Prior art

This analysis identifies the most relevant prior art for US patent 10898709, focusing on key patent citations that predate its priority date of March 19, 2015. While these references generally disclose systems and methods for nerve stimulation to treat sleep-disordered breathing, the distinguishing features of US10898709, particularly its independent (asynchronous) stimulation protocols and convertible operational modes, appear to differentiate it from the cited art based on their brief descriptions. Therefore, these prior art documents are more likely to serve as background art or for obviousness arguments under 35 U.S.C. § 103, rather than direct anticipation under 35 U.S.C. § 102 for the specific novel aspects of US10898709. A definitive claim-by-claim anticipation analysis requires a more in-depth legal and technical review beyond the scope of this summary.

The following U.S. patent documents are considered highly relevant due to their focus on nerve stimulation for sleep-disordered breathing and their publication dates preceding the priority date of US10898709:

1. US8340785B2

• Full Citation: US8340785B2, Christopherson et al., "Implantable system for treating sleep disordered breathing," assigned to Inspire Medical Systems, Inc.
• Publication/Filing Date: Filed: 2008-05-09; Published: 2012-12-25.
• Brief Description: This patent describes an implantable system and method for treating sleep disordered breathing by stimulating an airway patency-related nerve. The system includes an implantable pulse generator and a sensing lead with a sensor for sensing respiration. Stimulation is applied in response to an actual or impending respiratory event (e.g., apnea, hypopnea, snoring) or during an inspiratory effort. The stimulation parameters (e.g., amplitude, pulse width, frequency) can be adjusted.
• Potential Anticipation (35 U.S.C. § 102): This patent broadly anticipates elements related to an "implantable system for treating sleep disordered breathing" (e.g., preamble of claims 1, 7, 13) and a "stimulation element to stimulate an airway-patency-related nerve" (e.g., elements of claims 1, 7, 13). It also discloses sensing respiratory information via sensing elements (e.g., for claims 7, 13, 14), and a therapy manager to manage stimulation (e.g., claims 7, 13). However, its primary focus on responsive or synchronized stimulation based on sensed events or inspiratory effort does not appear to anticipate the asynchronous stimulation protocols or the specific convertible operation modes (claims 1-6, 8-12, 20-22) that are central to US10898709.

2. US8024036B2

• Full Citation: US8024036B2, Erickson et al., "Implantable neurostimulation device and method for treating sleep apnea," assigned to Medtronic, Inc.
• Publication/Filing Date: Filed: 2007-12-19; Published: 2011-09-20.
• Brief Description: This patent discloses an implantable neurostimulation device and method for treating sleep apnea. The system comprises an implantable signal generator and at least one lead for delivering therapy. It is configured to detect sleep apnea events and deliver stimulation to one or more nerves (e.g., hypoglossal nerve) to mitigate or prevent these events. The therapy can be responsive to a detected event or delivered proactively, and often involves using sensed physiological parameters like respiration or heart rate to control stimulation.
• Potential Anticipation (35 U.S.C. § 102): Similar to US8340785B2, this patent anticipates the general concept of an implantable neurostimulation device for treating sleep apnea by stimulating a nerve, including components like an implantable pulse generator and leads (e.g., preamble of claims 1, 7, 13). It also addresses detecting sleep apnea events and using sensed physiological parameters (e.g., for claims 7, 13, 14). However, its emphasis on event-responsive or proactively controlled stimulation, likely synchronized or dependent on sensed parameters, does not explicitly disclose or anticipate the asynchronous and independent stimulation protocols of US10898709 (e.g., claims 1-6, 13, 20-22) or the specific convertible modes (claims 7-12).

3. US7942824B2

• Full Citation: US7942824B2, Kroll et al., "Integrated sleep diagnosis and treatment device and method," assigned to Cleveland Medical Devices Inc.
• Publication/Filing Date: Filed: 2007-07-27; Published: 2011-05-17.
• Brief Description: This patent describes an integrated device and method for sleep diagnosis and treatment, particularly for apnea. The device can perform both diagnostic functions (by sensing physiological parameters like respiratory airflow, effort, blood oxygenation) and therapeutic functions. It applies therapy, such as nerve stimulation or positive airway pressure, in response to the diagnosed sleep disorders.
• Potential Anticipation (35 U.S.C. § 102): This reference covers the broad idea of a system that senses physiological parameters to diagnose and treat sleep disorders, including using nerve stimulation as a therapy. Thus, it potentially anticipates elements relating to sensing respiratory information and applying stimulation to treat sleep disordered breathing (e.g., claims 7, 13 and their sub-elements concerning sensing). However, the description focuses on responsive therapy triggered by diagnostic findings, which differs from the asynchronous stimulation (claims 1-6, 13, 20-22) and the specific convertible operation based on sensor signal quality (claims 7-12) as defined in US10898709.

4. US7715921B2

• Full Citation: US7715921B2, Gelfand et al., "System and method for treating sleep disordered breathing," assigned to Philips Electronics North America Corporation.
• Publication/Filing Date: Filed: 2007-07-12; Published: 2010-05-11.
• Brief Description: This patent describes a system and method for treating sleep disordered breathing (SDB) through neural stimulation. The system identifies SDB events or conditions (e.g., based on airflow, impedance, or oxygen saturation) and delivers electrical stimulation to an upper airway dilator muscle or nerve, such as the hypoglossal nerve, to maintain airway patency. The stimulation can be synchronized with respiratory effort or delivered in response to a detected event.
• Potential Anticipation (35 U.S.C. § 102): This patent anticipates a system for treating SDB using neural stimulation of an airway dilator nerve, including the use of sensed physiological parameters (airflow, impedance, oxygen saturation) to identify SDB events (e.g., preamble of claims 1, 7, 13, and sensing aspects of claims 7, 13-19). Like the other cited prior art, its teaching of stimulation synchronized with respiratory effort or responsive to detected events does not appear to anticipate the asynchronous stimulation protocols (claims 1-6, 13, 20-22) or the convertible operation features (claims 7-12) of US10898709.