Illinois Patent of the Month – February 2026

Quick Summary:U.S. Patent No. 12,527,622, titled “System for minimally invasive tissue ablation and sealing,” has been selected as the Illinois Patent of the Month for February 2026. Assigned to Innoblative Designs, Inc., this innovation introduces Saline-coupled Radiofrequency Ablation (SIRA) technology to address high reoperation rates in breast conserving surgery. The patent benchmarks favorably against competitors by offering a conformable, therapeutic solution for surgical margins and meets the strict “Four-Part Test” criteria for R&D Tax Credit eligibility under IRC Section 41.

Illinois Patent of the Month: A Comprehensive Research Report on U.S. Patent No. 12,527,622

Report Overview

The landscape of modern surgical oncology is increasingly defined by the convergence of precision engineering, biophysics, and data-driven innovation. In recognition of a transformative advancement in this domain, United States Patent No. 12,527,622, titled “System for minimally invasive tissue ablation and sealing,” has been awarded the distinguished title of Illinois Patent of the Month for February 2026.

This patent, applied for on April 4, 2022, and officially issued on January 20, 2026, is assigned to Innoblative Designs, Inc., a medical technology company headquartered in Chicago, Illinois. The selection of this patent was not the result of a traditional, subjective review process. Instead, it was identified through a rigorous, algorithmic evaluation conducted by Swanson Reed. Utilizing proprietary Artificial Intelligence (AI) technology, the selection committee scanned, parsed, and analyzed a dataset comprising over 1,000 potential patents granted within the jurisdiction during the eligibility period. The AI utilized a multi-dimensional scoring matrix—the inventionINDEX—to evaluate candidates based on technological novelty, commercial viability, claimed utility, and potential for societal benefit. Out of this extensive field, Patent No. 12,527,622 emerged as the preeminent innovation, securing its place as the Illinois Patent of the Month.

The selection of the Innoblative patent is predicated heavily on its profound real-world impact. While many patents remain theoretical or represent incremental manufacturing improvements, this invention addresses a critical, unresolved clinical failure mode in breast cancer treatment: the high rate of reoperation following breast-conserving surgery (lumpectomy). By benchmarking the technology against existing standards of care and competitor devices, the analysis reveals a superior engineering approach to intraoperative margin management. This report provides an exhaustive analysis of the patent’s technical claims, its superiority over competitors, its market potential, and its eligibility for the Research and Development (R&D) Tax Credit under Internal Revenue Code (IRC) Section 41.


Introduction: The Intersection of AI and Surgical Innovation

The Selection Methodology

The designation of “Patent of the Month” by Swanson Reed is a hallmark of industrial and technological excellence. In an era where the volume of intellectual property filings is exponential, identifying truly disruptive innovation requires tools that transcend human processing speeds. For the February 2026 cycle, Swanson Reed’s AI-driven analytical engine processed over 1,000 patents issued to Illinois-based assignees or inventors.

The AI evaluation model prioritizes patents that demonstrate:

  1. Technological Robustness: The complexity and novelty of the engineering solution.
  2. Market Disruptability: The potential to displace existing standards of care.
  3. Scalability: The capacity for the technology to be applied across multiple indications or industries.
  4. Social Utility: The direct benefit to human health, safety, or environmental sustainability.

Patent No. 12,527,622 scored in the top percentile across these metrics. The AI identified the patent’s specific claims regarding “multi-source fluid delivery” and “flexible shaft architecture” as solving a long-standing geometric problem in electrosurgery—the inability to uniformly ablate irregular tissue cavities. This technical nuance, combined with the immense humanitarian impact of improving breast cancer outcomes, solidified its selection.

Patent Profile

  • Patent Number: US 12,527,622
  • Title: System for minimally invasive tissue ablation and sealing
  • Assignee: Innoblative Designs, Inc. (Chicago, IL)
  • Inventors: Zachary Rzeszutek, Tyler Wanke, Robert F. Rioux, Alyssa Bailey, Thomas Kurth
  • Application Date: April 4, 2022
  • Issue Date: January 20, 2026
  • Core Technology: Saline-coupled Radiofrequency Ablation (SIRA) utilizing a conformable, spherical applicator.

