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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
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 18-21, 29, and 32 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 claims 18-19, 29, and 32, the limitations “a wearing position of the user is stressed for supporting” and “a wearing position of the user is naturally placed” render the claims indefinite. It’s not clear what “a wearing position of the user” is directed to as it may be the posture of the user or the orientation or location of the wearable device on the person of the user. Furthermore, it’s not clear how a wearing position is “stressed” or what (the user?) is supported by the intended function of “for supporting”. In addition, “naturally placed” is a relative term which renders the claim indefinite. The term “naturally placed” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Upon review of the disclosure, the Examiner is unable to determine the intended meaning of these claim limitations, and Applicant’s assistance in clarifying the claims is respectfully requested.
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.
Claims 15-16, 18-19, 22, 27, 29, and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see
this section of the MPEP for additional information.
First, the broadest reasonable interpretation of the claim as a whole is
established:
Claims 15 and 27claim a wearable device and method for reporting a respiratory tract infection evaluation based on an audio signal and a PPG signal.
Step 1 of the analysis is the question: “Is the claim to a process, machine,
manufacture, or composition of matter?” and the answer is determined to be yes, as the
claims as a whole are directed to a manufacture and a method.
For Step 2, the preliminary question is whether the eligibility of the claim is self-
evident. The answer is determined to be no, as the claim is not immediately self-evident
as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural
phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
While the terms “set forth” and “describe” are thus both equated with “recite”, their
different language is intended to indicate that there are different ways in which an
exception can be recited in a claim. For instance, the claims in Diehr set forth a
mathematical equation in the repetitively calculating step, the claims in Mayo set forth
laws of nature in the wherein clause, meaning that the claims in those cases contained
discrete claim language that was identifiable as a judicial exception. The claims in Alice
Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 15, as a representative claim, recites the following limitations:
obtain a respiratory rate of the user based on PPG signal
obtain a respiratory tract infection evaluation report of the user based on the audio signal and the first respiratory rate
The above identified claim limitations comprise an explicit claim recitation of an abstract idea. Therefore, rather than merely involve a judicial exception, the claims are directed to the identified judicial exception.
This claim language is identified as an abstract idea, because in MPEP §
2106.04(a)(2) III B. this language is similar to concepts relating to organizing or
analyzing information in a way that can be performed mentally or are analogous to
human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d
1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods
of logic circuit design, comprising converting a functional description of a level sensitive
latch into a hardware component description of the latch. 839 F.3d at 1140; 120 USPQ2d at 1475. Although the patentee argued that the claims were intended to be
used in conjunction with computer-based design tools, the claims did not include any
limitations requiring computer implementation of the methods and thus do not involve
the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The
court therefore concluded that the claims “read on an individual performing the claimed
steps mentally or with pencil and paper,” and were directed to a mental process of
“translating a functional description of a logic circuit into a hardware component
description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea is similar to Synopsys because the
language reads on an individual performing the claimed evaluation of respiration rate and respiratory tract infection mentally or with the aid of a pencil and paper. They do not require any specific computer implementation or details of computer technology and therefore are directed to a mental process of evaluating a subject’s respiration using human equivalent decision-making or judgment.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified.
In claim 15: wearable device, first sensor, second sensor (PPG), processor
Claim 16: second sensor (accelerometer)
The sensors (audio, PPG, accelerometer) are recited broadly as performing their well known functions. The sensors are merely gathering data prior to performance of the identified abstract idea. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The processor appears to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
No, the claim does not recite additional elements that integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
The additional elements were identified in the analysis under Step 2A Prong Two, above.
The sensors (audio, PPG, accelerometer) are recited broadly as performing their well known functions. See cited reference to Nicolo et al. (Nicolo et al. “Respiratory Frequency during Exercise: The Neglected Physiological Measure”, 2017, p. 78 listing available sensor devices commonly used in the field of physiological monitoring). The sensors are merely gathering data prior to performance of the identified abstract idea. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The processor appears to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
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.
