DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment to the claims filed 15 October 2025 has been entered. Claim(s) 34 is/are currently amended. Claim(s) 1-33 and 35-47 has/have been canceled. New claim(s) 48-49 has/have been added. Claim(s) 34 and 48-49 is/are pending.
Objections and/or Rejections Withdrawn
Objections to the claims, rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Objections
Claim(s) 34 is/are objected to because of the following informalities: "using data from acoustic sensor" should be amended/corrected to "using data from the acoustic sensor".
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 34 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 34 and claims dependent thereon, the limitation(s) "maintaining a running tally of the filtered plurality of pulse wave transit time measurements; refining the patient specific calibration curve slope based on the running tally of the filtered plurality of pulse wave transit time measurements" lack(s) sufficient support in the application as filed. The only mention of a "running tally" in the specification as filed is in paragraph [0160], which states in its entirety, "At decision block 1414, the process 1400 determines whether the estimated blood pressure change satisfies a condition that warrants performance of an action (e.g., whether the estimated blood pressure change is significant enough to perform an action). The condition can be, for example, a blood pressure change that exceeds a threshold blood pressure change value, cuff triggering value, a patient alarm triggering value, and/or the like. The condition can be patient-specific based on patient-specific factors or generic to all patients. If the condition is satisfied, the process 1400 proceeds to block 1416, wherein an appropriate action is performed based on the satisfied condition. For example, if an estimated blood pressure change exceeds a threshold change, a blood pressure cuff measurement can be triggered to determine and/or confirm the accuracy of the estimated blood pressure change. In some embodiments, the new blood pressure measurement can be added to a running tally to refine the individualized patient calibration factor."
Said paragraph explicitly states the "new blood pressure measurement" can be added to a running tally to refine the calibration factor. The only "blood pressure measurement" referenced in this paragraph is the "blood pressure cuff measurement." The paragraph explicitly refers to the blood pressure derived from PWTT measurements as "estimated blood pressure," rather than blood pressure measurements. Accordingly, paragraph [0160] indicates cuff-based blood pressure measurements can be added to a running tally as they are performed, and as new cuff-based blood pressure measurements are acquired, a patient-specific slope can be refined (e.g., recalibrated). There is nothing in the above-noted paragraph that indicates the filtered plurality of pulse wave transit time measurements are similarly maintained in a "running tally," or the patient-specific calibration curve slope is refined based thereon. Therefore, claim 34 encompasses new matter.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 34 and 48-49 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2007/0066910 A1 (previously cited, Inukai) in view of US 2002/0001390 A1 (previously cited, Kawaguchi), US 2011/0066010 A1 (previously cited, Moon), US 2010/0317933 A1 (previously cited, Colman), "Relation between Heart Rate and Pulse Transit Time during Paced Respiration" (previously cited, Drinnan) and US 2011/0021929 A1 (previously cited, Sethi).
Regarding claims 34-35, Inukai teaches/suggests a method of reducing blood pressure cuff measurements (e.g., ¶ [0011]), the method comprising:
estimating a pulse wave transit time (PWTT) measurement from a plurality of non-invasive sensors, the plurality of non-invasive sensors, wherein the plurality of non-invasive sensors include an ECG sensor configured to be positioned near the heart of the user (¶ [0026] ECG electrode 20 attached to a predetermined position of the chest of a patient), and an optical sensor configured to be secured to a finger of the user (¶ [0026] finger sensor 30 that optically senses and outputs a plethysmograph) (¶ [0033], ¶ [0066] calculating pulse wave propagation time on the basis of an ECG detected by the electrocardiogram electrode 20 and a plethysmograph sensed by the finger sensor 30);
estimating a blood pressure measurement from the PWTT measurement (¶ [0033], ¶ [0067] estimating blood pressure based on pulse wave propagation time) based on a calibration curve having a patient-specific calibration curve slope determined at a first time, wherein the calibration curve maps PWTT measurements with blood pressure measurements (e.g., ¶¶ [0083]-[0084] estimated blood pressure equation having coefficients a and β calibrated based on measurements acquired from the patient);
refining the patient specific calibration curve slope based on PWTT measurements and a new blood pressure cuff measurement (¶ [0081] estimated blood pressure, or coefficients a and β are calculated with each cuff blood pressure measurement obtained, e.g., periodically); and
using the refined patient specific calibration curve slope to determine a new estimate of a blood pressure measurement at a second time that is later than the first time (¶ [0081] estimated blood pressures after each new cuff measurement).
