DETAILED ACTION
Applicant’s arguments, filed 12/22/20258, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant canceled claims 5 and 17 and added claims 25-26.
Claims 1-4, 6-16, and 18-26 are pending and hereby under examination.
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 because in Fig. 6, box 607 “thorough” is misspelled and should be “through”. 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 1, line 11 through the end of the claim recites a “machine-readable medium” with a “processor” having executable “instructions” with details particular to various processing steps stored thereon; however, the specification fails to include these terms or details of the arrangement. Examiner notes that certain dependent claims refer to additional executable instruction details which are also not found in the specification.
The amendment filed 12/22/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The paragraph beginning on page 4, line 24 includes new matter not previously disclosed in the specification, including “non-transitory machine-readable medium storing computer-executable instructions” or a “memory or storage device”. Applicant asserts that it would have been apparent to one of ordinary skill in the art, based on the original specification and figures, that the systems and method would be implemented using a processor and non-transitory machine-readable medium as claimed. However, the assertion by the Applicant that it would be obvious to one of ordinary skill in the art, without previous disclosure of the new matter added to the specification, does not resolve the introduction of the new matter into the disclosure of the invention. Applicant adds a broad collection of new matter, such as many different types of storage devices, memory types, processing hardware for executing AI/ML algorithms, software modules, code, and operations carried out via the executable instructions. Without previous disclosure of these elements, it calls into question if the Applicant has possession of the new matter at the time of filing.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claims 18 and 22 are objected to because of the following informalities:
Claim 18, line 4 should read “displaying the digitized PCG data …”.
Claim 22, line 9, “patent” should read “patient”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 6-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 claims a “non-transitory machine-readable medium having instructions stored thereon” that was not disclosed prior to the specification filed 12/22/2025, which contains new matter, such as the non-transitory machine-readable medium, not previously written in the disclosure of the instant application (see above). Without disclosure of such a non-transitory machine-readable medium, it is unclear if the inventors has possession of the invention as claimed at the time of filing. For examination purposes, the claimed new matter will still be considered as part of the claimed subject matter.
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 1-4, 6-16, and 18-26 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.
Regarding claims 1, 13, and 15, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the limitations following the phrase “optionally” will be considered optional and not required to meet the claim. Claims 2-4, 6-14, 16, and 18-26 are also rejected due to their dependence on claims 1 and 15.
Regarding claims 1 and 15, the claims recite “analyzing, by the processor, the digitized sounds with inertial data …” or “analyzing the digitized PCG data together with one or more additional signals comprising inertial data, visual pose data, … (ECG), … (PPG), and/or other skin surface signals …”. There is no recitation in the claims of collecting inertial data (or the other listed types of data) or a sensor to collect the listed data. Is this data pre-determined, measured by a different device in the system, or measured by a sensor in the stethoscope? For examination purposes, the claims will be interpreted such that a sensor of the system captures the additional data and is used to analyze the PCG data.
Regarding claim 6, the phrase "selectively" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 6 and 18 recite the limitation “each clip” in line 8 and line 6, respectively. There is insufficient antecedent basis for this limitation in the claims.
Claims 6 and 18 recite the limitation “processed sound clips” in line 11 and line 8, respectively. There is insufficient antecedent basis for this limitation in the claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 7-10, 12, 14-16, 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Rinderknecht (US 20210386309 – cited by Applicant) and Kapoor (US 20170049339).
