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 .
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, 3-14, and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0246014 GALARNEAU et al., hereinafter “Galarneau”, in view of WO 2021/234037 Tiron et al., hereinafter “Tiron” (both cited previously).
Regarding claim 1, Galarneau discloses a system for determining respiration of a subject (Abstract and Para 49 the preamble is given no patentable weight), the system (Figure 3, element 100) comprising: an accelerometer (Figure 3, element 90) configured to sense body status of the subject at a first sampling rate and generate a first accelerometer signal (Para 35-36 and 54); a controller coupled to the accelerometer (Figure 3, element 80) and configured to control sampling rates of the accelerometer (Para 50); and a first filter comprising a low pass filter (Para 34 and 37), wherein the first filter is configured to process the first accelerometer signal and generate a body orientation signal corresponding to a body orientation of the subject (Para 38), wherein the controller is further configured to determine if the body orientation of the subject is recumbent based on the body orientation signal (Para 23 and 57).
Galarneau does not disclose a magnetometer configured to sense the body status of the subject when a body orientation of the subject is recumbent and generate a magnetometer signal at the first sampling rate; a controller coupled to the magnetometer; an envelope detector; and wherein the first filter is further configured to process the magnetometer signal to generate a body direction signal corresponding to a body direction of the subject, wherein the controller is further configured to determine if the subject is motionless based on the body direction signal.
However, Tiron discloses a system to monitor breathing of a subject (Abstract) and teaches a magnetometer (Para 46; attorneys arguments are addressed in the “response to arguments” below. Para 46 disclose that the motion sensors include a magnetometer, therefore this limitation is taught) configured to sense the body status of the subject when a body orientation of the subject is recumbent (Abstract; the motion signals of this application are used to monitor respiration when the user is sleeping, therefore recumbent, however further consider Para 444 that discloses supine and prone positions and Para 51 that describes sensing the users gait from motion data; i.e. magnetometer data as defined by Para 46) and generate a magnetometer signal at the first sampling rate (Para 71-72 discloses applying a filter comprising an envelope detector to the motion signals, i.e. the magnetometer signal; Para 46); a controller coupled to the magnetometer (Para 46); an envelope detector (Para 84, 194, and 235, see also Para 71-72); and wherein the first filter is further configured to process the magnetometer signal to generate a body direction signal corresponding to a body direction of the subject (Para 61, 195, 199, and 201; the motion signals, i.e. the magnetometer signal as defined by Para 46, is used to determine body position, see also Para 444 that discloses motion processing to determine a change in body position from supine to prone, therefore further defining a determination of body direction), wherein the controller is further configured to determine if the subject is motionless based on the body direction signal (Para 46; to determine movement is to determine no movement).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an envelope detector and a magnetometer, as taught by Tiron, in the invention of Galarneau, in order to provide median frequency (Tiron; Para 238) and to measure motion (Tiron; Para 46).
Regarding claim 3, Galarneau discloses the accelerometer is further configured to sense body movement at a second sampling rate and generate a second accelerometer signal (Para 55 and 61), wherein the second sampling rate is greater than the first sampling rate (Para 55 and 61; see also Claim 2), and further comprising: a second filter comprising a bandpass filter (Para 37).
Galarneau does not disclose the second filter is configured to process the second accelerometer signal and to generate a respiration signal corresponding to the respiration of the subject, wherein the controller is further configured to determine if the respiration signal is regular.
However, Tiron teaches the second filter is configured to process the second accelerometer signal and to generate a respiration signal corresponding to the respiration of the subject (Para 85), wherein the controller is further configured to determine if the respiration signal is regular (Para 524; Figure 8B shows the control system and the outputting of a sleep score and output features, see also Para 460).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed generating a respiratory signal from the accelerometer signal, as taught by Tiron, in the invention of Galarneau, in order to measure respiratory effort (Tiron; Para 85).
Regarding claim 4, Galarneau discloses the controller is further configured to determine a body heading signal of the subject based at least in part on processing the body orientation signal and the body direction signal (Para 27).
