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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “the handheld grip” as referenced in claims 85b and 90 must be shown or the feature canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claims, which are both labeled as claim 85, have been renumbered to 85a and 85b.
Claim 85a is objected to because of the following informalities: in line 7, the claim reads “spaced apart form…,” which seems to be a typographical error. Appropriate correction is required.
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.
Claim 85b is 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 85b, it is unclear as to which claim 85b is dependent on, and whether claim 85b is meant to depend on the prior claim, or claim 85a, or claim 84. Claim 85a references the patch that is mentioned in claim 85b, whereas claim 84 does not reference the limitations of claim 85b. For the purposes of examination, Examiner has interpreted that claim 85b is dependent on claim 85a.
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 71-90 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Eligibility Step 1 – The Four Categories of Statutory Subject Matter
Claims 71-90 fall within one of the four categories of statutory subject matter. Claims 1-87 are drawn to “a method” (i.e., a process) and claims 88-90 are drawn to “a wearable monitoring device” (i.e., a machine), and thus fall within one of the four statutory categories.
Eligibility Step 2A, Prong One
Claims 71-90 recite an abstract idea:
Regarding independent claims 71 and 88, the limitation of “processing the ACM signals to generate one or more output signals, the one or more output signals including (i) a heart sound output signal; (ii) a lung sound output signal; (iii) a chest wall motion output signal; or (iv) any combination of (i) to (iii)” in independent claim 71 and independent claim 88 is directed to an abstract idea.
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, where a mental process is being performed in a computer environment. For example, in FairWarning IP, LLC v. Iatric Sys., Inc., the patentee claimed a system and method of detecting fraud and/or misuse in a computer environment, in which information regarding accesses of a patient’s personal health information was analyzed according to one of several rules (i.e., related to accesses in excess of a specific volume, accesses during a pre-determined time interval, or accesses by a specific user) to determine if the activity indicates improper access. 839 F.3d. at 1092, 120 USPQ2d at 1294. The court determined that these claims were directed to a mental process of detecting misuse, and that the claimed rules here were "the same questions (though perhaps phrased with different words) that humans in analogous situations detecting fraud have asked for decades, if not centuries." 839 F.3d. at 1094-95, 120 USPQ2d at 1296.
In the instant case, the identified abstract idea is similar to FairWarning because the language reads on a human implementing an old practice in a new environment, where the claimed processing of heart or lung sound output signals and chest wall motion output signals is performable with a stethoscope, where the limitations add an electronic component to said stethoscope. The claims do not require the use of a computer beyond the recitation of a general-purpose processor to gather information about a subject, therefore they are not self-evidently patent eligible. They appear to be directed to an abstract idea of gathering data for analysis. For instance, a medical professional could observe heart and lung sounds as well as chest wall motion utilizing a stethoscope and then analyze the observed measurements.
Eligibility Step 2A, Prong Two
Claims 71-90 do not recite additional elements that integrate the judicial exception into a practical application:
Regarding independent claim 71, the limitations of “receiving ACM signals” and “processing the ACM signals to generate one or more output signals” generally link the use of the mental process to a particular field and merely use a computer as a tool to perform the mental process. The limitation of “an electronics module including a first accelerometer contact microphone (ACM) unit and a second ACM unit” is merely insignificant, extra-solution activity used for data gathering.
Regarding dependent claim 73, the limitation of “a plurality of electrodes” is merely insignificant, extra-solution activity used for data gathering.
Regarding dependent claim 74, the limitation of “applying a low-pass filter to the ACM signals” generally links the use of the mental process to a particular field and merely use a computer as a tool to perform the mental process.
Regarding dependent claim 75, the limitation of “applying a high-pass filter to the ACM signals” generally links the use of the mental process to a particular field and merely use a computer as a tool to perform the mental process.
Regarding dependent claim 76, the limitation of “applying a band-pass filter to the ACM signals” generally links the use of the mental process to a particular field and merely use a computer as a tool to perform the mental process.
Regarding dependent claim 77, the limitation of “a third ACM unit” is merely insignificant, extra-solution activity used for data gathering, and the limitation of “receiving a third ACM signal from the third ACM unit” generally links the use of the mental process to a particular field and merely use a computer as a tool to perform the mental process.
Regarding dependent claim 79, the limitation of “receiving additional sensor data” generally links the use of the mental process to a particular field and merely use a computer as a tool to perform the mental process.
