DETAILED ACTION
This Office Action is in response to the filing of the application on 8/02/2023. As per the initial filing, no claims have been amended, added, or cancelled. Thus, claims 1-15 are pending in the application.
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 .
Drawings
The drawings are objected to because Figs. 1-6 fail to comply with 37 CFR 1.84(b)(1) whereby photographs are not ordinarily permitted unless there is no other practicable means for showing the claimed invention. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 6, and 11 are objected to because of the following informalities:
Claim 1 recites the term “a breath training session” in line 10. Examiner suggests changing to read --the breath training session-- in order to clarify that it is the same breath training session as claimed earlier.
Claim 1 recites the term “values, analyze,” in lines 11-12. Examiner suggests changing to read --values; analyze-- in order to remove an extraneous comma and improve readability.
Claim 6 recites the term “values, analyze,” in line 12. Examiner suggests changing to read --values; analyze-- in order to remove an extraneous comma and improve readability.
Claim 11 recites the term “values, analyze,” in line 12. Examiner suggests changing to read --values; analyze-- in order to remove an extraneous comma and improve readability.
Appropriate correction is required.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6-8, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kennedy et al. (WO 2020/092701).
Regarding claim 1, Kennedy discloses a portable smart device designed to be held by a user or worn by the user, the portable smart device for determining a breathing quality of a user during a breath training session (see [0089]-[0090] and [0160]-[0161] where the system uses smart sensing and analytics to determining quality of a breath training session), the portable smart device comprising: one or more sensors configured to detect physiological parameter values of the user during the breath training session (see [0075]-[0078] where the system includes at least a flow rate sensor and pressure sensor); and a processor coupled to the one or more sensors (see [0084] and [0198] where the central controller which connects to and receives data from the sensors), the processor configured to: receive Mode II physiological parameter values from a positive airway pressure (PAP) device utilized by the user during PAP therapy, the Mode II physiological parameter values measured by the PAP device during the PAP therapy (see [0132]-[0134] where the central controller compares the measure of a presence of apnea/ hypopnea with a first threshold during a PAP, and determines whether this measurement has exceeded the threshold during a time period, thus indicating an apnea/ hypopnea event), develop and execute a breath training session based on the Mode II physiological parameter values (see [0149] where base pressure is continually computed in order to compute and adjust the EPAP during ventilation therapy), analyze, the physiological parameter values of the user detected by the one or more sensors during the breath training session to determine Mode I physiological parameter values, the Mode I physiological parameter values measured by the portable smart device during the breath training session (see [0173] and [0180] where a different mode is able to monitor breathing and cardiac activity to check the efficacy of a treatment), and transmit the physiological parameter values to the PAP device for adjustment of the PAP therapy (see [0180] where the sensed breathing/ cardiac values during the monitoring mode is able to be used for adjustment of applied therapy; see also [0237]).
Regarding claim 2, Kennedy discloses wherein the Mode II physiological parameter values include at least one of length and frequency of occurrence of Apnea events (see [0167]-[0169] where a triggering event (apnea/ hypopnea) is detected, and further see [0216] where an apnea-hypopnea index is derived from the detection of apnea/ hypopnea), and wherein the Mode I physiological parameter values include at least one of heart rate, heart rate variability, breathing rate, breathing rate variability, vagal tone, breath holding capability, variations in breath holding capability, blood oxygen saturation level and blood oxygen saturation level variability (see [0173] and [0180]).
Regarding claim 3, Kennedy discloses wherein the Mode II physiological parameter values include at least one of a mean duration and a maximum duration of Apnea events as measured during PAP therapy (see [0134] where the detected apnea/ hypopnea is compared to a first threshold for a predetermined period of time (maximum duration) to determine the apnea/ hypopnea is occurring).