Regarding claim 1, Rinderknecht discloses a system for providing instructions to a user for manipulating a stethoscope to obtain sound from a body of a patient, the system comprising:
a digital stethoscope (Fig. 2, handheld device 20) comprising a vibration (Paragraphs 0079 and 0083) transducer (Paragraph 0071, “The amplified motion can therefore subsequently be recorded through any number of non-invasive transducers such as piezoelectric, capacitive, piezoresistive, optical, acoustic, ultrasound or electromagnetic”) that receives and digitizes sound and a transmitter in operable communication with the vibration transducer for transmitting the digitized sound (Paragraph 0054), wherein the digital stethoscope is configured to be placed on the body of the patient in a location to obtain sound (Fig. 2, placed against the carotid artery);
a user interface device in operable communication with the transmitter of the digital stethoscope, the user interface device comprising a display and being configured to receive the digitized sound transmitted by the transmitter (Fig. 3, smartphone unit 200);
a processor in operable communication with the user interface device (Paragraph 0106); and
a non-transitory machine-readable medium in operable communication with the processor, the non-transitory machine-readable medium having instructions stored thereon that (Paragraphs 0108-0109), when executed by the processor, perform the following steps:
receiving, by the processor, the digitized sound, via the transmitter (Paragraph 0055, “As illustrated, smartphone 200 communicates with/between sensor device 100 employing signals 120/220 as in “paired” BLUETOOTH devices or via another protocol. The smartphone may receive information corresponding to a hemodynamic signal as further treated below. Such a signal may be stored and/or processed via connection with the Internet—as in so-called Cloud 202 computing”), from the digital stethoscope positioned at multiple anatomical sites (Figs. 14A-C; Paragraphs 0089-0093, wherein the method includes sensing at multiple locations), optionally over multiple time points and optionally under multiple body states, including upright and reclined;
determining, by the processor, a direction to move the digital stethoscope for relocation on the body of the patient (Paragraphs 0090-0093);
transmitting, by the processor, to the user interface device one or more commands viewable by the user on the display regarding the direction to move the digital stethoscope for relocation on the body of the patient (Paragraphs 0090-0093);
optionally applying adaptive weighting, including time-varying and source-component dependent weights, and frequency filtering to enhance diagnostically relevant portions of the digitized sound;
performing automatic segmentation of periodic portions of the digitized sound (Paragraph 0086, “ Indeed, any cardiac cycle detection and/or segmentation of heart waveforms is potentially aided by the use of Embedded Frequencies”; Paragraph 0102)
optionally storing clinically valuable portions of the digitized sound (Paragraph 0055) and discarding non-informative data to optimize memory use and focus on diagnostically meaningful information;
While Rinderknecht discloses analyzing the digitized sound to determine the location of the digital stethoscope relative to the body of the patient (Paragraph 0027), Rinderknecht fails to analyze the sound with inertial data.
Additionally, Rinderknecht discloses a system for cardiovascular disease diagnosis (Paragraph 0005). However, Rinderknecht fails to disclose computing diagnostic scores, tracking diagnostic scores over time to form longitudinal trajectories and displaying temporal trends, wherein the longitudinal trajectories assess progression or changes in patient condition, and generating alerts based on progression patterns observed in longitudinal trajectories.
However, Kapoor teaches a diagnostic system stethoscope (Fig. 16) wherein the sensor sleeve includes an accelerometer (Paragraph 0068; Fig. 15), which Kapoor discuses is useful for measuring inclination, position, orientation, or acceleration of the patient. Additionally, Kapoor teaches measuring a myocardial performance index (Paragraph 0075), a systolic performed index (Paragraph 0077), and scoring data to track the data and send notification of data trends (Paragraph 0098). Kapoor discusses this is useful for heart murmur, arrhythmia, and failure detection as well as tracking when trends fall below thresholds (Paragraph 0098).
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 modified Rinderknecht to incorporate the teachings of Kapoor. Doing so is useful for measuring inertial parameters of the patient and for detecting heart disease parameters and when trends fall below threshold.
Regarding claim 2, Rinderknecht further discloses wherein the one or more commands for moving the digital stethoscope comprise direct queues that visually indicate the direction to move the stethoscope (Paragraph 0091).
Regarding claim 3, Rinderknecht further discloses recording, with at least one of the digital stethoscope and the user interface device, at least one of the sound and the further sound from the body of the patient prior to receiving by the processor (Paragraph 0054, wherein the handheld sensor collects a signal and transmits the signal thereafter).
Regarding claim 4, Rinderknecht further discloses processing, with the user interface device, at least one of the sound and the further sound by one or more of filtering, amplifying (Paragraph 0023).
Regarding claim 7, Rinderknecht further discloses wherein the digital stethoscope further comprises at least one sensor (Paragraph 0056, “Specifically, a face or facing surface 106 of base 102 incorporates additional sensors”) for obtaining sensor information comprising at least one of biometric, directional, and positional information from the body of the patient (Paragraph 0056, “These may include an ECG electrode 110′, an optical sensor or sensor region 112 and/or microphone(s) 114. Optional use of two microphones allows for direction sound sensing for homing in on an improved or ideal signal sensing location”), the at least one sensor being in operable communication with the transmitter (Paragraph 0054), and
wherein the digital stethoscope is configured to transmit the sensor information to the user interface device (Paragraph 0054).