Regarding dependent claim 83, the limitation of “one or more light sources” is merely insignificant, extra-solution activity used for data gathering.
Regarding dependent claim 85a, the limitation of “a patch” generally links the use of the mental process to a particular field, and the limitations of “receiving additional ACM signals” and “processing the additional ACM signals to generate one or more additional output signals” generally links the use of the mental process to a particular field and merely use a computer as a tool to perform the mental process.
Regarding dependent claim 85b, the limitation of “a handheld grip” generally links the use of the mental process to a particular field.
Regarding dependent claim 86, the limitation of “transmitting, in realtime, the one or more output signals to a remote computing device” generally links the use of the mental process to a particular field and merely use a computer as a tool to perform the mental process.
Regarding independent claim 88, the limitations of “receiving and processing signal data from the first ACM unit and the second ACM unit,” “receiving ACM signals,” and “processing the ACM signals to generate one or more output signals” generally link the use of the mental process to a particular field and merely use a computer as a tool to perform the mental process, and the limitations of “a wearable monitoring device,” “an electronics module,” and “a first accelerometer contact microphone (ACM) unit; a second ACM unit” are merely insignificant, extra-solution activity used for data gathering.
Regarding dependent claim 89, the limitation of “patch including a receptacle” generally links the use of the mental process to a particular field.
Regarding dependent claim 90, the limitation of “a handheld grip for removably receiving the electronics module” generally links the use of the mental process to a particular field.
Eligibility Step 2B
Claims 71 and 88 do not amount to significantly more than the abstract ideas recited therein:
Regarding independent claim 71, the limitations of “receiving ACM signals” and “processing the ACM signals to generate one or more output signals” generally link the use of the mental process to a particular field and merely use a computer as a tool to perform the mental process. The limitation of “an electronics module including a first accelerometer contact microphone (ACM) unit and a second ACM unit” is merely insignificant, extra-solution activity used for data gathering. Furthermore, the ACM units are taught by Jones et al. (U.S. Pub. No. 2012/0209131 A1), which teaches a method of creating accelerometer contact microphones with sensing surfaces (Figure 8, which shows sensor array 802) as set forth in Paragraph 36 and Claim 2, and Ayazi et al (U.S. Pub. No. 2021/0127202 A1) , which teaches that an exemplary MEMS device includes an accelerometer contact microphone (Abstract) hence showing that ACM units are well-known and routine in the art.
Regarding independent claim 88, the limitations of “receiving and processing signal data from the first ACM unit and the second ACM unit,” “receiving ACM signals,” and “processing the ACM signals to generate one or more output signals” generally link the use of the mental process to a particular field and merely use a computer as a tool to perform the mental process, and the limitations of “a wearable monitoring device,” “an electronics module,” and “a first accelerometer contact microphone (ACM) unit; a second ACM unit” are merely insignificant, extra-solution activity used for data gathering. Furthermore, the ACM units are taught by Jones et al. (U.S. Pub. No. 2012/0209131 A1), which teaches a method of creating accelerometer contact microphones with sensing surfaces (Figure 8, which shows sensor array 802) as set forth in Paragraph 36 and Claim 2, and Ayazi et al (U.S. Pub. No. 2021/0127202 A1) , which teaches that an exemplary MEMS device includes an accelerometer contact microphone (Abstract) hence showing that ACM units are well-known and routine in the art.
Regarding dependent claims 72-87 and 89-90, the limitations of these claims further define the limitations already indicated as being directed to the abstract idea as recited in claims 71 and 88.
Dependent claims 72, 74-76, 78-82, 84-87, and 89-90 further define the abstract idea.
Dependent claims 73, 77, and 83 further define the data gathering, where the limitations of “a plurality of electrodes,” “a third ACM unit,” “one or more light sources” are merely insignificant, extra-solution activity used for data gathering.
Therefore, these additional elements do not amount to significantly more than the judicial exception and the claimed subject matter appears to be ineligible under §101.
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 71-72, 77, 81-82, and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (hereinafter “Kim”) (U.S. Pub. No. 2019/0105011 A1, IDS reference 17 from IDS dated 09/11/2023) in view of Jones et al. (hereinafter “Jones”) (U.S. Pub. No. 2012/0209131 A1, IDS reference 6 from IDS dated 09/11/2023).
