DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 14 October 2025 has been entered. Claim(s) 1, 13-14, 20 and 23 is/are currently amended. Claim(s) 9, 17-18, 21 and 25 has/have been canceled. Claim(s) 1-8, 10-16, 19-20 and 22-24 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 101 and/or under 35 U.S.C. 112(b) (or pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-8, 10-16, 19-20 and 22-24 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 1, claim 13, claim 23 and claims dependent thereon, the limitation "identifying, by the computer, one or more test respiratory timing patterns directly from one or more test respiratory audio signals originating from the test subject in the absence of using a device monitoring respiratory movements of the test subject, comprising transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject" of claim 1 and the comparable limitations of claims 13 and 23 are indefinite.
Firstly, it is unclear in what manner the timing pattern(s) are identifying "directly" from the test audio signals when said signals are required to be "transformed" to secondary signal(s). Are the timing patterns identifying "directly" from test respiratory (e.g., raw) audio signals? And if so, are the transformed or secondary signal(s) not further utilized by the method/system in any manner? For the purpose of this Office action, the above-noted limitation will be discussed with the understanding that "directly" refers to only audio data being used to determine the timing pattern(s) (i.e., without data from any other sensor(s), such as a sensor(s) for obtaining the recited respiratory movements of the test subject), and the timing pattern(s) are identified from the transformed audio data, or secondary signal(s). For example, within the scope of, "identifying, by the computer, one or more test respiratory timing patterns from one or more test respiratory audio signals originating from the test subject in the absence of using a device monitoring respiratory movements of the test subject, wherein identifying the one or more test respiratory timing patterns comprises transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject, and identifying the respiratory timing patterns from the secondary signal(s)."
Secondly, it is unclear in what manner the test respiratory audio signal(s) are required to be transformed. While the newly-added limitations are essentially repeated in the specification (¶ [059]), the specification fails to sufficiently disclose an algorithm for such a transformation, or clearly identify or describe what "a breath sound level at baseline" refers. Is "a breath sound level at baseline" a measured value that is used in the transformation, or is "indicating a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject" merely descriptive of the result of applying a particular transformation? If the former, does baseline refer to a sound intensity, a period of time, etc.? If the latter, what particular types of transformations or processing result in such a secondary signal(s)?
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-8, 10-16, 19-20 and 22-24 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 13, claim 23 and claims dependent thereon, as discussed with respect to rejections under 35 U.S.C. 112(b), the limitation "transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject" lacks sufficient support in the application as filed. As noted in MPEP 2161.01(I), claims may fail to satisfy the written description requirement when the invention is claimed and described in functional language but the specification does not sufficiently identify how the invention achieves the claimed function. Specifically, the specification fails to sufficiently describe the algorithm (e.g., the necessary steps and/or flowcharts) for performing the claimed function in sufficient detail for one of ordinary skill in the art to reasonably conclude that the inventor possessed the claimed subject matter at the time of filing.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-8, 10-16, 19-20 and 22-24 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more.
The pending claims recite the steps of transforming test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject; identifying respiratory timing patterns in respiratory audio signals using respiratory cycle timing parameters (e.g., Ti, Te, fR, Ttot and/or a ratio of two or more thereof); and calculating a degree of abnormality, or an abnormality score/degree of abnormality of the respiratory timing pattern that is associated with one or more therapies, based on/using an algorithm, or comparing the respiratory timing patterns to reference respiratory timing patterns that are associated with one or more therapies to identify substantial matches therebetween, to detect or predict the presence and/or severity of a disease, disorder or condition, such as asthma, COPD, any other condition which affects a respiratory timing pattern, etc.
