DETAILED ACTION
Claims 1-18 are hereby the present claims under consideration.
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 .
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15 line 1 it appears that “systema” should read “system”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “obtaining … a set of photoplethysmography (PPG) data from two or more PPG sensors for a patient for a period of time” and “determining one or more measurements associated with jugular venous pressure using the segmented PPG data from the two or more PPG sensors” but it is unclear if the received PPG signals may be from any location on the body or must be associated with the jugular vein in order to calculate the “one or more measurements associated with jugular venous pressure”. In particular, it is unclear if any PPG measurement, such as one taken in an arm or leg or on an artery, is considered to be sufficient for determining parameters related to the jugular vein. For the purposes of this examination, the limitation will be interpreted as requiring the PPG signals being taken at the jugular vein for the purposes of the determination as discussed below. This rejection is further applied to the similar recitations of claims 6 and 10.
Claim 1 recites “associated with the jugular venous pressure” but it is unclear what level of “association” is required in order to satisfy this limitation. It is unclear if any hemodynamic measurement such as arterial blood pressure, may be consider “associated with” jugular venous pressure since the two measurements are both related to the circulatory system of which the jugular vein is a part. For the purposes of this examination, the limitation will be interpreted as the determined metric must be calculated from PPG signals taken at the jugular vein. This rejection is further applied to the similar recitations of claims 6 and 10.
Claims 2-5 are rejected by virtue of their dependence on claim 1.
Claims 7-18 are rejected by virtue of their dependence on claim 6.
Claims 11-18 are rejected by virtue of their dependence on claim 10.
Claim 5 recites “comparing the JPVE signals to criteria to determine whether the JVPE signals are sufficient” but it is unclear what “criteria” the JVPE signals may be compared to and how this comparison results in an indication of “sufficient”. It is unclear what a “sufficient” signal entails. For the purposes of this examination, the limitation will be interpreted as a presence or non-presence of PPG signals. This rejection is further applied to the similar recitations of claim 14.
Claim 9 recites “separately disposed on a target area” but it is unclear what relationship is meant to be conveyed by “separately disposed” for the purposes of this examination, the limitation will be interpreted as requiring some amount of distance between the PPG sensors. This rejection is further applied to the similar recitations of claim 18.
Claim 10 recites “The system further comprising” but does not indicate from which claim it depends. It is unclear if claim 10 is meant to be dependent from one of claim 6-9 or be its own independent claim. For the purposes of this examination, claim 10 is interpreted as being dependent from claim 6.
Claim 10 recites “one or more processors”, “a set of electrocardiogram (ECG) data”, “one or more ECG sensors”, “a set of photoplethysmography (PPG) data”, “two or more PPG sensors”, and “one or more measurements associated with the jugular venous pressure” but it is unclear if each of these limitations are the same as, related to, or different from “a controller”, “ECG data”, “a set of electrocardiogram (ECG) sensors”, “PPG data”, “a set of photoplethysmography (PPG) sensors”, and “one or more measurements associated with the jugular venous pressure” of claim 6 respectively. For the purposes of this examination, each of the limitations will be interpreted as referring to the same elements as their corresponding limitation in the other claim.
Claim 14 recites “causing PPG adjustment instructions to be displayed” but it is unclear which element of the claimed system performs the displaying. The processor may be configured to cause a display but it would seem that in order for a processor to carry out this function then the system would require the presence of a display element. For the purposes of this examination, the limitation will be interpreted as the instructions being displayed through any type of output device.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5-6, 10, 12, and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “determining one or more measures associated with jugular venous pressure using the segmented PPG data from the two or more PPG sensors”. The specification indicates that the PPG signals may be used to determine a pulse wave velocity in paragraphs 0056-0057 and a pressure measurement in paragraph 0059. However, the specification does not disclose how the pressure measurement may be determined. The determination of relative changes in pressure (i.e. indicating higher or lower pressure) is considered well known in the art and thus supported despite the lack of description on how such a parameter is calculated. However the specification further indicates that jugular venous pressure in mmHg may also be determined, (i.e. an absolute pressure). Such a determination of the actual blood pressure using only the pulse wave velocity and/or PPG measurements is not considered to be well known as several variables such as venous stiffness have not been determined or otherwise estimated. The specification does not disclose a particular method for calculating such a pressure measurement. Additionally, the full scope of “one or more measures associated with jugular venous pressure” is not considered to be fully supported by the disclosed calculation of pulse wave velocity (PWV) and relative pressure. In particular, the disclosed species of parameters are not considered sufficient to support the claimed genus of parameters. This rejection is further applied to the similar recitations of claims 6 and 10.
