DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The preliminary amendment to the claims filed 18 December 2024 has been entered. Claim(s) 2-81 has/have been canceled. New claim(s) 82-105 has/have been added. Claim(s) 1 and 82-105 and is/are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation ("BRI") using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The BRI of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked.
As explained in MPEP § 2181(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term "means" or "step" or a term used as a substitute for "means" that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term "means" or "step" or the generic placeholder is modified by functional language, typically, but not always linked by the transition word "for" (e.g., "means for") or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term "means" or "step" or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word "means" (or "step") in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word "means" (or "step") in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word "means" (or "step") are being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word "means" (or "step") are not being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word "means," but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "noise cancelling component arranged to…," "feature extractor arranged to…," "a data analysis component…," and "a machine learning component" in claims 1 and 96; and "PCG filtering components arranged to…," "a PCG amplification component arranged to…," "ambient filtering components arranged to…," and "an ambient amplification component arranged to…," in claims 82-83.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed respective functions (Fig. 13, pg. 21, line 23 – pg. 22, 1, etc., data processor programmed for the functions claimed; structure of Fig. 6, etc.), and equivalents thereof.
If Applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f), Applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f).
Claim Objections
Claim(s) 1 and 82-105 is/are objected to because of the following informalities.
With respect to claims 1, 85 and 96-97, acronyms and/or abbreviations (ECG, RA, LA, RLD) should be defined at least at their first appearance in the claims.
With respect to claims 85 and 97, the occurrences of "lefttwardly" should be corrected to "leftwardly" or merely "leftward."
With respect to claims 87 and 92, each occurrence of "the wearable device" should be amended to "the wearable garment" for consistency with prior limitations.
With respect to all the dependent claims, the preambles should be amended to begin with a definite article, e.g., with respect to claim 82, "The system as claimed in claim 1 […]."
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 pre-AIA 35 U.S.C. 112, first paragraph:
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.
Claim(s) 90, 93, 101, 103 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 90, claim 101 and claims dependent thereon, the limitation "wherein data obtained from the at least one ultrasound sensor and data derived from the at least one PPG sensor are used to detect the presence of fluid in a patient's lungs" of claim 90 and the comparable limitation of claim 101 lack sufficient support in the application as filed. While these limitations are essentially repeated in the specification as filed (e.g., pg. 6, lines 4-6), Applicant fails to sufficiently disclose how and/or an algorithm for using data derived from the at least one PPG sensor, specifically, is/may be utilized in detecting the presence of fluid in a patient's lungs.
Regarding claim 93, claim 103 and claims dependent thereon, Applicant discloses, "As illustrated in Figure 7, in this example the vest 82 also includes a data collection device 92 that synchronously receives signals from the PCG devices 10 and the ECG electrodes 86, 88, 90. Synchronously receiving data enables data processing components to map time dependency and spatial dependency" (pg. 15, lines 23-26). There appears to be no other disclosure relevant to the above-noted limitations. The above-noted disclosure fails to adequately identify of what said time and spatial dependencies may be mapped. Specifically, there is no indication that time and spatial dependencies of "synchronously extracted features" may be mapped. Further, there is no algorithm disclosed describing how said mapping may be performed. Accordingly, the limitation "wherein the system is arranged to map time and spatial dependency of synchronously extracted features" of claim 93, and the comparable limitation of claim 103 lack sufficient support in the application as filed, and encompass and/or are directed to new 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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 91, 94, 100, 102, 104 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 91, claim 102 and claims dependent thereon, the limitation "wherein signals from the at least one ultrasound sensor, the at least one PCG device, the at least one PPG sensor and/or the at least one ECG electrode are synchronously received" of claim 91 and the limitation "comprising synchronously receiving signals from at least one ultrasound device, at least one PPG sensor, the PCG devices and/or the ECG electrodes" are indefinite. The use of "and/or" encompasses any one of the claimed sensors being "synchronously received." It is unclear to what said reception is "synchronous," when the limitation refers to only signals from any one of the recited devices. The examiner notes amending "and/or" to "and" would overcome this rejection.