Inukai as modified does not expressly teach the disclosed method comprises triggering an alarm when the new estimate of the blood pressure measurement meets an alarm condition and when the new estimate of the blood pressure measurement is confirmed with a separate blood pressure cuff measurement. However, Inukai does disclose the above-noted steps are a feature(s) of a "normal" blood pressure monitoring apparatus (e.g., ¶ [0010] "A blood pressure monitoring apparatus normally monitors whether the blood pressure continuously calculated on the basis of the pulse wave propagation time falls within a normal range or not. If the blood pressure is abnormal, a more accurate blood pressure measurement is performed by using a cuff or the like, and an alarm is output if the measurement result is also abnormal."). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Inukai with triggering an alarm when the new estimate of the blood pressure measurement meets an alarm condition and when the new estimate of the blood pressure measurement is confirmed with a separate blood pressure cuff measurement in order to confirm abnormal blood pressure estimates with a more accurate measurement prior to issuing an alarm, thereby reducing false alarms.
Inukai as modified further discloses estimation of PWTT measurements may comprise compensation of pre-ejection period (PEP) (¶ [0066]), but does not disclose the plurality of non-invasive sensors further comprise an acoustic sensor, or the compensation of PEP is based on data from the acoustic sensor. However, Inukai does disclose PEP may change from person to person and/or within the same person (e.g., ¶¶ [0008]-[0009]).
Kawaguchi teaches/suggests a method comprising estimating PWTT measurements from a plurality of non-invasive sensors, wherein the plurality of non-invasive sensors include an acoustic sensor configured to be positioned near a heart of a user (heart-sound microphone 12), an ECG sensor (ECG 24 including two electrodes 22), and an optical sensor (photoelectric-pulse-wave sensor 28; ¶ [0063]) (¶ [0064] calculating pulse-wave propagation time DT), wherein the estimation comprises compensation of PEP using data from the acoustic sensor (¶ [0064] DT is calculated by determining a time difference between a time when an ECG wave representing excitation of the ventricular muscle is detected by the ECG 24 and the time of detection of rising point of the photoelectric pulse wave and subtracting PEP, which is the difference between a timing of the portion of the ECG and timing of opening of the aortic valve using the heart-sound waveform, as described in ¶¶ [0040]-[0046]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Inukai with the plurality of sensors further comprising an acoustic sensor, wherein the estimation of the PWTT measurements comprises compensation of PEP using data from the acoustic sensor, as taught/suggested by Kawaguchi in order to facilitate deriving a current, user-specific PEP value, thereby allowing a more accurate/reliable PWTT measurement(s) to be continuously determined (Kawaguchi, ¶ [0015]), and more accurate/reliable blood pressure to be continuously estimated based thereon (Inukai, ¶¶ [0008]-[0009]).
Inukai as modified does not disclose estimating a plurality of PWTT measurements from the plurality of non-invasive sensors, applying an averaging filter to the plurality of PWTT measurements, and estimating the blood pressure measurement from the filtered plurality of PWTT measurements.
Moon discloses a comparable method of reducing blood pressure cuff measurements, the method comprising estimating a plurality of PWTT measurements; applying an averaging filter to the plurality of PWTT measurements; and estimating a blood pressure measurement from the filtered plurality of PWTT measurements (¶ [0114] the body sensor averages PTT values over a 10-20 second period, and displays a new blood pressure measurement every second using a rolling average; ¶ [0103]; etc.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Inukai to further comprise estimating a plurality of PWTT measurements from the plurality of non-invasive sensors, applying an averaging filter to the plurality of PWTT measurements, and estimating a blood pressure measurement from the filtered plurality of PWTT measurements as taught/suggested by Moon in order to improve accuracy/reliability of the blood pressure estimate by smoothing out short-term fluctuations in the PWTT measurement.
Moon (or Inukai as modified thereby) discloses an averaging window time range (e.g., 10-20 seconds) that may be applied to the plurality of PWTT measurements, but does not disclose the averaging filter is based on a variability in heart rate data.