Regarding claim 6, Kennedy discloses a positive airway pressure (PAP) device having a mask worn by the user (see Fig. 1C patient interface 3000 and [0032]), the PAP device for monitoring apnea events during PAP therapy (see [0134]), the PAP device comprising: a fan for applying positive airway pressure to the mask worn by the user during the PAP therapy (see [0072]); one or more sensors configured to detect physiological parameter values of the user during PAP therapy (see [0075]-[0078] where the system includes at least a flow rate sensor and pressure sensor); and a processor coupled to the one or more sensors (see [0084] and [0198] where the central controller which connects to and receives data from the sensors), the processor configured to: receive Mode I physiological parameter values from a portable smart device (see [0089]-[0090] and [0160]-[0161] where the system uses smart sensing and analytics to determining quality of a breath training session), the Mode I physiological parameter values measured by the portable smart device during a breath training session (see [0173] and [0180] where a different mode is able to monitor breathing and cardiac activity to check the efficacy of a treatment), develop and execute PAP therapy based on the Mode I physiological parameter values (see [0180] where the sensed breathing/ cardiac values during the monitoring mode is able to be used for adjustment of applied therapy), analyze, the physiological parameter values of the user detected by the one or more sensors during the PAP therapy to determine Mode II physiological parameter values (see [0132]-[0134] where the central controller compares the measure of a presence of apnea/ hypopnea with a first threshold during a PAP, and determines whether this measurement has exceeded the threshold during a time period, thus indicating an apnea/ hypopnea event), and transmit the Mode II physiological parameter values to the portable smart device for adjustment of the breath training (see [0149] where base pressure is continually computed by the processor in order to compute and adjust the EPAP during ventilation therapy; see also [0237]).
Regarding claim 7, Kennedy discloses wherein the Mode II physiological parameter values include at least one of length and frequency of occurrence of Apnea events (see [0167]-[0169] where a triggering event (apnea/ hypopnea) is detected, and further see [0216] where an apnea-hypopnea index is derived from the detection of apnea/ hypopnea), and wherein the Mode I physiological parameter values include at least one of heart rate, heart rate variability, breathing rate, breathing rate variability, vagal tone, breath holding capability, variations in breath holding capability, blood oxygen saturation level and blood oxygen saturation level variability (see [0173] and [0180]).
Regrading claim 8, Kennedy discloses wherein the Mode II physiological parameter values include at least one of a mean duration and a maximum duration of Apnea events as measured during PAP therapy (see [0134] where the detected apnea/ hypopnea is compared to a first threshold for a predetermined period of time (maximum duration) to determine the apnea/ hypopnea is occurring).
Regarding claim 11, Kennedy discloses an integrated positive airway pressure (PAP) device having a mask worn by the user (see Fig. 1C patient interface 3000 and [0032]), the PAP device for monitoring apnea events during PAP therapy (see [0134]), and for performing breath training (see [0089]-[0090] and [0160]-[0161] where the system uses smart sensing and analytics to determining quality of a breath training session), the PAP device comprising: a fan for applying positive airway pressure to the mask worn by the user during the PAP therapy (see [0072]); one or more sensors configured to detect physiological parameter values of the user during PAP therapy (see [0075]-[0078] where the system includes at least a flow rate sensor and pressure sensor); and a processor coupled to the one or more sensors (see [0084] and [0198] where the central controller which connects to and receives data from the sensors), the processor configured to: detect, via the one or more sensors, Mode I physiological parameter values measured by the PAP device during a breath training session (see [0173] and [0180] where a different mode is able to monitor breathing and cardiac activity to check the efficacy of a treatment), develop and execute PAP therapy based on the Mode I physiological parameter values (see [0180] where the sensed breathing/ cardiac values during the monitoring mode is able to be used for adjustment of applied therapy), analyze, the physiological parameter values of the user detected by the one or more sensors during the PAP therapy to determine Mode II physiological parameter values (see [0132]-[0134] where the central controller compares the measure of a presence of apnea/ hypopnea with a first threshold during a PAP, and determines whether this measurement has exceeded the threshold during a time period, thus indicating an apnea/ hypopnea event), adjust the breath training breath training based on the Mode II physiological parameter values (see [0149] where base pressure is continually computed by the processor in order to compute and adjust the EPAP during ventilation therapy), and adjust the PAP therapy based on the Mode I physiological parameter values (see [0180] where the sensed breathing/ cardiac values during the monitoring mode is able to be used for adjustment of applied therapy; see also [0237]).
