patent was not a matter of subjective preference but the result of a rigorous, data-driven evaluation process utilizing advanced Artificial Intelligence (AI) technology. The AI selection engine analyzed a field of over 1,000 potential candidates—spanning biotechnology, mechanical engineering, and software systems—filed within the relevant period. The algorithms were calibrated to prioritize not merely technical novelty, but “real-world impact,” isolating inventions with the highest potential to democratize healthcare, improve patient outcomes, and disrupt entrenched market inefficiencies. Patent 12,516,964 emerged as the undisputed victor, identified as a “Keystone Patent” that solves a decades-old problem in cancer treatment: the precise, cost-effective management of respiratory motion during radiation delivery.

The selection of EmpNia’s technology for the February 2026 award is predicated on its immediate and profound applicability to the clinical environment. While many patents remain theoretical or require years of translational development, the technology described in Patent 12,516,964—commercialized as the eMotus system—addresses a critical, daily bottleneck in cancer centers worldwide. The AI analysis highlighted the invention’s unique capability to decouple motion management from high-capital infrastructure, thereby “unlocking” precision medicine for community clinics that previously could not afford the requisite equipment. By utilizing advanced Fiber Bragg Grating (FBG) sensing technology within a disposable form factor, the patent introduces a novel economic model to radiation oncology: the shift from fixed-asset dependence to a flexible, consumable-based workflow. This report provides an exhaustive analysis of the technology, benchmarking it against legacy competitors, forecasting its economic and clinical trajectory, and detailing the specific R&D Tax Credit implications for innovations of this magnitude.

The Clinical Imperative: The Challenge of Respiratory Motion

To fully appreciate the superiority of the invention described in Patent 12,516,964, one must first understand the clinical battlefield it enters. Radiation therapy, specifically Image-Guided Radiation Therapy (IGRT) and Stereotactic Body Radiation Therapy (SBRT), relies on the precise delivery of high-dose radiation to a tumor while sparing the surrounding healthy tissue. This creates a geometric challenge of the highest order, particularly in the thorax and abdomen.

The Problem of the Moving Target

In the thorax and abdomen, tumors are not static targets. They move with the patient’s respiration. A tumor located in the lung, liver, or pancreas can travel significant distances—often 2 to 3 centimeters—during a single breathing cycle. If the radiation beam is static while the tumor moves, two catastrophic errors occur:

1. The Miss (Under-dosing): The tumor moves out of the high-dose zone, leading to under-dosing and potential cancer recurrence.
2. The Collateral Damage (Toxicity): The radiation beam strikes healthy tissue (e.g., healthy lung parenchyma, the heart, or the esophagus) that has moved into the target zone, leading to toxicity and long-term side effects.

Historically, oncologists managed this uncertainty by adding “margins”—essentially expanding the target area to encompass the entire path of the tumor’s motion. While this ensured the tumor was hit, it necessitated irradiating a large volume of healthy tissue, limiting the total dose that could be safely delivered.

The Evolution of Motion Management

Over the last two decades, “Respiratory Gating” and “Breath-Hold” techniques emerged to solve this. The concept is simple: turn the radiation beam on only when the tumor is in a specific position (gating) or ask the patient to hold their breath to freeze the tumor in place (breath-hold). However, the execution of this concept has been fraught with technological complexity.

• Generation 1: Mechanical Compression. Primitive methods involved physically pressing a plate against the patient’s abdomen to force shallow breathing. This was uncomfortable and often ineffective for internal motion.
• Generation 2: Spirometry. Patients breathed into a tube to measure air volume. This was invasive, unhygienic, and prone to drift errors.
• Generation 3: Optical Surface Monitoring (The Incumbent Standard). Systems like Varian’s RPM (Real-time Position Management) or Vision RT use cameras to track a plastic block placed on the patient’s chest or the skin surface itself. While effective, these systems are expensive (costing hundreds of thousands of dollars), require complex calibration, and often struggle with “surrogate errors”—where the skin moves, but the internal tumor does not.