Regarding claim 71, Kim teaches a method (Abstract, where “A method for continuous acoustic signature recognition and classification includes a step of obtaining an audio input signal from a resonant microphone array positioned proximate to a target, the audio input signal having a plurality of channels. The target produces characterizing audio signals depending on a state or condition of the target. A plurality of features is extracted from the audio input signal with a signal processor. The plurality of features is classified to determine the state of the target”), comprising: providing an electronics module (Figure 1, acoustics monitoring system 10) including a first accelerometer contact microphone (ACM) unit (Figure 1, resonant microphone array 12, resonant microphone 141) and a second ACM unit (Figure 1, resonant microphone array 12, resonant microphone 142); contacting the first ACM unit and the second ACM unit to skin of a user (¶[0050], where “FIG. 1 also depicts adhesive layer 32 and strap 34, either of which can secure the acoustic monitoring system to the target, for example, a human subject's chest”); receiving ACM signals, the ACM signals including a first ACM signal and a second ACM signal from the first ACM unit and the second ACM unit, respectively (¶[0043], where “Each resonant microphone 14j provides an audio signal over a corresponding channel”), wherein the ACM signals are associated with sounds from within the user (¶[0042], where “With reference to FIG. 1, acoustic monitoring system 10 is used to perform the method for monitoring respiration. The method includes a step of obtaining audio input signals from a resonant microphone array 12 … resonant microphone array 12 is placed on the subject at a location from which audio signals from the lungs can be observed”); and processing the ACM signals to generate one or more output signals (¶[0045], where “Each pre-filtered audio input signal is provided to a signal processor 16 over a multichannel bus 18 that carries each audio input signal individually over a corresponding conductive path to pre-amplifier and ADC 20. Each of the pre-filtered signal from the resonant microphone is pre-amplified, before being digitized by ADC. ADC 20 converts each audio signal to a digitized pre-filtered audio input signal. FIG. 1 also depicts common bus 22 that is also in electrical communication with ADC 20. Microprocessor 24 acts on the digital pre-filtered audio input signals, and extracts audio features which then are classified into predetermined respiratory states or conditions”), the one or more output signals including (i) a heart sound output signal (¶[0042], where “the method and system can be used to monitor heart sounds to detect murmurs”); (ii) a lung sound output signal (¶[0042], where “resonant microphone array 12 is placed on the subject at a location from which audio signals from the lungs can be observed,” ¶[0047], where “Microprocessor 24 transforms the pre-filtered audio input signal (e.g., the digitized pre-filtered audio input signals) into a feature vector or plurality of features ... microprocessor 24 outputs the feature vector ... microprocessor 24 determines whether the audio input signal matches with a specific sound or sounds through a classification algorithm that may employ machine-learning. The classification can provide a determination as to the state or condition of the target; for example, a determination as to whether or not the subject is wheezing or is about to have an asthma attack”); (iii) a chest wall motion output signal; or (iv) any combination of (i) to (iii).
Although Kim teaches an acoustics system with resonant microphones (Figure 1), Kim does not explicitly teach that the microelectromechanical (MEM) microphones are accelerometer contact microphones (ACM).
Jones teaches a method for a portable cardio-acoustic device (Abstract), and further teaches that it is known to use microelectromechanical circuits to make accelerometer contact microphones with sensing surfaces (Figure 8, which shows sensor array 802) as set forth in Paragraph 36 and Claim 2 to provide a means for sensing body sounds in a small compact form without having excess noise from ambient sources.
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Jones, which teaches that the MEM microphones are ACMs, with the invention of Kim since such a modification would provide the predictable results of having an array of small compact microphones that operate without sensing ambient or environmental noises.
Regarding claim 72, Kim in combination with Jones teaches all limitations of claim 71 as described in the rejection above.
Kim teaches that the first and second ACM units contact the skin of the user at a chest of the user (¶[0050], where “FIG. 1 also depicts adhesive layer 32 and strap 34, either of which can secure the acoustic monitoring system to the target, for example, a human subject's chest”).
Regarding claim 77, Kim in combination with Jones teaches all limitations of claim 71 as described in the rejection above.
Kim teaches contacting a third ACM unit (Figure 1, resonant microphone array 12, resonant microphone 146) to the skin of the user (¶[0050], where “FIG. 1 also depicts adhesive layer 32 and strap 34, either of which can secure the acoustic monitoring system to the target, for example, a human subject's chest”), the third ACM unit being positioned outside of a line extending through the first ACM unit and the second ACM unit (Figure 1, resonant microphone 141, 142, and 146, where there is an inherent line between the first and second ACM unit as they are parallel to one another); and receiving a third ACM signal from the third ACM unit, the ACM signals including the third ACM signal (¶[0043], where “Each resonant microphone 14j provides an audio signal over a corresponding channel”).
