DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 4/23/26 is acknowledged.
Claims 9-17 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/23/26.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 12/7/23 has/have been acknowledged and is/are being considered by the Examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 18-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sarlija et al. (U.S. Pub. 2023/0337961 hereinafter “Sarlija” priority 4/22/22 and 8/31/22).
Regading claims 1 and 18, Sarlija discloses a sleep monitoring system and method (e.g. Fig. 3), comprising: at least one sensor (e.g. 101) configured to sense physiological changes of a subject during a test period, the test period having a plurality of epochs (e.g. ¶11), and being configured to form corresponding sensor information for the plurality of the epochs (e.g. ¶11); at least one controller (e.g. 310) configured to: receive the sensor (e.g. 402) information for the plurality of the epochs during the test period from each of the at least one sensor (e.g. ¶11); derive a hypnodensity profile (e.g. 406) for each epoch of the plurality of epochs based upon the received sensor information for the plurality of the epochs (e.g. ¶108); calculate at least one hypnodensity feature based upon the hypnodensity profile for each epoch of the plurality of epochs (e.g. ¶108); determine a composite feature based on the at least one hypnodensity feature over the plurality of epochs (e.g. 410); compare the composite feature to a at least one predetermined indicator related to sleep apnea (e.g. 510); and determine a presence and/or severity of apnea based upon the comparison (e.g. 414, 540).
Regarding claim 2, Sarlija further discloses wherein at least one of the at least one sensor is configured to measure sleep (e.g. ¶¶41-42).
Regarding claim 3, Sarlija further discloses wherein the at least one controller (e.g. 110) is further configured to monitor the at least one sensor in accordance with a test type (e.g. ¶¶44, 53).
Regarding claim 4, Sarlija further discloses a mobile station (MS) (e.g. 106) having a display, wherein the at least one controller is further configured to transmit the determined presence and/or severity of apnea to the MS and to render the determined presence and/or severity of apnea on the display (e.g. ¶¶11, 94, 111, 135).
Regarding claims 5 and 19, Sarlija further discloses wherein the at least one controller is configured to calculate the at least one hypnodensity feature as information entropy, and is configured to determine an average of the information entropy (DA) over the plurality of epochs as the composite feature (e.g. ¶108).
Regarding claims 6 and 20, Sarlija further discloses wherein the at least one predetermined indicator is at least one predetermined threshold for the presence and/or the severity of apnea (e.g. ¶135).
Regarding claim 7, Sarlija further discloses wherein the hypnodensity profile is derived using a model of sleep classes, wherein the model is determined from training data from a population in which at least some of the population are determined to exhibit at least some degree of sleep apnea, and wherein the at least one predetermined threshold is determined from the training data (e.g. ¶¶11, 81 and 133).
Claim Rejections - 35 USC § 103
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarlija as applied to claims 1-7 and 18-20 above, and further in view of De Groot et al. (U.S. Pub. 2020/0405222 hereinafter “DeGroot”).
Regarding claim 8, Sarlija discloses the claimed invention except for the system using multiple thresholds to analyze the AHI data. However, DeGroot teaches that it is known to use four separate thresholds as set forth in Paragraph 7 to provide known analysis to determine apnea severity. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Sarlija, with four thresholds as taught by DeGroot, since such a modification would provide the predictable results of using well-known thresholds to determine normal, mild, moderate and severe apnea.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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