These limitations, as drafted, are a process that, under a broadest reasonable interpretation (BRI) thereof, covers performance of the limitations in the mind but for the recitation of generic computer components (e.g., computer, electronic processor, etc.). That is, other than reciting the steps are performed by a generic computer component, nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the "by a computer" language, identifying respiratory timing patterns in respiratory audio signals using respiratory cycle timing parameters encompasses a user observing said signals, or a representation thereof, to mentally/manually estimate timing parameters and identify a pattern in the signal(s). For example, the prior art of record (e.g., US 2014/0155773 A1 to Stamatopoulos) sufficiently discloses the claimed timing parameters/patterns are observable in respiratory cycle timing parameters (see, e.g., 6B). Similarly, the limitation of detecting or predicting the presence and/or severity of a disease, disorder or condition (e.g., asthma) encompasses the user comparing the observed respiratory timing patterns, or parameters thereof, to reference timing patterns, such as a historic or baseline reference timing pattern for the test subject to determine if the test subject's pattern is abnormal (or how abnormal said pattern is) relative to his/her usual pattern, or to reference timing patterns observed from a population of healthy individuals and individuals having said disease, disorder or condition (or various severity levels thereof) to determine if the test subject's pattern matches one or more of said population-based reference timing patterns. Lastly, the newly-add step of transforming the test respiratory audio signals into one or more secondary signals appears to encompass identifying an envelope of the audio signals (e.g., by manually/visually connecting peaks in the test respiratory audio signals). If claim limitations, under a BRI thereof, cover performance of the limitations in the mind but for the recitation of generic computer components, they fall within the mental processing grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
Alternatively/Additionally, each of the step of identifying respiratory timing patterns in respiratory audio signals using respiratory cycle timing parameters (¶ [060] of the specification as filed) and of detecting or predicting the presence and/or severity of a disease, disorder or condition (¶ [029], ¶ [031], ¶ [038], etc.) encompasses employing mathematical algorithms, such as multi-variable models, classifiers, machine learning algorithms, etc. Further, the transforming step apparently encompasses mathematical transforms and/or algorithms, such as applying a Hilbert transform, an envelope detection algorithm, etc. Therefore, the above-noted claim limitations also fall within the mathematical concepts grouping of abstract ideas. See MPEP 2106.04(a)(2)(I). Accordingly, the pending claims recites at least one abstract idea.
This judicial exception is not integrated into a practical application. The claims recite the additional elements of using a generic computing component (e.g., computer, electronic processor) to perform the abstract idea(s); a generic component(s) or sensor(s) for acquiring said audio signals (e.g., microphone, a "remote communication device" including a microphone); receiving the test respiratory audio signals originating from the test subject either in real-time or as a recording from said sensor(s) and/or and the step of administering one or more therapies to the test subject to treat the disease, disorder, and/or condition.
The computing component(s) is recited at a high-level of generality (e.g., as a generic computer and/or processor performing generic computer functions of identifying and categorizing patterns), such that its recitation amounts to no more than mere instructions to apply the exception using a generic computer component. The component(s)/sensor(s) for acquiring the test respiratory audio signals and the step of the computer component receiving the test respiratory audio signals amount to mere data gathering elements or activities required to perform the abstract idea, such that their recitation amounts to the addition of insignificant extra-solution activity to the abstract idea. Lastly, the step of administering one or more therapies to the test subject to treat the disease, disorder, and/or condition is not particular, but is instead merely instructions to apply the exception in a generic way. Accordingly, the additional elements do not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a generic computer component to perform the abstract idea amounts to mere instructions to implement the exception using a generic computer component. The additional element of administering one or more generic therapies to the test subject amounts to no more than adding the words "apply it" (or an equivalent) with the judicial exception, and/or generally links the use of the abstract idea to a particular field of use (e.g., using the abstract idea before, during and/or after treatment has been administered). In re-evaluating the extra-solution additional elements under step 2B of the Office's eligibility analysis, the steps of the computer receiving the test respiratory audio signals is comparable to concepts identified by the courts as well-understood, routine and/or conventional computer function(s) (e.g., MPEP 2106.05(d)(II), e.g., "receiving or transmitting data over a network"). Additionally, the prior art of record provides sufficient evidence that the claimed data gathering component(s)/sensor(s) are commercially-available products capable of obtaining test respiratory audio signals originating from a test subject from which respiratory timing patterns may be identified (see Stamatopoulos, ¶ [0064]; Rahman, ¶ [0015]; etc.). When considered in combination, the additional elements amount to no more than acquiring the data necessary to perform the abstract idea using well-understood, routine and/or conventional means/methods as an input to a generic computer being used as a tool to perform the abstract idea (e.g., using software to tailor information and provide it to the user on a generic computer), and, in some claims, reciting the field of use in which the abstract idea is applied (e.g., before, during and/or after administering medication). Accordingly, the additional elements, either alone or combination, do not amount to significantly more than the abstract idea itself. Therefore, the pending claims are not patent eligible.