Claim 3 recites “determining one or more hemodynamic metrics using the one or more measurements associated with the jugular venous pressure”. The specification recites only that pressure measurements may be determined from the determined PWV in paragraph 0059. Furthermore, the specification does not disclose the particular method used to make these pressure determinations. While the relative pressure determination is considered to be well known, as described above, the absolute pressure determination is not considered to be well known and since no method for its calculation has been provided, the determination of the absolute pressure from the PWV is not considered to be supported by the specification. Additionally, the disclosure of determining pressure measurements from PWV signals are not considered to be a sufficient number of disclosed species to support the claimed genus of determining any hemodynamic metrics from any measurements “associated with” jugular venous pressure. This rejection is further applied to the similar recitations of claim 12.
Claim 5 recites “processing each PPG segment through a trained model to determine whether to classify each PPG segment as a jugular venous pulse (JVPE) signal”. The specification does not appear to describe how a given pulse may be classified as a JVPE signal. In particular, paragraphs 0052-0054 provide a statement of functionality and further recite that a number of features may be extracted and used to train a model. The model is then applied to the signal to classify whether a PPG segment is classified as a JVPE signal. These recitations do not detail how an input PPG signal is processed to determine the recited outputs. In particular, the particular steps taken to process the input signal into the output of JVPE classification are not provided. Additionally, the specification does not detail the structure or particular training method of the “trained algorithm” the recitations stating that a variety of algorithm architectures may be used and providing a list of possible training data is not considered. sufficient disclosure to support the claimed trained model which classified PPG signals as JVPE or non JVPE. In particular MPEP 2161.01 recites “It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement”. The specification does not provide the particular algorithm or process for carrying out the recited function. This rejection is further applied to the similar recitations of claim 14.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-18 are directed to a method of processing PPG and ECG signals using a computational algorithm, which is an abstract idea. Claims 1-18 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a process
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] segmenting the PPG data for each PPG sensor using the ECG data
[B1] determining one or more measurements associated with jugular venous pressure using the segmented PPG data from the two or more PPG sensors
These elements [A1]-[B1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] obtaining a set of electrocardiogram (ECG) data from one or more ECG sensors and a set of photoplethysmography (PPG) data from two or more PPG sensors for a patient for a period of time
This element [A2] of claim 1 does not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “obtaining a set of electrocardiogram (ECG) data from one or more ECG sensors and a set of photoplethysmography (PPG) data from two or more PPG sensors for a patient for a period of time” does not qualify as significantly more because this limitation merely describes the nature of the ECG and PPG data and does not incorporate the ECG sensor or PPG sensors as part of the claimed invention. Also, the recitation “obtaining a set of electrocardiogram (ECG) data from one or more ECG sensors and a set of photoplethysmography (PPG) data from two or more PPG sensors for a patient for a period of time” is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the PPG sensors and ECG sensors are both routine, conventional, and/or well-known in the art as evidenced by Applicant’s lack of a particular description regarding the structure and method of operation of these elements.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 2-5 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 5: a trained model;
Each of these claim limitations does not integrate the exception into a practical application. In particular, the element of claim 5 is nothing more than the computer implementation/automation of an abstract mental process of making a comparison or performing a classification of a signal into one of a number of set groups, which is what a trained user may perform when provided with certain criteria to compare a signal to.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The analysis of claim 6 and its dependents is performed in light of the above analysis of claim 1 and may be abridged where limitations are similar.
The analysis of claim 6 is as follows:
Step 1: Claim 6 is drawn to a machine
Step 2A – Prong One: Claim 6 recites an abstract idea. In particular, claim 6 recites the following limitations:
[A1] determine one or more measurements associated with jugular venous pressure using the PPG data and the ECG data
These element [A1] of claim 6 is drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 6 recites the following limitations that are beyond the judicial exception:
[A2] a set of photoplethysmography (PPG) sensors
[B2] a set of electrocardiogram (ECG) sensors
[C2] a controller
These elements [A2]-[C2] of claim 6 does not integrate the exception into a practical application of the exception. In particular, the elements [A2]-[B2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [C2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 6 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular the ECG and PPG sensors are routine, conventional, and/or well known as described in the above analysis of claim 6.
