DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the response to this office action, the Examiner respectfully requests that support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line numbers in the specification and/or drawing figure(s). This will assist the Examiner in prosecuting this application.
Specification
The application specification failed to disclose a description of application drawing fig. 8, that is listed, but has not been referred and no description of it anywhere in the application specification.
Appropriate correction is required.
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 of this title, 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 1-2, 6, 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Butera et al (US 20200029886 A1, hereinafter Butera) and in view of references Cunningham (US 20210345985 A1).
Claim 1: Butera teaches an auscultation system (title and abstract, ln 1-9, a device 300 in figs. 3A/3B, para 34, with an external computing device for processing and analyzing the captured auscultation sound signals) comprising:
a personal computing device (the external computing device of the device 300, para 35) being configured to access an electronic health record of a patient (through wireless network communication to obtain the processed auscultation sound signals, para 35);
a plurality of recording devices (device 300 in figs. 3A/3B, including multiple assemblies containing a molding 310 with a transducer 330 in fig. 3A/3B, e.g., external/internal auscultation devices 120’/110’ in fig. 5, para 38 and deposited again patient organs discussed in the ear canal, nasal, and against throat discussed above) being configured to be removably positionable on the patient (placeable to fit inside of patient body, e.g., an ear or nasal cavity and channel the desired internal acoustic signals from inside the body, para 34) wherein the plurality of recording devices is configured to record sounds within a body of the patient (recording auscultation of patient’s body, e.g., within nasal and an ear of the patient, para 34 and sound from throat, para 38), each recording device of the plurality of recording devices comprising:
a front side (opening 320 in fig. 3A) and an interior space (channel and a space to place a transducer 330 in figs. 3A/3B);
a power source (the device 300 including microphone preamplifier, a DSP, etc., to perform audio frequency dynamic range control DRC, and/or equalization EQ, para 35 and thus, power source is inherency for the microphone preamplifier and DSP);
a processor (the DSP of the device 300 above) being electrically coupled to the power source (inherency for the functions of the DSP, discussed above);
a plurality of microphones (one or more transducers 330 in the device 300, and convert the acoustic signals into electrical signals, and processed by at least microphone preamplifier, etc., para 34-35);
a transmitting device (communicating to the external computing device by receiving processed auscultation sound data from transducer 330 via a wireless network communication, para 35, and thus, inherency for the device 300 to have a transmitter for the communication to the external computing device above) being electrically coupled to the processor (inherency as to microphone preamplifier connected to the DSP, para 35, 37 and discussed above), the transmitter being in wireless communication with the personal computing device (discussed above, including the wireless communication to the external computing device of the device 300, para 35);
a plurality of microphones (one or more transducers 330 in the device 300, para 34, and with the microphone amplifier, para 35) being electrically coupled to the processor (via microphone preamplifier to the DSP, para 35), each microphone of the plurality of microphones having a forward face being exposed within the front side (the transducer 330 and through a channel to the open 320 in figs. 3A/3B) wherein the plurality of microphones is configured to detect the sounds within the body of the patient (placed within an ear and/or a nasal cavities, para 25, and disposed against a patient throat if external auscultation device 120, para 38 and for recording auscultation of a body, para 34, e.g., );
the processor being configured to convert the sounds into an audio recording (via audio processing module 510 and placing the converted digital audio data to the storage 520 via an analog-to-digital converter 512 in fig. 5, para 39 and/or through an audio pre-processing module 513 to analysis buffer 514 that holds the processed audio signal in a memory, para 39); and
the transmitting device being configured to transmit the audio recording to the personal computing device (via wireless network and receiving communication from the transducer, para 35 and discussed above).
However, Butera does not explicitly teach the disclosed power source being positioned in the interior space and the personal computing device is also being configured to modify the disclosed electronic health record of the patient, play the audio recording, and save the audio recording to the electronic health record and does not explicitly teach wherein the transmitting device is or includes a transceiver.
