DETAILED ACTION
Applicant’s arguments, filed on 10/06/2025, 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.
Applicants have amended their claims, filed on 10/6/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-20 are the current claims 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 as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference character “902c” in Figure 11 does not appear in the specification;
Reference character “1410” in Figure 14A does not appear in the specification;
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Claim Objections
Claims 19-20 are objected to because of the following informalities:
In claim 19, line 11, “for the the disease state” should read “for the disease state”
In claim 20, line 9, “for the the disease state” should read “for the disease state”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is 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 claim 7, the claim recites the limitation “a photoplethysmographic signal” in line 4. IT is unclear if this is referring to “the one or more photoplethysmographic signals” introduced in claim 1, or another signal. If it is meant to refer to the signals from claim 1, it should read “the one or more photoplethysmographic signals”. If it is meant to refer to another signal, it should be distinguished from the photoplethysmographic signals from claim 1. For purposes of examination, it is being interpreted as referring to the photoplethysmographic signals introduced in claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shadforth (WO 2020136569) in further view of Chazal (“An introduction to Topological Data Analysis: fundamental and practical aspects for data scientists”).
Regarding independent claim 1, Shadforth teaches a method to non-invasively assess a disease state or an abnormal condition ([0006]: “The exemplified methods and systems employs non-invasively acquired biophysical measurements of a subject in a residue analysis that generates a point cloud data set that is then structured as a three-dimensional volumetric object to which machine extractable features associated with a geometric associated aspect of the three-dimensional volumetric object may be derived and used for in the training and/or classification of a disease state.”), the method comprising:
obtaining, by one or more processors ([0024]: “the method including obtaining, by one or more processors”), a biophysical signal data set of the subject ([0024]: “a plurality of biophysical signal data sets of a subject”), the biophysical signal data set comprising one or more photoplethysmographic signals ([0011]: “Not intending to be limited by example, one may classify biophysical signals into types or categories that can include, for example, … photoplethysmography”);
determining, by the one or more processors, values of one or more waveform associated properties of the one or more photoplethysmographic signals ([0068]: “The system 100a generates a three-dimensional representation (or equivalent two- dimensional representation) of the residue model within a set of acquired biophysical signals collected by a measurement system 102 (also referred to as “phase space recorder” or “PSR” device). The term generally refers to a methodology that directly represent a physiological system, or sub-system of interest, as a multidimensional space in which each of the axes corresponds to one of the variables required to represent the state of the system. Residue model of other biophysical signal types (e.g., waveforms of photoplethysmographic signals) as discussed herein may be generated”); and
determining, by the one or more processors, an estimated value for a presence of the disease state or the abnormal condition, based, in part, on the determined values of the one or more waveform associated properties ([0007]: “the analysis is used to facilitate the isolation or estimation of behaviors of the subject’s physiological system as a dynamical system for the evaluation and/or prediction of presence of a disease state.”), wherein the estimated value for the disease state or the abnormal condition is used in a model to non-invasively estimate the presence of the expected disease state or the abnormal condition ([0067]: “Fig. 1 is a diagram of an exemplary system 100 (shown as 100a) configured to generate a residue model to assess (e.g., non-invasively assess) a physiological system to predict and/or estimate presence or non-presence of disease in such physiological system”),
wherein the estimated value is subsequently outputted for use in a diagnosis of the expected disease state or the condition ([0065]: “while the present disclosure is directed to the beneficial assessment of biophysical signals in the diagnosis and treatment of cardiac -related pathologies and conditions and/or neurological-related pathologies and conditions, such assessment can be applied to the diagnosis and treatment (including, surgical, minimally invasive, and/or pharmacologic treatment) of any pathologies or conditions in which a biophysical signal is involved in any relevant system of a living body.”), and further wherein the one or more waveform associated properties comprise topological values of the one or more photoplethysmographic signals ([0151]: “the more restricted the possible available states observed in the chaotic behavior of the physiological system, the more likely the subject has an underlying disease or condition (associated with damaged tissue) that is responsible for the restriction, supporting a correlation to the geometric and topographic features observed in the phase space analysis data sets / images as disclosed herein”).
However, Shadforth does not teach the topological values being of a polygon defined among fiduciary points of the one or more photoplethysmographic signals.
Chazal discloses information on topological data analysis. Specifically, Chazal teaches determining important topological values from a polygon defined among fiduciary points (Page 2: “Topological or geometric information is extracted from the structures built on top of the data. This may either results in a full reconstruction, typically a triangulation, of the shape underlying the data from which topological/geometric features can be easily extracted or, in crude summaries or approximations from which the extraction of relevant information requires specific methods, such as e.g. persistent homology.”). Shadforth and Chazal are analogous arts as they are both related to analyzing data to determine topological information.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the polygon from Chazal into the method from Shadforth as Shadforth is silent on how it determines the topological values, and Chazal discloses suitable analysis steps to determine topological values in an analogous art.