Further, the element [C2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 7-18 depend from claim 6, and recite the same abstract idea as claim 6. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claims 7-8 and 16-17: the PPG sensor disposed on a patch, a plurality of the sensors in an array
Claims 9 and 18: the PPG sensors being separately disposed on the target area.
Claim 10: one or more processors, one or more hardware storage devices
Claim 10: one or more ECG/PPG sensors (These elements have already been addressed above regarding claim 6)
Claim 14: a trained model;
Each of these claim limitations does not integrate the exception into a practical application. In particular, the element of claim 14 is nothing more than the computer implementation/automation of an abstract mental process of making a comparison or performing a classification of a signal into one of a number of set groups, which is what a trained user may perform when provided with certain criteria to compare a signal to.
The elements of claims 7-8 and 16-17 are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the PPG sensors are PPG sensor patched having a two or more PPG sensors configured into an array. Such a configuration of PPG sensors are routine, conventional, and/or well-known as evidenced by Applicant’s lack of a particular description as to the structure or functionality of the PPG sensors configured in such a manner. In particular, paragraphs 0030 and 0034-0036 and Figs. 1C-3 illustrate a number of configurations of the PPG sensors in a patch but do not describe the particular structure of operation of the PPG sensors or how the operation is altered by implementing the sensors into a patch. Furthermore, no particular statement of criticality if provided for a certain arrangement or “array” of the PPG sensors which indicates that the implementation of PPG sensor into a patch and into an array is routine, conventional, and/or well-known and does not produce a surprising technical effect. Such an assertion is further evidenced by:
US Patent Application Publication Number US 20180317854 A1 hereinafter Chao which teaches that conventional PPG sensors may include arrays of emitter and arrays of receivers (each emitter and receiver pair may be considered a PPG sensor and thus an array of both is considered an array of PPG sensors) in paragraph 0006.
US Patent Application Publication Number US 20130085354 A1 hereinafter Hete which teaches that PPG sensors are conventional and securing them through adhesives or tape is a conventional way to secure them to the body in paragraph 0034.
US Patent Application Publication Number US 20230197289 A1 hereinafter deLaubenfels teaches that wearable devices such as instrumented patches are commercially available to detect a variety of physiological parameters including PPG signals in paragraph 0038.
Additionally, the elements of claims 9 and 18 are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the PPG sensors are generic multiple generic PPG sensors which is a mere duplication of a well-known element and their arrangement being “separately disposed” on a target area does not meaningfully limit their placement to particular points or provide them with a particular structural configuration. For example, two conventional PPG sensors disposed on different fingers may satisfy the limitation of being “separately disposed” on the “target area” of the hand. The limitation is drawn towards a generic configuration and/or arrangement of the generic sensors without an indication of a surprising technical effect and thus is not considered to amount to significantly more than the abstract idea itself.
Also, this limitation from claim 10 of the processor and hardware storage devices are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
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 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lin Us Patent Application Publication Number US 2020/0163557 A1 hereinafter Lin in view of Sweeney US Patent Application Publication Number US 2022/0054029 A1 hereinafter Sweeney
Regarding claim 6, Lin discloses a system (Abstract), comprising:
a photoplethysmography (PPG) sensors configured to record PPG data for one or more periods of time (Paragraph 0033: the carotid pulse wave detector; Fig. 2 reference 11; Paragraph 0036: the pulse sensor may be a PPG sensor);
a set of electrocardiogram (ECG) sensors configured to record ECG data for one or more periods of time (Paragraph 0033: the ECG sensors on the chest; Fig. 2 reference 21;); and
a controller to simultaneously record the PPG data and the ECG data for the one or more periods of time (Paragraph 0033: the controller receives both the PPG and ECG data);
the controller being configured to determine one or more measurements associated with carotid pressure using the PPG data and the ECG data (Paragraphs 0043-0046).
Lin fails to further disclose the system including a set of PPG sensors and determining parameters for the jugular vein.
