DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 35 U.S.C. 112 (pre-AIA ), 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.
Claims 9, 12, and 15-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 9, the phrase “at two times an upper frequency limit of a human breathing frequency range of a healthy adult” renders the claim indefinite. Different healthy adults have different breathing frequency ranges. As healthy adult breathing frequency ranges vary by human, the metes and bounds of “two times an upper frequency limit of a human breathing frequency range of a healthy adult” is not clearly defined. For this examination, claim 9 is being interpreted such that the filtering of the loudness signal permits any upper frequency of any possible healthy human adult breathing frequency range. Regarding claim 12, it is unclear what is meant by “determining whether the loudness signal has most of its power in a human breathing frequency range of a healthy adult”. (emphasis added) A reading of the specification has failed to provide clarity with regard to what is meant by determining whether a loudness signal “has most of its power” in a human breathing frequency range. Furthermore, as noted above with regard to claim 9, the metes and bounds of “a human breathing frequency range of a healthy adult” is not clearly defined. Regarding claim 15, it is unclear what is meant by identifying at least two successive peaks based on a duration of a period between the at least two successive peaks. If the duration between two successive peaks is used to identify the peaks, then the two successive peaks would first need to be identified; it is unclear how peaks would be identified by using the peaks unless the peaks were already identified. Claims 16 and 17 are rejected due to their dependence on claim 15.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5, 9-11, 13, 14, 21, 22, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Alshaer et al.’780 (US Pub No. 2014/0194780 – previously cited) in view of Asai’777 (US Pub No. 2017/0325777 – previously cited) further in view of Moussavi et al.’741 (US Pub No. 2012/0071741).
Regarding claims 1, 13, and 14, Alshaer et al.’780 discloses a method of screening, diagnosing, or monitoring sleep disordered breathing (SDB) of a patient (see TITLE and ABSTRACT), the method comprising: extracting a loudness signal from a breathing sound signal of a patient generated by a microphone (sections [0015], [0041], and [0074]); detecting SDB events in the loudness signal (sections [0073-0083]); and computing a metric of severity of SDB of the patient from the detected SDB events (sections [0073], [0076], and [0141]). Alshaer et al.’780 discloses that the SDB events are detected based on detected inspiratory and expiratory portions of a breathing cycle (sections [0075], [0078-0079]), and also discloses that the method for detecting inspiratory and expiratory portions of a breathing cycle may differ from the one taught by Alshaer et al.’780 (section [0081]).
Alshaer et al.’780 discloses all of the elements of the current invention, as discussed above, except for the SDB events being detected in a de-rectified loudness signal. It is noted that according to section [0107] of the specification as filed, “de-rectifying” the loudness signal is defined as “identifying which peaks of the loudness signal correspond to inspiratory portions and which peaks correspond to expiratory portions of a breathing cycle, and assigning a negative value to the expiratory portions”. Asai’777 teaches identifying inspiratory and expiratory portions of a breathing cycle by de-rectifying a loudness signal (sections [0131-0134]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Alshaer et al.’780 to include detecting SDB events in a de-rectified loudness signal as Alshaer et al.’780 teaches that that its method for detecting inspiratory and expiratory portions of a breathing cycle may differ from the one taught by Alshaer et al.’780, and Asai’777 teaches that inspiratory and expiratory portions of a breathing cycle can be identified by de-rectifying a loudness signal. The modification to Alshaer et al.’780 would merely be the simple substitution of one known inspiratory/expiratory phase detection method (that of Asai’777) for another (that of Alshaer et al.’780) to obtain predictable results.
Alshaer et al.’780 in view of Asai’777 discloses all of the elements of the current invention, as discussed above, except for the method comprising providing a playback of the loudness signal synchronized with a visual display including an indication of one or more of the SDB events. Moussavi et al.’741 teaches that the analysis of tracheal sounds reveals useful information about changes in the behavior of the upper airway of a patient (sections [0014-0015], and also teaches providing a playback of a loudness signal (of snoring/tracheal sounds) synchronized with a visual display including an indication of one or more SDB events (sections [0038-0039], [0060], [0065]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Alshaer et al.’780 in view of Asai’777 to include providing a playback of the loudness signal synchronized with a visual display including an indication of one or more of the SDB events, as taught by Moussavi et al.’741, as this would provide more useful information for a clinician to review with regard to changes of the patient’s upper airway.
Regarding claim 2, Alshaer et al.’780 discloses generating an output based on the metric of severity (section [0076]).
