Utah Patent of the Month – January 2026

A Paradigm Shift in Infection Control

Introduction to the Award-Winning Innovation

In the contemporary landscape of medical device engineering, few innovations manage to bridge the chasm between sophisticated theoretical physics and urgent, bedside clinical necessity as effectively as the newly issued United States Patent No. 12,527,945. Officially applied for on November 13, 2022, and granted on January 20, 2026, this intellectual property is titled “Disposable fiber optic introducer component of a light delivery system for preventing, reducing and/or eliminating infections during institutional or in-home use”. The patent, assigned to Light Line Medical, Inc., protects a critical component of a novel infection control ecosystem: a disposable interface designed to deliver therapeutic visible light directly into the lumen of indwelling catheters. In recognition of its technological sophistication and potential to disrupt the standard of care, this patent has been awarded the distinguished title of Utah Patent of the Month. This selection was not the result of a traditional subjective review board but was instead determined through a rigorous, data-driven process utilizing Artificial Intelligence (AI) technology. The AI algorithms, utilizing Swanson Reed’s proprietary inventionINDEX metric, analyzed a dataset of over 1,000 potential patents filed within the jurisdiction, filtering for novelty, technical complexity, and commercial viability. Patent 12,527,945 emerged from this exhaustive digital screening as the preeminent innovation of its cohort.

The designation of Patent 12,527,945 as the Utah Patent of the Month is predicated primarily on its profound and immediate real-world impact. While the domain of intellectual property is often populated by incremental improvements or theoretical abstractions, this invention addresses a tangible global health crisis: Catheter-Associated Infections (CAIs). The AI-driven selection committee identified that the integration of a disposable fiber optic introducer into a catheter system represents a fundamental architectural shift in how medical devices interact with the biological environment. By facilitating visible light photo-disinfection, the invention offers a non-antibiotic, non-toxic, and continuous mechanism to prevent biofilm formation, addressing the twin challenges of hospital-acquired infections (HAIs) and the escalating threat of antimicrobial resistance (AMR). The selection underscores a broader shift in innovation valuation, moving beyond pure engineering novelty to prioritize technologies that deliver measurable societal and economic benefits, specifically the potential to save lives and reduce the multi-billion dollar burden on the healthcare system.

The Clinical and Economic Imperative: Why This Patent Matters

To fully appreciate the superiority of the invention described in Patent 12,527,945, one must first understand the magnitude of the problem it solves. The medical device industry has long struggled with the innate incompatibility between synthetic materials and the human immune system, a struggle that manifests most acutely in the form of infections.

The Burden of Healthcare-Associated Infections (HAIs)

Healthcare-Associated Infections (HAIs) represent one of the most significant causes of morbidity and mortality in modern healthcare systems. Among these, device-associated infections are particularly pernicious because the device itself—the catheter—provides a superhighway for pathogens to bypass the body’s natural physical barriers (skin and mucous membranes) and enter sterile compartments like the bloodstream, urinary tract, or peritoneum.

• Central Line-Associated Bloodstream Infections (CLABSI): These are among the deadliest HAIs. Mortality rates for patients who acquire a CLABSI can exceed 12-25%. Beyond the human toll, the financial cost is staggering, with treatment costs averaging between $45,000 and $90,000 per incident.
• Catheter-Associated Urinary Tract Infections (CAUTI): As the most common type of HAI, CAUTIs drive massive antibiotic usage, contributing significantly to the selection pressure that breeds resistant organisms.
• Peritoneal Dialysis (PD) Peritonitis: For patients with End-Stage Renal Disease (ESRD), Peritoneal Dialysis offers a life-enhancing home-based therapy. However, the fear of peritonitis—an infection of the lining of the abdomen—remains the “Achilles heel” of PD, preventing widespread adoption and forcing millions of patients into expensive, quality-of-life-limiting in-center hemodialysis.

