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 .
Claim Rejections - 35 USC § 102
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)(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 1-7, and 9-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by John et al. (US 2021/0401332; hereinafter John).
Regarding claim 1, John discloses self monitoring and case assistant or achieving glycemic goals. John shows a method for determining a physiological parameter (see abstract, fig. 6, 7 and 10), comprising the steps of: providing a PPG sensor device configured to measure a single PPG signal (see par. [0032], [0072], [0213], [0218]; fig. 1) comprising a non-modulated component (see par. [0169], fig. 3, 6, 7) and a time-modulated component (see par. [0024]; fig. 3, 6 and 7), wherein the time-modulated component comprises at least an arterial pulsatility component (see par. [0025], [0070]) and a venous pulsatility component (see par. [0026], [0070], [0077], [0095], [0096]); using the PPG sensor device to measure the single PPG signal on a user see par. [0032], [0072], [0213], [0218]; fig. 1, the PPG signal containing at least two cardiac cycles (see fig. 3, 6, 7, and 14; par. [0072]); identifying individual PPG pulses from the single PPG signal, each individual PPG pulse corresponding to a cardiac cycle (see par. [0029], [0033], [0046], fig. 3-6, 7 and 10); for each individual PPG pulse, determining a set of at least one venous-related feature indicative of the contribution of venous pulsatility to the time-modulated component of the PPG pulse from at least a waveform parameter characterizing the shape of the PPG pulse (see par. [0029], [0033], [0046], [0070], [0095], [0096], [0153], [0169]-[0175]; fig. 3-6, 7 and 10); assigning a weighting factor to each pulse, comprising calculating the weighting factor by using a weighting function comprising a mathematical operator inputted with said set of at least one venous-related feature (see par. [0038], [0049], [0158], [0168], [0169], [0186], [0187], [0272]); computing a weighted-average PPG pulse by using the individual PPG pulses and their respective weighting factors (see par. [0088], [0091], [0156], [0164], [0165], [0167], [0185], [0203], [0204]); and determining the physiological parameter by using the weighted-average PPG pulse (see par. [0088], [0091], [0156], [0164], [0165], [0167], [0185], [0203], [0204]).
Regarding claim 2, John shows the amplitude of the diastolic peak of the PPG pulse divided by the amplitude of systolic peak (see par. [0095], [0096], [0121], [0183], [0236]).
Regarding claim 3, John shows wherein determining at least one venous-related feature comprises determining a plurality of venous-related features (see par. [0142]; and obtaining at least one combined venous-related feature by combining any one of said plurality of venous-related features (see par. [0029], [0033], [0046], [0070], [0153], [0169]-[0175]; fig. 3-6, 7 and 10).
Regarding claim 4, John shows wherein the weighting function comprises a classifier configured such that the value of the weighting factor depends on the value of said at least one venous-related feature (see par. [0029], [0033], [0046], [0070], [0153], [0169]-[0175]; fig. 3-6, 7 and 10).
Regarding claim 5, the examiner notes that the current specification states example of venous-related features which correlates positively or negatively with contribution of venous pulsatility of the PPG signal as the amplitude of diastolic peak of the PPG pulse divide by the amplitude of the systolic peak (see par. [0076, [0077] of the PG pub. version of the specification). John shows wherein each venous-related feature in the set of at least one venous-related feature correlates positively or negatively with the contribution of venous pulsatility to the PPG signal (par. [0029], [0033], [0046], [0070], [0090], [0095], [0096], [0153], [0169]-[0175]; fig. 3-6, 7 and 10 disclose the amplitude of diastolic peak of the PPG pulse divide by the amplitude of the systolic peak).
Regarding claim 6, the examiner notes that the current specification states example of venous-related features which correlates with contribution of venous pulsatility of the PPG signal John shows herein the weighting function is configured such that an increase in the value of a venous-related feature that correlates positively with the contribution of venous pulsatility to the PPG signal makes the value of the weighting factor to decrease (see par. [0029], [0033], [0046], [0070], [0090], [0095], [0096], [0153], [0169]-[0175]; fig. 3-6, 7 and 10), whereas an increase in the value of a venous-related feature that correlates negatively with the contribution of venous pulsatility to the PPG signal makes the value of the weighting factor to increase (par. [0029], [0033], [0046], [0070], [0090], [0095], [0096], [0153], [0169]-[0175]; fig. 3-6, 7 and 10).