It is against this backdrop of expensive, complex, and imperfect solutions that Patent 12,516,964 enters the arena. The AI selection process identified this patent as superior because it bypasses the limitations of camera-based systems entirely, offering a direct, physical measurement of respiratory strain that is immune to the environmental challenges of a radiation bunker.

Technological Analysis: The Superiority of Patent 12,516,964

The Minnesota Patent of the Month for February 2026 describes a “Method and apparatus for breath-hold monitoring” that fundamentally disrupts the existing hierarchy of motion management devices. The core of the invention lies in its use of Fiber Bragg Grating (FBG) sensors embedded in a disposable, wearable patch.

The Core Innovation: Fiber Optic Sensing

Unlike camera-based systems that watch the patient from a distance, or spirometers that invade the airway, the EmpNia device (eMotus) places the sensor directly on the patient’s torso in a flexible, non-invasive patch.

The Physics of Fiber Bragg Gratings:

The patent details the use of optical fibers treated with a “Bragg Grating”—a periodic variation in the refractive index of the fiber core. When light is sent down the fiber, the grating reflects a specific wavelength (the Bragg wavelength) back to the source.

• Strain Sensitivity: If the fiber is stretched or bent—even microscopically—the spacing of the grating changes.
• Wavelength Shift: This physical change causes an immediate, precise shift in the reflected wavelength of light.
• Application: As the patient breathes, their chest wall expands and contracts. The disposable patch stretches in unison. The FBG sensor detects this strain with sub-millimeter precision, converting the mechanical motion of breathing into a high-fidelity optical signal.

Superiority Through “Vendor-Agnostic” Design

One of the primary reasons this patent was selected as the Minnesota Patent of the Month is its “Universal Compatibility.” Legacy manufacturers design motion management systems to lock customers into their ecosystem. A Varian respiratory gating camera is designed to work best with a Varian accelerator. Patent 12,516,964 describes a system that is vendor-agnostic. Because the signal processing happens in the independent eMotus unit and is fed to the treatment machine via standard interfaces (or manual gating prompts), it creates a universal standard. This allows a hospital with a mixed fleet of machines (e.g., an Elekta Linac and a GE CT scanner) to use a single, unified motion management protocol.

The “Disposability” Paradox

In medical devices, “disposable” often implies “cheap quality.” However, in this patent, disposability is a feature of precision. By using a fresh sensor for every patient, the system eliminates the wear-and-tear degradation that plagues reusable mechanical belts or bellows. Furthermore, the disposable sensor pad solves the “Line of Sight” problem. Camera-based systems (Vision RT, Varian RPM) fail if the camera’s view of the patient is blocked by the gantry or a therapist. Since the EmpNia sensor is taped to the patient, it can never be blocked. It provides continuous, uninterrupted data regardless of patient position or machine rotation.

Signal Fidelity via Photonics

Electronic sensors in a radiation bunker are notoriously noisy because Linear Accelerators (Linacs) generate massive electromagnetic interference (EMI). Electronic wires can act as antennas, picking up static that ruins the signal. The EmpNia patent utilizes optical fibers, which use light, not electricity. Light is immune to electromagnetic interference. This intrinsic physical property allows the eMotus system to provide a perfectly clean signal even while a high-energy radiation beam is active—a feat that requires heavy shielding and filtering for electronic competitors.

Comparative Benchmark Analysis

The AI selection process prioritized Patent 12,516,964 because it offers a “Dominant Design” that is superior to current market leaders. The following comparative analysis benchmarks the EmpNia technology against the primary incumbents: Varian Medical Systems (RPM/RGSC), Elekta (ABC), and Vision RT (SGRT).

Comparison of Core Architecture

Detailed Competitor Breakdown

The Varian RPM (Real-time Position Management) System:

For years, the Varian RPM has been the industry workhorse. It utilizes a plastic block with two infrared reflective dots placed on the patient’s chest. An infrared camera mounted on the wall emits light, which bounces off the dots and returns to the camera. The camera tracks the vertical motion of these dots.

