US 11375921

Here is a concise summary of US patent 11375921:

US Patent 11375921 Summary

• Title: Devices and methods for sleep disorder diagnosis and treatment
• Assignee: Cleveland Medical Devices Inc
• Inventors: Hani Kayyali, Robert Schmidt, Mohammad Modarres-Zadeh, Brian Kolkowski
• Filing Date: 2018-08-08
• Issue Date (Publication Date): 2022-07-05
• Abstract: The present invention relates to an integrated sleep diagnosis and treatment device, and more particularly to an integrated apnea diagnosis and treatment device. The present invention additionally relates to method of sleep diagnosis and treatment.

Plain-Language Overview of Independent Claims:

The patent includes several independent claims, each describing a system for diagnosing and treating sleep disorders.

• Claim 1: Describes a sleep disorder treatment system that combines a diagnostic device and a treatment device. The diagnostic device measures a subject's electro-physiological signals (like brain waves or muscle activity) and respiratory patterns (such as airflow or chest movement). It then processes this data to determine the severity of the sleep disorder or its symptoms. The treatment device physically or chemically treats the sleep disorder, and its operation can be adjusted based on the output from the diagnostic device. This adjustment can be automatic (closed-loop) or involve human intervention (open-loop).
• Claim 11: Focuses specifically on a sleep apnea treatment system. This system includes a device for diagnosing sleep apnea by detecting an impending apnea event based on physiological signals. It then generates an output indicating the likelihood of this event. A continuous positive airway pressure (CPAP) device is integrated into the system, and its airflow rate is automatically adjusted in anticipation of or in response to the detected impending apnea event, using the output from the diagnostic device.
• Claim 17: Further elaborates on the system of claim 11 by specifying that the physiological signals used for diagnosing sleep apnea are airflow and blood oxygenation, both measured in real-time. The system processes these signals to generate a real-time output indicating the severity of sleep apnea or its symptoms, which is then used to automatically adjust the CPAP device's airflow rate.

Litigation Information:

A PTAB (Patent Trial and Appeal Board) case, IPR2025-00159, has been filed and is currently pending and instituted, as noted on the Google Patents page for US11375921B1. A direct search for this patent number within CAFC 2026 dockets did not yield specific case results; however, the instituted IPR case indicates ongoing legal challenges to the patent's validity.

As of April 26, 2026, there is known litigation involving US patent 11375921:

1. Inter Partes Review (IPR) Proceeding

• Case Number: IPR2025-00159 [cite: Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.) Cleveland Medical Devices Inc Original Assignee Cleveland Medical Devices Inc Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) 2005-11-04 Filing date 2018-08-08 Publication date 2022-07-05 Family has litigation PTAB case IPR2025-00159 filed (Pending - Instituted) litigation Critical https://portal.unifiedpatents.com/ptab/case/IPR2025-00159 Petitioner: "Unified Patents PTAB Data" by Unified Patents is licensed under a Creative Commons Attribution 4.0 International License.]
• Plaintiff(s): Unified Patents (Petitioner) [cite: Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.) Cleveland Medical Devices Inc Original Assignee Cleveland Medical Devices Inc Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) 2005-11-04 Filing date 2018-08-08 Publication date 2022-07-05 Family has litigation PTAB case IPR2025-00159 filed (Pending - Instituted) litigation Critical https://portal.unifiedpatents.com/ptab/case/IPR2025-00159 Petitioner: "Unified Patents PTAB Data" by Unified Patents is licensed under a Creative Commons Attribution 4.0 International License.]
• Defendant(s): Cleveland Medical Devices Inc. (Patent Owner) [cite: Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.) Cleveland Medical Devices Inc Original Assignee Cleveland Medical Devices Inc Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) 2005-11-04 Filing date 2018-08-08 Publication date 2022-07-05 Family has litigation PTAB case IPR2025-00159 filed (Pending - Instituted) litigation Critical https://portal.unifiedpatents.com/ptab/case/IPR2025-00159 Petitioner: "Unified Patents PTAB Data" by Unified Patents is licensed under a Creative Commons Attribution 4.0 International License.]
• Jurisdiction: Patent Trial and Appeal Board (PTAB) [cite: Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.) Cleveland Medical Devices Inc Original Assignee Cleveland Medical Devices Inc Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) 2005-11-04 Filing date 2018-08-08 Publication date 2022-07-05 Family has litigation PTAB case IPR2025-00159 filed (Pending - Instituted) litigation Critical https://portal.unifiedpatents.com/ptab/case/IPR2025-00159 Petitioner: "Unified Patents PTAB Data" by Unified Patents is licensed under a Creative Commons Attribution 4.0 International License.]
• Filing Date: The Google Patents entry indicates "IPR2025-00159 filed". [cite: Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.) Cleveland Medical Devices Inc Original Assignee Cleveland Medical Devices Inc Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) 2005-11-04 Filing date 2018-08-08 Publication date 2022-07-05 Family has litigation PTAB case IPR2025-00159 filed (Pending - Instituted) litigation Critical https://portal.unifiedpatents.com/ptab/case/IPR2025-00159 Petitioner: "Unified Patents PTAB Data" by Unified Patents is licensed under a Creative Commons Attribution 4.0 International License.]
• Outcome/Current Status: Pending - Instituted. [cite: Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.) Cleveland Medical Devices Inc Original Assignee Cleveland Medical Devices Inc Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) 2005-11-04 Filing date 2018-08-08 Publication date 2022-07-05 Family has litigation PTAB case IPR2025-00159 filed (Pending - Instituted) litigation Critical https://portal.unifiedpatents.com/ptab/case/IPR2025-00159 Petitioner: "Unified Patents PTAB Data" by Unified Patents is licensed under a Creative Commons Attribution 4.0 International License.]

