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 .
Response to Amendment
This office action is in response to the remarks filed on 07/14/2025.
The amendment filed 07/14/2025 has been entered. Claims 8-12 and 21-32 remain pending in the application, and claims 1-7 and 13-20 have been canceled, and claims 33-35 have been newly added.
This office action is in response to the remarks filed on 07/14/2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 8-9 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Elliot (WO 2014125431 A1, of record) in view of Rekimoto (US 20090143688 A1) and Ha et al. (US 20100049059 A1, of record, hereinafter "Ha").
Regarding claim 8, Elliot teaches a personal hand-held monitor (PHHM) configured to derive one or more measurements of a parameter related to health of a subject from data collected by the PHHM (The present invention relates to means for collecting personal health data. In particular, the invention relates a personal hand-held monitor (hereafter "a PHHM") comprising a signal acquisition device for acquiring signals which can be used to derive one or more measurements of a parameter related to the health of a user, page 1 lines 2-6), wherein the parameter comprises blood pressure at systole (SBP) and blood pressure at diastole (DBP) (the processing means can analyse the signals received over a period of time and varying over a range of pressures from the pressure sensor to determine the SBP and/or DBP of the subject, page 33 lines 16-18), the PHHM comprising:
a signal acquisition device (SAD) which includes a pressure sensor (there is provided a PHHM comprising a signal acquisition device for acquiring signals which can be used to derive a measurement of a parameter related to the health of the user, the signal acquisition device being integrated with a PHHCD, which PHHM includes a blood flow occlusion means that is a sealed vessel containing an essentially incompressible fluid in which is immersed a pressure sensor which is adapted to provide electrical signals to the processor of the PHHCD, page 23 line 32-page 24 line 3);
and a processor (processing means p. 33; processor is adapted to extract a waveform from the electrical signals; page 24 lines 6-7)
wherein the SAD is adapted to be pressed against a finger to make the pressure measurement, or have the finger pressed against (Pressing the occlusion means against a body part, such as a finger, or vice versa creates a pressure within the body part. The pressure sensor measures, directly or indirectly, the pressure between the occlusion means and the body part, page. 32 lines 26-32) it to make a pressure measurement (a signal acquisition device for acquiring signals which can be used to derive one or more measurements of a parameter related to the health of a user, page 1 lines 2-6).
Elliot, however, does not teach:
wherein the processor of the PHHM is adapted to make (i) one or more estimates of the degree of rotation of the finger about its long axis and (ii) one or more estimates of the tilt of the finger against the pressure sensor about an axis that is perpendicular to its long axis based on the pressure measurement and to correct existing estimates of SBP and DBP in light of one or more of these estimates of the degree of rotation and one or more of these estimates of the tilt.
Rekimoto is considered analogous to the instant application as a blood flow imaging system is disclosed (abstract).
Rekimoto teaches:
wherein the processor of the PHHM is adapted to make (i) one or more estimates of the degree of rotation of the finger … and (ii) one or more estimates of the tilt of the finger against the pressure sensor …. based on the pressure measurement (As shown in FIG. 2A, when a finger FG is brought into contact with the imaging section 101, a vein pattern in a right part of the drawing can be obtained. As shown in FIG. 2B, when the finer FG is moved up, down, right and left, the vein pattern also moves up, down, right and left according to the movements of the finger FG. As shown in FIG. 2C, when the finger FG rotates about a contact surface with the imaging section 101, the vein pattern also rotates about a certain point [0069]; [0059] discloses detection of a change in pressure, to see if pressure is applied/removed; [0073] discloses blood flow volume changes depending on a degree of user's tension and a pressure to be applied to a body surface).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Elliot to include wherein the processor of the PHHM is adapted to make (i) one or more estimates of the degree of rotation of the finger and (ii) one or more estimates of the tilt of the finger against the pressure sensor based on the pressure measurement, as taught by Rekimoto. Doing so would allow to check for the user’s health state, as suggested by Rekimoto ([0083]).
The combined invention still does not teach [wherein the processor of the PHHM is adapted to make (i) one or more estimates of the degree of rotation of the finger] about its long axis and [(ii) one or more estimates of the tilt of the finger against the pressure sensor] about an axis that is perpendicular to its long axis [based on the pressure measurement and] to correct existing estimates of SBP and DBP in light of one or more of these estimates of the degree of rotation and one or more of these estimates of the tilt.
Ha is considered analogous to the instant application as "blood pressure measuring apparatus and method, in which a blood pressure measuring posture of a person to be examined is calculated on the basis of signals that are measured by an inclination measuring unit, so as to guide the person to be examined to maintain a reference measuring posture" (Abstract).
