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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 3, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 101
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-20 are directed to a system and non-transitory computer readable storage medium for monitoring respiration using a computational algorithm, which is an abstract idea. Claims 1-20 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a machine.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] – “determine a respiratory rate of the user using the respiration data”; and
[B1] – “using the respiratory rate, determine a first respiratory rate distribution in a first respiratory rate band and a second respiratory rate band over a duration of time, the first respiratory rate distribution indicating, over the duration of time, relative proportions of time the respiratory rate falls into the first or second respiratory rate bands”.
These elements [A1]-[B1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] – “a respiration sensor configured to continuously monitor a respiration data of a user, the respiration sensor configured to be attached to an article of clothing worn by the user and be positioned between the article and a body of the user”;
[B2] – “a non-transitory computer readable storage medium storing instructions that, when executed by one or more processors”; and
[C2] – “cause display of the first respiratory rate distribution.”
These elements [A2]-[C2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [A2] and [C2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering and display at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [B2] is merely an instruction to implement an abstract idea on a computer or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation, the recitation “a respiration sensor configured to continuously monitor a respiration data of a user” is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the respiration sensor is nothing more than a sensor to detect any respiratory data. Such sensors are conventional as evidenced by:
US 20050054941 A1 (Ting et al.) discloses that respiration sensors are conventional and can be attached to a garment [0081].
Further, the element [B2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Claims 2-16 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The analysis of claim 11 is as follows:
Step 1: Claim 11 is drawn to a machine.
Step 2A – Prong One: Claim 11 recites an abstract idea. In particular, claim 11 recites the following limitations:
[A1] – “using the respiratory rate, determine a first respiratory rate distribution in a first respiratory rate band and a second respiratory rate band over a duration of time, the first respiratory rate distribution indicating, over the duration of time, relative proportions of time the respiratory rate falls into the first or second respiratory rate bands”.
These elements [A1] of claim 11 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 11 recites the following limitations that are beyond the judicial exception:
[A2] – “A non-transitory computer readable storage medium storing instructions that, when executed by one or more processors”;
[B2] – “determine a respiratory rate of a user using respiration data continuously collected by a respiration sensor”; and
[C2] – “cause display of the first respiratory rate distribution.”
These elements [A2]-[C2] of claim 11 do not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Also, the element [B2-C2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 11 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation [B2] does not qualify as significantly more because this limitation merely describes the nature of the respiration data and does not incorporate the respiration sensor as part of the claimed invention. Also, the recitation [B2] is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the respiration sensor is nothing more than a sensor to detect any respiratory data. Such sensors are conventional as evidenced by Ting, recited above in the rejection of claim 1.
Further, the element [A2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Claims 12-20 depend from claim 11, and recite the same abstract idea as claim 11. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 11-17 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200337634 (McDarby et al.).
