DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10 October 2025 has been entered.
Status of Claims
Claim(s) 1, 2, 7-8 and11 is/are currently amended. Claim(s) 3, 5-6, 13 and15 has/have been canceled. Claim(s) 1-2, 4, 7-12, 14 and 16-19 is/are pending, with claim(s) 4 and 17-18 withdrawn from consideration for being drawn to a non-elected invention and/or species.
Rejections Withdrawn
Rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Interpretation
As noted in the prior Office action (mailed 10 April 2025), claims reciting the limitations "a computation unit," and "mobile evaluation and a representation unit" have been interpreted to invoke 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph). Additionally, the newly added "means for" limitations of claim 2 (e.g., "means for performing […]," "means for association […]," etc. additionally invoke 35 U.S.C. 112(f).
Claim Objections
Claim(s) 1-2 and 7 is/are objected to because of the following informalities.
In claims 1-2, each occurrence of "a mobile evaluation and a representation unit," or "the mobile evaluation and the representation unit" should be amended/corrected to "a/the mobile evaluation and representation unit" for consistency with the language of the application as filed (e.g., beginning ¶ [0364]). Consequently, in claim 2, each occurrence of "wherein the mobile evaluation and representation unit are configured" should be corrected to "wherein the mobile evaluation and representation unit is configured."
In claim 7, "wherein the time point are used for" should be corrected to "wherein the time point is used for."
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-2, 7-12, 14, 16 and 19 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 1, claim 2 and claims dependent thereon, as noted above, each of the "computation unit" and "evaluation and representation unit" have been interpreted to invoke 35 U.S.C. 112(f). However, the written description fails to disclose and/or clearly disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
With respect to the "computation unit," Applicant discloses said unit "can also be integrated in a medical monitoring device" and "[the] use of other computation units such as, for example, a smartphone is also possible" (¶ [0152]). Similarly, Applicant discloses, said unit can be "integrated in the air pressure cuff" (¶ [0038]); "The evaluation and representation unit can be, for example, a smart device or a medical monitoring device, for example, a Drager monitor" (¶ [0364]); etc. It is unclear if each of "computation unit" and "evaluation and representation unit" are each a component of a medical monitoring device or smart phone, a "medical monitoring device" itself, etc. Additionally, the structure of a "medical monitoring device" itself is unclear.
Regarding claim 1 and claims dependent thereon, the limitation "determining a plurality of values, wherein the plurality of values include pulse wave transit time, pulse wave velocity, pulse wave contour or electrical activity of a heart" is indefinite. It is unclear if a "plurality of values" requires at least two different types of values to be determined (e.g., determining PWTT and PWV), or encompasses determining multiple instances of one type of value (e.g., a time series of PWTT value).
The combination of limitations "determining a plurality of values, wherein the plurality of values include pulse wave transit time, pulse wave velocity, pulse wave contour or electrical activity of a heart […] measuring the pulse wave transit time and the pulse wave velocity by combining at least two sensors selected from the group consisting of: a plethysmography sensor, a blood pressure cuff device and an electrocardiogram (ECG) sensor, with the limitation that only one ECG sensor is used; measuring the pulse wave contour by at least one sensor selected from the group consisting of: a plethysmography sensor, a blood pressure cuff device or an electrocardiogram (ECG) sensor; measuring the electrical activity of the heat by an electrocardiogram (ECG) sensor" is further indefinite. The claim requires that a plurality of values are determined, said values including PWTT, PWV, pulse wave contour, or electrical activity. This limitation is itself indefinite, as discussed above. The limitation may be reasonably interpreted multiple ways having a different scope, e.g., to encompass determining any one of PWTT, PWV, pulse wave contour, or electrical activity over time; to encompass determining any two of PWTT, PWV, pulse wave contour, electrical activity at least one time; etc. In either case, the limitation does not require all of PWTT, PWV, pulse wave contour, and electrical activity to be determined. However, the later limitations positively recite measuring each of PWTT, PWV, pulse wave contour, and electrical activity by a particular sensor or combination of particular sensors, leading to ambiguity about how many values are actually required to be determined and/or measured (i.e., determining any one of PWTT, PWV, pulse wave contour or electrical activity at least twice is required, determining any two of PWTT, PWV, pulse wave contour and electrical activity at least once is required, determining/measuring each/all of PWTT, PWV, pulse wave contour, electrical activity is required). For the purpose of this Office action, since the "determining" limitation does not require each of PWTT, PWV, pulse wave contour and electrical activity to be determined, the above-noted limitations will be further discussed with the understanding that the later "measuring" limitations are intended to limit the manner in which the particular value(s) is/are measured when said value(s) are included in the determined plurality of values. Alternatively stated, that each "measuring" limitation is only required by the claim when the particular value(s) of said measuring limitation is/are included in the determined plurality of values.