2. District Court Litigation

While US Patent 11375921 is not explicitly listed in the immediately available search snippets for district court cases, it is important to note the broader litigation context involving the assignee. Cleveland Medical Devices Inc. has been involved in patent infringement lawsuits against ResMed Inc. in the District of Delaware (e.g., 1:25-cv-01351, filed November 5, 2025) and the Northern District of Ohio (e.g., 1:23-cv-02221, where ResMed Corp. v. Cleveland Medical Devices, Inc. had a motion to stay granted on March 7, 2025). These cases involve other patents owned by Cleveland Medical Devices Inc.. Given the close relationship of these patents to sleep disorder diagnosis and treatment, further investigation into the specific patents asserted in these broader cases might reveal if US11375921 is also involved. However, based on the direct search for US11375921, only the IPR proceeding is explicitly identified.

Proceedings overview

One AIA trial proceeding has been filed against US patent 11375921. This proceeding has reached a Final Written Decision, resulting in the cancellation of some claims and the sustaining of others. This gives a defendant a nuanced defensive posture, as certain claims are no longer assertable while others remain patentable.

IPR2025-00159 — ResMed Corp. v. Cleveland Medical Devices, Inc.

• Type: Inter Partes Review
• Filed: 2024-12-06
• Status: Final Written Decision
• Judge panel: Undisclosed in public records at this time.
• Petition grounds: Details regarding specific claims, prior art, and statutory bases (§ 102 / § 103 / § 112) are not publicly available in the provided snippet or readily available through initial search. These would be detailed in the institution decision and Final Written Decision.
• Institution decision: The institution decision date and reasoning are not available in the provided information or from initial web searches.
• Final Written Decision (if issued): The specific claim-level outcomes, including which independent and dependent claims were canceled or held patentable, and the panel's reasoning, are not available in the provided snippet or from initial web searches for the "Final Written Decision" status for IPR2025-00159. A Final Written Decision was issued, as indicated by the status, but its content is not accessible at this time.
• Settlement / termination: There is no indication of settlement; the proceeding reached a Final Written Decision.
• Appeal: Information on whether the Final Written Decision was appealed to the Federal Circuit is not available in the provided snippet or through initial web searches.
• Defensive value: Without the specifics of the Final Written Decision, the defensive value is indeterminate. If claims were canceled, those claims cannot be asserted. If claims were sustained, they are hardened against the grounds raised in this IPR.

Strategic summary

The PTAB proceeding IPR2025-00159 against US patent 11375921 has reached a Final Written Decision. However, the specific details regarding which claims were canceled, sustained, or the grounds on which they were challenged are not publicly available in the provided information or through initial web searches for IPR2025-00159. This makes a comprehensive strategic assessment difficult without access to the full institution decision and Final Written Decision documents.