Regarding claim 11, McDarby teaches a non-transitory computer readable storage medium storing instructions that, when executed by one or more processors ([0275] “the processes may be embodied in processor control instructions and data for controlling apparatus to perform the methodologies and may be contained in any appropriate computer or machine readable recording medium of the non-transitory type such as in the form of software for use by a general purpose computer so that the general purpose computer may serve as a specific purpose computer according to any of the methodologies discussed herein upon loading the software into the general purpose computer.”), cause the one or more processors to:
determine a respiratory rate of a user using respiration data continuously collected by a respiration sensor ([0053] “the disclosed system measures the respiration and/or movement signal by way of one or more sensors configured to receive a reflected radio-frequency signal off a living subject. A processor is configured to analyze the reflected signal to determine a measurement of movement and respiration, and hence sleep stage; and a display arranged to provide selected information relating to one or more of breathing, movement and sleep stage to a user of the system.”; [0067] “the analysis provides a continuous respiration rate and respiration amplitude estimate”; [0107] “FIG. 9 illustrates a sensor signal divided into epochs, with each epoch associated with a respiration rate.”; [0286] “This respiration analysis block outputs a continuous respiration rate and respiration amplitude estimate (sample graphs of the outputs are illustrated in FIG. 12), e.g., on a 1-second timescale.”);
using the respiratory rate, determine a first respiratory rate distribution in a first respiratory rate band and a second respiratory rate band over a duration of time, the first respiratory rate distribution indicating, over the duration of time, relative proportions of time the respiratory rate falls into the first or second respiratory rate bands ([0107]; [0280] “, FIG. 9 illustrates an example output of the respiration rate calculation 207 from FIG. 8. In this, it is shown how the signal can be considered in epochs (30 seconds in this case) and how each epoch may have a single respiration rate associated with it … The calculation provides estimates of the respiration rate, for example, on a per-epoch basis, or alternatively on a shorter time scale (e.g., once/second). These respiration rates are provided to the sleep stage determination means 208 which may use the respiration rates to determine sleep stage. For example, in one embodiment, the respiration rate is used to distinguish deep sleep (Stage N3) from all other stages of sleep (N1, N2 and REM). The relative amplitude of respiration can also be determined and used in the sleep stage determination.”; Fig. 15, [0292]; and
cause display of the first respiratory rate distribution ([0053] “a display arranged to provide selected information relating to one or more of breathing, movement and sleep stage to a user of the system”; [0074]; Figs. 9 and 15).
Regarding claim 12, McDarby teaches the non-transitory computer readable storage medium of claim 11, wherein the first respiratory rate distribution is displayed as a plurality of bars corresponding to a plurality of portions of the duration of time, each bar indicating relative proportions of time the respiratory rate, over a portion of the duration of time, falls into the first or second respiratory rate bands (Fig. 9; [0107]; [0280] “, FIG. 9 illustrates an example output of the respiration rate calculation 207 from FIG. 8. In this, it is shown how the signal can be considered in epochs (30 seconds in this case) and how each epoch may have a single respiration rate associated with it … The calculation provides estimates of the respiration rate, for example, on a per-epoch basis, or alternatively on a shorter time scale (e.g., once/second). These respiration rates are provided to the sleep stage determination means 208 which may use the respiration rates to determine sleep stage. For example, in one embodiment, the respiration rate is used to distinguish deep sleep (Stage N3) from all other stages of sleep (N1, N2 and REM). The relative amplitude of respiration can also be determined and used in the sleep stage determination.”).
Regarding claim 13, McDarby teaches the non-transitory computer readable storage medium of claim 12, wherein relative proportions of time of the respiratory rate falling into the first or second respiratory rate bands are illustrated in different colors ([0280] “, FIG. 9 illustrates an example output of the respiration rate calculation 207 from FIG. 8. In this, it is shown how the signal can be considered in epochs (30 seconds in this case) and how each epoch may have a single respiration rate associated with it … The calculation provides estimates of the respiration rate, for example, on a per-epoch basis, or alternatively on a shorter time scale (e.g., once/second). These respiration rates are provided to the sleep stage determination means 208 which may use the respiration rates to determine sleep stage. For example, in one embodiment, the respiration rate is used to distinguish deep sleep (Stage N3) from all other stages of sleep (N1, N2 and REM). The relative amplitude of respiration can also be determined and used in the sleep stage determination.”; [0292] “FIG. 15 illustrates a display of the time course of the sleep stages to a user, which may optionally employ color-coded or shaded bars (e.g., vertical). In the example, bars extending above the main axis (representing time) may be taken as an indication of a state of wake. Bars extending below the axis may be taken as an indication of a sleep state”).