The limitations "obtaining the at least two values of the plurality of values by a blood pressure cuff device and a computation unit […] measuring the pulse wave transit time and the pulse wave velocity by combining at least two sensors selected from the group consisting of: a plethysmography sensor, a blood pressure cuff device and an electrocardiogram (ECG) sensor, with the limitation that only one ECG sensor is used; measuring the pulse wave contour by at least one sensor selected from the group consisting of: a plethysmography sensor, a blood pressure cuff device or an electrocardiogram (ECG) sensor; measuring the electrical activity of the heat by an electrocardiogram (ECG) sensor" are indefinite. The first of the above-noted limitations indicates the plurality of values are determined by "a blood pressure cuff device," while the latter limitations indicate that only the pulse wave transit time and the pulse wave velocity may either be measured by a blood pressure cuff device, or by entirely different sensors (e.g., ECG and pleth), and pulse wave contour and electrical activity are not measured by a blood pressure cuff device but different sensors (e.g., pleth and/or ECG). Alternatively, if there is some intended difference in scope between "determining" and measuring" the values, said difference is not readily apparent.
The limitations "obtaining the at least two values of the plurality of values by a blood pressure cuff device and a computation unit, wherein the computation unit is configured to record, analyze, and transmit data from the blood pressure cuff device; wherein the blood pressure cuff device and the computation unit are connected wirelessly to a mobile evaluation and a representation unit, wherein the mobile evaluation and the representation unit are remote from both the blood pressure cuff device and the computation unit; wherein the at least two different blood pressure values taken at each different breathing state have different values due to a natural variation due to differences in respiratory sinus arrhythmia between the each different breathing state; […] wherein the blood pressure cuff device used to measure the pulse wave transit time, the pulse wave velocity and the pulse wave contour is either the same as or different from the blood pressure cuff device used to obtain the blood pressure values" are indefinite. Firstly, there is insufficient antecedent basis for "the at least two different blood pressure values" in the limitation "wherein the at least two different blood pressure values taken at each different breathing state have different values […] and for "the blood pressure cuff device used to obtain the blood pressure values." Secondly, it is unclear to what "is either the same as or different from the blood pressure cuff device used to obtain the blood pressure values" refers, since, as mentioned above, there is neither antecedent basis for "blood pressure measurement values," nor any indication such values are obtained from a blood pressure cuff device. To the best of the examiner's understanding in view of the application as filed, particularly in view of the additional indefiniteness of the obtaining and measuring limitations discussed above, "obtaining the at least two values of the plurality of values by a blood pressure cuff device" appears to have been intended to recite that at least two different blood pressure values are obtained/measured by the blood pressure cuff device and a computation unit, each of said at least two different blood pressure values being associated with a respective one of the determined plurality of values, with the latter above-noted limitation indicating, when the determined plurality of values are obtained with a blood pressure cuff device, the same or a different blood pressure cuff device may be used to obtain blood pressure values. Claim 1 will be further discussed with this understanding below.
Regarding claim 2 and claims dependent thereon, the limitations "wherein the means for performing the non-invasive continuous measurement includes at least a plethysmography sensor, and a computation unit; wherein the means for performing the base measurement also includes a means for association with the at least two reference values which are the states used to determine use for calibration or not to use for calibration; wherein means for association to the state determined to use for calibration includes those values of the base measurement are in the same way at the at least two reference values associated to the breathing state" are indefinite. Firstly, the relationship between the computation unit and the "means for association" is unclear, particularly as there is no clear disclosure of a "means for association" in the application as filed. Secondly, there is insufficient antecedent basis for "the states used to determine use for calibration or not to use for calibration." It is unclear if this refers to the previously recited breathing states, and, if so, how said breathing states relate to or are used to determine "use for calibration or not to use for calibration." It is further unclear to what "wherein means for association to the state determined to use for calibration includes those values of the base measurement are in the same way at the at least two reference values associated to the breathing state" requires. Specifically, "those values of the base measurement are in the same way at the at least two reference values associated to the breathing state" is syntactically unclear, as it is not readily apparent to what base measurements being "in the same way" refers and/or how said "way" relates to a breathing state, a use for calibration state, etc. For the purpose of this Office action, the above-noted limitations will be further discussed with the understanding that the computation unit is/functions as the "means for association," wherein said unit/means associates the base measurement(s) with a breathing state, or an indication of the measurement time (e.g., timestamp) that is associated with a breathing state.