Regarding claim 81, Kim in combination with Jones teaches all limitations of claim 77 as described in the rejection above.
Kim teaches that the electronics module includes the third ACM unit (Figure 1, resonant microphone array 12, resonant microphone 146).
Regarding claim 82, Kim in combination with Jones teaches all limitations of claim 77 as described in the rejection above.
Kim teaches that a line between the first ACM unit and the second ACM unit is perpendicular a line between the second ACM unit and the third ACM unit (Figure 1, resonant microphone 141, 142, and 146, where there is an inherent line between the first and second resonant microphones as they are parallel and an inherent perpendicular line between the second and third resonant microphones since the third microphone is below the second).
Regarding claim 88, Kim teaches a wearable monitoring device (Figure 1, ¶[0050], where “adhesive layer 32 and strap 34, either of which can secure the acoustic monitoring system to the target, for example, a human subject's chest”), comprising: an electronics module positionable against skin of a user (Figure 1, acoustics monitoring system 10, ¶[0050], where “FIG. 1 also depicts adhesive layer 32 and strap 34, either of which can secure the acoustic monitoring system to the target, for example, a human subject's chest”), the electronics module comprising: a first accelerometer contact microphone (ACM) unit (Figure 1, resonant microphone array 12, resonant microphone 141); a second ACM unit (Figure 1, resonant microphone array 12, resonant microphone 142); and electronic components for receiving (¶[0042], where “With reference to FIG. 1, acoustic monitoring system 10 is used to perform the method for monitoring respiration. The method includes a step of obtaining audio input signals from a resonant microphone array 12 … resonant microphone array 12 is placed on the subject at a location from which audio signals from the lungs can be observed,” ¶[0043], where “Each resonant microphone 14j provides an audio signal over a corresponding channel”) and processing signal data from the first ACM unit and the second ACM unit (¶[0045], where “Each pre-filtered audio input signal is provided to a signal processor 16 over a multichannel bus 18 that carries each audio input signal individually over a corresponding conductive path to pre-amplifier and ADC 20. Each of the pre-filtered signal from the resonant microphone is pre-amplified, before being digitized by ADC. ADC 20 converts each audio signal to a digitized pre-filtered audio input signal. FIG. 1 also depicts common bus 22 that is also in electrical communication with ADC 20. Microprocessor 24 acts on the digital pre-filtered audio input signals, and extracts audio features which then are classified into predetermined respiratory states or conditions”), the electronic components being configured to perform operations including: receiving ACM signals while the first ACM unit and the second ACM unit are contacting the skin of the user (¶[0043], where “Each resonant microphone 14j provides an audio signal over a corresponding channel,” ¶[0050], where “FIG. 1 also depicts adhesive layer 32 and strap 34, either of which can secure the acoustic monitoring system to the target, for example, a human subject's chest”), the ACM signals being associated with sounds from within the user (¶[0042], where “With reference to FIG. 1, acoustic monitoring system 10 is used to perform the method for monitoring respiration. The method includes a step of obtaining audio input signals from a resonant microphone array 12 … resonant microphone array 12 is placed on the subject at a location from which audio signals from the lungs can be observed”); and processing the ACM signals to generate one or more output signals (¶[0045], where “Each pre-filtered audio input signal is provided to a signal processor 16 over a multichannel bus 18 that carries each audio input signal individually over a corresponding conductive path to pre-amplifier and ADC 20. Each of the pre-filtered signal from the resonant microphone is pre-amplified, before being digitized by ADC. ADC 20 converts each audio signal to a digitized pre-filtered audio input signal. FIG. 1 also depicts common bus 22 that is also in electrical communication with ADC 20. Microprocessor 24 acts on the digital pre-filtered audio input signals, and extracts audio features which then are classified into predetermined respiratory states or conditions”), the one or more output signals including (i) a heart sound output signal (¶[0042], where “the method and system can be used to monitor heart sounds to detect murmurs”); (ii) a lung sound output signal (¶[0042], where “resonant microphone array 12 is placed on the subject at a location from which audio signals from the lungs can be observed,” ¶[0047], where “Microprocessor 24 transforms the pre-filtered audio input signal (e.g., the digitized pre-filtered audio input signals) into a feature vector or plurality of features ... microprocessor 24 outputs the feature vector ... microprocessor 24 determines whether the audio input signal matches with a specific sound or sounds through a classification algorithm that may employ machine-learning. The classification can provide a determination as to the state or condition of the target; for example, a determination as to whether or not the subject is wheezing or is about to have an asthma attack”); (iii) a chest wall motion output signal; or (iv) any combination of (i) to (iii).