Regarding claim 5, Galarneau discloses the controller is further configured to determine that the subject is asleep (Para 122)
Galarneau does not disclose detecting that the subject is asleep based at least in part on processing the respiration signal and at least one of the body orientation signal, the body direction signal, and the body heading signal.
However, Tiron teaches detecting that the subject is asleep based at least in part on processing the respiration signal and at least one of the body orientation signal, the body direction signal, and the body heading signal (Para 42, 444, and 445).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed determining sleep cycle from the different signals, as taught by Tiron, in the invention of Galarneau, in order to determine sleep-wake data (Tiron; Para 42).
Regarding claim 6, Galarneau discloses all the limitations of claim 4.
Galarneau does not disclose the controller is further configured to determine inspiration and expiration phases of the respiration of the subject based at least in part on processing the respiration signal and at least one of the body orientation signal, the body direction signal, and the body heading signal.
However, Tiron teaches the controller is further configured to determine inspiration and expiration phases of the respiration of the subject based at least in part on processing the respiration signal (Para 37) and at least one of the body orientation signal, the body direction signal, and the body heading signal (Para 271).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed determine inspiration and expiration phases, as taught by Tiron, in the invention of Galarneau, in order to determine respiratory features (Tiron; Para 37).
Regarding claim 7, Galarneau discloses a stimulation system (Figure 3, element 84) for generating nerve stimulation signals (Para 40); and a lead coupled to the stimulation system and comprising a neural interface at its distal end (Para 25), wherein the controller is coupled to the stimulation system and further configured to control generating the nerve stimulation signals during the inspiration phase of the respiration of the subject (Figure 3, elements 80 and 84 and Para 43).
Regarding claim 8, Galarneau discloses the first sampling rate is one sample in a range of every 2 to 10 seconds (Para 55 and 113; 2 second interval).
Regarding claim 9, Galarneau discloses the second sampling rate is in a range of 1 to 10 Hz (Para 55; 32 Hz or lower includes 1-10 Hz).
Regarding claim 10, Galarneau discloses the low pass filter has a cutoff frequency in a range of 0.1 to 2.0 Hz (Para 38; 1Hz).
Regarding claim 11, Galarneau discloses the bandpass filter has a passband within a range of 0.1 to 2.0 Hz (Para 37).
Regarding claim 12, Galarneau discloses all the limitations of claim 3.
Galarneau does not disclose a gyroscope coupled to the controller and configured to sense body direction change and generate a gyroscope signal at the second sampling rate, wherein the second filter is further configured to process the gyroscope signal to provide a body direction change signal corresponding to the body direction change of the subject, wherein the controller is further configured to determine that the respiration of the subject is regular based on the body direction change signal.
However, Tiron teaches a gyroscope (Para 46) coupled to the controller (Para 46) and configured to sense body direction change (Para 51; falls) and generate a gyroscope signal at the second sampling rate (Para 72), wherein the second filter is further configured to process the gyroscope signal to provide a body direction change signal corresponding to the body direction change of the subject (Para 61, 195, 199, and 201), wherein the controller is further configured to determine that the respiration of the subject is regular based on the body direction change signal (Para 524; Figure 8B shows the control system and the outputting of a sleep score and output features, see also Para 460).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a gyroscope, as taught by Tiron, in the invention of Galarneau, in order to measure motion (Tiron; Para 46).
Regarding claim 13, Galarneau discloses the controller is further configured to determine that the subject is vertical based on at least one of the body orientation signal, body direction signal, and body heading signal (Para 33 and 53), wherein the first and second filters comprise digital filters having internal initial states; and, wherein the controller is further configured to reset the internal initial states of the first and second filters to initial states (Para 34, and 37-38).
