Obviousness

Obviousness Analysis of US Patent 12096973 under 35 U.S.C. § 103

This analysis identifies combinations of prior art references that would render the independent claims (Claims 1, 10, 19, and 20) of US patent 12096973 obvious to a person having ordinary skill in the art (PHOSITA) as of the patent's priority date of April 9, 2020. The prior art references considered are those explicitly mentioned within the text of US12096973 or identified in the previously generated "PTAB challenges" section as prior art cited against the patent.

Key Prior Art References:

• US20180235728A1 (Townley): Titled "Systems and methods for therapeutic nasal neuromodulation," this publication describes a handheld device with a shaft and a retractable/expandable multi-segment end effector (therapeutic assembly) having electrodes to apply radiofrequency (RF) energy. It focuses on therapeutic neuromodulation of postganglionic parasympathetic fibers innervating the nasal mucosa, particularly in the sphenopalatine foramen (SPF) region, to treat rhinosinusitis and associated symptoms like congestion, thereby improving sleep. (Publication Date: August 23, 2018)
• US10632328B1 (Hahn): Titled "Methods for treating nasal tissue," this patent teaches methods for treating chronic rhinitis using a handheld RF ablation device. It involves inserting an applicator into the nasal cavity, placing an active electrode adjacent to the inferior turbinate, and applying RF energy to reduce inflammation and/or engorgement of the inferior turbinate. (Filed: June 5, 2017; Granted: April 28, 2020)
• US10772990B1 (Hahn): Titled "Handheld radiofrequency ablation device," this patent also describes a handheld RF ablation device for nasal cavity treatment, aiming to reduce inflammation and/or engorgement of mucosal tissue in the turbinates, especially the inferior turbinate, to address conditions such as rhinitis and congestion. (Filed: March 9, 2018; Granted: September 15, 2020)
• US20160331459A1: Titled "Therapeutic neuromodulation system and method," this publication describes a general neuromodulation system comprising an energy generator, a controller, and an applicator with electrodes, capable of providing real-time feedback. (Publication Date: November 17, 2016)
• US20180133460A1: Titled "Therapeutic neuromodulation system and method," this publication is similar to US20160331459A1, further detailing systems for neuromodulation with an energy generator, controller, and applicator, including system feedback mechanisms. (Publication Date: May 17, 2018)

Motivation to Combine Prior Art References:

The motivation for a PHOSITA to combine these references arises from the recognized need to provide more comprehensive, efficient, and user-friendly treatment for rhinitis and associated sleep problems. US12096973 itself acknowledges the limitations of existing treatments, stating they "are either temporary or are not accurate and cause significant collateral damage" and that surgeons often need to "reposition an end effector when attempting to treat multiple areas within the nasal cavity," leading to "inaccuracy when delivering energy" and increased procedure time. These identified problems inherently provide a strong motivation for a PHOSITA to combine known solutions to overcome them.

Obviousness of Independent Claims

Claim 1 (Method Claim)

Claim 1 describes a method for improving sleep by treating rhinitis, congestion, or rhinorrhea through energy delivery to disrupt neural signals and/or cause local hypoxia, reducing mucus and engorgement, and improving nasal breathability.

Combination: US20180235728A1 (Townley) in combination with US10632328B1 (Hahn) or US10772990B1 (Hahn).

• US20180235728A1 (Townley) explicitly teaches delivering RF energy to target sites in the nasal cavity to therapeutically modulate postganglionic parasympathetic fibers that innervate the nasal mucosa. This directly addresses "disrupt[ing] multiple neural signals to... mucus producing and/or mucosal engorgement elements" to treat rhinosinusitis and symptoms like nasal congestion.
• US10632328B1 (Hahn) and US10772990B1 (Hahn) teach applying RF energy to the inferior turbinate to reduce inflammation and/or engorgement of mucosal tissue. This would predictably result in "local hypoxia of... mucosal engorgement elements" and "reducing... mucosal engorgement within a nose of the patient and reducing or eliminate one or more symptoms associated with at least one of rhinitis, congestion, and rhinorrhea to improve nasal breathability."

Motivation: A PHOSITA would be motivated to combine these teachings to provide a comprehensive treatment for rhinitis and congestion. Townley '728 addresses the neurological component of mucus production and engorgement, while the Hahn patents address direct tissue reduction for engorgement. Combining these two known and complementary mechanisms within a single therapeutic approach would be an obvious solution to achieve a more complete and effective reduction of symptoms and improve nasal breathability, thereby enhancing sleep, as explicitly desired by the inventors of US12096973.

Claim 10 (System Claim)

Claim 10 describes a therapeutic system with a handheld device, elongate body, and a retractable/expandable multi-segment end effector. The end effector includes a first flexible segment configured to fit around the anterior middle turbinate and a second flexible segment for a cavity posterior to the middle turbinate, both positioning energy delivery elements.

Combination: US20180235728A1 (Townley) in combination with general anatomical knowledge and engineering principles.

• US20180235728A1 (Townley) discloses a handheld device for nasal neuromodulation, featuring an elongate body (shaft) and a retractable and expandable multi-segment end effector with electrodes. It states that the end effector "can be retractable/expandable and have multiple segments" and is configured to be advanced into the nasal cavity and positioned at target sites.
• The '973 patent itself describes its multi-segment end effector as "configured to complement anatomy at multiple different locations within the nasal cavity" and having "specific geometry when in a deployed configuration to complement anatomy of respective locations within the nasal cavity."

