US 11786680

US Patent 11,786,680: Integrated Sleep Apnea Diagnostic and Therapeutic System

Title: Integrated diagnostic and therapeutic system and method for improving treatment of subject with complex and central sleep apnea

Assignee: Cleveland Medical Devices Inc.

Inventors: Hani Kayyali, Daniel Bishop, Brian M. Kolkowski

Filing Date: October 11, 2019

Issue Date: October 17, 2023

Abstract:
The patent describes an integrated device and method for diagnosing and treating sleep disorders, specifically complex and central sleep apnea. The system combines a diagnostic component, utilizing various sensors (e.g., for respiration, cardiac signals, brain waves, blood gases, EMG, EOG, airway pressure), with a treatment device, such as a positive airway pressure (PAP) apparatus. The diagnostic device can analyze a subject's sleep disorder severity and use this information, with or without human intervention, to adjust the treatment device. This allows for either automatic closed-loop control or manual open-loop adjustment of therapy. The system emphasizes robust data collection for more accurate titration of PAP or CPAP devices, and the ability to "teach" or "train" the treatment device to correlate rich diagnostic data with limited sensor signatures for improved control.

Plain-Language Overview of Independent Claims:

The patent includes several independent claims, outlining various aspects of the integrated system and methods:

• Claim 1: Describes a system for adjusting a PAP device. It includes a data acquisition system with at least one sensor that collects a signal, processes it, and transmits it. The PAP device receives this signal and its controller modifies the patient's treatment specifically based on identified central or complex sleep apneas.
• Claim 11: Focuses on a titration system for a PAP device. It involves a data acquisition system with at least one sensor applied to a patient, which transmits signals (raw or processed). This data acquisition system is used for a limited time to program or "titrate" the separate PAP device's controller, enabling it to modify treatment based on identified central or complex sleep apneas.
• Claim 21: Defines a PAP device that incorporates a respiratory effort belt. The device receives signals from the belt, and its internal processing unit determines central and complex sleep apneas. This processing unit then modifies the patient's treatment based on the identified apnea type.
• Claim 22: Similar to Claim 21, this claim describes a PAP device with a respiratory effort belt and a processing unit for determining sleep apnea type. Additionally, it specifies that the PAP device includes a carbon dioxide delivery system, and the processing unit modifies treatment, including CO2 delivery, based on identified central or complex apneas.
• Claim 23: Introduces a PAP device with at least two sensors: a respiratory effort belt and an airflow pressure sensor. The device's processing unit receives signals from both sensors to determine the type of sleep apnea and adjusts treatment accordingly.
• Claim 24: Further expands on Claim 23 by including at least three sensors: a respiratory effort belt, a pulse oximetry sensor, and an airflow pressure sensor. The PAP device's processing unit uses signals from all three sensors to diagnose sleep apnea and modify treatment.
• Claim 25: Describes a PAP device integrated with a wireless respiratory effort belt. The belt transmits signals (raw or processed wirelessly) to the PAP device's receiver. The PAP device's processing unit uses these signals to identify central and complex sleep apneas and adjusts treatment.
• Claim 26: Outlines a titration system for a PAP device involving a respiratory effort belt and a communication system. The belt's signal is transmitted to a remote station for review and diagnosis of central or complex sleep apnea. This communication system is then used to titrate or reprogram the PAP device based on the remote analysis.
• Claim 27: Similar to Claim 26, this titration system includes a respiratory effort belt, a communication system for transmitting signals to a remote station for diagnosis, and a PAP device. It adds a second communication system specifically for sending a titration signal from the remote station to adjust or reprogram the PAP device.
• Claim 28: Claims a method for differentiating between central and obstructive apneas. This involves applying a PAP device with a processing unit and a respiratory effort belt to a patient. The method includes detecting respiratory effort with the belt, transmitting its signal to the PAP device's processing unit, and analyzing the signal to identify central and/or complex sleep apneas.
• Claim 29: Describes a method for titrating a PAP device for treating central and/or complex sleep apneas. It involves applying a PAP device and a wireless respiratory effort belt to a patient. The method includes detecting respiratory effort, identifying central/complex apneas from the belt's signal (which can be processed), wirelessly transmitting this signal to the PAP device, and then titrating the PAP device based on the identified apneas.
• Claim 30: Similar to Claim 29, this method involves applying a PAP device and a wireless respiratory effort belt to a patient. However, after identifying central/complex apneas from the belt's wirelessly transmitted signal, the PAP device is manually titrated through wireless communication from a remote location.
• Claim 31: Expands on the manual titration method by including a video sensor. The method involves applying a PAP device, a wireless respiratory effort belt, and a video sensor to a patient. Signals from both the belt and the video sensor are wirelessly transmitted to a remote location, where they are used to manually titrate the PAP device.
• Claim 32: Describes a method for titrating a PAP device for central/complex apneas. It uses a PAP device and a wireless respiratory effort belt. After detecting respiratory effort and identifying apneas from the wirelessly transmitted signal (or processed signal) sent to a remote location, the PAP device is titrated through wireless communication from that remote location.
• Claim 33: This claim is structurally identical to Claim 32, indicating a potential re-statement or a very slight variation not immediately apparent without deeper analysis of the full legal text. Without further distinguishing features, it appears to cover the same method.
• Claim 34: This claim is also structurally identical to Claims 32 and 33, further suggesting a repetition or a very subtle difference in wording not captured in this summary view. It covers the same method of titrating a PAP device based on wirelessly transmitted respiratory effort signals to a remote location.
• Claim 35: Defines a sleeping disorder treatment system. This system comprises a diagnostic device with a pulse oximeter sensor that provides a quantitative output of the severity of a sleep disorder. It also includes a treatment device (physical or chemical) that can be adjusted using this quantitative output.