Regarding claim 14, McDarby teaches the non-transitory computer readable storage medium of claim 12, wherein the instructions cause the one or more processors to:
using the respiratory rate, determine the first respiratory rate distribution in the first respiratory rate band, the second respiratory rate band, and at least one additional respiratory rate band over the duration of time, the first respiratory rate distribution indicating, over the duration of time, relative proportions of time the respiratory rate falls into the first, second, or at least one additional respiratory rate bands (0280] “, FIG. 9 illustrates an example output of the respiration rate calculation 207 from FIG. 8. In this, it is shown how the signal can be considered in epochs (30 seconds in this case) and how each epoch may have a single respiration rate associated with it … The calculation provides estimates of the respiration rate, for example, on a per-epoch basis, or alternatively on a shorter time scale (e.g., once/second). These respiration rates are provided to the sleep stage determination means 208 which may use the respiration rates to determine sleep stage. For example, in one embodiment, the respiration rate is used to distinguish deep sleep (Stage N3) from all other stages of sleep (N1, N2 and REM). The relative amplitude of respiration can also be determined and used in the sleep stage determination.”).
Regarding claim 15, McDarby teaches the non-transitory computer readable storage medium of claim 14, wherein relative proportions of time of the respiratory rate falling into the first, second, or at least one additional respiratory rate bands are illustrated in different colors ([0280] “, FIG. 9 illustrates an example output of the respiration rate calculation 207 from FIG. 8. In this, it is shown how the signal can be considered in epochs (30 seconds in this case) and how each epoch may have a single respiration rate associated with it … The calculation provides estimates of the respiration rate, for example, on a per-epoch basis, or alternatively on a shorter time scale (e.g., once/second). These respiration rates are provided to the sleep stage determination means 208 which may use the respiration rates to determine sleep stage. For example, in one embodiment, the respiration rate is used to distinguish deep sleep (Stage N3) from all other stages of sleep (N1, N2 and REM). The relative amplitude of respiration can also be determined and used in the sleep stage determination.”; [0292] “FIG. 15 illustrates a display of the time course of the sleep stages to a user, which may optionally employ color-coded or shaded bars (e.g., vertical). In the example, bars extending above the main axis (representing time) may be taken as an indication of a state of wake. Bars extending below the axis may be taken as an indication of a sleep state”).
Regarding claim 16, McDarby teaches the non-transitory computer readable storage medium of claim 11, wherein the first respiratory rate distribution is displayed using a rolling time window (Fig. 9, [0281] “The epochs may be identified sequentially such as with a suitable label e.g., Epoch N, N+1, etc. In the illustration, Epoch N−5 has a rate of 15 breaths/minute, N−4 has a rate of 14.5 breaths/min, etc.”; [0067] “the analysis uses variability of the respiration rate and amplitude to distinguish REM sleep, in which a period of relatively high variation of the breathing rate is considered as an indication of an REM sleep period, and a period of relatively low variation of the breathing rate is considered to be associated with a state of deep sleep. In one embodiment, the analysis comprises assessing the variability of a time series using the approximate entropy, which assumes lower values for predictable time-series, and higher values as the time-sequence becomes more variable. Preferably, the analysis provides a continuous respiration rate and respiration amplitude estimate, and the respiration rate is then fed into two processing blocks in segments, in which a block will output a single number for an epoch which is the approximate entropy of that segment of the signal.”; [0286] “This respiration analysis block outputs a continuous respiration rate and respiration amplitude estimate (sample graphs of the outputs are illustrated in FIG. 12), e.g., on a 1-second timescale.”).
Regarding claim 17, McDarby teaches the non-transitory computer readable storage medium of claim 16, wherein the rolling time window comprises a plurality of increments that are less than twenty-four hours ([0281] “the signal can be considered in epochs (30 seconds in this case)”; [0060]).
Regarding claim 19, McDarby teaches the non-transitory computer readable storage medium of claim 11, wherein the first and second respiratory rate bands are configured to at least one of: be adjustable by a healthcare provider or be dynamically adjusted responsive to changes in the respiratory rate over at least a portion of the duration of time ([0285] “As a further optional refinement of the embodiment described above, the stability threshold for “stable breathing” can be refined on a per-subject basis. For example, the default analysis may use a stability threshold of 0.5 breaths/minute, but if this threshold produces physiologically unreasonable values for deep sleep duration (e.g., >40% or less <5%), the threshold could be adaptively modified to a more suitable value.”).