Motivation: Given the objective of therapeutic neuromodulation in the nasal cavity, as taught by Townley '728, and the acknowledged anatomical variability within the nasal passages, a PHOSITA would be highly motivated to optimize the shape and configuration of the multi-segment end effector. The explicit goal of US12096973 is "highly conforming to anatomical variations" for "accurate, minimally invasive, and localized application of energy." Designing the flexible segments to specifically "fit around at least a portion of a middle turbinate" and "position one or more energy delivery elements into contact with one or more respective tissue locations in a cavity at a posterior position relative to the lateral attachment and posterior-inferior edge of the middle turbinate" would be a predictable engineering design choice for a PHOSITA applying known anatomical understanding to ensure optimal tissue contact and energy delivery for the intended neuromodulation, as already taught by Townley '728. This anatomical optimization is a predictable outcome of routine design efforts aiming to improve the effectiveness and safety of the device described in Townley '728.

Claim 19 (Handheld Device Claim)

Claim 19 describes a handheld device with an ergonomically designed handle with grip recesses, an elongate body having electrodes for the inferior turbinate, an end effector with electrodes for the SPF region, and distinct user-operated mechanisms for deployment and energy control positioned for simultaneous one-handed operation.

Combination: US20180235728A1 (Townley) in combination with US10632328B1 (Hahn) or US10772990B1 (Hahn), and general knowledge of ergonomic medical device design and user interface optimization.

• US20180235728A1 (Townley) discloses a handheld device including a handle, an elongate body (shaft), and a retractable and expandable multi-segment end effector with electrodes configured to deliver energy to the SPF region. It also refers to a controller within the handle.
• US10632328B1 (Hahn) and US10772990B1 (Hahn) teach the application of RF energy to the inferior turbinate to reduce engorgement.
• US20160331459A1 and US20180133460A1 (which are incorporated by reference in US12096973 for system aspects) generally teach neuromodulation systems with controllers and feedback mechanisms.

Motivation:

1. Dual Treatment Capability: As discussed for Claim 1 and 20, the motivation to combine treatments for the SPF region (Townley '728) and the inferior turbinate (Hahn '328/'990) into a single device is high for improved efficacy and efficiency. It would be an obvious engineering modification to equip the elongate body of the Townley '728 device with electrodes for treating the inferior turbinate, in addition to the end effector's electrodes for the SPF. The '973 patent itself describes the elongate body's electrodes as providing a "solution" to treat "larger areas within the nasal cavity... located outside of a treatment zone associated with the end effector," highlighting a known problem.
2. Ergonomics and User Interface: Designing handheld medical devices with ergonomic grips, including recesses to accommodate various hand sizes and grip styles (overhand/underhand), is a well-known principle in medical device engineering to enhance user comfort, control, and reduce fatigue during procedures. Similarly, providing separate user-operated mechanisms for distinct functions (e.g., end effector deployment and energy delivery) and positioning them for simultaneous one-handed operation is a routine design optimization aimed at improving usability and operational efficiency, especially for complex devices or procedures requiring precise, multi-stage control. Townley '728 already describes a controller, and improving its interface for "independent control of deployment of the end effector and energy delivery" for "simultaneous one-handed operation" would be an obvious design choice for a PHOSITA to enhance the utility of the device.

Claim 20 (Method of Treating Rhinosinusitis)

Claim 20 describes a method using a handheld device with an elongate body (first electrodes) and a multi-segment end effector (second electrodes). The method involves positioning the end effector at the SPF (first target site) and a portion of the elongate body at the inferior turbinate (second target site), then delivering energy from both sets of electrodes to achieve specific therapeutic effects at their respective sites.

Combination: US20180235728A1 (Townley) in combination with US10632328B1 (Hahn) or US10772990B1 (Hahn).

• US20180235728A1 (Townley) teaches advancing a multi-segment end effector into the nasal cavity to target the SPF region for neuromodulation of postganglionic parasympathetic nerves to treat rhinosinusitis.
• US10632328B1 (Hahn) or US10772990B1 (Hahn) disclose using a handheld device to apply RF energy to the inferior turbinate to reduce engorgement of tissue, thereby increasing volumetric flow through the nasal passage.

Motivation: As noted earlier, the '973 patent explicitly identifies the problem of requiring "repositioning of an end effector multiple times during a given procedure" to treat "multiple areas within the nasal cavity." This problem would strongly motivate a PHOSITA to combine the teachings of Townley '728 (SPF neuromodulation) and Hahn '328/'990 (inferior turbinate ablation) into a single, more efficient method. By designing a single handheld device (as described in Claim 19 and motivated above) where both the elongate body and the end effector can deliver energy, a PHOSITA would find it obvious to simultaneously or sequentially (without full repositioning) treat both the inferior turbinate and the SPF region. The desired effects (reducing engorgement of the inferior turbinate and modulating parasympathetic nerves at the SPF/microforamina) are directly taught by the respective prior art references. The combined treatment provides a more comprehensive and time-efficient solution to rhinosinusitis, a clear motivation for a PHOSITA.