Regarding claim 7, John shows the inverse of the amplitude of the diastolic peak of the PPG pulse divided by the amplitude of the systolic peak (see par. [0095], [0096], [0121], [0183], [0236]).
Regarding claim 9, John shows an amplitude of the dicrotic notch of the PPG pulse divided by the amplitude of the systolic peak (see par. [0095], [0096], [0121], [0183], [0236]).
Regarding claim 10, John shows computing a normalized PPG pulse by subtracting the end-diastolic value from the PPG pulse to obtain a subtracted PPG pulse and dividing the subtracted PPG pulse by the amplitude of the systolic peak (see par. [0094], [0151], [0105], [0176], [0266]; claim 9; fig. 4); and wherein said at least one venous-related feature is determined from at least a waveform parameter of the normalized PPG pulse (see par. [0094], [0151], [0105], [0176], [0266]; claim 9; fig. 4).
Regarding claim 11, John shows the mean value of the normalized PPG pulse (see par. [0088], [0091], [0156], [0164], [0165], [0167], [0185], [0203], [0204]).
Regarding claim 12, John shows computing a first time-derivative of the PPG pulse (see par. [0029]; fig. 5); and wherein said at least one venous-related feature is determined from at least a waveform parameter of the first time-derivative (see par. [0029], fig. 5).
Regarding claim 13, John shows that the amplitude of the pre-dicrotic notch local minimum of the first time-derivative divided by the amplitude of the first pre-dicrotic notch local maximum (see par. [0095], [0096], [0121], [0183], [0236]).
Regarding claim 14, John shows computing a second time-derivative of the PPG pulse; and wherein said at least one venous-related feature is determined from at least a waveform parameter of the second time-derivative (see par. [0029], fig. 5).
Regarding claim 15, John shows the amplitude of the second pre-dicrotic notch local maximum of the second time derivative divided by the amplitude the first pre-dicrotic notch local maximum (see par. [0095], [0096], [0121], [0183], [0236]).
Regarding claim 16, John discloses self monitoring and case assistant or achieving glycemic goals. John shows a non-transitory computer readable medium storing a program causing a computer to execute the method comprising: using a PPG sensor device to measure a single PPG signal on a user (see par. [0032], [0072], [0213], [0218]fig. 1, 6, 7 and 10)), the single PPG signal comprising at least an arterial pulsatility component (see par. [0025], [0070]) and a venous pulsatility component (see par. [0026], [0070], [0077], [0095], [0096],), the PPG signal containing at least two cardiac cycles (see fig. 3, 6, 7, and 14; par. [0072]); identifying individual PPG pulses from the single PPG signal (see par. [0141]), each individual PPG pulse corresponding to a cardiac cycle (see par. [0029], [0033], [0046], fig. 3-6, 7 and 10), and having a non-modulated component (see par. [0169], fig. 3, 6, 7) and a time-modulated component (see par. [0024]; fig. 3, 6 and 7); for each individual PPG pulse, determining a set of at least one venous-related feature indicative of the contribution of venous pulsatility to the time-modulated component of the individual PPG pulse from at least a waveform parameter characterizing the shape of the individual PPG pulse (see par. [0029], [0033], [0046], [0070], [0095], [0096], [0153], [0169]-[0175]; fig. 3-6, 7 and 10); assigning a weighting factor to each pulse, comprising calculating the weighting factor by using a weighting function comprising a mathematical operator inputted with said set of at least one venous-related feature (see par. [0038], [0049], [0158], [0168], [0169], [0186], [0187], [0272]); computing a weighted-average PPG pulse by using the PPG pulses and their respective weighting factors (see par. [0088], [0091], [0156], [0164], [0165], [0167], [0185], [0203], [0204]); and determining the physiological parameter by using the weighted-average PPG pulse (see par. [0088], [0091], [0156], [0164], [0165], [0167], [0185], [0203], [0204]).