Cunningham teaches an analogous field of endeavor by disclosing an auscultation system (title and abstract, ln 1-14 and a remote health monitoring system in fig. 1 and including an auscultation device 102 in fig. 1, para 65) and wherein the auscultation system comprising
a personal computing device (a healthcare provider device 112, or a remote server 114, in fig. 1, para 65) being configured to access and modify an electronic health record of a patient (through wireless link in fig. 1 and store and/or process self-auscultation data for remote monitoring of the patient 104, para 129 and the raw or processed audio data transmitted from the mobile device 108 to the healthcare provider device 112 or the remote server 114, para 159 and the healthcare provider 106 further process and/or modify the audio data about patient 104 in fig. 1, para 159);
a recording device (the self-auscultation device 102 with the mobile device 108 to form an auscultation system, and used by a patient 104, para 65 and including a listening device 110, or earpiece or wireless earpiece component, para 87) being configured to be removable positionable on the patient (e.g., placed in contact with the patient’s chest, para 52) wherein the recording device is configured to record sounds within a body of the patient, the recording device (through a inclusive microphone 206 of the listening device 110 to detect sounds for self-auscultation of the patient 104, para 66 and e.g., placed on the patient’s chest for collecting sound from the heart and lungs, para 52 and operated to record sound, para 55) comprising:
a front side (diaphragm 320, para 73, or a concavity 302 facing to the direction 304 in fig. 3, para 67) and an interior space (a space covered by a chest piece 202 and a cap 312 mounted on the chest piece 202, para 70);
a power source (a battery in the listening device 110, para 87) being positioned in the interior space (a size of the battery is limited by the listening devices, para 142, i.e., contained in the interior space inherently);
a processor being electrically coupled to the power source (one or more processors 2002 in fig. 20, included in the listening device 110, or the wireless earpiece component above, connected to the battery in fig. 20, e.g., a SoC, para 87);
a transceiver (a BTLE wireless transceiver in the auscultation device 102 as a wireless earpiece component and containing a transmitter, etc., para 87) being electrically coupled to the processor (through RF circuitry 2004 in fig. 20), the transceiver being in wireless communication with a personal computing device (transmitting/receiving data between the listening device and the mobile device 108);
a microphone being electrically coupled to the processor (a microphone 206 connected to the 2002 in fig. 20 and in fig. 2) and having a forward face being exposed within the front side (the microphone 206 facing to the concavity 302 and diaphragm 320 in fig. 3) and the microphone is configured to detect the sounds within the body of the patient (auscultation sound from lungs through patient’s chest, para 52);
the processor being configured to convert the sounds into an audio recording (audio data are generated through the processor, para 123 and transmitting audio data out, para 88 and through the mobile device 108 to a healthcare provider device 112 or the server 114, para 159);
the transceiver being configured to transmit the audio recording to the personal computing device (through the transceiver and RF circuitry 2004 to transmit audio data from the listening device 110 to the mobile device 108 in fig. 1, para 123 and then to the server 114, para 159), the personal computing device being configured to play the audio recording (remotely monitoring the patient with the S-A audio data files 2014, para 127, similar operations of elements 112, 108, and 114, para 130, e.g., displaying the recorded sounds indicating a particular health condition or health trend by health sound recorder app 2012 on the mobile device 108, para 167), save the audio recording to the electronic health record (S-A audio data files 2014 in memory 2010 of the mobile device 112 in fig. 20 continued, and created by the health sound recorder application 2012, para 166) for benefits of improving the performance of the auscultation system (by increasing accuracy even though performed by a patient to monitor the health sounds and status and generating accurate sound data, para 15, by improving audio performance of the system, para 118 and fidelity of recorded audio data, para 138, by adjusting microphone gain based on background noise levels, sampling rate of the ADC in listening device 110, para 138) in a cost-saving manner (by monitoring battery usage level to enhance the battery operation time, para 126 and battery usage configuration, para 15).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the power source being positioned in the interior space and the personal computing device is also being configured to modify the the electronic health record of the patient, playing the audio recording, and saving the audio recording to the electronic health record and the transceiver including the transmitter, etc., discussed above, as taught by Cunningham, to the personal computing device, the battery with the interior space, and the transmitting device in the auscultation system, as taught by Butera, for the benefits discussed above.
Claim 2: the combination of Butera and Cunningham further teaches, according to claim 1 above, the auscultation system further teaches, an adhesive pad being coupled to the front side of each recording device of the plurality of recording devices (Butera, an adhesive material with the external auscultation device 120, e.g., adhesive material used to attach the device 120 at the midline of the neck, inferior to the thyroid cartilage, para 30 and Cunningham, using adhesive bond to fix a digital identification tag 322 in fig. 3 and avoiding background noise in the collected auscultation sound signals from microphone 206, para 140) wherein the adhesive pad is configured to removably couple each recording device of the plurality of recording devices to the patient (Butera, the adhesive material with the external auscultation device 120, para 30, inherently removable of the auscultation device from a midline of patient chest, para 30).
Claim 6: the combination of Butera and Cunningham further teaches, according to claim 1 above, the processor further comprising a memory (Butera, analysis buffer 514, etc., in fig. 5 and Cunningham, memory connected to the processor 2002 in fig. 20) being configured to store a standard reading (Butera, ANN 530 trained by audio signals comprising the opening and closing of Eustachian tubes, as standard reading for operation match, para 40, and ANN 540 trained with audio signals comprising bolus transits, para 40 and Cunningham, the library of audio data files 2020 stored in the memory, para 165, including predetermined auscultation data, para 15, and predetermined frequency content of the one or more test tones, para 16 or historical records as the reference, para 166), the processor being configured to compare the sounds to the standard reading (Butera, the matching performed to identify whether an intra-aural event occurred, whether a velopharyngeal event occurred and a time during of the velopharyngeal event, para 40, and Cunningham, comparing the recorded audio data and predetermined auscultation audio data, para 160-162 and performed by app 2016 of the mobile device 108 in fig. 20), the transceiver being configured to send an alert to the personal computing device when the sounds deviate from the standard reading (Butera, annotating in a display that a first/second intra-aural event 440 occurs after the bolus transit 450, and a breath sound marked as 460 in fig. 6, etc., para 42 and Cunningham, the app 2012 determining and displaying the recorded sounds with particular health condition or health trend, para 167).