Ha teaches:
wherein the processor of the PHHM is adapted to make (i) one or more estimates of the degree of rotation of the finger about its long axis (figs. 3a and 3b of Ha, reproduced below, shows angles ‘θ1’ and ‘θ2’ which is a rotation about the long axis of the index finger, shown in the figures below; figs. 3a and 3b disclosed in [0046]).
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Fig. 3(a) and (b) of Ha reproduced above
and (ii) one or more estimates of the tilt of the finger against the pressure sensor about an axis that is perpendicular to its long axis based on the pressure measurement and to correct existing estimates of SBP and DBP ([0034]-[0035] discloses removing/filtering/correcting values based off movement of the of the arm/finger of the user) in light of one or more of these estimates of the degree of rotation and one or more of these estimates of the tilt ("central processing unit 60 can calculate a blood pressure measuring posture of the person to be examined, on the basis of the data that is measured by the inclination measuring unit 20 [0036]; When it is determined that the person to be examined does not maintain the reference measuring posture, the central processing unit 60 outputs a voice or a message that urges the person to be examined to take the reference measuring posture, thereby guiding a correct blood pressure measuring posture[0036]; FIG. 5 shows an example of when a message is displayed on a screen of a display unit 70, when a person to be examined does not maintain a reference measuring posture. That is, when it is determined that the height of the blood pressure measuring apparatus or a direction where the blood pressure measuring apparatus and the finger of the person to be examined form is not matched with the reference rotation angle β, the central processing unit 60 outputs a message informing that the height or direction is not matched with the reference rotation angle through the screen of the display unit 70, as shown in FIG. 5, thereby guiding the person to be examined to maintain the reference measuring posture[0066], Fig. 5).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include the processor of the PHHM is adapted to make (i) one or more estimates of the degree of rotation of the finger about its long axis and (ii) one or more estimates of the tilt of the finger against the pressure sensor about an axis that is perpendicular to its long axis based on the pressure measurement and to correct existing estimates of SBP and DBP in light of one or more of these estimates of the degree of rotation and one or more of these estimates of the tilt, as taught by Ha. Doing so would allow for the blood pressure measuring posture of the person to be examined can be correctly guided by inclination sensors, the person to be examined can accurately measure the blood pressure using a noninvasive and a nonpressurized method, as suggested by Ha (abstract). Ha further suggests that "[s]hortage of accuracy results from not only an error due to deviation of individual persons in the blood pressure measuring method using the pulse transit time but also an error due to inaccuracy of the posture of wearing the measuring apparatus caused by miniaturization of the measuring apparatus" ([0011]), and "Accordingly, it is an object of the present invention to provide an apparatus and method for measuring blood pressure that can calculate the posture of a person to be examined using inclination sensors and guide the person to be examined to maintain an accurate blood pressure measuring posture, thereby accurately measuring blood pressure using a pulse transit time (PTT)" ([0012]).
Regarding claim 9, modified Elliot teaches the PHHM of claim 8, as discussed above. Elliot, however, does not teach wherein the processor is adapted to establish empirical relationships between the one or more estimate(s) of the degree of rotation, the one or more estimate(s) of tilt, or both and the difference between the estimate of SBP and a true value of SBP or the difference between the estimate of DBP and a true value of and DBP.