The Clinical Imperative: Why Real-World Impact Drove This Selection

To understand the magnitude of this invention, one must first understand the clinical crisis it addresses. The “real-world impact” cited in the award justification refers specifically to the limitations of Breast Conserving Surgery (BCS).

The Standard of Care and Its Failures

Breast cancer is the most common malignancy in women worldwide. For early-stage disease, the standard of care has shifted from total mastectomy (removing the entire breast) to breast-conserving surgery, commonly known as lumpectomy. In this procedure, the surgeon removes the tumor along with a rim (margin) of healthy tissue, aiming to preserve the cosmetic appearance of the breast while ensuring all cancer is removed.

However, the procedure suffers from a critical flaw: the inability to detect microscopic residual disease in real-time.

  • The “Goldilocks” Dilemma: Surgeons must balance removing enough tissue to clear the cancer (oncologic safety) with leaving enough tissue to preserve the breast’s shape (cosmetic outcome).
  • Pathology Delay: After the tumor is removed, it is sent to a pathology lab. It takes 3 to 7 days to process the tissue and determine if the margins are “clean” (cancer-free) or “positive” (cancer cells found at the edge).
  • The Reoperation Rate: If margins are positive, the patient must return to the operating room for a second surgery (re-excision) to remove more tissue. Current statistics indicate that 20% to 25% of women undergoing lumpectomy require a reoperation.

The Human and Economic Cost

The real-world impact of this failure rate is staggering:

  • Patient Trauma: Reoperation causes significant psychological distress, anxiety, and physical pain. It also delays the start of adjuvant therapies like radiation or chemotherapy, which can impact overall survival.
  • Surgical Risks: Every additional surgery increases the risk of infection, hematoma, and adverse reaction to anesthesia.
  • Cosmetic Deformity: Repeated resection of tissue leads to poorer cosmetic outcomes and asymmetry, often necessitating reconstructive surgery.
  • Financial Burden: The cost of a re-excision surgery is substantial, estimated at $12,000 to $16,000 per episode. With hundreds of thousands of lumpectomies performed annually in the U.S., reoperations drain hundreds of millions of dollars from the healthcare system.

The Solution: Patent No. 12,527,622 describes a technology designed to eliminate this “wait and see” approach. By delivering therapeutic ablation to the cavity during the initial surgery, it aims to destroy any residual microscopic disease immediately, effectively rendering the margin status moot and preventing the need for reoperation. This potential to significantly improve the quality of life for millions of women was the primary driver for its selection as the Illinois Patent of the Month.


Technical Analysis: The Superiority of Patent No. 12,527,622

The patent details a specific engineering breakthrough: the SIRA™ (Saline-coupled Intraoperative Radiofrequency Ablation) technology. This section deconstructs the patent claims to explain why this approach is technically superior to existing electrosurgical methods.

The Physics of Ablation: Overcoming Impedance

To appreciate the innovation, one must understand the limitations of traditional Radiofrequency Ablation (RFA).

  • Traditional RFA (The Dry Interface): Standard electrosurgical devices (like the Bovie pencil or traditional RFA needles) pass electrical current through tissue. The tissue’s resistance generates heat. However, as tissue heats up, water vaporizes (desiccation). Dried tissue acts as an insulator, causing electrical impedance to skyrocket. This stops the flow of current and causes the tissue closest to the electrode to char (carbonize). Charring creates a barrier that prevents heat from penetrating deeper, resulting in shallow, unpredictable ablation.
  • The Innoblative Solution (The Wet Interface): Patent 12,527,622 describes a system with “a plurality of different fluid sources” delivering conductive fluid (saline) to the ablation site. The device “weeps” saline at the electrode-tissue interface.
  • Virtual Electrode: The saline acts as a “virtual electrode,” increasing the effective surface area of electrical contact.
  • Impedance Management: By keeping the interface hydrated, the device prevents desiccation and charring. This allows the current to continue flowing, driving heat deeper into the target tissue (the margins) in a controlled, predictable manner.
  • Uniformity: The fluid distribution ensures that the entire target area receives the same thermal dose, eliminating “hot spots” and “cold spots.”