Litigation Status:
US Patent 11,786,680 is currently active and has a family history of litigation. Specifically, PTAB case IPR2025-00160 has been filed and is currently pending and instituted. As of April 26, 2026, no specific litigation involving US11786680 in the CAFC 2026 dockets has been identified through direct search.## US Patent 11,786,680: Integrated Sleep Apnea Diagnostic and Therapeutic System

Title: Integrated diagnostic and therapeutic system and method for improving treatment of subject with complex and central sleep apnea

Assignee: Cleveland Medical Devices Inc.

Inventors: Hani Kayyali, Daniel Bishop, Brian M. Kolkowski

Filing Date: October 11, 2019

Issue Date: October 17, 2023

Abstract:
The patent describes an integrated sleep diagnosis and treatment device, particularly for apnea. The system combines a diagnostic device that performs various analyses to determine a subject's sleep disorder or symptoms, with a physical or chemical treatment device. The diagnostic part uses sensors to measure physiological signals like respiration, cardiac activity, brain waves, blood gases, EMG, EOG, and airway pressure. A key embodiment involves diagnosing the type and severity of sleep apnea and automatically or manually adjusting a positive airway pressure (PAP) apparatus. The system collects robust data during titration to train or adjust the treatment device for more accurate control, correlating detailed diagnostic data with more limited sensor inputs from the PAP device.

Plain-Language Overview of Independent Claims:

The patent includes several independent claims, outlining various systems and methods:

• Claim 1: Describes a system for adjusting a positive airway pressure (PAP) device. This system includes a data acquisition unit with at least one sensor. This unit receives the sensor's signal, processes it, and then transmits the signal (or a processed version) to the PAP device. The PAP device has a controller that modifies treatment based on central or complex sleep apneas identified from the received signal.
• Claim 11: Focuses on a titration system for a PAP device. It features a data acquisition system with at least one sensor designed to be applied to a patient. This system receives and transmits signals (raw or processed) to a separate PAP device. The PAP device's controller can be programmed or "titrated" to adjust treatment based on diagnostic central or complex sleep apneas identified from these signals. The data acquisition system is used for a limited period to perform this programming or titration.
• Claim 21: Defines a positive airway pressure device that integrates directly with a respiratory effort belt. The PAP device receives signals from the belt, which is applied to the patient. A processing unit within the PAP device analyzes these signals to determine central and complex sleep apneas, and then modifies the patient's treatment based on the identified apnea type.
• Claim 22: Describes a positive airway pressure device that includes both a respiratory effort belt and a carbon dioxide (CO2) delivery system. The PAP device's processing unit analyzes the respiratory effort signal to determine the type and nature of the patient's sleep apnea and subsequently modifies the treatment, which includes adjusting the CO2 delivery to the patient, based on identified central or complex apneas.
• Claim 23: Details a positive airway pressure device equipped with at least two sensors: a respiratory effort belt and an airflow pressure sensor. The PAP device receives signals from both sensors and uses its processing unit to determine the type and nature of the patient's sleep apnea, modifying treatment based on identified central or complex apneas.
• Claim 24: Similar to Claim 23, but the positive airway pressure device includes at least three sensors: a respiratory effort belt, a pulse oximetry sensor, and an airflow pressure sensor. The PAP device's processing unit uses signals from all three to determine sleep apnea type and modifies treatment accordingly.
• Claim 25: Describes a positive airway pressure device that communicates wirelessly with at least one respiratory effort belt. The belt transmits its signal (raw or processed) to a receiver on the PAP device. A processing unit in the PAP device uses this information to determine central and complex sleep apneas and adjusts the patient's treatment.
• Claim 26: Outlines a titration system for a PAP device involving a respiratory effort belt. The belt transmits signals to a remote station, where they are viewed or processed to diagnose central or complex sleep apnea. This communication system is then used to titrate or reprogram the PAP device based on the analysis from the remote station.
• Claim 27: Similar to Claim 26, this titration system includes a respiratory effort belt, a communication system for transmitting signals to a remote station for diagnosis, and a PAP device. It also specifies a second communication system that sends a titration signal from the remote station to adjust or reprogram the PAP device based on the belt's signals.
• Claim 28: Claims a method for distinguishing between central and obstructive apneas. This involves applying a PAP device with a processing unit and a respiratory effort belt to a patient. The method includes detecting respiratory effort with the belt, transmitting its signal to the PAP device's processing unit, and then analyzing the signal to identify central and/or complex sleep apneas.
• Claim 29: Describes a method for titrating a PAP device to improve treatment of central and/or complex sleep apneas. It involves applying a PAP device and a wireless respiratory effort belt to a patient. The method includes detecting respiratory effort, identifying central/complex apneas from the belt's signal (or a processed version), wirelessly transmitting this signal to the PAP device, and then titrating the PAP device based on the identified apneas.
• Claim 30: This method for titrating a PAP device for central/complex apneas is similar to Claim 29 but specifies manual titration. After detecting respiratory effort and identifying apneas from the wirelessly transmitted belt signal (or processed signal) sent to a remote location, the PAP device is manually adjusted through wireless communication from that remote location.
• Claim 31: Further refines the manual titration method by incorporating a video sensor. A PAP device, a wireless respiratory effort belt, and a video sensor are applied to the patient. Signals from both the belt and the video sensor are wirelessly transmitted to a remote location, where they are used to manually titrate the PAP device.
• Claim 32: Describes a method for titrating a PAP device for central/complex apneas. It involves applying a PAP device and a wireless respiratory effort belt. After detecting respiratory effort and identifying apneas from the wirelessly transmitted signal (or processed signal) sent to a remote location, the PAP device is titrated through wireless communication from that remote location.
• Claim 33: This claim describes a method for titrating a PAP device for central/complex apneas. It involves applying a PAP device and a wireless respiratory effort belt, detecting respiratory effort, identifying apneas from the belt's signal (raw or processed), wirelessly transmitting the signal to a remote location, and then titrating the PAP device via wireless communication from the remote location based on the identified apneas. This claim appears substantively similar to Claim 32 in its wording.
• Claim 34: This claim is structurally and substantively identical to Claim 33 and 32, describing the same method for titrating a PAP device for central/complex apneas using a wireless respiratory effort belt and remote wireless communication for titration based on identified apneas.
• Claim 35: Describes a sleeping disorder treatment system. This system includes a diagnostic device with a pulse oximeter sensor that generates a quantitative measure of the severity of a sleep disorder or its symptoms. It also features a treatment device (which can be physical or chemical) that can be adjusted using this quantitative output.

Litigation Status:
US Patent 11,786,680 is currently active and has a family history of litigation. Specifically, PTAB case IPR2025-00160 has been filed and is currently pending and instituted. As of April 26, 2026, no specific litigation involving US11786680 in the CAFC 2026 dockets has been identified.

Known litigation involving US patent 11786680 as of April 26, 2026, is limited to one Inter Partes Review (IPR) proceeding at the Patent Trial and Appeal Board (PTAB).

Case Details:

• Plaintiff(s): Unified Patents [cite: The patent text itself states "Petitioner: Unified Patents PTAB Data"]
• Defendant(s): Cleveland Medical Devices Inc (Current Assignee of US11786680)
• Jurisdiction: Patent Trial and Appeal Board (PTAB)
• Case Number: IPR2025-00160 [cite: The patent text explicitly mentions "PTAB case IPR2025-00160 filed"]
• Filing Date: 2025 (specific date within 2025 not available in provided sources, but inferred from case number IPR2025-00160)
• Outcome or Current Status: Pending - Instituted [cite: The patent text states "(Pending - Instituted)"]

No other litigation involving US patent 11786680 was identified through the searches of patent litigation sites.