Ha, however, teaches: wherein the processor (a central processing unit 60 [0030], Fig. 1) is adapted to establish empirical relationships between the one or more estimate(s) of the degree of rotation, the one or more estimate(s) of tilt, or both and the difference between the estimate of SBP and a true value of SBP or the difference between the estimate of DBP and a true value of and DBP (calculates a blood pressure measuring posture of the person to be examined on the basis of the signals measured by the inclination measuring unit, determines whether the person to be examined maintains a predetermined reference measuring posture by comparing the calculated blood pressure measuring posture of the person to be examined and the predetermined reference measuring posture, and measures the blood pressure of the person to be examined on the basis of the living body signal that is measured by the living body signal measuring unit [0013]; paragraph [0066] describes determining whether the posture of the finger matches up with the reference rotation angle β. When it is determined that the finger is not matched with the reference rotation angle, a message is output that there is not a match and guides the person to the reference measuring posture. Conversely, in Paragraph [0067], when it is determined that the posture of the finger is correctly corresponded to the reference rotation angle β, the signals are detected and the blood pressure measurement is performed. These two paragraphs demonstrate an empirical relationship between one or more estimates of rotation and the differences between the best estimates of SBP and DBP, and the true arterial blood pressure. In other words, Ha teaches an empirical relationship between the rotation angle and the reference measuring posture, and further uses the relationship to accurately measure the true blood pressure of the subject, [0018] further discloses that the blood pressure is measured throughout the positioning process, and compared to the “reference” posture, i.e. true value of the blood pressure compared to the estimated blood pressure).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include wherein the processor is adapted to establish empirical relationships between the one or more estimate(s) of the degree of rotation, the one or more estimate(s) of tilt, or both and the difference between the estimate of SBP and a true value of SBP or the difference between the estimate of DBP and a true value of and DBP, as taught by Ha. Doing so would allow for the blood pressure measuring posture of the person to be examined can be correctly guided by inclination sensors, the person to be examined can accurately measure the blood pressure using a noninvasive and a nonpressurized method, as suggested by Ha (abstract). Ha further suggests that "[s]hortage of accuracy results from not only an error due to deviation of individual persons in the blood pressure measuring method using the pulse transit time but also an error due to inaccuracy of the posture of wearing the measuring apparatus caused by miniaturization of the measuring apparatus" ([0011]), and "Accordingly, it is an object of the present invention to provide an apparatus and method for measuring blood pressure that can calculate the posture of a person to be examined using inclination sensors and guide the person to be examined to maintain an accurate blood pressure measuring posture, thereby accurately measuring blood pressure using a pulse transit time (PTT)" ([0012]).
Regarding claim 33, modified Elliot teaches the PHHM of claim 8 as discussed above. Elliot further teaches wherein the existing estimates of SBP and DBP ((the processing means can analyse the signals received over a period of time and varying over a range of pressures from the pressure sensor to determine the SBP and/or DBP of the subject, page 33 lines 16-18) are saved on a remote data processing system (The acquired signals may be analogue or digital and, if analogue, may be converted to digital form for subsequent analysis by the processor of the PHHCD or for analysis by a remote data processing facility with which the PHHCD communicates using the internet or other data communication means, Page 5 lines 15-19).
Regarding claim 34, Elliot teaches a device configured to derive systolic blood pressure (SBP) and diastolic blood pressure (DBP), the device comprising:
a signal acquisition device comprising a pressure sensor (there is provided a PHHM comprising a signal acquisition device for acquiring signals which can be used to derive a measurement of a parameter related to the health of the user, the signal acquisition device being integrated with a PHHCD, which PHHM includes a blood flow occlusion means that is a sealed vessel containing an essentially incompressible fluid in which is immersed a pressure sensor which is adapted to provide electrical signals to the processor of the PHHCD, page 23 line 32-page 24 line 3), wherein the signal acquisition device is adapted to be pressed against a finger or have the finger pressed against it (Pressing the occlusion means against a body part, such as a finger, or vice versa creates a pressure within the body part. The pressure sensor measures, directly or indirectly, the pressure between the occlusion means and the body part, page. 32 lines 26-32) to make a pressure measurement (a signal acquisition device for acquiring signals which can be used to derive one or more measurements of a parameter related to the health of a user, page 1 lines 2-6); and
a processor that is adapted to:
transmit the estimate of SBP and the estimate of DBP (the processing means can analyse the signals received over a period of time and varying over a range of pressures from the pressure sensor to determine the SBP and/or DBP of the subject, page 33 lines 16-18 to a remote data processing system (Some or all of the data analysis of the signals concerning blood pressure may be conducted on the remote computers, page 39 lines 16-20 The acquired signals may be analogue or digital and, if analogue, may be converted to digital form for subsequent analysis by the processor of the PHHCD or for analysis by a remote data processing facility with which the PHHCD communicates using the internet or other data communication means, Page 5 lines 15-19).
Elliot, however, does not teach a processor that is adapted to:
derive an estimate of SBP and an estimate of DBP; make an estimate of the degree of rotation of the finger about its long axis based on the pressure measurement; make an estimate of the tilt of the finger about an axis that is perpendicular to its long axis based on the pressure measurement; and correct the estimate of SBP and the estimate of DBP in light of the estimate of the degree of rotation and the estimate of the tilt.
Rekimoto is considered analogous to the instant application as a blood flow imaging system is disclosed (abstract).
