DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s submission filed on 1/13/2026 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 84 and 91 are objected to because of the following informalities:
in claim 84, line 3: “at least one processor” should be “at least one processor, the method comprising:”;
in claim 84, lines 14-15: “a blood pressure assessment” should be “the blood pressure assessment”; and
in claim 91, line 4: the space before the period should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 93 and 95 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 93 recites “classifying, in real-time via the at least one processor, the plurality of PPG waveforms according to the identified pattern” in lines 9-10, but it is not clear what this step is conveying. First, are all the PGS waveforms being classified into a single classification according to the identified pattern or are they each being classified in various classifications according to the identified pattern? Second, what are the PPG waveforms being classified as, i.e., classifying the PPG waveforms as what? Clarification is required.
Claim 95 is rejected by virtue of their dependence from claim 93.
Claim 95 recites “using a machine learning model for generating the blood pressure assessment of the subject” in lines 1-2, but it is not clear if this recitation is the same as, related to, or different from “processing, in real-time via the at least one processor, the PPG waveforms based on the classifying of the plurality of PPG waveforms to generate the blood pressure assessment of the subject” of claim 93, lines 12-14. Both the use of the machine learning model and the processing of the PPG waveforms are used to generate the blood pressure assessment, but the claim language does not link these two actions together. The relationship between these two recitations should be made clear.
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 84, 87, and 90-95 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 84, 87, and 90-93 are directed to a method of generating a physiological assessment using a computational algorithm, which is an abstract idea. Claims 84, 87, and 90-93 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).
The analysis of claim 84 is as follows:
Step 1: Claim 84 is drawn to a process.
Step 2A – Prong One: Claim 84 recites an abstract idea. In particular, claim 84 recites the following limitations:
[A1] 84. A method of generating a blood pressure assessment of a subject
[B1] wherein the PPG data signal comprises a plurality of PPG waveforms;
[C1] processing, in real-time, the PPG data signal to determine consistency of the PPG waveforms, the processing comprising determining a ratio of a peak of a first PPG waveform to a peak of a second PPG waveform, wherein the first PPG waveform and the second PPG waveform are PPG waveforms in the plurality of PPG waveforms that are temporally adjacent;
[D1] classifying at least a portion of the PPG data signal according to the determined consistency of the PPG waveforms based on a comparison of the ratio to a threshold, wherein the portion of the PPG data signal is classified as consistent if the ratio exceeds the threshold;
[E1] generating, in real-time, a blood pressure assessment for the subject based on only the portion of the PPG data signal classified as consistent, wherein the blood pressure assessment is more accurate than if the entire PPG data signal had been utilized.
These elements [A1]-[E1] of claim 84 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations and/or (2) 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 84 recites the following limitations that are beyond the judicial exception:
[A2] a wearable device worn by the subject, wherein the wearable device comprises a photoplethysmography (PPG) sensor and at least one processor;
[B2] obtaining a PPG data signal from the PPG sensor;
[C2] using the processor for the real-time processing ([C1]) and real-time generating ([E1]); and
[D2] providing the blood pressure assessment for display to the subject.
The elements [A2]-[D2] of claim 84 do not integrate the exception into a practical application of the exception. In particular, the sensor of the element [A2] and the element [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). The element [C2] and the processor of the element [A2] used for real-time processing are merely instructions 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). The element [D2] is merely insignificant extrasolution activity to the judicial exception, e.g., simply displaying the results of the algorithm that uses conventional, routine, and well known elements.
Step 2B: Claim 84 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the sensor of the element [A2] and the element [B2] 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 sensor worn on the body of the subject is conventional as evidenced by:
U.S. Patent Application Publication No. 2019/0209084 (Bryant)(previously cited) disclosing that photoplethysmographic sensors are commonly available and in use in a variety of fitness, wrist-worn devices, such as the FitBit® and Garmin fitness tracking devices (paragraph 0018 of Bryant);
U.S. Patent Application Publication No. 2019/0365331 (Tsai)(previously cited) disclosing that it is conventional known to have PPG sensing, processing, and displaying on a wearable device (paragraph 0002 of Tsai); and
U.S. Patent Application Publication No. 2017/0367657 (Pande)(previously cited) disclosing that wrist-bands, watches, and other wearable heart-rate monitors using PPG sensors are commonly available (paragraph 0002 of Pande).