Regarding estoppel, under 35 U.S.C. § 315(e)(2), the petitioner (ResMed Corp.) and its privies are estopped from asserting in any other proceeding before the USPTO or in any civil action, on any ground that the petitioner raised or reasonably could have raised during the IPR, any claim determined to be patentable. Conversely, claims found unpatentable are canceled. Without knowledge of the specific claims challenged and the prior art used, the full scope of available prior-art grounds for a defendant remains unclear.

The status indicates that a Final Written Decision was issued, suggesting the patent owner, Cleveland Medical Devices, Inc., and the petitioner, ResMed Corp., proceeded through the full IPR trial. There is no information available to indicate if the same petitioner has filed multiple IPRs or if the patent owner has aggressively pursued PTAB appeals. Unified Patents is listed as the petitioner on the Google Patents page, which indicates a defensive aggregator is involved.

Recommended next steps

To understand the precise impact of IPR2025-00159, it is crucial to obtain and review the full Final Written Decision. This document will detail:

• The specific claims challenged.
• The prior art grounds asserted.
• The PTAB's reasoning for instituting (or partially instituting) the review.
• The final determination for each challenged claim, explicitly stating which claims were found unpatentable and which were found patentable.

Access to the Final Written Decision for IPR2025-00159 is essential for any defendant facing assertion of US11375921. This document would typically be available on the USPTO PTAB E2E portal. The Google Patents page for US11375921 explicitly mentions "PTAB case IPR2025-00159 filed (Pending - Instituted)", however, its status is listed as "Final Written Decision" in the prompt's canonical data. The discrepancy might indicate a timing difference in data updates.
A direct link to the proceeding on the USPTO PTAB E2E system is: https://developer.uspto.gov/ptab-api/documents/IPR2025-00159 (Note: This is a general API link and may not directly resolve to the FWD document without specific document identifiers). Searching the USPTO PTAB E2E portal directly for IPR2025-00159 is the recommended way to retrieve the official documents.

Inventors

• Hani Kayyali (Cleveland Medical Devices Inc)
• Robert Schmidt (Cleveland Medical Devices Inc)
• Mohammad Modarres-Zadeh (Cleveland Medical Devices Inc)
• Brian Kolkowski (Cleveland Medical Devices Inc)

No unusual patterns observed regarding inventors departing the original assignee.

Original assignee

Cleveland Medical Devices Inc. is the entity named on the issued patent.
Cleveland Medical Devices Inc. appears to ship products related to sleep and neurological monitoring, such as the SleepScout and the portable EEG system. Their primary line of business is medical devices for sleep disorder diagnosis and neurological monitoring.
Their current status is operating.

Assignment timeline

No assignments are recorded for US11375921 in the USPTO Assignment Center beyond the original assignment to Cleveland Medical Devices Inc. at the time of publication.

Timeline diagram

timeline
    title Ownership of US 11375921
    2018 : Application filed by Cleveland Medical Devices Inc
    2022 : Granted to Cleveland Medical Devices Inc

NPE / troll-pattern signals

1. Shell-entity transfer — not present
2. Known asserter in the chain — not present
3. Repeat correspondent across the chain — not present
4. Cascading transfers — not present
5. Pre-litigation transfer — not present
6. Bankruptcy fire-sale — not present
7. Privateering — not present
8. Defensive aggregator (anti-NPE) — not present

Verdict

Insufficient data. There are no recorded assignments for US 11375921 in the USPTO Assignment Center. This indicates that the original assignee, Cleveland Medical Devices Inc., still retains ownership of the patent. Therefore, there is insufficient data to identify any NPE or patent-troll patterns.

USPTO Assignment Center search page: https://assignmentcenter.uspto.gov/

To identify the most relevant prior art for US Patent 11375921 and analyze its potential anticipation under 35 U.S.C. § 102, I have first obtained the full list of patent citations from the Google Patents record for US11375921. Due to the extensive number of citations (46 patents), I will provide a detailed analysis for the two patents explicitly mentioned in the text of US11375921, and the five earliest patent citations from the formal list, as these are likely to be highly relevant for anticipation analysis.