Rekimoto teaches:
make an estimate of the degree of rotation of the finger … based on the pressure measurement (As shown in FIG. 2A, when a finger FG is brought into contact with the imaging section 101, a vein pattern in a right part of the drawing can be obtained. As shown in FIG. 2B, when the finer FG is moved up, down, right and left, the vein pattern also moves up, down, right and left according to the movements of the finger FG. As shown in FIG. 2C, when the finger FG rotates about a contact surface with the imaging section 101, the vein pattern also rotates about a certain point [0069]; [0059] discloses detection of a change in pressure, to see if pressure is applied/removed; [0073] discloses blood flow volume changes depending on a degree of user's tension and a pressure to be applied to a body surface).;
make an estimate of the tilt of the finger about an axis…based on the pressure measurement (As shown in FIG. 2A, when a finger FG is brought into contact with the imaging section 101, a vein pattern in a right part of the drawing can be obtained. As shown in FIG. 2B, when the finer FG is moved up, down, right and left, the vein pattern also moves up, down, right and left according to the movements of the finger FG. As shown in FIG. 2C, when the finger FG rotates about a contact surface with the imaging section 101, the vein pattern also rotates about a certain point [0069]; [0059] discloses detection of a change in pressure, to see if pressure is applied/removed; [0073] discloses blood flow volume changes depending on a degree of user's tension and a pressure to be applied to a body surface).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Elliot to include make an estimate of the degree of rotation of the finger based on the pressure measurement, and make an estimate of the tilt of the finger based on the pressure measurement, as taught by Rekimoto. Doing so would allow to check for the user’s health state, as suggested by Rekimoto ([0083]).
The combined invention still does not teach
derive an estimate of SBP and an estimate of DBP; transmit the estimate of SBP and the estimate of DBP [to a remote data processing system]; [make an estimate of the degree of rotation of the finger about] its long axis [based on the pressure measurement; [make an estimate of the tilt of the finger about] an axis that is perpendicular to its long axis [based on the pressure measurement]; and correct the estimate of SBP and the estimate of DBP in light of the estimate of the degree of rotation and the estimate of the tilt.
Ha is considered analogous to the instant application as "blood pressure measuring apparatus and method, in which a blood pressure measuring posture of a person to be examined is calculated on the basis of signals that are measured by an inclination measuring unit, so as to guide the person to be examined to maintain a reference measuring posture" (Abstract).
Ha teaches:
make an estimate of the degree of rotation of the finger about its long axis based on the pressure measurement (figs. 3a and 3b of Ha, reproduced below, shows angles ‘θ1’ and ‘θ2’ which is a rotation about the long axis of the index finger, shown in the figures below; figs. 3a and 3b disclosed in [0046]).;
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Fig. 3(a) and (b) of Ha reproduced above
make an estimate of the tilt of the finger about an axis that is perpendicular to its long axis based on the pressure measurement; and correct the estimate of SBP and the estimate of DBP ([0034]-[0035] discloses removing/filtering/correcting values based off movement of the of the arm/finger of the user) in light of the estimate of the degree of rotation and the estimate of the tilt ("central processing unit 60 can calculate a blood pressure measuring posture of the person to be examined, on the basis of the data that is measured by the inclination measuring unit 20 [0036]; When it is determined that the person to be examined does not maintain the reference measuring posture, the central processing unit 60 outputs a voice or a message that urges the person to be examined to take the reference measuring posture, thereby guiding a correct blood pressure measuring posture[0036]; FIG. 5 shows an example of when a message is displayed on a screen of a display unit 70, when a person to be examined does not maintain a reference measuring posture. That is, when it is determined that the height of the blood pressure measuring apparatus or a direction where the blood pressure measuring apparatus and the finger of the person to be examined form is not matched with the reference rotation angle β, the central processing unit 60 outputs a message informing that the height or direction is not matched with the reference rotation angle through the screen of the display unit 70, as shown in FIG. 5, thereby guiding the person to be examined to maintain the reference measuring posture[0066], Fig. 5).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include derive an estimate of SBP and an estimate of DBP, transmit the estimate of SBP and the estimate of DBP to a remote data processing system, make an estimate of the degree of rotation of the finger about its long axis based on the pressure measurement make an estimate of the tilt of the finger about an axis that is perpendicular to its long axis based on the pressure measurement, and correct the estimate of SBP and the estimate of DBP in light of the estimate of the degree of rotation and the estimate of the tilt, as taught by Ha. Doing so would allow for the blood pressure measuring posture of the person to be examined can be correctly guided by inclination sensors, the person to be examined can accurately measure the blood pressure using a noninvasive and a nonpressurized method, as suggested by Ha (abstract). Ha further suggests that "[s]hortage of accuracy results from not only an error due to deviation of individual persons in the blood pressure measuring method using the pulse transit time but also an error due to inaccuracy of the posture of wearing the measuring apparatus caused by miniaturization of the measuring apparatus" ([0011]), and "Accordingly, it is an object of the present invention to provide an apparatus and method for measuring blood pressure that can calculate the posture of a person to be examined using inclination sensors and guide the person to be examined to maintain an accurate blood pressure measuring posture, thereby accurately measuring blood pressure using a pulse transit time (PTT)" ([0012]).