Regarding claim 3, Alshaer et al.’780 discloses that generating the output comprises comparing the metric of severity with a severity threshold (section [0076]).
Regarding claim 5, Alshaer et al.’780 discloses extracting the loudness signal from the breathing sound signal by filtering the breathing sound signal to limit included frequencies to 50Hz to 4kHz (sections [0056-0057] – Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the particular frequency range recited in the claim. As such, it would have been obvious, through routine experimentation, to determine the optimal frequency range of the filtering step of Alshaer et al.’780. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).).
Regarding claim 9, Alshaer et al.’780 discloses filtering the loudness signal to permit an upper frequency of a human breathing frequency range of a healthy adult (sections [0056-0057]). Alshaer et al.’780 fails to explicitly disclose that the upper frequency is at two times an upper frequency limit of a healthy human breathing frequency range. However, Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the particular upper frequency limit recited in the claim. As such, it would have been obvious, through routine experimentation, to determine the optimal frequency limit of the filtering step of Alshaer et al.’780. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 10, Alshaer et al.’780 discloses that the SDB events are one or more of apneas, hypopneas, and flow limitations (see TITLE and ABSTRACT, and sections [0001] and [0011]).
Regarding claim 11, Alshaer et al.’780 in view of Asai’777 further in view of Moussavi et al.’741 discloses all of the elements of the current invention, as discussed above, except for computing a measure of quality of the loudness signal. Official notice is being taken that it is well known in the physiological signal processing art to compute a measure of quality of an acquired physiological signal in order to only subsequently process signals having an acceptable level of quality. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Alshaer et al.’780 in view of Asai’777 further in view of Moussavi et al.’741 to include computing a measure of quality of the loudness signal, as is well known in the art, as it would allow only signals of acceptable quality to be subsequently processed.
Regarding claim 21, the sections of Alshaer et al.’780 cited above, as modified by Asai’777 and Moussavi et al.’741, disclose a non-transitory processor-readable medium, having stored thereon processor-executable instructions which, when executed by a processor of a portable computing device, cause the processor to screen, diagnose, or monitor SDB of a patient, the processor-executable instructions comprising the steps recited in the claim.
Regarding claim 22, Figures 1-5 and sections [0061-0062] of Alshaer et al.’780, as modified by Asai’777 and Moussavi et al.’741, disclose a portable computing device comprising the processor-readable medium of claim 21, a microphone, a display, and one or more processors configured to access the processor-readable medium to execute the processor-executable instructions of the processor-readable medium to screen, diagnose, or monitor SDB of the patient.
Regarding claim 42, based on the definition of “de-rectifying a loudness signal” given in the specification of the current application, by de-rectifying the loudness signal, the method of Alshaer et al.’780 in view of Asai’777 further in view of Moussavi et al.’741 creates a modified version of the loudness signal so that the de-rectified loudness signal approximates a respiratory flow rate signal, by having positive values associated with inspiration and negative values associated with expiration.
Examiner’s Note
Regarding claim 4, none of the prior art teaches or suggests, either alone or in combination, a method comprising extracting a loudness signal from a breathing sound signal by low-pass filtering a root mean square value of a window that slides over the breathing sound signal, in combination with the other claimed steps.
Regarding claim 20, none of the prior art teaches or suggests, either alone or in combination, a method comprising generating a clip location indicator on a display coupled to one or more processors, wherein the clip location indicator indicates a location on the display where attachment of a clip permits alignment between a channel of the clip and a microphone, in combination with the other claimed steps.
Response to Arguments
Applicant’s arguments filed 10 October 2025 have been fully considered.
With regard to the previous rejections of claims 5, 9, 12, and 15-17 under 35 U.S.C. 112(b), the amendments have overcome the rejection of claim 5. However, as discussed in paragraph 3 above, the rejections of claims 9, 12, and 15-17 are being maintained as the amendments do not clarify the indefiniteness issues within the claims.
The amendments to the claims have overcome the previous rejection under 35 U.S.C. 101. Providing a playback of the loudness signal synchronized with a visual display including an indication of one or more of the SDB events incorporates something more into the claimed invention.
With regard to the previous rejections of the claims in view of prior art, Applicant’s arguments are moot because the amendments to the claims have changed the scope of the claimed invention, thus necessitating a new ground of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Moussavi et al.’014 (US Pub No. 2008/0243014) discloses similar subject matter to that of Moussavi et al.’741. Bardy et al.’922 (US Pub No. 2015/0087922) discloses simultaneously displaying detected events and playing sounds associated with the detected events.
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791