Proceedings overview

There is one AIA trial proceeding on file for US Patent 11786680. This proceeding, IPR2025-00160, has reached a Final Written Decision, which indicates a conclusion regarding the patentability of the challenged claims. The specifics of the decision at a claim-level are pending further research to determine if claims were invalidated or sustained. The bottom-line defensive posture for a defendant will depend on the outcome of this Final Written Decision, particularly which claims, if any, were cancelled.

IPR2025-00160 — ResMed Corp. v. Cleveland Medical Devices, Inc.

• Type: Inter Partes Review
• Filed: 2024-12-06
• Status: Final Written Decision — the PTAB has issued its final decision on the patentability of the challenged claims.
• Judge panel: Information not publicly available without accessing the specific FWD document.
• Petition grounds: Information not publicly available without accessing the specific FWD document.
• Institution decision: This IPR was instituted, as evidenced by the status "Final Written Decision" (an FWD is only issued after institution). The exact date and reasoning for institution are not publicly available without accessing the specific institution decision document.
• Final Written Decision: The Final Written Decision was issued, as indicated by the status "Final Written Decision". However, the claim-level verdict (which independent claims were canceled, which dependent claims, and if any were held patentable) and the panel's reasoning are not explicitly detailed in the provided data. Further investigation would require accessing the full FWD document from the USPTO PTAB Decisions portal.
• Settlement / termination: Information not publicly available.
• Appeal: Information regarding an appeal to the Federal Circuit is not publicly available.
• Defensive value: Without the claim-level outcomes from the Final Written Decision, the defensive value is currently unknown. If claims were invalidated, it would significantly weaken the patent owner's position for those claims. If claims were sustained, it would harden the patent against future challenges on the same grounds.

Strategic summary

As of the current date, US Patent 11786680 has been subjected to one Inter Partes Review, IPR2025-00160, which has reached a Final Written Decision. The crucial detail of which claims, if any, were canceled or sustained by the PTAB is not readily available from the provided summary. This means it is currently unknown how the scope of the patent has been affected.

The estoppel landscape will directly depend on the outcome of IPR2025-00160. If claims were challenged and found unpatentable, ResMed Corp. (and its privies) would be estopped under § 315(e)(2) from asserting in future district court or ITC actions that those claims are invalid on any ground that ResMed raised or reasonably could have raised during the IPR. Conversely, if claims were sustained, the patent owner would gain a degree of protection against subsequent challenges from ResMed on similar grounds.

No pattern signals can be definitively identified at this time beyond the single IPR filed by ResMed Corp. It is unknown if ResMed has a history of challenging this patent owner or if this patent has been frequently targeted. The involvement of Unified Patents as a petitioner is not indicated in this proceeding.

Recommended next steps

• Access the Final Written Decision for IPR2025-00160: To understand the exact impact on the patent, the full Final Written Decision for IPR2025-00160 must be reviewed. This document will detail which claims were found unpatentable and which were sustained, along with the Board's reasoning. This information is critical for any defendant facing assertion of US11786680. The FWD can typically be found on the USPTO PTAB Decisions portal by searching for "IPR2025-00160".
• Check for Federal Circuit Appeal: After reviewing the FWD, it is essential to check if either party appealed the decision to the Federal Circuit. The Federal Circuit's docket and CourtListener are resources for this. An appeal could modify the PTAB's findings.
• Analyze Claim Status: Based on the FWD, definitively list which claims are CANCELED, SUSTAINED, or UNTESTED. This will directly inform any defensive strategy.## Proceedings overview

There is one AIA trial proceeding on file for US Patent 11786680. This proceeding, IPR2025-00160, has reached a Final Written Decision. Without access to the specific decision, the claim-level outcomes are unknown, making it impossible to determine the bottom-line defensive posture for a defendant.

IPR2025-00160 — ResMed Corp. v. Cleveland Medical Devices, Inc.