• The Flaw (The Cosine Error): If the patient breathes heavily using their abdomen but the block is on their upper chest, the block may tilt. The camera can misinterpret a tilt as a translation (movement), leading to false gating signals.
• The Flaw (Hysteresis): Patients often breathe in a loop—the path of the chest wall during inhalation is different from exhalation. RPM systems often struggle to distinguish these phases accurately without complex predictive algorithms that can drift over time.
• The Flaw (Setup): The camera is a fixed point. If the treatment couch is rotated (a “kick” angle) to treat a breast or lung from a different trajectory, the camera’s view of the block might be obstructed by the Gantry head (the part of the machine that shoots radiation). This requires the therapist to enter the room and reposition the block or the camera, breaking the workflow.
• EmpNia’s Superiority: Patent 12,516,964 eliminates the cosine error because the strain sensor measures expansion along the surface, not vertical displacement relative to a camera. It eliminates line-of-sight issues entirely because there is no camera.

The Vision RT (Surface Guided Radiation Therapy – SGRT) System: Vision RT projects a structured light pattern (a grid of red lines) onto the patient’s skin. Three ceiling-mounted cameras read the distortion of this grid to create a real-time 3D map of the patient’s surface.

• The Flaw (The “Region of Interest” Problem): SGRT requires the user to define a “Region of Interest” (ROI) on the skin to track. If this ROI is chosen on soft tissue (like the breast) which is deformable, rather than the rigid sternum, the correlation between the skin surface and the internal tumor can be poor.
• The Flaw (Cost): These systems require three cameras, complex calibration boards, and high-end GPUs. The cost is often prohibitive for smaller centers.
• EmpNia’s Superiority: The EmpNia system provides similar high-fidelity data at a fraction of the cost, democratizing access to high-precision gating.

Elekta Active Breathing Coordinator (ABC): This system uses a spirometer (a tube in the mouth) to measure air volume and a valve to physically block the patient’s breath at a certain volume.

• The Flaw (Invasiveness): Patients, especially those with lung cancer or anxiety, struggle to tolerate a tube in their mouth and a nose clip. It is highly invasive.
• The Flaw (Hygiene): The tubing requires sterilization or replacement, adding to biohazard waste and workflow friction.
• EmpNia’s Superiority: The eMotus patch is non-invasive. The patient breathes naturally without obstruction, leading to higher compliance and less anxiety.

Real-World Impact and Future Potential

The selection of Patent 12,516,964 for the Minnesota Patent of the Month was driven largely by its potential for immediate, tangible human impact. The AI analysis engine identified this technology not just as an incremental improvement, but as an “enabler” of advanced care in resource-constrained settings.

Democratization of Advanced Care (Health Equity)

Currently, “Deep Inspiration Breath Hold” (DIBH)—a technique vital for protecting the heart during breast cancer treatment—is often limited to large academic centers that can afford expensive surface guidance systems. When treating left-sided breast cancer, the heart sits directly behind the breast tissue. By taking a deep breath, the lungs expand and physically push the heart away from the chest wall, creating a safety gap. Without DIBH, the heart receives incidental radiation, which can lead to radiation-induced heart disease years later. Small community clinics often forgo this technique due to the $250,000 capital outlay required for systems like Vision RT. The technology in Patent 12,516,964 lowers the barrier to entry significantly. By offering a “pay-per-treatment” disposable model, a small rural clinic in Minnesota (or anywhere globally) can offer world-class heart-sparing treatments without a massive capital investment. This is a massive step toward health equity, ensuring a patient’s zip code does not dictate their long-term cardiac health.

Workflow Velocity and Economic Impact

In the business of oncology, time is the most valuable currency. A linear accelerator is a multi-million-dollar asset that must treat 30-50 patients per day to be profitable. Legacy motion management systems often add 10-15 minutes to a treatment slot for setup and calibration.

The EmpNia system, with its “peel-and-place” workflow, aims to reduce this setup time to under 3 minutes.

