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 .
DETAILED ACTION
The Amendment filed on November 06, 2025 to the Office action dated July 16, 2025 is acknowledged and has been entered. Claims 4-5, 11-12and 18-29 have been canceled. Claims 2-21 are pending and under examination in this Office action.
Information Disclosure Statement
As an initial matter, Applicant is reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this application. An IDS for the prior arts cited in the IDS filed for the parent applications of the instant application should be filed.
Terminal Disclaimer
The terminal disclaimer filed on November 06, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. US 11,980,451 B2 and US 11,234,604 B2 and has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment
The rejection to claims 4-6, 11-13 and 18-20 under 35 U.S.C. 112(b) is now withdrawn in view of the claim amendment.
The non-statutory double patenting rejection is now withdrawn in view of the terminal disclaimer filed and recorded on November 06, 2025.
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 2-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 2-8 are directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Claims 9-15 are drawn to a “system” which describes one of the four statutory categories, i.e., a machine.
Claims 16-21 are drawn to a “non-transitory computer-readable medium” which describes one of the four statutory categories, i.e., a manufacture.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 2, 9 and 16 recite (“sets forth” or “describes”) the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), or alternatively, “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: “determining a pulse wave velocity (PWV) based on the first distance, the second distance, and a differential PAT of the first PAT and the second PAT; and determining a blood pressure measurement of the subject based on the PWV”.
In claims 2, 9 and 16, the above recited steps are mathematical concepts, which is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. A velocity is known to be a distance change over a time period. Hence one may obtain the pulse wave velocity by calculating the distance difference between the first distance and the second distance, and by dividing the distance difference by the differential PAT that is the time difference between the two pulse waves. Further, the mathematical relationship to convert the pulse wave velocity to the blood pressure is well-known in the field of art. One may obtain the blood pressure using the pulse wave velocity with the known mathematical relationship of the two parameters. Therefore, each of the above steps are grouped as mathematical concepts, hence an abstract idea.
Alternatively, in claims 2, 9 and 16, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. If a person were to visually examine, i.e., perform an observation, the first distance, the second distance, and the differential PAT of the first PAT and the second PAT, he/she would be able to identify the distance differential via simple subtraction, and then identify the PWV via a ratio of the distance differential and the PAT differential. He/she would further be able to obtain the blood pressure based on the known mathematical relationship between the pulse wave velocity and the blood pressure, either mentally, with a pen and paper, or with a generic computer. There is nothing recited in the claim to suggest an undue level of complexity in how the pulse wave velocity and the blood pressure to be determined. Therefore, a person would be able to perform the determination mentally, with a pen and paper. or with a generic computer.
Prong Two: Claims 2, 9 and 16 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recites additional steps of determining PPG sensed from two different locations, hence difference distances from the heart, and two PATs each corresponding to the first and the second distance.
These steps represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated bio-information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 2, 9 and 16 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of determining PPG sensed from two different locations, hence difference distances from the heart, and two PATs each corresponding to the first and the second distance. These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality.
The PPG signal is sensed by a PPG sensor at a corresponding PAT. When the PPG signal is sensed by multiple PPG sensors at multiple locations, each PPG signal corresponds to its own PAT, and is sensed by the PPG sensor at each corresponding distance to the heart. These additional limitations merely represent insignificant, conventional pre-solution activities well-understood in the industry of pulse wave-based bio-information estimation, as evidenced by Messerschmi et al., US 2014/0051941 A1, hereinafter Messerschmi.
In Messerschmi, it teaches in [0021] that the portable device includes a first sensor 120 and a second sensor 122, each is a PPG sensor that measures a PPG signal. Each is at a distance to the heart.
Accordingly, these additional steps and tools for measuring a pulse wave signal and contact pressure, and outputting a notification amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept. The claims hence are not patent eligible.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons:
further define the differential distance that is used to calculate the PWV (claims 3, 10 and 17)
further define the blood pressure measurement (claims 5, 12 and 19)
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
further define the data collection timing (claims 4, 11 and 18)
further define the position of the sensor (claims 6, 13 and 20)
further extra-solution activity of displaying the determined blood pressure measurement (claims 8, 15 and 21).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2, 4-9, 11-16 and 18-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Messerschmi et al., US 2014/0051941 A1, hereinafter Messerschmi.