Sweeney teaches a system including at least two PPG sensor for determining the pulse wave velocity (PWV) of a blood vessel. The sensors may be arranged in a patch and spaced apart from each other (Paragraphs 0061-0062; Figs. 3 and 4). The system may be positioned over the jugular vein to determine the pulse wave velocity of the jugular vein (Paragraphs 0013, 0037 and 0063) Sweeney teaches that PWV may be used to determine pressure changes in a blood vessel (Paragraphs 0059-0060).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the PPG patch and processing methods of Sweeney into the system of Lin and modify the system of Lin to monitor jugular vein parameters rather than carotid artery parameters because the patch provides multiple PPG sensors which can be utilized as a separate measurement modality for PWV as described in paragraphs 0013 and 0061 of Sweeney which may provide a more accurate or less computationally intense measurement modality of PWV than the PPG and ECG combination measurement of Lin paragraph 0044. Additionally, it would be obvious to one of ordinary skill in the art prior to the effective filling date of the invention to alter the system of Lin to measure jugular vein parameters rather than carotid artery because the two vessels are close in proximity and the measurement modality of one is readily adapted to the other and thus is an application of a known technique to a known device ready for improvement to yield predictable results.
Regarding claim 7, Lin in view of Sweeney teaches the system according to claim 6. Modified Lin further teaches the system wherein the set of PPG sensors are disposed on a patch (Paragraph 0034: the pulse wave detector may be disposed on an adhesive patch substrate).
Regarding claim 8, Lin in view of Sweeney teaches the system according to claim 7. Modified Lin fails to further teach the system wherein the set of PPG sensors include a plurality or sensors disposed in an array.
Sweeney teaches a system wherein the set of PPG sensors include a plurality or sensors disposed in an array (Paragraphs 0062-0063: an array of pulse sensing structures including a plurality of PPG sensors; Fig. 4 references 22-25).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the array of sensors taught by Sweeny into the system of Lin because utilizing multiple sensors may allow them to be utilized as a separate measurement modality for PWV as described in paragraphs 0013 and 0061 of Sweeney which may provide a more accurate or less computationally intense measurement modality of PWV than the PPG and ECG combination measurement of Lin paragraph 0044.
Regarding claim 9, Lin in view of Sweeney teaches the system according to claim 6. Modified Lin fails to further teach the system wherein the set of PPG sensors are configured to be separately disposed on a target area.
Sweeney teaches a system wherein the set of PPG sensors are configured to be separately disposed on a target area. (Paragraphs 0061-0063: an array of pulse sensing structures including a plurality of PPG sensors which are each disposed in a separate part of a target area; Figs. 3 and 4 references 27, 29, 30 and 22-25).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the array of sensors taught by Sweeny into the system of Lin because utilizing multiple sensors may allow them to be utilized as a separate measurement modality for PWV as described in paragraphs 0013 and 0061 of Sweeney which may provide a more accurate or less computationally intense measurement modality of PWV than the PPG and ECG combination measurement of Lin paragraph 0044.
Claims 1-4, 10-13, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lin Us Patent Application Publication Number US 2020/0163557 A1 hereinafter Lin in view of Sweeney US Patent Application Publication Number US 2022/0054029 A1 hereinafter Sweeney further in view of Tomlinson US Patent Application Publication Number US 2021/0275110 A1 hereinafter Tom.
Regarding claim 1, Lin discloses a method for noninvasively determining one or more measurements associated with carotid artery pressure and/or associated metrics (Abstract), comprising:
obtaining a set of electrocardiogram (ECG) data from one or more ECG sensors and a set of photoplethysmography (PPG) data from PPG sensors for a patient for a period of time (Paragraph 0033: the ECG sensors on the chest and the carotid pulse wave detector; Fig. 2 references 11 and 21; Paragraph 0036: the pulse sensor may be a PPG sensor);
determining one or more measurements associated with carotid artery pressure using the PPG data from the PPG sensors (Paragraphs 0043-0046: the system may determine pulse wave velocity and/or mean arterial pressure from the PPG and ECG data).
Lin fails to further disclose the method being directed towards characteristics of the jugular vein, including two or more PPG sensors, segmenting the PPG data for each PPG sensor using the ECG data, and using the segmented PPG data in the determination.
Sweeney teaches systems for determining the pulse wave velocity of blood flowing within a blood vessel (Abstract). Thus, Sweeney falls within the same field of endeavor as Applicant’s inventions.