Regarding claim 14, Galarneau discloses a method for determining respiration of a subject (Abstract and Para 49 the preamble is given no patentable weight and Figure 4), the method (Figure 4) comprising: sensing, using an accelerometer (Figure 3, element 90), body status of the subject at a first sampling rate (Para 35-36 and 54) in a range of every 2 to 10 seconds (Para 55 and 113; 2 second interval); generating, using the accelerometer, a first accelerometer signal (Para 35-36 and 54); processing the first accelerometer signal with a first filter and generating a body orientation signal (Para 38), wherein the first filter comprises a low pass filter (Para 34 and 37), wherein the low pass filter comprises a cutoff frequency in a range of 0.1 to 2.0 Hz (Para 38; 1Hz); and determining if a body orientation is recumbent based on the body orientation signal (Para 23 and 57).
Galarneau does not disclose an envelope detector; sensing, using a magnetometer, the body status of the subject at the first sampling rate when the body orientation is recumbent; generating, using the magnetometer, a magnetometer signal; processing the magnetometer signal with the first filter to generate a body direction signal; and determining if the body status of the subject is motionless based on the body direction signal.
However, Tiron discloses a method to monitor breathing of a subject (Abstract) and teaches an envelope detector (Para 84, 194, and 235); sensing, using a magnetometer (Para 46; attorneys arguments are addressed in the “response to arguments” below. Para 46 disclose that the motion sensors include a magnetometer, therefore this limitation is taught), the body status of the subject at the first sampling rate when the body orientation is recumbent (Abstract; the motion signals of this application are used to monitor respiration when the user is sleeping, therefore recumbent, however further consider Para 444 that discloses supine and prone positions and Para 51 that describes sensing the users gait from motion data; i.e. magnetometer data as defined by Para 46); generating, using the magnetometer, a magnetometer signal (Para 71-72 discloses applying a filter comprising an envelope detector to the motion signals, i.e. the magnetometer signal; Para 46); processing the magnetometer signal with the first filter to generate a body direction signal (Para 61, 195, 199, and 201; the motion signals, i.e. the magnetometer signal as defined by Para 46, is used to determine body position, see also Para 444 that discloses motion processing to determine a change in body position from supine to prone, therefore further defining a determination of body direction); and determining if the body status of the subject is motionless based on the body direction signal (Para 46; to determine movement is to determine no movement).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an envelope detector and a magnetometer, as taught by Tiron, in the invention of Galarneau, in order to provide median frequency (Tiron; Para 238) and to measure motion (Tiron; Para 46).
Regarding claim 16, Galarneau discloses sensing, using the accelerometer, body motion of the subject at a second sampling rate (Para 55 and 61) in a range of 1 to 10 Hz (Para 55; 32 Hz or lower includes 1-10 Hz); generating, using the accelerometer, a second accelerometer signal(Para 55 and 61); wherein the second filter comprises a bandpass filter with a passband within a range of 0.1 to 2.0 Hz (Para 37).
Galarneau does not disclose generate a respiration signal by processing the second accelerometer signal with a second filter; and determining if the respiration signal is regular based on the respiration signal.
However, Tiron teaches generate a respiration signal by processing the second accelerometer signal with a second filter (Para 85); and determining if the respiration signal is regular based on the respiration signal (Para 524; Figure 8B shows the control system and the outputting of a sleep score and output features, see also Para 460).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed generating a respiratory signal from the accelerometer signal, as taught by Tiron, in the invention of Galarneau, in order to measure respiratory effort (Tiron; Para 85).
Regarding claim 17, Galarneau discloses generating a body heading signal by processing the body orientation signal with the body direction signal (Para 27); and determining if the subject is asleep (Para 122).
Galarneau does not disclose determining that the subject is asleep based on at least one of the body orientation signal, the body direction signal, and the body heading signal.
However, Tiron teaches determining that the subject is asleep based on at least one of the body orientation signal, the body direction signal, and the body heading signal (Para 42, 444, and 445).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed determining sleep cycle from the different signals, as taught by Tiron, in the invention of Galarneau, in order to determine sleep-wake data (Tiron; Para 42).
Regarding claim 18, Galarneau discloses all the limitations of claim 16.