Although Kim teaches an acoustics system with resonant microphones (Figure 1), Kim does not explicitly teach that the microelectromechanical (MEM) microphones are accelerometer contact microphones (ACM).
Jones teaches that it is known to use microelectromechanical circuits to make accelerometer contact microphones with sensing surfaces (Figure 8, which shows sensor array 802) as set forth in Paragraph 36 and Claim 2 to provide a means for sensing body sounds in a small compact form without having excess noise from ambient sources.
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Jones, which teaches that the MEM microphones are ACMs, with the invention of Kim since such a modification would provide the predictable results of having an array of small compact microphones that operate without sensing ambient or environmental noises.
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Jones as applied to claim 71 above, and further in view of Thomsen et al. (hereinafter “Thomsen”) (U.S. Pub. No. 2013/0030259 A1, IDS reference 7 from IDS dated 09/11/2023).
Regarding claim 73, Kim in combination with Jones teaches all limitations of claim 71 as described in the rejection above.
Kim teaches contacting a plurality of electrodes to the skin of the user at the same time as the first ACM unit and second ACM unit are contacting the skin of the user (Figure 3E, resonant microphone element 70, ¶[0054], where “sensing layers consist of evaporated top Al electrode 58 and bottom Al electrode 60, … to form a resonant microphone element 70 which is part of the array.” Examiner takes the position that since the electrodes are part of the resonant microphone array which is part of the acoustic monitoring system, and since the acoustic monitoring system attaches to the target, such as a human subject's chest, that the electrodes contact the skin of the user at the same time as the ACM units.) and the plurality of electrodes being electrically coupled to the electronics module (Figures 3A-3E, Figure 3E, electrodes 58 and 60, which are coupled to the resonant microphone and consequently also coupled to the acoustics monitoring system, or electronics module).
Although Kim teaches electrodes in contact with the ACM, neither Kim nor Jones teaches receiving electrical signals via the plurality of electrodes, the received electrical signals being acquired while the received ACM signals are being acquired.
Thomsen teaches a monitoring system suitable for attachment to a surface of a subject and for monitoring physiological signals of a subject wearing the system (Abstract), and further teaches receiving electrical signals via the plurality of electrodes (¶[0130], where “the monitoring system according to the present invention has a first sensor measuring electrical signals with electrodes, such as a measuring of ECG or respiration rate”), the received electrical signals being acquired while the received ACM signals are being acquired (¶[0035],where “The system has to comprise at least one first sensor, which can receive a first signal, and at least one second sensor, which can receive a second physiological signal from the subject having the system attached, which second physiological signal is different from the first signal. It is to be understood that the first and second sensor may be contained within the same physical sensor, if a sensor element is able to receive two or more different signals.” Examiner takes the position that since Kim teaches that the electrodes are a component of the resonant microphone and the sensing layers that the electrodes function at the same time as the resonant microphone. Furthermore, Thomsen teaches collection of first and second signals with first and second sensors such that the electrode of Thomsen, when implemented with Kim, will collect data at the same time as the resonant microphone of Kim.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Thomsen, which teaches receiving electrical signals via the plurality of electrodes, the received electrical signals being acquired while the received ACM signals are being acquired, with the modified invention of Kim in order to measure ECG or respiration rate (Thomsen ¶[0130]).
Claims 74-75 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Jones as applied to claim 71 above, and further in view of Landesberg et al. (hereinafter “Landesberg”) (U.S. Pub. No. 2009/0036790 A1).
Regarding claim 74, Kim in combination with Jones teaches all limitations of claim 71 as described in the rejection above.
Although Kim teaches processing the ACM signals to generate one or more output signals (¶[0045]), neither Kim nor Jones teach that processing the ACM signals to generate the chest wall motion output signal includes applying a low-pass filter to the ACM signals.