Regarding claim 8, Rinderknecht further discloses wherein the at least one sensor comprises at least one of: membrane arranged on a bell of the digital stethoscope (Figs. 2 and 8A-C, base 102 with membrane 440), an infrared sensor (Paragraph 0068), a strain gauge (Paragraph 0012, “Indeed, the waveform may be acquired through any of microwave, strain-gauge, piezoresistive, capacitive, optical, or acoustic sensors”), and an electrode (Fig. 3, electrode 110’).
Regarding claim 9, Rinderknecht further discloses receiving, by the processor, the sensor information (Paragraph 0055, “The smartphone may receive information corresponding to a hemodynamic signal as further treated below”); and analyzing, by the processor, the sensor information (Paragraph 0055, “Such a signal may be stored and/or processed via connection with the Internet—as in so-called Cloud 202 computing.”).
Regarding claim 10, Rinderknecht further discloses displaying the sensor information on the display of the user interface device (Paragraph 0058, “Such information may be further processed and depicted as shown in FIG. 4B on screen or display 320 and further commented on below”).
Regarding claim 12, Rinderknecht further discloses obtaining at least one of a video and image of the body of the patient (Paragraph 0091, “auditory and or visual signal(s) for a user are assigned to information streaming from a/the camera in the sensor device platform. As shown in FIG. 14A in more general terms, a hemodynamic signal is sensed”); displaying the at least one video and image on the user interface device; and presenting the commands relative to the at least one video and image (Paragraph 0091, “This signal is modified or manipulated at 702 in any of various ways possibly described above or others, then output as a user identified or identifiable signal at 704. Such signaling may be auditory (e.g., as in from resolution to an intelligible signal out of noise, as from nothing to hearing a signal, as in an accelerated beeping to achieve a “lock,” etc.) or visual (e.g., as indicated by light blinking or intensity, as gauged by a meter, etc.) as described above or otherwise”).
Regarding claim 14, Rinderknecht further discloses wherein the strain gauge is in operable communication with the membrane arranged on the bell, wherein, in use, the membrane contacts the body of the patient (Paragraph 0017, “the membrane is located or placed in contact with the skin where signal acquisition is desired (i.e., between the optical sensor and the skin)”), wherein, in use, the strain gauge obtains a measure of pressure applied to the body of the patient by the membrane (Paragraphs 0049 and 0071); and wherein the instructions when executed by the processor further perform the following step: analyzing, by the processor, at least one of the digitized sound and the sensor information relative to the pressure measurement (Paragraphs 0078-0080 and 0083-0084).
Regarding claim 15, Rinderknecht discloses a method for obtaining phonocardiographic (PCG) data from a body of a patient, the method comprising:
providing a digital stethoscope (Fig. 2, handheld device 20) comprising a vibration (Paragraphs 0079 and 0083) transducer (Paragraph 0071, “The amplified motion can therefore subsequently be recorded through any number of non-invasive transducers such as piezoelectric, capacitive, piezoresistive, optical, acoustic, ultrasound or electromagnetic”) that receives and digitizes the PCG data (Paragraph 0009, “The embodiments described herein can obtain electrocardiogram (i.e., EKG or ECG), phonocardiogram, and arterial pulse waveforms.”) and a transmitter operably connected to the vibration transducer for transmitting the digitized PCG data (Paragraph 0054);
receiving from the transmitter the digitized PCG data with a user interface device comprising a display, the digitized PCG data being received, via the transmitter (Paragraph 0055, “As illustrated, smartphone 200 communicates with/between sensor device 100 employing signals 120/220 as in “paired” BLUETOOTH devices or via another protocol. The smartphone may receive information corresponding to a hemodynamic signal as further treated below. Such a signal may be stored and/or processed via connection with the Internet—as in so-called Cloud 202 computing”), from the digital stethoscope positioned at one or more anatomical sites (Figs. 14A-C; Paragraphs 0089-0093, wherein the method includes sensing at multiple locations), optionally over multiple time points and optionally under multiple body states, including upright and reclined;
transmitting the digitized PCG data with the user interface device to a compute infrastructure resource (Paragraph 0055, “As illustrated, smartphone 200 communicates with/between sensor device 100 employing signals 120/220 as in “paired” BLUETOOTH devices or via another protocol. The smartphone may receive information corresponding to a hemodynamic signal as further treated below. Such a signal may be stored and/or processed via connection with the Internet—as in so-called Cloud 202 computing”);