Regarding claim 94, claim 104 and claims dependent thereon, there is insufficient antecedent basis for "the ECG signal" in the limitation "wherein the ECG signal includes…" in the claims. Claims 94 and 104 will be further discussed with the understanding "the ECG signal" refers to the previously recited "body electrical signals."
Regarding claim 100 and claims dependent thereon, there is insufficient antecedent basis for "the PPG data" in the limitation "using the PPG data to derive physiological parameters…" in the claims. Claim 100 will be further discussed with the understanding it is dependent on claim 99, which provides sufficient antecedent basis for the above-noted term, rather than dependent on claim 96 as written.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim(s) 1, 84, 88-89, 91-93, 95-96, 99-100, 102-103 and 105 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0108440 A1 (Stevens) in view of US 2019/0000413 A1 (Adler).
Regarding claim 1, Stevens discloses/suggests a system for monitoring body generated data (e.g., Fig. 2), the system comprising:
a wearable garment (wearable sensor array; ¶ [0055]; ¶ [0081]; ¶ [0084]; etc.) comprising:
at least one phonocardiogram (PCG) sensing device (¶ [0028]; ¶¶ [0039]-[0045]; etc., vibro-acoustic sensor(s)) disposed at a location selected to optimize collection of relevant body audio signals (e.g., ¶ [0080]), the PCG sensing device including:
a body audio sensing device including a body audio sensing transducer arranged to sense animal body audio when the body audio sensing device is disposed adjacent an animal body in a body audio sensing position, wherein an acoustic path for body audio is defined between the animal body and the body audio sensing transducer when the body audio sensing device is disposed in the body audio sensing position, the body audio sensing device producing a body audio signal indicative of animal body audio (¶ [0040] vibro-acoustic transducer arrangement coupled to the skin and optimized for sensing and transducing acoustic phenomena occurring within a target living organism's or patient's body, and manifesting themselves at the skin surface; ¶ [0074] sensors provide output in the form of a time-varying signal, digitized as a sequence of amplitude values; etc.);
at least one electrocardiograph (ECG) electrode disposed at a location selected to optimize collection of relevant body electrical signals (¶ [0028]; ¶¶ [0046]-[0051] bio-electric sensors for an ECG unit);
a feature extractor arranged to synchronously extract a plurality of features from the noise processed body audio signal and the body electrical signals and to use the synchronously extracted features to produce at least one feature vector comprising a plurality of features derived from the body audio signals and the body electrical signals (¶ [0028]; ¶ [0074]; etc. sensor signals may be repeatedly sampled over a time window and the synchronized raw signal amplitude patterns from each sensor catenated into a single feature vector); and
a data analysis component arranged to use the at least one feature vector to predict at least one medical anomaly associated with the animal body, the data analysis component comprising at least one machine learning component trained to learn relationships between the feature vectors and medical anomalies (¶ [0017]; ¶ [0028]; ¶¶ [0079]-[0086]; etc., feature vector is used to query a trained machine learning module to identify likelihood of an anomaly (e.g., cardiac arrest, heart attack) and/or predict future tangential or causative diseases).
Stevens does not expressly disclose the PCG sensing device includes an ambient audio sensing device including an ambient audio sensing transducer arranged to sense ambient audio present in an environment adjacent the phonocardiogram sensing device when the body audio sensing device is disposed in the body audio sensing position and produce an ambient audio signal usable to increase the signal to noise ratio of the body audio signal; or a noise cancelling component arranged to use the ambient audio signal to remove ambient associated noise from the body audio signal and thereby produce a noise processed body audio signal having an increased signal to noise ratio. However, Stevens does disclose/suggest identifying and removing non-physiological signals captured by the vibro-acoustic sensor(s) as background ambient noise (e.g., ¶ [0077]).