Landesberg teaches a method of monitoring lung ventilation of a subject that comprises recording signals from a plurality of sensing location on the chest of the subject, at least a portion of the signals being indicative of a local motion of the chest at a respective sensing location, and operating a data processing system to analyze the signals such as to determine a status of the ventilation. Landesberg further teaches that processing the ACM signals to generate the chest wall motion output signal includes applying a low-pass filter to the ACM signals (¶0135], where “chest wall displacement is thus evaluated using the low frequency signals, after amplification and passing though a low-pass filter with a cutoff frequency of about 30 Hz”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Landesberg, which teaches that processing the ACM signals to generate the chest wall motion output signal includes applying a low-pass filter to the ACM signals, with the modified invention of Kim in order to separate signals indicative of chest wall displacement from the signals indicative of breath sounds (Landesberg ¶[0135]).
Regarding claim 75, Kim in combination with Jones teaches all limitations of claim 71 as described in the rejection above.
Although Kim teaches processing the ACM signals to generate one or more output signals (¶[0045]), neither Kim nor Jones teach that processing the ACM signals to generate the lung sound output signal includes applying a high-pass filter to the ACM signals.
Landesberg teaches that processing the ACM signals to generate the lung sound output signal includes applying a high-pass filter to the ACM signals (¶[0149], where “R2LF describes the ratio between the flow into the right lung and the flow into the left lung. The magnitude of the flow is preferably determined from the magnitude of the high frequency signals transmitted from the respective sensing locations. The high frequency signals relate to the breath sound and originate from the airflow in the bronchial tree of each side … a high pass filter characterized by frequency cutoff of about 30 Hz can be employed”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Landesberg, which teaches that processing the ACM signals to generate the lung sound output signal includes applying a high-pass filter to the ACM signals, with the modified invention of Kim in order to amplify sensor date (Landesberg ¶[0170]).
Claim 76 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Jones as applied to claim 71 above, and further in view of Grajales et al. (hereinafter “Grajales”) (U.S. Pub. No. 2006/0129067 A1).
Regarding claim 76, Kim in combination with Jones teaches all limitations of claim 71 as described in the rejection above.
Although Kim teaches processing the ACM signals to generate one or more output signals (¶[0045]), neither Kim nor Jones teach that processing the ACM signals to generate the heart sound output signal includes applying a band-pass filter to the ACM signals.
Grajales teaches a method for monitoring physiological parameters that is useful for remote auscultation of the heart and lungs (Abstract), and further teaches that processing the ACM signals to generate the heart sound output signal includes applying a band-pass filter to the ACM signals (¶[0024], where “the band-pass filter 430 of the signal-conditioning module 110 is tuned to select only the main first and second (S1 and S2) heart sounds. The S1 is the most prominent beat of the ventricle contraction (systole) and the S2 is the atrium contraction (diastole)”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Grajales, which teaches that processing the ACM signals to generate the heart sound output signal includes applying a band-pass filter to the ACM signals, with the modified invention of Kim in order to target only a particular physiological parameter of interest (Grajales ¶[0023]).
Claims 78 and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Jones as applied to claim 71 above, and further in view of Ayazi et al. (hereinafter “Ayazi”) (U.S. Pub. No. 2021/0127202 A1).
Regarding claim 78, Kim in combination with Jones teaches all limitations of claim 77 as described in the rejection above.
Kim teaches that a first distance between the first ACM unit and the second ACM unit is known, and that a second distance between the second ACM unit and the third ACM unit is known (Figure 1, resonant microphone 141, 142, and 146. Examiner takes the position that since the resonant microphones are specifically placed on an array that the distances between the units are inherently known.).
Neither Kim nor Jones teach identifying one or more source locations of the one or more output signals via triangulation based at least in part on the first ACM signal, the second ACM signal, the third ACM signal, the first distance, and the second distance.
Ayazi teaches MEMS devices and methods of using the devices, where the exemplary MEMS device includes an accelerometer contact microphone (Abstract), and further teaches identifying one or more source locations of the one or more output signals via triangulation based at least in part on the first ACM signal, the second ACM signal, the third ACM signal, the first distance, and the second distance (¶[0190], where “more than one accelerometer contact microphone may be positioned about a subject to receive additional health information … Each contact microphone may capture the vibrations emanating from the person, and the data from this array of contact microphones may be used to determine a source of the vibrations (i.e., sounds). An example of this method is to position three contact microphones on the person and triangulate the source of the vibrations”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Ayazi, which teaches identifying one or more source locations of the one or more output signals via triangulation based at least in part on the first ACM signal, the second ACM signal, the third ACM signal, the first distance, and the second distance, with the modified invention of Kim in order to help locate a source of a disease state and help early diagnosis of diseases (Ayazi ¶[0190]).
