Obviousness

Obviousness Analysis (35 U.S.C. § 103) for US Patent 12096974

This analysis will identify potential combinations of prior art that would render the claims of US Patent 12096974 obvious to a person having ordinary skill in the art (POSA). The analysis will focus on the references explicitly cited within US12096974: U.S. Publication No. 2016/0331459 and U.S. Publication No. 2018/0133460.

Prior Art References:

• P1: U.S. Publication No. 2016/0331459 (Hereinafter "US '459")
• P2: U.S. Publication No. 2018/0133460 (Hereinafter "US '460")

As noted in the prior art section, US12096974 itself states that these publications describe "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, are described in at least U.S. Publication No. 2016/0331459 and U.S. Publication No. 2018/0133460, the contents of each of which are incorporated by reference herein in their entireties."

A direct search for the full text of US20160331459A1 and US20180133460A1 did not immediately yield the patent documents themselves. Therefore, the analysis of their specific content and how they could be combined for obviousness will rely on the description provided within US12096974, which explicitly incorporates their contents by reference.

General Understanding of the Cited References (based on US12096974):

From the descriptions in US12096974, both US '459 and US '460 are understood to pertain to nerve monitoring systems and consoles for neuromodulation devices. This includes aspects like:

• Evaluation and feedback algorithms.
• Real-time feedback capabilities for optimal therapy.
• Monitoring parameters such as temperature and impedance.
• Detecting nerve locations and activity.
• Automated control of energy delivery.

Given this, a POSA would understand these references to disclose technologies related to the intelligent control and monitoring of energy-delivery therapeutic devices, particularly in the context of neuromodulation.

Obviousness Analysis of Independent Claims:

Claim 1 (Method for improving patient's sleep)

• Claim 1: A method for improving a patient's sleep by treating at least one of rhinitis, congestion, and rhinorrhea within a sino-nasal cavity of the patient, the method comprising: delivering energy to one or more target sites within a sino-nasal cavity of the patient to disrupt multiple neural signals to, and/or result in local hypoxia of, mucus producing and/or mucosal engorgement elements, thereby reducing production of mucus and/or 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 of the patient.

Combination of P1 (US '459) and P2 (US '460):

While US '459 and US '460 primarily describe the control systems rather than the specific energy delivery methods for nasal treatment, a POSA would find it obvious to apply the advanced monitoring and control techniques of these references to a known therapeutic energy delivery method for nasal conditions.

• Motivation to Combine: A POSA, recognizing the goal of precise and effective neuromodulation for conditions like rhinitis (as highlighted in US12096974's background), would be motivated to integrate the sophisticated feedback and control mechanisms taught by US '459 and US '460 with any therapeutic energy delivery approach. The stated purpose of these references is to ensure "optimal therapy" and "real-time feedback," which directly addresses the challenges of treating delicate nasal structures and achieving desired therapeutic effects with minimal collateral damage. Therefore, it would be obvious to use such a system to precisely deliver energy to disrupt neural signals or cause local hypoxia, as claimed in Claim 1. The general concept of delivering energy to disrupt neural signals for therapeutic purposes, especially for conditions affecting the nasal cavity, is well-established in the art. The novelty in Claim 1 lies more in the specific outcome of improving sleep by treating rhinitis symptoms through neural signal disruption and/or local hypoxia.

Claim 10 (Therapeutic device - structural)

• Claim 10: A therapeutic device comprising: a handle; an elongate body extending from the handle, the elongate body comprising an outer sheath and a hypotube disposed within the outer sheath; and a retractable and expandable multi-segment end effector operably associated with the elongate body, the end effector comprising a plurality of energy delivery elements and having at least a first flexible segment and a second flexible segment that are spaced apart from one another, each of the first and second segments comprising a plurality of energy delivery elements, wherein the first segment comprises a first set of flexible support elements configured in a deployed configuration to fit around at least a portion of a middle turbinate at an anterior position relative to a lateral attachment and a posterior-inferior edge of the middle turbinate, and wherein the second segment comprises a second set of flexible support elements configured in a deployed configuration to 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.

Combination with other hypothetical prior art (not explicitly cited):

US '459 and US '460, as described, do not directly disclose the specific structural details of the multi-segment end effector, its ability to conform to nasal anatomy (e.g., around the middle turbinate), or the dual-segment design for targeting anterior and posterior regions. They focus on the control aspects.

Therefore, without additional prior art describing such a multi-segment, conformable end effector for nasal treatment with distinct anterior and posterior segments, it is not possible to render Claim 10 obvious solely based on US '459 and US '460. A POSA might be motivated to control such a device using the teachings of US '459 and US '460 if the device itself were known, but these references do not teach the device's specific physical configuration.

Claim 15 (Therapeutic device - functional)

• Claim 15: A therapeutic device comprising: a handle; an elongate body extending from the handle, the elongate body comprising a plurality of energy delivery elements provided along a length thereof configured to deliver energy to a first target site within a nasal cavity of a patient; and a retractable and expandable multi-segment end effector operably associated with the elongate body, the end effector comprising a plurality of energy delivery elements configured to deliver energy to a second target site within the nasal cavity, wherein the second target site is separate and remote from the first target site, and wherein the end effector is configured to transition from a retracted configuration to an expanded configuration for positioning the plurality of energy delivery elements of the end effector at the second target site.