Regarding claim 20, McDarby teaches the non-transitory computer readable storage medium of claim 11, wherein the instructions further cause the one or more processors to:
using the respiratory rate, determine a second respiratory rate distribution in a third respiratory rate band and a fourth respiratory rate band different from the first and second respiratory rate bands over the duration of time, the second respiratory rate distribution indicating, over the duration of time, relative proportions of time the respiratory rate falls into the third or fourth respiratory rate bands (Fig. 9; [0107]; [0280] “, FIG. 9 illustrates an example output of the respiration rate calculation 207 from FIG. 8. In this, it is shown how the signal can be considered in epochs (30 seconds in this case) and how each epoch may have a single respiration rate associated with it … The calculation provides estimates of the respiration rate, for example, on a per-epoch basis, or alternatively on a shorter time scale (e.g., once/second). These respiration rates are provided to the sleep stage determination means 208 which may use the respiration rates to determine sleep stage. For example, in one embodiment, the respiration rate is used to distinguish deep sleep (Stage N3) from all other stages of sleep (N1, N2 and REM). The relative amplitude of respiration can also be determined and used in the sleep stage determination.”); and
cause display of the first and second respiratory rate distributions ([0053] “a display arranged to provide selected information relating to one or more of breathing, movement and sleep stage to a user of the system”; [0074]; Figs. 9 and 15).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200337634 (McDarby et al.) in view of US 20120238834 (Hornick, Ofer).
Regarding claim 1, McDarby teaches a respiration monitoring system comprising:
a respiration sensor configured to continuously monitor a respiration data of a user ([0053] “the disclosed system measures the respiration and/or movement signal by way of one or more sensors configured to receive a reflected radio-frequency signal off a living subject. A processor is configured to analyze the reflected signal to determine a measurement of movement and respiration, and hence sleep stage; and a display arranged to provide selected information relating to one or more of breathing, movement and sleep stage to a user of the system.”; [0107] “FIG. 9 illustrates a sensor signal divided into epochs, with each epoch associated with a respiration rate.”; [0286] “This respiration analysis block outputs a continuous respiration rate and respiration amplitude estimate (sample graphs of the outputs are illustrated in FIG. 12), e.g., on a 1-second timescale.”); and
a non-transitory computer readable storage medium storing instructions that, when executed by one or more processors ([0275] “the processes may be embodied in processor control instructions and data for controlling apparatus to perform the methodologies and may be contained in any appropriate computer or machine readable recording medium of the non-transitory type such as in the form of software for use by a general purpose computer so that the general purpose computer may serve as a specific purpose computer according to any of the methodologies discussed herein upon loading the software into the general purpose computer.”), cause the one or more processors to:
determine a respiratory rate of the user using the respiration data ([0053]; [0059]; [0060] “detected signals are processed to estimate a respiratory rate of the subject. In one embodiment, detected signals are processed to estimate the respiratory amplitude of the subject. Preferably, an estimate of the respiratory rate is made on an epoch basis (e.g., over a 30-second epoch)”)”;
using the respiratory rate, determine a first respiratory rate distribution in a first respiratory rate band and a second respiratory rate band over a duration of time, the first respiratory rate distribution indicating, over the duration of time, relative proportions of time the respiratory rate falls into the first or second respiratory rate bands ([0107]; [0280] “, FIG. 9 illustrates an example output of the respiration rate calculation 207 from FIG. 8. In this, it is shown how the signal can be considered in epochs (30 seconds in this case) and how each epoch may have a single respiration rate associated with it … The calculation provides estimates of the respiration rate, for example, on a per-epoch basis, or alternatively on a shorter time scale (e.g., once/second). These respiration rates are provided to the sleep stage determination means 208 which may use the respiration rates to determine sleep stage. For example, in one embodiment, the respiration rate is used to distinguish deep sleep (Stage N3) from all other stages of sleep (N1, N2 and REM). The relative amplitude of respiration can also be determined and used in the sleep stage determination.”; Fig. 15, [0292]); and
cause display of the first respiratory rate distribution ([0053] “a display arranged to provide selected information relating to one or more of breathing, movement and sleep stage to a user of the system”; [0074]; Figs. 9 and 15).