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) 15-19, 21-22, 27-29, and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rahman et al. (U.S. Patent Application Publication No. 2019/0298224) hereinafter referred to as Rahman; in view of Fox et al. (U.S. Patent Application Publication No. 2023/0099622) hereinafter referred to as Fox.
Regarding claim 15, Rahman teaches a wearable device, wherein the wearable device comprises:
at least one first sensor, configured to obtain an audio signal of a user (¶[0025], ¶[0028] microphone collecting breathing and/or voice data);
at least one second sensor, configured to obtain a physiological parameter signal of the user (¶¶[0092-0093]),
wherein the at least one second sensor comprises a photoplethysmography (PPG) sensor, the PPG sensor is configured to obtain a PPG signal of the user (¶¶[0092-0093]); and
at least one processor (¶[0025] processor), configured to:
obtain a first respiratory rate of the user based on the PPG signal (Fig. 8, respiratory rate RR based on sensor fusion between PPG data, accelerometer, and gyroscope).
Rahman does not teach obtaining a respiratory tract infection evaluation report of the user based on the audio signal and the first respiratory rate.
Attention is drawn to the Fox reference, which teaches obtaining a respiratory tract infection evaluation report of a user (¶[0083] events include presence of an illness such as the common cold or the flu) based on an audio signal (¶[0094] microphone detecting respiratory events) and a first respiratory rate (¶[0080] respiration rate incorporated into event detection).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the respiratory sensor system of Rahman to include a respiratory tract infection report, as taught by Fox, because Fox teaches a need for improved systems for inferring states and stages of a user’s condition (Fox ¶[0013]).
Regarding claim 16, Rahman as modified teaches the wearable device according to claim 15.
Rahman further teaches wherein the at least one second sensor further comprises at least one accelerometer (ACC) sensor (¶[0035]), the at least one ACC sensor is configured to obtain an ACC signal of the user (¶[0094]), and the at least one processor is further configured to obtain a second respiratory rate of the user based on the ACC signal (Fig. 8, respiratory rate Est RR based on accelerometer).
Regarding claim 17, Rahman as modified teaches the wearable device according to claim 16.
Rahman further teaches wherein the at least one processor is further configured to perform filtering (¶[0068] processing performed on each sensor data) and fusion (¶¶[0096-0097]) on the first respiratory rate and the second respiratory rate, to obtain a third respiratory rate of the user (Fig. 8, 3 sensor outputs are fused to obtain a final RR).
Regarding claim 18, Rahman as modified teaches the wearable device according to claim 16.
Rahman further teaches wherein the at least one processor is further configured to obtain a posture classification result of the user based on the ACC signal (¶[0076] categories of posture state), the posture classification result comprises a first posture, the first posture comprises a state in which a wearing position of the user is stressed for supporting (Fig. 2).
Fox further teaches the at least one processor is configured to obtain the respiratory tract infection evaluation report (¶[0083] events include presence of an illness such as the common cold or the flu) based on an audio signal (¶[0094] microphone detecting respiratory events) and a first respiratory rate (¶[0080] respiration rate incorporated into event detection).
Regarding claim 19, Rahman as modified teaches the wearable device according to claim 17.
Rahman further teaches wherein the at least one processor is further configured to obtain a posture classification result of the user based on the ACC signal (¶[0076] categories of posture state), the posture classification result comprises a second posture (¶[0076] categories of posture state, plurality of postures), the second posture comprises a state in which a wearing position of the user is naturally placed (¶[0076] categories of posture state, ¶[0078] supine, for example).
Fox further teaches the at least one processor is configured to obtain the respiratory tract infection evaluation report (¶[0083] events include presence of an illness such as the common cold or the flu) based on an audio signal (¶[0094] microphone detecting respiratory events) and a first respiratory rate (¶[0080] respiration rate incorporated into event detection).
