DETAILED ACTION
This Office Action is in response to the communication dated 26 March 2026 concerning Application No. 18/481,043 filed on 04 October 2023.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of Claims
Claims 1-27 are pending and currently under consideration for patentability; claims 24 and 25 have been amended; claims 26 and 27 have been added as new claims.
Response to Arguments
Applicant's arguments filed 26 March 2026 have been fully considered, but they are not persuasive.
Applicant argues that Muhlsteff does not disclose or suggest the limitation of “storing a plurality of calibrations factors, each of which is associated with a respective one of a plurality of different postures, or a respective one of a plurality of different activity levels, or a respective one of a plurality of different heart rate (HR) ranges, or a respective one of a plurality of different combinations of at least two of postures, activity levels and HR ranges for a patient” (Arguments, p. 12). The Examiner respectfully disagrees and directs Applicant to those sections of the Muhlsteff reference cited in the text of the rejection below which describe storing calibration factors associated with different postures. The Examiner further submits that the limitations of postures, activity levels, and heart rate ranges are presented in the alternative, and the Muhlsteff reference reads on the posture-based calibration factors.
Applicant argues that “Muhlsteff neither stores calibration factors nor identifies and uses one or more of the stored calibration factors (identified at the identifying step) to determining one or more values indicative of the patient’s arterial blood pressure” (Arguments, p. 17). The Examiner respectfully disagrees, as Muhlsteff describes performing the calibration steps and storing calibration factors in a look-up table ([0016], [0025]) as well as describing that the lookup table may be used in the monitoring period ([0039]). Therefore, the Examiner respectfully maintains that Muhlsteff describes stored calibration factors and using the stored calibration factors to determine values indicative of the patient’s arterial blood pressure.
Applicant has added new claims 26 and 27, which the Examiner has addressed below.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 4, 10, 11, 16, 18, 19, and 24 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Muhlsteff et al. (US 2011/0144456 A1).
Regarding claims 1, 16, and 24, Muhlsteff describes a method, system, and non-transitory processor storage device, comprising:
storing a plurality of calibrations factors via memory ([0025], storage device), each of which is associated with a respective one of a plurality of different postures ([0034], [0039]: “before a monitoring period is started, a calibration procedure is performed for different postures of the patient…a look-up table is created by this procedure”; [0025], a storage device is provided in which pre-calibrated values are stored)
obtaining a signal indicative of activity of the patient’s heart, via electrodes and/or sensors ([0034], ECG sensor)
obtaining a signal indicative of changes in arterial blood volume of the patient, via electrodes and/or sensors ([0034], pulse wave sensor for plethysmographic measurement)
determining a pulse arrival time value by determining a time from a feature of the signal indicative of activity of the patient’s heart to a feature of the signal indicative of changes in arterial blood volume of the patient ([0002]: “it is common practice to use the pulse arrival time (PAT), which is defined as the time-delay between the R-peak of the QRS wave from the ECG and the arrival of the arterial pulse wave at the periphery, e.g. measured by a plethysmographic sensor”)
determining a current posture of the patient via one or more sensors ([0033]: “in order to detect the posture of the patient…an acceleration sensor 1 is attached to the patient 2”)
identifying one or more of the stored calibration factors that correspond to the current posture ([0025], [0039], use of the look-up table)
determining one or more values indicative of the patient’s arterial blood pressure based on the PAT value and the one or more of the stored calibration factors identified at the identifying step ([0016]: “determining the blood pressure value based on pre-calibrated values for pulse arrival time signal vs. DC component of the accelerometer signal…pre-calibrated values of the blood pressure for pulse arrival time signal vs. DC components of the accelerometer signal is provided in a look-up table which has been generated in a preceding calibration procedure…an analytical correction function for the blood pressure on the basis of values for pulse arrival time signal vs. DC component of the accelerometer signal can be provided”)
Regarding claims 3 and 18, Muhlsteff describes wherein
the obtaining the signal indicative of activity of the patient’s heart comprises sensing an electrocardiogram signal ([0034])
the obtaining the signal indicative of changes in arterial blood volume of the patient comprises sensing a photoplethysmography signal or an impedance plethysmography signal ([0017], obtaining a plethysmographic signal by optical or bioimpedance means)
Regarding claim 4, Muhlsteff describes wherein
the determining at least one of the current posture, or the current activity level, or the current HR of the patient comprises determining the current posture of the patient ([0033])
the identifying one or more of the stored calibration factors comprises identifying one or more stored calibration factors that correspond to the current posture of the patient ([0025], [0039])
the determining the one or more values indicative of the patient’s arterial blood pressure comprises determining the one or more values indicative of the patient’s arterial blood pressure based on the PAT value and at least one of the one or more stored calibration factors that correspond to the current posture of the patient ([0016])
Regarding claims 10 and 19, Muhlsteff inherently describes wherein the one or more values indicative of the patient’s arterial blood pressure comprises one or more of a value indicative of the patient’s systolic pressure, diastolic pressure, pulse pressure, and mean arterial pressure ([0016], Muhlsteff describes determining the arterial blood pressure, and the Examiner respectfully submits that expressing an arterial blood pressure as a systolic pressure over a diastolic pressure, i.e., 120/80, is well-known, routine, and conventional in the art, as is calculating pulse pressure [PP=PS-PD], and mean arterial pressure [MAP = ⅓PS + ⅔PD]).