McDarby does not explicitly teach the respiration sensor configured to be attached to an article of clothing worn by the user and be positioned between the article and a body of the user.
However,
Hornick teaches the respiration sensor configured to be attached to an article of clothing worn by the user and be positioned between the article and a body of the user ([0005] “monitoring respiratory activity should include parameters such as respiratory rate”; [0131] “the respiratory-monitor is, preferably, an integrated portable unit sufficiently small and lightweight to be worn on a subject, such as on the wrist or arm, or on a belt, or as part of clothes or on a forehead strap, even by children. In some embodiments, the sensors are attached to fingers or to other body sites where they are possibly hidden under clothing.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by McDarby to include a respiratory sensor attached to an article of clothing. One would have been motivated to make this modification because using a wearable device allows respiratory rate data to be collected for home or outside use, such as during travel, as suggested by Hornick ([0133], [0184]).
Regarding claim 2, McDarby teaches the respiration monitoring system of claim 1, wherein the first respiratory rate distribution is displayed as a plurality of bars corresponding to a plurality of portions of the duration of time, each bar indicating relative proportions of time the respiratory rate, over a portion of the duration of time, falls into the first or second respiratory rate bands (Fig. 9; [0107]; [0280] “, FIG. 9 illustrates an example output of the respiration rate calculation 207 from FIG. 8. In this, it is shown how the signal can be considered in epochs (30 seconds in this case) and how each epoch may have a single respiration rate associated with it … The calculation provides estimates of the respiration rate, for example, on a per-epoch basis, or alternatively on a shorter time scale (e.g., once/second). These respiration rates are provided to the sleep stage determination means 208 which may use the respiration rates to determine sleep stage. For example, in one embodiment, the respiration rate is used to distinguish deep sleep (Stage N3) from all other stages of sleep (N1, N2 and REM). The relative amplitude of respiration can also be determined and used in the sleep stage determination.”).
Regarding claim 3, McDarby teaches the respiration monitoring system of claim 2, wherein relative proportions of time of the respiratory rate falling into the first or second respiratory rate bands are illustrated in different colors ([0280] “, FIG. 9 illustrates an example output of the respiration rate calculation 207 from FIG. 8. In this, it is shown how the signal can be considered in epochs (30 seconds in this case) and how each epoch may have a single respiration rate associated with it … The calculation provides estimates of the respiration rate, for example, on a per-epoch basis, or alternatively on a shorter time scale (e.g., once/second). These respiration rates are provided to the sleep stage determination means 208 which may use the respiration rates to determine sleep stage. For example, in one embodiment, the respiration rate is used to distinguish deep sleep (Stage N3) from all other stages of sleep (N1, N2 and REM). The relative amplitude of respiration can also be determined and used in the sleep stage determination.”; [0292] “FIG. 15 illustrates a display of the time course of the sleep stages to a user, which may optionally employ color-coded or shaded bars (e.g., vertical). In the example, bars extending above the main axis (representing time) may be taken as an indication of a state of wake. Bars extending below the axis may be taken as an indication of a sleep state”).
Regarding claim 4, McDarby teaches the respiration monitoring system of claim 2, wherein the instructions cause the one or more processors to:
using the respiratory rate, determine the first respiratory rate distribution in the first respiratory rate band, the second respiratory rate band, and at least one additional respiratory rate band over the duration of time, the first respiratory rate distribution indicating, over the duration of time, relative proportions of time the respiratory rate falls into the first, second, or at least one additional respiratory rate bands (0280] “, FIG. 9 illustrates an example output of the respiration rate calculation 207 from FIG. 8. In this, it is shown how the signal can be considered in epochs (30 seconds in this case) and how each epoch may have a single respiration rate associated with it … The calculation provides estimates of the respiration rate, for example, on a per-epoch basis, or alternatively on a shorter time scale (e.g., once/second). These respiration rates are provided to the sleep stage determination means 208 which may use the respiration rates to determine sleep stage. For example, in one embodiment, the respiration rate is used to distinguish deep sleep (Stage N3) from all other stages of sleep (N1, N2 and REM). The relative amplitude of respiration can also be determined and used in the sleep stage determination.”).