The Biology of Biofilms: The Unsolved Challenge

The core failure of previous technologies lies in their inability to effectively manage biofilms. A biofilm is a structured community of bacteria enclosed in a self-produced polymeric matrix that adheres to an inert surface, such as a polyurethane catheter. Once a biofilm forms on the inner or outer surface of a catheter, it becomes extremely difficult to eradicate.

• Antibiotic Tolerance: Bacteria within a biofilm can be up to 1,000 times more resistant to antibiotics than their planktonic (free-floating) counterparts. The matrix acts as a physical shield, preventing drugs from reaching the bacteria.
• Immune Evasion: The biofilm also protects pathogens from the host’s immune cells, rendering natural defenses ineffective.
• The Patent’s Solution: The technology in Patent 12,527,945 addresses this by preventing the biofilm from forming in the first place. By delivering high-intensity visible light, the system creates a hostile environment for bacteria on the catheter surface, disrupting their ability to colonize and form the matrix.

Technological Deep Dive: The Engineering of Patent 12,527,945

The patent does not merely describe a light source; it describes a complex, integrated system designed for clinical reality. The innovation centers on the “Disposable Fiber Optic Introducer,” a component that solves the logistical and economic hurdles of bringing light therapy into the body.

The Core Invention: The Disposable Interface

The crux of the invention is the separation of the system into two distinct parts: a reusable “Light Engine” (containing the expensive laser diodes, power management, and control logic) and a disposable “Fiber Optic Introducer” (the sterile interface that enters the patient).

This architecture is critical for several reasons:

1. Infection Control: In medical environments, any component that touches a patient or enters a sterile field must be sterilized or discarded. By making the light-delivery element disposable, Light Line Medical ensures that there is zero risk of cross-contamination between patients.
2. Optical Coupling Efficiency: One of the primary engineering challenges in photonics is “coupling”—getting light from a source into a fiber without losing energy. The patent describes a mechanism to efficiently couple high-intensity light from the reusable engine into the disposable fiber, ensuring that the therapeutic dose reaching the bacteria is sufficient to kill them.
3. Mechanical Flexibility: The introducer is designed to navigate the tortuous paths of human anatomy (e.g., the urethra or the convoluted path of a central venous line) without kinking or breaking, which would interrupt light transmission.

Mechanism of Action: Visible Light Photo-Disinfection

The technological superiority of the patent lies in its use of visible light, specifically in the violet-blue spectrum (approximately 405 nm), rather than Ultraviolet (UV) light. This distinction is the fundamental driver of its safety and efficacy profile.

Photodynamic Inactivation (PDI)

The mechanism relies on a photo-physical process known as Photodynamic Inactivation.

• Endogenous Targets: Many pathogenic bacteria, including Staphylococcus aureus and Pseudomonas aeruginosa, naturally produce porphyrins as byproducts of their metabolic synthesis of heme.
• Excitation: When these intracellular porphyrins are exposed to high-intensity light at specific wavelengths (e.g., 405 nm), they absorb the photon energy and transition to an excited triplet state.
• Reactive Oxygen Species (ROS): As the excited porphyrins return to their ground state, they transfer energy to molecular oxygen, creating Reactive Oxygen Species (ROS), primarily singlet oxygen.
• Cellular Destruction: These ROS are highly reactive and cytotoxic. They attack multiple cellular structures simultaneously—oxidizing lipids in the cell membrane, damaging DNA, and denaturing essential proteins. This multi-target attack causes rapid cell death.

The Safety Paradox: Why It Kills Bacteria but Not Humans

A critical innovation described in the research surrounding this patent is the differential toxicity. Human (mammalian) cells have evolved complex antioxidant defense mechanisms (such as catalase and superoxide dismutase) to manage oxidative stress. Consequently, mammalian cells can neutralize the levels of ROS generated by the device, leaving them unharmed. Bacteria, being more primitive, lack these robust defenses and are rapidly overwhelmed by the oxidative burst. This allows the device to be used continuously inside the human body without causing tissue necrosis, a feat impossible with UV light or chemical sterilants.