Adler discloses/suggests a system for monitoring body generated data (e.g., Fig. 6), the system comprising:
a wearable garment (garment 76) comprising at least one PCG sensing device (detection-and-transmission units 90 that, aside from inclusion of sound transmitters 92, are similar/identical to sound detectors described with respect to Fig. 1) disposed at a location selected to optimize collection of relevant body audio signals (e.g., ¶ [0135]), the PCG sensing device including:
a body audio sensing device including a body audio sensing transducer arranged to sense animal body audio when the body audio sensing device is disposed adjacent an animal body in a body audio sensing position, wherein an acoustic path for body audio is defined between the animal body and the body audio sensing transducer when the body audio sensing device is disposed in the body audio sensing position, the body audio sensing device producing a body audio signal indicative of animal body audio (¶ [0101] piezoelectric microphone 38 (see Fig. 1) for detecting sound waves emanating from a body of a subject and generating a microphone output in response thereto); and
an ambient audio sensing device including an ambient audio sensing transducer arranged to sense ambient audio present in an environment adjacent the phonocardiogram sensing device when the body audio sensing device is disposed in the body audio sensing position, the ambient audio sensing device producing an ambient audio signal indicative of the ambient audio (¶ [0105] second microphone 50 (see Fig. 1) configured to detect ambient noise that does not emanate from the body of the subject and generate a noise-detection output); and
a noise cancelling component arranged to use the ambient audio signal to remove ambient associated noise from the body audio signal and thereby produce a noise processed body audio signal having an increased signal to noise ratio (e.g., ¶ [0105] processor uses the noise-detection output to guide the filtering of noise from the output received from piezoelectric microphone 38).
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 system of Stevens with the PCG sensing device(s) including an ambient audio sensing device including an ambient audio sensing transducer arranged to sense ambient audio present in an environment adjacent the phonocardiogram sensing device when the body audio sensing device is disposed in the body audio sensing position and produce an ambient audio signal usable to increase the signal to noise ratio of the body audio signal; and a noise cancelling component arranged to use the ambient audio signal to remove ambient associated noise from the body audio signal and thereby produce a noise processed body audio signal having an increased signal to noise ratio as disclosed/suggested by Adler in order to facilitate detecting and removing/filtering out non-physiological signals, i.e., background ambient noise, captured by the PCG sensor(s), or body audio sensing device(s) thereof (Adler, ¶ [0105]; Stevens, ¶ [0077]; etc.).
Regarding claim 84, Stevens as modified discloses and/or suggests the system comprises a plurality of PCG sensing devices, the plurality of PCG sensing devices comprising a front plurality of PCG devices that includes PCG devices disposed during use on opposite sides of a sternum of the animal body in alignment with a pulmonary artery, PCG devices disposed during use on opposite sides of the sternum of the animal body in alignment with a tricuspid valve, a PCG device disposed during use adjacent a mitral area on the midclavicular line, and/or a PCG device disposed during use adjacent a midaxillary area on the midaxillary line (e.g., ¶ [0080] cardiac auscultation can be simultaneously completed at all four major sites: mitral area (at the apex beat, as the left ventricle is closest to the thoracic cage), tricuspid area (inferior right sternal margin at the point closest to the valve in which auscultation is possible), the pulmonary area (left second intercostal space close to the sternum where the infundibulum is closest to the thoracic cage), and aortic area (right second intercostal space close to the sternum where the ascending aorta is nearest the thoracic cage)); and/or
a rear plurality of PCG devices that includes PCG devices disposed on opposite sides of a vertical centerline just below a scapula of the animal body, PCG devices disposed on opposite sides of the vertical centerline at a middle portion of the back of the animal body, and/or PCG devices disposed on opposite sides of the vertical centerline adjacent lower lobes of the lungs of the animal body (e.g., ¶ [0080] pulmonary auscultation is commonly completed over each of the five lobes of the lungs from both the anterior and posterior sides); and/or
at least one neck PCG device disposed at a patient's neck area to sense audio from the carotid artery (e.g., ¶ [0084] distension in carotid artery as picked up by the vibro-acoustic sensor and position sensors over the base of the neck).