Claim Rejections 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-8, 11, 13-16, 19-20 and 23 is/are rejected under 35 U.S.C. 103 as obvious over WO 2018/128976 A1 (previously cited, Zabel) in view of US 2020/0093459 A1 (previously cited, Rahman); or alternatively, over Zabel in view of Rahman and US 2022/0007965 A1 (Tiron).
Regarding claims 1 and 4-6, Zabel discloses/suggests a method of detecting a presence and/or severity of a disease, disorder, or condition in a test subject at least partially using a computer (e.g., Fig. 1, respiratory monitoring platform 124 and/or computing device 106 or 206), the method comprising:
(a) identifying, by the computer, one or more test respiratory timing patterns directly from one or more test respiratory audio signals originating from the test subject in the absence of using a device monitoring respiratory movements of the test subject using one or more respiratory cycle parameters comprising an inspiratory time (Ti), an expiratory time (Te), a respiratory rate (fR), a total respiratory cycle time (Ttot), and/or a ratio of two or more of thereof obtained from the test respiratory audio signals (¶ [0061] respiratory monitoring platform 124 receives respiratory parameter signals from a sensor 104 via a computing device(s) 106, 206, and determines, from each signal, characteristics or features of a breathing pattern, e.g., signal processing algorithms identify characteristics or features in a repeated breath pattern, such as inhalation time, exhalation time, etc.; ¶ [0041] sensor 104 may be an acoustic sensor(s)); and
(b) calculating, by the computer and using the respiratory cycle parameter(s), a degree of abnormality of the respiratory timing patterns based on an algorithm that assigns an abnormality score, wherein the abnormality score correlates with the presence and/or severity of a given disease, disorder, or condition to thereby detect the presence and/or severity of the disease, disorder, or condition in the test subject (e.g., ¶ [0061] respiratory monitoring platform 124 calculates a breathing score that correlates to the severity of a user's asthma symptoms); or
(c) identifying, by the computer and using the respiratory cycle parameter(s), one or more substantial matches between the test respiratory timing patterns and one or more reference respiratory timing patterns identified in one or more reference respiratory signals originating from one or more reference subjects, wherein the reference subjects are healthy or have a disease, disorder, or condition, wherein at least a subset of the reference respiratory timing patterns correlates with the presence and/or severity of the disease, disorder, or condition, in a given subject thereby detecting the presence and/or severity of the disease, disorder, or condition in the test subject (¶ [0061] the breathing score is calculated based comparing the identified characteristics or features of the breathing pattern to a dictionary of respiratory characteristics/features derived from both normal and asthmatic people; etc.).
Zabel does not disclose identifying the test respiratory timing pattern(s) comprises transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject.
Rahman discloses a method comprising identifying one or more test respiratory timing patterns directly from one or more test respiratory audio signals originating from a test subject in the absence of using a device monitoring respiratory movements of the test subject (e.g., Fig. 4 respiratory phase analysis of audio breathing data 400), said identifying comprising transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject (¶ [0060] producing envelope signal 405, see Fig. 4A) from which parameter(s) such as an inspiratory time (Ti), an expiratory time (Te) may be derived (e.g., ¶ [0061]).
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 method of Zabel with transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject, as taught/suggested by Rahman in order to facilitate obtaining the test respiratory audio signals using commercially available microphones, such as existing microphones in consumer electronic devices, thereby eliminating the need for specialized sensors (Rahman, ¶ [0078]; ¶ [0015]), and to facilitate performing a respiratory phase analysis of said data (Rahman, ¶¶ [0060]-[0062]) for identification of the timing pattern(s).