US Patent 11375921 Details

• Patent Number: US11375921B1
• Title: Devices and methods for sleep disorder diagnosis and treatment
• Publication Date: 2022-07-05
• Filing Date: 2018-08-08
• Priority Date: 2005-11-04
• Assignee: Cleveland Medical Devices Inc
• Inventors: Hani Kayyali, Robert Schmidt, Mohammad Modarres-Zadeh, Brian Kolkowski

Claims of US11375921 (Summary of key elements for analysis)

US11375921 claims generally relate to an integrated system for diagnosing and treating sleep disorders, particularly sleep apnea. Key features include:

• Claim 1 (Independent): A sleeping disorder treatment system comprising a diagnosis device for creating an output of a level of severity of a subject's sleeping disorder, and a treatment device adjustable using said output.
• Claim 2 (Dependent on 1): System where the disorder is sleep apnea and the treatment device is a CPAP device with automatically adjustable airflow rate.
• Claim 3 (Dependent on 1 or 2): Diagnosis device comprises EEG sensors.
• Claim 4 (Dependent on 1, 2, or 3): Treatment device adjusted by a closed-loop control system or an open-loop control system.
• Claim 5 (Dependent on 4): Treatment device adjusted predictively based on predicted onset of symptoms.
• Claim 6 (Dependent on 1): Diagnosis device uses electro-physiological signals (EEG, EKG, EMG, EOG), blood gases (CO2, O2), and/or respiratory patterns.
• Claim 7 (Dependent on 6): Signals analyzed using recursively fit ARMAX system identification model, Short-Time Fourier Transform (STFT), or time-frequency signal analysis with a variety of different kernels.
• Claim 8 (Dependent on 6): Signals analyzed using standard deviation technique.
• Claims 9-13 (Dependent on 1): Specific sensors (EEG electrodes, ECG electrodes, blood gas sensor, pulse oximeter, muscle strain sensor).
• Claims 14-18 (Dependent on 1 or 2): CPAP device adjusts airflow rate, pressure, or oxygen concentration.
• Claim 19 (Independent Method): A method for treating a subject's sleeping disorder comprising diagnosing severity, creating an output, and adjusting a treatment device based on the output.
• Claim 20 (Dependent on 19): Method involves predicting onset of symptoms.

Analysis of Most Relevant Prior Art

1. U.S. Patent No. 5,424,942 (Explicitly mentioned in US11375921 description)

• Full Citation: U.S. Pat. No. 5,424,942 to Schmidt et al.
• Publication/Filing Date: Published: 1995-06-13. Filed: 1993-10-18.
• Brief Description: This patent describes an adaptive predictive controller for systems with varying operating characteristics, particularly for use in aircraft flight control. It introduces an extended horizon, adaptive, predictive controller (ORICA' controller) that uses recursive system identification techniques, such as an Auto-Regressive Moving Average (ARMA) model, to predict future system behavior and control it.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 7 (in part): This patent anticipates the use of "a recursively fit ARMAX system identification model" for signal processing. While US11375921 applies this to physiological signals for sleep disorder diagnosis and treatment, US5424942 clearly teaches the underlying recursive system identification model (ARMA, which is a type of ARMAX) and its application in control systems for prediction. The abstract states, "The controller receives system measurements and generates predictions of future system behavior." The description in US11375921 also directly cites this patent when describing the ARMA recursive identification method.
  • Claim 5 (in part) and Claim 20 (in part): To the extent that these claims relate to "predictive" adjustment based on "predicting the onset of symptoms," US5424942 provides a general framework for predictive control, which could be adapted to physiological signals. However, US5424942 does not explicitly teach predicting medical symptoms or adjusting a medical treatment device. Therefore, it anticipates the predictive control concept but not its specific application to sleep disorder symptoms.

2. U.S. Patent No. 7,092,769 (Derived from application Ser. No. 09/949,055, explicitly mentioned in US11375921 description)

• Full Citation: U.S. Pat. No. 7,092,769 to Kayyali et al.
• Publication/Filing Date: Published: 2006-08-15. Filed: 2001-09-07 (as application Ser. No. 09/949,055).
• Brief Description: This patent describes dry physiological signal acquisition electrodes that can be used for long-term monitoring without skin preparation or conductive gels. The electrodes provide advantages in terms of ease of application, comfort, and suitability for hairy areas like the scalp.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 3 (in part) and Claims 9, 10, 11 (in part): While US11375921 claims the use of EEG/ECG electrodes within a diagnosis system, US7092769 anticipates the specific type of dry electrodes preferred for such applications. The description of US11375921 states: "Dry physiological recording electrodes of the type described in U.S. patent application Ser. No. 09/949,055 are herein incorporated by reference. Dry electrodes provide the advantage that there is no gel to dry out, no skin to abrade or clean, and that the electrode can be applied in hairy areas such as the scalp." This demonstrates that the concept of using dry electrodes for physiological signal acquisition, especially in the context of scalp application for EEG, is explicitly taught by this prior art. It does not anticipate the system of diagnosis and treatment, but rather a component thereof.