Sweeney teaches a system including at least two PPG sensor for determining the pulse wave velocity (PWV) of a blood vessel. The sensors may be arranged in a patch and spaced apart from each other (Paragraphs 0061-0062; Figs. 3 and 4). The system may be positioned over the jugular vein to determine the pulse wave velocity of the jugular vein (Paragraphs 0013, 0037 and 0063) Sweeney teaches that PWV may be used to determine pressure changes in a blood vessel (Paragraphs 0059-0060).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the PPG patch and processing methods of Sweeney into the method of Lin and modify the method of Lin to monitor jugular vein parameters rather than carotid artery parameters because the patch provides multiple PPG sensors which can be utilized as a separate measurement modality for PWV as described in paragraphs 0013 and 0061 of Sweeney which may provide a more accurate or less computationally intense measurement modality of PWV than the PPG and ECG combination measurement of Lin paragraph 0044. Additionally, it would be obvious to one of ordinary skill in the art prior to the effective filling date of the invention to alter the system of Lin to measure jugular vein parameters rather than carotid artery because the two vessels are close in proximity and the measurement modality of one is readily adapted to the other and thus is an application of a known technique to a known device ready for improvement to yield predictable results.
Lin in view of Sweeney fails to further teach the method including segmenting the PPG data for each PPG sensor using the ECG data, and using the segmented PPG data in the determination.
Tom teaches a system for synchronizing a target device to a cardiac cycle, including: (a) a target device that collects data or performs an operation that is to be timed to the cardiac cycle; (b) a signaling device that emits a signal indicating the occurrence of a cardiac contraction and/or ECG feature; and (c) a calibration device that determines the relationship of the signal from the signaling device to the actual cardiac cycle (Abstract). Thus, Tom is reasonably pertinent to the problem at hand.
Tom teaches that PPG signals may be synchronized over the same time period and the PPG signals may be segmented according to features used to identify cardiac cycles in ECG measurements (Paragraph 0080; Fig. 8A).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to modify the method of Lin in view of Sweeny to include the synchronization and segmentation of signals as taught by Tom because the synchronization of signals would help any analysis of both the PPG and ECG signals by preventing chronological delays in the signal readings which may affect the determination of some parameters such as pulse wave transit time. Additionally, the segmentation of the PPG signal by using features of the ECG signal provides the method with a consistent window generation method that is less affected by changes in heart rate for analysis of features that are associated with the cariad cycle. It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to use the segmented PPG signals for any analysis of the PPG signals because such a modification is a simple substitution of one known element (unsegmented PPG signals) for another known element (segmented PPG signals) with no surprising technical effect.
Regarding claim 10, Lin in view of Sweeney teaches the system according to claim 6 (As best interpreted given the above presented 35 USC 112(b) rejections above). Modified Lin further teaches the system further comprising:
one or more processors (Paragraph 0033: the controller); and
one or more hardware storage devices (Paragraph 0041: storage devices) having stored thereon computer-executable instructions which are executable by the one or more processors to cause the computing system to perform at least the following:
obtaining a set of electrocardiogram (ECG) data from one or more ECG sensors and a set of photoplethysmography (PPG) data from PPG sensors for a patient for a period of time (Paragraph 0033: the ECG sensors on the chest and the carotid pulse wave detector; Fig. 2 references 11 and 21; Paragraph 0036: the pulse sensor may be a PPG sensor);
determining one or more measurements associated with carotid artery pressure using the PPG data from the PPG sensors (Paragraphs 0043-0046: the system may determine pulse wave velocity and/or mean arterial pressure from the PPG and ECG data).
Lin fails to further disclose the system being directed towards characteristics of the jugular vein, including two or more PPG sensors, segmenting the PPG data for each PPG sensor using the ECG data, and using the segmented PPG data in the determination.