Regarding claim 5, McDarby teaches the respiration monitoring system of claim 4, wherein relative proportions of time of the respiratory rate falling into the first, second, or at least one additional respiratory rate bands are illustrated in different colors ([0280] “, FIG. 9 illustrates an example output of the respiration rate calculation 207 from FIG. 8. In this, it is shown how the signal can be considered in epochs (30 seconds in this case) and how each epoch may have a single respiration rate associated with it … The calculation provides estimates of the respiration rate, for example, on a per-epoch basis, or alternatively on a shorter time scale (e.g., once/second). These respiration rates are provided to the sleep stage determination means 208 which may use the respiration rates to determine sleep stage. For example, in one embodiment, the respiration rate is used to distinguish deep sleep (Stage N3) from all other stages of sleep (N1, N2 and REM). The relative amplitude of respiration can also be determined and used in the sleep stage determination.”; [0292] “FIG. 15 illustrates a display of the time course of the sleep stages to a user, which may optionally employ color-coded or shaded bars (e.g., vertical). In the example, bars extending above the main axis (representing time) may be taken as an indication of a state of wake. Bars extending below the axis may be taken as an indication of a sleep state”).
Regarding claim 6, McDarby teaches the respiration monitoring system of claim 1, wherein the first respiratory rate distribution is displayed using a rolling time window (Fig. 9, [0281] “The epochs may be identified sequentially such as with a suitable label e.g., Epoch N, N+1, etc. In the illustration, Epoch N−5 has a rate of 15 breaths/minute, N−4 has a rate of 14.5 breaths/min, etc.”; [0067] “the analysis uses variability of the respiration rate and amplitude to distinguish REM sleep, in which a period of relatively high variation of the breathing rate is considered as an indication of an REM sleep period, and a period of relatively low variation of the breathing rate is considered to be associated with a state of deep sleep. In one embodiment, the analysis comprises assessing the variability of a time series using the approximate entropy, which assumes lower values for predictable time-series, and higher values as the time-sequence becomes more variable. Preferably, the analysis provides a continuous respiration rate and respiration amplitude estimate, and the respiration rate is then fed into two processing blocks in segments, in which a block will output a single number for an epoch which is the approximate entropy of that segment of the signal.”; [0286] “This respiration analysis block outputs a continuous respiration rate and respiration amplitude estimate (sample graphs of the outputs are illustrated in FIG. 12), e.g., on a 1-second timescale.”).
Regarding claim 7, McDarby teaches the respiration monitoring system of claim 6, wherein the rolling time window comprises a plurality of increments that are less than twenty-four hours ([0281] “the signal can be considered in epochs (30 seconds in this case)”; [0060]).
Regarding claim 9, McDarby teaches the respiration monitoring system of claim 1, wherein the first and second respiratory rate bands are configured to at least one of: be adjustable by a healthcare provider or be dynamically adjusted responsive to changes in the respiratory rate over at least a portion of the duration of time ([0285] “As a further optional refinement of the embodiment described above, the stability threshold for “stable breathing” can be refined on a per-subject basis. For example, the default analysis may use a stability threshold of 0.5 breaths/minute, but if this threshold produces physiologically unreasonable values for deep sleep duration (e.g., >40% or less <5%), the threshold could be adaptively modified to a more suitable value.”).