Regarding claims 88-89, Stevens as modified discloses and/or suggests the system further comprises at least one photoplethysmography (PPG) sensor for monitoring changes in blood volume and blood oxygenation (¶¶ [0058]-[0059] pulse oximeter and/or optical sensor, such as a PPG sensor), wherein data from the PPG sensor(s) is used to derive physiological parameters associated with heart rate variability, blood pressure, ankle-brachial pressure, cardiovascular disease, aging, neurological disorder, lung disease and/or respiratory rate (e.g., ¶ [0059] heart rate, severity of venous reflux disease, venous function, etc.).
Regarding claim 91, Stevens as modified discloses and/or suggests the system further comprises at least one ultrasound sensor and at least one PPG sensor (¶¶ [0058]-[0059] other physiological sensors may be employed and incorporated into the sensor array, including ultrasound, pulse oximeter/PPG, etc.), wherein signals from the at least one ultrasound sensor, the at least one PCG device, the at least one PPG sensor and/or the at least one ECG electrode are synchronously received (e.g., ¶ [0028] signals from sensors of the sensor array are synchronized).
Regarding claim 92, Stevens as modified discloses and/or suggests the wearable garment includes a wireless transceiver arranged to facilitate communication of data indicative of the PCG and ECG signals from the wearable device/garment (Fig. 2, sensor array includes a communication interface for communication with, e.g., a mobile device, which records the sensed heart/acoustic and ECG data; ¶ [0022] said communication may be wireless).
Regarding claim 93, Stevens as modified discloses and/or suggests the system is arranged to map time and spatial dependency of synchronously extracted features (¶ [0028] raw data may be stored in a time-indexed log in a memory to facilitate synchronization; ¶ [0053] rendered tissue or volumes may be shown in 3D as well as displayed in time-resolved 4D animations; etc.).
Regarding claim 95, Stevens as modified discloses and/or suggests the feature vector includes: features associated with a PCG signal that are obtained using time domain properties, frequency domain properties, energy properties, entropy properties and/or kurtosis properties (e.g., ¶ [0066] derived measures; ¶ [0074] time-varying sensor signals may also be processed rather than used in raw form, e.g., the short-time Fourier transform may be used to determine the sinusoidal frequency and phase content of discrete portions of a time-varying signal within a time window; etc.).
Regarding claim 96, Stevens discloses/suggests a method of monitoring an animal body for a medical anomaly, the method comprising:
providing at least one phonocardiogram (PCG) sensing device (¶ [0028]; ¶¶ [0039]-[0045]; etc., vibro-acoustic sensor(s)) incorporated into a wearable garment (wearable sensor array; ¶ [0055]; ¶ [0081]; ¶ [0084]; etc.), each PCG sensing device including: a body audio sensing device including a body audio sensing transducer arranged to sense animal body audio when the body audio sensing device is disposed adjacent an animal body in a body audio sensing position, wherein an acoustic path for body audio is defined between the animal body and the body audio sensing transducer when the body audio sensing device is disposed in the body audio sensing position (¶ [0040] vibro-acoustic transducer arrangement coupled to the skin and optimized for sensing and transducing acoustic phenomena occurring within the body and manifesting themselves at the skin surface);
disposing each PCG sensing device at a location on the animal body selected to optimize collection of relevant body audio signals (e.g., ¶ [0080]);
using each PCG sensing device to produce body audio signals indicative of animal body audio adjacent each phonocardiogram sensing device (e.g., ¶ [0074] sensors provide output in the form of a time-varying signal, digitized as a sequence of amplitude values; etc.);
providing at least one electrocardiograph (ECG) electrode on the wearable garment at a location selected to optimize collection of relevant body electrical signals (¶ [0028]; ¶¶ [0046]-[0051] bio-electric sensors for an ECG unit);
synchronously extracting a plurality of features from the noise processed body audio signals and the body electrical signals and using the synchronously extracted features to produce at least one feature vector comprising a plurality of features derived from the body audio signals and the body electrical signals (¶ [0028]; ¶ [0074]; etc. sensor signals may be repeatedly sampled over a time window and the synchronized raw signal amplitude patterns from each sensor catenated into a single feature vector); and
using at least one machine learning component to predict at least one medical anomaly associated with the animal body the data analysis component using the at least one feature vector, the at least one machine learning component trained to learn relationships between the feature vector and medical anomalies (¶ [0017]; ¶ [0028]; ¶¶ [0079]-[0086]; etc., feature vector is used to query a trained machine learning module to identify likelihood of an anomaly (e.g., cardiac arrest, heart attack) and/or predict future tangential or causative diseases).