Sweeney teaches a system including at least two PPG sensor for determining the pulse wave velocity (PWV) of a blood vessel. The sensors may be arranged in a patch and spaced apart from each other (Paragraphs 0061-0062; Figs. 3 and 4). The system may be positioned over the jugular vein to determine the pulse wave velocity of the jugular vein (Paragraphs 0013, 0037 and 0063) Sweeney teaches that PWV may be used to determine pressure changes in a blood vessel (Paragraphs 0059-0060).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the PPG patch and processing method of Sweeney into the system of Lin and modify the system of Lin to monitor jugular vein parameters rather than carotid artery parameters because the patch provides multiple PPG sensors which can be utilized as a separate measurement modality for PWV as described in paragraphs 0013 and 0061 of Sweeney which may provide a more accurate or less computationally intense measurement modality of PWV than the PPG and ECG combination measurement of Lin paragraph 0044. Additionally, it would be obvious to one of ordinary skill in the art prior to the effective filling date of the invention to alter the system of Lin to measure jugular vein parameters rather than carotid artery because the two vessels are close in proximity and the measurement modality of one is readily adapted to the other and thus is an application of a known technique to a known device ready for improvement to yield predictable results.
Lin in view of Sweeney fails to further teach the method including segmenting the PPG data for each PPG sensor using the ECG data, and using the segmented PPG data in the determination.
Tom teaches that PPG signals may be synchronized over the same time period and the PPG signals may be segmented according to features used to identify cardiac cycles in ECG measurements (Paragraph 0080; Fig. 8A).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to modify the system of Lin in view of Sweeny to include the synchronization and segmentation of signals as taught by Tom because the synchronization of signals would help any analysis of both the PPG and ECG signals by preventing chronological delays in the signal readings which may affect the determination of some parameters such as pulse wave transit time. Additionally, the segmentation of the PPG signal by using features of the ECG signal provides the method with a consistent window generation method that is less affected by changes in heart rate for analysis of features that are associated with the cariad cycle. It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to use the segmented PPG signals for any analysis of the PPG signals because such a modification is a simple substitution of one known element (unsegmented PPG signals) for another known element (segmented PPG signals) with no surprising technical effect.
Examiner’s Note: all dependent claims are rejected with the understanding that the analysis carried out in Lin drawn towards the carotid artery are readily applied in a similar manner to the jugular vein.
Regarding claims 2 and 11, Lin in view of Sweeney further in view of Tom teaches the method and system according to claims 1 and 10 respectively. Modified Lin fails to further teach the method wherein the two or more PPG sensors include a first PPG sensor and a second PPG sensor, and wherein the determining the one or more measurements associated with the jugular venous pressure using the segmented PPG data includes:
determining pulse wave velocity using the segmented PPG data received from the first PPG sensor and the segmented PPG data from the second PPG sensor;
wherein the one or more measurements associated with the jugular venous pressure includes the pulse wave velocity.
Sweeney teaches a method wherein the two or more PPG sensors include a first PPG sensor and a second PPG sensor (Paragraphs 0061-0062: the first and second sensors), and wherein the determining the one or more measurements associated with the jugular venous pressure using the PPG data includes: determining pulse wave velocity using the PPG data received from the first PPG sensor and the PPG data from the second PPG sensor; wherein the one or more measurements associated with the jugular venous pressure includes the pulse wave velocity (Paragraphs 0013 and 0061-0062).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the PPG patch and processing methods of Sweeney into the method of Lin and modify the method of Lin to monitor jugular vein parameters rather than carotid artery parameters because the patch provides multiple PPG sensors which can be utilized as a separate measurement modality for PWV as described in paragraphs 0013 and 0061 of Sweeney which may provide a more accurate or less computationally intense measurement modality of PWV than the PPG and ECG combination measurement of Lin paragraph 0044.
Modified Lin fails to further teach the method including utilizing the segmented PPG signals.
Tom teaches that PPG signals may be synchronized over the same time period and the PPG signals may be segmented according to features used to identify cardiac cycles in ECG measurements (Paragraph 0080; Fig. 8A).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to modify the method of modified Lin to use the segmented PPG signals of Tom for any analysis of the PPG signals because such a modification is a simple substitution of one known element (unsegmented PPG signals) for another known element (segmented PPG signals) with no surprising technical effect.
Regarding claims 3 and 12, Lin in view of Sweeney further in view of Tom teaches the method and system according to claims 2 and 11 respectively. Modified Lin fails to further teach the method further comprising: determining one or more hemodynamic metrics using the one or more measurements associated with the jugular venous pressure
Sweeney teaches that the pressure in the measured vessel may be determined using the PWV (Paragraphs 0059-0060).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the pressure measurement of Sweeney into the method of modified Lin because Lin already teaches determining a mean arterial pressure (Lin: paragraphs 0043-0046) and the pressure determination method of Sweeney is a simple substitution of one known pressure measurement technique for another with no surprising technical effect.