• The Math of Efficiency: Saving 10 minutes per patient on 10 breath-hold patients a day saves nearly 1.5 hours of machine time.
• The Revenue Implication: This allows the clinic to treat 4-6 additional patients per day, generating significant additional revenue while reducing patient waitlists.
• The Rationale: This direct link between the technology (disposable sensors) and the business outcome (throughput) was a key factor in the AI’s selection of this patent.

Future Potentials: Beyond Oncology

While the patent is rooted in radiation therapy, the underlying technology—high-sensitivity, EMI-immune, disposable physiological sensing—has vast “Blue Ocean” potential:

• MRI Monitoring: Because the sensor uses light (no metal), it is perfectly safe for MRI environments, where patient monitoring is currently very difficult due to the massive magnetic fields. The patent 12,516,964 explicitly mentions “compensating for dynamic changes… during a controlled interaction,” which covers MRI-guided interventions.
• Neonatal Care: The extreme sensitivity of FBG sensors could allow for non-invasive respiration monitoring of premature infants without heavy electronic leads that can damage fragile skin.
• Sleep Medicine: A disposable home-use patch for diagnosing sleep apnea could replace cumbersome take-home wiring kits.
• Post-Surgical Monitoring: Cheap, disposable patches could monitor respiratory depression in patients on opioids in general wards, preventing failure-to-rescue events.

R&D Tax Credit Analysis: Substantiating the Innovation

For companies like EmpNia, and for the clinics adopting such technology to improve their own processes, the Research and Development (R&D) Tax Credit (IRC Section 41) represents a vital mechanism for recouping investment. However, claiming this credit requires strictly satisfying the IRS’s “Four-Part Test.”

Swanson Reed, a specialized R&D tax advisory firm, utilizes a rigorous methodology to document and substantiate these claims. Below is a detailed analysis of how a project utilizing the technology in Patent 12,516,964 meets each component of the 4-Part Test, and how Swanson Reed facilitates this process.

The Four-Part Test Applied to Patent 12,516,964

Test 1: Permitted Purpose (The “New or Improved” Requirement)

• Definition: The activity must relate to a new or improved function, performance, reliability, or quality of a business component (product, process, software, technique, formula, or invention).
• Application to Patent: The development of the eMotus system clearly meets this. The “Business Component” is the respiratory monitoring device. The “Permitted Purpose” is to improve the reliability of tumor tracking (by eliminating EMI noise), improve the performance of the workflow (by reducing setup time), and improve the quality of the signal (via FBG technology).
• Swanson Reed’s Role: Swanson Reed would document the specific “baseline” performance of legacy systems (e.g., Varian RPM) and clearly articulate the specific performance metrics (e.g., signal-to-noise ratio, setup time reduction) that the R&D project aimed to improve, establishing a clear Permitted Purpose.

Test 2: Technological in Nature (The “Hard Science” Requirement)

• Definition: The process of experimentation must rely on principles of the physical or biological sciences, engineering, or computer science.
• Application to Patent: The invention is deeply rooted in Physics (Optics) and Mechanical Engineering. The development required calculating the refractive index of the fiber core, designing the Bragg Grating period to reflect specific wavelengths, and engineering the mechanical coupling of the polymer patch to the human skin to ensure efficient strain transfer. It does not rely on soft sciences like psychology or market research.
• Swanson Reed’s Role: Swanson Reed’s team, which includes qualified engineers and scientists (not just accountants), would gather the technical schematics, optical physics calculations, and engineering logs to prove that the work was fundamentally technical. This prevents the common audit risk where the IRS claims the work was merely “aesthetic” or “routine”.