Further, the element [C2] and the processor of element [A2] used for real-time processing do 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)). Also, the processor worn on the body of the subject is conventional as evidenced by:
Bryant disclosing that photoplethysmographic sensors are commonly available and in use in a variety of fitness, wrist-worn devices, such as the FitBit® and Garmin fitness tracking devices (paragraph 0018 of Bryant);
Tsai disclosing that it is conventional known to have PPG sensing, processing, and displaying on a wearable device (paragraph 0002 of Tsai); and
Pande disclosing that wrist-bands, watches, and other wearable heart-rate monitors using PPG sensors are commonly available (paragraph 0002 of Pande).
The element [D2] is simply displaying the results of the algorithm that uses conventional, routine, and well known 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 87, 90-92, and 94 depend from claim 84, and recite the same abstract idea as claim 84. 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 exception of the use of the processor.
As previously mentioned, the processor does not integrate the exception into a practical application since it is merely instructions 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). Also, the processor does not recite additional elements that amount to significantly more than the judicial exception itself because the processor worn on the body of the subject is conventional as evidenced by: paragraph 0018 of Bryant, paragraph 0002 of Tsai, and paragraph 0002 of Pande and it 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); 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.
The analysis of claim 93 is as follows:
Step 1: Claim 93 is drawn to a process.
Step 2A – Prong One: Claim 93 recites an abstract idea. In particular, claim 93 recites the following limitations:
[A1] 93. A method of generating a blood pressure assessment of a subject, the method comprising:
[B1] wherein the PPG data signal comprises a plurality of PPG waveforms;
[C1] processing, in real-time, the plurality of PPG waveforms to identify a pattern corresponding to a shape of an autocorrelation of one or more subsets of the plurality of PPG waveforms that is indicative of high or low morphological similarity;
[D1] classifying, in real-time, the plurality of PPG waveforms according to the identified pattern; and
[E1] processing, in real-time, the PPG waveforms based on the classifying of the plurality of PPG waveforms to generate the blood pressure assessment of the subject, such that the blood pressure assessment is more accurate than if all of the plurality of PPG waveforms had been utilized.
These elements [A1]-[E1] of claim 93 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations and/or (2) 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 93 recites the following limitations that are beyond the judicial exception:
[A2] a wearable device worn by the subject, wherein the wearable device comprises a photoplethysmography (PPG) sensor and at least one processor;
[B2] obtaining a PPG data signal from the PPG sensor; and
[C2] using the processor for the real-time processing ([C1]), the real-time classifying ([D1]), and the real-time processing ([E1]).
The elements [A2]-[C2] of claim 93 do not integrate the exception into a practical application of the exception. In particular, the sensor of the element [A2] and the element [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). The element [C2] and the processor of the element [A2] used for real-time processing are merely instructions 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 93 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the sensor of the element [A2] and the element [B2] 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. In particular, the PPG sensor worn on the body of the subject is conventional as evidenced by:
Bryant disclosing that photoplethysmographic sensors are commonly available and in use in a variety of fitness, wrist-worn devices, such as the FitBit® and Garmin fitness tracking devices (paragraph 0018 of Bryant);
Tsai disclosing that it is conventional known to have PPG sensing, processing, and displaying on a wearable device (paragraph 0002 of Tsai); and
Pande disclosing that wrist-bands, watches, and other wearable heart-rate monitors using PPG sensors are commonly available (paragraph 0002 of Pande).
Further, the element [C2] and the processor of the element [A2] used for real-time processing do 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)). Also, the processor worn on the body of the subject is conventional as evidenced by:
Bryant disclosing that photoplethysmographic sensors are commonly available and in use in a variety of fitness, wrist-worn devices, such as the FitBit® and Garmin fitness tracking devices (paragraph 0018 of Bryant);
Tsai disclosing that it is conventional known to have PPG sensing, processing, and displaying on a wearable device (paragraph 0002 of Tsai);
Pande disclosing that wrist-bands, watches, and other wearable heart-rate monitors using PPG sensors are commonly available (paragraph 0002 of Pande).
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.
Claim 95 depends from claim 93, and recite the same abstract idea as claim 93. Furthermore, this claim only contains recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 84, 87, 91-92, and 94 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2009/0326349 (McGonigle)(previously presented), in view of U.S. Patent Application Publication No. 2007/0123787 (Kitajima)(previously presented), and further in view of U.S. Patent Application Publication No. 2014/0073861 (Rodriguez-Llorente)(previously cited).