The limitations "a means for performing a calibration using the at least two reference values and at least two values of the base measurement; a means for applying the calibration of the at least two reference values and at least two values of the base measurement to determine at least one target value which are continuous blood pressure values, wherein the means for applying the calibration includes a mobile evaluation and a representation unit; […] wherein the mobile evaluation and representation unit are [sic] configured to jointly process the at least two reference values and the values of the base measurement with state determined to use for calibration to perform the calibration to obtain a calibration mapping, which are parameters for a mathematically function which takes values of the base measurement to generate the at least one target value; and wherein the mobile evaluation and the representation unit are [sic] configured to process other values of the base measurement, which are not associated to the at least two reference values to obtain another at least one target value" are indefinite. While the claims indicate the "means for applying the calibration" includes a mobile evaluation and representation unit, there is no comparable indication for the "means for performing a calibration," despite the later limitations indicating the mobile evaluation and representation unit "process[es] the at least two reference values and the values of the base measurement with state determined to use for calibration to perform the calibration." Accordingly, the relationship between the means for performing a calibration and the mobile evaluation and representation unit is unclear. Does the mobile evaluation and representation unit function as the recited means for performing a calibration, is an additional means/structure required by the system, etc.
Regarding claim 10 and claims dependent thereon, the limitation(s) "wherein pressurized blood pressure measurements and non-pressurized measurements of the pulse wave transit time, pulse wave velocity and/or pulse wave contour…" is indefinite. It is unclear to what "pressurized blood pressure measurements" and "non-pressurized measurements" refers, as there is no indication in claim 1 as to the pressurization state when a pulse wave transit time, pulse wave velocity, pulse wave contour, etc. are determined, and/or no indication as to how/when (or to acquire what measurements) the blood pressure cuff device is utilized in obtaining or determining any of the required measurements.
Regarding claim 11 and claims dependent thereon, the limitation "wherein when at least one sensor selected form the group consisting of: a blood pressure cuff device or a loading sensor is been used for the measurements of the pulse wave transit time, pulse wave velocity, pulse wave contour, the applied loading of those sensors is reduced" is indefinite. Firstly, it is unclear what, if step(s), if any, is/are required by the above-noted limitation. Said limitation does not limit the method to using any particular sensor(s), but at best, appears to describe the result(s) of using a particular sensor. Secondly, there is insufficient antecedent basis for "the applied loading of those sensors" in the claim. Lastly, it is unclear relative to what reference "loading of those sensors" is reduced, specifically as claim 10 recites/requires "non-pressurized measurements of the pulse wave transit time, pulse wave velocity and/or pulse wave contour."
Regarding claim 12, claim 14 and claims dependent thereon, there is insufficient antecedent basis for "the pressurized blood pressure measurement" in the limitation "further comprising an air pressure cuff used for the pressurized blood pressure measurement" of claim 12 and in the limitation "further comprising an air pressure cuff used for the pressurized blood pressure measurement" of claim 14.
Regarding claim 16 and claims dependent thereon, there is insufficient antecedent basis for "the respiratory state carried out" in the limitation "further comprising: detecting the respiratory state carried out by means of […]."
Regarding claim 19 and claims dependent thereon, the limitation "converting the measured values of the subsequent non-pressurized measurements into at least one blood pressure value by means of data collected during at least one pressurized blood pressure measurement" is indefinite. The relationship between "by means of data collected during at least one pressurized blood pressure measurement" and the "results" calibrated in claim 1 is indefinite, particularly as claim 1 does not clearly require any "pressurized blood pressure measurement." Is additional data used in combination with the results of claim 1 in the conversion to at least one blood pressure value of claim 19?
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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.
Claim(s) 1-2, 7-11, 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0155767 A1 (previously cited, Fukuda) in view of and US 2012/0136261 A1 (previously cited, Sethi), US 2016/0073905 A1 (previously cited, Murai) and US 2016/0213332 A1 (Ukawa).