Regarding claim 12, Kennedy discloses wherein the Mode II physiological parameter values include at least one of length and frequency of occurrence of Apnea events (see [0167]-[0169] where a triggering event (apnea/ hypopnea) is detected, and further see [0216] where an apnea-hypopnea index is derived from the detection of apnea/ hypopnea), and wherein the Mode I physiological parameter values include at least one of heart rate, heart rate variability, breathing rate, breathing rate variability, vagal tone, breath holding capability, variations in breath holding capability, blood oxygen saturation level and blood oxygen saturation level variability (see [0173] and [0180]).
Regarding claim 13, Kennedy discloses wherein the Mode II physiological parameter values include at least one of a mean duration and a maximum duration of Apnea events as measured during PAP therapy (see [0134] where the detected apnea/ hypopnea is compared to a first threshold for a predetermined period of time (maximum duration) to determine the apnea/ hypopnea is occurring).
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.
Claims 4-5, 9-10, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kennedy as applied to claims 1, 3, 6, 8, 11, and 13 respectively, above, and further in view of Tiron et al. (WO 2020/104465).
Regarding claim 4, Kennedy discloses wherein the processor is further configured to: compare the at least one of the mean duration and the maximum duration of Apnea events to a Mode I breath holding target duration (see [0216] where measured value from the therapy can include statistical analysis of the apnea/ hypopnea events, measuring a duration of the event and comparing to a conventional scoring means value), develop the breath training session by adjusting parameters in the breath training session when the mean duration and the maximum duration of Apnea events is greater than the Mode I breath holding target duration (see [0173] and [0180] where the breath training session is able to monitor values of the sleep cycle, including breathing rate, breathing rate variability, breathing signal waveform shape (inspiration, expiration pauses) and duration of activity, which is then used to adjust the breath training session; see also [0237]), and transmit an adjustment parameter to the PAP device when the mean duration and the maximum duration of Apnea events is less than the Mode I breath holding target duration (see [0173], [0180], and [0237] where measured values include the duration of apnea events, which are then compared to some threshold value and sent to the PAP device to control the settings thereof), the adjustment parameter instructing the PAP device to reduce pressure or shut off the PAP device for a least a duration of the PAP therapy (see [0173] where a reduction in PAP pressure is determined from the collected data, and see [0137] where pressure of the system can be reduced via the central controller).
Kennedy lacks a detailed description of the processor configured to: develop the breath training session by increasing the breath holding target duration in the breath training session.
However, Tiron teaches a respiratory monitoring and control device, where the intensity of detected apnea signals over a period of time can be measured, and developing the breath training session by increasing the breath holding target duration in the breath training session (see [0181]-[0184] where the intensity of modulation is related to the detection of apneas over a time period, and the modulation can be adjusted by increasing effort and duration of the modulation as seen in [0191]-[0193]) .
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apnea detection and control feedback of the Kennedy device to include changes to the breath holding target duration as taught by Tiron, as it would allow for changes to the breathing parameters with respect to the detection of the apneas, for better control and prevention of said apneas.
Regarding claim 5, the modified Kennedy discloses wherein the Mode II physiological parameter values are measured by deactivating or decreasing pressure for a duration of the PAP therapy (Kennedy; see [0137] where the pressure of the PAP therapy can be reduced, and measurements of the parameters occur during the operation of the PAP device as seen in [0132]-[0134]).
