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 .
Response to Amendment
The amendment to the claims filed 11 May 2026 has been entered. Claim(s) 1-2, 7, 10-11 and 16 is/are currently amended. Claim(s) 3, 5-6, 13 and 15 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 Claim(s) 1-2, 4, 7-12, 14 and 16-19 is/are pending, with claim(s) 4 and 17-18 withdrawn from consideration for being drawn to a non-elected invention and/or species.
Objections and/or Rejections Withdrawn
Objections to the claims and/or rejections under 35 U.S.C. 112(b) (or pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.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 Interpretation
As noted in the prior Office action(s), claims reciting the limitation a "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 "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) 2 is/are objected to because of the following informalities: "a mobile evaluation and a representation unit" (line 17 of pg. 4), and "the mobile evaluation and representation unit are configured" (line 1 of pg. 5) should be respectively amended/corrected to "a mobile evaluation and representation unit" and "the mobile evaluation and representation unit is configured" for consistency with the language of the application as filed (e.g., beginning ¶ [0364]).
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) 1-2, 7-12, 14, 16 and 19 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 1, claim 2 and claims dependent thereon, the limitation "wherein the computation unit has a processor and memory that are collectively configured to record, analyze, and transmit data from the blood pressure cuff device" of claim 1, and the limitation "a computation unit having a microprocessor architecture executing a specific calibration algorithm" of claim 2 lack sufficient support in the application as filed. 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, an evaluation and representation 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 from this disclosure if the "computation unit" and "evaluation and representation unit" are each a component of a medical monitoring device or smart phone; are the medical monitoring device or smart phone itself; etc. In any case, however, Applicant fails to clearly disclose the computation unit is "a processor and memory collectively configured to record, analyze, and transmit data from the blood pressure cuff device" or a "microprocessor architecture executing a specific calibration algorithm" as recited in amended claims 1 and 2, respectively.
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, "evaluation and representation unit" limitations 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. 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. However, it is unclear if the "evaluation and representation unit" is a component of a medical monitoring device or smart phone, the medical monitoring device or smartphone itself, etc.
Regarding claim 1 and claims dependent thereon, the limitation "determining at least two different values of at least one of a pulse wave transit time, a pulse wave velocity, a pulse wave contour or electrical activity of a heart, wherein each of the at least two different values is associated with a blood pressure value of a pulse pressure wave, and wherein each of the at least two values are measured at a different breathing state" is indefinite. It is unclear if determining "at least two different values" requires determining at least two different types of the value types recited (e.g., determining at least a PWTT and a PWV associated with a blood pressure value of a pulse pressure wave, each measured at a different breathing state), or encompasses determining at least two instances of one type of value (e.g., a first PWTT value associated with a blood pressure value of a pulse pressure wave during inhalation and a second PWTT value associated with a blood pressure value of a pulse pressure wave during exhalation).
The combination of limitations "determining at least two different values of at least one of a pulse wave transit time, a pulse wave velocity, a 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, the 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, the 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 (i.e., at least two values) is 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 at least two determined 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. If this is consistent with Applicant's intention, the claim should be amended to clearly reflect this intention.
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, the 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, the 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 different 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 is remote from both the blood pressure cuff device and the computation unit; wherein the blood pressure values of each of the at least two different values taken at each different breathing state has a 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, "the blood pressure value of each of the at least two different values" is indefinite. The "at least two different values" are recited as being a PWTT, a PWV, and pulse wave contour or electrical activity, not blood pressure values. At best, the prior limitations indicate each of the at least two different values are associated with a blood pressure value. 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, there is no indication in the claims that a blood pressure device is used to obtain blood pressure values associated with each of the at least two different values. 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 different values by a blood pressure cuff device" appears to have been intended to recite that at least two different blood pressure values are obtained by a blood pressure cuff device and a computation unit, each of said blood pressure values being associated with a respective one of the determined at least two values, with the latter above-noted limitation indicating, when the determined at least two 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. If this is consistent with Applicant's intention, the claim should be amended to clearly reflect this intention.
Lastly, the limitation "wherein the pulse wave transit time, the pulse wave velocity and/or the pulse wave contour are one or both of pressurized blood pressure measurements and non-pressurized measurements" is indefinite. It is unclear in what manner a PWTT, a PWV and/or a pulse wave contour are "blood pressure measurements." Rather, Applicant's own claim limitations indicate these values (PWTT, PWV and/or pulse wave contour) are "associated with" blood pressure measurements. Further, it is unclear in what manner a PWTT, a PWV and/or a pulse wave contour can be both "pressurized" and "non-pressurized," as these appear to be mutually exclusive states.
