DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 4-13 are pending.
This action is Final.
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, 4-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 1
detect whether a change in a posture of a user from a first posture to a second posture occurs based on a time interval between two different waveform components included in the pulse wave signal, wherein the first posture is a standing or sitting posture and the second posture is a lying posture
based on the change in the posture being detected, correct a reference blood pressure based on a blood pressure variation caused by the change in the posture ,
correct the one or more feature values based on a variation in one or more pulse wave signal feature values caused by the change in the posture, and
estimate the blood pressure based on the corrected reference blood pressure and the corrected one or more feature values,
calculate the time interval between two different waveform components that constitute the pulse wave signal,
compare the time interval with a predetermined threshold,
determine that the user's posture is the second posture when the time interval is greater than or equal to the threshold, and
determine that the user's posture is the first posture when the time interval is less than the threshold;
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 1
a pulse wave sensor configured to measure a pulse wave signal of a user; and
a processor configured to:
obtain, based on the pulse wave signal, one or more feature values corresponding to the blood pressure,
an output interface configured to display the estimated blood pressure on a display
The structures/functions related to sensor and obtaining data are features for insignificant data gathering aspects of the claimed systems, the processor is claimed as a tool for implementing the identified exceptions, and the output interface configured to display are insignificant post solution aspects of outputting the calculated data. These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those identified above in step 2A. Such limitations related to the sensors are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm, and thus, do not add a meaningful limitation to the functions of the system as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm/mental processes. In addition, these sensor structures are known from McCombie et al. (McCombie, US 2016/0143546), Kwon et al. (Kwon’757, US 2019/0110757) and Tal et al. (Tal, US 2018/0116534), and in general are generic sensors in generic locations producing the expected photoplethysmographic (PPG) related data signals. The computer structures cited above are claimed as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The additional limitations recited in the dependent claims are directed to further generic sensors for determining posture which are known from McCombie, or further details of the claimed exception(s) (A more specific abstraction is still an abstraction). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-10, 13 are rejected under 35 U.S.C. 103 as being unpatentable over McCombie et al. (McCombie, US 2016/0143546) in view of Kwon et al. (Kwon, US 2021/0177287).
Regarding claim 1, McCombie teaches an apparatus for estimating blood pressure (see title and abstract), comprising:
a pulse wave sensor configured to measure a pulse wave signal of a user (see at least optical system/PPG, especially [0022], [0034]); and
a processor (see at least Figure 2 CPU 22, [0030], [0032], [0036]) configured to:
obtain, based on the pulse wave signal, one or more feature values corresponding to the blood pressure (see at least [0039]-[0056] such as PWV, PAT, PEP, VTT),
detect whether a change in a posture of a user from a first posture to a second posture occurs based on a time interval between two different waveform components included in the pulse wave signal (see at least [0057]-[0067] processor detects the change in the waveforms caused by posture change, [0060] delta PAT),
based on the change in the posture being detected, correct a reference blood pressure based on a blood pressure variation caused by the change in the posture (see entire document, especially [0047]-[0048] correct estimated MAP),
correct the one or more feature values based on a variation in one or more pulse wave signal feature values caused by the change in the posture (see entire document, especially [0042]-[0043], [0047]-[0048], [0057]-[0067] determine offset PWV or PAT), and
estimate the blood pressure based on the corrected reference blood pressure and the corrected one or more feature values (see entire document, especially determining systolic or diastolic pressure from MAP [0047], [0050]), and
an output interface configured to display the estimated blood pressure on a display (see at least [0024]).
However, the limitations of wherein the first posture is a standing or sitting posture and the second posture is a lying posture, and wherein the processor further configured to: calculate the time interval between two different waveform components that constitute the pulse wave signal, compare the time interval with a predetermined threshold, determine that the user's posture is the second posture when the time interval is greater than or equal to the threshold, and determine that the user's posture is the first posture when the time interval is less than the threshold are not directly taught.