Claims 10-12 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Elliot (WO2014125431A1, of record) in view of Rekimoto and (US 20090143688 A1) and Ha et al. (US 20100049059 A1, of record, hereinafter "Ha"),and Ohno (US 20170181648 A1).
Regarding claim 10, modified Elliot teaches the PHHM of claim 9, as discussed above. Elliot, however, does not teach wherein the estimates of SBP and DBP are found by calculating, respectively, a weighted average of a plurality of separate estimates of SBP and a weighted average of a plurality of separate estimates of DBP where the weights for each of the plurality of separate estimates of SBP and DBP represent where the weights for each of the plurality of separate estimates of SBP and DBP represent are determined by: empirical analysis of a theoretical contribution to the weighted averages.
Ohno is considered analogous to the instant application as “Blood pressure estimation device, blood pressure estimation method, blood pressure measurement device, and recording medium” is disclosed (title).
Ohno teaches:
wherein the estimates of SBP and DBP are found by calculating, respectively, a weighted average of a plurality of separate estimates of SBP and a weighted average of a plurality of separate estimates of DBP where the weights for each of the plurality of separate estimates of SBP and DBP represent where the weights for each of the plurality of separate estimates of SBP and DBP represent are determined by: empirical analysis of a theoretical contribution to the weighted averages ([0067]-[0072] and [0074]-[0076] discloses a “degree of similarity” or a “degree of correlation” which is used to calculate blood pressure, these are calculated using “blood pressure information”, which are stored values/plurality of estimates of SBP and DBP, which are used to correlate the values of the signal to value of SBP and DBP, para. [0073] and [0074] further disclose that the blood pressure is estimated using the a weighted average value using with the “degree of similarity”, i.e. the correlation values, i.e. the “empirical analysis of a theoretical contribution to the weighted averages” ).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include wherein the estimates of SBP and DBP are found by calculating, respectively, a weighted average of a plurality of separate estimates of SBP and a weighted average of a plurality of separate estimates of DBP where the weights for each of the plurality of separate estimates of SBP and DBP represent where the weights for each of the plurality of separate estimates of SBP and DBP represent are determined by: empirical analysis of a theoretical contribution to the weighted averages, as taught by Ohno. Doing so would accurately measure a blood pressure, as suggested by Ohno ([0019]).
Regarding claim 11, modified Elliot teaches the PHHM of claim 10, as discussed above.
Elliot, however, does not teach wherein the processor of the PHHM is adapted to use these empirical relationships to correct the estimates of SBP and DBP to give corrected estimates of SBP and DBP.
Ha, however teaches, wherein the processor of the PHHM (a central processing unit 60 [0030], Fig. 1) is adapted to use these empirical relationships to correct the estimates of SBP and DBP to give corrected estimates of SBP and DBP (calculates a blood pressure measuring posture of the person to be examined on the basis of the signals measured by the inclination measuring unit, determines whether the person to be examined maintains a predetermined reference measuring posture by comparing the calculated blood pressure measuring posture of the person to be examined and the predetermined reference measuring posture, and measures the blood pressure of the person to be examined on the basis of the living body signal that is measured by the living body signal measuring unit [0013]; [0066]-[0067] and Fig. 5. Paragraph [0066] describes determining whether the posture of the finger matches up with the reference rotation angle β. When it is determined that the finger is not matched with the reference rotation angle, a message is output that there is not a match and guides the person to the reference measuring posture. Conversely, in Paragraph [0067], when it is determined that the posture of the finger is correctly corresponded to the reference rotation angle β, the signals are detected and the blood pressure measurement is performed. These two paragraphs demonstrate empirical relationships to correct the estimates of SBP and DBP to give more accurate estimates of SBP and DBP. In other words, Ha teaches the empirical relationships between the rotation; angle and the reference measuring posture that are used to correct the estimates of the blood pressure to give a more accurate estimate of the blood pressure; Shortage of accuracy results from not only an error due to deviation of individual persons in the blood pressure measuring method using the pulse transit time but also an error due to inaccuracy of the posture of wearing the measuring apparatus caused by miniaturization of the measuring apparatus [0011]; Accordingly, it is an object of the present invention to provide an apparatus and method for measuring blood pressure that can calculate the posture of a person to be examined using inclination sensors and guide the person to be examined to maintain an accurate blood pressure measuring posture, thereby accurately measuring blood pressure using a pulse transit time (PTT) [0012])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include wherein the processor of the PHHM is adapted to use these empirical relationships to correct the estimates of SBP and DBP to give corrected estimates of SBP and DB, as taught by Ha. Doing so would allow for the blood pressure measuring posture of the person to be examined can be correctly guided by inclination sensors, the person to be examined can accurately measure the blood pressure using a noninvasive and a nonpressurized method, as suggested by Ha (abstract). Ha further suggests that "[s]hortage of accuracy results from not only an error due to deviation of individual persons in the blood pressure measuring method using the pulse transit time but also an error due to inaccuracy of the posture of wearing the measuring apparatus caused by miniaturization of the measuring apparatus" ([0011]), and "Accordingly, it is an object of the present invention to provide an apparatus and method for measuring blood pressure that can calculate the posture of a person to be examined using inclination sensors and guide the person to be examined to maintain an accurate blood pressure measuring posture, thereby accurately measuring blood pressure using a pulse transit time (PTT)" ([0012]).