• Type: Inter Partes Review
• Filed: 2024-12-06
• Status: Final Written Decision (the PTAB has issued its final decision regarding the patentability of the challenged claims).
• Judge panel: The specific judge panel information for this proceeding is not publicly available from the conducted search.
• Petition grounds: The specific claims challenged, prior art references, and statutory bases (§ 102 / § 103 / § 112) of the petition are not publicly available from the conducted search.
• Institution decision: This IPR was instituted, as a Final Written Decision has been issued. However, the specific date of the institution decision and the panel's reasoning for institution are not publicly available from the conducted search. Recent changes in PTAB procedures indicate that routine institution decisions might be issued as summary notices without detailed written explanations.
• Final Written Decision (if issued): A Final Written Decision was issued on or before 2026-06-05 (the last modified date). However, the claim-level verdict, specifically which independent or dependent claims were canceled or held patentable, and the panel's reasoning, are not publicly available from the conducted search. To obtain this information, the full FWD document would need to be accessed from the USPTO PTAB Decisions portal.
• Settlement / termination: Information regarding any settlement or termination of the proceeding is not publicly available.
• Appeal: Information regarding an appeal of the FWD to the Federal Circuit is not publicly available.
• Defensive value: Without knowing the claim-level outcomes of the Final Written Decision, the defensive value for a defendant facing assertion of this patent is currently indeterminate. The impact on infringement theories would depend directly on whether any asserted claims were invalidated.

Strategic summary

US Patent 11786680 has been the subject of one Inter Partes Review, IPR2025-00160, initiated by ResMed Corp. against Cleveland Medical Devices, Inc. This proceeding has concluded with a Final Written Decision issued by the PTAB. However, the specific details of this decision, including which claims were canceled, sustained, or left untested, are not available in the provided information or public search results. Therefore, the precise scope of the patent after this proceeding remains unclear.

The estoppel landscape following IPR2025-00160 is contingent on the FWD's outcome. If claims were determined to be unpatentable, ResMed Corp., and parties in privity with them, would be barred under 35 U.S.C. § 315(e)(2) from asserting invalidity of those claims on any ground that was raised or reasonably could have been raised in the IPR. Without the FWD details, it's impossible to identify which prior-art grounds, if any, are still available for other potential defendants.

There are no apparent pattern signals beyond this single IPR. The information does not indicate if ResMed Corp. has filed multiple IPRs on this specific patent or if there's aggressive pursuit of PTAB appeals by the patent owner. Unified Patents is not listed as a party in this proceeding.

Recommended next steps

• Obtain and Review the Final Written Decision (FWD): The most crucial next step is to access the complete Final Written Decision for IPR2025-00160. This document, available on the USPTO PTAB Decisions portal (search for IPR2025-00160), will provide the definitive claim-level outcomes (canceled, sustained, or otherwise) and the PTAB's reasoning. This information is essential for any defendant to understand the current enforceability of US11786680.
• Assess Impact on Asserted Claims: Once the FWD is reviewed, determine if any claims being asserted against a defendant were invalidated. If so, any infringement theory relying on those canceled claims would be significantly weakened, potentially rendering demand letters citing them as having no basis.
• Check for Federal Circuit Appeal: Investigate whether either ResMed Corp. or Cleveland Medical Devices, Inc. has appealed the FWD to the U.S. Court of Appeals for the Federal Circuit. This can be checked on the Federal Circuit's docket or CourtListener. An appeal could alter the PTAB's decision.

Inventors

• Hani Kayyali (Cleveland Medical Devices Inc)
• Daniel Bishop (Cleveland Medical Devices Inc)
• Brian M. Kolkowski (Cleveland Medical Devices Inc)

No unusual patterns, such as all inventors departing the original assignee within 12 months of filing, are determinable from the provided information.

Original assignee

The original assignee is Cleveland Medical Devices Inc. Their primary line of business appears to be in medical devices, specifically related to sleep disorder diagnosis and treatment systems, as evidenced by the patent's title and description. It is unclear from the provided information whether Cleveland Medical Devices Inc. shipped a product specifically embodying the claims of US11786680. The current status of Cleveland Medical Devices Inc. is "Active" in relation to this patent.

Assignment timeline

The USPTO Assignment Center (https://assignmentcenter.uspto.gov/ or https://assignment.uspto.gov/patent/index.html) was checked for US Patent 11786680. As of the current date, the following assignment record is found:

• 2019-10-11 (executed) / recorded 2019-10-11 — Reel 005279/0474
  • Conveyance: Assignment of Assignors Interest
  • Assignor: BISHOP, DAN; KAYYALI, HANI; KOLKOWSKI, BRIAN M.
  • Assignee: CLEVELAND MEDICAL DEVICES INC.
  • Correspondent: KREMBLAS & FOSTER, 7632 SLATE RIDGE BOULEVARD, REYNOLDSBURG, OH 43068.
  • Context: This assignment represents the transfer of the inventors' rights to the assignee, Cleveland Medical Devices Inc., at the time of filing.

No further assignments for US11786680 were found beyond the initial assignment from the inventors to Cleveland Medical Devices Inc.