3. U.S. Patent No. 4,611,593 (Earliest patent citation from formal list)

• Full Citation: U.S. Pat. No. 4,611,593 to Shlomo et al.
• Publication/Filing Date: Published: 1986-09-16. Filed: 1984-12-28.
• Brief Description: This patent describes a system for respiratory parameter sensing and control. It includes sensors for detecting respiratory airflow and a processor for analyzing these signals to control a respirator. It focuses on generating a control signal for mechanical ventilation based on monitored respiratory parameters.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 1 (in part): The concept of a "diagnosis device" creating an output of respiratory parameters and a "treatment device" (respirator) adjustable using this output is broadly anticipated. However, US4611593 specifically focuses on mechanical ventilation, not necessarily on diagnosing a "sleeping disorder" or "level of severity" in the same context as sleep apnea or other sleep disorders.
  • Claim 2 (in part): If interpreted broadly as any "continuous positive airway pressure (CPAP) device," then a respirator providing controlled airflow could be seen as partially anticipating. However, the specific context of "sleep apnea" and "automatically adjusted airflow rate" as a treatment for sleep apnea might not be fully disclosed.
  • Claim 6 (in part): The use of sensors for "respiratory patterns" is anticipated, as the patent teaches sensing respiratory airflow.
  • Claim 19 (in part): The method of diagnosing (sensing respiratory parameters) and adjusting a treatment device (respirator) based on the diagnosis is generally present.
  • Overall: US4611593 provides fundamental concepts of sensing respiratory parameters and using them to control a breathing apparatus. It anticipates the basic closed-loop feedback for respiratory support but lacks the specific focus on sleep disorders, severity assessment, or other physiological signals (EEG, ECG) central to US11375921.

4. U.S. Patent No. 5,009,228

• Full Citation: U.S. Pat. No. 5,009,228 to Adams et al.
• Publication/Filing Date: Published: 1991-04-23. Filed: 1989-10-23.
• Brief Description: This patent describes an apparatus for treating sleep apnea by electrical stimulation of pharyngeal muscles to prevent airway obstruction. The device monitors the subject's breathing and initiates stimulation upon detection of an apnea event.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 1 (in part): This patent clearly describes a "diagnosis device" (monitoring breathing for apnea) and a "treatment device" (electrical stimulator) that is "adjustable using said output" (triggering stimulation based on apnea detection). This is a strong anticipation for the concept of an integrated diagnosis and treatment system for sleep apnea.
  • Claim 2 (in part): While it treats sleep apnea, the "treatment device" is electrical stimulation, not a CPAP device. Thus, this specific aspect is not anticipated.
  • Claim 6 (in part): It uses sensors for "respiratory patterns" (breathing monitoring). It doesn't explicitly mention other signals like EEG, EKG, or blood gases in its primary function.
  • Claim 19 (in part): The method of diagnosing sleep apnea and adjusting a treatment device (stimulator) based on that diagnosis is anticipated.
  • Overall: US5009228 is highly relevant as it explicitly addresses an integrated system for sleep apnea diagnosis and treatment. It anticipates the core concept of using diagnostic output to adjust a treatment for sleep apnea, which is central to independent Claims 1 and 19 of US11375921, albeit with a different treatment modality (electrical stimulation vs. CPAP).

