Obviousness

Obviousness Analysis of US Patent 11998262 under 35 U.S.C. § 103

This analysis assesses the obviousness of US patent 11998262 ("the '262 patent") based on the prior art explicitly identified and described within the patent text itself, as of the current date of April 26, 2026. The priority date of the '262 patent is April 9, 2020.

I. Summary of Claimed Invention

The '262 patent describes systems and methods for improving sleep by therapeutically treating rhinitis, congestion, and/or rhinorrhea. The core invention addresses shortcomings of existing treatments (e.g., temporary relief, inaccuracy, collateral damage) by providing a sophisticated handheld neuromodulation device (102) and associated methods.

Key features of the claimed invention, as described in the patent, include:

• A handheld device (102) comprising an elongate body (116), a retractable and expandable multi-segment end effector (114), and a handle (118).
• The multi-segment end effector (114) includes at least a first (proximal) flexible segment (122) and a second (distal) flexible segment (124). These segments have specific geometries in a deployed configuration to complement and conform to anatomical structures within the nasal cavity (e.g., middle turbinate, posterior cavity) and include electrodes (136) for precise, focused RF thermal energy application to therapeutically modulate neural structures. The first segment may have a bilateral geometry.
• The elongate body (116) itself includes one or more electrodes (137) provided along its length, configured to deliver energy to specific target sites in the nasal passage (e.g., inferior turbinate) that are separate and remote from the end effector's primary treatment zone, thereby reducing tissue engorgement and increasing volumetric flow. This allows for dual energy delivery in conjunction with the end effector's neuromodulation, without needing to reposition the end effector.
• The handle (118) is ergonomically designed for ambidextrous, one-handed operation (overhand/underhand grip styles) and includes independent user-operated mechanisms (126, 128) for deploying the end effector and controlling energy output, with user inputs positioned for simultaneous one-handed access.
• Markings (e.g., text, symbols, color-coding) on the handle and/or elongate body provide visual indication of the end effector's spatial orientation (linear, axial, depth position) prior to deployment.
• The method involves delivering energy (e.g., RF thermal ablation, cryo-ablation) via such a device to disrupt neural signals and/or cause local hypoxia of mucus-producing and mucosal engorgement elements, particularly targeting postganglionic parasympathetic nerves at foramina and microforamina of the palatine bone, and/or reducing engorgement of turbinate tissue to improve nasal breathability and, consequently, sleep.

II. Identified Prior Art References

The '262 patent explicitly identifies and describes the following as prior art or related technology:

1. Conventional nose breathing aids and pharmacotherapy: The patent describes these as providing temporary relief, creating new obstructions (nasal dilators), or having suboptimal efficacy and undesirable side effects (nasal sprays, pharmaceutical agents).
2. Existing surgical procedures for rhinitis: These are characterized as "not accurate and cause significant collateral damage" and failing to adequately treat underlying symptoms or address sleeping problems.
3. U.S. Publication No. 2016/0331459 ("the '459 publication"): This publication is cited in the '262 patent as describing "Additional features and functions of the nerve monitoring system 108, as well as other functions of the various components of the console 104, including the evaluation/feedback algorithms 110 for providing real-time feedback capabilities for ensuring optimal therapy for a given treatment is administered."
4. U.S. Publication No. 2018/0133460 ("the '460 publication"): Similar to the '459 publication, this is also cited for "Additional features and functions of the nerve monitoring system 108, as well as other functions of the various components of the console 104, including the evaluation/feedback algorithms 110 for providing real-time feedback capabilities for ensuring optimal therapy for a given treatment is administered."

These '459 and '460 publications predate the priority date of April 9, 2020. The '262 patent also explicitly states that "the devices described herein... may be included and incorporated in any of the treatment devices, systems, and methods illustrated and described in U.S. Publication No. 2016/0331459 and U.S. Publication No. 2018/0133460". This indicates a close relationship and suggests that the '459 and '460 publications establish a general context for neuromodulation systems for nasal conditions.

III. Obviousness Analysis

A person having ordinary skill in the art (PHOSITA) at the time of the invention (i.e., before April 9, 2020) would possess knowledge of general medical device design, nasal anatomy, rhinitis pathophysiology, and energy-based neuromodulation techniques.

Combination of Prior Art: U.S. Publication Nos. 2016/0331459 and 2018/0133460 in view of general knowledge of medical device design and the recognized problems in rhinitis treatment.