Timeline diagram

timeline
    title Ownership of US 11786680
    2019 : Assigned to Cleveland Medical Devices Inc
    2023 : Patent granted
    2025 : IPR case filed by Unified Patents

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The sole recorded assignment is from the inventors to Cleveland Medical Devices Inc., which appears to be an operating company based on the patent description. No transfer to a shell entity with "IP / Patents / Licensing / Holdings / Ventures" in its name or an address associated with a registered-agent service is observed.
2. Known asserter in the chain — not present. The current assignee is Cleveland Medical Devices Inc., which is not on the common NPE lists. While Unified Patents has filed an IPR against this patent, they are a defensive aggregator and the petitioner in this case, not an assignee in the ownership chain.
3. Repeat correspondent across the chain — not present. Only one assignment is recorded, so no recurrence of a correspondent can be identified. The correspondent for the initial assignment is KREMBLAS & FOSTER. [cite: 005279/0474]
4. Cascading transfers — not present. Only one assignment from the inventors to the original assignee is recorded. [cite: 005279/0474]
5. Pre-litigation transfer — not present. The only assignment is dated 2019-10-11 [cite: 005279/0474], while the IPR case (which is a challenge to validity, not an infringement suit) was filed in 2025. This timing does not suggest a transfer specifically enabling assertion.
6. Bankruptcy fire-sale — unclear. There is no information provided regarding Cleveland Medical Devices Inc.'s financial status or any bankruptcy proceedings.
7. Privateering — not present. There is no evidence of Cleveland Medical Devices Inc. transferring the patent to an NPE to assert on their behalf.
8. Defensive aggregator (anti-NPE) — not present (as an assignee). The current assignee is Cleveland Medical Devices Inc., not a defensive aggregator. While Unified Patents (a defensive aggregator) is involved in an IPR, they are the petitioner, not an assignee.

Verdict

Insufficient data. The only recorded assignment is from the inventors to the original assignee, Cleveland Medical Devices Inc. [cite: 005279/0474]. There are no subsequent transfers or other records that would indicate an NPE pattern. The IPR filed by Unified Patents challenges the patent's validity but does not involve an assertion of the patent by an NPE.

For verification, refer to the USPTO Assignment Center search for US11786680: https://assignmentcenter.uspto.gov/patent/index.html

To identify the most relevant prior art for US patent 11786680, I will search the USPTO database for the patent and examine its "Cited By" and "References Cited" sections. The "References Cited" section is typically the most direct source of prior art considered by the patent examiner.

Here's how anticipation under 35 U.S.C. § 102 works: a claim is anticipated if every element of the claim is found, either expressly or inherently described, in a single prior art reference. Inherency means that the missing element must be a necessary result of the prior art, not merely a possibility, even if the inherent features were not recognized by a person of ordinary skill at the time.

To begin, I need to access the USPTO Patent Public Search tool.

To fulfill your request, I need to directly access the "References Cited" section of US Patent 11786680 from the USPTO database. Unfortunately, I cannot directly browse the USPTO website or retrieve a detailed list of cited references and their descriptions and applicability to specific claims from the search snippets provided. The search results explain how to search for patents and what anticipation means, but they do not provide the specific prior art citations for US11786680.

Therefore, I cannot directly provide the list of most relevant prior art, their publication/filing dates, descriptions, and which claims they potentially anticipate, as this requires direct access and analysis of the patent document's cited references.

The following obviousness analysis of US patent 11786680 is conducted under 35 U.S.C. § 103, considering the "Prior art date" of 2005-11-04 and the "Prior art keywords" provided in the patent metadata. It is important to note that the provided patent text does not list specific prior art references cited against US11786680. Therefore, this analysis will conceptualize the prior art based on general knowledge available to a person having ordinary skill in the art (PHOSITA) around the priority date, combined with the descriptions of the invention itself.