McGonigle teaches a method comprising:
obtaining a photoplethysmography (PPG) data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle) from the PPG sensor (the sensor 418 of FIG. 4 of McGonigle), wherein the PPG data signal comprises a plurality of PPG waveforms;
processing, via the at least one processor, the PPG data signal to determine consistency of the PPG waveforms (determining consistency using the amplitude levels of the signal peaks and/or the time-distance between the signal peaks; abstract and paragraphs 0002-0006, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle).
McGonigle further teaches that signal peaks, signal troughs, interpeak distances, and other features may be identified and used to determine consistency (paragraph 0078 of McGonigle). Further, McGonigle teaches that inconsistent features are caused by noise (paragraph 0077 of McGonigle). Kitajima teaches that a ratio of two adjacent peaks is a metric that determines if peaks are of diagnostic significance as opposed to noise (paragraphs 0059-0066 of Kitajima) in PPG sensing (paragraph 0033 of Kitajima). Further, Kitajima teaches the comparison of the ratio of two adjacent peaks to a threshold for the identification of peaks of diagnostic significance (paragraphs 0061-0064, 0066-0068, 0081-0082, 0119, and 0127 of Kitajima). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the ratio of two adjacent peaks as a metric to determine consistency and the comparison of the ratio to a threshold for identifying consistency since McGonigle teaches other features may be identified so as to determine consistency and a ratio of two adjacent peaks with its comparison to a threshold is such a feature that determines consistent features of diagnostic significance in PPG signals.
McGonigle teaches the removal of those portions of the signal that are not consistent (abstract, claims 7 and 17, and paragraphs 0006, 0096 and 0109 of McGonigle). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to remove the inconsistent portions of the PPG signal before processing since it provides a more accurate signal.
McGonigle teaches a method comprising: obtaining a photoplethysmography (PPG) data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, 0112-0114 of McGonigle) from a PPG sensor (the sensor 418 of FIG. 4 of McGonigle) worn on a body of the subject (paragraph 0040 of McGonigle). Rodriguez-Llorente teaches that blood pressure can be determined from PPG signals (paragraph 0202 of Rodriguez-Llorente) and displayed on a monitor (paragraphs 0184 and 0195 of Rodriguez-Llorente). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine blood pressure from the PPG signal of McGonigle and display it on a monitor since it would provide and convey diagnostic health information about the subject that is useful in determining cardiovascular health.
McGonigle teaches the obtainment of the signal in real time (paragraph 0081 of McGonigle). Kitajima teaches the processing in real-time (paragraphs 0098, 0104, and 0131 of Kitajima). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to process the signals in real-time, as suggested by Kitajima, since it provides the blood pressure at the soonest possible time for consideration.
With respect to claim 84, the combination teaches or suggests a method of generating a blood pressure assessment of a subject (the assessment suggested by paragraph 0202 of Rodriguez-Llorente) via a wearable device worn by the subject (paragraph 0040 of McGonigle; FIGS. 2 and 4 of McGonigle), wherein the wearable device comprises a photoplethysmography (PPG) sensor (the sensor 418 of FIG. 4 of McGonigle) and at least one processor (the CPU 24 of FIG. 4 of McGonigle), the method comprising:
obtaining a PPG data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle) from the PPG sensor (the sensor 418 of FIG. 4 of McGonigle), wherein the PPG data signal comprises a plurality of PPG waveforms;
processing, in real-time via the at least one processor, the PPG data signal to determine consistency of the PPG waveforms, the processing comprising determining a ratio of a peak of a first PPG waveform to a peak of a second PPG waveform, wherein the first PPG waveform and the second PPG waveform are PPG waveforms in the plurality of PPG waveforms that are temporally adjacent (the comparison of the ratio of two adjacent peaks to a threshold for the identification of the peaks of diagnostic significance of Kitajima; the real-time processing suggested by Kitajima);
classifying at least a portion of the PPG data signal according to the determined consistency of the PPG waveforms based on a comparison of the ratio to a threshold, wherein the portion of the PPG data signal is classified as consistent if the ratio exceeds the threshold (the classification of the peaks meeting the threshold as diagnostic significant as opposed to noise);
generating, in real-time via the at least one processor, a blood pressure assessment for the subject based on only the portion of the PPG data signal classified as consistent (the removal of the inconsistent portions of the PPG signal before the blood pressure determination of Rodriguez-Llorente; the real-time processing suggested by Kitajima), wherein the blood pressure assessment is more accurate than if the entire PPG data signal had been utilized; and
providing the blood pressure assessment for display to the subject (the display of the blood pressure determined from the PPG signals, as suggested by Rodriguez-Llorente).