Colman teaches/suggests a method comprising estimating a plurality of index values, wherein each index value is estimated by applying an averaging filter to the values of the parameter(s) used to produce the PI value (e.g., ¶ [0057] PI value may be updated continuously and it may be calculated from an average of the values of the parameters that are used to produce the PI value), wherein the averaging filter is based on a variability in the parameter data (¶ [0057]; ¶ [0059]; etc.).
Since Inukai and Moon disclose a blood pressure measurement is estimated based on the PWTT measurements, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Inukai with the averaging filter being based on a variability in the measured data, such as variability of the PWTT measurements, as taught/suggested by Colman, for example, by using the lower end of the above-noted averaging window range (e.g., 10 seconds) when PWTT measurements are stable, and the upper end of said averaging window range (e.g., 20 seconds) when PWTT measurements are unstable) to increase the reliability and/or accuracy of the estimated blood pressure (i.e., an "index" determined from the PWTT values) by adapting the averaging filter based on measured data (Colman, ¶ [0057]; ¶ [0059]; etc.).
Inukai as modified does not expressly teach the averaging filter is based on a variability in heart rate data. Rather, as discussed above, since Inukai as modified discloses a blood pressure measurement is calculated based on the filtered plurality of PWTT measurements, the disclosure of Colman teaches/suggests the averaging filter (e.g., averaging time thereof) being based on a variability in the PWTT measurements. However, Drinnan discloses there is a strong relationship between changes in PWTT (PTT) and changes in heart rate data (cardiac beat-to-beat, or RR, interval), with PWTT changes following heart rate data changes by a delay of approximately three heartbeats (pg. 431, Conclusion), such that it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Inukai with the averaging filter being based on a variability in heart rate data, rather than variability in the PWTT measurements, in order to proactively adapt the averaging filter to compensate for changes (variability, instability, etc.) in the data used to calculate the plurality of blood pressure measurements, since Drinnan discloses correlated changes in PWTT measurements are observable earlier in heart rate data (pg. 431, Conclusion) and/or as a simple substitution of variability within one type of data (variability in HR data) known to be correlated with another type of data (variability in PWTT measurements) to yield no more than predictable results. See MPEP 2143(I)(B).
Inukai as modified does not expressly disclose the method further comprises maintaining a running tally of the filtered plurality of PWTT measurements, and refining the patient-specific calibration curve slope based on the running tally of new blood pressure measurements the filtered plurality of PWTT measurements and a new/corresponding blood pressure cuff measurement(s).
Sethi teaches/suggests a method comprising estimating a blood pressure measurement from PWTT based on a patient-specific calibration curve that maps PWTT to blood pressure (e.g., ¶¶ [0001]-[0003]); maintaining a running tally of a plurality of PWTT measurements and corresponding reference blood pressure measurements; and refining the patient specific calibration curve based on the running tally/tallies (¶ [0072]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Inukai with maintaining a running tally of the filtered plurality of PWTT measurements and refining the patient specific calibration curve based on the running tally of the filtered plurality of PWTT measurements and new blood pressure cuff measurements and as taught and/or suggested by Sethi in order to enable deriving the slope from a relatively large data set (Sethi, ¶ [0072]).
Regarding claim 48, Inukai as modified teaches/suggests determining that a heart rate has changed over time by a heart rate threshold since the first time (Fig. 2, S113-114, calculating increase/decrease in RR interval, and determining if said increase/decrease correlates with an increase/decrease in PWTT or blood pressure estimated from PWTT).
Regarding claim 49, Inukai as modified teaches/suggests triggering another blood pressure cuff measurement for recalibration based on the determination that the heart rate has changed over time by the heart rate threshold (Fig. 2, S114-116, when the RR interval and PWTT/blood pressure correlation is opposite its normal state, a blood pressure measurement using a cuff is performed and blood pressure corrected, which may comprise calibrating the equation for calculating the estimated blood pressure value, as described in ¶ [0058]).
Double Patenting
The nonstatutory double patenting (hereinafter "NSDP") rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A NSDP rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional NSDP rejection provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a NSDP rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/ patents/apply/applying-online/eterminal-disclaimer
Claim(s) 34 and 48-49 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 of US Patent No. 10,052,037 in view of Inukai, Sethi and Kawaguchi.