Comprehensive Competitive Benchmarking

To rigorously validate the claim that Patent 12,527,945 represents a superior technology, we must benchmark it against the current market leaders and alternative modalities. The infection control market is currently dominated by three categories: Ultraviolet (UV) systems, Chemical/Antibiotic Coated Catheters, and Standard Manual Protocols.

Competitor 1: Ultraviolet (UV) Light Systems

Primary Market Player: PuraCath Medical. Technology: Utilization of UV-C light (200-280 nm) to sterilize catheter connection hubs.

Comparative Analysis:

Verdict: The technology in Patent 12,527,945 is superior because it resolves the fundamental “Material vs. Biology” conflict. UV light kills bacteria but destroys the catheter and harms the patient. Visible light kills bacteria while preserving the catheter and protecting the patient.

Competitor 2: Antimicrobial and Antibiotic Coated Catheters

Primary Market Players: C.R. Bard, Teleflex, Cook Medical. Technology: Catheters impregnated with antibiotics (e.g., minocycline/rifampin) or antiseptics (chlorhexidine, silver ions) that elute over time.

Comparative Analysis:

Verdict: Patent 12,527,945 offers a durable, non-chemical solution. In an era where antibiotic resistance is a top global health threat, shifting from chemical dependence to physical disinfection (photonics) is a superior strategic pathway.

Competitor 3: Standard Manual Protocols (“Scrub the Hub”)

Method: Relying on nursing staff to manually scrub catheter hubs with alcohol wipes before every access.

Comparative Analysis:

• Human Error: Standard care is entirely dependent on compliance. In a busy ICU, adherence to the 15-second scrub rule is often low.
• Scope: Scrubbing only cleans the entry point. It does nothing for bacteria that have already migrated inside the lumen or formed a biofilm on the internal surface.
• LLM Advantage: The system described in the patent automates disinfection. By delivering light continuously or on a fixed schedule, it removes human variability from the equation. It treats the entire fluid path, ensuring sterility regardless of nursing compliance levels.

Real-World Impact: Current and Future Potentials

The “Real-World Impact” criterion was the decisive factor in this patent’s selection as the Utah Patent of the Month. The implications of this technology extend far beyond the engineering lab.

Transforming Home Dialysis

One of the most immediate applications of this technology is in Peritoneal Dialysis (PD).

• Current State: Only ~15% of US dialysis patients utilize home PD, despite it being cheaper and offering better quality of life than in-center hemodialysis. The primary barrier is the patient’s fear of infecting their catheter (peritonitis).
• Patent Impact: The “disposable fiber optic introducer” allows for a system that patients can easily use at home. By simply connecting the light source, the catheter is disinfected automatically. This “peace of mind” technology could catalyze a massive shift toward home modalities, saving the healthcare system billions in dialysis costs and freeing patients from the tether of dialysis clinics.
• Economic Scale: Increasing PD utilization is a federal mandate (via the ESRD Treatment Choices Model). This technology is a critical enabler for meeting these federal targets.

Combatting Antimicrobial Resistance (AMR)

The World Health Organization has declared AMR one of the top 10 global public health threats facing humanity.

• Current State: We are running out of effective antibiotics. Treating a single case of resistant Staphylococcus aureus can require toxic, last-resort drugs.
• Patent Impact: By preventing infections physically (using light), this technology reduces the aggregate volume of antibiotics prescribed in hospitals. Fewer infections mean fewer antibiotics, which means less selection pressure for resistant organisms. It preserves the efficacy of our existing drug arsenal for future generations.

Future Potentials and Platform Expansion

The patent describes a “platform technology.” The concept of a disposable light introducer is not limited to one type of catheter.

• Respiratory Care: Adaptation for Endotracheal Tubes to prevent Ventilator-Associated Pneumonia (VAP), a major killer in ICUs, particularly highlighted during the COVID-19 pandemic.
• Urinary Care: Application in Foley catheters to prevent CAUTIs in nursing homes and long-term care facilities.
• Military Medicine: In battlefield scenarios (Role 1 or Role 2 care), maintaining sterile conditions for IV lines is nearly impossible. A self-disinfecting catheter powered by a portable battery pack could drastically reduce sepsis rates among wounded service members during transport.
• Global Health: In developing nations where sterile supply chains are unreliable, a reusable light engine with low-cost disposable fibers could bring first-world infection control standards to resource-constrained environments.

