DETAILED ACTION
The Examiner acknowledges the amendments received 17 July 2026. Claim 19 is cancelled; claims 15 and 17-18 are withdrawn; claims 1-14, 16 and 20-21 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 17 July 2026 have been fully considered but they are not persuasive. The Applicant argues (page 7, “Remarks”) “When the claim later refers to "the determination," there is only one possible antecedent - the determination of the sleep stage and/or sleep quality metric. There is no ambiguity and no alternative referent. Under established claim construction principles, "the determination" can only refer back to the sole act of determining recited in the claim. As such, the claim is clear that the "determination" is the same as the step "determine the sleep stage and/or sleep quality metric".”
The Examiner respectfully disagrees with this assessment of the claim. Amendment to the claim to read “the determining step” or similar language would render the claim clear and definite.
The Applicant further argues (pages 8-9) the prior art rejection of claim 1, including subject matter from previous claim 19. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14, 16 and 19-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 requires “the determination” in line 11. It is unclear whether this “determination” is the same as the step “determine the sleep stage and/or sleep quality metric” in the above clause, or a different determination.
Claim Rejections - 35 USC § 101
In view of the amendments received 17 July 2026, the Examiner withdraws the rejection of claims 1, 4-7, 9, 11-12, 14 and 16 under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6-14, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ramanan et al (U.S. 9,687,177) in view of Ni et al (U.S. 7,252,640). Ramanan discloses (col. 2, lines 6-57) one or more sensors (“flow sensor”), wherein each sensor is configured to collect sensor data indicative of respiratory activity and/or a physical state of the human subject (“The controller may optionally be coupled with a flow sensor to measure the flow of breathable gas. The controller may then also include a processer controlled flow generator to provide a controlled respiratory pressure treatment regime based on the detected state.”) when placed on, in proximity to, or implanted in, the human subject (col. 7, line 60-col. 8, line 15, especially “Thus, in some embodiments, the device itself may optionally be implemented with a flow sensor for measuring a respiratory flow signal for use with implemented methodologies. For example, flow to or through a nasal cannula or mask may be measured using a pneumotachograph and differential pressure transducer or similar device such as one employing a bundle of tubes or ducts to derive a flow signal.”); and a controller (col. 7, lines 42-60) comprising a processor and memory, communicatively linked to the one or more sensors and configured to receive the sensor data from the one or more sensors (col. 39, line 23-col. 40, line 4, especially “The device may also include a sensor or data interface 1214, such as a bus, for receiving/transmitting data such as programming instructions, flow data, pressure data, sleep quality data, sleep state data, sleep stability data, arousal data and other output or input of the previously described modules.”), and determine the sleep stage and/or sleep quality metric for the human subject, using the received sensor data, wherein the controller is configured to perform the determination using a trained classifier comprising an electronic representation of a classification system (col. 13, line 43-col. 14, line 20, “Markov Classification system” and “Non-Stationary Markov Classification system”).
Ramanan discloses the claimed invention except for a stimulation system for delivering stimulation to a nerve. Ni, however, discloses (col. 1, line 62-col. 2, line 61; Figure 3) a system and method for determining sleep quality (e.g., sleep apnea) and (col. 5, lines 15-31) a stimulation system communicatively linked to the controller and configured to deliver stimulation to a nerve (“hypoglossal nerve”) which innervates an upper airway muscle of the human subject based on the sleep quality metric of the human subject determined by the controller.
Ni and Ramanan both disclose systems and method for diagnosing and treating obstructive sleep apnea (Ramanan col. 9, lines 27-47). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ramanan’s machine learning classifier with Ni’s electrical stimulation in order to provide instantaneous treatment to a detected apnea episode.
Regarding claim 2, Ramanan discloses (col. 7, line 61-col. 8, line 15) the one or more sensors each comprise at least a pressure sensor (“flow to or through a nasal cannula or mask may be measured using a pneumotachograph and differential pressure transducer or similar device”).
Regarding claim 3, Ramanan discloses (col. 7, line 61-col. 8, line 15) each sensor is independently positioned on, in proximity to the human subject (“flow to or through a nasal cannula or mask may be measured using a pneumotachograph and differential pressure transducer or similar device”).
Regarding claim 6, Ramanan discloses (col. 2, lines 50-57) the controller is configured to determine the sleep stage and/or sleep quality metric for the human subject using a) sensor data received from exactly 1 sensors (“flow sensor”).
