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 .
Response to Amendment
The amendment filed on 05/26/2026 has been entered. Claims 1 - 5 and 16 - 20 are pending.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, 5, 16, 19, & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shouldice (US 20230404793 A1) in view of Kayser (EP 3245943 A1).
In regard to claim 1, Shouldice discloses a system (FIG. 1) that includes a control system (FIG. 1, component 110) with a processor (FIG. 1, component 112) and memory storying instructions (FIG. 1, component 114; paragraph [0034]), a display (FIG. 1, component 172), a therapy system (FIG. 1, component 120), and one or more sensors (FIG. 1, component 130), including non-contact sensors, such as a camera (FIG. 1, component 150) and infrared sensor (FIG. 1, component 152), which can be used to determine a movement of a user (paragraphs [0056] - [0057]), where sensor data including video and movement data (paragraph [0095]; FIG. 5, component 502) is used by the control system (FIG. 1, component 110) to detect an event (FIG. 5, component 510), such as a restless leg or sleep apnea (paragraph [0046]). Based on the detected event (FIG. 5, component 502), which corresponds to a disease or condition, the control system determines a treatment, such as electrical stimulation using the therapy device (paragraph [0125]), for the patient. The therapy provided by the therapy system (FIG. 1, component 120) is adjusted based on the information processed by the control system (FIG. 5, component 528) in a feedback loop (paragraph [0111]) and the therapy adjustments are made dynamically in real-time using real-time sensor data (paragraph [0023]). The therapy device comprises a nerve stimulation device which is used to provide an electrical stimulus to a nerve in order to elicit a specific response (paragraph [0125]). Examiner notes that Applicant describes the “neurostimulus device” as a device which provides an electrical stimulus to a particular area of a patient, including a particular nerve in paragraph [0078] of the specification which is met by the therapy device discussed by Shouldice.
While Shouldice discloses a that their system includes monitoring a user’s movement using a plurality of sensors, including a camera (FIG. 1, component 150; paragraphs [0056] - [0057]), in order to detect an event that is correlated with a disease or condition, such as restless leg syndrome or sleep apnea (paragraph [0046]), they do not specify that the camera is a depth-sensing camera or that the steps executed by the processor include detecting a pattern of movement of the patient in a region of interest (ROI) with the non-contact monitoring system based on a change in a depth signal over time or that a pattern of movement is correlated to a disease or condition.
However, Kayser teaches a non-contact monitoring system for monitoring a patient (FIG. 1) that includes the steps of detecting a ROI by generating masks of the chest area and the leg area (FIG. 4, see “Maske”; page 5, paragraphs 3 - 8). The ROIs are imaged using a depth camera (page 3, paragraph 2), such as an active infrared time of flight camera, active structured infrared camera, or infrared stereo camera with infrared lamp (page 3, paragraph 2), and the images are processed to determine at least one motion characteristic for each depth image of the at least one ROI within the generated mask (page 7, paragraph 1). The processing includes detecting the average depth data corresponding to the torso region of each respective depth image wherein respiratory movement is associated with at least one motion signal that comprises a temporal sequence where all measurements are taken together to reflect the entire respiratory movement over the measurement period (page 7, paragraphs 3 - 6). Kayser additionally discloses that the lateral displacement of the ROI masks corresponding to the leg region to determine a pattern of leg movement (page 8, paragraph 4 - page 9, paragraph 3; page 9, paragraph 7). Kayser further discloses that their invention includes the steps of identifying pathological movement patterns which correspond to individual movements (page 7, paragraphs 6 - 7; page 9, paragraph 7) and using the data to determine if a person suffers from a sleep disorder, including sleep apnea based on a comparison of the measured respiratory movements patterns with pathological respiratory movement patterns using a pattern matching algorithm (page 7, paragraph 6 - 7) or restless leg movement syndrome based on the frequency of detected pathological movement signals of the legs (page 8, paragraph 5; page 15, paragraph 4).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the non-contact monitoring system disclosed by Shouldice with the teaching of Kayser that includes the use of a depth-sensing camera to detect a pattern of movement of a patient in an ROI based on changes in the depth signal over time and correlating the detected pattern of movement to a disease or condition such as sleep apnea or restless leg syndrome, because Shouldice already discusses the use of cameras for collecting video and motion data to determine the occurrence of an event correlated with a disease or condition, such as sleep apnea or restless leg syndrome, such that modifying Shouldice with the teachings of Kayser would be considered combining prior art elements, in this case the system disclosed by Shouldice and the sensor and steps of processing of sensor data taught by Kayser, to yield the predictable results of identifying an event correlated with a disease or condition such as sleep apnea or restless leg syndrome.
In regard to claim 4, Shouldice as modified discloses the invention of claim 1, wherein the steps further comprise: notifying a user via the display of the determined treatment for the patient for the detected disease or condition. Shouldice discloses that the system presents a display to a user or medical professional with the treatment or adjustment parameters (paragraph [0039]; paragraph [0116]).