Regarding claim 11, the Shadforth/Chazal combination teaches the method of claim 1 further comprising: causing, by the one or more processors, generation of a visualization of the estimated value for the presence of the disease state, abnormal condition, or the indication of either (Shadforth, [0031]: “the method includes causing, by the one or more processors, generation of a visualization of generated volumetric object as a three- dimensional object, wherein the three-dimensional object is rendered and displayed at a display of a computing device and/or presented in a report.”; [0006]: “The exemplified methods and systems employs non-invasively acquired biophysical measurements of a subject in a residue analysis that generates a point cloud data set that is then structured as a three-dimensional volumetric object to which machine extractable features associated with a geometric associated aspect of the three-dimensional volumetric object may be derived and used for in the training and/or classification of a disease state.”), wherein the generated visualization is rendered and displayed at a display of a computing device and/or presented in a report (Shadforth, [0031]: “the method includes causing, by the one or more processors, generation of a visualization of generated volumetric object as a three- dimensional object, wherein the three-dimensional object is rendered and displayed at a display of a computing device and/or presented in a report.”; [0006]: “The exemplified methods and systems employs non-invasively acquired biophysical measurements of a subject in a residue analysis that generates a point cloud data set that is then structured as a three-dimensional volumetric object to which machine extractable features associated with a geometric associated aspect of the three-dimensional volumetric object may be derived and used for in the training and/or classification of a disease state.”).
Regarding claim 12, the Shadforth/Chazal combination teaches the method of claim 1, wherein the values of one or more waveform associated properties are used in the model selected from the group consisting of a linear model, a decision tree model, a random forest model, a support vector machine model, and a neural network model (Shadforth, [0125]: “the mathematical reconstruction is based on … linear models optimized using cyclical coordinate descent”; [0136]: “the parametric features are derived from the volumetric object generated from the residue point cloud model/data set and are assessed by a trained neural network classifier configured to assess for presence or non presence of a disease state or other condition”).
Regarding claim 13, the Shadforth/Chazal combination teaches the method of claim 12, wherein the model further includes features selected from the group consisting of: one or more depolarization or repolarization wave propagation associated features; one or more depolarization wave propagation deviation associated features; one or more cycle variability associated features; one or more dynamical system associated features; one or more cardiac waveform topologic and variations associated features; one or more PPG waveform topologic and variations associated features; one or more cardiac or PPG signal power spectral density associated features; one or more cardiac or PPG signal visual associated features; and one or more predictability features (Shadforth, [0098]: “six simultaneously sampled signals are captured from a resting subject as a raw differential channel signal data set (e.g., comprising channels that may be called“ORTHl”,“ORTH2”, and“ORTH3”) in which the signals embed the inter lead timing and phase information of the acquired signals specific to the subject. Geometrical contrast arising from the interference in the phase plane of the depolarization wave with the other orthogonal leads can be used to facilitate superimposition of phase space information on a three-dimensional representation of, in one example, the heart”; [0007]: “the analysis is used to facilitate the isolation or estimation of behaviors of the subject’s physiological system as a dynamical system for the evaluation and/or prediction of presence of a disease state.”; [0012]: “By way of example only, two biophysical signal types that may be useful in the cardiovascular context include cardiac signals that may be acquired via conventional electrocardiogram (ECG/EKG) equipment, bipolar wide-band biopotential (cardiac) signals that may be acquired from other equipment such as those described herein, and signals that may be acquired by various plethysmographic techniques, such as, e.g., photoplethysmography.”; [0011]: “one may classify biophysical signals into types or categories that can include, for example, … visual observation”; [0002]: “the present disclosure relates to non-invasive methods that utilize acquired biophysical signal (e.g., a cardiac signal, a brain/neurological signal, signals associated with other biological systems, etc.) and using that biophysical signal in the prediction and localization of cardiac and/or non-cardiac disease and pathologies.”).
Regarding claim 14, the Shadforth/Chazal combination teaches the method of claim 1, wherein the disease state or abnormal condition is selected from the group consisting of coronary artery disease, pulmonary hypertension, pulmonary arterial hypertension, pulmonary hypertension due to left heart disease, rare disorders that lead to pulmonary hypertension, left ventricular heart failure or left-sided heart failure, right ventricular heart failure or right-sided heart failure, systolic heart failure, diastolic heart failure, ischemic heart disease, and arrhythmia (Shadforth, [0013]: “techniques for acquiring and analyzing biophysical signals are described in particular for use in diagnosing the presence, non presence, localization (where applicable), and/or severity of certain disease states or conditions in, associated with, or affecting, the cardiovascular (or cardiac) system, including for example pulmonary hypertension (PH), coronary artery disease (CAD), and heart failure (e.g., left-side or right-side heart failure)).
Regarding claim 15, the Shadforth/Chazal combination teaches the method of claim 1 further comprising: acquiring, by one or more acquisition circuits of a measurement system, voltage gradient signals over the one or more channels (Shadforth, [0159]: “Referring still to Figs. 2B-2G, 3B-3G, 4B-4G, and 5B-5G, the red color regions of the presented coloring indicate rapidly changing amplitude, e.g., of the voltage gradient, at these points, and the blue color regions indicate relatively stable amplitudes.”; [0069]: “The biophysical signal data set 108 includes a plurality of acquired signals (e.g., acquired from three distinct channels)”), wherein the voltage gradient signals are acquired at a frequency greater than about 1 kHz (Shadforth, [0032]: “each of the acquired biophysical signal data sets comprises a wide-band phase gradient biopotential signal data set that is simultaneously acquired at a sampling rate selected from the group consisting of about 1 kHz, about 2 kHz, about 3 kHz, about 4 kHz, about 5 kHz, about 6 kHz, about 7 kHz, about 8 kHz, about 9 kHz, about 10 kHz, and greater than 10kHz.”); and generating, by the one or more acquisition circuits, the obtained biophysical signal data set from the acquired voltage gradient signals (Shadforth, [0011]: “Passive and active biophysical signal acquisition generally refers to the observation of natural or induced electrical, magnetic, optical, and/or acoustics emittance of the body tissue. Non-limiting examples of passive and active biophysical signal acquisition means include, e.g., voltage/potential, current, magnetic, optical, acoustic and other non-active ways of observing the natural emittance of the body tissue, and in some instances, inducing such emittance”; [0095]: “The measurement system 102, in some embodiments, is configured to acquire biophysical signals that may be based on the body’s biopotential via biopotential sensing circuitries as biopotential biophysical signals”).