Geometric Innovation: The Spherical Applicator

The second major engineering challenge in lumpectomy is geometry. A lumpectomy cavity is roughly spherical but irregular.

  • The Competitor Flaw: Most ablation devices are needle-shaped (designed for liver tumors) or flat (designed for skin). Using a straight needle to treat a spherical cavity is geometrically impossible without multiple overlapping punctures, which is time-consuming and prone to error (gaps in treatment).
  • The Patent 12,527,622 Advantage: The patent describes a flexible shaft connected to a distal tip that is spherical in shape. This applicator is:
  • Conformable: It expands to fill the cavity, pressing against the tissue walls.
  • Circumferential: It treats the entire surface area of the cavity simultaneously (360 degrees) rather than requiring the surgeon to “paint” the cavity point-by-point.
  • Flexible: The “flexible and resilient shaft” allows the device to be inserted through a small incision and navigated to the target site without traumatizing the skin or surrounding breast tissue.

Benchmarking Against Competitors

The following analysis benchmarks the Innoblative technology against its primary market competitors.

Competitor 1: Medtronic / Covidien (Traditional RFA)

Technology: Devices like the Cool-tip™ or StarBurst™ systems.

Mechanism: Needle-based electrodes, often with internal water cooling (not saline infusion into tissue).

Why Patent 12,527,622 is Superior:

  • Geometry: Medtronic’s devices are rigid needles designed to pierce solid organs. They cannot conform to a hollow cavity. Using them in a breast lumpectomy requires “stitching” multiple ablations together, which is imprecise.
  • Impedance: Internal cooling protects the electrode but does not actively hydrate the tissue. Charring remains a risk at high powers. The Innoblative patent’s active fluid delivery into the tissue is a superior method for maintaining conductivity.

Competitor 2: IceCure Medical (Cryoablation)

Technology: ProSense™ System.

Mechanism: Liquid nitrogen freezes tissue, creating an “ice ball.”

Why Patent 12,527,622 is Superior:

  • Speed: Cryoablation is slow. A freeze-thaw-freeze cycle can take 20 to 40 minutes. The SIRA device, utilizing RF energy, can achieve therapeutic temperatures in minutes, fitting seamlessly into the surgical workflow.
  • Control: An ice ball grows indiscriminately. It is harder to shape an ice ball to a thin surgical margin than it is to apply a contact-based RF sphere.
  • Hemostasis: Freezing does not stop bleeding. The Innoblative patent explicitly claims “sealing” capabilities. The RF energy coagulates blood vessels (hemostasis) while it ablates, reducing the risk of post-operative hematomas.

Competitor 3: Dune Medical (MarginProbe)

Technology: MarginProbe.

Mechanism: RF spectroscopy (Diagnostic only). It measures electrical differences between cancer and healthy tissue.

Why Patent 12,527,622 is Superior:

  • Action: MarginProbe is diagnostic. It tells the surgeon, “There might be cancer here.” The surgeon then has to cut more tissue, which degrades the cosmetic result. Innoblative is therapeutic. It does not just find the problem; it fixes it by destroying the cells.
  • Workflow: MarginProbe requires ex-vivo testing of the removed tissue. SIRA treats the patient directly.

Competitor 4: Hologic (BioZorb)

Technology: BioZorb Marker.

Mechanism: A 3D spiral marker placed in the cavity to help radiation oncologists target the site later.

Why Patent 12,527,622 is Superior:

  • Function: BioZorb is a passive marker. It has no therapeutic effect on cancer cells. SIRA is an active treatment device. While BioZorb helps future radiation, SIRA potentially reduces the need for aggressive radiation by sterilizing the bed immediately.