In regard to claim 5, Shouldice as modified discloses the invention of claim 1, wherein the steps further comprise: correlating the detected pattern of movement to restless leg syndrome (Kayser, page 8, paragraph 5; page 15, paragraph 4).
In regard to claim 16, Shouldice discloses a system (FIG. 1) that includes a control system (FIG. 1, component 110) with a processor (FIG. 1, component 112) and memory storying instructions (FIG. 1, component 114; paragraph [0034]), a therapy system (FIG. 1, component 120), and one or more sensors (FIG. 1, component 130), including non-contact sensors, such as a camera (FIG. 1, component 150) and infrared sensor (FIG. 1, component 152), which can be used to determine a movement of a user (paragraphs [0056] - [0057]), where sensor data including video and movement data (paragraph [0095]; FIG. 5, component 502) is used by the control system (FIG. 1, component 110) to detect an event (FIG. 5, component 510), such as a restless leg or sleep apnea (paragraph [0046]). Based on the detected event (FIG. 5, component 502), which corresponds to a disease or condition, the control system determines a treatment, such as electrical stimulation using the therapy device (paragraph [0125]), for the patient. The therapy provided by the therapy system (FIG. 1, component 120) is adjusted based on the information processed by the control system (FIG. 5, component 528) in a feedback loop (paragraph [0111]) and the therapy adjustments are made dynamically in real-time using real-time sensor data (paragraph [0023]). The therapy device comprises a nerve stimulation device which is used to provide an electrical stimulus to a nerve in order to elicit a specific response (paragraph [0125]). Examiner notes that Applicant describes the “neurostimulus device” as a device which provides an electrical stimulus to a particular area of a patient, including a particular nerve in paragraph [0078] of the specification which is met by the therapy device discussed by Shouldice.
While Shouldice discloses that their system includes monitoring a user’s movement using a plurality of sensors, including a camera and infrared sensor (FIG. 1, component 150; paragraphs [0056] - [0057]), in order to detect an event that is correlated with a disease or condition, such as restless leg syndrome or sleep apnea (paragraph [0046]), they do not specify that the camera is a depth-sensing camera or that the steps executed by the processor include receiving, from the depth-sensing camera, a depth signal corresponding to a ROI of the patient, detecting a pattern of movement of the patient in the (ROI) based on one or more changes in the depth signal over time, and correlating the pattern of movement to a disease or condition.
However, Kayser teaches a non-contact monitoring system for monitoring a patient (FIG. 1) that includes the steps of detecting a ROI by generating masks of the chest area and the leg area (FIG. 4, see “Maske”; page 5, paragraphs 3 - 8). The ROIs are imaged using a depth camera (page 3, paragraph 2), such as an active infrared time of flight camera, active structured infrared camera, or infrared stereo camera with infrared lamp (page 3, paragraph 2), and the images are processed to determine at least one motion characteristic for each depth image of the at least one ROI within the generated mask (page 7, paragraph 1). The processing includes detecting the average depth data corresponding to the torso region of each respective depth image wherein respiratory movement is associated with at least one motion signal that comprises a temporal sequence where all measurements are taken together to reflect the entire respiratory movement over the measurement period (page 7, paragraphs 3 - 6). Kayser additionally discloses that the lateral displacement of the ROI masks corresponding to the leg region to determine a pattern of leg movement (page 8, paragraph 4 - page 9, paragraph 3; page 9, paragraph 7). Kayser further discloses that their invention includes the steps of identifying pathological movement patterns which correspond to individual movements (page 7, paragraphs 6 - 7; page 9, paragraph 7) and using the data to determine if a person suffers from a sleep disorder, including sleep apnea based on a comparison of the measured respiratory movements patterns with pathological respiratory movement patterns using a pattern matching algorithm (page 7, paragraph 6 - 7) or restless leg movement syndrome based on the frequency of detected pathological movement signals of the legs (page 8, paragraph 5; page 15, paragraph 4).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the non-contact monitoring system disclosed by Shouldice with the teaching of Kayser that includes the use of a depth-sensing camera to detect a pattern of movement of a patient in an ROI based on changes in the depth signal over time and correlating the detected pattern of movement to a disease or condition such as sleep apnea or restless leg syndrome, because Shouldice already discusses the use of cameras for collecting video and motion data to determine the occurrence of an event correlated with a disease or condition, such as sleep apnea or restless leg syndrome, such that modifying Shouldice with the teachings of Kayser would be considered combining prior art elements, in this case the system disclosed by Shouldice and the sensor and steps of processing of sensor data taught by Kayser, to yield the predictable results of identifying an event correlated with a disease or condition such as sleep apnea or restless leg syndrome.
In regard to claim 19, Shouldice as modified discloses the invention of claim 16. Shouldice further discloses a display (FIG. 1, component 172) configured to present a display to a user or medical professional with the treatment or adjustment parameters based on the correlated condition or disease (paragraph [0039]; paragraph [0116]).
In regard to claim 20, Shouldice as modified discloses the invention of claim 16, wherein the steps further comprise: correlating the detected pattern of movement to restless leg syndrome (page 8, paragraph 5; page 15, paragraph 4).