Claims 2, 9 and 16. Messerschmi teaches in FIGS.1 and 5-6 and 9 a method comprising, a system comprising, and a non-transitory computer-readable medium having instructions stored thereon which, when executed by a processing device ([0073]: the controller assembly 900 includes a processor 902), cause the processing device to:
determining, from a first photoplethysmogram (PPG) sensed at a first point that is a first distance from a heart of the subject, a first pulse arrival time (PAT) corresponding to the first distance ([0021]: the portable device 101 also includes a first sensor 120 spaced a fixed, known distance 124 apart from a second sensor 122; and [0027]: each of the first and second sensors 120, 122 comprises an optical type of sensor, and in particular, a reflective type photoplethysmography (PPG) sensor; FIG.3: a first location A refers to where the first sensor 120 contacts the skin; and FIG.8: the first blood pulse waveform 800 arrival time that corresponds to the dashed line at left);
determining, from a second PPG sensed at a second point that is a second distance from the heart of the subject, a second PAT corresponding to the second distance ([0021]: the portable device 101 also includes a first sensor 120 spaced a fixed, known distance 124 apart from a second sensor 122; and [0027]: each of the first and second sensors 120, 122 comprises an optical type of sensor, and in particular, a reflective type photoplethysmography (PPG) sensor; FIG.3: a location B refers to where the second sensor 122 contacts the skin; and FIG.8: the second blood pulse waveform 802 arrival time that corresponds to the dashed line at right), wherein
the first PPG and the second PPG are sensed concurrently with each other (FIG.8: the collection of first blood pulse waveform 800 (the first PPG) detected by the first sensor 120 and the second blood pulse waveform 820 (The second PPG) detected by the second sensor 122 starts at the same time);
determining a pulse wave velocity (PWV) based on the first distance, the second distance, and a differential PAT of the first PAT and the second PAT ([0058]: a pulse wave velocity (PWV) is the difference in the distance between the first and second sensors 120, 122 divided by the difference in the pulse transit time between the first and second sensors 120, 122: PWV=distance 124/ΔPAT 804); and
determining a blood pressure measurement of the subject based on the PWV ([0058]: the PWV relates to the central aortic blood pressure (also referred to as the central arterial blood pressure (CABP)): PWV=f(CABP)).
Claims 4, 11 and 18. Messerschmi teaches all the limitations of claims 2, 9 and 16 including determining, based on a PPG taken at the first distance, a PAT corresponding to the first distance; determining, based on a PPG taken at the second distance and, a PAT corresponding to the second distance; determining a PAT differential based on the PPG taken at the first distance and the PPG taken at the second distance; and determining the blood pressure measurement of the subject based on the PAT differential (See the rejection to claims 2, 9 and 16: Messerschmi [0021], [0027], FIG.3, FIG.8, and [0058]).
Messerschmi further teaches
determining a plurality of subsequent blood pressure measurements of the subject based on a plurality of subsequently determined PATs and a recorded PPG corresponding to each of the plurality of subsequently determined PATs ([0005]: the processing and communication capabilities of the portable device can be harnessed to provide a beginning-to-end measurement experience to the user. Physiological measurements include, but are not limited to, blood pressure measurements; [0003]: in the case of blood pressure measurements, a plurality of measurements obtained over a 24 hour or longer time period are of increasing importance in the practice of medicine; and FIG.8: the first waveform and the second waveform are monitored in a time course such that a plurality of differential PATs are obtained for a plurality of blood pressure measurements).
Since the blood pressure measurements are performed a plurality times, the measurement time at the second time is considered “a first time after the plurality of subsequent blood pressure measurements” as claimed. Referring to FIG.8, it may be the measurement time associated with the third peaks of 800 and 802 (where 800 and 802 label are placed) that is referring to the “first time” as claimed, which is after the previous two times points associated with the previous two peaks.
Claims 5, 12 and 19. Messerschmi further teaches that
the blood pressure measurement of the subject is inversely proportional to the differential PAT ([0058]: PWV=distance 124/ΔPAT 804; and the PWV relates to the central aortic blood pressure (also referred to as the central arterial blood pressure (CABP)): PWV=f(CABP)).
According to the above cited equation, a blood pressure is inversely proportional to a differential PAT, including the second differential PAT.
Claims 6, 13 and 20. Messerschmi further teaches that
the first distance corresponds to a distance between a location on a body of the subject where the first PPG is sensed and the heart of the subject (FIG.4: the first PPG is sensed by the first sensor 120 that is at a distance to the heart).