Comparative Summary Table

Feature Innoblative (Patent 12,527,622) Medtronic (RFA) IceCure (Cryo) MarginProbe
Primary Function Therapeutic Ablation & Sealing Therapeutic Ablation Therapeutic Ablation Diagnostic Detection
Applicator Shape Spherical (Cavity Conformable) Rigid Needle Rigid Needle Flat Probe
Energy Source Saline-Coupled RF Standard RF Liquid Nitrogen RF Spectroscopy
Impedance Control Active Saline Infusion (Superior) Passive Cooling N/A N/A
Cycle Time Minutes Minutes 20-40 Minutes 5-10 Minutes
Hemostasis Yes (Sealing) Yes No No
Target Surgical Margins (Cavity) Solid Tumors Solid Tumors Excised Tissue Surface

Real-World Impact and Future Potentials

The “impact” metric used by the AI selection process extends beyond the immediate surgical application. It encompasses the broader implications for healthcare delivery and the future trajectory of the technology.

Current Real-World Impact: The “One and Done” Surgery

The immediate deployment of the invention described in Patent 12,527,622 is in the SIRA™ device for Breast Conserving Surgery.

  • Regulatory Milestones: The technology has already received FDA Breakthrough Device Designation, a status reserved for devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases. Furthermore, the FDA has granted an Investigational Device Exemption (IDE), allowing Innoblative to proceed with clinical feasibility studies in the United States.
  • Patient Outcomes: By enabling surgeons to deliver a controlled depth of thermal necrosis (e.g., 5mm to 1cm) to the cavity walls, the technology allows for the destruction of “skip lesions” or microscopic foci of cancer that the surgeon’s knife missed. This promises to drastically reduce the 20-25% reoperation rate, ensuring that women leave the operating room cancer-free after their first procedure.
  • Cosmetic Preservation: Because the device destroys cells thermally rather than requiring the physical removal of more tissue, it preserves the volume of the breast, leading to superior cosmetic outcomes compared to aggressive surgical re-excision.

Economic Impact: Value-Based Care

In the current US healthcare environment, hospitals are increasingly reimbursed based on value (outcomes per dollar) rather than volume (fee-for-service).

  • Cost Avoidance: By preventing reoperations, the technology directly reduces the cost of care per patient episode.
  • Operating Room Efficiency: The “sealing” capability (hemostasis) reduces intraoperative bleeding, potentially shortening surgical time and reducing the need for drains and post-operative management of seromas.
  • Adoption Potential: Because the device is compatible with standard electrosurgical generators found in almost every operating room, it does not require hospitals to purchase expensive capital equipment (unlike Intraoperative Radiation Therapy, which requires million-dollar bunkers). This lowers the barrier to adoption, maximizing its real-world reach.

Future Potentials: A Platform Technology

The patent’s title, “System for minimally invasive tissue ablation and sealing,” is intentionally broad. The technology platform—flexible fluid-coupled ablation—has potential applications far beyond breast cancer.

  • Soft Tissue Sarcomas: Like breast cancer, sarcomas are large, irregular tumors where positive margins are a major concern. The conformable nature of the applicator makes it an ideal candidate for treating sarcoma resection beds.
  • Endoscopic and Laparoscopic Surgery: The patent emphasizes a “flexible shaft.” This suggests that future iterations could be miniaturized to fit through standard ports (trocars) or endoscopes. This would allow for the ablation of internal cysts, liver resection margins, or even gynecological applications (e.g., endometrial ablation) using the same physics.
  • Trauma and General Surgery: The “sealing” aspect of the patent suggests utility in trauma surgery for controlling hemorrhage from large surface areas (e.g., a liver laceration) where precise bipolar tweezers are too small and simple packing is insufficient.
  • Veterinary Medicine: High-value veterinary oncology is a growing market. The technology could be adapted for treating tumors in companion animals, providing a testing ground for further data collection.