Regarding claims 4 and 13, Lin in view of Sweeney further in view of Tom teaches the method and system according to claims 3 and 12 respectively. Modified Lin fails to further teach the method further comprising: outputting the one or more measurements associated with the jugular venous pressure and/or the one or more hemodynamic metrics (Paragraphs 0055-0056: the determined metrics may be displayed. Modified Lin as presented in claim 3 teaches the determined metrics including the jugular PWV and/or vessel pressure).
Regarding claim 15, Lin in view of Sweeney further in view of Tom teaches the system according to claim 10. Modified Lin further teaches the system further comprising: the PPG sensors configured to record the PPG data for one or more periods of time; and the one or more ECG sensors configured to record the ECG data for one or more periods of time (Paragraphs 0033 and 0046; Fig. 11: the signals includes ECG and PPG waveforms indicating multiple waves for each measurement modality. Thus the signals are recorded over one or more periods of time, or cardiac cycles).
Modified Lin fails to teach two of more PPG sensors.
Sweeney teaches a system including at least two PPG sensor for determining the pulse wave velocity (PWV) of a blood vessel. The sensors may be arranged in a patch and spaced apart from each other (Paragraphs 0061-0062; Figs. 3 and 4). The system may be positioned over the jugular vein to determine the pulse wave velocity of the jugular vein (Paragraphs 0013, 0037 and 0063) Sweeney teaches that PWV may be used to determine pressure changes in a blood vessel (Paragraphs 0059-0060).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the PPG patch and processing method of Sweeney into the system of modified Lin because the patch provides multiple PPG sensors which can be utilized as a separate measurement modality for PWV as described in paragraphs 0013 and 0061 of Sweeney which may provide a more accurate or less computationally intense measurement modality of PWV than the PPG and ECG combination measurement of Lin paragraph 0044.
Regarding claim 16, Lin in view of Sweeney further in view of Tom teaches the system according to claim 15. Modified Lin further teaches the system wherein the two or more PPG sensors are disposed on a patch (Paragraph 0034: the pulse wave detector may be disposed on an adhesive patch substrate).
Regarding claim 17, Lin in view of Sweeney further in view of Tom teaches the system according to claim 16. Modified Lin fails to further teach the system wherein the two or more PPG sensors include a plurality or sensors disposed in an array.
Sweeney teaches a system wherein the set of PPG sensors include a plurality or sensors disposed in an array (Paragraphs 0062-0063: an array of pulse sensing structures including a plurality of PPG sensors; Fig. 4 references 22-25).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the array of sensors taught by Sweeny into the system of modified Lin because utilizing multiple sensors may allow them to be utilized as a separate measurement modality for PWV as described in paragraphs 0013 and 0061 of Sweeney which may provide a more accurate or less computationally intense measurement modality of PWV than the PPG and ECG combination measurement of Lin paragraph 0044.
Regarding claim 18, Lin in view of Sweeney further in view of Tom teaches the system according to claim 15. Modified Lin fails to further teaches the system wherein the two or more PPG sensors are configured to be separately disposed on a target area.
Sweeney teaches a system wherein the set of PPG sensors are configured to be separately disposed on a target area. (Paragraphs 0061-0063: an array of pulse sensing structures including a plurality of PPG sensors which are each disposed in a separate part of a target area; Figs. 3 and 4 references 27, 29, 30 and 22-25).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the array of sensors taught by Sweeny into the system of modified Lin because utilizing multiple sensors may allow them to be utilized as a separate measurement modality for PWV as described in paragraphs 0013 and 0061 of Sweeney which may provide a more accurate or less computationally intense measurement modality of PWV than the PPG and ECG combination measurement of Lin paragraph 0044.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lin Us Patent Application Publication Number US 2020/0163557 A1 hereinafter Lin in view of Sweeney US Patent Application Publication Number US 2022/0054029 A1 hereinafter Sweeney further in view of Tomlinson US Patent Application Publication Number US 2021/0275110 A1 hereinafter Tom as applied to claims 2 and 11 above and further in view of Ghosh US Patent Application Publication Number US 2018/0325457 A1 hereinafter Ghosh in view of Watson US Patent Application Publication Number US 2010/0013642 A1 hereinafter Watson
Regarding claims 5 and 14, Lin in view of Sweeney further in view of Tom teaches the method and system according to claims 2 and 11 respectively. Modified Lin fails to further teach the method further comprising: processing each PPG segment through a trained model to determine whether to classify each PPG segment as a jugular venous pulse (JVPE) signal; comparing the JPVE signals to criteria to determine whether the JVPE signals are sufficient; causing PPG adjustment instructions to be displayed if the JVPE signals are insufficient; and determining the one or more measurements associated with the jugular venous pressure if the JVPE signals are sufficient.