Claims 7 and 14. Messerschmi further teaches that
the first PPG is performed by a first optical sensor of a device (120) and the second PPG is performed by a second optical sensor of the device (122) ([0021]: the portable device 101 also includes a first sensor 120 spaced a fixed, known distance 124 apart from a second sensor 122; and [0027]: each of the first and second sensors 120, 122 comprises an optical type of sensor, and in particular, a reflective type photoplethysmography (PPG) sensor; FIG.3: a first location A refers to where the first sensor 120 contacts the skin).
Claims 8, 15 and 21. Messerschmi further teaches
displaying the determined blood pressure measurement of the subject on a display (102) of a device in communication with a mobile computing device (101) ([0068]: the information display module is configured to facilitate display of one or more user interface screen including such physiological measurement(s) on the touch sensor panel 102; and [0005]: Physiological measurements include, but are not limited to, blood pressure measurements).
Examiner’s Notes
Claims 3, 10 and 17 are not rejected under prior arts.
The limitations recited in claims 3, 10 and 17 in regard to the features of “determining a third distance as a difference between the first distance and the second distance, wherein the first distance is from the first point to the heart, and the second distance is from the second point to the heart; and determining the PWV by dividing the third distance by the differential PAT", in combination with the other claimed elements, is/are not taught or disclosed in the prior arts.
Response to Arguments
Applicant’s arguments in regard to the rejection under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Examiner first of all respectfully points out that, the claim limitation being identified as the abstract idea, as indicated in the instant Office action, page 4, is “determining a pulse wave velocity (PWV) based on the first distance, the second distance, and a differential PAT of the first PAT and the second PAT; and determining a blood pressure measurement of the subject based on the PWV”
Applicant asserted on p.8 of the Remarks, ¶-1 that “claim 2 does not recite the abstract idea of using a mathematic concept to determine “a pulse wave velocity (PWV) based on the first distance, the second distance, and a differential PAT of the first PAT and the second PAT; and determining a blood pressure measurement of the subject based on the PWV”.
Examiner respectfully disagrees and notes that, as considered in the rejection, a pulse wave velocity is a type of velocity. A velocity is known to be a distance change over a time period. Hence one may obtain the pulse wave velocity by calculating the distance difference between the first distance and the second distance, and by dividing the distance difference by the differential PAT that is the time difference between the two pulse waves. Further, the mathematical relationship to convert the pulse wave velocity to the blood pressure is well-known in the field of art. One may obtain the blood pressure using the pulse wave velocity with the known mathematical relationship of the two parameters. Without further details in the claim to show how the PWV is determined based on the distance and the differential PAT, and how the blood pressure is determined based on the PWV to show that these determination is not a mathematical concept, Examiner could only rely on the physical definition and how the determination is performed conventionally for her consideration. Therefore, each of the above steps are grouped as mathematical concepts, hence an abstract idea.
Applicant further asserted on p.8, ¶-2 that “claim 2 does not recite a mental process. Claims do not recite a mental process when they do not contain limitations that can practically be performed in the human mind, for instance when the human mind is not equipped to perform the claim limitations…Here, the human mind is not capable of (1) “determining, from a first PPG sensed at a first point…Nor is the human mind capable of (2) “determining a PWV based on the first distance, the second distance, and a differential PAT of the first PAT and the second PAT” (Remarks, p.8, emphasis added).
Examiner respectfully disagrees and notes that, in regard to the above feature (1), it is not part of the abstract idea identified abstract. This limitation is considered an additional element (see Rejection, Step 2A Prong two, and Step 2B). Hence, the argument whether it is a mental process is irrelevant. In regard to the above feature (2), as noted in the rejection, p.4 of the instant Office action - A velocity is known to be a distance change over a time period. Hence one may obtain the pulse wave velocity by calculating the distance difference between the first distance and the second distance, and by dividing the distance difference by the differential PAT that is the time difference between the two pulse waves. Hence, if a person were to visually examine, i.e., perform an observation, the first distance, the second distance, and the differential PAT of the first PAT and the second PAT, he/she would be able to identify the distance differential via simple subtraction, and then identify the PWV via a ratio of the distance differential and the PAT differential. He/she would further be able to obtain the blood pressure based on the known mathematical relationship between the pulse wave velocity and the blood pressure, either mentally, with a pen and paper, or with a generic computer. There is nothing recited in the claim to suggest an undue level of complexity in how the pulse wave velocity and the blood pressure to be determined. Similar to the consideration of this feature being a mathematical concept, without further details in the claim to show how the PWV is determined based on the distance and the differential PAT, and how the blood pressure is determined based on the PWV to show that these determination cannot be reasonably performed as a mental process, Examiner could only rely on the physical definition and how the determination is performed conventionally for her consideration. Therefore, the above feature (2) is considered as a mental process, hence an abstract idea.