R&D Tax Credit Analysis: Leveraging the Innovation

The development of Patent No. 12,527,622 represents a textbook case of “Qualified Research” under IRC Section 41. For companies like Innoblative Designs, Inc., claiming the Research & Development (R&D) Tax Credit is essential for recouping the high costs of innovation. Swanson Reed, as a specialist R&D tax advisory firm, utilizes a structured methodology to substantiate these claims.

The following analysis details how the specific activities involved in creating this patent meet the Four-Part Test, the statutory requirement for R&D credit eligibility.

The Four-Part Test Applied to Patent 12,527,622

To qualify, the research activities must satisfy all four of the following criteria:

Part 1: Permitted Purpose

The Requirement: The activity must relate to a new or improved business component (product, process, software, technique, formula, or invention) held for sale, lease, or license, with the purpose of improving functionality, performance, reliability, or quality.

Application to the Patent:

  • Business Component: The “SIRA™ Device” and the “System for minimally invasive tissue ablation” are the business components.
  • Purpose: The development aimed to improve performance (uniformity of ablation), functionality (ability to conform to a cavity), and quality (patient outcomes/reduced reoperation).
  • Exclusions: Swanson Reed ensures that no activities related to cosmetic design (e.g., the color of the handle) or routine data collection are included. The claim focuses strictly on the therapeutic capabilities defined in the patent.

Part 2: Technological in Nature

The Requirement: The activity must fundamentally rely on the principles of the hard sciences—physical, biological, engineering, or computer sciences.

Application to the Patent:

The development of this patent required high-level engineering in multiple disciplines:

  • Biomedical Engineering: Determining the dielectric properties of breast tissue versus tumor tissue to optimize frequency and power settings.
  • Fluid Dynamics: Modeling the flow rates of the saline infusion to ensure a stable “virtual electrode” layer without causing fluid overload or steam pops.
  • Materials Science: Selecting polymers for the “flexible shaft” that provide the necessary rigidity for insertion (pushability) while maintaining the flexibility to navigate anatomy (trackability) and biocompatibility for internal use.
  • Electrical Engineering: Designing the electrode geometry to deliver uniform current density across a spherical surface.

Part 3: Elimination of Uncertainty

The Requirement: 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 of the component.

Application to the Patent:

Innoblative faced significant technical uncertainties, including:

  • Design Uncertainty: “Can we design an expandable spherical tip that collapses sufficiently to fit through a standard incision?”
  • Methodological Uncertainty: “How do we route multiple fluid channels through a flexible shaft without compromising its structural integrity or causing kinks?”
  • Capability Uncertainty: “Can we achieve a consistent 1cm depth of ablation in variable tissue densities without causing thermal injury to the overlying skin?”
  • Swanson Reed Approach: We substantiate this by documenting the “failure to success” pathway—archiving design iterations, failed prototypes, and test results that prove the answers were not known at the start.

Part 4: Process of Experimentation

The Requirement: The taxpayer must engage in a process designed to evaluate one or more alternatives to achieve a result. This includes simulation, modeling, and systematic trial and error.

Application to the Patent:

The path to Patent 12,527,622 involved a rigorous experimental process:

  • Simulation: Use of Finite Element Analysis (FEA) to model heat transfer and current density distributions on the spherical tip.
  • Prototyping: Iterative 3D printing and molding of shaft designs to test flexibility and durability.
  • Bench Testing: Ex-vivo ablation studies on liver or breast tissue models to measure ablation zones.
  • Animal Studies: In-vivo porcine studies to validate hemostasis (sealing) and tissue necrosis in a living model.
  • Clinical Feasibility: The IDE trials currently underway represent the final stage of experimentation to validate safety and efficacy in humans.

Swanson Reed: Substantiation and Audit Defense

Successfully claiming the R&D credit requires more than just meeting the definitions; it requires robust documentation. Swanson Reed employs a unique combination of expertise and technology to assist clients like Innoblative.