R&D Tax Credit Analysis: Meeting the Four-Part Test

The development of the technology described in Patent 12,527,945 is a quintessential example of “Qualified Research” as defined by Internal Revenue Code (IRC) Section 41. For companies like Light Line Medical, claiming the Research and Development (R&D) Tax Credit is not just a financial benefit but a strategic necessity to fund continued innovation.

To qualify for the credit, the research activities must satisfy the Four-Part Test. Below is a detailed analysis of how the development of the “Disposable fiber optic introducer” meets each rigorous requirement.

Test 1: Permitted Purpose

Requirement: The activity must relate to a new or improved business component (product, process, software, formula, technique) with the specific aim of improving functionality, performance, reliability, or quality.

Application to Patent 12,527,945:

• Business Component: The specific “Disposable Fiber Optic Introducer” and the integrated “Light Delivery System.”
• Nature of Improvement: The project aimed to create a new capability: the delivery of therapeutic visible light inside a catheter lumen using a disposable interface. This represents a functional improvement over prior art (which lacked internal delivery or used toxic UV) and an improvement in reliability (automated vs. manual disinfection).
• Substantiation: The patent claims themselves serve as primary evidence of the “Permitted Purpose.” The abstract explicitly states the purpose is “preventing, reducing and/or eliminating infectious agents,” which directly maps to improving the quality (safety) and performance (efficacy) of the medical device.

Test 2: Elimination of Uncertainty

Requirement: The taxpayer must demonstrate that, at the outset of the project, there was uncertainty regarding the capability to develop the component, the method of development, or the appropriate design of the component.

Application to Patent 12,527,945:

Developing a fiber optic system for in vivo use involves significant technical uncertainty that standard engineering knowledge could not resolve without investigation:

• Optical Uncertainty: How to efficiently couple light from a reusable engine into a disposable fiber without significant insertion loss? There was uncertainty regarding the alignment tolerances and the refractive index matching required at the disposable interface.
• Thermal Uncertainty: High-intensity light generates heat. There was uncertainty regarding the design necessary to dissipate this heat to prevent the catheter from exceeding ISO 10993 thermal safety limits (typically <42°C) while maintaining a lethal dose for bacteria.
• Material Uncertainty: Could a fiber optic material be found that was flexible enough to navigate a catheter without breaking, yet rigid enough to be inserted? Standard glass fibers are too brittle; standard plastic fibers might attenuate the specific 405nm wavelength too heavily.

Test 3: Process of Experimentation

Requirement: The taxpayer must engage in a process designed to evaluate one or more alternatives to eliminate the uncertainty. This involves simulation, modeling, or systematic trial and error.

Application to Patent 12,527,945:

The development of this patent required a documented, iterative experimental process:

• Alternative Evaluation: The team likely evaluated multiple fiber core materials (e.g., PMMA vs. silica) and cladding types to optimize light transmission and flexibility.
• Systematic Testing:
  • Microbiological Assays: Testing various wavelengths (400nm, 405nm, 420nm) and intensities against different pathogens (MRSA, Candida) to determine the Minimum Inhibitory Concentration (MIC) for light.
  • Thermal Profiling: Using thermocouples and thermal imaging to measure heat generation in prototype catheters under various duty cycles.
  • Mechanical Stress Testing: Subjecting the disposable introducer to repeated flexion and insertion tests to determine the failure point.
• Iterative Design: The patent reflects the final design resulting from the elimination of failed prototypes (e.g., connectors that leaked light or fibers that snapped). Documentation of these failures is critical for the credit.

Test 4: Technological in Nature

Requirement: The process of experimentation must rely on the principles of the hard sciences (physics, biology, engineering, computer science).