Regarding claim 17, John discloses self monitoring and case assistant or achieving glycemic goals. John shows shows a PPG sensor device comprising a light source (see par. [0032], [0072], [0213], [0218]; fig. 1) and a light receiver and configured to measure a PPG signal (see par. [0032], [0072], [0213], [0218]; fig. 1); comprising a non-modulated component (see par. [0169], fig. 3, 6, 7) and a time-modulated component (see par. [0024]; fig. 3, 6 and 7), wherein the time-modulated component comprises at least an arterial pulsatility component (see par. [0025], [0070]) and a venous pulsatility component (see par. [0026], [0070], [0077], [0095], [0096]); the PPG sensor device further comprising a processing module configured to execute the method comprising: measuring a PPG signal on a user (see par. [0032], [0072], [0213], [0218]; fig. 1), the PPG signal containing at least two cardiac cycles (see fig. 3, 6, 7, and 14; par. [0072]); identifying PPG pulses from the PPG signal, each PPG pulse corresponding to a cardiac cycle and having a non-modulated component (see par. [0169], fig. 3, 6, 7) and a time-modulated component (see par. [0024]; fig. 3, 6 and 7); for each PPG pulse, determining a set of at least one venous-related feature indicative of the contribution of venous pulsatility to the time-modulated component of the PPG pulse from at least a waveform parameter characterizing the shape of the PPG pulse (see par. [0029], [0033], [0046], [0070], [0095], [0096], [0153], [0169]-[0175]; fig. 3-6, 7 and 10); assigning a weighting factor to each pulse, comprising calculating the weighting factor by using a weighting function comprising a mathematical operator inputted with said set of at least one venous-related feature (see par. [0038], [0049], [0158], [0168], [0169], [0186], [0187], [0272]); computing a weighted-average PPG pulse by using the PPG pulses and their respective weighting factors (see par. [0088], [0091], [0156], [0164], [0165], [0167], [0185], [0203], [0204]); and determining the physiological parameter by using the weighted-average PPG pulse (see par. [0088], [0091], [0156], [0164], [0165], [0167], [0185], [0203], [0204]).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yousefi et al. (US 2015/0196257; hereinafter Yousefi), in view of Wei et al. (US 2018/0085012; hereinafter Wei).
Regarding claim 8, Yousefi discloses the invention substantially as described in the 102 rejection above, but fails to explicitly state wherein the PPG signal is measured at the thorax or the upper arm, above the level of the seventh intercostal space.
Wei discloses a system and method for physiological parameter monitoring. Wei teaches wherein the PPG signal is measured at the thorax or the upper arm, above the level of the seventh intercostal space (see par. [0084]).
Therefore, it would have been obvious to one of ordinary skill in the art, to have utilized the teaching of wherein the PPG signal is measured at the thorax or the upper arm, above the level of the seventh intercostal space in the invention of Yousefi, as taught by Wei, to provide additional location to measure PPG signals from multiple body locations.
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive. In response to Applicant’s argument with respect to prior art rejection of claim 1, the examiner respectfully disagrees. The examiner maintains that prior art John does disclose all the claim limitation set forth in claim 1, particularly the claim limitation of assigning a weighting factor to each pulse and computing a weighted-average PPG pulse by using the individual PPG pulses and their respective weighting factors. The examiner notes that claim 1 does not define a specific weighting factor or what is the weighting factor. Claim 1 merely limits that the weight factor is a weighting function comprising a mathematical operator inputted within at least one venous-related feature which the examiner maintains is taught by John. John does show assigning a weighting factor to each pulse, comprising calculating the weighting factor by using a weighting function comprising a mathematical operator inputted with said set of at least one venous-related feature (par. [0038], [0049], [0158], [0168], [0169], [0186], [0187], [0272] states assigning weight factor to each pulse such as which pulses are good and convenient good pulse wave); and computing a weighted-average PPG pulse by using the individual PPG pulses and their respective weighting factors (par. [0088], [0091], [0156], [0164], [0165], [0167], [0185], [0203], [0204] calculate the mean/average weighted PPG pulse).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pantelopoulos et al. (US 2017/0209055) disclose PPG based pulse wave analysis using wearable device.
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 SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797