analyzing the PCG digitized data together with one or more additional signals comprising inertial data, visual pose data, electrical signals including electrocardiogram (ECG), optical signals (including photoplethysmography (PPG), and/or other skin-surface signals (Paragraphs 0009, 0013-0014, and 0056) to localize the position of the digital stethoscope on the body of the patient by performing single or multisite analysis to assess difference from expectations or variation of physiological signals across the one or more anatomical sites (Paragraph 0027);
calculating a direction to move the digital stethoscope for relocation on the body of the patient (Paragraph 0090-0093);
transmitting to the user interface device one or more instructions viewable on the display regarding the direction for relocating the stethoscope on the body of the patient (Paragraph 0090-0093);
acquiring additional digitized PCG data from the body of the patient with the relocated digital stethoscope (Paragraph 0093, “… sensing may then occur at 700 after which the process ends at 706”);
optionally applying adaptive weighting, including time-varying and source-component dependent weights, and frequency filtering to enhance diagnostically relevant portions of the digitized PCG data;
performing automatic segmentation of periodic portions of the digitized PCG data (Paragraph 0086, “ Indeed, any cardiac cycle detection and/or segmentation of heart waveforms is potentially aided by the use of Embedded Frequencies”; Paragraph 0102);
optionally performing attribution by mapping diagnostic outputs to the segmented portions of the digitized PCG data and corresponding anatomical sites;
optionally storing clinically valuable portions of the digitized PCG data and discarding non-informative data to optimize memory use and focus on diagnostically meaningful information;
While Rinderknecht discloses a system for cardiovascular disease diagnosis (Paragraph 0005), Rinderknecht fails to disclose computing diagnostic scores, tracking diagnostic scores over time to form longitudinal trajectories and displaying temporal trends, wherein the longitudinal trajectories assess progression or changes in patient condition, and generating alerts based on progression patterns observed in longitudinal trajectories.
However, Kapoor teaches a diagnostic system stethoscope (Fig. 16) wherein the sensor sleeve includes an accelerometer (Paragraph 0068; Fig. 15), which Kapoor discuses is useful for measuring inclination, position, orientation, or acceleration of the patient. Additionally, Kapoor teaches measuring a myocardial performance index (Paragraph 0075), a systolic performed index (Paragraph 0077), and scoring data to track the data and send notification of data trends (Paragraph 0098). Kapoor discusses this is useful for heart murmur, arrhythmia, and failure detection as well as tracking when trends fall below thresholds (Paragraph 0098).
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 modified Rinderknecht to incorporate the teachings of Kapoor. Doing so is useful for measuring inertial parameters of the patient and for detecting heart disease parameters and when trends fall below threshold.
Regarding claim 16, Rinderknecht further discloses the user interface device processing the digitized PCG data by at least one of filtering, amplifying (Paragraph 0023) prior to transmitting to the compute infrastructure resource.
Regarding claim 19, Rinderknecht further discloses wherein the digital stethoscope further comprises at least one sensor (Paragraph 0056, “Specifically, a face or facing surface 106 of base 102 incorporates additional sensors”) for obtaining sensor information comprising at least one of biometric, directional, and positional information from the body of the patient (Paragraph 0056, “These may include an ECG electrode 110′, an optical sensor or sensor region 112 and/or microphone(s) 114. Optional use of two microphones allows for direction sound sensing for homing in on an improved or ideal signal sensing location”), wherein the at least one sensor is operably connected to the transmitter (Paragraph 0054) and the method further comprises transmitting the sensor information to the compute infrastructure resource with the user interface device (Paragraph 0055, “The smartphone may receive information corresponding to a hemodynamic signal as further treated below. Such a signal may be stored and/or processed via connection with the Internet—as in so-called Cloud 202 computing”).
Regarding claim 20, Rinderknecht discloses wherein the at least one sensor comprises at least one of: a membrane arranged on a bell of the digital stethoscope (Figs. 2 and 8A-C, base 102 with membrane 440), an infrared sensor (Paragraph 0068), a strain gauge (Paragraph 0012, “Indeed, the waveform may be acquired through any of microwave, strain-gauge, piezoresistive, capacitive, optical, or acoustic sensors”), and an electrode (Fig. 3, electrode 110’).