Regarding claim 16, the Shadforth/Chazal combination teaches the method of claim 1 further comprising: acquiring, by one or more acquisition circuits of a measurement system, the one or more photoplethysmographic signals (Shadforth, [0095]: “The measurement system 102, in some embodiments, is configured to acquire biophysical signals that may be based on the body’s biopotential via biopotential sensing circuitries as biopotential biophysical signals … other signal types are acquired in combination with the biopotential biophysical signals, e.g., waveforms of photoplethysmographic signals”); and generating, by the one or more acquisition circuits, the obtained biophysical data set from the acquired one or more photoplethysmographic signals (Shadforth, [0159]: “Referring still to Figs. 2B-2G, 3B-3G, 4B-4G, and 5B-5G, the red color regions of the presented coloring indicate rapidly changing amplitude, e.g., of the voltage gradient, at these points, and the blue color regions indicate relatively stable amplitudes.”; [0069]: “The biophysical signal data set 108 includes a plurality of acquired signals (e.g., acquired from three distinct channels)”).
Regarding claim 17, the Shadforth/Chazal combination teaches the method of claim 1, wherein the one or more processors are located in a cloud platform (Shadforth, [0024]: “the method including obtaining, by one or more processors, a plurality of biophysical signal data sets of a subject; generating, by the one or more processors, a residue model comprising a point-cloud residue data set generated from an analysis of the plurality of biophysical signal data sets”).
Regarding claim 18, the Shadforth/Chazal combination teaches the method of claim 1, wherein the one or more processors are located in a local computing device (Shadforth, [0082]: “the three-dimensional volumetric object generated from a residue analysis, and parameters derived therefrom, may be interpreted manually or used as part of a machine learned classifier or predictor module that may be configured to assist in the determination of the presence or absence of disease or condition. Such a module may be local or remote to the assessment system 110”; [0178]: “program modules and other data may be located in both local and remote computer storage media including memory storage devices.”).
Regarding independent claim 19, Shadforth teaches a system (Abstract, “The exemplified methods and systems employs non-invasively acquired biophysical measurements of a subject in a residue analysis that is structured as a three-dimensional volumetric object to which machine extractable features associated with a geometric associated aspect of the three-dimensional volumetric object may be derived and used for in the training and/or prediction of a disease state.”) comprising:
a processor ([0024]: “the method including obtaining, by one or more processors”); and
a memory having instructions stored thereon, wherein execution of the instructions by the processor causes the processor to ([0037]: “a system is disclosed comprising a processor and a memory having instructions thereon, wherein the instructions when executed by the processor, cause the processor to perform any of the above method.”):
obtain a biophysical signal data set of a subject ([0024]: “a plurality of biophysical signal data sets of a subject”), a biophysical signal data set comprising one or more photoplethysmographic signals ([0011]: “Not intending to be limited by example, one may classify biophysical signals into types or categories that can include, for example, … photoplethysmography”;
determine values of one or more waveform associated properties of the one or more photoplethysmographic signals ([0068]: “The system 100a generates a three-dimensional representation (or equivalent two- dimensional representation) of the residue model within a set of acquired biophysical signals collected by a measurement system 102 (also referred to as “phase space recorder” or “PSR” device). The term generally refers to a methodology that directly represent a physiological system, or sub-system of interest, as a multidimensional space in which each of the axes corresponds to one of the variables required to represent the state of the system. Residue model of other biophysical signal types (e.g., waveforms of photoplethysmographic signals) as discussed herein may be generated”); and
determine an estimated value for a presence of a disease state or an abnormal condition based, in part, on the determined values of the one or more waveform associated properties ([0007]: “the analysis is used to facilitate the isolation or estimation of behaviors of the subject’s physiological system as a dynamical system for the evaluation and/or prediction of presence of a disease state.”), wherein the estimated value for the disease state or the abnormal condition is used in a model to non-invasively estimate a presence of the disease state or the abnormal condition ([0067]: “Fig. 1 is a diagram of an exemplary system 100 (shown as 100a) configured to generate a residue model to assess (e.g., non-invasively assess) a physiological system to predict and/or estimate presence or non-presence of disease in such physiological system”),
wherein the estimated value is subsequently outputted for use in a diagnosis of the disease state or the condition ([0065]: “while the present disclosure is directed to the beneficial assessment of biophysical signals in the diagnosis and treatment of cardiac -related pathologies and conditions and/or neurological-related pathologies and conditions, such assessment can be applied to the diagnosis and treatment (including, surgical, minimally invasive, and/or pharmacologic treatment) of any pathologies or conditions in which a biophysical signal is involved in any relevant system of a living body.”), and further wherein the one or more waveform associated properties comprise topological values of the one or more photoplethysmographic signals ([0151]: “the more restricted the possible available states observed in the chaotic behavior of the physiological system, the more likely the subject has an underlying disease or condition (associated with damaged tissue) that is responsible for the restriction, supporting a correlation to the geometric and topographic features observed in the phase space analysis data sets / images as disclosed herein”).