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 blood pressure association with the at least two reference values which are measurement time states used to determine use for calibration or not to use for calibration; wherein the means for blood pressure association to the measurement time 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 blood pressure association" is unclear, particularly as there is no clear disclosure of a "means blood pressure for association" in the application as filed. Secondly, it is unclear to what "wherein means for blood pressure association to the measurement time 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 blood pressure 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. Claim 1 requires PWTT, PWV, and/or pulse wave contour to be "one or both" of pressurized and non-pressurized "blood pressure" measurements. It is unclear if the limitations of claim 10 are requiring that both pressurized and non-pressurized measurements are required, if each of the pressurized and non-pressurized measurements are made at different points on the body, etc.
Regarding claim 11 and claims dependent thereon, the limitation "wherein when at least one sensor selected form the group consisting of: the 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, an 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. 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, the limitation "the pressurized blood pressure measurement" in claim 12 and the limitation "further comprising an air pressure cuff used for the pressurized blood pressure measurement" of claim 14 are indefinite. It is unclear to what said limitation refers. Claim 1 recites PWTT, PWV, and pulse contour may be non-pressurized measurements. Further, as discussed above, the above-noted values (PWTT, PWV, pulse contour) are not "blood pressure" measurements, but are recited as being associated with blood pressure measurements. Accordingly, it is unclear if "the pressurized blood pressure measurement" refers to one of a PWTT, PWV or pulse contour value, a blood pressure measurement associated with one of these values, etc.
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? Further, it is unclear in what manner a non-pressurized measurement of blood pressure is/may be "converted" to at least one blood pressure value, as it is, itself, a blood pressure value.
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 (previously cited, Ukawa).
Regarding claims 1 and 16, Fukuda discloses/suggests a method for obtaining continuous values of blood pressure (e.g., ¶ [0166]), the method comprising:
determining at least two different pressurized and/or non-pressurized measurement values including pulse wave transit time (PWTT) and/or pulse wave velocity (PWV), wherein each of the at least two different values is measured at a different patient state (¶ [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 including a processor and memory (control unit(s) 150, 240, etc.; ¶ [0290]; etc.) 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 a blood pressure value corresponding to each of the at least two values at each different patient state (i.e., 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 values using the at least two blood pressure values measured for each different patient state via a 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 a single 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 disclose and/or suggest an alternative to the ventilator disclosed by Sethi for obtaining a blood pressure value correlated with two different predetermined breathing states with a single respiratory cycle (i.e., inhalation and subsequent 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) within a single respiratory cycle as disclosed/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 disclosed 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);
a plethysmography sensor (pulse wave information measurement apparatus 620, or pulse wave measurement unit 210) and a computation unit having a microprocessor architecture executing a specific calibration algorithm (control unit(s) 150, 240, etc.; ¶ [0290]; etc.) 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. 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/suggesting 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 and/or non-pressurized measurements of 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, non-pressurized and/or reduced-load 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 discloses and/or 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 calibration 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 have been fully considered but they are not persuasive.
With respect to rejections under 35 U.S.C. 112(b), Applicant contends, "With respect to the 'mobile evaluation and representation unit', the 'mobile evaluation and representation unit' is now clearly defined as a remote electronic device, such as a smartphone, smartwatch, or medical monitoring device, configured to receive, process, and display the measured and calibrated data" (Remarks, pg. 12).
The examiner respectfully disagrees. The claims fail to "define," or limit the structure of, the mobile evaluation and representation unit in any manner, let alone as "a remote electronic device, such as a smartphone, smartwatch, or medical monitoring device, configured to receive, process, and display the measured and calibrated data."
With respect to the remaining rejections, Applicant generally submits that the amendments to the claims address and/or overcome the indefiniteness previously identified by the examiner (Remarks, pgs. 12-14).
The examiner respectfully disagrees. The amendments to the claims fail to clarify many of the previously identified issues. For example, the amendments fail to, inter alia, clarify if determining "at least two different values" requires determining two different types of values listed (e.g., a PWTT, and a PWV) or is satisfied by determining two different values of PWTT (e.g., during each breathing state); sufficiently identify the corresponding structure of each limitation that invokes 35 U.S.C. 112(f); fail to clearly identify which sensors are required for measuring the different values; clarify the relationship between the control unit and a "means for association" or "means for blood pressure association;" etc.
With respect to the prior art rejections, Applicant contends, "However, Claims 1 and 2, as amended, of the current application teaches calibration during a single respiration. Instead, Amended Claim 1, in part, utilizes naturally occurring respiratory-induced blood pressure fluctuations during spontaneous breathing. These variations are significantly smaller and therefore substantially more difficult to detect and process reliably which Fukuda cannot perform. Therefore, Fukuda fails to teach the ability to calibrate a small difference in measuring taken throughout a single respiration as required by amended Claims 1 and 2" (Remarks, pgs. 16).