Regarding claim 21, Rahman as modified teaches the wearable device according to claim 19.
Rahman further teaches wherein the at least one processor is further configured to: prompt the user to switch to the second posture when the user is in a first posture (¶[0078] switch to supine) and the first respiratory rate is beyond a preset range (¶[0054] quality metrics including preset range of respiratory rate signal); and the at least one processor is further configured to: in response to an operation performed by the user for switching to the second posture (¶[0078] re-attempt measurement process after postural change), obtain the third respiratory rate based on the PPG signal and the ACC signal (Fig. 6, 8)
Fox further teaches the at least one processor is configured to obtain the respiratory tract infection evaluation report (¶[0083] events include presence of an illness such as the common cold or the flu) based on an audio signal (¶[0094] microphone detecting respiratory events) and a first respiratory rate (¶[0080] respiration rate incorporated into event detection).
Regarding claim 22, Rahman as modified teaches the wearable device according to claim 15.
Rahman further teaches wherein the wearable device is a wearable watch, a wearable bracelet, or a wearable monitor (¶[0031]).
Regarding claims 27-29, 31/32, the claims are directed to a method/wearable device comprising substantially the same subject matter as the device of claims 15-16, 18-19, and 21 and are rejected under substantially the same sections of Rahman and Fox.
Claim(s) 20 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rahman and Fox as applied to claims 15 and 27 above, and further in view of Coyle et al. (U.S. Patent Application Publication No. 2005/0119586) hereinafter referred to as Coyle; in view of Etemad et al. (U.S. Patent Application Publication No. 2015/0272483) hereinafter referred to as Etemad.
Regarding claims 20 and 30, Rahman as modified teaches the wearable device according to claim 19/28.
Rahman further teaches wherein the wearable device further comprises at least one low-pass filter (¶[0094]), the at least one low-pass filter is configured to perform low-pass filtering on the ACC signal (¶¶[0094-0095]).
Rahman does not teach a cut-off frequency of the low-pass filter is 1 Hz;
the at least one processor configured to:
calculate a mean value and a standard deviation of the ACC signal, and
calculate a power spectrum based on a low-pass filtered ACC signal, to obtain a position and an amplitude of a peak point of the power spectrum; and
the at least one processor is further configured to input the mean value and the standard deviation of the ACC signal and the position and the amplitude of the peak point of the power spectrum into a classification model, to obtain the posture classification result.
Attention is drawn to the Coyle Reference which teaches a cut-off frequency of a low-pass filter applied to accelerometer signals is 1 Hz for detecting posture classification (¶[0052]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the low-pass filter of Rahman as modified to use a cut-off frequency of 1Hz, as taught by Coyle, because characteristic postural change signals are below 1Hz (Coyle ¶[0052]).
Rahman as modified does not teach the at least one processor configured to:
calculate a mean value and a standard deviation of the ACC signal, and
calculate a power spectrum based on a low-pass filtered ACC signal, to obtain a position and an amplitude of a peak point of the power spectrum; and
the at least one processor is further configured to input the mean value and the standard deviation of the ACC signal and the position and the amplitude of the peak point of the power spectrum into a classification model, to obtain the posture classification result.
Attention is drawn to the Etemad reference, which teaches at least one processor configured to:
calculate a mean value and a standard deviation of the ACC signal (¶[0222]), and
calculate a power spectrum based on a low-pass filtered ACC signal, to obtain a position and an amplitude of a peak point of the power spectrum (¶[0260] maximum within a window, ¶[0261] FFT); and
the at least one processor is further configured to input the mean value and the standard deviation of the ACC signal and the position and the amplitude of the peak point of the power spectrum into a classification model (¶[0265]), to obtain the posture classification result (¶[0245]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the postural classification of Rahman as modified to use a combination of statistics and spectral analysis, as taught by Etemad, to improve tracking accuracy (¶[0300]).