Regarding claim 9, Kennedy discloses wherein the processor is further configured to: develop the PAP therapy when the mean duration and the maximum duration of Apnea events is greater than a Mode I breath holding target duration (see [0173] and [0180] where the breath training session is able to monitor values of the sleep cycle, including breathing rate, breathing rate variability, breathing signal waveform shape (inspiration, expiration pauses), and develop the PAP therapy by reducing pressure or shutting off the PAP device for a least a duration of the PAP therapy when the mean duration and the maximum duration of Apnea events is less than the Mode I breath holding target duration (see [0173] where a reduction in PAP pressure is determined from the collected data, and see [0137] where pressure of the system can be reduced via the central controller, the reduction in pressure in response to a comparison of apnea duration).
Kennedy lacks a detailed description of the processor configured to: increase pressure during PAP therapy when apnea events are greater than a Mode I breath holding target duration.
However, Tiron teaches a respiratory monitoring and control device, where the intensity of detected apnea signals over a period of time can be measured, and developing the breath training session by increasing the pressure when apnea events are greater than a Mode I breath holding target duration (see [0181]-[0184] where the intensity of modulation is related to the detection of apneas over a time period, and the modulation can be adjusted by increasing effort and duration of the modulation as seen in [0191]-[0193]) .
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apnea detection and control feedback of the Kennedy device to include changes to the breath holding target duration as taught by Tiron, as it would allow for changes to the breathing parameters with respect to the detection of the apneas, for better control and prevention of said apneas.
Regarding claim 10, Kennedy discloses wherein the Mode II physiological parameter values are measured by deactivating or decreasing pressure for a duration of the PAP therapy (Kennedy; see [0137] where the pressure of the PAP therapy can be reduced, and measurements of the parameters occur during the operation of the PAP device as seen in [0132]-[0134]).
Regarding claim 14, Kennedy discloses wherein the processor is further configured to: develop the PAP therapy when the mean duration and the maximum duration of Apnea events is greater than a Mode I breath holding target duration (see [0173] and [0180] where the breath training session is able to monitor values of the sleep cycle, including breathing rate, breathing rate variability, breathing signal waveform shape (inspiration, expiration pauses), and develop the PAP therapy by reducing pressure or shutting off the PAP device for a least a duration of the PAP therapy when the mean duration and the maximum duration of Apnea events is less than the Mode I breath holding target duration (see [0173] where a reduction in PAP pressure is determined from the collected data, and see [0137] where pressure of the system can be reduced via the central controller, the reduction in pressure in response to a comparison of apnea duration).
Kennedy lacks a detailed description of the processor configured to: increase pressure during PAP therapy when apnea events are greater than a Mode I breath holding target duration.
However, Tiron teaches a respiratory monitoring and control device, where the intensity of detected apnea signals over a period of time can be measured, and developing the breath training session by increasing the pressure when apnea events are greater than a Mode I breath holding target duration (see [0181]-[0184] where the intensity of modulation is related to the detection of apneas over a time period, and the modulation can be adjusted by increasing effort and duration of the modulation as seen in [0191]-[0193]) .
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apnea detection and control feedback of the Kennedy device to include changes to the breath holding target duration as taught by Tiron, as it would allow for changes to the breathing parameters with respect to the detection of the apneas, for better control and prevention of said apneas.
Regarding claim 15, Kennedy discloses wherein the Mode II physiological parameter values are measured by deactivating or decreasing pressure for a duration of the PAP therapy (Kennedy; see [0137] where the pressure of the PAP therapy can be reduced, and measurements of the parameters occur during the operation of the PAP device as seen in [0132]-[0134]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Bassin (US Pub. 2018/0117270), Brewer et al. (US Pub. 2014/0330155), Chou (US Pat. 8,939,149), and Bassin (US Pat. 11,452,829) are cited to show similar PAP controlling systems that rely on a feedback of sensed values and/or detection of apneas.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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