Test 3: Elimination of Uncertainty (The “Technical Risk” Requirement)

• Definition: At the outset of the project, there must be uncertainty regarding the capability to develop the product, the method of development, or the appropriate design of the product.
• Application to Patent: Developing a disposable fiber optic sensor involves immense uncertainty.
  • Uncertainty of Design: “Can we manufacture a Fiber Bragg Grating cheaply enough to be disposable?” (Traditionally, these are expensive aerospace components).
  • Uncertainty of Method: “How do we couple a glass fiber to a flexible plastic patch without the glass breaking when the patient moves?”
  • Uncertainty of Capability: “Can the interrogator unit resolve the wavelength shift accurately in real-time with low latency?”
  • Evidence: The very existence of the patent application proves that the solution was not obvious and required discovery.
• Swanson Reed’s Role: Swanson Reed utilizes the “TaxTrex” AI platform to interview technical staff and contemporaneously document these uncertainties as they occurred. They would extract project emails and meeting minutes that show engineers asking, “We don’t know if this polymer will hold the fiber correctly,” which effectively locks in the proof of uncertainty.

Test 4: Process of Experimentation (The “Systematic Trial” Requirement)

• Definition: Substantially all of the activities must constitute a process of experimentation involving simulation, evaluation of alternatives, and systematic trial and error to resolve the technical uncertainty.
• Application to Patent: The development of eMotus likely involved:
  • Hypothesis: “A silicone-based adhesive will transfer chest wall strain to the fiber.”
  • Testing: Prototyping various patch materials (Silicone vs. Polyurethane).
  • Analysis: Finding that Silicone absorbed too much strain, leading to weak signals.
  • Refinement: Switching to a stiffer polymer backing.
  • Retesting: verifying the new design.
  • This iterative cycle—Hypothesis, Test, Analyze, Refine—is the textbook definition of the Process of Experimentation.
• Swanson Reed’s Role: This is where claims often fail. The IRS requires proof that alternatives were evaluated. Swanson Reed would document the “failed attempts” (e.g., the discarded patch designs) just as rigorously as the final success. Their “6-Eye Review” process ensures that the narrative of experimentation is cohesive and links directly back to the technical uncertainties identified in Test 3.

How Swanson Reed Facilitates the Claim

Claiming the R&D tax credit for a complex medical device patent is high-stakes. The IRS frequently audits high-dollar claims. Swanson Reed provides a specialized service model designed to secure these claims:

1. Specialized Expertise: Unlike generalist CPA firms, Swanson Reed focuses exclusively on the R&D tax credit. Their team includes engineers who understand Fiber Bragg Gratings and can speak the same language as the inventors at EmpNia. This ensures that the technical nuance of the innovation is not lost in translation to the tax forms.
2. The “Six-Eye Review”: Every claim undergoes a mandatory review by three distinct experts: a Qualified Engineer (to validate the technology), a Scientist (to validate the experimental process), and a Tax Attorney/CPA (to validate the legal compliance). This triple-check mechanism creates a fortress of substantiation around the claim.
3. Audit Defense: Swanson Reed provides audit support. Because their documentation (via TaxTrex) is generated contemporaneously and structured around the 4-Part Test from day one, they can rapidly respond to IRS Information Document Requests (IDRs) with organized, defensible evidence.
4. TaxTrex AI Technology: Just as EmpNia uses technology to solve clinical problems, Swanson Reed uses their proprietary TaxTrex AI to solve compliance problems. This system automates the extraction of technical data from project management tools, ensuring that no eligible R&D activity (or expense) is overlooked.

Final Thoughts

The designation of U.S. Patent No. 12,516,964 as the Minnesota Patent of the Month for February 2026 is a recognition of innovation that matters. By solving the complex problem of respiratory motion in cancer therapy with an elegant, disposable, fiber-optic solution, EmpNia Inc. and Manojeet Bhattacharya have created a technology that is technically superior to the incumbents and ethically vital for the democratization of healthcare.

The “eMotus” system serves as a prime example of the type of high-risk, high-reward engineering that the R&D Tax Credit was designed to foster. Through the rigorous application of the 4-Part Test and the specialized support of firms like Swanson Reed, such innovations can continue to be funded, developed, and deployed, ensuring that Minnesota remains a global beacon of medical technology.