Alternatively/Additionally, Tiron discloses/suggests a method comprising transforming test respiratory audio signals (e.g., ¶ [0185] recording breathing related sound of a person using a microphone) into one or more secondary signals that indicate a proportional increase in breath sound intensity for a test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject (¶¶ [0185]-[0189] envelope generation and normalization process). 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 method of Zabel with transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject, as taught/suggested by Tiron in order to reduce influence of large artifacts to provide a cleaner secondary signal for further processing (Tiron, ¶¶ [0185]-[0189]).
Regarding claims 7-8, Zabel as modified discloses/suggests the disease, disorder, or condition comprises one or more of asthma, chronic obstructive pulmonary disease (COPD), heart failure, sleep apnea, any respiratory disorder, any cardiovascular disorder, and any condition that modifies respiratory timing pattern (e.g., ¶ [0061] asthma; ¶ [0078] asthma and/or COPD; etc.).
Regarding claim 11, Zabel as modified discloses/suggests the method comprises repeating steps (a) and (b) or (c) at one or more different time points (¶ [0092] severity scores are generated over a period of several days to several weeks).
Regarding claims 13-16 and 20, Zabel discloses/suggests a system comprising:
at least one microphone (¶ [0041] sensor 104 may be an acoustic sensor(s)); and,
at least one controller operably connected at least to the microphone, which controller comprises, or is capable of accessing, computer readable media comprising non-transitory computer-executable instructions which, when executed by at least one electronic processor (e.g., memory/programming that configures respiration monitoring platform 124 to perform its disclosed function(s)) perform at least:
receiving one or more test respiratory audio signals originating from a test subject via the microphone (¶ [0061] respiratory monitoring platform 124 receives respiratory parameter signals from sensor 104 via a computing device(s) 106, 206);
identifying one or more test respiratory timing patterns directly from the test respiratory audio signals in the absence of using a device monitoring respiratory movements of the test subject using one or more respiratory cycle parameters comprising an inspiratory time (Ti), an expiratory time (Te), a respiratory rate (fR), a total respiratory cycle time (Ttot), and/or a ratio of two or more of thereof obtained from the test respiratory audio signals (¶ [0061] respiratory monitoring platform 124 receives respiratory parameter signals from a sensor 104 via a computing device(s) 106, 206, and determines, from each signal, characteristics or features of a breathing pattern, e.g., signal processing algorithms identify characteristics or features in a repeated breath pattern, such as inhalation time, exhalation time, etc.; ¶ [0041] sensor 104 may comprise an acoustic sensor(s)); and
calculating, using the respiratory cycle parameter(s), an abnormality score of the test respiratory timing patterns using an algorithm, and calculating a degree of abnormality of the test respiratory pattern(s) based on an algorithm (e.g., ¶ [0061] respiratory monitoring platform 124 calculates a breathing score that correlates to the severity of a user's asthma symptoms), or
querying a database to identify, using the respiratory cycle parameter(s), one or more substantial matches between the test respiratory timing patterns and one or more reference respiratory timing patterns to detect the presence and/or severity of a disease, disorder, or condition in the test subject, wherein the database comprises one or more entries corresponding to one or more reference respiratory timing patterns identified in one or more reference respiratory signals originating from one or more reference subjects when the reference subjects are healthy or have the disease, disorder, or condition, wherein at least a subset of the reference respiratory timing patterns correlates with and/or is predictive of the presence and/or severity of the disease, disorder, or condition in a given subject to thereby detect and/or characterize the severity of the disease, disorder, or condition in the test subject (¶ [0061] the breathing score is calculated based comparing the identified characteristics or features of the breathing pattern to a dictionary of respiratory characteristics/features derived from both normal and asthmatic people; etc.).
Zabel does not disclose identifying the test respiratory timing pattern(s) comprises transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject.
Rahman discloses a method comprising identifying one or more test respiratory timing patterns directly from one or more test respiratory audio signals originating from a test subject obtained via at least one microphone of a remote communication device (¶ [0078]; ¶ [0015]; etc.) in the absence of using a device monitoring respiratory movements of the test subject (e.g., Fig. 4 respiratory phase analysis of audio breathing data 400), said identifying comprising transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject (¶ [0060] producing envelope signal 405, see Fig. 4A) from which parameter(s) such as an inspiratory time (Ti), an expiratory time (Te) may be derived (e.g., ¶ [0061]).