Regarding claim 12, modified Elliot teaches the PHHM of claim 10, as discussed above. Elliot further teaches wherein the processor is adapted to derive the empirical relationships using machine learning to find the optimum corrections from a large body of measured results (There are thus five separate measurements and several pieces of data that may be combined using an optimising mathematical algorithm such as a Bayesian estimator to obtain the most reliable estimate of BP, page. 13).
Regarding claim 22, modified Elliot teaches the PHHM of claim 10, as discussed above. Elliot further teaches wherein the plurality of separate estimates of SBP are derived from two or more analyses of the parameter related to health of the subject (BP may be estimated by combining the data from four different types of evidence: pulse wave velocity, pulse volume, sphygmomanometry and pulse rate, page 13).
Regarding claim 23, modified Elliot teaches the PHHM of claim 10, as discussed above. Elliot further teaches wherein the plurality of separate estimates of DBP are derived from two or more analyses of the parameter related to health of the subject (BP may be estimated by combining the data from four different types of evidence: pulse wave velocity, pulse volume, sphygmomanometry and pulse rate, page 13).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Elliot (WO2014125431A1, of record) in view of Rekimoto and (US 20090143688 A1) and Ha (US 20100049059 A1, of record),and Ohnemus (US 20140135592 A1)
Regarding claim 21, modified Elliot teaches the PHHM of claim 8, as discussed above.
Elliot, however does not teach wherein the processor is adapted to display to the subject an indication of how the estimates of SBP and DBP compare with a blood pressure statistic of the general population.
Ohnemus is considered analogous to the instant application as a deice for health related information is disclosed (abstract).
Ohnemus, however, teaches:
wherein the processor (processor [0185]) is adapted to display (FIG. 15 illustrates a data presentation format [0018]; a display portion 302 configured to operate in a plurality of modes and display information corresponding to the modes [0036]) to the subject an indication of how the estimates of SBP and DBP compare with a blood pressure statistic of the general population (Referring to FIG. 15, the user's individual medical parameters (e.g.,, the medical data provided as a part the Metric Health Model) can be compared against other users .. systolic blood pressure (sBP), diastolic blood pressure (dBP), … are shown on a graph 1412. …. Thus, the user can compare their individual parameters to a group of friends and the average for a large population group [0165]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include wherein the processor is adapted to display to the subject an indication of how the estimates of SBP and DBP compare with a blood pressure statistic of the general population, as taught by Ohnemus. Doing so allows for comparative bench marking (against friends, co-workers, etc.) with other users, as suggested by Ohnemus ([0165])
Claim 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Elliot (WO2014125431A1, of record) in view of Rekimoto and (US 20090143688 A1) and Ha et al. (US 20100049059 A1, of record, hereinafter "Ha")Ohno (US 20170181648 A1), and Tran (US 20150269825 A1)
Regarding claim 24, modified Elliot teaches the PHHM of claim 10, as discussed above. Elliot, however, does not teach wherein the processor is adapted to calculate the weighted average for SBP using the plurality of separate estimates of SBP, the weights for the plurality of separate estimates of SBP, and a measure of precision for each of the plurality of separate estimates of SBP.