Kwon teaches a related process for determining blood pressure and posture changes (see at least title and abstract), and teaches a technique to monitor pulse waveform components directly for changes compared to thresholds to determine posture changes from sitting and laying down, which reasonably teaches the claimed features of wherein the first posture is a standing or sitting posture and the second posture is a lying posture, and wherein the processor further configured to: calculate the time interval between two different waveform components that constitute the pulse wave signal, compare the time interval with a predetermined threshold, determine that the user's posture is the second posture when the time interval is greater than or equal to the threshold, and determine that the user's posture is the first posture when the time interval is less than the threshold (see at least Figures 1-10, [0062]-[0063], [0072]-[0076] “The posture change detector 430 may determine the current posture (e.g., lying position) of the user is different from the reference posture (e.g., sitting position) when at least one of the first difference value, the second difference value, and the third difference value is greater than a corresponding one of the predetermined first threshold value, the predetermined second threshold value, and the predetermined third threshold value.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including identifying changes in postures of patients to include differentiating sitting/standing from lying positions in order to identify potential errors needing correction in blood pressure measurements derived from such pulse wave signal information.
Regarding claim 4, the limitations are met by McCombie in view of Kwon, where McCombie teaches further comprising: at least one of an acceleration sensor, an angular velocity sensor, a gyro sensor, a geomagnetic sensor, or a barometric pressure sensor, wherein the processor is further configured to detect the change in the posture based on data measured through at least one of the acceleration sensor, the angular velocity sensor, the gyro sensor, the geomagnetic sensor, or the barometric pressure sensor (see at least Figure 1, [0036], [0057]-[0060]).
Regarding claim 5, the limitations are met by McCombie in view of Kwon, where McCombie teaches wherein the processor is further configured to: correct the reference blood pressure by adding the blood pressure variation caused by the change in the posture to the reference blood pressure (see at least [0049] equation 9); and correct the one or more feature values by subtracting the variation in the one or more pulse wave signal feature values caused by the change the posture from the one or more feature values (see at least [0047] equation 8 subtract offset of pwv0).
Regarding claim 6, the limitations are met by McCombie in view of Kwon, where McCombie teaches wherein the blood pressure variation caused by the change in the posture is a general-purpose blood pressure variation including statistical values of blood pressure variations of each of a plurality of users, and wherein the variation in the one or more pulse wave signal feature values caused by the change in the posture is a variation in one or more general-purpose pulse wave signal feature values comprising statistical values of variations in one or more pulse wave signal feature values of each of the plurality of users (see at least [0057]-[0067] where posture change is generalized across all population without difference i.e. male to female uses the same equations).
Regarding claim 7, the limitations are met by McCombie in view of Kwon, where McCombie teaches wherein the processor is further configured to correct the general-purpose blood pressure and the variation in the one or more general-purpose pulse wave signal feature values based on at least one of a height of the user, an age of the user, a weight of the user, a gender of the user, or a vascular elasticity of the user (see at least where posture correction occurs based on arm height changes in a user, see at least [0058]-[0062]).
Regarding claim 8, the limitations are met by McCombie in view of Kwon, where McCombie teaches wherein the blood pressure variation caused by the change in the posture is a blood pressure variation for each user including a variation in the blood pressure measured in each of the first posture and the second posture of the user, which is caused by the change in the posture, and wherein the variation in the one or more pulse wave signal feature values caused by the change in the posture is a variation in one or more pulse wave signal feature values for each user including a variation in one or more pulse wave signal feature values measured in each of the first posture and the second posture of the user, which is caused by the change in the posture (see at least [0057]-[0067] change in posture is first and second, i.e. initial and different positions).
Regarding claim 9, the limitations are met by McCombie in view of Kwon, where McCombie teaches wherein the change in the blood pressure caused by the change in the posture is a combination of a general-purpose blood pressure variation and a blood pressure variation corresponding to each user, and wherein the variation in the one or more pulse wave signal feature values is a combination of a variation in the one or more general-purpose pulse wave signal feature values and a variation in one or more pulse wave signal feature values corresponding to each user (see at least [0039]-[0067] interpreted as both individualized aspects and predetermined aspects of the calculations which fall under generalizations).
Regarding claim 10, the limitations are met by McCombie in view of Kwon, where McCombie teaches wherein the reference blood pressure is measured through a cuff at a time of calibration (see entire document, especially [0016]-[0017], [0055]-[0056]).