Regarding claim 80, Kim in combination with Jones and Ayazi teaches all limitations of claim 78 as described in the rejection above.
Kim teaches that the first distance is between 3.2 mm and 12.2 mm and that the second distance is between 26 mm and 39 mm (Figure 2B, resonant microphone 14j, dimensions D1 and D2, dimension l ¶[0051], where “D1 and D2, are each independently from about 0.5 to about 10 mm ... l is a dimension of base 48 supporting cantilever paddle 36. Typically, l is from about 0.2 to 1 mm”).
Examiner takes the position that the claimed dimensions are not critical to the claimed device, and the claimed dimensions are obvious since the only difference between the prior art and the claim is a recitation of relative dimensions. According to Gardner v. TEC Syst., Inc., the Federal Circuit held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Claim 79 is rejected under 35 U.S.C. 103 as being unpatentable over Kim, Jones, and Ayazi as applied to claim 78 above, and further in view of Watrous (U.S. Pub. No. 2002/0052559 A1).
Regarding claim 79, Kim in combination with Jones and Ayazi teaches all limitations of claim 78 as described in the rejection above.
None of Kim, Jones, nor Ayazi teaches receiving additional sensor data and determining a location of the electronics module with respect to the user based at least in part on the additional sensor data.
Watrous teaches a diagnostic decision support system that provides diagnostic decision support for auditory evaluation of anatomical features, where the system processes an acoustic signal for medical applications by acquiring acoustic data representative of an acoustic signal associated with an anatomical function, and further teaches receiving additional sensor data and determining a location of the electronics module with respect to the user based at least in part on the additional sensor data (¶[0040], where “The sensor position can be inferred with respect to a … position indicator located on the acoustic sensor, or measured with reference to a standard location by a position sensor.” Examiner takes the position that position data of an acoustic sensor is additional sensor data and that the location of the sensor when attached to a user would be with respect to the user.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Watrous, which teaches receiving additional sensor data and determining a location of the electronics module with respect to the user based at least in part on the additional sensor data, with the modified invention of Kim since position of the acoustic sensor on the chest surface is an important parameter in auscultation (Watrous ¶[0039]).
Claim 83 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Jones as applied to claim 71 above, and further in view of Wilder-Smith et al. (hereinafter “Wilder”) (U.S. Pub. No. 2011/0092790 A1, IDS reference 4 from IDS dated 09/11/2023).
Regarding claim 83, Kim in combination with Jones teaches all limitations of claim 71 as described in the rejection above.
Neither Kim nor Jones teaches illuminating one or more light sources based at least in part on the generated one or more output signals, the one or more light sources positioned to be visible by the user while the first ACM unit and second ACM unit are contacting the skin of the user, wherein illumination of the one or more light sources is indicative of successful acquisition of the one or more output signals.
Wilder teaches a biosensor that can obtain physiological data from an individual, where the biosensor may collect electrodermal activity, skin temperature, and other information (Abstract), and further teaches illuminating one or more light sources based at least in part on the generated one or more output signals (¶[0032], where “A biosensor 620 is shown with … an LED 624 … biosensor 620 may be used for collecting electrodermal activity readings, accelerometer readings, skin temperature readings, heart rate, heart rate variability, or other information,” ¶[0033], where “The LED 624 may blink when the biosensor 620 turns on. The LED 624 may also be used to indicate that the biosensor 620 is continuing to operate.” Examiner takes the position that since the LED indicates biosensor operation, that the LED will illuminate based on output signals as output signals will be collected if the device is operating properly.), the one or more light sources positioned to be visible by the user while the first ACM unit and second ACM unit are contacting the skin of the user (Figure 6B, where LED 624 is on a face visible to a user), wherein illumination of the one or more light sources is indicative of successful acquisition of the one or more output signals (¶[0033], where “The LED 624 may blink when the biosensor 620 turns on. The LED 624 may also be used to indicate that the biosensor 620 is continuing to operate.” Examiner takes the position that since the LED indicates that the biosensor is operating that there will be a successful acquisition of the collected signals as these signals would not be acquired if the device were not operating properly.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Wilder, which teaches illuminating one or more light sources based at least in part on the generated one or more output signals, the one or more light sources positioned to be visible by the user while the first ACM unit and second ACM unit are contacting the skin of the user, wherein illumination of the one or more light sources is indicative of successful acquisition of the one or more output signals, with the modified invention of Kim in order to indicate that the biosensor is continuing to operate (Wilder ¶[0033]).