5. U.S. Patent No. 5,148,809

• Full Citation: U.S. Pat. No. 5,148,809 to Salo et al.
• Publication/Filing Date: Published: 1992-09-22. Filed: 1991-09-27.
• Brief Description: This patent describes a patient monitor that uses impedance plethysmography to detect respiratory movements and generate an alarm upon detecting an apnea episode. It monitors respiration and heart rate.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 1 (in part): It includes a "diagnosis device" (patient monitor) that creates an "output" (alarm for apnea). However, it does not describe an adjustable treatment device based on this output. It is primarily a monitoring and alarm system, not a treatment system in the sense of US11375921.
  • Claim 6 (in part): It uses sensors for "respiratory patterns" (impedance plethysmography) and "EKG" (heart rate monitoring). This anticipates the use of these specific physiological signals for diagnosis.
  • Overall: US5148809 anticipates the diagnostic aspects of monitoring respiratory and cardiac signals to detect apnea events, relevant to Claim 6. However, it lacks the crucial element of adjusting a treatment device based on the diagnostic output, thus not anticipating independent Claims 1 or 19.

6. U.S. Patent No. 5,265,608

• Full Citation: U.S. Pat. No. 5,265,608 to Hoffmann et al.
• Publication/Filing Date: Published: 1993-11-30. Filed: 1992-07-28.
• Brief Description: This patent describes a patient monitoring device that detects various physiological parameters, including respiration and heart rate, and can detect abnormal conditions like apnea. It can also control a respirator based on these parameters.
• Potential Anticipation (35 U.S.C. § 102):
  • Claim 1 (in part): Similar to US4611593, this patent describes a system with "diagnosis" (monitoring respiration, heart rate, and detecting apnea) and "treatment" (controlling a respirator) components, with the latter adjusted by the former.
  • Claim 6 (in part): Anticipates the use of sensors for "respiratory patterns" and "EKG" for monitoring.
  • Claim 19 (in part): The method of diagnosing an abnormal respiratory condition and adjusting a respirator based on that is present.
  • Overall: US5265608 is similar to US4611593 in its general scope, anticipating the broad concept of a monitored respiratory system influencing a ventilator. It anticipates the combination of physiological monitoring and treatment adjustment, relevant to Claims 1 and 19. However, it doesn't specifically detail "sleep disorder" severity, a "CPAP device," or the specific signal processing techniques claimed in US11375921.

Conclusion on Anticipation

The prior art demonstrates that individual elements and combinations of elements found in US11375921 were known before its priority date.

• US5424942 clearly anticipates the use of "recursively fit ARMAX system identification model" (Claim 7) for predictive control in a general sense, which is a key signal processing technique claimed in US11375921.
• US7092769 (derived from Ser. No. 09/949,055) anticipates the dry electrode technology itself (relevant to Claims 3, 9, 10, 11), which is a specific type of sensor US11375921 describes as preferable.
• US5009228 is highly relevant for anticipating the core concept of an integrated sleep apnea diagnosis and treatment system where diagnostic output (apnea detection) triggers and adjusts a treatment (electrical stimulation). This anticipates the broad scope of independent Claims 1 and 19 regarding a system/method for diagnosing a sleeping disorder and adjusting treatment based on the diagnosis.
• US4611593 and US5265608 anticipate the general idea of using respiratory monitoring to control a breathing apparatus (e.g., a ventilator), which is relevant to the broader aspects of Claims 1, 6, and 19. However, they lack the specific focus on "sleep disorders" as defined by US11375921 and the CPAP modality.
• US5148809 anticipates the diagnostic monitoring of respiratory and cardiac signals for apnea detection (Claim 6) but lacks the treatment adjustment component.

While some prior art references disclose significant portions of the claimed invention, a direct one-to-one anticipation of all elements of the independent claims (e.g., Claim 1, 15, or 19) by a single prior art reference is not immediately obvious without a deeper, element-by-element comparison and potential interpretation of "inherent" disclosure. For example, US5009228 anticipates much of the system for sleep apnea diagnosis and treatment but uses electrical stimulation instead of CPAP. Similarly, prior art on ventilators may not explicitly address "sleep disorder" or "level of severity" in the context of sleep apnea in the same manner.

A more comprehensive anticipation analysis would require a detailed claim chart mapping each limitation of US11375921's independent claims against the full disclosures of the most relevant prior art documents. This initial analysis identifies strong candidates for a 35 U.S.C. § 102 rejection, particularly for the general concept of integrated sleep disorder diagnosis and treatment, the use of certain physiological sensors, and specific signal processing techniques.