Applicant further asserted on p.9, “claim 2 includes features directed to a non-invasive technique for determination of a subject’s blood pressure that overcomes many drawbacks with previous standard blood pressure detection methods such as the use of a cuff, which is bulky, costly, and does not allow continuous monitoring. Thus, the features of claim 2 improve the technical field of mobile blood pressure monitoring, and would integrate any recited judicial exception into a practical application of the exception”.
Examiner respectfully disagrees and notes that, any element that may be considered being either integrating the abstract idea into a practical application, or sufficient to amount the abstract idea to significantly more needs to be additional elements to the identified judicial exception. In this case, the additional element recited in claim 2 is the first and the second determining step, i.e., “determining, from a first/second PPG from a first/second distance, a first/second PAT corresponding to the corresponding distance”. These additional elements are considered merely serving to gather and feed information to the abstract idea and to output a notification based on the abstract idea (Step 2A, Prong 2), while generically implementing it on conventionally used tools evidenced by Messerschmi et al. (Step 2B).
Applicant’s arguments in regard to the rejection to claims 2, 9 and 16 under 35 U.S.C. 102(a)(2), in particular the teaching of Messerschmidt, have been fully considered but they are not persuasive.
Applicant asserted that Messerschmidt does not teach the first three determining steps of claim 2, i.e., determining a first PAT, determining a second PAT, and determining a PWV based on the first distance, the second distance, and the differential PAT of the first PAT and the second PAT. Applicant asserted that “determining a pulse wave velocity based on the distance between the first and second sensors (as disclosed by Messerschmidt), is not analogous to "determining a pulse wave velocity (PWV) based on the first distance, the second distance, and a differential PAT of the first PAT and the second PAT," where the first distance corresponds to the distance between the first point where the first PPG is sensed and the heart of the user and the second distance corresponds to the distance between the second point where the second PPG is sensed and the heart of the user. This is further evidenced by the fact that the distance 124 of Messerschmidt is fixed (as the sensors on the device of Messerschmidt do not move around).”
Examiner respectfully disagrees and notes the following in regard to claim 2, with the same consideration applies to claims 9 and 16: the claimed limitation of determining a pulse wave velocity (PWV) based on the first distance, the second distance, and a differential PAT of the first PAT and the second PAT” is broadly recited such that the PWV is associated with the first distance, the second distance and the differential PAT (i.e., “determining…based on…” as claimed). Messerschmidt teaches in [0058] the formula for calculating the PWV: PWV=distance 124/ΔPAT. In this equation, distance 124 is the distance between the first PPG sensor 120 and the second PPG sensor 122. In Messerschmi, the first sensor 120 is at a first distance from the heart and it detects changes in the reflected light over time corresponding to a first blood pulse wave form 800. The second blood pulse waveform 802 is similarly obtained from the second sensor 122 that is at a second distance from the heart. Further in [0058], it teaches that ΔPAT is derived from the first and second blood pulse waveforms 800 and 802. Hence, the PWV of Messerschmi that is determined based on the distance 124 and the differential PAT is considered being determined based on “the first distance, and the second distance, and the differential PAT” as claimed. The waveforms 800 and 802 are associated with the first distance and the second distance. The distance 124 is also associated with the first distance and the second distance. The PWV hence is associated with the first distance and the second distance.
Applicant is reminded that the current claim language merely broadly recites that the PWV is determined based on the first distance, the second distance, and a differential PAT. If there is any particular relationship that may distinguish the claimed feature over the prior art, it is not yet reflected in the claim. Applicant asserted that “the distance 124 of Messerschmidt is fixed and the sensors do not move around”. Since this feature is not recited at all in the claim. It is unclear how this argument is relevant. If the specification supports that the sensors need to be moved around and the distance between the sensors are a variable when determining the PWV, Applicant is suggested to properly reflect such a feature in the claims.
Based on the above considerations, claims 2-21 remain rejected.
Conclusion
THIS ACTION IS MADE FINAL. 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 YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798