However, Shadforth does not teach the topological values being of a polygon defined among fiduciary points of the one or more photoplethysmographic signals.
Chazal discloses information on topological data analysis. Specifically, Chazal teaches determining important topological values from a polygon defined among fiduciary points (Page 2: “Topological or geometric information is extracted from the structures built on top of the data. This may either results in a full reconstruction, typically a triangulation, of the shape underlying the data from which topological/geometric features can be easily extracted or, in crude summaries or approximations from which the extraction of relevant information requires specific methods, such as e.g. persistent homology.”). Shadforth and Chazal are analogous arts as they are both related to analyzing data to determine topological information.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the polygon from Chazal into the system from Shadforth as Shadforth is silent on how it determines the topological values, and Chazal discloses suitable analysis steps to determine topological values in an analogous art.
Regarding independent claim 20, Shadforth teaches a non-transitory computer-readable medium having instructions stored thereon, wherein execution of the instructions by a processor causes the processor to ([0038]: “a non-transitory computer readable medium is disclosed having instructions stored thereon, wherein execution of the instructions, cause the processor to perform any of the above method.”):
obtain a biophysical signal data set of a subject ([0024]: “a plurality of biophysical signal data sets of a subject”), a biophysical signal data set comprising one or more photoplethysmographic signals ([0011]: “Not intending to be limited by example, one may classify biophysical signals into types or categories that can include, for example, … photoplethysmography”);
determine values of one or more waveform associated properties of the one or more photoplethysmographic signals ([0068]: “The system 100a generates a three-dimensional representation (or equivalent two- dimensional representation) of the residue model within a set of acquired biophysical signals collected by a measurement system 102 (also referred to as “phase space recorder” or “PSR” device). The term generally refers to a methodology that directly represent a physiological system, or sub-system of interest, as a multidimensional space in which each of the axes corresponds to one of the variables required to represent the state of the system. Residue model of other biophysical signal types (e.g., waveforms of photoplethysmographic signals) as discussed herein may be generated”); and
determine an estimated value for a presence of a disease state or an abnormal condition based, in part, on the determined values of the one or more waveform associated properties ([0007]: “the analysis is used to facilitate the isolation or estimation of behaviors of the subject’s physiological system as a dynamical system for the evaluation and/or prediction of presence of a disease state.”), wherein the estimated value for the disease state or the abnormal condition is used in a model to non-invasively estimate a presence of the disease state or the abnormal condition ([0067]: “Fig. 1 is a diagram of an exemplary system 100 (shown as 100a) configured to generate a residue model to assess (e.g., non-invasively assess) a physiological system to predict and/or estimate presence or non-presence of disease in such physiological system”),
wherein the estimated value is subsequently outputted for use in a diagnosis of the disease state or the condition ([0065]: “while the present disclosure is directed to the beneficial assessment of biophysical signals in the diagnosis and treatment of cardiac -related pathologies and conditions and/or neurological-related pathologies and conditions, such assessment can be applied to the diagnosis and treatment (including, surgical, minimally invasive, and/or pharmacologic treatment) of any pathologies or conditions in which a biophysical signal is involved in any relevant system of a living body.”), and further wherein the one or more waveform associated properties comprise topological values of the one or more photoplethysmographic signals ([0151]: “the more restricted the possible available states observed in the chaotic behavior of the physiological system, the more likely the subject has an underlying disease or condition (associated with damaged tissue) that is responsible for the restriction, supporting a correlation to the geometric and topographic features observed in the phase space analysis data sets / images as disclosed herein”).
However, Shadforth does not teach the topological values being of a polygon defined among fiduciary points of the one or more photoplethysmographic signals.
Chazal discloses information on topological data analysis. Specifically, Chazal teaches determining important topological values from a polygon defined among fiduciary points (Page 2: “Topological or geometric information is extracted from the structures built on top of the data. This may either results in a full reconstruction, typically a triangulation, of the shape underlying the data from which topological/geometric features can be easily extracted or, in crude summaries or approximations from which the extraction of relevant information requires specific methods, such as e.g. persistent homology.”). Shadforth and Chazal are analogous arts as they are both related to analyzing data to determine topological information.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the polygon from Chazal into the system from Shadforth as Shadforth is silent on how it determines the topological values, and Chazal discloses suitable analysis steps to determine topological values in an analogous art.
Claims 2-9 are rejected under 35 U.S.C. 103 as being unpatentable over the Shadforth/Chazal combination as applied to claim 1 above, and further in view of Tzvieli (US 20200085311).
Regarding claim 2, the Shadforth/Chazal combination teaches the method of claim 1.
However, the Shadforth/Chazal combination does not teach wherein the step of determining the values of one or more waveform associated properties comprises: determining, by the one or more processors, one or more values of amplitude-associated features extracted from a photoplethysmographic signal or a derivative thereof, wherein the one or more amplitude-associated features include a feature selected from the group consisting of: a feature comprising a statistical assessment of fiduciary landmarks determined in at least one of the one or more photoplethysmographic signals; a feature comprising a statistical assessment of fiduciary landmarks determined in a velocity plethysmographic signal derived from at least one of the one or more photoplethysmographic signal; and a feature comprising a statistical assessment of fiduciary landmarks determined in an acceleration-plethysmographic signal derived from at least one of the one or more photoplethysmographic signal.