Ohno, however teaches wherein the processor (processing device [0023]) is adapted to calculate the weighted average for SBP using the plurality of separate estimates of SBP, the weights for the plurality of separate estimates of SBP ([0067]-[0072] and [0074]-[0076] discloses a “degree of similarity” or a “degree of correlation” which is used to calculate blood pressure, these are calculated using “blood pressure information”, which are stored values/plurality of estimates of SBP and DBP, which are used to correlate the values of the signal to value of SBP and DBP, para. [0073] and [0074] further disclose that the blood pressure is estimated using the a weighted average value).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include the processor is adapted to calculate the weighted average for SBP using the plurality of separate estimates of SBP, the weights for the plurality of separate estimates of SBP, as taught by Ohno. Doing so would accurately measure a blood pressure, as suggested by Ohno ([0019]).
The combined invention still does not teach calculating a measure of precision for each of the plurality of separate estimates of SBP.
Tran is considered analogous to the instant application as it shares a similar field of endeavor of wireless monitoring devices ([0002]).
Tran teaches a measure of precision for each of the plurality of separate estimates of SBP ([0019], [0179], [0047] discloses that the processor can generate statistics of a patient’s blood pressure, including systolic and diastolic blood pressure, including standard deviation, i.e. precision, [0186] discloses that the blood pressure data includes systolic and diastolic blood pressure).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include a measure of precision for each of the plurality of separate estimates of SBP, as taught by Tran. Doing so would non-invasively measures blood pressure can be done in a matter of seconds without affecting the patient as suggested by Tran ([0179]).
Regarding claim 25, modified Elliot teaches the PHHM of claim 24, as discussed above. Elliot, however, does not teach wherein the processor is adapted to calculate the weighted average for SBP using SBP:
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wherein SBPm is the mth separate estimate of SBP, wherein Wm is the weight attributed to SBPm, and wherein Qm is the measure of precision for SBPm
Ohno, however, teaches wherein the processor is adapted to calculate the weighted average for SBP using … SBPm is the mth separate estimate of SBP, [and] Wm is the weight attributed to SBPm ([0067]-[0072] and [0074]-[0076] discloses a “degree of similarity” or a “degree of correlation” which is used to calculate blood pressure, these are calculated using “blood pressure information”, which are stored values/plurality of estimates of SBP and DBP, which are used to correlate the values of the signal to value of SBP and DBP, para. [0073] and [0074] further disclose that the blood pressure is estimated using the a weighted average value).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include wherein the processor is adapted to calculate the weighted average for SBP using: SBPm is the mth separate estimate of SBP, [and] Wm is the weight attributed to SBPm , as taught by Ohno. Doing so would accurately measure a blood pressure, as suggested by Ohno ([0019]).
The combined invention still does not teach the measure of precision for SBPm.
Tran teaches [calculating] using the measure of precision for SBPm ([0019], [0179], [0047] discloses that the processor can generate statistics of a patient’s blood pressure, including systolic and diastolic blood pressure, including standard deviation, i.e. precision, [0186] discloses that the blood pressure data includes systolic and diastolic blood pressure)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include the measure of precision for SBPm, as taught by Tran. Doing so would non-invasively measures blood pressure can be done in a matter of seconds without affecting the patient as suggested by Tran ([0179]).
Regarding claim 26, modified Elliot teaches the PHHM of claim 25 as discussed above. Elliot, however, does not teach wherein the processor is adapted to find quality of the weighted average for SBP by calculating a standard deviation between the plurality of separate estimates of SBP.
Tran, however, teaches wherein the processor is adapted to find quality of the weighted average for SBP by calculating a standard deviation between the plurality of separate estimates of SBP ([0019], [0179], [0047] discloses that the processor can generate statistics of a patient’s blood pressure, including systolic and diastolic blood pressure, including standard deviation, [0186] discloses that the blood pressure data includes systolic and diastolic blood pressure).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include wherein the processor is adapted to find quality of the weighted average for SBP by calculating a standard deviation between the plurality of separate estimates of SBP, as taught by Tran. Doing so would non-invasively measures blood pressure can be done in a matter of seconds without affecting the patient as suggested by Tran ([0179]).
Regarding claim 27, modified Elliot teaches the PHHM of claim 10. Elliot, however, does not teach wherein the processor is adapted to calculate the weighted average for DBP using the plurality of separate estimates of DBP, the weights for the plurality of separate estimates of DBP, and a measure of precision for each of the plurality of separate estimates of DBP.