Stevens does not expressly disclose each PCG sensing device includes an ambient audio sensing device including an ambient audio sensing transducer arranged to sense ambient audio present in an environment adjacent the phonocardiogram sensing device when the body audio sensing device is disposed in the body audio sensing position, or the method comprises using each PCG sensing device to produce ambient audio signals indicative of the ambient audio present in the environment adjacent each PCG sensing device; and using the ambient audio signals to remove ambient associated noise from the body audio signals and thereby produce noise processed body audio signals having an increased signal to noise ratio.
Adler discloses/suggests a method comprising providing at least one PCG sensing device (detection-and-transmission units 90) incorporated into a wearable garment (garment 76), each PCG sensing device including a body audio sensing device including a body audio sensing transducer arranged to sense animal body audio when the body audio sensing device is disposed adjacent an animal body in a body audio sensing position, wherein an acoustic path for body audio is defined between the animal body and the body audio sensing transducer when the body audio sensing device is disposed in the body audio sensing position (¶ [0101] piezoelectric microphone 38 (see Fig. 1) for detecting sound waves emanating from a body of a subject); and an ambient audio sensing device including an ambient audio sensing transducer arranged to sense ambient audio present in an environment adjacent the phonocardiogram sensing device when the body audio sensing device is disposed in the body audio sensing position (¶ [0105] second microphone 50 (see Fig. 1) configured to detect ambient noise that does not emanate from the body of the subject);
using each phonocardiogram sensing device to produce body audio signals indicative of animal body audio (e.g., output generated by microphone 38) and ambient audio signals indicative of the ambient audio present in the environment adjacent each phonocardiogram sensing device (e.g., output generated by microphone 50, noise-detection output, etc.); and
using the ambient audio signals to remove ambient associated noise from the body audio signals and thereby produce noise processed body audio signals having an increased signal to noise ratio (e.g., ¶ [0105] processor uses the noise-detection output to guide the filtering of noise from the output received from piezoelectric microphone 38).
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 method of Stevens with each PCG sensing device including an ambient audio sensing device including an ambient audio sensing transducer arranged to sense ambient audio present in an environment adjacent the phonocardiogram sensing device when the body audio sensing device is disposed in the body audio sensing position, and the method including using each PCG sensing device to produce ambient audio signals indicative of the ambient audio present in the environment adjacent each PCG sensing device; and using the ambient audio signals to remove ambient associated noise from the body audio signals and thereby produce noise processed body audio signals having an increased signal to noise ratio as disclosed/suggested by Adler in order to facilitate detecting and removing/filtering out non-physiological signals, i.e., background ambient noise, captured by the PCG sensor(s), or body audio sensing device(s) thereof (Adler, ¶ [0105]; Stevens, ¶ [0077]; etc.).
Regarding claims 99-100, Stevens as modified discloses and/or suggests the method further comprises using at least one photoplethysmography (PPG) sensor to obtain PPG data for monitoring changes in blood volume and blood oxygenation (¶¶ [0058]-[0059] pulse oximeter and/or optical sensor, such as a PPG sensor); and using the PPG data to derive physiological parameters associated with heart rate variability, blood pressure, ankle-brachial pressure, cardiovascular disease, aging, neurological disorder, lung disease and/or respiratory rate (e.g., ¶ [0059] heart rate, severity of venous reflux disease, venous function, etc.).
Regarding claim 102, Stevens as modified discloses and/or suggests the method further comprises synchronously receiving signals from at least one ultrasound device, at least one PPG sensor, the PCG devices and/or the ECG electrodes (¶ [0028] signals from sensors of the sensor array are synchronized; ¶¶ [0058]-[0059] other physiological sensors may be employed and incorporated into the sensor array, including ultrasound, pulse oximeter/PPG, etc.).