Motivation to Combine:
The '262 patent itself identifies several problems with existing rhinitis treatments, including their temporary nature, lack of accuracy, propensity for collateral damage, and failure to adequately address sleep problems. These identified problems would have motivated a PHOSITA to improve existing neuromodulation systems for nasal applications to achieve more precise, effective, and less invasive treatments with long-term relief. The '262 patent explicitly incorporates the systems and methods of the '459 and '460 publications, suggesting a known foundation upon which the current invention is built.

How the Combination Renders the Claims Obvious:

1. Neuromodulation System as a Foundation: The '459 and '460 publications provide a foundational understanding of neuromodulation systems, including the console (104), energy generator (106), controller (107), nerve monitoring system (108), and real-time feedback algorithms (110) for delivering optimal therapy. A PHOSITA would readily understand how to integrate an energy delivery device with such a system for therapeutic neuromodulation.

2. Multi-Segment End Effector for Anatomical Conformity: The '262 patent notes the "highly variable" location of the sphenopalatine foramen (SPF) and accessory foramina, making precise nerve targeting difficult with prior methods that caused "significant collateral damage." To address this, a PHOSITA, seeking to improve accuracy and minimize collateral damage in a complex anatomical space like the nasal cavity, would be motivated to design an end effector that "highly conforms to anatomical variations." It would have been obvious to employ flexible, expandable, multi-segment structures (e.g., loops or leaflets made of shape memory materials like nitinol as described in the '262 patent) with electrodes to better conform to specific regions, such as around turbinates and within posterior cavities, to ensure consistent tissue contact for energy delivery. The general concept of expandable medical devices with multiple segments and electrodes for tissue contact is well-established in the art.

3. Electrodes on the Elongate Body for Dual Treatment Sites: The '262 patent explicitly identifies a problem with existing devices: the need to "reposition an end effector when attempting to treat multiple areas within the nasal cavity, particularly those areas that are located outside of any given treatment zone." The solution offered by the '262 patent is to include "one or more electrodes provided on one or respective portions along a length thereof" of the elongate body (116), in addition to the end effector electrodes. A PHOSITA, motivated to improve procedural efficiency and address multiple rhinitis symptoms simultaneously (e.g., nerve modulation in the SPF region and turbinate engorgement reduction), would find it obvious to integrate additional electrodes onto the shaft of the device. This allows for concurrent or sequential treatment of separate anatomical targets (e.g., the inferior turbinate for engorgement and the palatine bone microforamina for parasympathetic nerve modulation) without repeated repositioning, thus improving efficiency and reducing the risk of inaccuracy.

4. Ergonomic Handle with Independent Controls and Markings: To enhance "precise control and feedback" and enable "simultaneous one-handed operation of both user inputs during a procedure", improving the ergonomics of the handle (118) and separating controls for deployment and energy delivery would be an obvious design choice for a PHOSITA. Providing an ambidextrous grip (e.g., via recesses for fingers) and distinct mechanisms (126, 128) is a standard practice in developing user-friendly surgical instruments. Similarly, incorporating visual "markings (e.g., text, symbols, color-coding insignia, etc.)" on the handle and/or shaft to provide "spatial orientation of the end effector while the end effector is in a nasal cavity" is a known technique to aid precise placement and reduce procedural errors, particularly when navigating complex internal anatomies with variable visibility.

5. Method Claims: The method for improving sleep by treating rhinitis, congestion, and rhinorrhea through energy delivery to disrupt neural signals and/or cause local hypoxia, leading to reduced mucus production/engorgement and improved nasal breathability, would also be obvious. The '459 and '460 publications teach neuromodulation systems for therapeutic treatment, and the '262 patent itself states the problem of rhinitis impacting sleep. The idea of targeting neural pathways (parasympathetic nerves) or tissue responsible for engorgement (e.g., inferior turbinates) with energy to alleviate rhinitis symptoms was known prior to the '262 patent, as evidenced by the patent's own problem statement regarding "current aids and surgical procedures". The detailed application via the specific device features discussed above would be an obvious implementation for achieving these known therapeutic goals more effectively.

In summary, a PHOSITA, motivated by the recognized deficiencies of existing rhinitis treatments and leveraging the neuromodulation systems described in the '459 and '460 publications, would find it obvious to modify such systems by incorporating (1) anatomically conforming, multi-segment end effectors for improved precision, (2) additional electrodes on the elongate body for efficient multi-site treatment, and (3) ergonomic handle designs with clear controls and spatial indicators for enhanced user experience and safety. These modifications would represent predictable improvements to existing technology for a known problem, leading to the device and method claimed in US11998262.