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 system of Zabel with a remote communication device comprising the microphone and identifying the test respiratory timing pattern(s) comprises transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject, as taught/suggested by Rahman in order to obtain the test respiratory audio signals using commercially available microphones, such as existing microphones in consumer electronic devices, thereby eliminating the need for specialized sensors (Rahman, ¶ [0078]; ¶ [0015]) and to facilitate performing a respiratory phase analysis of said data (Rahman, ¶¶ [0060]-[0062]) for identification of the timing pattern(s).
Alternatively/Additionally, Tiron discloses/suggests a method comprising transforming test respiratory audio signals (e.g., ¶ [0185] recording breathing related sound of a person using a microphone) into one or more secondary signals that indicate a proportional increase in breath sound intensity for a test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject (¶¶ [0185]-[0189] envelope generation and normalization process). 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 system of Zabel with transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject, as taught/suggested by Tiron in order to reduce influence of large artifacts to provide a cleaner secondary signal for further processing (Tiron, ¶¶ [0185]-[0189]).
Regarding claim 19, Zabel as modified discloses/suggests the disease, disorder, or condition comprises one or more of asthma, chronic obstructive pulmonary disease (COPD), heart failure, sleep apnea, any respiratory disorder, any cardiovascular disorder, and any condition that modifies respiratory timing pattern (e.g., ¶ [0061] asthma; ¶ [0078] asthma and/or COPD; etc.).
Regarding claim 23, Zabel discloses/suggests a computer readable media comprising non-transitory computer-executable instructions which, when executed by at least one electronic processor (e.g., memory/programming that configures respiration monitoring platform 124 to perform its disclosed function(s)), perform a method comprising:
identifying one or more test respiratory timing patterns directly from one or more test respiratory audio signals originating from a test subject in the absence of using a device monitoring respiratory movements of the test subject (¶ [0061] respiratory monitoring platform 124 receives respiratory parameter signals from a sensor 104 via a computing device(s) 106, 206, and determines, from each signal, characteristics or features of a breathing pattern, e.g., signal processing algorithms identify characteristics or features in a repeated breath pattern, such as inhalation time, exhalation time, etc.; ¶ [0041] sensor 104 may be an acoustic sensor(s)); and
calculating an abnormality score of the test respiratory timing patterns using an algorithm, wherein the abnormality score correlates with the presence and/or severity of a given disease, disorder, or condition to thereby detect the presence and/or severity of the disease, disorder, or condition in the test subject (e.g., ¶ [0061] respiratory monitoring platform 124 calculates a breathing score that correlates to the severity of a user's asthma symptoms); or
identifying one or more substantial matches between the test respiratory timing patterns and one or more reference respiratory timing patterns identified in one or more reference respiratory signals originating from one or more reference subjects and when the reference subjects are healthy or have a disease, disorder, or condition, wherein at least a subset of the reference respiratory timing patterns correlates with the presence and/or severity of the disease, disorder, or condition in a given subject to thereby detect the presence and/or severity of the disease, disorder, or condition in the test subject (¶ [0061] the breathing score is calculated based comparing the identified characteristics or features of the breathing pattern to a dictionary of respiratory characteristics/features derived from both normal and asthmatic people; etc.).
Zabel does not disclose identifying the test respiratory timing pattern(s) comprises transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject.
Rahman discloses a method comprising identifying one or more test respiratory timing patterns directly from one or more test respiratory audio signals originating from a test subject in the absence of using a device monitoring respiratory movements of the test subject (e.g., Fig. 4 respiratory phase analysis of audio breathing data 400), said identifying comprising transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject (¶ [0060] producing envelope signal 405, see Fig. 4A) from which parameter(s) such as an inspiratory time (Ti), an expiratory time (Te) may be derived (e.g., ¶ [0061]).
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 method of Zabel with transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject, as taught/suggested by Rahman in order to facilitate obtaining the test respiratory audio signals using commercially available microphones, such as existing microphones in consumer electronic devices, thereby eliminating the need for specialized sensors (Rahman, ¶ [0078]; ¶ [0015]), and to facilitate performing a respiratory phase analysis of said data (Rahman, ¶¶ [0060]-[0062]) for identification of the timing pattern(s).