Claims 2 - 3 & 17 - 18 are rejected under 35 U.S.C. 103 as being unpatentable over Shouldice (US 20230404793 A1) in view of Kayser (EP 3245943 A1) as applied to claims 1 and 16 above, and further in view of Yu (WO 2019173237 A1).
In regard to claim 2, Shouldice as modified discloses the invention of claim 1. While both Shouldice and Kayser discuss a non-contact imaging system for monitoring respiratory and leg movements using an imaging sensor (Shouldice FIG. 1, components 150 & 152; Kayser, FIG. 1, see “Sensor”), they do not disclose that the steps further comprise: detecting movement of the patient by a change in the light intensity over time.
However, Yu teaches a non-contact monitoring system for tracking and analyzing the motion of a patient (FIG. 1B, component 102) that can be used in a variety of applications including in homes, hospitals, and sleep labs (paragraph [0192]) that includes collecting motion data and/or patient images and further analyzed to determine movement or a position of the patient or a portion of the patient as a function of time using the intensity variation due to motion or light absorption that is observed in the image (paragraphs [0085] - [0086]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the non-contact monitoring system for determining the presence of respiratory and leg movements disclosed by Shouldice as modified with the teaching that movement of a region or portion of a patient can be monitored over time as a function of light intensity from Yu because it would be considered combining prior art elements, in this case the steps of analyzing imaging data to detect movement of a patient, according to known methods to yield the predictable result of monitoring a region of interest of a patient over time.
In regard to claim 3, Shouldice as modified discloses the invention of claim 2, wherein the system further comprises a projector, configured to project a feature onto the patient in the ROI, and wherein the steps further comprise: detecting movement of the patient from a light intensity reflection signal, by the depth-sensing camera, of a feature projected on the patient in the ROI. Yu further teaches that the non-contact monitoring system can track positioning information or movement of the chest by placing one or more markers on the chest of the patient and processing the imaging data. The dot markers can be projected onto the chest using a dot projector (paragraph [0148]).
In regard to claim 17, Shouldice as modified discloses the invention of claim 16. While both Shouldice and Kayser discuss a non-contact imaging system for monitoring respiratory and leg movements using an imaging sensor (Shouldice FIG. 1, components 150 & 152; Kayser, FIG. 1, see “Sensor”), they do not disclose that the pattern of movement of the patient is detected based on a change in a light intensity signal over time.
However, Yu teaches a non-contact monitoring system for tracking and analyzing the motion of a patient (FIG. 1B, component 102) that can be used in a variety of applications including in homes, hospitals, and sleep labs (paragraph [0192]) that includes collecting motion data and/or patient images and further analyzed to determine movement or a position of the patient or a portion of the patient as a function of time using the intensity variation due to motion or light absorption that is observed in the image (paragraphs [0085] - [0086]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the non-contact monitoring system for determining the presence of respiratory and leg movements disclosed by Shouldice as modified with the teaching that movement of a region or portion of a patient can be monitored over time as a function of light intensity from Yu because it would be considered combining prior art elements, in this case the steps of analyzing imaging data to detect movement of a patient, according to known methods to yield the predictable result of monitoring a region of interest of a patient over time.
In regard to claim 18, Shouldice as modified discloses the invention of claim 17, further comprising: a projector configured to project a feature onto the patient in the ROI, wherein the pattern of movement of the patient is detected based on a light intensity reflection signal of the feature. Yu further teaches that the non-contact monitoring system can track positioning information or movement of the chest by placing one or more markers on the chest of the patient and processing the imaging data. The dot markers can be projected onto the chest using a dot projector (paragraph [0148]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 05/26/2026, with respect to the rejection of claims 2, 3, 5, and 20 under 35 U.S.C. 112 have been fully considered and are persuasive. The rejections of claims 2, 3, 5, and 20 under 35 U.S.C. 112 have been withdrawn.
Applicant’s arguments, see Remarks, filed 05/26/2026, with respect to the rejection of claims 1, 2, 4, 5, 16, 17, 19, and 20 under 35 U.S.C. 101 have been fully considered and are persuasive. The rejections of claims 1, 2, 4, 5, 16, 17, 19, and 20 under 35 U.S.C. 101 have been withdrawn.
Applicant’s arguments, see Remarks, filed 05/26/2026, with respect to the rejection of claims 16 and 20 under 35 U.S.C. 102 and claims 1 - 5, 17, 18, and 19 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection of independent claims 1 and 16 is made in view of Shouldice (US 20230404793 A1) in view of Kayser (EP 3245943 A1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nakata (AU 2012308234 A1) discloses a therapy device that applies bio-feedback mechanisms to treat a detected condition associated with apnea that includes applying an electrical signal to stimulate a nerve or the brain based on information collected by a non-contact monitoring device (paragraphs [0016] - [0017]; FIG. 14B)
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 SIENNA CHRISTINE PYLE whose telephone number is (703)756-5798. The examiner can normally be reached 8 am - 5:30 pm M - T; Off first Fridays; 8 am - 4 pm second Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791
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