With respect to claim 87, the combination teaches or suggests that the peak of the second PPG waveform is consecutive to the peak of the first PPG waveform in the PPG data signal (the comparison of the ratio of two adjacent (i.e., consecutive) peaks to a threshold for the identification of the peaks of diagnostic significance of Kitajima).
With respect to claim 91, the combination teaches or suggests that the method further comprises processing, via the at least one processor, the plurality of PPG waveforms in the PPG signal to identify a pattern of one or more subsets of the plurality of PPG waveforms that is indicative of high or low morphological similarity (the comparison of the ratio of two adjacent peaks to a threshold for the identification of the peaks of diagnostic significance of Kitajima which is indicative of high morphological similarity of PPG waveforms to identify a cluster (or pattern) of peaks of diagnostic significance).
With respect to claim 92, Kitajima teaches the comparison of the ratio of two adjacent peaks to a threshold for the identification of peaks of diagnostic significance (paragraphs 0061-0064, 0082, 0119, and 0127 of Kitajima). Kitajima further teaches that the threshold can be arbitrarily set depending on a feature of pulsation of a subject or a predicted symptom (paragraph 0064 of Kitajima). Thus, Kitajima teaches that the threshold is subject to change and can be set based on a feature of pulsation of the subject or the predicted symptom. As such, the threshold value is a results-effective variable that would have been optimized through routine experimentation based on a feature of pulsation of a subject or a predicted symptom. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the threshold value so as to obtain the feature of pulsation of the subject or the predicted symptom. Thus, the features of “wherein the threshold is 0.4444” would have been obvious.
With respect to claim 94, Rodriguez-Llorente teaches that blood pressure can be determined from PPG signals (paragraph 0202 of Rodriguez-Llorente) and displayed on a monitor (paragraphs 0184 and 0195 of Rodriguez-Llorente). Rodriguez-Llorente discloses that the subject’s age, weight, and diagnosis may be used to select and provide coefficients for equations from which, for example, pulse rate, blood pressure, and other measurements may be determined based on the PPG signals to determine blood pressure. These equations may contain coefficients that depend upon a subject’s physiological characteristics (paragraph 0202 of Rodriguez-Llorente). Rodriguez-Llorente teaches that neural networks are used to receive the combination of inputs to determine updated coefficients or other parameters as new data is analyzed (paragraph 0686 of Rodriguez-Llorente). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use neural networks to update coefficients when determining blood pressure from PPG signals since it takes into account new data for better accuracy.
With respect to claim 94, the combination teaches or suggests using a machine learning model for generating the blood pressure assessment for the subject based on only the portion of the PPG data signal classified as consistent (using the neural networks of Rodriguez-Llorente to update coefficients when determining blood pressure from PPG signals after the removal of the inconsistent portions of the PPG signal ).
Claims 93 and 95 are rejected under 35 U.S.C. 103 as being unpatentable over McGonigle, in view of Kitajima, and further in view of Rodriguez-Llorente, and further in view of U.S. Patent Application Publication No. 2006/0241506 (Melker)(previously cited).
McGonigle teaches a method comprising:
obtaining a photoplethysmography (PPG) data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle) from the PPG sensor (the sensor 418 of FIG. 4 of McGonigle), wherein the PPG data signal comprises a plurality of PPG waveforms;
processing, via the at least one processor, the PPG data signal to determine consistency of the PPG waveforms (determining consistency using the amplitude levels of the signal peaks and/or the time-distance between the signal peaks; abstract and paragraphs 0002-0006, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle).
McGonigle further teaches that signal peaks, signal troughs, interpeak distances, and other features may be identified and used to determine consistency (paragraph 0078 of McGonigle). Further, McGonigle teaches that inconsistent features are caused by noise (paragraph 0077 of McGonigle). Kitajima teaches that a ratio of two adjacent peaks is a metric that determines if peaks are of diagnostic significance as opposed to noise (paragraphs 0059-0066 of Kitajima) in PPG sensing (paragraph 0033 of Kitajima). Further, Kitajima teaches the comparison of the ratio of two adjacent peaks to a threshold for the identification of peaks of diagnostic significance (paragraphs 0061-0064, 0066-0068, 0081-0082, 0119, and 0127 of Kitajima). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the ratio of two adjacent peaks as a metric to determine consistency and the comparison of the ratio to a threshold for identifying consistency since McGonigle teaches other features may be identified so as to determine consistency and a ratio of two adjacent peaks with its comparison to a threshold is such a feature that determines consistent features of diagnostic significance in PPG signals.