Tzvieli discloses a system and method for measuring photoplethysmographic signals and detecting a transient ischemic attack. Specifically, Tzvieli teaches wherein the step of determining the values of one or more waveform associated properties comprises: determining, by the one or more processors, one or more values of amplitude-associated features extracted from the one or more photoplethysmographic signals or a derivative thereof ([0162]: “Some examples of feature values that may be generated based on a pulse waveform include: the area under the pulse waveform, the amplitude of the pulse waveform”), wherein the one or more amplitude-associated features include a feature selected from the group consisting of: a feature comprising a statistical assessment of fiduciary landmarks determined in at least one of the one or more photoplethysmographic signals; a feature comprising a statistical assessment of fiduciary landmarks determined in a velocity plethysmographic signal derived from at least one of the one or more photoplethysmographic signal; and a feature comprising a statistical assessment of fiduciary landmarks determined in an acceleration-plethysmographic signal derived from at least one of the one or more photoplethysmographic signal ([0083]: “The analysis of PPG signals usually includes the following steps: filtration of a PPG signal (such as applying bandpass filtering and/or heuristic filtering), extraction of feature values from fiducial points in the PPG signal (and in some cases may also include extraction of feature values from non-fiducial points in the PPG signal), and analysis of the feature values.”; [0087]: “Fiducial points in the first derivative of the PPG signal (velocity photoplethysmogram, VPG) may include: the maximum slope peak in systolic of VPG 925; the local minima slope in systolic of VPG 926; the global minima slope in systolic of VPG 927; and the maximum slope peak in diastolic of VPG 928.”; [0088]: “Fiducial points in the second derivative of the PPG signal (acceleration photoplethysmogram, APG) may include: a 930, which is the maximum of APG prior to the maximum of VPG; b 931, which is the first local minimum of APG following a; c 932, which is the greatest maximum of APG between b and e, or if no maxima then the first of (i) the first maximum of VPG after e, and (ii) the first minimum of APG after e; d 933, which is the lowest minimum of APG after c and before e, or if no minima then coincident with c; e 934, which is the second maximum of APG after maximum of VPG and before 0.6 of the duration of the cardiac cycle, unless the c wave is an inflection point, in which case take the first maximum; and f 935, which is the first local minimum of APG after e and before 0.8 of the duration of the cardiac cycle.”; [0090]: “Feature values of the PPG signal may also be extracted from relationships in the PPG signal and/or its derivatives. The following are some non-limiting examples such possible feature values: pulse width, peak to peak time, ratio of areas before and after dicrotic notch in a complete cycle, baseline wander (BW), which is the mean of the amplitudes of a beat's peak and trough; amplitude modulation (AM), which is the difference between the amplitudes of each beat's peak and trough; and frequency modulation (FM), which is the time interval between consecutive peaks.”). Shadforth and Tzvieli are analogous arts as they are both methods that use photoplethysmographic signals to analyze and determine the condition of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the analysis of amplitude-associated features from Tzvieli into the method from the Shadforth/Chazal combination, as it provides the user with a deeper analysis of their condition, as well as provide more information to the method to determine the disease state of the user, making the analysis more accurate and thorough.
Regarding claim 3, the Shadforth/Chazal/Tzvieli combination teaches the method of claim 2, wherein the fiduciary landmarks determined in the at least one of the one or more photoplethysmographic signals comprise pulse base landmarks, diastolic peak landmarks, systolic peak landmarks, minimum landmarks, minimums proximal to peaks landmarks (Tzvieli, [0162]: “Some examples of feature values that may be generated based on a pulse waveform include: the area under the pulse waveform, the amplitude of the pulse waveform, a derivative and/or second derivative of the pulse waveform, a pulse waveform shape, pulse waveform energy, and pulse transit time (to the respective ROI). Optionally, some feature values may be derived from fiducial points identified in the PPG signals; these may include values such as magnitudes of the PPG signal at certain fiducial points, offsets between different fiducial points at the like, and/or other differences between fiducial points. Some examples of fiducial point-based feature values may include one or more of the following: a magnitude of a systolic peak, a magnitude of a diastolic peak, duration of the systolic phase, and duration of the diastolic phase”).
Regarding claim 4, the Shadforth/Chazal/Tzvieli combination teaches the method of claim 2, wherein the fiduciary landmarks determined in the velocity plethysmographic signal or the acceleration plethysmographic signal comprise pulse base landmarks, peak landmarks, or minimum landmarks (Tzvieli, [0086]: “Fiducial points in the PPG signal may include: the systolic notch 920, which is the minimum at the PPG signal onset; the systolic peak 921, which is the maximum of the PPG signal; the dicrotic notch 922, which coincident with e 934 (see below at the second derivative of the PPG signal); and the diastolic peak 923, which is the first local maximum of the PPG signal after the dicrotic notch and before 0.8 of the duration of the cardiac cycle, or if there is no such local maximum, then the first local maximum of the second derivative after e and before 0.8 of the duration of the cardiac cycle.”).
Regarding claim 5, the Shadforth/Chazal/Tzvieli combination teaches the method of claim 2, wherein the statistical assessment is selected from the group consisting of a mean of the amplitude of the one or more photoplethysmographic signals, a standard deviation of the amplitude of the one or more photoplethysmographic signals, a maximum amplitude of the one or more photoplethysmographic signals, a minimum amplitude of the one or more photoplethysmographic signals, and a minimum amplitude of an assessed peak in the one or more photoplethysmographic signals (Tzvieli, [0162]: “Some examples of feature values that may be generated based on a pulse waveform include: the area under the pulse waveform, the amplitude of the pulse waveform”; [0086]: “Fiducial points in the PPG signal may include: the systolic notch 920, which is the minimum at the PPG signal onset; the systolic peak 921, which is the maximum of the PPG signal; the dicrotic notch 922, which coincident with e 934 (see below at the second derivative of the PPG signal); and the diastolic peak 923, which is the first local maximum of the PPG signal after the dicrotic notch and before 0.8 of the duration of the cardiac cycle, or if there is no such local maximum, then the first local maximum of the second derivative after e and before 0.8 of the duration of the cardiac cycle.”).