Regarding claim 13, the limitations are met by McCombie in view of Kwon, where McCombie teaches wherein the processor is further configured to estimate the blood pressure by linearly combining the corrected reference blood pressure and the corrected one or more feature values (see entire document, especially [0047]-[0050] reasonably reads on using equation 8/9 in the application of equations 10/11).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over McCombie et al. (McCombie, US 2016/0143546) in view of Kwon et al. (Kwon, US 2021/0177287) as applied to claim 1 above, and further in view of Kwon et al. (Kwon’757, US 2019/0110757) and Tal et al. (Tal, US 2018/0116534).
Regarding claim 11, the limitations are met by McCombie in view of Kwon as modified above, except the limitations of wherein the one or more feature values corresponding to the blood pressure comprises one or more cardiac output (CO) feature values corresponding to CO and one or more total peripheral resistance (TPR) feature values corresponding to TPR are not directly taught by the proposed modifications. It is noted that Kwon does teach relationship of MAP, CO and TPR, but such teaching is not part of the rejection of claim 1 (see Kwon [0049]-[0052], [0095]).
Kwon’757 teaches a related system which determines blood pressure through analysis of pulse wave features including CO and TPR and reasonably teaches wherein the one or more feature values corresponding to the blood pressure comprises one or more cardiac output (CO) feature values corresponding to CO and one or more total peripheral resistance (TPR) feature values corresponding to TPR (see entire document, especially Figures 4, 5A-5B, [0005], [0026]-[0027], [0056]-[0057], [0070], [0087]-[0100]). Tal teaches a related system for determining blood pressure (see title and abstract), and teaches a process where blood pressures determined by different techniques can be combined and weighted to form a composite blood pressure (see entire document, especially [0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of deriving blood pressure using CO and TPR (Kwon’757), where the combining of different techniques is prima facie obvious in view of Tal teachings of a process of such to form a composite blood pressure from different techniques in order to analyze blood pressure values over the course of time with different techniques and weighting based on quality of such derivation.
Regarding claim 12, the limitations are met by McCombie in view of Kwon, Kwon’757 and Tal, where Kwon’757 teaches wherein the one or more CO feature values comprise a ratio between a maximum amplitude value of a pulse wave signal and an area of a predetermined section of the pulse wave signal, and wherein the one or more TPR feature values comprise a ratio between an amplitude value of a first reflection wave component of the pulse wave signal and an amplitude value of a propagation wave component of the pulse wave signal (see Figure 5B).
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims and specification.
Applicant’s arguments regarding the drawing objections have been fully considered and are persuasive due to the amendments to the specification; the objections are withdrawn.
Applicant’s arguments regarding the specification objections have been fully considered and are persuasive due to the amendments to the specification; the objections are withdrawn.
Applicant’s arguments regarding the claim objections have been fully considered and are persuasive due to the amendments to the claims; the objections are withdrawn.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered but are not persuasive. Applicant argues that the claims should be streamlined analyzed. The examiner respectfully disagrees as the claims are to a system of a processor, sensor and output to display, with functional configurations of the processor. Applicant further argues that there are no judicial exceptions claimed as the claimed features cannot all be performed mentally or by pen and paper, and that there are no mathematical formula claimed. The examiner respectfully disagrees. The claims form functional features completed by a processor which include functions which can be completed mentally and/or by pen and paper including math like comparing a value to a threshold or completing math. Applicant is correct that the claims do not expressly recite a formula or equation, but that is not a requirement for mathematical concepts being recited in the claim as the claim clearly is directed to mathematical calculations claimed in prose. MPEP 2106: “A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the “mathematical concepts” grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word “calculating” in order to be considered a mathematical calculation. For example, a step of “determining” a variable or number using mathematical methods or “performing” a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.”. Lastly, applicant conclusory argues that the claims are unconventional features, but does not address the art prevalence of these structures. As such, this argument is not persuasive. The rejections are respectfully maintained as presented above to account for the amendments to the claims.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered but are not persuasive and are moot in view of the new grounds of rejection necessitated by the amendments to the claims; the rejections are undated to account for the amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791