Sweeney teaches the determination of one or more measurements associated with the jugular venous pressure with PPG signals (Paragraphs 0013, 0059-0060, and 0061-0062).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the determinations of various measurements of Sweeney into the method of modified Lin because Lin already teaches determining a mean arterial pressure and PWV (Lin: paragraphs 0043-0046) and the determination methods of Sweeney are a simple substitution of one known pressure measurement technique for another with no surprising technical effect.
Modified Lin fails to further teach the method further comprising: processing each PPG segment through a trained model to determine whether to classify each PPG segment as a jugular venous pulse (JVPE) signal; comparing the JPVE signals to criteria to determine whether the JVPE signals are sufficient; causing PPG adjustment instructions to be displayed if the JVPE signals are insufficient; and the determinations being made with the “sufficient” signals.
Ghosh teaches a method including evaluating the quality of photoplethysmography (PPG) signal measured from a patient monitor (e.g., a finger sensor or the like), multiple features of the PPG signal are extracted and analyzed to facilitate assigning a score to the PPG signal or portions (e.g., heartbeats) thereof. Heartbeats in the PPG signal are segmented out using concurrently captured electrocardiograph (ECG) signal, and for each heartbeat, a plurality of extracted features are analyzed (Abstract). Thus, Ghosh is reasonably pertinent to the problem at hand.
Ghosh teaches that a classifier may be used to classify PPG signals as clean or noisy based on signal features. The PPG signals may further be classified based on their degree of matching a template (Paragraphs 0015-0020 and 0029). It is noted that the determination of “clean” beats is further considered to teach the comparison of signals to criteria to determine if they are sufficient. The “criteria” is considered presence or non-presence and thus the determination of any “clean” signals is considered “sufficient”.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the classifier to determine clean signals as taught by Ghosh into the method of modified Lin because Ghosh teaches that such a classifier is useful for removing PPG signals with high amounts of noise, outliers, or other features that may affect the accuracy of determinations made from the signals (Ghosh: Paragraphs 0015-0020). Furthermore, it would be obvious to use only the “clean” signals for any determinations carried out as these signals have been determined to be of sufficient quality and may thus result in more accurate parameters being determined.
Modified Lin fails to further teach the method further comprising: causing PPG adjustment instructions to be displayed if the JVPE signals are insufficient.
Watson teaches a method and system are provided for evaluating in patient monitoring whether a signal is sensed optimally by receiving a signal, transforming the signal using a wavelet transform, generating a scalogram based at least in part on the transformed signal, identifying a pulse band in the scalogram, identifying a characteristic of the pulse band, determining, based on the characteristic of the pulse band, whether the signal is sensed optimally; and triggering an event (Abstract). Thus, Watson is reasonably pertinent to the problem at hand.
Watson teaches method of evaluating signal quality in a PPG signal (Paragraph 0087). Watson teaches that if the signals do not meet respective thresholds then an alert may trigger. The alert may include an indication to move the sensor, an indication to move the sensor closer to an artery, an indication to move the sensor away from an artery, or an indication that the sensor is not optimally located. The alerts or indications may be sent to a display and provided to the user (Paragraph 0091). Thus, Watson teaches that is PPG signals are not of sufficient quality then a display may be provided to the user indicating that the sensor should be moved.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the alerts taught by Watson into the method of modified Lin such that if a certain number, percentage, or proportion of detected PPG signals are determined to be of insufficient quality by the classifier taught by Ghosh, then the system provides an alert to relocate the PPG sensor. Such a modification would provide the benefit of indicating to a user than a PPG sensor position is not optimal if a certain portion of the received data is consider too noisy for use. Such an indication may allow the user to relocate the sensor to a proper location and provide the system with an improved data stream of less noisy signals resulting in improved outputs.
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791