Regarding claim 103, Stevens as modified discloses and/or suggests the method comprises mapping time and spatial dependency of at least some synchronously extracted features (¶ [0028] raw data may be stored in a time-indexed log in a memory to facilitate synchronization; ¶ [0053] rendered tissue or volumes may be shown in 3D as well as displayed in time-resolved 4D animations; etc.).
Regarding claim 105, Stevens as modified discloses and/or suggests the feature vector includes: features associated with a PCG signal that are obtained using time domain properties, frequency domain properties, energy properties, entropy properties and/or kurtosis properties (e.g., ¶ [0066] derived measures; ¶ [0074] time-varying sensor signals may also be processed rather than used in raw form, e.g., the short-time Fourier transform may be used to determine the sinusoidal frequency and phase content of discrete portions of a time-varying signal within a time window; etc.).
Claim(s) 82-83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Adler as applied to claim(s) 1 above, and further in view of US 5,492,129 A (Greenberger).
Regarding claims 82-83, Stevens as modified discloses/suggests the limitations of claim 1, as discussed above, but does not expressly disclose the body audio sensing device includes PCG filtering components arranged to filter body audio signals produced by the body audio sensing transducer; and/or a PCG amplification component arranged to amplify body audio signals produced by the body audio sensing transducer; or the ambient audio sensing device includes ambient filtering components arranged to filter ambient audio signals produced by the ambient audio sensing transducer; and/or an ambient amplification component arranged to amplify ambient audio signals produced by the ambient audio sensing transducer. Specifically, Adler (or Stevens as modified thereby) does not expressly disclose how the output of the ambient audio sensing device is used to filter noise from the output of the body audio sensing device to produce the noise processed body audio signal.
Greenberger discloses/suggests at least one sensing device (chest piece 12a, 80a), the sensing device including: a body audio sensing device including a body audio sensing transducer arranged to sense animal body audio when the body audio sensing device is disposed adjacent an animal body in a body audio sensing position and produce a body audio signal indicative of animal body audio, wherein an acoustic path for body audio is defined between the animal body and the body audio sensing transducer when the body audio sensing device is disposed in the body audio sensing position (internal microphone 24a, 24b, 82a, 82b); and an ambient audio sensing device including an ambient audio sensing transducer arranged to sense ambient audio present in an environment adjacent the sensing device when the body audio sensing device is disposed in the body audio sensing position and produce an ambient audio signal indicative of the ambient audio (external microphone 26a, 26b, 84a, 84b); and a noise cancelling component arranged to use the ambient audio signal to remove ambient associated noise from the body audio signal and thereby produce a noise processed body audio signal having an increased signal to noise ratio (Figs. 2A, 3A, etc. cancellation filter),
wherein the body audio sensing device includes body audio filtering components arranged to filter body audio signals produced by the body audio sensing transducer (Fig. 3A, anti-alias filter 152, 162); and/or a body audio amplification component arranged to amplify body audio signals produced by the body audio sensing transducer (Fig. 2A, 3A, amplifier 40, 40a, 83, 83a), and
wherein the ambient audio sensing device includes ambient filtering components arranged to filter ambient audio signals produced by the ambient audio sensing transducer (Fig. 2A, filter 44, 86; Fig. 3A, anti-alias filter 153, 163 and/or adaptive FIR filter 156, 166); and/or an ambient amplification component arranged to amplify ambient audio signals produced by the ambient audio sensing transducer (Figs. 2A, 3A, amplifier 42, 42a, 85, 85a).
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 system of Stevens with the body audio sensing device including PCG/body audio filtering components arranged to filter body audio signals produced by the body audio sensing transducer; and/or a PCG/body audio amplification component arranged to amplify body audio signals produced by the body audio sensing transducer; and the ambient audio sensing device including ambient filtering components arranged to filter ambient audio signals produced by the ambient audio sensing transducer; and/or an ambient amplification component arranged to amplify ambient audio signals produced by the ambient audio sensing transducer as disclosed and/or suggested by Greenberger in order to facilitate closely matching the ambient audio signal to the noise component contained in the body audio signal for subtraction thereof (Greenberger, col. 4, lines 23-58).