Regarding claim 21, Rinderknecht further discloses displaying the sensor information on the display of the user interface device (Paragraph 0058, “Such information may be further processed and depicted as shown in FIG. 4B on screen or display 320 and further commented on below”).
Regarding claim 22, Rinderknecht further discloses
analyzing the sensor information from the at least one sensor; combining the analysis of the digitized PCG data with the analysis of the sensor information (Paragraph 0071, “Similar techniques may be applied to measure physiological wave information that exists at different frequencies such as arterial waves versus phonocardiograms. The signal can be recorded using an optical reflective light sensor (e.g., with sensor 112 or 316). In another embodiment, a combination or array of these structures may be used to probe local arterial mechanical properties”);
determining a location of the digital stethoscope on the body of the patient; determining a direction of movement for relocating the stethoscope on the body of the patient; transmitting instructions to the user interface device viewable by the user for relocation of the digital stethoscope on the body of the patient (Paragraphs 0090-0093); and
obtaining further digitized PCG data from the body of the patient (Paragraph 0093, “… sensing may then occur at 700 after which the process ends at 706”).
Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Rinderknecht as applied to claims 4 and 15 above, and further in view of Jeevannavar (US 20210030390 – cited by Applicant).
Regarding claim 6, Rinderknecht further discloses wherein the digitized sound is shown on the display of the user interface device (Fig. 3), and wherein the instructions when executed by the processor further perform the following steps:
determining, by the processor, one or more attributes in the digitized sound, wherein the attributes comprise extracted features of the digitized sound (Paragraphs 0084-0087; Paragraph 0096-0097);
selectively performing further processing on the portions of the digitized sound corresponding to the determined attributes, including normalizing the determined attributes and scaling sub-band signals, and reconstituting each clip via summation (Paragraphs 0076 and 0094; Figs. 4B, 12, 13A-C);
indicating the position of the one or more attributes on the displayed digitized sound (Figs. 13A-C).
Rinderknecht fails to disclose determining attributions using artificial intelligence (AI) based on the determined attributes and processed sound clips, wherein the attributions represent contributions of the determined attributes to diagnostic or analytic output.
However, Jeevannavar teaches a stethoscope configured to analyze electronic sound waveforms, wherein a machine learning model determines contributions of attributes to diagnostic or analytic output (Paragraphs 0050 and 0079-0080). Jeevannavar discusses this is useful for better mapping and improved diagnosis (Paragraph 0010).
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 modified Rinderknecht to incorporate the teachings Jeevannavar for better mapping and improved diagnosis using a machine learning algorithm.
Regarding claim 18, Rinderknecht further discloses determining with the compute infrastructure resource one or more attributes in the digitized PCG data, wherein the attributes comprise extracted features of the digitized PCG data (Paragraph 0027; Paragraphs 0084-0087);
selectively performing further processing on the portions of the digitized sound corresponding to the determined attributes, including normalizing the determined attributes and scaling sub-band signals, and reconstituting each clip via summation (Paragraphs 0076 and 0094; Figs. 4B, 12, 13A-C);
indicating the position of the one or more attributes on the displayed digitized sound (Figs. 13A-C).
displaying the digitized PCG data on the display of the user interface device (Fig. 3);
indicating the position of the one or more attributes on the displayed digitized sound (Figs. 13A-C).
Rinderknecht fails to disclose determining attributions using artificial intelligence (AI) based on the determined attributes and processed sound clips, wherein the attributions represent contributions of the determined attributes to diagnostic or analytic output.
However, Jeevannavar teaches a stethoscope configured to analyze electronic sound waveforms, wherein a machine learning model determines contributions of attributes to diagnostic or analytic output (Paragraphs 0050 and 0079-0080). Jeevannavar discusses this is useful for better mapping and improved diagnosis (Paragraph 0010).
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 modified Rinderknecht to incorporate the teachings Jeevannavar for better mapping and improved diagnosis using a machine learning algorithm.
Claims 11, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Rinderknecht and Jeevannavar as applied to claims 9 and 22 above, and further in view of Yoo (US 8764655 - cited by Applicant).
Regarding claim 11, while Rinderknecht discloses a display for presenting to the user auditory or visual signaling to guide a user to the correct position (Paragraphs 0090-0093), Rinderknecht fails to disclose a homunculus on the display.