Although the claims at issue are not identical, they are not patentably distinct from each other. Specifically, claim 1 of US 10,052,037 recites a method of reducing blood pressure cuff measurements, the method comprising estimating a plurality of PWTT measurements from a plurality of non-invasive sensors (means for detecting electrical information, cardiac ejection information, arterial pulse information) (acquiring a set of arterial PWTT measurements); applying an adaptive averaging filter to the plurality of PWTT measurements, wherein the averaging filter is based on a variability in heart rate data (applying an averaging filter having an averaging parameter based on variability in a heart rate signal); estimating a blood pressure measurement from the filtered plurality of PWTT measurements (monitoring blood pressure based on applying the averaging filter to the set of arterial PWTT measurements), wherein the plurality of sensors comprise a pulse oximeter (means for measuring arterial pulse information, as evidenced by Inukai), an ECG sensor (means for measuring electrical information, as evidenced by Inukai), and an acoustic sensor (means for measuring cardiac ejection information, as evidenced by Kawaguchi).
Claim 1 of US 10,052,037 does not recite the method further comprises estimating the blood pressure measurement based on a calibration curve mapping pulse wave transit time to blood pressure having a patient-specific calibration curve slope; determining a change in heart rate with respect to a previous measurement of heart rate at the earlier time; and triggering a blood pressure cuff measurement for recalibration based on said determination. However, as discussed with respect to the prior art rejections above, Inukai teaches/suggests a comparable system/method that estimates blood pressure from pulse wave transit time and triggers recalibration measurements in the manner claimed. Further, Kawaguchi discloses PWTT can alternatively be calculated using three sensors, i.e., a pulse oximeter, an ECG sensor, and an acoustic sensor, wherein data from the acoustic sensor is used to adjust the PWTT measurements based on a pre-ejection period. It would have been obvious to modify claim 1 of US 10,052,037 with the above-noted feature(s) as taught and/or suggested by Inukai and Kawaguchi in order to increase accuracy of the blood pressure measurements by using a calibration curve that is specific to the patient (Inukai, ¶ [0084]) and updated as needed to maintain its accuracy (Inukai, ¶ [0034]) and by using a patient-specific PEP.
Claim 1 of US 10,052,037 as modified does not recite maintaining a running tally of PWTT and blood pressure measurements; refining the patient specific calibration curve slope based on the running tally; and using the refined patient specific calibration curve slope to determine a new estimate of blood pressure measurement as a second, later time. However, as discussed with respect to the prior art rejections above, Inukai and Sethi teach/suggest such feature(s). It would have been obvious to modify claim 1 of US 10,052,037 with the above-noted feature(s) as taught and/or suggested by Inukai and Sethi for at least the reasons discussed above with respect to the prior art rejections.
Lastly, claim 1 of US 10,052,037 as modified does not recite triggering an alarm when the new estimate of the blood pressure measurement meets an alarm condition and when the new estimate of the blood pressure measurement is confirmed with a separate blood pressure cuff measurement. However, Inukai discloses such a feature is included in "normal" blood pressure monitoring, such that it would have been obvious to modify claim 1 of US 10,052,037 with the above-noted feature(s) for at least the reasons discussed above with respect to the prior art rejections.
Claim(s) 34 and 48-49 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 of US Patent No. 11,234,602 in view of Inukai, Sethi Kawaguchi, and Drinnan.
Although the claims at issue are not identical, they are not patentably distinct from each other. Specifically, claims 1 and 8 of US 11,234,602 recites a method of reducing blood pressure cuff measurements, the method comprising estimating a plurality of PWTT measurements from a plurality of non-invasive sensors (first and second sensors) (plurality of PWTT measurements); applying an adaptive averaging filter to the plurality of PWTT measurements, wherein the averaging filter is based on heart rate data (applying an averaging filter that is dynamically adjusted based on characteristics of heart rate data to the plurality of PWTT measurements); estimating a blood pressure measurement from the filtered plurality of PWTT measurements (deriving a blood pressure measurement based at least in part on the averaged plurality of PWTT measurements), wherein the plurality of sensors comprise a pulse oximeter (second sensor configured to output an arterial pulse signal, as evidenced by Inukai), and an acoustic sensor (first sensor configured to output a cardiac ejection signal, as evidenced by Kawaguchi).