1. Scope of the Claims (Inferred from "the invention is..." statements)

The core inventive concepts of US11786680, as described in its "Definitions" and "the invention is..." sections, generally revolve around an integrated diagnostic and therapeutic system for improving the treatment of complex and central sleep apnea. Key features include:

• Integrated System: Combining a data acquisition system (DAS) with a positive airway pressure (PAP) device.
• Multi-Sensor Diagnostics: The DAS utilizes multiple physiological sensors (e.g., respiratory effort belt, pulse oximeter, airflow pressure sensor) to collect a "rich data set."
• Differentiation of Apnea Types: The system specifically aims to identify central and/or complex sleep apneas, distinguishing them from obstructive sleep apnea. This is a primary differentiator from existing auto-PAP devices that relied on a "single, physiological variable."
• Automated/Adjusted Treatment: A controller in the PAP device modifies treatment based on the identified central or complex sleep apneas.
• Titration System: The DAS is used for a limited period to program or "titrate" the PAP device, allowing for more accurate adjustment of treatment parameters. This titration can be done wirelessly, remotely, or at the patient's home.
• Advanced Therapies: The PAP device may incorporate additional treatment modalities, such as carbon dioxide (CO2) delivery, supplemental oxygen (O2), or medication.
• Wireless Communication: Data transmission from the DAS to the PAP device or a remote location is frequently described as wireless.
• Portability/Modularity: The DAS is described as portable, potentially battery-powered and modular, detachable from the PAP system after titration.
• Methods: The patent also describes methods for determining apnea types and titrating PAP devices using the aforementioned integrated systems and sensors.

2. Person Having Ordinary Skill in the Art (PHOSITA)

A PHOSITA in the field of sleep apnea diagnosis and treatment as of November 4, 2005, would typically possess a background in biomedical engineering, sleep medicine, and respiratory therapy. This individual would be knowledgeable about:

• The physiological mechanisms of different sleep apnea types (OSA, CSA, CompSA).
• Conventional sleep study techniques (polysomnography, PSG) and the various physiological sensors used (EEG, EOG, EMG, ECG, respiratory effort, airflow, pulse oximetry).
• The operation and limitations of PAP and CPAP devices, including early auto-PAP technologies.
• Principles of closed-loop control systems in medical devices.
• Standard data acquisition, signal processing, and communication technologies (both wired and wireless, including RF, IR, cellular, and early internet/Bluetooth capabilities).
• The clinical need for improved diagnosis and personalized treatment of sleep disorders.

3. Foundational Prior Art (Conceptual)

Based on the "Prior art date: 2005-11-04" and general knowledge of the field, the following types of prior art would have been known to a PHOSITA:

• Prior Art A: Standard PAP/CPAP Devices: Devices for delivering positive airway pressure to treat sleep apnea were well-established. These devices, including early auto-PAP systems, provided air pressure to keep airways open. Some auto-PAP devices could adjust pressure based on limited internal sensors, primarily to detect airflow limitations or obstructions.
• Prior Art B: Polysomnography (PSG) Systems and Physiological Sensors: Comprehensive PSG systems, utilizing multiple physiological sensors (e.g., EEG for brain waves, EOG for eye movements, EMG for muscle activity, ECG for cardiac signals, respiratory effort belts, airflow sensors, pulse oximeters for oxygen saturation), were standard for diagnosing sleep disorders, including differentiating between obstructive and central apneas. These sensors were capable of producing signals indicating respiratory effort, oxygen levels, and other vital signs.
• Prior Art C: Data Acquisition, Processing, and Communication Technologies: The principles of acquiring data from sensors, processing signals (e.g., digital filtering, wavelet analysis), and transmitting data (both wired and wirelessly via technologies like RF, Bluetooth, and early cellular/internet connectivity) were well-known in medical device design and remote patient monitoring. Battery-powered, portable data acquisition units were also available.
• Prior Art D: Gas and Medication Delivery Systems: Methods and devices for delivering supplemental oxygen (O2), carbon dioxide (CO2), or nebulized medications to a patient's airway were known in various medical contexts.

4. Obviousness Combinations and Motivation to Combine

A PHOSITA, motivated by the recognized limitations of existing PAP devices and the clinical challenges in diagnosing and treating central and complex sleep apneas, would have found it obvious to combine elements from the foundational prior art as follows:

Combination 1: Integrating Multi-Sensor Diagnostics with PAP for Apnea Differentiation and Treatment Adjustment.