McGonigle teaches the removal of those portions of the signal that are not consistent (abstract, claims 7 and 17, and paragraphs 0006, 0096 and 0109 of McGonigle). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to remove the inconsistent portions of the PPG signal before processing since it provides a more accurate signal.
McGonigle teaches a method comprising: obtaining a photoplethysmography (PPG) data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, 0112-0114 of McGonigle) from a PPG sensor (the sensor 418 of FIG. 4 of McGonigle) worn on a body of the subject (paragraph 0040 of McGonigle). Rodriguez-Llorente teaches that blood pressure can be determined from PPG signals (paragraph 0202 of Rodriguez-Llorente) and displayed on a monitor (paragraphs 0184 and 0195 of Rodriguez-Llorente). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine blood pressure from the PPG signal of McGonigle and display it on a monitor since it would provide and convey diagnostic health information about the subject that is useful in determining cardiovascular health.
McGonigle teaches the obtainment of the signal in real time (paragraph 0081 of McGonigle). Kitajima teaches the processing in real-time (paragraphs 0098, 0104, and 0131 of Kitajima). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to process the signals in real-time, as suggested by Kitajima, since it provides the blood pressure at the soonest possible time for consideration.
The combination teaches or suggests a step of obtaining a photoplethysmography (PPG) data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle) from the PPG sensor (the sensor 418 of FIG. 4 of McGonigle). The combination also teaches or suggests the use of the diagnostically significant peaks in the PPG waveforms for the determination of blood pressure. Melker teaches the use of autocorrelation so as to zero in on the waveform patterns for processing (paragraph 0035 of Melker). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an autocorrelation function prior to the analysis of the peaks to determine diagnostically significant peaks since it zeros in the waveforms in a more efficient manner.
With respect to claim 93, the combination teaches or suggests a method of generating a blood pressure assessment of a subject (the assessment suggested by paragraph 0202 of Rodriguez-Llorente) via a wearable device worn by the subject (paragraph 0040 of McGonigle; FIGS. 2 and 4 of McGonigle), wherein the wearable device comprises a photoplethysmography (PPG) sensor (the sensor 418 of FIG. 4 of McGonigle) and at least one processor (the CPU 24 of FIG. 4 of McGonigle), the method comprising:
obtaining a PPG data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle) from the PPG sensor (the sensor 418 of FIG. 4 of McGonigle), wherein the PPG data signal comprises a plurality of PPG waveforms;
processing, in real-time via the at least one processor, the plurality of PPG waveforms to identify a pattern corresponding to a shape of an autocorrelation of one or more subsets of the plurality of PPG waveforms that is indicative of high or low morphological similarity (the use of autocorrelation so as to zero in on the waveform patterns for processing as suggested by Melker; the real-time processing suggested by Kitajima); and
classifying, in real-time via the at least one processor, the plurality of PPG waveforms according to the identified pattern (the classification of the waveforms as identified for further processing; the real-time processing suggested by Kitajima); and
processing, in real-time via the at least one processor, the PPG waveforms based on the classifying of the plurality of PPG waveforms to generate the blood pressure assessment of the subject (using the diagnostically significant peaks in the blood pressure determination of Rodriguez-Llorente; the real-time processing suggested by Kitajima), such that the blood pressure assessment is more accurate than if all of the plurality of PPG waveforms had been utilized.
With respect to claim 95, Rodriguez-Llorente teaches that blood pressure can be determined from PPG signals (paragraph 0202 of Rodriguez-Llorente) and displayed on a monitor (paragraphs 0184 and 0195 of Rodriguez-Llorente). Rodriguez-Llorente discloses that the subject’s age, weight, and diagnosis may be used to select and provide coefficients for equations from which, for example, pulse rate, blood pressure, and other measurements may be determined based on the PPG signals to determine blood pressure. These equations may contain coefficients that depend upon a subject’s physiological characteristics (paragraph 0202 of Rodriguez-Llorente). Rodriguez-Llorente teaches that neural networks are used to receive the combination of inputs to determine updated coefficients or other parameters as new data is analyzed (paragraph 0686 of Rodriguez-Llorente). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use neural networks to update coefficients when determining blood pressure from PPG signals since it takes into account new data for better accuracy. Thus, the combination teaches or suggests using a machine learning model for generating the blood pressure assessment of the subject (using the neural networks of Rodriguez-Llorente to update coefficients when determining blood pressure from PPG signals).