Claim(s) 85 and 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Adler as applied to claim(s) 1 and 96 above, and further in view of US 2018/0168458 A1 (Pekander).
Regarding claims 85 and 97, Stevens as modified discloses/suggests the limitations of claims 1 and 96, as discussed above, but does not disclose the ECG electrode(s) comprises: a right arm/atria (RA) ECG electrode disposed rightward of an atria of the animal body; a left arm/atria (LA) ECG electrode disposed leftward of the atria; a right leg drive (RLD) ECG electrode disposed vertically in alignment with the RA ECG electrode at a location below the heart of the animal body; and the wearable garment includes a RLD amplifier that uses signals obtained from the RA and LA electrodes to drive a feedback electrical signal into the animal body at the RLD electrode, the feedback signal serving to improve the common mode rejection by counteracting a common mode signal that would otherwise be present in the RA and LA electrodes.
Pekander discloses/suggests a system comprising an RA ECG electrode disposed rightward of an atria of the animal body (Fig. 1, capacitive electrode 3 in the right arm position RA); an LA ECG electrode disposed leftward of the atria (Fig. 1, capacitive electrode 3 in the left arm position LA); an RLD ECG electrode disposed vertically in alignment with the RA ECG electrode at a location below the heart of the animal body (Fig. 1, galvanic electrode 4 in the right leg position RL); and an RLD amplifier (Fig. 1, inverting amplifier 124) that uses signals obtained from the RA and LA electrodes to drive a feedback electrical signal into the animal body at the RLD electrode, the feedback signal serving to improve the common mode rejection by counteracting a common mode signal that would otherwise be present in the RA and LA electrodes (¶ [0028]).
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 system/method of Stevens with the wearable garment (e.g., ECG unit thereof) including an RA ECG electrode disposed rightward of an atria of the animal body; an LA ECG electrode disposed leftward of the atria; an RLD ECG electrode disposed vertically in alignment with the RA ECG electrode at a location below the heart of the animal body; and an RLD amplifier that uses signals obtained from the RA and LA electrodes to drive a feedback electrical signal into the animal body at the RLD electrode, the feedback signal serving to improve the common mode rejection by counteracting a common mode signal that would otherwise be present in the RA and LA electrodes as disclosed and/or suggested by Pekander in order to facilitate rejecting common mode noise (Pekander, ¶ [0028]), extracting small electro-physiological signals from the much larger noise signals (Stevens, ¶ [0048]), etc.
Claim(s) 86-87, 90, 98 and 101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Adler as applied to claim(s) 1 and 96 above, and further in view of US 2019/0046158 A1 (Kroon).
Regarding claims 86-87 and 98, Stevens as modified discloses/suggests the limitations of claims 1 and 96, as discussed above, and further discloses the system comprises at least one ultrasound sensor (e.g., ¶ [0058]). Stevens as modified further discloses/suggests said ultrasound sensor(s) may be disposed on the wearable device/garment (e.g., ¶ [0058] additional sensors, such as an ultrasound sensor for internal organ scan, may be incorporated into the sensor array, which may be disposed in a wearable garment, e.g., ¶ [0055], ¶ [0084], etc.). Stevens as modified neither expressly discloses the ultrasound sensor(s) obtains respiratory and heart cycle data, nor expressly discloses the ultrasound sensor(s) is disposed on the wearable device such that during use the at least one ultrasound sensor is disposed adjacent a patient's heart or thorax.
Kroon discloses/suggests a system comprising at least one ultrasound sensor (ultrasound transducers 16) for obtaining respiratory and heart cycle data (¶ [0037], ¶ [0074], ¶ [0080], etc.) disposed on a wearable device (Fig. 1, transducer unit 14), such that during use the at least one ultrasound sensor is disposed adjacent a patient's heart or thorax (Fig. 1, ¶ [0073], etc.).