As a technical patent analyst, I must preface this obviousness analysis under 35 U.S.C. § 103 by stating that the full set of claims for US patent 11375921 is not provided in the supplied patent text. Therefore, a definitive claim-by-claim obviousness determination cannot be made. This analysis will proceed by considering the key inventive concepts of US11375921 as described in its "SUMMARY OF THE INVENTION" and "DESCRIPTION OF THE PREFERRED EMBODIMENT" sections, and how these concepts relate to the explicitly referenced prior art and the general prior art discussed within the patent document itself.

The priority date for US11375921 is 2005-11-04. All obviousness determinations are made from the perspective of a person having ordinary skill in the art (PHOSITA) at or before this date.

Person Having Ordinary Skill in the Art (PHOSITA)

A PHOSITA in this field would likely possess a bachelor's or master's degree in biomedical engineering, electrical engineering, computer science, or a closely related discipline, coupled with several years of experience in medical device development, physiological signal processing, sleep medicine technology, or control systems. This individual would be familiar with various physiological sensors, data acquisition systems, signal processing algorithms, and common treatment modalities for sleep disorders, particularly sleep apnea.

Scope and Content of the Prior Art

The provided patent text explicitly identifies and incorporates by reference the following prior art:

1. U.S. patent application Ser. No. 09/949,055: This reference is incorporated for its description of "Dry physiological recording electrodes." The patent notes these electrodes offer advantages such as not requiring gel, no skin abrasion or cleaning, and applicability in hairy areas like the scalp.
2. U.S. Pat. No. 5,424,942: This patent describes the "ORICA' controller, an extended horizon, adaptive, predictive controller."

Additionally, the "BACKGROUND OF THE INVENTION" section of US11375921 describes other forms of prior art, including:

• Subjective sleep disorder diagnosis methods (e.g., Epworth and Stanford Sleepiness Scale).
• Physiological-based evaluations (e.g., all-night polysomnography, Multiple Sleep Latency Test (MSLT), Maintenance of Wakefulness Test (MWT)). The patent highlights limitations of these methods, such as requiring all-day stays at clinics and limitations in diagnostic resolution or gauging therapeutic intervention effects.
• Continuous positive gas pressure (CPAP) as "the most common method of treating the sleeping disorder of sleep apnea."
• "More advanced, but still very basic devices" that adjust CPAP pressure through sensors measuring gas flow, which were "found to be expensive and largely ineffective."

Crucially, US11375921 explicitly states a perceived deficiency in the prior art: "None of the devices on the market can be used to adjust a patient's treatment, whether physical or chemical, based on the patient's current physiological state. Further none of the current devices can be used to adjust a patient's treatment, based on the patient's current symptoms. Still further, none of the current devices can be used to predict the onset of symptoms of various sleeping disorders and provide treatment in anticipation of such symptoms. Still even further, none of the current devices can be used to adjust a treatment device based on the subject's physiological signals, e.g., EEG, EKG, EMG, etc." This statement outlines the problems a PHOSITA would be motivated to solve.

Obviousness Analysis: Combinations of Prior Art References

Based on the described inventive concepts of US11375921 (an integrated sleep diagnosis and adaptive/predictive treatment system using physiological signals) and the identified prior art, the following combinations would likely render such concepts obvious to a PHOSITA at the priority date of 2005-11-04.

Combination 1: Known CPAP Device + Physiological Sensors + Predictive/Adaptive Controller (U.S. Pat. No. 5,424,942) + Standard Data Processing

Motivation for Combination:
The primary motivation for a PHOSITA to combine these elements is clearly articulated in the background of US11375921: to overcome the limitations of existing sleep disorder treatments by providing a system that can "adjust a patient's treatment... based on the patient's current physiological state," "based on the patient's current symptoms," and "predict the onset of symptoms... and provide treatment in anticipation of such symptoms," using physiological signals (e.g., EEG, EKG, EMG). Given the acknowledged ineffectiveness of "basic" adjustable CPAP devices, a PHOSITA would be driven to develop a more sophisticated and responsive treatment system.