Regarding claim 7, Ramanan discloses (col. 15, line 27-col. 16, line 8) the trained classifier was trained using a baseline dataset, wherein the baseline dataset comprises data generated during a prior single night polysomnography ("PSG") study of the human subject (“the Awake state and REM sleep state may be considered to be similar to the R&K sleep scoring. These states in relation to the respiratory flow are illustrated in FIG. 22 (awake) and FIG. 23 (NREM). The NREM Sleep state may be considered to be stages 3 and 4 (slow wave sleep) and parts of stage 2.”).
Regarding claim 8, Ramanan discloses (col. 7, line 61-col. 8, line 15) the baseline dataset comprises sensor data from one or more sensors, where each sensor comprise at least a pressure sensor (“flow to or through a nasal cannula or mask may be measured using a pneumotachograph and differential pressure transducer or similar device”).
Regarding claim 9, Ramanan discloses (col. 17, lines 29-34) the classifier comprises a machine learning algorithm.
Regarding claim 10, Ramanan discloses (col. 2, lines 50-57) the one or more sensors configured to collect sensor data indicative of respiratory activity and/or a physical state of the human subject does not include an electroencephalography ("EEG") sensor (“flow sensor to measure the flow of breathable gas”).
Regarding claim 11, Ramanan discloses (col.15, line 27-col. 16, line 8) the sleep stage for the human subject is determined to be a sleep stage selected from awake, or N1, N2, N3, or REM sleep (items i.)-iv.)).
Regarding claim 12, Ramanan discloses (col. 4, line 65-col. 5, line 16 and col. 28, line 60-col. 29, line 26) the sleep quality metric for the human subject is determined to be a numeric score (“embodiments of the sleep stability detection module quantify a level of sleep related disturbance that occurs during the patient's sleep session. For example, a detector with such a module may generate a score between 0 and 1 at the end of each breath cycle indicating the level of sleep disturbance. In such a case, a score of 1 can indicate maximum sleep stability. The score may then grade progressively lower levels of sleep stability as the score decreases to 0.”).
Regarding claim 13, Ramanan discloses (col. 28, line 60-col. 29, line 26) the system is configured to output the determined sleep stage and/or sleep quality metric to a graphical or text-based interface of an electronic device (“The intensity value, length, autonomic activation values, type of disturbance identified, etc. may optionally be stored in a memory of the device, used by other assessment modules (e.g., the sleep quality assessment module 120) and/or displayed on a visual output display of the user interface module 124.”).
Regarding claim 14, Ramanan discloses (Figure 1) the electronic device is at least a discrete controller of the system or a computer.
Regarding claim 16, Ramanan discloses (col. 2, lines 6-57) providing the system of providing the system of determining the sleep stage and/or sleep quality metric for the human subject, using the provided system (“A first aspect of some embodiments of the present technology is to provide methods and devices to detect sleep quality. Another aspect of some embodiments of the present technology is to provide methods and devices to detect sleep state.”).
Regarding claim 20, Ni discloses (col. 5, lines 15-31) the controller is configured to cause the stimulation system to at least apply the stimulation based on the sleep quality metric of the human subject.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable Ramanan et al (U.S. 9,687,177) in view of Ni et al (U.S. 7,252,640), in further view of Mashiach et al (U.S. 2014/0039579). Ramanan and Ni disclose the claimed invention except for assessing sleep stage/quality metric based on biomarker data generated from an assay of one or more biological fluid or tissue samples. Mashiach, however, teaches method and device of neural modulation for treatment of sleep apnea (par. 0004). Severity of a detected physiological condition may be defined as a deviation from normal range of the condition, and may be determined by a deviation in, for example, a position of certain tissue or body parts in a subject, a rate of change or direction of change in a position of certain tissue or body parts in a subject, blood oxygen level, blood glucose level, pulse rate, and breathing rate or any other parameter of normal bodily function (par. 0224).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor blood glucose level as taught by Mashiach in the system of Ramanan and Ni so that the severity of sleep apnea can be determined using multiple factors.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ramanan et al (U.S. 9,687,177) in view of Ni et al (U.S. 7,252,640), and further in view of Mashiach et al (U.S. 2014/0039579). Ramanan and Ni disclose the claimed invention except for changing an amplitude, pulse width, or frequency of the stimulation. Mashiach, however, teaches a method and device of neural modulation for treatment of sleep apnea (par. 0004). Mashiach further teaches that one processor may be configured to adjust at least one characteristic of the modulation control signal based on a severity of the sleep disordered breathing, the at least one characteristic of the modulation control signal including voltage amplitude, current amplitude, pulse frequency, or pulse duration. (par. 0030).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust any of the known stimulation signal characteristics including voltage amplitude, current amplitude, pulse frequency, or pulse duration as taught by Mashiach in the system of Ramanan in view of Ni in order to provide appropriate stimulation signal based on the severity of sleep disorder.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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