Galarneau does not disclose determining inspiration and expiration phases of the respiration of the subject based on the respiration signal.
However, Tiron teaches determining inspiration and expiration phases of the respiration of the subject based on the respiration signal (Para 37).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed determine inspiration and expiration phases, as taught by Tiron, in the invention of Galarneau, in order to determine respiratory features (Tiron; Para 37).
Regarding claim 19, Galarneau discloses generating, using a stimulation system (Figure 3, element 84), nerve stimulation signals (Para 40); providing a lead coupled to the stimulation system and having a neural interface at its distal end (Para 25); and generating nerve stimulation signals during the inspiration phase of the respiration of the subject (Figure 3, elements 80 and 84 and Para 43).
Regarding claim 20, Galarneau discloses all the limitations of claim 14.
Galarneau does not disclose sensing, using a gyroscope, body direction changes and generating a gyroscope signal at a second sampling rate; processing the gyroscope signal with a second filter comprising a bandpass filter with a passband within a range of 0.1 to 2.0 Hz; providing a body direction change signal corresponding to the body direction change of the subject; and determining that the respiration of the subject is regular based on the body direction change signal.
However, Tiron teaches sensing, using a gyroscope (Para 46), body direction changes (Para 51; falls) and generating a gyroscope signal at a second sampling rate (Para 72); processing the gyroscope signal with a second filter comprising a bandpass filter with a passband within a range of 0.1 to 2.0 Hz (Para 37); providing a body direction change signal corresponding to the body direction change of the subject (Para 61, 195, 199, and 201); and determining that the respiration of the subject is regular based on the body direction change signal (Para 524; Figure 8B shows the control system and the outputting of a sleep score and output features, see also Para 460).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a gyroscope, as taught by Tiron, in the invention of Galarneau, in order to measure motion (Tiron; Para 46).
Regarding claim 21, Galarneau discloses determining that the subject is vertical based on at least one of the body orientation signal, body direction signal, and body heading signal (Para 33 and 53); and resetting internal initial states of the first and second filters comprising digital filters to their initial states (Para 34, and 37-38).
Response to Arguments
Applicant's arguments filed 02/25/2026 have been fully considered but they are not persuasive.
First attorney argues that a magnetometer is listed among a dozen of possible sensor types (including blood pressure monitors, thermometers, pulse oximeters, heart rate monitors, accelerometers, gyroscopes, cameras and others) and a mere listing does not teach a magnetometer that is configured to sense. Examiner respectfully disagrees. First examiner does not know what disclosure applicant is referring to, Para 46 of Tiron clearly discloses “The motion sensor can include one or more inertial sensors, such as accelerometers, gyroscopes, and magnetometers”. This disclosure in itself is enough to read on a magnetometer being disclosed. Every disclosure of a motion signal in Tiron can be interpreted to be a signal measured by a magnetometer, since para 46 clearly states that the motion sensor can be a magnetometer. Therefore, any paragraph examiner cites that refers to “a motion signal” is interpreted to be a signal from a magnetometer since reference Tiron defines this signal as a motion signal/sensor. If applicant does not agree with this disclosure under BRI, examiner suggests amending the claim to define a magnetometer signal.
Regarding the argument of the first filter, examiner respectfully disagrees. Para 71-72 disclose applying a filter comprising an envelope detector to the motion signals, i.e. the magnetometer signal; Para 46.
In regards to the last argument made by applicant, applicant argues that “detecting a body position” is a high-level statement does not disclose generating a body direction signal, nor does it describe filtering any inertial or magnetic sensor output to determine directional bearing. Examiner respectfully disagrees. As shown by the rejection above Para 61, 195, 199, and 201; the motion signals, i.e. the magnetometer signal as defined by Para 46, is used to determine body position, see also Para 444 that discloses motion processing to determine a change in body position from supine to prone, therefore further defining a determination of body direction. Nothing in the claims state “determining directional bearing from a magnetic sensor”. Examiner suggests further defining how the body direction signal is measured.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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