DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/24/2026 has been entered.
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, 6-9, 12-13 are pending.
This action is Non-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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 4, 6-9, 12-13 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Under a broadest reasonable interpretation, the limitations “a main body to be worn on a wrist of a user” and “a wrist strap connected to the main body and to be worn around the wrist of the user” encompass or are directed to human organisms. The rejection can be overcome by amendment to read “a main body adapted to be worn on a wrist of a user” and “a wrist strap connected to the main body and adapted to be worn around the wrist of the user”. The dependent claims are rejected for depending on a rejected claim.
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, 6-9, 12-13 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) and Kwon et al. (Kwon’757, US 2019/0110757) and Tal et al. (Tal, US 2018/0116534).
Regarding claim 1, McCombie teaches a wearable device for estimating blood pressure (see title and abstract), comprising:
a main body to be worn on a wrist of a user (see at least Figure 1, [0035]);
a wrist strap connected to the main body and to be worn around the wrist of the user (see at least Figure 1, [0035] “like a watch” implies or in the alternative is obvious that the component can be fixed with straps as is known for watches);
a pulse wave sensor configured to measure a pulse wave signal of the 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 the 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]);
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);
wherein the reference blood pressure is measured through a cuff at a time of calibration (see entire document, especially [0016]-[0017], [0055]-[0056]).
However, the limitations of the pulse wave sensor provided on a rear surface of the main body, and the display is provided on a front surface of the main body, 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 the two different waveform components that constitute the pulse wave signal, compare the time interval with a predetermined threshold, determine that the posture is the second posture when the time interval is greater than or equal to the threshold, and determine that the 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 structures of a witchlike device which have a pulse sensor on one surface and a display on another, which reasonably teaches the pulse wave sensor provided on a rear surface of the main body, and the display is provided on a front surface of the main body in addition to displaying remotely (see at least Figures 7A-B, [0127], [0037], [0064], [0129]), 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 sensing and displaying features in a wrist-worn device as rearrangements of parts suggested in the art for such purposes, and 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.
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 prior proposed modification and rejection (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 4, the limitations are met by McCombie in view of Kwon and Kwon’757 and Tal, 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 6, the limitations are met by McCombie in view of Kwon and Kwon’757 and Tal, 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 and Kwon’757 and Tal, where McCombie teaches wherein the processor is further configured to correct the general-purpose blood pressure variation 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 and Kwon’757 and Tal, 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 and Kwon’757 and Tal, 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 12, the limitations are met by McCombie in view of Kwon and 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).
Regarding claim 13, the limitations are met by McCombie in view of Kwon and Kwon’757 and Tal, 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).
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims filed 4/24/2026.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered and are partially persuasive. The combination of structures and arguments are sufficient to overcome the prior rejection as a combination, that is more likely than not, patent eligible, but the form of the claims necessitate a new rejection as applied above.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered but are not persuasive in view of the amendments to the claims; the rejections have been updated.
Conclusion
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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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
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