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 .
Response to Amendment
Claims 31-54 are currently pending. Claims 46-53 remain withdrawn. Claims 31, 35, 36, 43, 44, 46, and 48 have been amended. Claim 54 has been added. Claims 35, 36, and 43 have been amended to overcome the claim objections and claims 35 and 43 have been amended to overcome the 35 U.S.C. 112(b) rejections set forth in the Non-Final Office Action mailed on 20 October 2025.
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.
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.
Claims 31, 33-35, 41, 42, 44, 45, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Smith ‘513 (US Pub No. 2013/0116513 – previously cited) in view of Hallwachs ‘563 (US Pub No. 2015/0363563 – previously cited) further in view of Shin et al. ‘448 (US Pub No. 2017/0172448).
Regarding claim 31, Smith ‘513 teaches telemedicine system (Title, Abstract) comprising:
a medical device (Fig. 1 sensor sub-system 101, user input sub-system 103 and [0026], [0033]) is configured to upload or send patient datasets to the remote web server (Fig. 1 communications sub-system 104 and [0042]), directly from an internet-connected app running either on the device or on an intermediary device ([0053]; “telephone system…Internet…”);
and in which the medical device includes (i) a speech microphone configured to detect and/or record patient speech (Fig. 1 microphone 130 and [0034]) and (ii) a second microphone in the medical device configured to detect and/or record clinically relevant sounds (Fig. 1 auscultation sensor 110 and [0173]) and generate an audio dataset from those sounds ([0102]; “The user dictates into microphone 130, the sound is stored digitally, either in raw or compressed form, and the stored recording is then transferred via the Communications sub-system to a speech recognition system located on a remote computer.” [0122]; “Information data from the text-to-speech (data-to-speech) processor 203 is also accessed or generated, and converted to speech.”);
and in which the internet-connected app is hence configured to enable real-time voice communication from the patient to a healthcare professional at the same time as the audio dataset is being shared with the healthcare professional at a different location than the patient via the remote web server (Fig. 5 telephone network 606, data network 607 and [0182]; “At the patient care center, voice, data, or measurements can be received via the telephone or data network and analyzed by a human or machine. Responses can be given verbally in real time using a telephone hookup, or sent to the patient via a data network to their email access address 612. The analyst 605 can also take control of the measurement device 601d, in order to control the taking of data.”);
and the system is configured to enable the healthcare professional to select whether to listen to real-time voice communication from the patient or to listen to the audio dataset in real-time by muting, fully or partly, either the real-time voice communication or the audio dataset ([0181]-[0182]).
Smith ‘513 teaches all of the elements of the current invention as mentioned above except for multiple medical devices that are each configured to generate patient datasets, and a remote web server connected to each medical device.
Hallswachs ‘563 teaches multiple medical devices that are each configured to generate patient datasets (Fig. 1 any number of client stations 314 and [0063], [0014]) and a remote web server connected to each medical device (Fig. 1 network 312 and [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the telemedicine system of Smith ‘513 to include multiple medical devices that are each configured to generate patient datasets, and a remote web server connected to each medical device as Hallswachs ‘563 teaches that this will aid in authorizing multiple parties such as patients, potential patients, significant others of patients or potential patients, friends of patients or potential patients, family members, doctors, nurses, medical assistants, insurers, home care staff, and hospital administrators into a system ([0064]).
Smith ‘513 teaches all of the elements of the current invention as mentioned above except for the internet-connected app is configured to process the patient speech separately from the audio dataset.
Shin et al. ‘448 teaches a bio-processor may receive a biological signal from the sensing electrodes selected by the bio-processor, process (for example, amplification, noise removal, and analog-to-digital conversion) the signal, generate biological data BDATA from the processed signal, and store the biological data BDATA in the memory ([0005], [0086]). Examiner notes that selecting the electrodes to process is interpreted as “separately processing” data from a dataset.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the internet-connected app of Smith ‘513 to include processing the patient speech separately from the audio dataset as Shin et al. ‘448 teaches that this will aid in processing desired data ([0005]).