Regarding claim 6, the Shadforth/Chazal/Tzvieli combination teaches the method of claim 5.
However, the Shadforth/Chazal/Tzvieli combination does not teach wherein the step of determining the values of the one or more waveform associated properties comprises: determining, by the one or more processors, one or more values of duration-associated features extracted from a photoplethysmographic signal or a derivative thereof, wherein the one or more amplitude-associated features include a feature selected from the group consisting of: a feature comprising a statistical assessment of a beat-to-beat duration of fiduciary landmarks determined in at least one of the one or more photoplethysmographic signals; a feature comprising a statistical assessment of the beat-to-beat duration of fiduciary landmarks determined in the velocity plethysmographic signal derived from at least one of the one or more photoplethysmographic signals; and a feature comprising a statistical assessment of the beat-to-beat duration of fiduciary landmarks determined in the acceleration-plethysmographic signal derived from at least one of the one or more photoplethysmographic signals.
Tzvieli teaches wherein the step of determining the values of the one or more waveform associated properties further comprises: determining, by the one or more processors, one or more values of duration-associated features extracted from the one or more photoplethysmographic signals or a derivative thereof ([0090]: “Feature values of the PPG signal may also be extracted from relationships in the PPG signal and/or its derivatives. The following are some non-limiting examples such possible feature values: pulse width, peak to peak time, ratio of areas before and after dicrotic notch in a complete cycle, baseline wander (BW), which is the mean of the amplitudes of a beat's peak and trough; amplitude modulation (AM), which is the difference between the amplitudes of each beat's peak and trough; and frequency modulation (FM), which is the time interval between consecutive peaks.”), wherein the duration-associated features include a feature selected from the group consisting of: a feature comprising a statistical assessment of a beat-to-beat duration of fiduciary landmarks determined in at least one of the one or more photoplethysmographic signals; a feature comprising a statistical assessment of the beat-to-beat duration of fiduciary landmarks determined in the velocity plethysmographic signal derived from at least one of the one or more photoplethysmographic signals; and a feature comprising a statistical assessment of the beat-to-beat duration of fiduciary landmarks determined in the acceleration-plethysmographic signal derived from at least one of the one or more photoplethysmographic signals ([0090]: “Feature values of the PPG signal may also be extracted from relationships in the PPG signal and/or its derivatives. The following are some non-limiting examples such possible feature values: pulse width, peak to peak time, ratio of areas before and after dicrotic notch in a complete cycle, baseline wander (BW), which is the mean of the amplitudes of a beat's peak and trough; amplitude modulation (AM), which is the difference between the amplitudes of each beat's peak and trough; and frequency modulation (FM), which is the time interval between consecutive peaks.”; [0087]: “Fiducial points in the first derivative of the PPG signal (velocity photoplethysmogram, VPG) may include: the maximum slope peak in systolic of VPG 925; the local minima slope in systolic of VPG 926; the global minima slope in systolic of VPG 927; and the maximum slope peak in diastolic of VPG 928.”; [0088]: “Fiducial points in the second derivative of the PPG signal (acceleration photoplethysmogram, APG) may include: a 930, which is the maximum of APG prior to the maximum of VPG; b 931, which is the first local minimum of APG following a; c 932, which is the greatest maximum of APG between b and e, or if no maxima then the first of (i) the first maximum of VPG after e, and (ii) the first minimum of APG after e; d 933, which is the lowest minimum of APG after c and before e, or if no minima then coincident with c; e 934, which is the second maximum of APG after maximum of VPG and before 0.6 of the duration of the cardiac cycle, unless the c wave is an inflection point, in which case take the first maximum; and f 935, which is the first local minimum of APG after e and before 0.8 of the duration of the cardiac cycle.”; [0090]: “Feature values of the PPG signal may also be extracted from relationships in the PPG signal and/or its derivatives. The following are some non-limiting examples such possible feature values: pulse width, peak to peak time, ratio of areas before and after dicrotic notch in a complete cycle, baseline wander (BW), which is the mean of the amplitudes of a beat's peak and trough; amplitude modulation (AM), which is the difference between the amplitudes of each beat's peak and trough; and frequency modulation (FM), which is the time interval between consecutive peaks.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the analysis of duration-associated features from Tzvieli into the method from the Shadforth/Chazal/Tzvieli combination, as it provides the user with a deeper analysis of their condition, as well as provide more information to the method to determine the disease state of the user, making the analysis more accurate and thorough.
Regarding claim 7, the Shadforth/Chazal combination teaches the method of claim 1.
However, the Shadforth/Chazal combination does not teach wherein the step of determining the values of one or more waveform associated properties comprises: determining, by the one or more processors, one or more values of duration-associated features extracted from a photoplethysmographic signal or a derivative thereof, wherein the one or more amplitude-associated features include a feature selected from the group consisting of: a feature comprising a statistical assessment of duration between fiduciary landmarks in periodic beats determined in at least one of the one or more photoplethysmographic signals; a feature comprising a statistical assessment of duration between fiduciary landmarks in periodic beats determined in a velocity plethysmographic signal derived from at least one of the one or more photoplethysmographic signals; and a feature comprising a statistical assessment of duration between fiduciary landmarks in periodic beats determined in the acceleration plethysmographic signal derived from at least one of the one or more photoplethysmographic signals.
