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 .
Examiner’s Note
Due to claim amendments, claim 11 is now a generic claim that is generic to both species I and II (as per the Restriction/Election Requirement mailed August 14th, 2025). It is being examined below.
Claim Status
Claims 11-19 were pending for examination in Application No. 18/332,389 filed June 9th, 2023. In the remarks and amendments received on January 30th, 2026, claims 11, 13, and 18 are amended, claims 12 and 14 are cancelled, and claims 31 and 32 are added. Accordingly, claims 11, 13, 15-19, and 31-32 are pending for examination in the application.
Response to Arguments
Applicant’s arguments filed January 30th, 2026, with respect to the rejection of claim 11, have been fully considered but are moot because the arguments do not apply to the new combination of references, facilitated by Applicant’s newly submitted amendments being used in the current rejection.
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) 11, 15, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mestha et al. (US-20150094597-A1) and further in view of Vogel et al. (US-20160278647-A1).
Regarding claim 11, Mestha teaches:
determining a respiratory region of a patient (Fig. 4, and “Video camera 402 is rotatably fixed to support arm 404 such that the camera's field of view 405 can be directed by a technician onto target region 406,” Para [0057]);
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detecting, by a sensor, sensor data (from an “image-based depth sensing device”) including a plurality of distances (“depth”) between a position of the sensor (Fig. 1, 402) and the respiratory region (Fig. 1, 406), wherein the plurality of distances comprise changes in distance between the sensor and the respiratory region of the patient over time (“the image-based depth sensing device used to obtain video images of the subject's target region from which the time-varying sequence of depth maps is obtained,” Para [0056]);
determining, by a machine learning model (“artificial intelligence”), a sensed quality of the determined respiratory region (“the identified breathing pattern is processed by an artificial intelligence algorithm to determine whether an alert condition exists,” Para [0065]) based on the detected sensor data (“At step 502, receive a time-varying sequence of depth maps of a target region of a subject of interest being monitored for breathing pattern identification,” Para [0060]).
Mestha fails to teach the following limitations as further claimed. Mestha in view of Vogel, however, further teaches:
A method for qualifying sensor alignment relative to a patient (Vogel, “determine whether the wearable sensor device 210 is currently worn and/or misaligned based on the alignment sensor data,” Para [0037]), comprising:
determining whether the sensed quality of the determined respiratory region (Mestha, “an area or region of the subject where respiratory function can be assessed,” Para [0044]) satisfies a misalignment condition (Vogel, “The mobile computing device 720 can include a misalignment module 728 configured to determine that the wearable sensor device is misaligned with a body feature or surface when heart rate information collected by the heart rate detector does not correspond with expected heart rate values,” Para [0068]);
classifying a characteristic of the misalignment condition (the sensor is the wrong size for the person; Vogel, “the notification can include suggestions to switch to an alternative size of the wearable device 210 (e.g., small, medium or large) in order to improve the accuracy of the heart rate information,” Para [0060]),
and generating an instruction to provide a misalignment notification based at least partially on the classified characteristic (Vogel, “the notification can include suggestions to switch to an alternative size of the wearable device 210 (e.g., small, medium or large) in order to improve the accuracy of the heart rate information,” Para [0060]).
Vogel is considered to be analogous to the claimed invention because they are in the same field of devices that can detect misalignment of a sensor based on inaccurate sensor readings. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the teachings of Vogel into Mestha for the benefit of fewer false positives for medical conditions.
Regarding claim 15, the rejection of claim 11 is incorporated herein. Mestha in view of Vogel teaches the method of claim 11, and Mestha further teaches:
wherein the sensed quality of the determined respiratory region includes one of a detected size and a detected shape (“extracting 3D shape descriptors from each of the depth maps”) of the determined respiratory region (“the analysis of depth maps may include extracting 3D shape descriptors from each of the depth maps being analyzed in the depth map sequence, and the comparison may include computing differences in shapes as determined by the 3D shape descriptors,” Para [0086]).
Regarding claim 17, the rejection of claim 11 is incorporated herein. Mestha in view of Vogel teaches the method of claim 11, and Vogel further teaches visually displaying the misalignment notification (Vogel, “A notification can be generated for display on the mobile computing device 230 when the wearable sensor device 210 is improperly positioned or otherwise misaligned,” Para [0036]), and wherein the misalignment notification comprises notification of a corrective action to modify an alignment of the sensor relative to the patient (Vogel, “the notification can instruct the user 260 to adjust a position of the wearable sensor device 210,” Para [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the teachings of Vogel into Mestha for the benefit of more accurate physiological data monitoring.
Claim 19 recites limitations that would have been obvious to try, in light of there being only two finite solutions to the recognized problem – to keep the machine on or off in the absence of a patient. It would have been obvious to one of ordinary skill in the art to “determining a presence or absence of the patient in the patient environment, and de-activating the determination of the misalignment condition upon determining that the patient is absent” for the benefit of saving power and reducing wear and tear of the machine. Both would constitute a predictable result. See MPEP 2143 and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claim(s) 13 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mestha et al. (US-20150094597-A1) in view of Vogel et al. (US-20160278647-A1) as applied to claim 11, and further in view of Sabesan et al. (US-20150094605-A1).