Claim 84 is rejected under 35 U.S.C. 103 as being unpatentable over Kim, Jones and Wilder as applied to claim 83 above, and further in view of Bishay et al. (hereinafter “Bishay”) (U.S. Pub. No. 2012/0088999 A1, IDS reference 5 from IDS dated 09/11/2023).
Regarding claim 84, Kim in combination with Jones and Wilder teaches all limitations of claim 83 as described in the rejection above.
Although Wilder teaches an LED that blinks when the biosensor turns on and that can be used to indicate biosensor operation (¶[0033]), none of Kim, Jones, nor Wilder teaches determining that at least one of the one or more output signals is not being successfully acquired; and adjusting illumination of the one or more light sources based on the determination that the at least one of the one or more output signals is not being successfully acquired.
Bishay teaches an ambulatory electrocardiographic (ECG) monitor with a jumpered sensing electrode and a flexible and stretchable electrode mounting panel with a layer of skin adhesive (Abstract), and further teaches determining that at least one of the one or more output signals is not being successfully acquired; and adjusting illumination of the one or more light sources based on the determination that the at least one of the one or more output signals is not being successfully acquired (¶[0051], where “monitor 41 is constructed in a modular fashion and includes a flexible housing and standoff-separated skin adhesion assembly … An indicator light 49, such as a light emitting diode, visually signals the patient 12 that the monitor 11 is working. A steady light signifies normal operation, while a blinking light indicates a problem.” Examiner takes the position that since the light indicates either normal operation or a problem, that indicating a problem also indicates unsuccessful signal acquisition.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Bishay, which teaches determining that at least one of the one or more output signals is not being successfully acquired and adjusting illumination of the one or more light sources based on the determination that the at least one of the one or more output signals is not being successfully acquired, with the modified invention of Kim in order to visually signal to the patient whether the monitor is working (Bishay ¶[0051]).
Claim 85a is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Jones as applied to claim 71 above, and further in view of Page et al. (hereinafter “Page”) (U.S. Pub. No. 2005/0090725 A1, IDS reference 3 from IDS dated 09/11/2023) and Johnson (U.S. Pub. No. 2011/0137210 A1).
Regarding claim 85a, Kim in combination with Jones teaches all limitations of claim 71 as described in the rejection above.
Although Kim teaches receiving ACM signals and processing the ACM signals to generate one or more additional output signals, the one or more output signals including (i) an additional heart sound output signal; (ii) an additional lung sound output signal; (iii) an additional chest wall motion output signal; or (iv) any combination of (i) to (iii) (¶[0042], ¶[0043], ¶[0045], ¶[0047]) and Jones teaches that the microelectromechanical (MEM) microphones are accelerometer contact microphones (ACM) (Figure 8, which shows sensor array 802, ¶[0036], Claim 2), neither Kim nor Jones teach moving the device to a second location to collect second ACM signals. Neither Kim nor Jones teach coupling the electronics module to a patch that is securable to the skin of the user, wherein contacting the first ACM unit and the second ACM unit to the skin of the user occurs while the patch is secured to the skin of the user at a first location; removing the electronics module from the patch; contacting the first ACM unit and the second ACM unit to the skin of the user at a second location spaced apart form the first location; receiving additional ACM signals while the first ACM unit and the second ACM unit contact the skin of the user at the second location; processing the additional ACM signals to generate one or more additional output signals, the one or more additional output signals including (i) an additional heart sound output signal; (ii) an additional lung sound output signal; (iii) an additional chest wall motion output signal; or (iv) any combination of (i) to (iii); and re-coupling the electronics module to the patch, wherein re-coupling the electronics module to the patch causes the first ACM unit and second ACM unit to contact the skin of the user at the first location.
Page teaches a photoacoustic measurement system (Abstract), and further teaches coupling the electronics module to a patch that is securable to the skin of the user (¶[0059], where “A thin wafer or coupling substrate in the form of a disk shaped element includes a bottom side 3 and a top side 4 as well as a circular periphery. The bottom side is configured and arranged to directly engage the skin tissue surface at the test site”), wherein contacting the first ACM unit and the second ACM unit to the skin of the user occurs while the patch is secured to the skin of the user at a first location (¶[0059], where “A thin wafer or coupling substrate in the form of a disk shaped element includes a bottom side 3 and a top side 4 as well as a circular periphery. The bottom side is configured and arranged to directly engage the skin tissue surface at the test site,” ¶[0060], where “Re