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
Claims 6-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/16/26.
Applicant’s election without traverse of Invention I (claims 1-5) in the reply filed on 9/16/26 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/25/26 is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: for the limitation “a housing sized to fit within a chest pock of a subject's garment,” Applicant is encouraged to change the limitation to recite -- a housing configured to fit within a chest pocket of a subject's garment—for clarity purposes. 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 1-5 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.
In claim 1, the limitation of “the housing being free of affixing features” in lines 2-3 seems unclear. Claim 2 then recites “wherein the affixing features comprise at least one of a fastener, a cord, a strap, a wire, or a buckle.” It remains unclear how there are affixing features if the housing as recited in claim 1 is free of affixing features. Are the affixing features connected to the wearable sensor device another way? Dependent claim 2-5 are rejected for the same deficiency in claim 1.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-5 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 includes the limitation of “a set of electrodes to directly contact the subject's chest.” As such, the limitation requires that a set of electrodes would encompass being in contact with a patient (human organism) under the broadest reasonable interpretation. Applicant should be recommended to change the claimed limitation to --a set of electrodes configured to directly contact the subject's chest-- in order to overcome this 101 rejection. Dependent claims 2-5 are rejected for the same deficiency in claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 4 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Jumbe (US 20210345939 filed on 11/12/20).
Regarding claim 1, Jumbe teaches a wearable sensor device, comprising: a housing sized to fit within a chest pock of a subject's garment (¶87-the sensing device 110 may include a wearable housing that may be applied to the subject (e.g., with an adhesive patch) ( FIG. 1A) or coupled to clothing or other garments worn by the subject; ¶356-the wearable housing may be coupled to a suitable garment (e.g., clothing such as a shirt or jacket, a chest strap, a belly band, arm band, etc.) for detecting vibroacoustic signals from a subject wearing the garment), the housing being free of affixing features (¶87-the sensing device 110 may include a wearable housing…coupled to clothing or other garments worn by the subject; ¶356-the wearable housing may be coupled to a suitable garment (e.g., clothing such as a shirt or jacket, a chest strap, a belly band, arm band, etc.) for detecting vibroacoustic signals from a subject wearing the garment); an electrocardiogram (ECG) sensor comprising internal circuitry within the housing (¶113-a sensing device 400 , which is another example variation of the sensing device 110 of the system 100, first and optionally second capacitive electrodes 460 , 470 for electrocardiogram (ECG) measurements; FIGS. 4A-4E) and a set of electrodes to directly contact the subject's chest when the housing is disposed in the subject's garment (¶86-the sensing device 110 may be configured to capture suitable parameters through clothing of the subject, or on direct contact with skin of the subject; ¶269-the system 100 may further include one or more capacitive/Non-contact sensor modules. Such sensor modules may include non-contact electrodes; Fig. 1A) and to conduct electrical signals to the internal circuitry (¶121-the one or more sensors may also be arranged on a flexible circuit board; ¶223-integration of DRL electrodes directly on the stethoscope nearby the EPIC sensors with the ability to measure electrical signals through clothing or other obstacles, and without any conductive path to the skin); a motion sensor disposed within the housing (¶102-the system 100 may include, as shown schematically in FIG. 2, a sensing device 200 which is hand-held. The sensing device 200 includes a sensor module comprising: a vibroacoustic sensor module 220; ¶38-a vibroacoustic sensor module including an accelerometer and a microphone; ¶109-one or more device orientation and/or positional sensors (e.g., Inertial Measuring Unit (IMU), accelerometer, gyroscope, etc.) may be used for user input and function manipulation of the sensing device (e.g., shaking or rotating the sensing device may toggle between device settings, wake up or put the sensing device into a sleep or standby mode, etc.); Fig. 2); an audio sensor disposed as least partially within the housing (¶102-the system 100 may include, as shown schematically in FIG. 2, a sensing device 200 which is hand-held. The sensing device 200 includes a sensor module comprising: a vibroacoustic sensor module 220; ¶38-a vibroacoustic sensor module including an accelerometer and a microphone; Fig. 2); a wireless communication transmitter (¶93-one or more of the sensing device 110 , the computing device 102 , the network, and the charging base 120 may be configured to communicate information among each other (e.g., in a wireless manner, over a network, etc.)); a processor in communication with the ECG sensor, the motion sensor, and the audio sensor (¶7-at least one processor may be configured to characterize a health or other bodily condition of the subject based at least in part on the extracted vibroacoustic biological signal component; ¶285-the processor 2310 may receive sensor data (e.g., before and/or or after sensor signal conditions); ¶113); and a memory in communication with the processor and having instructions stored thereon that, when executed, cause the processor (¶285-the processor 2310 may receive sensor data (e.g., before and/or or after sensor signal conditions) and the sensor data may be stored in one or more memory devices 2320; ¶284) to: receive, via the ECG sensor, the motion sensor, and the audio sensor, ECG data, acceleration data, and audio data (¶96-a signal processing system configured to extract from the detected sensor data a biological signal component originating from the subject; ¶512-the sensing device 400 was also arranged to collect additional sensor data such as IMU data, contextual data, heart beat; ¶109-a dedicated microphone may be used to receive vocal user input, one or more device orientation and/or positional sensors (e.g., Inertial Measuring Unit (IMU), accelerometer, gyroscope, etc.) may be used for user input and function manipulation of the sensing device (e.g., shaking or rotating the sensing device may toggle between device settings, wake up or put the sensing device into a sleep or standby mode, etc.); ¶116-collecting ECG data); and transmit the ECG data, acceleration data, and audio data via the wireless communication transmitter (¶90-the sensing device 110 may be configured to communicate (e.g., wirelessly communicate) with one or more computing devices 102 , such as a mobile computing device, smart watch, local data gateway, or computer for processing, analyzing, communication, and/or storage, etc. of sensor data and/or other suitable information; ¶109; ¶116).