Tzvieli teaches wherein the step of determining the values of one or more waveform associated properties comprises: determining, by the one or more processors, one or more values of duration-associated features extracted from a photoplethysmographic signal or a derivative thereof ([0090]: “Feature values of the PPG signal may also be extracted from relationships in the PPG signal and/or its derivatives. The following are some non-limiting examples such possible feature values: pulse width, peak to peak time, ratio of areas before and after dicrotic notch in a complete cycle, baseline wander (BW), which is the mean of the amplitudes of a beat's peak and trough; amplitude modulation (AM), which is the difference between the amplitudes of each beat's peak and trough; and frequency modulation (FM), which is the time interval between consecutive peaks.”), wherein the duration-associated features include a feature selected from the group consisting of: a feature comprising a statistical assessment of duration between fiduciary landmarks in periodic beats determined in at least one of the one or more photoplethysmographic signals; a feature comprising a statistical assessment of duration between fiduciary landmarks in periodic beats determined in a velocity plethysmographic signal derived from at least one of the one or more photoplethysmographic signals; and a feature comprising a statistical assessment of duration between fiduciary landmarks in periodic beats determined in the acceleration plethysmographic signal derived from at least one of the one or more photoplethysmographic signals ([0090]: “Feature values of the PPG signal may also be extracted from relationships in the PPG signal and/or its derivatives. The following are some non-limiting examples such possible feature values: pulse width, peak to peak time, ratio of areas before and after dicrotic notch in a complete cycle, baseline wander (BW), which is the mean of the amplitudes of a beat's peak and trough; amplitude modulation (AM), which is the difference between the amplitudes of each beat's peak and trough; and frequency modulation (FM), which is the time interval between consecutive peaks.”; [0087]: “Fiducial points in the first derivative of the PPG signal (velocity photoplethysmogram, VPG) may include: the maximum slope peak in systolic of VPG 925; the local minima slope in systolic of VPG 926; the global minima slope in systolic of VPG 927; and the maximum slope peak in diastolic of VPG 928.”; [0088]: “Fiducial points in the second derivative of the PPG signal (acceleration photoplethysmogram, APG) may include: a 930, which is the maximum of APG prior to the maximum of VPG; b 931, which is the first local minimum of APG following a; c 932, which is the greatest maximum of APG between b and e, or if no maxima then the first of (i) the first maximum of VPG after e, and (ii) the first minimum of APG after e; d 933, which is the lowest minimum of APG after c and before e, or if no minima then coincident with c; e 934, which is the second maximum of APG after maximum of VPG and before 0.6 of the duration of the cardiac cycle, unless the c wave is an inflection point, in which case take the first maximum; and f 935, which is the first local minimum of APG after e and before 0.8 of the duration of the cardiac cycle.”; [0090]: “Feature values of the PPG signal may also be extracted from relationships in the PPG signal and/or its derivatives. The following are some non-limiting examples such possible feature values: pulse width, peak to peak time, ratio of areas before and after dicrotic notch in a complete cycle, baseline wander (BW), which is the mean of the amplitudes of a beat's peak and trough; amplitude modulation (AM), which is the difference between the amplitudes of each beat's peak and trough; and frequency modulation (FM), which is the time interval between consecutive peaks.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the analysis of duration-associated features from Tzvieli into the method from the Shadforth/Chazal combination, as it provides the user with a deeper analysis of their condition, as well as provide more information to the method to determine the disease state of the user, making the analysis more accurate and thorough.
Regarding claim 8, the Shadforth/Chazal combination teaches the method of claim 1, wherein the step of determining the values of one or more waveform associated properties comprises: determining, by the one or more processors, one or more values of waveform geometry- associated features extracted from the one or more photoplethysmographic signals (Shadforth, [0025]: “the step of generating the three-dimensional volumetric object comprises performing a triangulation operation on the point-cloud residue of the plurality of biophysical signal data sets, wherein the triangulation operation is selected from the group consisting of Delaunay triangulation, Mesh generation, Alpha Hull triangulation, and Convex Hull triangulation.”).
The Shadforth/Chazal combination discloses assessing triangles defined among the photoplethysmographic signals, however the Shadforth/Chazal combination does not disclose analyzing fiduciary landmarks.