Regarding claim 33, Smith ‘513, as modified by Hallswachs ‘563, teaches where the intermediary device is a laptop or PC ([0053], [0059]), then the internet-connected app treats the patient speech and the audio dataset generated by the medical device in a way that satisfies the standard browser security model of allowing for multiple audio sources to be used at any given time ([0179]).
Regarding claim 34, Smith ‘513 teaches where the intermediary device is a smartphone or smartwatch ([0059]), then the internet-connected app processes both the patient speech and also the audio dataset generated by the medical device in a way that satisfies the standard smartphone or smartwatch model of allowing for multiple audio sources to be used at any given time only if they are integrated into a single app ([0053]).
Regarding claim 35, Smith ‘513 teaches in which the speech and audio datasets are each delivered over a stereo channel and a web app separates speech and audio datasets into two separate mono feeds and processes each mono feed differently (Abstract, [0102]; Voice recordings and auscultation may be separate audio output means.).
Regarding claim 41, Smith ‘513 teaches in which the speech microphone output is used to determine if the room is too noisy for a patient reading and/or if a patient is speaking when the exam is being recorded to enable a message to be shown or given to the patient to be silent and/or that there is too much noise to perform the examination ([0102]).
Regarding claim 42, Smith ‘513 teaches in which the medical device is a digital stethoscope ([0077]; “electronic stethoscope”) and the clinically relevant sound are auscultation sounds (Fig. 1 auscultation sensor 110 and [0173]).
Regarding claim 44, Smith ‘513 teaches in which the digital stethoscope comprises a first audio sensor that is configured to measure or sense body sounds (Fig. 1 stethoscope/auscultation sensor 110 and [0026]) and a second audio sensor that is configured to measure or sense sounds from the patient or the environment around the patient (Fig. 1 microphone 130 and [0034]).
Regarding claim 45, Smith ‘513 teaches in which the remote web server is configured to generate a unique web-link that is associated with a specific patient dataset; and in which the unique web-link enables the healthcare professional to review the specific patient dataset by selecting the web-link from within a web browser or from within any dedicated telemedicine application that opens web-links ([0045], [0106], [0179]; The security feature to prevent unauthorized access is interpreted as a unique link.).
Regarding claim 54, Smith ‘513 teaches in which the system is configured to enable the healthcare professional to initiate a live examination session with the patient ([0182]; “telephone hookup”), and during that live examination session, the healthcare professional can simultaneously listen to the audio dataset in real time and maintain real-time voice communication with the patient ([0182]; “At the patient care center, voice, data, or measurements can be received via the telephone or data network and analyzed by a human or machine. Responses can be given verbally in real time using a telephone hookup, or sent to the patient via a data network to their email access address. The analyst can also take control of the measurement device, in order to control the taking of data.”).
Claims 32, 37, 38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 further in view of Emmanouilidou et al. ‘876 (US Pub No. 2018/0317876 – previously cited).
Regarding claim 32, Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 teaches all of the elements of the current invention as mentioned above except for in which the system is configured to use the speech microphone to determine unwanted noise or noise that otherwise affects the quality of the audio dataset and to generate a warning if the unwanted noise exceeds a threshold.
Emmanouilidou et al. ‘876 teaches a spectral subtraction algorithm that are typically used in fields of communication or speech enhancement for noise reduction ([0073]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the speech microphone of Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 to include determining unwanted noise or noise that otherwise affects the quality of the audio dataset and to generate a warning if the unwanted noise exceeds a threshold as Emmanouilidou et al. ‘876 teaches that this is typical for speech enhancement for noise reduction.
Regarding claim 37, Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 teaches all of the elements of the current invention as mentioned above except for in which the clinically relevant audio datasets are processed to improve the quality of the audio from a clinical or diagnostic perspective.