Application to Patent 12,527,945:

The project is fundamentally rooted in the hard sciences, distinguishing it from non-qualified research (like market research or aesthetic design):

• Physics/Optics: The design relies on principles of photonics, refraction, numerical aperture, and light scattering profiles.
• Microbiology: The efficacy testing relies on understanding microbial physiology, porphyrin excitation spectra, and oxidative stress responses.
• Biomedical Engineering: The interface design relies on principles of biocompatibility and mechanical engineering.
• Chemistry: The material selection involves understanding polymer chemistry and photo-degradation resistance.

Claiming the Credit: How Swanson Reed Assists

Navigating the nuanced requirements of the R&D Tax Credit requires specialized expertise, particularly for complex medical device companies. Swanson Reed, as a leading specialist R&D tax advisory firm, provides a structured methodology to ensure that claims for innovations like Patent 12,527,945 are maximized and defensible.

TaxTrex: AI-Driven Documentation and Substantiation

One of the primary challenges for engineering teams is documentation. Engineers focus on inventing, not logging hours for the IRS. Swanson Reed addresses this with TaxTrex, a proprietary AI-driven platform.

• Real-Time Capture: Instead of attempting to reconstruct the “Process of Experimentation” years later (which introduces “hindsight bias” risks), TaxTrex surveys engineers periodically throughout the fiscal year.
• Technical Nexus: The AI helps establish the “nexus” between the expense (e.g., the salary of the optical physicist) and the qualified project (the disposable introducer). It timestamps technical uncertainties and experimental outcomes, creating a contemporaneous audit trail that is difficult for the IRS to challenge.
• Accessibility: TaxTrex allows companies to self-claim the credit in as little as 90 minutes, lowering the barrier to entry for startups like Light Line Medical that need to conserve burn rate.

The “Six-Eye Review”: Institutionalizing Quality Control

To ensure the defensibility of the claim, Swanson Reed employs a mandatory Six-Eye Review process for every client.

• Eye Pair 1: Qualified Engineer/Scientist: A subject matter expert reviews the technical narrative. For Patent 12,527,945, this reviewer would verify that the “uncertainties” claimed were truly technical challenges and not just standard engineering practice.
• Eye Pair 2: Tax Attorney: A legal specialist reviews the claim for compliance with current statutory law and court cases (e.g., Little Sandy Coal). They specifically analyze contracts to ensure “funded research” exclusions are handled correctly—a critical step for medical device companies that often receive grants.
• Eye Pair 3: CPA/Enrolled Agent: A financial expert verifies the calculation of the Base Amount and the accurate allocation of Qualified Research Expenses (QREs), such as wages, supplies (e.g., fiber optic prototypes), and contractor costs (e.g., third-party sterilization testing).

Audit Defense: creditARMOR

Recognizing that the IRS frequently scrutinizes high-value R&D claims, Swanson Reed offers creditARMOR, an audit defense and insurance product.

• Risk Management: This service uses AI to assess the risk profile of a claim before submission.
• Defense Support: In the event of an audit, Swanson Reed provides the specialized CPAs and attorneys needed to defend the claim, covering the professional fees associated with the defense. This allows innovators to claim the credit with confidence, knowing they have a safety net.

Final Thoughts

US Patent No. 12,527,945 represents a landmark achievement in the field of medical technology. By harnessing the safe, physical power of visible light to combat infection, it offers a solution that is clinically effective, economically viable, and critically necessary in the age of antibiotic resistance. Its recognition as the Utah Patent of the Month, driven by Swanson Reed’s AI-powered inventionINDEX, highlights the shift towards valuing innovation based on its tangible impact on human health.

For the innovators driving such progress, the R&D Tax Credit is a vital mechanism for sustainability. Through the rigorous application of the Four-Part Test—demonstrating the Permitted Purpose, Elimination of Uncertainty, Process of Experimentation, and Technological Nature of their work—companies can reclaim significant capital to reinvest in the next generation of life-saving devices. With the support of specialized partners like Swanson Reed and advanced tools like TaxTrex, the pathway from patent to patient is not only engineered for safety but also optimized for financial efficiency.