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 .
Election/Restrictions
Applicant’s election without traverse of claims 31-45 in the reply filed on 16 September 2025 is acknowledged. Claims 46-53 have been withdrawn.
Claim Objections
Claims 35, 36, and 43 are objected to because of the following informalities:
“the web app” in line 2 of claim 35 should read as “a web app”
“the clinically” in line 1 of claim 36 should read as “a clinically”
“the audio” in line 1 of claim 43 should read as “an audio”
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.
Claims 35 and 43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 35 recites the limitation “the audio signal” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear what “the audio signal” is referring to (patient speech, clinically relevant sounds, or both). Clarification is requested.
The term “strong enough” in claim 43 is a relative term which renders the claim indefinite. The term “strong enough” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what it means for a gain control to be a “strong enough signal.” It is unclear what makes the signal “strong enough” as the disclosure also does not provide a clear definition of “strong enough” or what the limitation encompasses. Clarification is requested.
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, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Smith ‘513 (US Pub No. 2013/0116513) in view of Hallwachs ‘563 (US Pub No. 2015/0363563 – cited by Applicant).
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 configured to treat that patient speech separately from the audio dataset and 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 via the remote web server (Fig. 5 telephone network 606, data network 607 and [0182];
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]).
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 the web app separates the audio signal into two separate mono feeds and processes each 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.).
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 Emmanouilidou et al. ‘876 (US Pub No. 2018/0317876).
Regarding claim 32, Smith ‘513 in view of Hallwachs ‘563 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 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 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 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 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 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 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 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 Telfort et al. ‘923 (US Pub No. 2020/0178923).
Regarding claim 36, Smith ‘513 in view of Hallwachs ‘563 teaches all of the elements of the current invention as mentioned above except for in which the 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 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 teaches all of the elements of the current invention as mentioned above except for in which the audio dataset channel has a gain control so a strong enough signal will 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 to include a gain control so a strong enough signal will 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 Choi ‘108 (US Pub No. 2019/0192108).
Regarding claim 39, Smith ‘513 in view of Hallwachs ‘563 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 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.
Conclusion
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