Regarding claim 13, the rejection of claim 11 is incorporated herein. Mestha in view of Vogel teaches the method of claim 11, but fails to teach the following limitations as further claimed. Mestha in view of Sabesan, however, further teaches:
wherein the classified characteristic of the misalignment condition comprises one or more of a type or magnitude of misalignment of the sensor (Sabesan, “If monitoring device 102 is not in the proper location and/or occupying the correct area, one or more messages may be generated and/or transmitted. For example, a message to move monitoring device 102 a specific distance (e.g., 1 inch, 2 inches, etc.) in a specific direction (e.g., up, down, left, right, up diagonal and left, down diagonal and right, etc.) may be generated and/or transmitted,” Para [0031]) relative to the determined respiratory region (Mestha, “an area or region of the subject where respiratory function can be assessed,” Para [0044]).
Sabesan is considered to be analogous to the claimed invention because they are in the same field of validating alignment of a sensor that monitors a patient. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the teachings of Sabesan into Mestha and Vogel for the benefit of more accurate sensor readings from the patient.
Regarding claim 32, the rejection of claim 13 is incorporated herein. Mestha in view of Vogel and Sabesan teach the method of claim 13, and Sabesan further teaches:
wherein the classified characteristic comprises the type of misalignment (“If monitoring device 102 is not in the proper location,” Para [0031]), and wherein the type of misalignment comprises one or more of a rotational misalignment, a translational misalignment (“If monitoring device 102 is not in the proper location… a message to move monitoring device 102 a specific distance (e.g., 1 inch, 2 inches, etc.) in a specific direction (e.g., up, down, left, right, up diagonal and left, down diagonal and right, etc.) may be generated and/or transmitted,” Para [0031]), an angle of misalignment, and a distance of misalignment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the teachings of Sabesan into Mestha and Vogel for the benefit of more accurate sensor readings from the patient.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mestha et al. (US-20150094597-A1) in view of Vogel et al. (US-20160278647-A1) as applied to claim 11, and further in view of Patel et al. (US-20210407152-A1).
Regarding claim 16, the rejection of claim 11 is incorporated herein. Mestha in view of Vogel teaches the method of claim 11, but fails to teach the following limitations as claimed.
Patel, however, further teaches wherein the sensed quality of the determined respiratory region includes a detected fill ratio of an image representing a mask (“anatomic mask/mesh image”) wearable by the patient (“a schematic diagram of a smart device with displaying patient's anatomic mask/mesh image in which the smart device is positioned to align overlay of the anatomic anchor points to real-time image of live patient displayed on screen,” Para [0034]).
Patel is considered to be analogous to the claimed invention because they are in the same field of aligning templates to ensure a region of interest is correctly identified and in view. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the teachings of Patel into Mestha and Vogel for the benefit of accurate region of interest identification.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mestha et al. (US-20150094597-A1) in view of Vogel et al. (US-20160278647-A1) as applied to claim 11, and further in view of Tzvieli et al. (US-20170095157-A1).
Regarding claim 18, the rejection of claim 11 is incorporated herein. Mestha in view of Vogel teach the methiod of claim 11, but fail to teach the following limitations as further claimed. Tzvieli, however, teaches:
wherein the machine learning model is pre-trained with labeled generated sensor data (“the machine-learning based model is generated based on labeled training data that includes samples, each of which includes feature values derived from values of the thermal measurements (and possibly other inputs) and labels indicative of the physiological response,” Para [0080]).
Tzvieli is considered to be analogous to the claimed invention because they are in the same field of detecting physiological abnormalities via sensors near the body. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the teachings of Tzvieli into Mestha and Vogel for the benefit of more accurate physiological risk assessment.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mestha et al. (US-20150094597-A1) in view of Vogel et al. (US-20160278647-A1) as applied to claim 11, and further in view of Alsindi et aal. (US-20230181116-A1).
Regarding claim 31, the rejection of claim 11 is incorporated herein. Mestha in view of Vogel teach the method of claim 11, but fail to teach the following limitations as further claimed. Alsindi, however, further teaches:
wherein the machine learning model is based on a demographic (“user’s age, height, and/or weight”) of the patient (“The device may estimate a user's tidal volume. This may be estimated from one or more of the following inputs: (i) information regarding the status of the user: for example the user's age, height and/or weight… This data may be combined using a suitable algorithm, for example one derived from machine learning, to estimate the user's tidal volume,” Para [0061]).
Alsindi is considered to be analogous to the claimed invention because they are both in the field of determining respiration data from a sensor. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the teachings of Alsindi into Mestha and Vogel for the benefit of more accurate respiration data measurements that are patient specific.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bernal et al. (US-20150265187-A1) teaches a method for non-contact monitoring of the respiratory regions of a person.
Menser et al. (US-20240065663-A1) teaches a device that captures depth images of a patient’s respiratory region in order to calculate a patient’s breathing signal.
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 RACHEL A OMETZ whose telephone number is (571)272-2535. The examiner can normally be reached 6:45am-4:00pm ET Monday-Thursday, 6:45am-1:00pm ET every other Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vu Le can be reached at 571-272-7332. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rachel Anne Ometz/Examiner, Art Unit 2668 2/17/26
/VU LE/Supervisory Patent Examiner, Art Unit 2668