Regarding claims 1 and 16, Fukuda teaches/suggests a method for obtaining continuous values of blood pressure (e.g., ¶ [0166]), the method comprising:
determining a plurality of values including pulse wave transit time (PWTT) and/or pulse wave velocity (PWV), wherein at least two values of the plurality of values are measured at different patient states (¶ [0050] pulse wave velocity v1, v2, which are obtained based on respective pulse wave transit times, as described in ¶ [0048], obtained when the subject is in first and second states, respectively), wherein the PWTT and/or PWV is determined/measured by combining a plethysmography (PPG) sensor (pulse wave information measurement apparatus 620, or pulse wave measurement unit 210), an electrocardiogram (ECG) sensor (ECG information measurement apparatus 610, or ECG measurement unit 110 thereof) and a computation unit (control unit(s) 150, 240) (e.g., Fig. 10, S125), wherein the computation unit is configured to record, analyze, and transmit data, and is connected wirelessly to a mobile evaluation and representation unit remote from the computation unit (mobile terminal 690);
obtaining at least one corresponding blood pressure value at each different patient state (for a total of at least two different blood pressure values) (¶ [0050] systolic pressure p1, p2 obtained when the subject is in the first and second state, respectively) by a blood pressure cuff device (¶ [0050] pressures p1, p2 may be obtained using a direct measurement method; ¶ [0003] where using a pressurized cuff is a direct measurement method), wherein the at least two blood pressure values taken at the different patient states have different values (e.g., ¶ [0050] the first state and the second state are not limited as long as they are states that produce a certain level of difference or more in the systolic pressure value of the measurement subject); and
calibrating results of the measured PWTT and/or PWV using the at least two blood pressure values measured for each different patient state via the mobile evaluation and representation unit (¶ [0050] determining constants a and b in the equation relating pulse wave velocity to blood pressure using the values for the pulse wave velocity v1 and v2 and the systolic pressure p1 and p2; ¶ [0066] calibration data including measured pulse wave transit time is received by mobile terminal 690, and mobile terminal 690 obtains the relationship between the pulse wave velocity and the systolic pressure value).
Fukuda does not teach the two different patient states are different breathing states, such that the at least two different blood pressure values have different values due to natural variation due to differences in respiratory sinus arrhythmia between the two different breathing states. However, as noted above, Fukuda discloses any different states producing a certain level of difference or more in the systolic pressure value of the measurement subject can be used for the calibration (e.g., ¶ [0050]).
Sethi discloses systolic and diastolic blood pressures vary about 10-15 mmHg with the respiration cycle, disclosing measurements acquired at two different breathing states within the respiratory cycle (e.g., about the end of exhalation and about the end of inhalation) can be utilized to calibration a pulse wave transit time and blood pressure measurement relationship or equation (e.g., Fig. 6, ¶¶ [0062]-[0065], etc.). While Sethi discloses the entire system may be ambulatory (e.g., ¶ [0037]), Sethi only expressly discloses using ventilator settings to determine respiratory state and associated measurements during the respiration-based calibration (¶¶ [0062]-[0065]).
Murai discloses/suggests a method comprising continuously measuring a blood pressure waveform as a list of time-value pairs, the blood pressure wave exhibiting fluctuations caused by the blood pressure; analyzing the fluctuations of the blood pressure waveform to determine a breathing state; and associating blood pressure values of the waveform with each breathing state (¶¶ [0043]-[0045] breathing period BP (one inhalation and one exhalation) corresponding to the breathing cycle is estimated from changes in blood pressure, e.g., Fig. 3). Ukawa discloses and/or suggests a comparable method comprising continuously measuring a blood pressure waveform by at least one pressure transducer of a blood pressure cuff device (Fig. 1, pulse wave measuring section 13 detecting the cuff pressure), said waveform similarly exhibiting fluctuations caused by the blood pressure and due to a natural variation due to differences in respiratory sinus arrhythmia between the breathing states (e.g., Figs. 4-5). Accordingly, Murai and Ukawa in combination disclose/suggest an alternative