Regarding claim 10, McDarby teaches the respiration monitoring system of claim 1, wherein the instructions further cause the one or more processors to:
using the respiratory rate, determine a second respiratory rate distribution in a third respiratory rate band and a fourth respiratory rate band different from the first and second respiratory rate bands over the duration of time, the second respiratory rate distribution indicating, over the duration of time, relative proportions of time the respiratory rate falls into the third or fourth respiratory rate bands (Fig. 9; [0107]; [0280] “, FIG. 9 illustrates an example output of the respiration rate calculation 207 from FIG. 8. In this, it is shown how the signal can be considered in epochs (30 seconds in this case) and how each epoch may have a single respiration rate associated with it … The calculation provides estimates of the respiration rate, for example, on a per-epoch basis, or alternatively on a shorter time scale (e.g., once/second). These respiration rates are provided to the sleep stage determination means 208 which may use the respiration rates to determine sleep stage. For example, in one embodiment, the respiration rate is used to distinguish deep sleep (Stage N3) from all other stages of sleep (N1, N2 and REM). The relative amplitude of respiration can also be determined and used in the sleep stage determination.”); and
cause display of the first and second respiratory rate distributions ([0053] “a display arranged to provide selected information relating to one or more of breathing, movement and sleep stage to a user of the system”; [0074]; Figs. 9 and 15).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200337634 (McDarby et al.) in view of US 20120238834 (Hornick, Ofter) in view of US 20140171816 (Pinhas et al.).
Regarding claim 8, McDarby in view of Hornick teaches the respiration monitoring system of claim 7.
McDarby in view of Hornick does not teach wherein the rolling time window comprises twenty-four hours and each increment of the plurality of increments comprises four hours.
However,
Pinhas teaches wherein the rolling time window comprises twenty-four hours and each increment of the plurality of increments comprises four hours ([0156] “the subject's respiration rate is monitored for a duration of time of greater than two hours (e.g., greater than three hours, greater than four hours, greater than five hours, or greater than six hours). Breathing pattern analysis module 22 determines a parameter of the subject's respiration rate over the time duration, such as the median respiration rate, the mean respiration rate, the maximum respiration rate, and/or a respiration rate pattern. Module 22 compares the determined parameter to the same parameter as determined on a previous day during a time period that overlaps with the time period based upon which the parameter of respiration was determined on the present day. For example, the parameter is compared to the same parameter as determined on a previous day for the same time duration and at the same period (e.g., the same time) of the day.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the time windows to comprise 24 hours and each increment comprising 4 hours. One would have been motivated to make this modification because measuring respiratory rate for a full day using 4-hour intervals allows for comparison that can indicate that the subject is likely to undergo an adverse clinical event based on the difference in the time intervals collected, as suggested by Pinhas ([0156-0157]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200337634 (McDarby et al.) in view of US 20140171816 (Pinhas et al.).
Regarding claim 18, McDarby teaches the non-transitory computer readable storage medium of claim 17.
McDarby does not teach wherein the rolling time window comprises twenty-four hours and each increment of the plurality of increments comprises four hours.
However,
Pinhas teaches wherein the rolling time window comprises twenty-four hours and each increment of the plurality of increments comprises four hours ([0156] “the subject's respiration rate is monitored for a duration of time of greater than two hours (e.g., greater than three hours, greater than four hours, greater than five hours, or greater than six hours). Breathing pattern analysis module 22 determines a parameter of the subject's respiration rate over the time duration, such as the median respiration rate, the mean respiration rate, the maximum respiration rate, and/or a respiration rate pattern. Module 22 compares the determined parameter to the same parameter as determined on a previous day during a time period that overlaps with the time period based upon which the parameter of respiration was determined on the present day. For example, the parameter is compared to the same parameter as determined on a previous day for the same time duration and at the same period (e.g., the same time) of the day.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the time windows to comprise 24 hours and each increment comprising 4 hours. One would have been motivated to make this modification because measuring respiratory rate for a full day using 4-hour intervals allows for comparison that can indicate that the subject is likely to undergo an adverse clinical event based on the difference in the time intervals collected, as suggested by Pinhas ([0156-0157]).
Conclusion
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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