Combination of P1 (US '459) and P2 (US '460) with a hypothetical device disclosing dual energy delivery:

Similar to Claim 10, US '459 and US '460 do not inherently describe a device with two distinct sets of energy delivery elements (one on the elongate body and one on a multi-segment end effector) capable of treating separate and remote target sites simultaneously without repositioning. The patent itself highlights this as an inventive solution to a problem with existing devices that require repositioning.

• Motivation to Combine: If a POSA had knowledge of a device that already included both an elongate body with its own electrodes and a separate multi-segment end effector with its own electrodes (even if less refined than US12096974), they would be motivated to apply the monitoring and control algorithms from US '459 and US '460 to optimize the energy delivery from both sets of electrodes. The goal of "optimal therapy" and precise application of energy, taught by US '459 and US '460, would naturally extend to controlling multiple energy sources within a single device for greater efficiency and accuracy. However, without a primary reference disclosing this dual-delivery structure, US '459 and US '460 alone do not make Claim 15 obvious.

Claim 19 (Method for improving patient's sleep - combined treatment)

• Claim 19: A method for improving a patient's sleep by treating at least one of rhinitis, congestion, and rhinorrhea within a sino-nasal cavity of the patient, the method comprising: advancing a treatment device into the sino-nasal cavity of the patient, the treatment device comprising an elongate body extending from a handle and a retractable and expandable end effector operably associated with the elongate body; delivering energy from one or more electrodes of the elongate body to tissue associated with an inferior turbinate within the sino-nasal cavity of the patient at a level sufficient to reduce engorgement of tissue associated therewith to thereby increase volumetric flow through a nasal passage of the patient and improve a patient's ability to breathe; and delivering energy from one or more electrodes of the end effector to one or more target sites associated with postganglionic parasympathetic nerves innervating nasal mucosa at microforamina of a palatine bone of the patient at a level sufficient to therapeutically modulate the postganglionic parasympathetic nerves, to thereby reduce or eliminate one or more symptoms associated with at least one of rhinitis, congestion, and rhinorrhea to improve nasal breathability of the patient and improve a patient's sleep.

Combination of P1 (US '459), P2 (US '460) with hypothetical references disclosing specific treatment sites and mechanisms:

Claim 19 describes a very specific method involving dual energy delivery to two distinct anatomical targets (inferior turbinate and microforamina of the palatine bone) for two specific effects (reducing engorgement and modulating parasympathetic nerves). While US '459 and US '460 teach general monitoring and control of neuromodulation, they do not disclose these specific anatomical targets or the precise combination of treatments.

• Motivation to Combine: If prior art existed that disclosed separately: (a) treating the inferior turbinate for engorgement using energy delivery from an elongate body, and (b) modulating postganglionic parasympathetic nerves at the palatine bone microforamina using an end effector, then a POSA would be motivated to combine these techniques into a single procedure using the control and feedback mechanisms of US '459 and US '460. The motivation would be to achieve a more comprehensive and controlled treatment for rhinitis symptoms and sleep improvement, leveraging the precision offered by the monitoring systems. However, without prior art that teaches these specific dual-site treatments and their respective mechanisms for nasal conditions, US '459 and US '460 alone would not make this method obvious.

Conclusion on Obviousness:

Based solely on the descriptions provided within US12096974 regarding U.S. Publication No. 2016/0331459 and U.S. Publication No. 2018/0133460, these references primarily provide background for advanced control, monitoring, and feedback in neuromodulation systems.

• Claim 1 (Method for improving patient's sleep): This claim, describing a general method of delivering energy to disrupt neural signals or cause local hypoxia to treat rhinitis symptoms, could be considered obvious in combination with other general prior art disclosing energy delivery for nasal conditions, using the sophisticated control taught by US '459 and US '460 to optimize the treatment. The motivation would be to improve precision and efficacy.
• Claim 10 (Therapeutic device - structural): This claim, detailing the specific structural design of the multi-segment end effector for conforming to the middle turbinate and targeting anterior/posterior regions, is not rendered obvious by US '459 and US '460, as these references do not describe the physical configuration of the end effector.
• Claim 15 (Therapeutic device - functional): This claim, describing a device with dual energy delivery from both the elongate body and the end effector to separate and remote target sites, is not rendered obvious by US '459 and US '460 alone. These references do not teach the underlying dual-delivery structure.
• Claim 19 (Method for improving patient's sleep - combined treatment): This claim, outlining a specific combined treatment method targeting the inferior turbinate and palatine bone microforamina, is not rendered obvious by US '459 and US '460 alone, as they do not disclose these particular anatomical targets or the specific combination of treatments.

To mount a stronger obviousness challenge against Claims 10, 15, and 19, additional prior art would be needed that describes the specific anatomical targeting, the multi-segment end effector design, and the dual-delivery mechanism. US '459 and US '460 would then serve as motivations for optimizing or controlling such combined systems and methods, rather than providing the primary teaching of the core inventive elements.