The examiner respectfully disagrees, and first notes contrary to Applicant's remarks, claim 2 does not require calibration during a single respiration. 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. This is further supported by Murai, which discloses blood pressure variation during a respiration cycle (i.e., difference between blood pressure during inhalation and exhalation) may be as large as 20 mmHg (e.g., ¶ [0044]).
Applicant further submits Sethi "primarily relies on clinically ventilator-controlled respiratory states;" and "[Neither] Murai nor Ukawa may provide assistance to Fukuda or Sethi in teaching each limitation now required by each of Claims 1 and 2, as amended. While one or both of Murai and Ukawa may provide a method of continuously measuring a blood pressure wave as a list of time-value pairs or continuously measuring a blood pressure waveform by at least one pressure transducer, Applicant respectfully asserts that Examiner has not provided articulatable reasoning with a rationale underpinning as to how the methods provided in either one or both of Murai and Ukawa can be substituted into the system of Sethi without significant changes to accomplish these methods described by Examiner herein" (Remarks, pg. 16).
The examiner respectfully disagrees, and first notes the rejection does not propose to substitute the "methods provided in either one or both of Murai and Ukawa […] into the system of Sethi" as Applicant contends. Sethi is not the primary reference and/or reference being modified in the rejection(s) of record. Rather, Sethi discloses/suggests the variation in blood pressure between inhalation and exhalation may be utilized to calibrate a non-invasive continuous blood pressure monitoring system. Murai and Ukawa disclose these blood pressure changes can be continuously measured over at least one respiration cycle and associated with a breathing state during the cycle (i.e., inhalation or exhalation) to identify a blood pressure value during inhalation and a blood pressure value during a following exhalation. Accordingly, as noted in the rejections of record above, it would have been obvious to modify Fukuda with determining blood pressure values associated with each breathing state as taught/suggested by Sethi, Murai and Ukawa 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).
Applicant further contends, "the device according to the method of Fukuda or Sethi consists of a training device or a clinical ventilation tube - in addition to the device for measuring the calibration basis and the device for measuring PTT. In contrast, however, Claims 1 and 2 of present application requires only the additional device for standard blood pressure measurement to provide the data necessary for calibration" (Remarks, pg. 17).
The examiner respectfully disagrees. The examiner is unable to locate any disclosure in Fukuda that a "training device" or a "clinical ventilation tube" is required thereby. Additionally, there is no language in the claims that necessarily precludes use or inclusion of a "training device" in some capacity. Further, as noted above, the proposed benefit of the modifications in view of Murai and Ukawa is that the respiration-based calibration disclosed by Sethi can be applied to spontaneously/naturally breathing (e.g., ambulatory) users, particularly as Murai discloses a relatively "large" variation in blood pressure may occur during a respiration cycle of said subjects.
In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning (Remarks, pgs. 17-18), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, the examiner is not "us[ing] 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" as Applicant contends (pg. 18). Rather, as noted above, the primary reference to Fukuda discloses any two patient 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]). Fukuda does not provide any minimum for said "certain level." Sethi discloses/suggests variation in blood pressure between inhalation and exhalation may be utilized to calibrate a non-invasive continuous blood pressure monitoring system. Murai discloses said variation may similarly occur in naturally/spontaneously breathing subjects, providing a variation of up to 20 mmHg between inhalation and exhalation blood pressures. Murai and Ukawa disclose these blood pressure changes can be continuously measured over at least one respiration cycle and associated with a breathing state during the cycle (i.e., inhalation or exhalation) to identify a blood pressure value during inhalation and a blood pressure value during a following exhalation.
Lastly, Applicant contends, "The Office must consider Claims 1 and 2 as a whole to understand that the method utilizes different states to associate breath states with the blood pressure value which is opposite the teaching of Fukuda" (Remarks, pg. 18-19).
It is unclear in what manner a "method utilizes different states to associate breath states with the blood pressure value" is opposite the teaching of Fukuda. As noted above, Fukuda provides no indication as to any minimum value must be achieved to meet a "certain level of difference" in blood pressure values between the different states. Further, even if the Fukuda could be interpreted to be limited to relatively large differences being required for calibration, Murai discloses relatively large differences (e.g., up to 20 mmHg) can be produced between inhalation blood pressure and exhalation blood pressure of non-ventilated subjects.
For at least the reasons above, the prior art rejections have been maintained.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Meredith Weare/Primary Examiner, Art Unit 3791
Prosecution Insights