Alternatively/Additionally, Tiron discloses/suggests a method comprising transforming test respiratory audio signals (e.g., ¶ [0185] recording breathing related sound of a person using a microphone) into one or more secondary signals that indicate a proportional increase in breath sound intensity for a test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject (¶¶ [0185]-[0189] envelope generation and normalization process). 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 method of Zabel with transforming the test respiratory audio signals into one or more secondary signals that indicate a proportional increase in breath sound intensity for the test subject relative to a breath sound level at baseline for the test subject, wherein the secondary signals do not represent a measure of breath sound loudness for the test subject, as taught/suggested by Tiron in order to reduce influence of large artifacts to provide a cleaner secondary signal for further processing (Tiron, ¶¶ [0185]-[0189]).
Claim(s) 2-3, 22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zabel in view of Rahman (or Zabel in view of Rahman and Tiron) as applied to claim(s) 1, 13 and 23, and further in view of WO 2019/089830 A1 (previously cited, Harris).
Regarding claims 2-3 and 24, Zabel as modified discloses/suggests the limitations of claims 1 and 23, as discussed above, but does not expressly disclose receiving the test respiratory audio signals originating from the test subject in substantially real-time, or receiving a recording of the test respiratory audio signals originating from the test subject.
Harris discloses a comparable method comprising, by a computer or electronic processor (¶¶ [0059]-[0060] base station, remote processor, remote server, etc.), receiving a sensor(s) signal in substantially real-time, or receiving a recording of a sensor(s) signal (e.g., ¶ [0060] sensors can communicate either in real-time or store data locally and transfer said data later).
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 method of Zabel with receiving the test respiratory audio signals originating from the test subject in substantially real-time, or receiving a recording of the test respiratory audio signals originating from the test subject as taught and/or suggested by Harris in order to facilitate determination of disease state based on the signal(s) (Harris, ¶ [0059]) and/or as a simple substitution of one suitable means/arrangement for communicating a test subject signal(s) to a, e.g., remote, computer/electronic processor for subsequent processing, such as determination of a disease state, for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 22, Zabel as modified discloses/suggests the limitations of claim 13, as discussed above, but does not expressly disclose the abnormality score the test respiratory timing patterns and/or entries of one or more members of the subset of the reference respiratory timing patterns are indexed to one or more therapies to treat the disease, disorder, or condition.
Harris discloses abnormality scores may be indexed to one or more therapies to treat the disease, disorder, or condition (e.g., ¶¶ [0121]-[0122] where alerts, which may be associated with different levels/categories of severity scores, may direct a change medication or medical plan).
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 system of Zabel with the abnormality score the test respiratory timing patterns and/or entries of one or more members of the subset of the reference respiratory timing patterns are indexed to one or more therapies to treat the disease, disorder, or condition as taught/suggested by Harris in order to in order to facilitate management of the test subject's disease/disorder/condition (e.g., asthma) (Zabel, ¶ [0092]) by identifying action plans suitable for effectively managing the test subject's disease/disorder/condition (Harris, ¶¶ [0121]-[0122], ¶ [0007], etc.).
Claim(s) 10-12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zabel in view of Rahman (or Zabel in view of Rahman and Tiron) as applied to claim(s) 1 and 13, and further in view of US 2007/0118054 A1 (previously cited, Pinhas).
Regarding claims 10-12, Zabel as modified discloses/suggests the limitations of claim 1, as discussed above, and further discloses/suggests the method comprises repeating steps (a) and (b) or (c) at one or more different time points (e.g., ¶ [0092]). Zabel further discloses drugs may be administered one or more therapies to the test subject to treat the disease, disorder, or condition (e.g., ¶ [0080] certain drugs can partially reverse the condition and allow for temporary relief in the asthma subject). Zabel does not expressly disclose the method comprises administering one or more therapies to the test subject before, during, and/or after repeating steps (a) and (b) or (c) to treat the disease, disorder, or condition.