to the ventilator disclosed by Sethi for obtaining a blood pressure value correlated with two different predetermined breathing states (i.e., inhalation and exhalation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Fukuda with obtaining the at least two blood pressure values by obtaining/continuously measuring a pulse pressure wave as a list of time-value pairs via at least one pressure transducer of a blood pressure cuff device and a computation unit; analyzing, by the computation unit, fluctuations (periodic changes) in the measured pressure wave to detect a breathing state; and identifying at least one pulse pressure value associated with each of two different breathing states (inhalation and exhalation) as taught/suggested by Murai and Ukawa, such that the at least two different blood pressure values have different values due to a natural variation due to differences in respiratory sinus arrhythmia between each breathing state as taught and/or suggested by Sethi, in order to acquire calibration data sets without requiring any additional action(s) by the user and in a manner that permits the user to be ambulatory and/or as a simple substitution of one set of different first and second states associated with different blood pressure values for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claims 2 and 8, Fukuda teaches and/or suggests a system for non-invasive and continuous blood pressure measurement, the system comprising:
a blood pressure measuring device for performing a blood pressure measurement to obtain at least two reference values (¶ [0050] direct measurement method means), wherein the at least two reference values include at least two blood pressure values, each blood pressure value being associated to a different patient state (e.g., ¶ [0050] pressures p1, p2 obtained using a direct measurement method);
plethysmography sensor (pulse wave information measurement apparatus 620, or pulse wave measurement unit 210) and a computation unit (control unit(s) 150, 240) for performing a base measurement, wherein the base measurement includes a non-invasive continuous measurement of a PWTT and/or PWV and wherein the computation unit is configured to associate reference values and base values to the different patient states (¶ [0050] pulse wave velocity v1, v2, which are obtained based on respective pulse wave transit times, as described in ¶ [0048], obtained when the subject is in first and second states, respectively);
a mobile evaluation and representation unit (mobile terminal 690), wherein the system is configured to transfer the at least two reference values from the blood pressure device to the mobile evaluation and representation unit (¶ [0066]);
wherein the mobile evaluation and representation unit is configured for:
performing a calibration using the at least two reference values and at least two values of the base measurement by jointly processing the at least two reference values and the values of the base measurement with state determined to use for calibration to perform the calibration to obtain a calibration mapping, which are parameters for a mathematical function which takes values of the base measurement to generate the at least one target value (e.g., ¶¶ [0049]-[0053], ¶ [0066], etc.); and
applying the calibrated mathematical function to subsequent values of the base measurement to determine/obtain at least one target value/continuous blood pressure values (e.g., ¶ [0166] PWV/PWTT is constantly, continuously determined and BP estimated based thereon using the calibrated function).
Fukuda does not teach the two different patient states are different breathing states, such that the at least two different blood pressure values have different values due to natural variation due to differences in respiratory sinus arrhythmia between the two different breathing states. However, as noted above, Fukuda discloses any different states producing a certain level of difference or more in the systolic pressure value of the measurement subject can be used for the calibration (e.g., ¶ [0050]).
Sethi discloses systolic and diastolic blood pressures vary about 10-15 mmHg with the respiration cycle, disclosing measurements acquired at two different breathing states within the respiratory cycle (e.g., about the end of exhalation and about the end of inhalation) can be utilized to calibration a pulse wave transit time and blood pressure measurement relationship or equation (e.g., Fig. 6, ¶¶ [0062]-[0065], etc.). While Sethi discloses the entire system may be ambulatory (e.g., ¶ [0037]), Sethi only expressly discloses using ventilator settings to determine respiratory state and associated measurements during the respiration-based calibration (¶¶ [0062]-[0065]).