Claim 1 of US 11,234,602 does not recite the method further comprises estimating the blood pressure measurement using based on a calibration curve mapping pulse wave transit time to blood pressure having a patient-specific calibration curve slope; determining a change in heart rate with respect to a previous measurement of heart rate at the earlier time; and triggering a blood pressure cuff measurement for recalibration based on said determination. However, as discussed with respect to the prior art rejections above, Inukai teaches/suggests a comparable system/method that estimates blood pressure from pulse wave transit time and triggers recalibration measurements in the manner claimed. Further, Kawaguchi discloses PWTT can alternatively be calculated using three sensors, i.e., a pulse oximeter, an ECG sensor, and an acoustic sensor, wherein data from the acoustic sensor is used to adjust the PWTT measurements based on a pre-ejection period. It would have been obvious to modify claim 1 of US 11,234,602 with the above-noted feature(s) as taught and/or suggested by Inukai and Kawaguchi in order to increase accuracy of the blood pressure measurements by using a calibration curve that is specific to the patient (Inukai, ¶ [0084]) and updated as needed to maintain its accuracy (Inukai, ¶ [0034]) and/or by using a patient-specific PEP value.
Claim 1 of US 11,234,602 as modified does not recite maintaining a running tally of PWTT and blood pressure cuff measurements; refining the patient specific calibration curve slope based on the running tally of new blood pressure measurements; and using the refined patient specific calibration curve slope to determine a new estimate of a blood pressure measurement at a second, later time. However, as discussed with respect to the prior art rejections above, Inukai and Sethi teach/suggest such feature(s). It would have been obvious to modify claim 1 of US 11,234,602 with the above-noted feature(s) as taught/suggested by Inukai and Sethi for at least the reasons discussed above with respect to the prior art rejections.
While claim 1 of US 11,234,602 as modified recites the averaging filter is adjusted based on characteristics of heart rate data, said claim does not expressly recite said characteristics include variability. Drinnan discloses there is a strong relationship between changes in PWTT (PTT) and changes in heart rate data (cardiac beat-to-beat, or RR, interval), with PWTT changes following heart rate data changes by a delay of approximately three heartbeats (pg. 431, Conclusion).
It would have been obvious to modify claims 1 and 8 of US 11,234,602 with the heart rate data characteristics including a variability of the heart rate data as a simple substitution of one suitable characteristic correlated with PWTT measurement characteristics for another to yield no more than predictable results. See MPEP 2143(I)(B).
Lastly, claim 1 of US 11,234,602 as modified does not recite triggering an alarm when the new estimate of the blood pressure measurement meets an alarm condition and when the new estimate of the blood pressure measurement is confirmed with a separate blood pressure cuff measurement. However, Inukai discloses such a feature is included in "normal" blood pressure monitoring, such that it would have been obvious to modify claim 1 of US 11,234,602 with the above-noted feature(s) for at least the reasons discussed above with respect to the prior art rejections.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to the prior art rejection(s), Applicant contends the cited prior art fails to teach or suggest each limitation of amended claim 34, asserting, "For example, Inukai mentions 'pre-ejection period' may subtracted using a 'statistically calculated' number from 'beforehand.' Inukai, at [0066]. Inukai does not teach using real time sensor data from the acoustic sensor. The rest of the references do not teach or suggest pre-ejection period. At least based on the amendments and for the reasons discussed above, Applicant respectfully submits that claim 34 is patentable over the cited references" (Remarks, pgs. 5-6).
The examiner respectfully disagrees. While Inukai alone does not disclose using data from the acoustic sensor to determine PEP and compensate PWTT measurements, Inukai does disclose PEP is variable from person to person, and even within the same person (¶¶ [0008]-[0009]). Further Kawaguchi, which was previously relied-upon in the rejection of dependent claim 36 (now canceled), does disclose/suggest this feature(s), as discussed in the rejection(s) of record above, such that it would have been an obvious modification(s) for at least the above-noted reason(s).
With respect to the double patenting rejection(s), Applicant "requests reconsideration and withdrawal of the rejections" in view of the amendment(s) to claim 34, including the "triggering" limitation as claimed (Remarks, pgs. 6-7). However, Inukai at least suggests said triggering feature or step, as discussed above. Accordingly, the double patenting rejection(s) have been maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: JP H05146415 A discloses confirming an alarm condition with a more accurate blood pressure cuff measurement prior to issuing an alarm.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791