Claims 93 and 95 are rejected under 35 U.S.C. 103 as being unpatentable over McGonigle, in view of Kitajima, and further in view of Rodriguez-Llorente, and further in view of U.S. Patent Application Publication No. 2014/0073866 (Engelbrecht)(previously cited).
McGonigle teaches a method comprising:
obtaining a photoplethysmography (PPG) data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle) from the PPG sensor (the sensor 418 of FIG. 4 of McGonigle), wherein the PPG data signal comprises a plurality of PPG waveforms;
processing, via the at least one processor, the PPG data signal to determine consistency of the PPG waveforms (determining consistency using the amplitude levels of the signal peaks and/or the time-distance between the signal peaks; abstract and paragraphs 0002-0006, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle).
McGonigle further teaches that signal peaks, signal troughs, interpeak distances, and other features may be identified and used to determine consistency (paragraph 0078 of McGonigle). Further, McGonigle teaches that inconsistent features are caused by noise (paragraph 0077 of McGonigle). Kitajima teaches that a ratio of two adjacent peaks is a metric that determines if peaks are of diagnostic significance as opposed to noise (paragraphs 0059-0066 of Kitajima) in PPG sensing (paragraph 0033 of Kitajima). Further, Kitajima teaches the comparison of the ratio of two adjacent peaks to a threshold for the identification of peaks of diagnostic significance (paragraphs 0061-0064, 0066-0068, 0081-0082, 0119, and 0127 of Kitajima). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the ratio of two adjacent peaks as a metric to determine consistency and the comparison of the ratio to a threshold for identifying consistency since McGonigle teaches other features may be identified so as to determine consistency and a ratio of two adjacent peaks with its comparison to a threshold is such a feature that determines consistent features of diagnostic significance in PPG signals.
McGonigle teaches the removal of those portions of the signal that are not consistent (abstract, claims 7 and 17, and paragraphs 0006, 0096 and 0109 of McGonigle). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to remove the inconsistent portions of the PPG signal before processing since it provides a more accurate signal.
McGonigle teaches a method comprising: obtaining a photoplethysmography (PPG) data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, 0112-0114 of McGonigle) from a PPG sensor (the sensor 418 of FIG. 4 of McGonigle) worn on a body of the subject (paragraph 0040 of McGonigle). Rodriguez-Llorente teaches that blood pressure can be determined from PPG signals (paragraph 0202 of Rodriguez-Llorente) and displayed on a monitor (paragraphs 0184 and 0195 of Rodriguez-Llorente). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine blood pressure from the PPG signal of McGonigle and display it on a monitor since it would provide and convey diagnostic health information about the subject that is useful in determining cardiovascular health.
McGonigle teaches the obtainment of the signal in real time (paragraph 0081 of McGonigle). Kitajima teaches the processing in real-time (paragraphs 0098, 0104, and 0131 of Kitajima). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to process the signals in real-time, as suggested by Kitajima, since it provides the blood pressure at the soonest possible time for consideration.
The combination teaches or suggests a step of obtaining a photoplethysmography (PPG) data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle) from the PPG sensor (the sensor 418 of FIG. 4 of McGonigle). The combination also teaches or suggests the use of the diagnostically significant peaks in the PPG waveforms for the determination of blood pressure. Engelbrecht teaches the use of autocorrelation so as to zero in on the waveform patterns before processing (paragraphs 0006 and 0188-0189 of Engelbrecht). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an autocorrelation function prior to the analysis of the peaks to determine diagnostically significant peaks since it zeros in the waveforms in a more efficient manner.