Murai discloses/suggests a method comprising continuously measuring a blood pressure waveform as a list of time-value pairs, the blood pressure wave exhibiting fluctuations caused by the blood pressure; analyzing the fluctuations of the blood pressure waveform to determine a breathing state; and associating blood pressure values of the waveform with each breathing state (¶¶ [0043]-[0045] breathing period BP (one inhalation and one exhalation) corresponding to the breathing cycle is estimated from changes in blood pressure, e.g., Fig. 3). Ukawa discloses and/or suggests a comparable method comprising continuously measuring a blood pressure waveform by at least one pressure transducer of a blood pressure cuff device (Fig. 1, pulse wave measuring section 13 detecting the cuff pressure), said waveform similarly exhibiting fluctuations caused by the blood pressure and due to a natural variation due to differences in respiratory sinus arrhythmia between the breathing states (e.g., Figs. 4-5). Accordingly, Murai and Ukawa in combination disclose/suggest an alternative to the ventilator disclosed by Sethi for obtaining a blood pressure value correlated with two different predetermined breathing states (i.e., inhalation and exhalation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Fukuda with the blood pressure measuring device comprising a blood pressure cuff device including at least one pressure transducer for continuously detecting a pulse pressure wave; the computation unit being configured to analyze fluctuations (periodic changes) in the measured pressure wave to detect breathing states and identify at least one pulse pressure value of the pressure wave associated with each of two different breathing states (inhalation and exhalation) as taught/suggested by Murai and Ukawa, such that the at least two reference blood pressure values have different values due to a natural variation due to differences in respiratory sinus arrhythmia between each breathing state, as taught and/or suggested by Sethi, in order to acquire calibration data sets without requiring any additional action(s) by the user and in a manner that permits the user to be ambulatory and/or as a simple substitution of one set of different first and second states associated with different blood pressure values for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 7, Fukuda as modified teaches/suggests the limitations of claim 1, and obtaining at least two blood pressure values of the pulse pressure wave via the blood pressure cuff device and the computation unit, wherein the at least two blood pressure values are measured at and associated with different breathing states; continuously measuring the pressure wave, which is a list of time-value pairs via at least one pressure transducer, wherein the pressure wave exhibits fluctuations caused by the blood pressure; and analyzing the fluctuations to obtain at least two blood pressure values, each associated with a different breathing state, by analyzing the fluctuations to determine breathing state as discussed above. Murai further discloses/suggests measurement of the breathing is a list of time-breathing state values (e.g., Fig. 3, inhalation and exhalation periods), indicating/suggests blood pressure values associated with time points within each state/period are associated with each breathing state (i.e., inhalation or exhalation). Murai further discloses/suggests pressure decreases at the time of inhalation and increase at the time of exhalation, indicating/suggesting a maximum peak is associated with exhalation and a minimum peak is associated with inhalation (¶ [0044]; ¶ [0064]; Fig. 3; etc.). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Fukuda with the measurement of the breathing being a list of time-breathing state values and obtaining the at least two blood pressure values by analyzing the fluctuations to obtain each blood pressure value associated with a respective time point within each breathing state (e.g., time point corresponding to a minimum peak indicating inhalation and/or time point corresponding to a maximum peak indicating exhalation) as taught/suggested Murai in order to enable selecting blood pressure values corresponding to a maximum difference (e.g., having at least a certain level of difference) in blood pressure throughout the breathing cycle for calibration.
Regarding claim 9, Fukuda as modified teaches/suggests determining a PWTT and/or PWV by means of an ECG (Fig. 3, electrocardiogram information measurement apparatus 610; ¶ [0059]; etc.).
Regarding claim 10, Fukuda as modified teaches/suggests the pressurized blood pressure measurements and non-pressurized measurements of the PWTT and/or PWV are each measured at different points on a body of a living being, wherein the different points are selected so that a bloodstream extending from or to the heart reaches the different points one after the other (Fig. 3, ECG may be measured at the chest, and the pulse wave may be measured at the finger; ¶ [0003] pressurized blood pressure measurements may be made at the arm; etc.).
Regarding claim 11, Fukuda as modified teaches/suggests the limitations of claim 10, as discussed above, and further discloses, after a calibration, measurements of PWTT and/or PWV are carried out (e.g., ¶ [0166]). Fukuda does not expressly disclose said measurements are carried out for at least 30 minutes. However, Fukuda does indicate the measurements can be "constantly continuously" measured (e.g., ¶ [0166]), and teaches/suggests changes in blood pressure when the user is asleep is thought to be important (e.g., ¶ [0005]). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Fukuda with measurements of PWTT and/or PWV being carried out for at least 30 minutes (e.g., overnight) in order to facilitate continuously measuring blood pressure, and/or changes therein, while a user sleeps.
Regarding claim 19, Fukuda as modified teaches/suggests the method further comprises carrying out subsequent non-pressurized measurements of the PWTT and/or PWV; and converting measured values of the subsequent non-pressurized measurements into at least one blood pressure value by means of data collected during at least one pressurized blood pressure measurement (i.e., the calibration of claim 1) (¶ [0166] PWV/PWTT is constantly, continuously determined and BP estimated based thereon using the calibrated function).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fukuda in view of and Sethi, Murai and Ukawa as applied to claim(s) 10 above, and further in view of US 2009/0099461 A1 (previously cited, Jones).
Regarding claim 12, Fukuda as modified teaches/suggests the limitations of claim 10, as discussed above, but does not expressly disclose a change in position of a measuring point relative to a Hydrostatic Indifference Point (HIP) or relative to the heart is detected by a position sensor and/or an acceleration sensor and is used to correct the pressurized blood pressure measurements.