Claim(s) 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rahman and Fox as applied to claims 15 and 27 above, and further in view of Li et al. (U.S. Patent Application Publication No. 2019/0357850) hereinafter referred to as Li.
Regarding claim 23, Rahman as modified teaches the wearable device according to claim 15.
Rahman as modified does not teach wherein the wearable device further comprises at least one first band-pass filter and at least one second band-pass filter;
the at least one first band-pass filter is configured to perform band-pass filtering on the PPG signal, to obtain positions of a peak point and a valley point of the PPG signal;
the at least one second band-pass filter is configured to perform band-pass filtering on the PPG signal, to obtain amplitudes of the peak point and the valley point of the PPG signal; and the at least one processor is further configured to obtain the first respiratory rate of the user based on the positions and the amplitudes of the peak point and the valley point of the PPG signal.
Attention is drawn to the Li reference, which teaches at least one first band-pass filter and at least one second band-pass filter (¶[0039] two band pass filters);
the at least one first band-pass filter is configured to perform band-pass filtering on the PPG signal, to obtain positions of a peak point and a valley point of the PPG signal (¶[0039], ¶¶[0133-0134]);
the at least one second band-pass filter is configured to perform band-pass filtering on the PPG signal, to obtain amplitudes of the peak point and the valley point of the PPG signal (¶[0039], ¶¶[0133-0134]); and
the at least one processor is further configured to obtain the first respiratory rate of the user based on the positions and the amplitudes of the peak point and the valley point of the PPG signal (¶¶[0133-0134]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the signal processing of Rahman as modified to include band-pass filters, as taught by Li, to improve the signal quality of the PPG signal (Li ¶[0039]).
Regarding claim 24, Rahman as modified teaches the wearable device according to claim 23.
Li further teaches wherein a frequency band of signals that are allowed to pass through the first band-pass filter comprises 0.5 Hz to 10 Hz (¶[0039]), and a frequency band of signals that are allowed to pass through the second band-pass filter comprises 0.1 Hz to 10 Hz (¶[0099]).
Regarding claim 25, Rahman as modified teaches the wearable device according to claim 23.
Rahman further teaches a baseline-removed ACC signal (¶[0060]) and the at least one processor is further configured to obtain a second respiratory rate of the user based on a filtered ACC signal (Fig. 8).
Rahman as modified does not teach wherein the wearable device further comprises at least one third band-pass filter;
the at least one third band-pass filter is configured to perform band-pass filtering on a ACC signal.
Li further teaches wherein the wearable device further comprises at least one third band-pass filter (¶[0039] two band pass filters respectively configured to filter the acceleration signal);
the at least one third band-pass filter is configured to perform band-pass filtering on an ACC signal (¶[0039] two band pass filters respectively configured to filter the acceleration signal).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rahman, Fox, and Coyle as applied to claims 25 above, and further in view of Coyle et al. (U.S. Patent Application Publication No. 2005/0119586) hereinafter referred to as Coyle.
Regarding claim 26, Rahman as modified teaches the wearable device according to claim 25.
Rahman as modified does not teach wherein a frequency band of signals that are allowed to pass through the third band-pass filter comprises 0.1 Hz to 0.5 Hz.
Attention is brought to the Coyle reference, which teaches wherein a frequency band of signals that are allowed to pass through the third band-pass filter comprises 0.1 Hz to 0.5 Hz (¶[0052], a combination of high-pass and low-pass filter creating a pass-band).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the low-pass filter of Rahman as modified to use a pass band comprising 0.1Hz to 1 Hz, as taught by Coyle, because characteristic postural change signals are below 1Hz (Coyle ¶[0052]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2010/0004552 to Zhang et al. teaches respiratory rate from PPG using a band-pass filter
U.S. Patent Application Publication No. 2019/0209022 to Sobol et al. teaches detecting the presence of a respiratory illness from auditory and accelerometer, PPG data.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792