Ohno, however, teaches wherein the processor (processing device [0023]) is adapted to calculate the weighted average for DBP using the plurality of separate estimates of DBP, the weights for the plurality of separate estimates of DBP ([0067]-[0072] and [0074]-[0076] discloses a “degree of similarity” or a “degree of correlation” which is used to calculate blood pressure, these are calculated using “blood pressure information”, which are stored values/plurality of estimates of SBP and DBP, which are used to correlate the values of the signal to value of SBP and DBP, para. [0073] and [0074] further disclose that the blood pressure is estimated using the a weighted average value).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include the processor is adapted to calculate the weighted average for DBP using the plurality of separate estimates of DBP, the weights for the plurality of separate estimates of DBP, as taught by Ohno. Doing so would accurately measure a blood pressure, as suggested by Ohno ([0019]).
Regarding claim 28, modified Elliot teaches the PHHM of claim 27, as discussed above. Elliot, however does not teach wherein the processor is adapted to calculate the weighted average for DBP using :
wherein DBPm is the mth separate estimate of DBP, wherein Wm is the weight attributed to DBPm, and wherein Qm is the measure of precision for DBPm
Ohno, however, teaches wherein the processor is adapted to calculate the weighted average for DBP using … DBPm is the mth separate estimate of DBP, wherein Wm is the weight attributed to DBPm (([0067]-[0072] and [0074]-[0076] discloses a “degree of similarity” or a “degree of correlation” which is used to calculate blood pressure, these are calculated using “blood pressure information”, which are stored values/plurality of estimates of SBP and DBP, which are used to correlate the values of the signal to value of SBP and DBP, para. [0073] and [0074] further disclose that the blood pressure is estimated using the a weighted average value).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include wherein the processor is adapted to calculate the weighted average for DBP using … DBPm is the mth separate estimate of DBP, wherein Wm is the weight attributed to DBPm, as taught by Ohno. Doing so would accurately measure a blood pressure, as suggested by Ohno ([0019]).
The combined invention still does not teach (calculating), Qm is the measure of precision for DBPm.
Tran, however, teaches, teaches [calculating] using the measure of precision for DBPm ([0019], [0179], [0047] discloses that the processor can generate statistics of a patient’s blood pressure, including systolic and diastolic blood pressure, including standard deviation, i.e. precision, [0186] discloses that the blood pressure data includes systolic and diastolic blood pressure)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include the measure of precision for SBPm, as taught by Tran. Doing so would non-invasively measures blood pressure can be done in a matter of seconds without affecting the patient as suggested by Tran ([0179]).
Regarding claim 29, modified Elliot teaches the PHHM of claim 28, as discussed above. Elliot, however, does not teach wherein the processor is adapted to find quality of the weighted average for SBP by calculating a standard deviation between the plurality of separate estimates of DBP.
Tran, however, teaches wherein the processor is adapted to find quality of the weighted average for DBP by calculating a standard deviation between the plurality of separate estimates of DBP ([0019], [0179], [0047] discloses that the processor can generate statistics of a patient’s blood pressure, including systolic and diastolic blood pressure, including standard deviation, [0186] discloses that the blood pressure data includes systolic and diastolic blood pressure).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include wherein the processor is adapted to find quality of the weighted average for DBP by calculating a standard deviation between the plurality of separate estimates of DBP, as taught by Tran. Doing so would non-invasively measures blood pressure can be done in a matter of seconds without affecting the patient as suggested by Tran ([0179]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Elliot (WO 2014125431A1, of record) in view of Rekimoto and (US 20090143688 A1) and Ha et al. (US 20100049059 A1, of record, hereinafter "Ha") , Ohno (US 20170181648 A1), and Proenca et al. (US 20170360314 A1, hereinafter “Proenca”).
Regarding claim 30, modified Elliot teaches the PHHM of claim 10, as discussed above.
Elliot, however does not teach wherein at least one of the weights for the plurality of separate estimates of SBP or DBP is set to zero.
Proenca is considered analogous to the instant application as “METHOD, APPARATUS AND COMPUTER PROGRAM FOR DETERMINING A BLOOD PRESSURE VALUE” is disclosed (title).
Proenca teaches wherein at least one of the weights for the plurality of separate estimates of SBP or DBP is set to zero (para. [0049] of Proenca discloses that the weighting factor of the signal ,is set to 0, para [0046] discloses that systolic and diastolic pressures are determined from the pulse signals).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Elliot to include wherein at least one of the weights for the plurality of separate estimates of SBP or DBP is set to zero, as taught by Proenca. Doing so would allow for improved signal quality.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Elliot (WO2014125431A1, of record) in view of Rekimoto and (US 20090143688 A1) and Ha et al. (US 20100049059 A1, of record, hereinafter "Ha"), Ohno (US 20170181648 A1), Proenca et al. (US 20170360314 A1, hereinafter “Proenca”), and Soy