AI-Driven Documentation (TaxTrex)

Swanson Reed utilizes TaxTrex, a proprietary AI language model, to streamline the substantiation process.

  • Real-Time Assessment: TaxTrex integrates with the company’s workflow to identify Qualifying Research Expenses (QREs) as they occur.
  • Linking Costs to Activities: The system creates a clear nexus between the wages of the engineers (e.g., Rzeszutek, Wanke) and the specific “uncertainties” they were solving (e.g., fluid channel design). This creates a contemporaneous audit trail that is far superior to retrospective estimates.
  • Efficiency: TaxTrex can prepare R&D tax credit claims in less than 90 minutes, allowing the technical team to focus on innovation rather than paperwork.

The Illinois R&D Credit

As the Illinois Patent of the Month, it is crucial to highlight that Innoblative can leverage the State of Illinois R&D Tax Credit in addition to the federal credit.

  • Benefit: The Illinois credit is 6.5% of qualifying expenses that exceed a base amount.
  • Sourcing: Qualifying research must be conducted within the state of Illinois. Swanson Reed’s Chicago office specializes in segregating costs to ensure that local engineering work is captured for the state credit, maximizing the return for Illinois-based innovators.

Audit Defense and Risk Management

Swanson Reed provides a “six-eye review” of every claim by a Qualified Engineer, a Scientist, and a CPA/Enrolled Agent.

  • InventionINDEX: We utilize the inventionINDEX metric to grade the strength of the patent and the associated R&D claim (e.g., giving it a “C+” to “A” grade). This allows the company to understand its risk profile.
  • Audit Readiness: By documenting the “Process of Experimentation” comprehensively (including hypotheses, tests, and conclusions), Swanson Reed ensures that the claim can withstand IRS scrutiny. The patent itself serves as the “gold standard” of proof that the work was novel and technological in nature.

Final Thoughts

The selection of U.S. Patent No. 12,527,622 as the Illinois Patent of the Month for February 2026 is a recognition of engineering excellence that transcends the laboratory. Innoblative Designs, Inc. has developed a technology that directly attacks one of the most persistent and damaging inefficiencies in cancer surgery. By replacing the “wait and see” approach of current lumpectomy protocols with a proactive, “treat and seal” methodology, the invention promises to reduce reoperation rates, lower healthcare costs, and, most importantly, alleviate the physical and emotional burden on breast cancer patients.

The patent’s “System for minimally invasive tissue ablation and sealing” represents a sophisticated convergence of fluid dynamics, materials science, and electrosurgical physics. It benchmarks favorably against all major competitors, offering a solution that is faster than cryoablation, more conformable than traditional RFA, and more therapeutic than diagnostic adjuncts.

Furthermore, the development of this technology stands as a prime example of the type of innovation the R&D Tax Credit was designed to foster. Through the rigorous application of the Four-Part Test and the advanced AI-driven substantiation methodologies provided by Swanson Reed, innovators like Innoblative can secure the capital necessary to bring such breakthrough devices from the concept stage to the operating room. This patent is not just a legal document; it is a blueprint for the future of surgical oncology.

Who We Are:

Swanson Reed is one of the largest Specialist R&D Tax Credit advisory firm in the United States. With offices nationwide, we are one of the only firms globally to exclusively provide R&D Tax Credit consulting services to our clients. We have been exclusively providing R&D Tax Credit claim preparation and audit compliance solutions for over 30 years. Swanson Reed hosts daily free webinars and provides free IRS CE and CPE credits for CPAs.

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The Research & Experimentation Tax Credit (or R&D Tax Credit), is a general business tax credit under Internal Revenue Code section 41 for companies that incur research and development (R&D) costs in the United States. The credits are a tax incentive for performing qualified research in the United States, resulting in a credit to a tax return. For the first three years of R&D claims, 6% of the total qualified research expenses (QRE) form the gross credit. In the 4th year of claims and beyond, a base amount is calculated, and an adjusted expense line is multiplied times 14%. Click here to learn more.

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