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 system of Stevens with an ultrasound sensor(s) for obtaining respiratory and heart cycle data, wherein the ultrasound sensor(s) is disposed on the wearable device such that during use the at least one ultrasound sensor is disposed adjacent a patient's heart or thorax, as disclosed/suggested by Kroon in order to a more comprehensive assessment of cardio-pulmonary state by considering additional data indicative thereof.
Regarding claims 90 and 101, Stevens as modified discloses/suggests the limitations of claims 88 and 100, as discussed above, and further discloses the system may further comprise at least one ultrasound sensor (e.g., ¶ [0058]), wherein the system is used to detect the presence of fluid in a patient's lung (e.g., ¶ [0080] detecting different states of disease in the lungs, such as fluid collecting in the base of the lungs that sounds like crackling as the alveolar sacks expand). Stevens as modified does not disclose data obtained from the at least one ultrasound sensor is used in detecting the presence of fluid in the patient's lungs.
Kroon discloses/suggests a system comprising at least one ultrasound sensor (ultrasound transducers 16 of transducer unit 14, Fig. 1), wherein data obtained from the at least one ultrasound sensor is used to detect the presence of fluid in a patient's lungs (e.g., ¶ [0075]).
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 system/method of Stevens with data obtained from the at least one ultrasound sensor being used to detect the presence of fluid in a patient's lungs (e.g., in combination with vibro-acoustic/PCG sensor data, as described in Stevens, ¶ [0080]) as disclosed and/or suggested by Kroon in order to enable a more comprehensive assessment of lung fluid status by considering additional data indicative thereof.
While Stevens as modified discloses/suggests the system comprises a PPG sensor to obtain PPG data, as noted above, Stevens as modified does not disclose PPG data is used to detect the presence of fluid in the patient's lungs. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system/method of Stevens with the PPG data being used to detect the presence of lung fluid because Applicant has not disclosed that using PPG data for this purpose provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, as noted with respect to rejections under 35 U.S.C. 112(a) above, Applicant fails to adequately disclose how/in what manner PPG data is even usable in such a determination. As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with detecting the presence of fluid in a patient's lung based on PCG (vibro-acoustic) data and ultrasound data as disclosed/suggested by Stevens as modified above because either arrangement presumably utilizes a multi-modal, and therefore more comprehensive (e.g., more accurate, reliable, etc.), technique to detect lung fluid.
Claim(s) 94 and 104 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Adler as applied to claim(s) 1 and 100 above, and further in view of US 2016/0183835 A1 (Varadan).
Regarding claims 94 and 104, Stevens as modified discloses/suggests the limitations of claims 1 and 100, as discussed above, and further discloses/suggests the ECG signal includes R peaks, P peaks, Q points, S-points and T-peaks of the ECG signal (e.g., ¶ [0083]), but does not expressly disclose the feature vector includes features derived using a time interval between R peaks, a difference between successive R peak time intervals, and/or a time between P and R peaks. However, Stevens does disclose features may include time relations between various ECG waves or peaks (e.g., ¶ [0083]), and more generally discloses/suggests features may include measures derived from acquired signals (¶ [0066]).
Varadan discloses/suggests a system comprising wearable garment including at least one ECG electrode disposed at a location selected to optimize collection of relevant body electrical signals, i.e., an ECG signal, wherein the ECG signal includes R peaks, P peaks, Q points, S-points and T-peaks (Fig. 9b); wherein the system is configured to extract ECG features including a difference between successive R peak time intervals, and/or a time between P and R peaks (e.g., ¶ [0068], ¶ [0070], etc. diagnostically relevant quantities obtained from the ECG include PR interval, RR interval, etc.) for use in assessing a medical condition(s) (e.g., ¶ [0079]).
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 system/method of Stevens with the feature vector including features derived using a time interval between R peaks, a difference between successive R peak time intervals, and/or a time between P and R peaks as disclosed/suggested by Varadan in order to provide diagnostically relevant input (e.g., derived measures) usable by model to predict medical anomalies (Varadan, ¶ [0079]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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