However, Yoo teaches a remote medical diagnostic device with a stethoscope wherein the display depicts images on a body to where the stethoscope sensor should be located (Fig. 4 and Col 21, lines 12-37). One of ordinary skill in the art would have been capable of applying this known method of displaying an image of a human body in Yoo to the display in Rinderknecht and the results would have been predictable to one of ordinary skill in the art.
Rinderknecht and Yoo are considered analogous to the claimed invention because they are in the same field of stethoscopes. One of ordinary skill in the art would have been capable of applying this known method of displaying an image of a human body in Yoo to the display in Rinderknecht and the results would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rinderknecht to incorporate the teachings of Yoo.
Regarding claim 23, Yoo further discloses wherein the display of the user interface device comprises a homunculus and the method further comprises displaying the instructions relative to the homunculus (Fig. 4 and Col 21, lines 12-37).
Regarding claim 24, Rinderknecht further teaches obtaining at least one of a video and image of the body of the patient (Paragraph 0091, “auditory and or visual signal(s) for a user are assigned to information streaming from a/the camera in the sensor device platform. As shown in FIG. 14A in more general terms, a hemodynamic signal is sensed”); displaying the at least one video and image on the user interface device; and presenting the commands relative to the at least one video and image (Paragraph 0091, “This signal is modified or manipulated at 702 in any of various ways possibly described above or others, then output as a user identified or identifiable signal at 704. Such signaling may be auditory (e.g., as in from resolution to an intelligible signal out of noise, as from nothing to hearing a signal, as in an accelerated beeping to achieve a “lock,” etc.) or visual (e.g., as indicated by light blinking or intensity, as gauged by a meter, etc.) as described above or otherwise”).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Rinderknecht and Jeevannavar as applied to claim 12 above, and further in view of Bates (US 20190279768 – cited by Applicant).
Regarding claim 13, while Rinderknecht discloses providing commands to the user to move the stethoscope to different parts of the body as above, Rinderknecht fails to disclose using a pose estimation model.
However, Bates teaches a system for acquisition of medical measurement data wherein a deep learning algorithm (Fig. 1, deep learning system 105; Paragraph 0021):
utilizing the at least one of the video and image of the body of the patient with a pose estimation model (Figs. 5A-B), configured to locate a position for each shoulder of the patient, wherein pose estimation is performed by the pose estimation model using feature extraction and matching algorithms to directly estimate relative position (Paragraph 0031);
defining a shoulder to shoulder line segment and a bisector line segment in the at least one video and image (Fig. 4E, white dots representing the left and right shoulder);
defining a relative coordinate system utilizing the shoulder to shoulder line segment (Paragraph 0099);
scaling predefined coordinates for auscultation sites and drawing a marker on the at least one video and image to indicate an initial position for beginning an examination (Paragraph 0082; Figs 4A-D);
tracking placement of the digital stethoscope using feature tracking limited to a region of a hand as determined form the pose estimation (Paragraph 0083, “Using a complementary object tracking deep learning algorithm, the algorithm tracks the identifiable marker (e.g. hand, stethoscope, IR LED) location and determines if the hand is holding the stethoscope has moved into the object tracking area 412”);
estimating positioning of the digital stethoscope even when the digital stethoscope is obscured by the hand, wherein the hand pose is used alone or in combination with sound-derived features to improve position determination (Paragraph 0083, “Using a complementary object tracking deep learning algorithm, the algorithm tracks the identifiable marker (e.g. hand, stethoscope, IR LED)”), optionally in combination with measured inertial motion; and
providing an augmented display guiding the user to relocate the digital stethoscope to an optimal position for auscultation, wherein the pose estimation and the estimated position of the digital stethoscope are used to enhance position determination based on sounds of interest (Paragraph 0059, wherein the camera and other sensors track reference signals relative to the body and monitor/guide placement of the instrument to a target location).
Bates discusses that using this algorithm benefits the patient in properly placing and aligning a device to a target location/position to ensure accurate and reliable readings (Paragraph 0031).
Rinderknecht and Bates are considered analogous to the claimed invention because they are in the same field of aiding placement of stethoscopes. Using a pose estimation algorithm benefits the patient in properly placing and aligning a device to a target location/position to ensure accurate and reliable readings. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rinderknecht to incorporate the teachings of Bates.
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Rinderknecht and Jeevannavar as applied to claims 8 and 20 above, and further in view of Atallah (US 20160235306).
