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 Arguments
Applicant’s arguments with respect to claim(s) 1-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pinczuk et al. (U.S. Pub. 2022/0273234 hereinafter “Pinczuk” – PCT filed 8/28/2020) in view of Hatlestad et al. (U.S. Pub. 2009/0069708 hereinafter “Hatlestad”) and further in view of Dugan (U.S. Pub. 2016/0374608 cited on IDS filed 4/28/22).
Regarding claims 1-2 and 14-15, Pinczuk discloses a positional sleep therapy system and method (e.g. 380), comprising: a sensor arrangement for detecting physiological parameters of a subject (e.g. 150-178); a detection system for detecting a sleeping position of the subject (e.g. 132, 138); an alert system for instructing a change in sleep position of the subject (e.g. 172); a feedback system for inducing a change in sleep position (e.g. 180); a breathing ventilation system to deliver positive airway pressure to the subject (e.g. 120; ¶¶41-45); and a controller (e.g. 110), wherein the controller is adapted to: identify, from the physiological parameters (e.g. ¶¶38, 79); and control the alert system to instruct the feedback system to induce a change in sleep position of the subject intended to remedy the condition (e.g. ¶¶38, 79) and control the breathing ventilation system to adjust one or more ventilation parameters to increase chest breathing in the subject (e.g. ¶¶42). Pinczuk discloses the claimed invention except for the system identifying fluid accumulation using bioimpedance. However, Hatlestad teaches that it is known to use impedance sensors mounted against the chest as set forth in Paragraphs 69, 76 and 86 to provide means for determining fluid accumulation within the body when the is in various sleep positions and providing an alert to the patient and/or doctor regarding the fluid buildup. 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 Pinczuk, with the edema analysis as taught by Hatlestad, since such a modification would provide the predictable results of combining a known sleep treatment system with a known analysis of edema to properly sense and control edema. Pinczuk in view of Hatlestad discloses the claimed invention except for the system using vibration to alert the user to change sleep position. However, Dugan teaches that it is known to use multiple vibrator motors to provide vibrations to the user as set forth in Paragraphs 42, 51, 229, 234-235 to provide low level vibrations that do not wake users but subconsciously encourages them to shift positions. 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 Pinczuk in view of Hatlestad, with vibrators as taught by Dugan, since such a modification would provide the predictable results of using multiple vibrator motors for providing low level vibrations that do not wake users but subconsciously encourages them to shift positions.
Regarding claim 3, meeting the limitations of claims 1-2 above, Pinczuk further discloses wherein the sensor arrangement comprises a blood oxygen saturation sensor (e.g. 154, 168).
Regarding claim 4, meeting the limitations of claim 1 above, Pinczuk further discloses wherein the sensor arrangement comprises a breathing sensor for monitoring a respiratory flow pattern (e.g. 134).
Regarding claim 5, meeting the limitations of claims 1 and 4 above, Pinczuk further discloses wherein the sleep therapy system further comprises an adaptive support ventilation system, and wherein the breathing sensor is part of the adaptive support ventilation system, wherein the controller is adapted to trigger the detection of body position based on the respiratory flow pattern (e.g. 120).
Regarding claim 6, meeting the limitations of claim 1 above, Pinczuk further discloses wherein the sensor arrangement comprises: a hemodynamic sensor thereby to enable detection of cardiac stress (e.g. 154, 156, 158).
Regarding claim 7, meeting the limitations of claims 1 and 6 above, Pinczuk further discloses wherein the controller is adapted to instruct a change in sleep position to a right side (e.g. see Fig. 6C).
Regarding claim 8, meeting the limitations of claims 1 and 6 above, Pinczuk further discloses wherein the sensor arrangement further comprises a breathing sensor for monitoring a respiratory flow pattern to enable detection of breathlessness (e.g. ¶113).
Regarding claim 9, meeting the limitations of claims 1, 6 and 8 above, Pinczuk further discloses wherein the breathing sensor is adapted to detect Cheyne-Stokes respiration (e.g. 29, 32).
Regarding claim 10, meeting the limitations of claims 1, 6 and 8-9 above, Pinczuk further discloses wherein the controller is adapted to instruct a change in sleep position to a left side when Cheyne-Stokes respiration is detected (e.g. 29, 32).
Regarding claim 11, meeting the limitations of claims 1 and 6 above, Pinczuk in view of Hatlestad further teach wherein the sensor arrangement comprises: an ECG sensor for detecting volume overload (e.g. 156); a heart rate sensor (e.g. 154); an oxygen saturation sensor (e.g. 168); and a bioimpedance sensor for identifying rostral fluid shift (e.g. Hastlestad, Paragraphs 69, 76 and 86 ).
Regarding claim 12, meeting the limitations of claim 1 above, Pinczuk further discloses wherein the sleep therapy system further comprises a breathing ventilation system, and wherein the controller is further adapted to control the breathing ventilation system in response to identified fluid accumulation in a region of the body of the subject (e.g. 120).
Regarding claim 13, meeting the limitations of claims 1 and 12 above, Pinczuk further discloses wherein the controller is adapted to control the breathing ventilation system provide increased chest breathing (e.g. 120; ¶56).
Regarding claim 16, meeting the limitations of claim 1 above, Dugan further discloses wherein the vibrators are worn on a belt (e.g. Fig. 2A).
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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/REX R HOLMES/Primary Examiner, Art Unit 3796