Jones teaches/suggests a method comprising detecting a position of a measuring point relative to a Hydrostatic Indifference Point (HIP) or relative to the heart to correct blood pressure measurements (e.g., ¶ [0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Fukuda with a change in position of a measuring point relative to a Hydrostatic Indifference Point (HIP) or relative to the heart being detected by a position sensor and/or an acceleration sensor and is used to correct the pressurized blood pressure measurements as taught and/or suggested by Jones in order to correct blood pressure measurements performed in a non-supine position (Jones, ¶ [0006]), thereby providing more accurate/reliable blood pressure measurement(s), particularly for ambulatory users.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fukuda in view of and Sethi, Murai and Ukawa as applied to claim(s) 2 above, and further in view of US 2009/0118628 A1 (previously cited, Zhou).
Regarding claim 14, Fukuda as modified teaches/suggests the limitations of claim 2, as discussed above, and further discloses the system further comprises an air pressure cuff used for the pressurized blood pressure measurement (¶ [0050] systolic pressures p1, p2 obtained when the subject is in the first and second states, which may be obtained by a direct measurement method (¶ [0050]), such as using a pressurized cuff (¶ [0003]); Ukawa, cuff 21), but does not expressly disclose the air pressure cuff has a sensor for determining an arm diameter. However, Zhou discloses determining arm size (circumference) to use in an, e.g., oscillometric, blood pressure measurement (e.g., ¶ [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Fukuda with the air pressure cuff having a sensor for determining an arm diameter (e.g., a broadly automatic means/method for determining arm size) as taught/suggested by Zhou in order to correct for a measurement bias that depends on the size of patient's arm (Zhou, ¶ [0008], thereby providing more accurate/reliable pressurized blood pressure measurement(s).
Response to Arguments
Applicant's arguments with respect to Miele have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. However, the examiner does note that some of said arguments are arguing features that are not claimed (e.g., Remarks, pgs. 18-19, "while claim 7 as amended herein, utilizes well known cuff based systems present today"). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant's remaining arguments applicable to the rejection(s) of record above have been fully considered but they are not persuasive.
With respect to rejections under 35 U.S.C. 112(b), Applicant contends, "For example the 'computation unit' is part of a blood pressure cuff which performs actions to determine blood pressure values at different states of the breathing cycle. Also, it has means to transmit that [sic] values to the 'evaluation and representation unit'. The 'evaluation and representation unit' is for example a smartwatch" (Remarks, pg. 12).
The computation unit being part of a blood pressure cuff does not clarify what the structure of the computation unit is. Further, the application as filed fails to disclose the evaluation and representation unit may be a smartwatch, as Applicant contends. At best, Applicant discloses a plethysmography sensor or multiple vital data sensors can be/have been integrated in a smart watch (¶ [0313]; ¶ [0316]; ¶ [0332]; etc.).
With respect to the prior art rejections, Applicant contends, "Fukuda does disclose its ability to be used in different states, but states that states must 'produce a certain level of difference or more in the systolic pressure value of the measurement subject.' Id. at [0050]. Fukuda further provides an example of the types of states being a first state being prior to exercise and at rest and the second state being immediately after exercise. Id. As such, it can be understood that the first and second states must have a relatively large difference. On the other hand, the current application calibrates during a single respiration. The difference throughout a single respiration is not large and is rather a small variation during the respiration. As such, the Examiner cannot use the fact that the current application teaches a new and novel method of calibration during a single respiration to assert that a method of calibrating measurements taken at different states, such as before and after exercise, teaches the current method of calibration" (Remarks, pgs. 16-17).
The claims do not require calibrating "during a single respiration." All that is required is that the reference/cuff blood pressure measurements are acquired during different breathing states, and that the blood pressure values are different in each state "due to a natural variation due to differences in respiratory sinus arrhythmia between the each [sic] different breathing state." Secondly, Fukuda does not disclose how large a difference in blood pressure between states must be, only referring to a difference of a "certain level," and disclosing exemplary first and second states. The examiner has not contended that Fukuda alone suggests the first and second states may be different breathing states. However, Sethi does disclose the blood pressure difference occurring between inhalation and exhalation is sufficiently different to enable calibrating a continuous blood pressure measurement device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
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/Meredith Weare/Primary Examiner, Art Unit 3791