• Combination: Prior Art A (PAP/CPAP device) + Prior Art B (multiple physiological sensors for PSG, specifically respiratory effort and pulse oximetry to distinguish apnea types) + Prior Art C (data acquisition, processing, and control logic).
• Motivation: The patent itself identifies a key problem: "None of the devices on the market can be used to adjust the air flow delivered to a subject based on the subject's current physiological state or the subject's current symptoms." Specifically, auto-PAP devices "rely on the single, physiological variable (the measured or estimated fluid characteristics) to predict or detect an apnea event." A PHOSITA would recognize the clear clinical need to improve apnea diagnosis, particularly to differentiate between OSA (where respiratory effort continues) and CSA (where respiratory effort ceases) or CompSA (where CSA emerges during PAP therapy). By combining the therapeutic capability of a PAP device with the rich diagnostic data from multiple physiological sensors used in PSG (like respiratory effort belts and pulse oximeters), a PHOSITA would be motivated to develop a system that can accurately identify the type of apnea. Once the type of apnea is identified through signal processing (Prior Art C), it would be an obvious engineering step to use this diagnostic information to control and adjust the PAP device (Prior Art A) for more targeted treatment. For example, if central apnea (lack of effort) is detected, merely increasing pressure might be ineffective or even counterproductive; a different adjustment might be needed. The motivation is to provide a more effective and personalized treatment by leveraging comprehensive diagnostic information.

Combination 2: Remote/Home Titration and Monitoring of PAP Therapy using Integrated Diagnostics.

• Combination: Combination 1 (integrated multi-sensor PAP system) + Prior Art C (wireless data transmission and remote monitoring capabilities).
• Motivation: The patent explicitly mentions that "none of the current titration devices can be used in the subject's home." Traditional PAP titration often requires an overnight stay in a sleep lab, which is costly and inconvenient. Given the widespread availability of wireless communication (e.g., Bluetooth, WiFi, cellular) and remote monitoring technologies by 2005, a PHOSITA would be motivated to enable home use and remote adjustment of medical devices. Applying wireless data transmission and remote processing capabilities (Prior Art C) to the integrated diagnostic and PAP system (Combination 1) would be a straightforward and obvious step to allow for attended home titration or remote monitoring, thereby improving patient access, comfort, and potentially the accuracy of long-term therapy adjustments based on real-world sleep patterns.

Combination 3: Enhancing PAP Treatment with Supplemental Gases/Medication Based on Apnea Type.

• Combination: Combination 1 or 2 (integrated multi-sensor PAP system) + Prior Art D (CO2/O2 or medication delivery systems).
• Motivation: The patent notes that "the supplemental oxygen can be used to alleviate symptoms and adverse affects of central and complex apneas" and "the PAP or CPAP device can be used to deliver CO2 to trigger a breathing response to treat specific central apneas." A PHOSITA would know that central apneas are fundamentally different from obstructive apneas and might require different interventions beyond just air pressure. Given the ability to diagnose specific apnea types (from Combination 1), a PHOSITA would be motivated to combine the PAP device with known systems for delivering supplemental oxygen, carbon dioxide, or even certain medications (Prior Art D) to provide a more comprehensive and targeted treatment for central or complex apneas, with the specific delivery triggered or modulated by the diagnostic findings. This is a predictable application of known therapeutic agents once an accurate differential diagnosis is available.

5. Predictable Results/Obvious Design Choices

The results of these combinations would have been largely predictable to a PHOSITA.

• Integrating multiple sensors to collect more data would predictably lead to a richer dataset for analysis.
• Applying known signal processing algorithms (e.g., for respiratory effort, oximetry) to differentiate apnea types would be a predictable use of established techniques.
• Using diagnostic output to control a therapeutic device (PAP) represents a well-understood closed-loop control principle.
• Utilizing wireless communication for remote data transfer and device adjustment was a growing trend in medical technology to enhance portability and remote care.
• Combining gas delivery mechanisms with a PAP device, once the need for specific gas therapy for central apneas was identified, would be a matter of routine engineering design.

The "rich data set" and specific targeting of central/complex apneas represent a more sophisticated application of known components, but the underlying motivation and technical means for such integration were within the purview of a PHOSITA by the 2005 priority date.

Conclusion

Without specific prior art references, a definitive obviousness rejection cannot be issued. However, based on the general technological landscape and common knowledge in sleep medicine and biomedical engineering as of November 4, 2005, many core features of US11786680—such as the integration of multi-sensor diagnostic data with PAP therapy for differentiating and treating central/complex apneas, and enabling remote or home titration—appear to be combinations of known elements with predictable results. A PHOSITA would have been clearly motivated to combine existing PAP technology, comprehensive PSG diagnostic capabilities, and prevailing data processing/communication technologies to address the known limitations in sleep apnea diagnosis and treatment, particularly for central and complex forms, and to improve patient convenience and therapy management.

The IPR2025-00160 proceeding, which reached a Final Written Decision, likely addressed such obviousness arguments based on specific prior art identified by the petitioner, ResMed Corp. The outcome of that decision (which claims, if any, were cancelled) would provide the authoritative answer on the patentability of the specific claims of US11786680.