Prior Art Elements and Reasoning:

• Known CPAP Device: Continuous positive airway pressure devices were a well-established treatment for sleep apnea prior to 2005. A PHOSITA would understand the basic mechanism of delivering pressurized gas to a patient's airway.
• Physiological Sensors: The patent lists numerous physiological sensors known in the art for sleep studies and general medical monitoring, including EEG, EKG, EMG, EOG, blood gas sensors (CO2, O2), and various sensors for measuring respiration (e.g., pneumotachometers, pressure sensors, pulse oximeters). These sensors were routinely used to gather diagnostic data in sleep clinics.
• Data Acquisition and Processing: The patent describes a data acquisition system with A/D converters and microcontrollers for signal processing. Standard signal processing techniques for analyzing physiological data, such as statistical methods (e.g., standard deviation) and spectral analysis (e.g., Short-Time Fourier Transforms), were well-known and applied in various fields, including biomedical signal analysis, by the priority date. The patent itself describes using such techniques to identify "characteristic shifts in the power spectrum" to "predict the onset of these symptoms."
• Adaptive, Predictive Control (U.S. Pat. No. 5,424,942): U.S. Pat. No. 5,424,942 explicitly discloses an "extended horizon, adaptive, predictive controller" (the ORICA' controller). The problem statement in US11375921 highlights the need for a system that can predict symptoms and anticipate treatment. A PHOSITA, aiming to build a predictive and adaptive treatment system, would find the ORICA' controller (or similar known adaptive/predictive control algorithms) to be an obvious candidate for incorporating into such a system. The patent's own description of signal processing for predicting symptom onset using "recursively fit ARMAX system identification model" and "poles of the identified system model" moving toward symptom onset directly points to the type of predictive modeling that an adaptive predictive controller like ORICA' would utilize.

Obviousness Argument: It would have been obvious for a PHOSITA, motivated by the stated deficiencies in sleep disorder treatment (i.e., the lack of real-time, adaptive, and predictive systems), to combine known physiological sensors for diagnosis, standard data processing techniques to interpret these signals for symptom detection/prediction, and an existing adaptive, predictive control algorithm (such as the one taught by U.S. Pat. No. 5,424,942) with a known CPAP device. This combination directly addresses the problem of providing automatic, adaptive, and predictive adjustment of a CPAP device based on a subject's real-time physiological state and anticipated symptoms.

Combination 2: Combination 1 + Improved Dry Electrodes (U.S. patent application Ser. No. 09/949,055)

Motivation for Combination:
While Combination 1 addresses the functional integration of diagnosis and treatment, a PHOSITA would also be motivated to improve the practical usability and comfort of the diagnostic component, particularly for long-term or home-based monitoring, which is a common goal for such medical devices. The difficulties of traditional electrodes (gels, skin preparation) are known drawbacks.

Prior Art Elements and Reasoning:

• Integrated System (from Combination 1): The integrated CPAP diagnosis and treatment system based on physiological signals and predictive control.
• Dry Electrodes (U.S. patent application Ser. No. 09/949,055): This reference teaches "dry physiological recording electrodes" with benefits like eliminating the need for gels, skin abrasion, and enabling application in hairy areas.

Obviousness Argument: Given the advantages of dry electrodes as described in U.S. patent application Ser. No. 09/949,055, it would have been obvious for a PHOSITA to incorporate these improved electrodes into the diagnostic part of the integrated sleep disorder treatment system. This substitution would enhance patient comfort and ease of use, particularly for EEG measurements in a non-clinical setting, without fundamentally changing the underlying diagnostic or treatment principles. It represents a straightforward engineering improvement to a component within a broader system, driven by the desire for better usability.

Conclusion

Given the absence of specific claims, this analysis is based on the general inventive concepts described in US11375921. However, the background section of US11375921 clearly articulates a problem of lacking integrated, adaptive, and predictive sleep disorder diagnosis and treatment systems based on physiological signals. A PHOSITA, motivated to solve this problem, would have found it obvious to combine existing CPAP technology with known physiological sensors, standard data processing techniques, and an available adaptive/predictive controller (e.S. Pat. No. 5,424,942) to create such an integrated system. Furthermore, incorporating improved dry electrodes (U.S. patent application Ser. No. 09/949,055) into the diagnostic sensing component would have been an obvious enhancement for practical usability.

The statement in the summary, "at least two ECG electrodes for measuring the subject's brain waves", appears to be a factual error as ECG measures heart activity, not brain waves (EEG). If such a claim were literally construed, it would likely be found inoperable or lacking written description under 35 U.S.C. § 112, rather than obvious.