Regarding claim 2, Jumbe teaches the device of claim 1, wherein the affixing features comprise at least one of a fastener, a cord, a strap, a wire, or a buckle (¶356-the wearable housing may be coupled to a suitable garment (e.g., clothing such as a shirt or jacket, a chest strap, a belly band, arm band, etc.) for detecting vibroacoustic signals from a subject wearing the garment).
Regarding claim 4, Jumbe teaches the device of claim 1, wherein the audio sensor is configured to capture environmental sounds (¶128-environmental disturbance data (e.g., ambient noise) may be used for noise cancellation from the relevant biological vibroacoustic signal component; ¶178-two or more voice coil sensors may be included in the sensing device (e.g., in the vibroacoustic sensor module) which may enable triangulation of faint body sounds detected by the voice coil sensors, and/or to better enable cancellation and/or filtering of noise such as environmental disturbances; ¶153-a microphone for detecting and measuring vibroacoustic waves).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Jumbe in view of Kovacs (US 20070208233 filed on 3/3/06).
Regarding claim 3, Jumbe teaches the device of claim 1. While Jumbe teaches that when sampling more than one sensor signal, Track-and-Hold components may help ensure proper time synchronization among the sensor signals, with synchrony accuracy in the range of nanoseconds (¶307), Jumbe does not explicitly teach digitizing circuitry, the digitizing circuitry comprising a real-time clock and synchronization circuitry; wherein digitizing circuitry synchronizes the ECG data, acceleration data, and the audio data based on a frequency of the real-time clock.
Kovacs teaches digitizing circuitry, the digitizing circuitry comprising a real-time clock and synchronization circuitry (¶8-a physiologic monitoring application-specific integrated circuit (ASIC) including an integrated real-time clock for generating a set of real time indicators; ¶53-real-time clock 62 may receive periodic base timing signals from the main integrated circuit synchronization clock that provides synchronization clock signals to digital control logic 60 and other components of integrated circuit 30); wherein digitizing circuitry synchronizes the ECG data, acceleration data, and the audio data based on a frequency of the real-time clock (¶51A-/D converter 58 is capable of digitizing signals received from multiple sensors, which may be sampled at different rates. A/D converter 58 is chosen so it is capable of digitizing at the maximum aggregate data rate from all sensors. For example, in some embodiments, ECG data is sampled at 256 samples/second, respiration data at 64 samples/second, and acceleration at 16 samples/second, while subject temperature, SpO2, and heart rate are sampled at 1 sample/second; ¶42-multiple components used in parallel, for amplifying and filtering signals received from different types of sensors, which may correspond to different signal amplitudes, frequency content, and A/D sampling rates. Such components may include components used only in some configurations. For example, amplification circuit 112 and filtering circuit 118 may include circuitry capable of processing signals from twelve ECG leads and a number of sensor types).
Kovacs relates to physiologic monitoring systems and methods, and in particular to physiologic monitors (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Jumbe to include digitizing circuitry, the digitizing circuitry comprising a real-time clock and synchronization circuitry; wherein digitizing circuitry synchronizes the ECG data, acceleration data, and the audio data based on a frequency of the real-time clock of Kovacs in order to digitize signals received from multiple sensors, which may be sampled at different rates (Kovacs, ¶51).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Jumbe in view of Golan (US 20230397888 filed on 6/14/23).
Regarding claim 5, Jumbe teaches the device of claim 1. However, Jumbe does not teach to pre-process the ECG data by filtering missing interbeat interval values.
Golan teaches pre-process the ECG data by filtering missing interbeat interval values (¶38-filter the input data (and/or associated information) based on a set of one or more criteria (e.g., inclusion and/or exclusion criteria). In some examples, these criteria can include excluding input data based on metadata-derived information, such as…missing metadata information (e.g., absence of one or more ECG technical parameters used to pre-process the input data)).
Golan relates generally to the signals processing and triage fields, and more specifically to a new and useful system and method for cardiac signal processing in the signals processing and triage fields (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Jumbe to include pre-processing the ECG data by filtering missing interbeat interval values of Golan in order to increase the fidelity of the ECG signal and/or the quality of the resulting analysis performed (Golan, ¶49).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20180028144: the chestpiece includes an acoustic transducer, at least four electrodes, a wireless communication device, and at least one processor, wherein the acoustic transducer is adapted to contact the skin of a patient, measure heart sounds of the patient, and send the heart sounds to the earpiece and the at least one processor is adapted to create a PCG waveform of the heart sounds, wherein the at least four electrodes are adapted to contact the skin of the patient and measure heart electrical signals of the patient and the at least one processor is adapted to create an ECG waveform of the heart electrical signals (claim 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, UNSU JUNG can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAURA HODGE/Examiner, Art Unit 3792
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