Emmanouilidou et al. ‘876 teaches a noise reduction system to repair clipping of the auscultation signal to provide the clean auscultation signal substantially free of distortions ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the clinically relevant audio datasets of Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 to include being processed to improve the quality of the audio from a clinical or diagnostic perspective as Emmanouilidou et al. ‘876 teaches that this will aid in having a clean auscultation signal substantially free of distortions.
Regarding claim 38, Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 teaches all of the elements of the current invention as mentioned above except for in which filters are applied to the speech sounds and also the clinically relevant sounds, after these sounds have been recorded, maintaining a raw audio file or files.
Emmanouilidou et al. ‘876 teaches a spectral subtraction algorithm that are typically used in fields of communication or speech enhancement for noise reduction ([0073]). Emmanouilidou et al. ‘876 also teaches a noise reduction system to repair clipping of the auscultation signal to provide the clean auscultation signal substantially free of distortions ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the speech sound and the clinically relevant sound of Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 to include applying filters to these sounds after these sounds have been recorded, maintaining a raw audio file or files as Emmanouilidou et al. ‘876 teaches that this is typical for speech enhancement for noise reduction and this will aid in having a clean auscultation signal substantially free of distortions.
Regarding claim 40, Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 teaches all of the elements of the current invention as mentioned above except for in which the speech microphone is used to capture audio that is used to reduce or remove sounds that are not relevant to the clinically relevant sound channel and hence the audio dataset.
Emmanouilidou et al. ‘876 teaches a spectral subtraction algorithm that are typically used in fields of communication or speech enhancement for noise reduction ([0073]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the speech microphone of Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 to include capturing audio that is used to reduce or remove sounds that are not relevant to the clinically relevant sound channel and hence the audio dataset as Emmanouilidou et al. ‘876 teaches that this is typical for speech enhancement for noise reduction.
Claims 36 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 further in view of Telfort et al. ‘923 (US Pub No. 2020/0178923 – previously cited).
Regarding claim 36, Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 teaches all of the elements of the current invention as mentioned above except for in which a clinically relevant audio dataset channel has a gain control to increase the strength of the signal.
Telfort et al. ‘923 teaches a sensor on a measurement sight to measure acoustic vibrations ([0160]) can be calibrated by a system increasing the gain of the sensor to increase a weak connection ([0161]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the clinically relevant audio dataset channel of Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 to include a gain control to increase the strength of the signal as Telfort et al. ‘923 teaches that this will aid in increasing a weak connection.
Regarding claim 43, Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 teaches all of the elements of the current invention as mentioned above except for in which the audio dataset channel has a gain control configured to increase the strength of the clinically relevant signal to be captured for the body recording.
Telfort et al. ‘923 teaches a sensor on a measurement sight to measure acoustic vibrations ([0160]) can be calibrated by a system increasing the gain of the sensor to increase a weak connection ([0161]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the audio dataset channel of Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 to include a gain control configured to increase the strength of the clinically relevant signal be captured for the body recording as Telfort et al. ‘923 teaches that this will aid in increasing a weak connection.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 further in view of Choi ‘108 (US Pub No. 2019/0192108 – previously cited).
Regarding claim 39, Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 teaches all of the elements of the current invention as mentioned above except for in which the healthcare professional and/or patient each have control of muting the speech channel and the clinically relevant sound channel separately if they want to only hear one or the other channel.
Choi ‘108 teaches a headset that has a function of delivering a voice or the auscultation sound to a patient having low hearing ability ([0038]-[0039], [0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified telemedicine system of Smith ‘513 in view of Hallwachs ‘563 further in view of Shin et al. ‘448 to include in which the healthcare professional and/or patient each have control of muting the speech channel and the clinically relevant sound channel separately if they want to only hear one or the other channel as Choi ‘108 teaches that this will aid in delivering either the voice or auscultation sound to a person with low hearing abilitt.
Response to Arguments
Applicant’s arguments with respect to the 35 U.S.C. 103 rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
It is noted that the claim status for claims 46-53 are incorrect. Although the Applicant has made amendments to the claims, these claims were also withdrawn as noted in the Response to Election filed 16 September 2025 and should be amended accordingly.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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