With respect to claim 93, the combination teaches or suggests a method of generating a blood pressure assessment of a subject (the assessment suggested by paragraph 0202 of Rodriguez-Llorente) via a wearable device worn by the subject (paragraph 0040 of McGonigle; FIGS. 2 and 4 of McGonigle), wherein the wearable device comprises a photoplethysmography (PPG) sensor (the sensor 418 of FIG. 4 of McGonigle) and at least one processor (the CPU 24 of FIG. 4 of McGonigle), the method comprising:
obtaining a PPG data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle) from the PPG sensor (the sensor 418 of FIG. 4 of McGonigle), wherein the PPG data signal comprises a plurality of PPG waveforms;
processing, in real-time via the at least one processor, the plurality of PPG waveforms to identify a pattern corresponding to a shape of an autocorrelation of one or more subsets of the plurality of PPG waveforms that is indicative of high or low morphological similarity (the use of autocorrelation so as to zero in on the waveform patterns before processing suggested by Engelbrecht; the real-time processing suggested by Kitajima); and
classifying, in real-time via the at least one processor, the plurality of PPG waveforms according to the identified pattern (the classification of the waveforms as identified for further processing; the real-time processing suggested by Kitajima); and
processing, in real-time via the at least one processor, the PPG waveforms based on the classifying of the plurality of PPG waveforms to generate the blood pressure assessment of the subject (using the diagnostically significant peaks in the blood pressure determination of Rodriguez-Llorente; the real-time processing suggested by Kitajima), such that the blood pressure assessment is more accurate than if all of the plurality of PPG waveforms had been utilized.
With respect to claim 95, Rodriguez-Llorente teaches that blood pressure can be determined from PPG signals (paragraph 0202 of Rodriguez-Llorente) and displayed on a monitor (paragraphs 0184 and 0195 of Rodriguez-Llorente). Rodriguez-Llorente discloses that the subject’s age, weight, and diagnosis may be used to select and provide coefficients for equations from which, for example, pulse rate, blood pressure, and other measurements may be determined based on the PPG signals to determine blood pressure. These equations may contain coefficients that depend upon a subject’s physiological characteristics (paragraph 0202 of Rodriguez-Llorente). Rodriguez-Llorente teaches that neural networks are used to receive the combination of inputs to determine updated coefficients or other parameters as new data is analyzed (paragraph 0686 of Rodriguez-Llorente). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use neural networks to update coefficients when determining blood pressure from PPG signals since it takes into account new data for better accuracy. Thus, the combination teaches or suggests using a machine learning model for generating the blood pressure assessment of the subject (using the neural networks of Rodriguez-Llorente to update coefficients when determining blood pressure from PPG signals).
Claims 89-90 are rejected under 35 U.S.C. 103 as being unpatentable over McGonigle, in view of Kitajima, and further in view of Rodriguez-Llorente, and further in view of U.S. Patent Application Publication No. 2017/0119314 (Just)(previously cited).
With respect to claim 89, the combination teaches or suggests a step of obtaining a photoplethysmography (PPG) data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle) from the PPG sensor (the sensor 418 of FIG. 4 of McGonigle). Just teaches that elevated physical activity sensed by an accelerometer may trigger an actuator to move a PPG sensor module towards the skin of a subject wearing a wearable device (paragraph 0159 of Just). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an accelerometer, an actuator for adjusting the PPG sensor relative to the skin of the subject, and the process of triggering the actuator when the accelerometer senses elevated activity so as to ensure higher quality readings during intensive movement. Thus, the combination teaches or suggests that the wearable device further comprises a motion sensor (the accelerometer of Just) and an actuator (the actuator of Just) configured to adjust a stability of the wearable device relative to a body of the subject (the adjustment of Just), and wherein the method further comprises adjusting the stability of the wearable device in response to a motion signal from the motion sensor during the obtaining of the PPG data signal from the PPG sensor (paragraph 0159 of Just).
With respect to claim 90, the combination teaches or suggests a step of obtaining a photoplethysmography (PPG) data signal (the PPG signal 416 of McGonigle; abstract and paragraphs 0002-0006, 0071, 0078, 0080, 0084-0086, 0090, 0094, 0097, 0099-100, 0106, 0110, and 0112-0114 of McGonigle) from the PPG sensor (the sensor 418 of FIG. 4 of McGonigle). Just teaches that sensor readings from a PPG sensor may be processed to determine the subject’s heart rate and if the heart rate is above an elevated threshold and sensor readings from an inertial sensor 202 (such as an accelerometer) may be processed to determine if the subject is active or at rest (paragraph 0103 of Just). Just further teaches that the results of the PPG sensor information and inertial sensor information trigger blood pressure readings (paragraph 0103 of Just). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to process the PPG signal to determine heart rate, determine if the heart rate is above an elevated threshold, and process inertial sensor information to determine physical activity so as to trigger the blood pressure reading based on these results so as to determine if the subject is at a high risk of a cardiac event (paragraph 0103 of Just). Thus, the combination teaches or suggests that the method further comprises processing the obtained PPG signal via the at least one processor to determine a heart rate value for the subject (the heart rate determination of Just), and then proceeding with the generating of the blood pressure assessment in response to determining, via the at least one processor, that the heart rate value is above or below a heart rate threshold (the blood pressure assessment when the heart rate is above an elevated threshold and inertial sensor information indicates an absence of physical activity).