Claim 8: the combination of Butera and Cunningham further teaches, according to claim 1 above, the personal computing device further comprising an application being configured to provide a user interface between the personal computing device and the plurality of recording devices (Butera, personal computing device, para 35, and Cunningham, the personal computing device 112 or server 114 in fig. 1), the application being configured to enable a user to adjust a plurality of audio settings of each recording device of the plurality of recording devices (Cunningham, including updating library sound with the most current abnormal symptomatic lung sounds being observed by the doctors, para 60 and through the mobile device 108, receiving firmware configuration commands form the mobile device 108, para 123, including microphone configuration, voice activation configuration, noise cancellation configuration, wireless protocol configuration, and device pairing configuration, para 137).
Claim 9: the combination of Butera and Cunningham further teaches, according to claim 8 above, the plurality of audio settings further comprising an amplification factor and a playback volume (Butera, normalization of audio level and DRC filtering, para 25, and performing superior frequency response control to allow for antural and realistic representation of acoustic environments to limit extremely loud transient sounds and to achieve a safe levels, para 37, e.g., a user provided with level control by which the mix between voice communication and situational awareness can be continually adjusted, para 37, and Cunningham, including altering a frequency response characteristics of the amplification provided by the listening device 110, para 138, e.g., amplification factor adjusted to amplify the most important frequency content of the sound waves generated by the valves in the heart, and similar adjustment for the lung and heart muscle, para 138 and including compensating in frequency bandwidth of listening device 110, para 149 and set to the listening device to an application-specific mode corresponding to specific settings for optimizing the listening device 110, para 133).
Claim 10: the combination of Butera and Cunningham further teaches, according to claim 8 above, the application being configured to enable the user to access a real-time audio feed of the sounds within the body of the patient from each recording device of the plurality of recording devices (Cunningham, listening the sounds to be monitored by using a second set of BluetoothTM earpieces by the patient, or splitting the pair of earpieces, e.g., the 1st earpiece for self-auscultation device 102 to detect sounds and second earpiece for the patient 104 to listen and monitor the sounds as they are performing the self-auscultation procedures, para 147).
Claims 3-5, 7, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Butera (above) and in view of references Cunningham (above) and West et al. (US 20140126732 A1, hereinafter West).
Claim 3: the combination of Butera and Cunningham, further teaches, according to claim 2 above, an outer edge of the front side (Butera, a portion of the molding 310 and being closed to the opening 320 in fig. 3A, and one or more transducers 330 of device 300 in figs. 3A/3B, para 34 and Cunningham, concavity 302 around the microphone 206 in fig. 2) and the plurality of microphones of each recording device of the plurality of recording devices (Butera, the one or more transducers 330 and discussed above) and an adhesive pad being coupled to the front side (Butera, an adhesive material with the external auscultation device 120, e.g., adhesive material used to attach the device 120 at the midline of the neck, inferior to the thyroid cartilage, para 30), except wherein the adhesive pad extends around outer edge of the front side wherein the adhesive pad surrounds the plurality of microphones of each recording device of the plurality of recording devices.
West teaches an analogous field of endeavor by disclosing an auscultation system (title and abstract, ln 1-10 and a system in fig. 3 and for multi-sensor flexible auscultation instruments to detect patient auscultation signal, para 43) and wherein a plurality of microphones 206 is disclosed (102 in fig. 2) and a pad (the acoustic coupler layer 103 in fig. 2) extends around an outer edge of the front side (the plurality of microphones 206 and outer edge along the acoustic coupler 103 as the front side in fig. 2) wherein the pad surrounds the plurality of microphones of the recording device (the microphone penetrated from the layers 121 and 103 in fig. 2) for benefits of enhancing operation performance of recording the auscultation sound (by accurate detection of the auscultation sound signal for early treatment, para 6, by accurately discriminating between normal and abnormal sounds, para 104 and by discriminating variety of noises, figs. 11A-11K,para 23 and further noise cancellation by DSP, para 42).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the pad extends around the outer edge of the front side wherein the pad surrounds the plurality of microphones of recording device, as taught by West, to the adhesive pad and the front side and the plurality of microphones in each of recording devices in the auscultation system, as taught by the combination of Butera and Cunningham, for the benefits discussed above.