Pinhas discloses a method comprising calculating a degree of abnormality of respiratory timing patterns based on an algorithm that assigns an abnormality score, wherein the abnormality score correlates with the presence and/or severity of a given disease, disorder, or condition, such as asthma (¶ [0424] calculating a clinical score, such as an asthma score, which may be calculated based on, e.g., respiration rate, expiration/inspiration ratio, patterns (¶ [0189])); administering one or more therapies to the test subject before, during, and/or after repeating steps (a) and (b) or (c) to treat the disease, disorder, or condition (¶ [0424] monitoring the improvement in the clinical score upon medication use and, over multiple such events, logging the improvement in score each time a new course of medication is given).
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 method of Zabel to comprise administering one or more therapies to the test subject before, during, and/or after repeating steps (a) and (b) or (c) to treat the disease, disorder, or condition as taught/suggested by Pinhas in order to facilitate management of the test subject's disease/disorder/condition (e.g., asthma) (Zabel, ¶ [0092]) by monitoring the effect of a treatment(s), tracking possible physiological habituation/adaptation to a treatment(s), recommending adjustments to medication dosage or alternative medications and/or combinations of medications to maintain adequate treatment efficacy, etc. (Pinhas, ¶ [0424]).
Regarding claim 20, Zabel as modified discloses/suggests the limitations of claim 1, as discussed above, but does not expressly disclose an abnormality score(s) and/or the substantial matches between the test respiratory timing patterns and the reference respiratory timing patterns are predictive of an impending asthmatic attack in the test subject.
Pinhas discloses an abnormality score(s) and/or reference respiratory timing pattern(s) that are predictive of an impending asthmatic attack in the test subject (e.g., ¶ [0267] level of wheezing and its timing with respect inspiration and/or expiration provides information for predicting an upcoming asthma attack).
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 system of Zabel with the abnormality score for the test respiratory timing patterns and/or the substantial matches between the test respiratory timing patterns and the reference respiratory timing patterns being predictive of an impending asthmatic attack in the test subject as taught/suggested by Pinhas in order to facilitate management of the test subject's disease, disorder, or condition (e.g., asthma) (Zabel, ¶ [0092]) by enabling administering early preventive treatment, which generally reduces required dosage of medication, and/or lowers mortality and morbidity (Pinhas, ¶ [0179]).
Response to Arguments
Applicant's arguments with respect to the prior art rejection(s) 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.
Applicant's arguments with respect to eligibility of the pending claims under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant contends, "As explained, for example, in the Background and Example sections of the application as filed directly identifying or predicting test respiratory timing patterns or parameters from respiratory audio signals (e.g., breath sounds), particularly without also using measures of respiratory movement obtained from a given patient, especially when considering the claims as a whole represent at a minimum an improvement to the functioning of a technology or technical field" (Remarks, pgs. 9-10).
The examiner respectfully disagrees. There is sufficient evidence that identifying respiratory timing patterns or parameters directly and only from test respiratory audio signals was known in the art at the time the present invention was filed (see, e.g., Stamatopoulos; Rahman; US 20180014752 A1 to Al-Ali (e.g., ¶ [0036]); etc.), such that it is unclear in what manner such a feature is an improvement. Further, Applicant discloses, "Current methods for characterizing respiratory patterns usually involve the use of devices and instrumentation that are cumbersome and could spread infection if used by different patients or involve multi-person contact" (e.g., ¶ [002]). Accordingly, even if using non-cumbersome and/or non-contact sensors to characterize respiratory patterns amounts to improvement, which the examiner does not concede, the pending claims are not commensurate in scope with said improvement. For example, there is no indication that the test respiratory audio signals are obtained via a sensor/microphone that is not cumbersome and/or does not contact the user. At best, a single dependent claim (claim 15) indicates a remote communication device comprises the microphone. There is no indication from what said communication device is remote, e.g., the user, the controller, etc., such that even the system of claim 15 does not require a non-contact microphone, but rather reasonably encompasses a contact microphone that communicates wirelessly with a controller/processor (e.g., as disclosed by Al-Ali, ¶ [0043]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 date of this final action.
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/Meredith Weare/Primary Examiner, Art Unit 3791