Response to Arguments
The Applicant’s arguments filed 1/13/2026 have been fully considered.
Claim objections
In view of the claim amendments filed on 1/13/2026, the previous claim objections are withdrawn. However, there are new grounds of claim objections.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 1/13/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn. However, there are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
35 U.S.C. 101
The Applicant asserts:
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These arguments are not persuasive. The use of a wearable device having a PPG sensor and processor does not make the claims patent eligible. The use of the PPG sensor does not integrate the exception into a practical application of the exception since it 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). The use of the PPG sensor does not recite additional elements that amount to significantly more than the judicial exception itself since it 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 sensor worn on the body of the subject is conventional as evidenced by the above teachings of Bryant, Tsai, and Pande.
The use of a processor does not integrate the exception into a practical application of the exception since it 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). The use of a processor does not recite additional elements that amount to significantly more than the judicial exception itself since it 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)). Also, the processor worn on the body of the subject is conventional as evidenced by the above teachings of Bryant, Tsai, and Pande.
The use of a display is merely insignificant extrasolution activity to the judicial exception, e.g., simply displaying the results of the algorithm that uses conventional, routine, and well known elements.
Prior art rejections
With respect to the rejection of claim 84, the Applicant asserts:
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The Applicant then asserts that Kitajima’s disclosure (1) is limited to notch/noise removal, (2) does not disclose the classification of portions of a PPG data signal as consistent segments for downstream processing or determining blood pressure using only such segments, and (3) does not mention blood pressure determination utilizing only the portion of the PPG data signal classified as consistent. Finally, the Applicant asserts that McGonigle, Kitajima, and the other references fail to disclose determining a ratio of peaks of temporally adjacent PPG waveforms; classifying at least a portion of the PPG data signal based on the ratio and threshold into consistent portions, and determining a blood pressure assessment based only on the portion classified as consistent.
This argument is not persuasive. McGonigle teaches that signal peaks, signal troughs, and interpeak distances and other features may be identified and used to determine consistency (paragraph 0078 of McGonigle). Further, McGonigle teaches that inconsistent features are caused by noise (paragraph 0077 of McGonigle). Kitajima teaches that a ratio of two adjacent peaks is a metric that determines if peaks are of diagnostic significance as opposed to noise (paragraphs 0059-0066 of Kitajima) in PPG sensing (paragraph 0033 of Kitajima). Further, Kitajima teaches the comparison of the ratio of two adjacent peaks to a threshold for the identification of peaks of diagnostic significance (paragraphs 0061-0064, 0066-0068, 0081-0082, 0119, and 0127 of Kitajima). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the ratio of two adjacent peaks as a metric to determine consistency and the comparison of the ratio to a threshold for identifying consistency since McGonigle teaches other features may be identified so as to determine consistency and a ratio of two adjacent peaks with its comparison to a threshold is such a feature that determines consistent features of diagnostic significance in PPG signals. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Also, McGonigle discloses the classification of portions of a PPG data signal as consistent segments for downstream processing using only such segments. In particular, McGonigle teaches the removal of those portions of the signal that are not consistent (abstract, claims 7 and 17, and paragraphs 0006, 0096 and 0109 of McGonigle). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to remove the inconsistent portions of the PPG signal before processing since it provides a more accurate signal. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Further, Rodriguez-Llorente teaches that blood pressure can be determined from PPG signals (paragraph 0202 of Rodriguez-Llorente) and displayed on a monitor (paragraphs 0184 and 0195 of Rodriguez-Llorente). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine blood pressure from the PPG signal of McGonigle and display it on a monitor since it would provide and convey diagnostic health information about the subject that is useful in determining cardiovascular health. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
With respect to the rejection of claim 93, the Applicant does not address this rejection by argument. The Examiner cannot find a reason to withdraw the rejection.
Conclusion
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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