Claim 4: the combination of Butera and Cunningham further teaches, according to claim 1 above, wherein the plurality of microphones (Butera, one or more transducers 330 in fig. 3A/3B, para 34), except explicitly teaching that the plurality of microphones is inset to the front side of each recording device of the plurality of recording devices, the plurality of microphones being exposed within the front side of each recording device of the plurality of recording devices.
West teaches an analogous field of endeavor by disclosing an auscultation system (title and abstract, ln 1-10 and a system in fig. 3 and for multi-sensor flexible auscultation instruments to detect patient auscultation signal, para 43) comprising:
a recording device (an electronic stethoscope 100 in fig. 1) comprising a plurality of microphones (microphones 102 in fig. 2) and wherein the plurality of microphones is inset to a front side of the recording device (an acoustic coupler 103 to pick signal up, para 45, i.e., front side of the device in fig. 2 or a bottom cover 201 in fig. 20), the plurality of microphones (206 in fig. 20) being exposed within the front side of the recording device of the recording device (the microphones 206 exposed to the bottom cover 201 in fig. 20) for benefits of enhancing operation performance of recording the auscultation sound (by accurate detection of the auscultation sound signal for early treatment, para 6, by accurately discriminating between normal and abnormal sounds, para 104 and by discriminating variety of noises, figs. 11A-11K,para 23 and further noise cancellation by DSP, para 42).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the plurality of microphones that is inset to the front side of the recording device, and the plurality of microphones being exposed within the front side of recording device, as taught by West, to the front side and the plurality of microphones in the auscultation system, as taught by the combination of Butera and Cunningham, for the benefits discussed above.
Claim 5: the combination of Butera and Cunningham further teaches, according to claim 1 above, the auscultation system further comprising a pair of wireless headphones being in wireless communication with the personal computing device (Butera, the external computing device and discussed in para 35 and Cunningham, smartphone 108 with speaker for playing recorded, para 55), the personal computing device being configured to play the audio recording (the discussed above, para 55), except through a pair of wireless headphones.
West teaches an analogous field of endeavor by disclosing an auscultation system (title and abstract, ln 1-10 and a system in fig. 3 and for multi-sensor flexible auscultation instruments to detect patient auscultation signal, para 43) comprising:
a personal computing device (a computer 114 in fig. 3) being configured to access and modify an electronic health record of a patient (receiving data from summation amplifier via an AD conversion in fig. 3 and by addition of a signal from a noise cancelling microphone, para 77) and wherein the personal computing device is configured to play the audio recording through a pair of wireless headphones (wireless headphones 110 in fig. 3, para 50, for live playback of the signal, para 61) for benefits of enhancing operation performance of recording the auscultation sound (by accurate detection of the auscultation sound signal for early treatment, para 6, by accurately discriminating between normal and abnormal sounds, para 104).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the personal computing device being configured to play the audio recording through the pair of wireless headphones, as taught by West, to the personal computing device playing the audio recording in the auscultation system, as taught by the combination of Butera and Cunningham, for the benefits discussed above.
Claim 7: the combination of Butera, Cunningham, and West further teaches, according to claim 6 above, further comprising an extrinsic communication network (Cunningham, e.g., a server 114 in fig. 1 and West, a data storage device 112 containing a server computer 114 with storage components 113 in fig. 3) being wirelessly connected to the personal computing device (Cunningham, the server 114 through a different wireless network to the mobile device 108 in fig. 1, and West, through BLUETOOTH wireless network in fig. 3), the extrinsic communication network being in wireless communication with the transceiver (Cunningham, through the mobile device 108 to the transceiver of the self-auscultation device 102 in fig. 1 and transceiver, para 87), the extrinsic communication network including a secondary computing device being configured to access and modify the electronic health record of the patient (Cunningham, the 112, 114 performed similar functions, including playback audio by display device in fig. 20 CONTINUED), the transceiver being configured to send the alert to the secondary computing device when the sounds deviate from the standard reading (Butera, displaying the annotated marks 440, 430, 450, etc., in fig. 6, discussed in claim 6 above, Cunningham, the app 2012 determining and displaying the recorded sounds with particular health condition or health trend, para 167 and West, displayed different non auscultation sound signals, such as specific sounds or noise segments in figs. 11A-11K, e.g., coughing pattern in fig. 11B, background noise such as crying and talking in fig. 11C, very fast breathing with crackles, fig. 11J, etc., para 23 and heart beat visible with normal, but coughing sound in higher level, through frequency-time representation in fig. 12, para 97 and clear coughing sound different from the normal heart beat rate in fig. 14).
Claim 11 recited an auscultation system including features of claims 1-10 and has been analyzed and rejected according to claims 1-10 above.
Conclusion
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/LESHUI ZHANG/
Primary Examiner,
Art Unit 2695