Tzvieli, combined with the Shadforth/Chazal combination, teaches wherein the one or more waveform geometry-associated features comprise a statistical assessment of a waveform- geometric assessment of one or more triangles defined among fiduciary landmarks determined in at least one of the one or more photoplethysmographic signals (Shadforth, [0025]: “the step of generating the three-dimensional volumetric object comprises performing a triangulation operation on the point-cloud residue of the plurality of biophysical signal data sets, wherein the triangulation operation is selected from the group consisting of Delaunay triangulation, Mesh generation, Alpha Hull triangulation, and Convex Hull triangulation.”; Tzvieli, [0083]: “The analysis of PPG signals usually includes the following steps: filtration of a PPG signal (such as applying bandpass filtering and/or heuristic filtering), extraction of feature values from fiducial points in the PPG signal (and in some cases may also include extraction of feature values from non-fiducial points in the PPG signal), and analysis of the feature values.”; [0087]: “Fiducial points in the first derivative of the PPG signal (velocity photoplethysmogram, VPG) may include: the maximum slope peak in systolic of VPG 925; the local minima slope in systolic of VPG 926; the global minima slope in systolic of VPG 927; and the maximum slope peak in diastolic of VPG 928.”; [0088]: “Fiducial points in the second derivative of the PPG signal (acceleration photoplethysmogram, APG) may include: a 930, which is the maximum of APG prior to the maximum of VPG; b 931, which is the first local minimum of APG following a; c 932, which is the greatest maximum of APG between b and e, or if no maxima then the first of (i) the first maximum of VPG after e, and (ii) the first minimum of APG after e; d 933, which is the lowest minimum of APG after c and before e, or if no minima then coincident with c; e 934, which is the second maximum of APG after maximum of VPG and before 0.6 of the duration of the cardiac cycle, unless the c wave is an inflection point, in which case take the first maximum; and f 935, which is the first local minimum of APG after e and before 0.8 of the duration of the cardiac cycle.”; [0090]: “Feature values of the PPG signal may also be extracted from relationships in the PPG signal and/or its derivatives. The following are some non-limiting examples such possible feature values: pulse width, peak to peak time, ratio of areas before and after dicrotic notch in a complete cycle, baseline wander (BW), which is the mean of the amplitudes of a beat's peak and trough; amplitude modulation (AM), which is the difference between the amplitudes of each beat's peak and trough; and frequency modulation (FM), which is the time interval between consecutive peaks.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the analysis of the fiduciary landmarks from Tzvieli into the method from the Shadforth/Chazal combination, as it provides more information that can be used in the analysis of the disease state of the user, as well as provide a more detailed, accurate result in the analysis.
Regarding claim 9, the Shadforth/Chazal/Tzvieli combination teaches the method of claim 8, wherein the one or more triangles are selected from the group consisting of: a triangle defined between pulse base landmarks, systolic peak landmarks, and diastolic peak landmarks determined in the at least one of the one or more photoplethysmographic signals (Tzvieli, [0162]: “Some examples of feature values that may be generated based on a pulse waveform include: the area under the pulse waveform, the amplitude of the pulse waveform, a derivative and/or second derivative of the pulse waveform, a pulse waveform shape, pulse waveform energy, and pulse transit time (to the respective ROI). Optionally, some feature values may be derived from fiducial points identified in the PPG signals; these may include values such as magnitudes of the PPG signal at certain fiducial points, offsets between different fiducial points at the like, and/or other differences between fiducial points. Some examples of fiducial point-based feature values may include one or more of the following: a magnitude of a systolic peak, a magnitude of a diastolic peak, duration of the systolic phase, and duration of the diastolic phase”; Chazal, Page 2: “Topological or geometric information is extracted from the structures built on top of the data. This may either results in a full reconstruction, typically a triangulation, of the shape underlying the data from which topological/geometric features can be easily extracted or, in crude summaries or approximations from which the extraction of relevant information requires specific methods, such as e.g. persistent homology.”).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the Shadforth/Chazal/Tzvieli combination as applied to claim 9 above, and further in view of Bolus (US 11660005).
Regarding claim 10, the Shadforth/Chazal/Tzvieli combination teaches the method of claim 9.
However, the Shadforth/Chazal/Tzvieli combination does not teach wherein the step of determining the values of one or more waveform associated properties comprises: determining, by the one or more processors, one or more values of SpO2-associated features extracted from a photoplethysmographic signal, wherein the one or more SpO2- associated features comprise a statistical assessment of a vector defined as a ratio of AC and DC components determined in at least two of the photoplethysmographic signals.
Bolus discloses a method for processing and analyzing biometric data. Specifically, Bolus teaches wherein the step of determining the values of one or more waveform associated properties comprises: determining, by the one or more processors, one or more values of SpO2-associated features extracted from the one or more photoplethysmographic signals, wherein the one or more SpO2- associated features comprise a statistical assessment of a vector defined as a ratio of AC and DC components determined in at least two of the one or more photoplethysmographic signals (Column 12, lines 21-27: “the oxygen saturation content is calculated. In one embodiment, the system can calculate the SpO2 content in a variety of ways by using the processed PPG's AC and DC data. The system can employ the optical ratio (R) to 25 calculate the SpO2 content. The optical ratio can be a ratio of ratios between the Red's AC and DC data and the IR's AC and DC data.”). Shadforth, Tzvieli, and Bolus are analogous arts as they are all methods that use photoplethysmographic signals to analyze and determine the condition of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the SpO2 features from Bolus into the method from the Shadforth/Chazal/Tzvieli combination as it provides the user with a deeper analysis of their condition, as well as provide more information to the method to determine the disease state of the user, making the analysis more accurate and thorough.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant amended their drawings and specification in an attempt to overcome the drawing objections, however reference character “902c” still does not appear in the specification. Additionally, applicant removed any mention of reference character “1410” from the specification, while it still appears in the drawings.
Applicant amended claims 19 and 20 in an attempt to overcome the claim objection on the limitation “for the of the disease state”, however this amendment introduced a new claim objection, as the claim now reads “for the the disease state”. The new claim objection attempts to remove the second mention of the word “the” in order for the claim to be grammatically correct.
Applicant argues that all the 112(b) rejections are overcome, however the 112(b) rejection of claim 7 is repeated, as no amendment has been made to the limitation of “a photoplethysmographic signal” in line 4, and it is still unclear what signal this is meant to refer to.
Applicant’s arguments with respect to the prior art rejections of claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791