Regarding claim 25, Rinderknecht further discloses wherein the probe may also measure temperature (Paragraph 0014). Rinderknecht fails to disclose generating a smooth surface temperature map using thermodynamic models together with site measurements obtained from multisite and multistate analysis derived from the digital stethoscope and an inferred core temperature derived from the infrared sensor, thereby enabling more accurate inference of core temperature as external body locations vary with respect to difference of each location relative to the core temperature.
However, Atallah teaches a system and method for non-invasive thermal monitoring wherein multiple temperatures are taken of a patient to generate a temperature map (Figs. 4A-B), in conjunction with a model (Paragraph 0041), to determine core temperature (Paragraphs 0039 and 0044). All the claimed elements were known in the prior art and one skilled in the art could have combined the stethoscope probe for measuring temperature of Rinderknecht with the method of determining core body temperature and generating a temperature map of Atallah by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.
Regarding claim 26, Rinderknecht further discloses wherein the probe may also measure temperature (Paragraph 0014). Rinderknecht fails to disclose generating a smooth surface temperature map using thermodynamic models together with site measurements obtained from multisite and multistate analysis derived from the digital stethoscope and an inferred core temperature derived from the infrared sensor, thereby enabling more accurate inference of core temperature as external body locations vary with respect to difference of each location relative to the core temperature.
However, Atallah teaches a system and method for non-invasive thermal monitoring wherein multiple temperatures are taken of a patient to generate a temperature map (Figs. 4A-B), in conjunction with a model (Paragraph 0041), to determine core temperature (Paragraphs 0039 and 0044). All the claimed elements were known in the prior art and one skilled in the art could have combined the stethoscope probe for measuring temperature of Rinderknecht with the method of determining core body temperature and generating a temperature map of Atallah by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.
Response to Arguments
Applicant’s arguments, see page 15, filed 12/22/2025, with respect to the drawings objections have been fully considered and are persuasive. Applicant has amended the specification and the drawings to incorporate reference numbers not previously included the specification or drawings and to fix reference numbers that referred to more than one element. The objections of the drawings has been withdrawn.
Applicant’s arguments, see page 15, filed 12/22/2025, with respect to the specification objections have been fully considered and are persuasive. Applicant has amended the specification to provide antecedent basis to claimed subject matter. The objection of the specification has been withdrawn.
Applicant’s arguments, see page 16, filed 12/22/2025, with respect to the claim objections have been fully considered and are not persuasive. Applicant has amended claim 13 per the suggestion of the Examiner; however, Applicant has not amended claim 18. The objection of claim 18 remains.
Applicant’s arguments, see page 17, filed 12/22/2025, with respect to the 35 U.S.C. §112(b) rejections have been fully considered and are persuasive. Applicant has amended the claims to clarify that only one sensor is required to meet the claim. The rejections of the claims has been withdrawn.
Applicant’s arguments, see page 17, filed 12/22/2025, with respect to the 35 U.S.C. §101 rejections have been fully considered and are persuasive. Applicant has amended the claim to explicitly recite a “non-transitory” machine-readable medium. The rejection of the claims has been withdrawn.
Applicant’s arguments, see page 17, filed 12/22/2025, with respect to the rejection(s) of claim(s) 1-24 under 35 U.S.C. §102(a)(1) and §103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rinderknecht and Kapoor above.
Applicant asserts that Rinderknecht fails to disclose the use of an inertial sensor, and that a person of ordinary skill in the art would not have any reason to modify Rinderknecht with inertial sensors because Rinderknecht does not recognize the problem of stethoscope motion. Examiner notes that Rinderknecht does disclose the use of one or more sensors within the probe (Paragraphs 0012-0013) and could be modified to incorporate other sensors. Additionally, there is no recitation of an inertial sensor “recognizing the problem” or solving a problem of stethoscope motion within the claim. Rather, the claim is directed to analyzing sound and inertial data to determine the location of the stethoscope relative to the body of the patient. Thus, the prior art combination above reads on the claim limitation.
Applicant asserts Bates fails to teach the amended claim language of claim 13 because Bates does not disclose the technical advantages of the claimed invention. Examiner disagrees per the rejection above.
The rejections above have been updated to reflect the amendments made to the claims. Claims 1-4, 6-16, and 18-26 remained rejected.
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.
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/NOAH M HEALY/Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791