Regarding claim 11, Muhlsteff describes
obtaining one or more values indicative of the patient’s arterial blood pressure from a non-implanted device ([0033] - [0034], sensors are attached to the patient and therefore are non-implanted), and based thereon, determining or updating one or more of the stored calibrations factors ([0034], [0039])
wherein the one or more of the stored calibrations factors, which is/are updated based on the one or more values indicative of the patient’s arterial blood pressure obtained from the non-implanted device, is dependent on the current posture when the one or more values indicative of the patient’s arterial blood pressure was obtained from the non-implanted device ([0039]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2, 17, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Muhlsteff in view of Wenzel et al. (US 2012/0215275 A1).
Regarding claims 2, 17, and 25 Muhlsteff describes the method of claim 1, the system of claim 16, and the processor readable storage device of claim 24, but Muhlsteff does not explicitly disclose at least one of triggering or adjusting therapy based on at least one of the one or more values indicative of the patient’s arterial blood pressure. However, Wenzel also describes a method for determining pulse arrival time and arterial blood pressure, including triggering or adjusting therapy based on at least one of the one or more values indicative of the patient’s arterial blood pressure ([0011]). As Wenzel is also directed towards determining pulse arrival time and arterial blood pressure, and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use the arterial blood pressure value determined by Muhlsteff in order to trigger or adjust therapy as described by Wenzel, as doing so advantageously allows the resulting method to suggest interventions that may beneficially modify the patient’s blood pressure.
Regarding claims 26 and 27, Muhlsteff describes the method of claim 1 and the system of claim 16, but Muhlsteff does not explicitly disclose wherein the determining one or more values indicative of the patient's arterial blood pressure based on the PAT value and the one or more of the stored calibration factors identified at the identifying step, comprises using one or more predetermined equations to determine the one or more values indicative of the patient's arterial blood pressure based on the PAT value and the one or more of the stored calibration factors identified at the identifying step. However, Wenzel also describes a method for determining pulse arrival time and arterial blood pressure, including using one or more predetermined equations to determine the one or more values indicative of the patient's arterial blood pressure based on the PAT value and the one or more of the stored calibration factors identified at the identifying step ([0056]). As Wenzel is also directed towards determining pulse arrival time and arterial blood pressure, and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a predetermined equation as described by Wenzel when using the method described by Muhlsteff, as doing so advantageously allows the resulting method to use patient specific correlation factors when determining the patient’s blood pressure.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Muhlsteff.
Regarding claim 5, although Muhlsteff does not explicitly disclose using the current activity level of the patient to identify the calibration factors which are then used for determining the patient’s arterial blood pressure, Muhlsteff does describe determining an accelerometer signal from the patient ([0007], [0015] - [0016]), which would be used to measure the current activity level of the patient. Based on this, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use the accelerometer signals as described by Muhlsteff in order to determine the current activity level of the patient, as doing so advantageously allows the blood pressure measurement to be corrected based on the activity level, thereby minimizing false alarms and/or unnecessary additional blood pressure measurements, as is a goal of Muhlsteff’s method (Abstract). The Examiner also notes that it is well-known in the art that a patient’s activity level affects the arterial blood pressure, motivating the skilled artisan to account for the activity level when using the blood pressure for diagnostic or therapeutic purposes.
Therefore, regarding claim 5, Muhlsteff suggests wherein
the determining at least one of the current posture, or the current activity level, or the current HR of the patient comprises determining the current activity level of the patient ([0015] - [0016], via the accelerometer signal)
the identifying one or more of the stored calibration factors comprises identifying one or more stored calibration factors that correspond to the current activity level of the patient ([0025], [0039], wherein the look-up table may be populated based on activity signals as measured via the accelerometer as described in [0015] - [0016])
the determining the one or more values indicative of the patient’s arterial blood pressure comprises determining the one or more values indicative of the patient’s arterial blood pressure based on the PAT value and at least one of the one or more stored calibration factors that correspond to the current activity level of the patient ([0016], wherein the calibration factors may be based on the accelerometer signals as described in [0015] - [0016])
Regarding claim 6, although Muhlsteff does not explicitly disclose using the current heart rate of the patient to identify the calibration factors which are then used for determining the patient’s arterial blood pressure, Muhlsteff does describe using the heart rate to generate the calibration factors used in determining the pulse arrival time ([0011], additional measures are taken when the pulse arrival time becomes longer or shorter than a threshold, preferably an upper and lower threshold are used which are dependent on the heart rate). Muhlsteff also describes obtaining an electrocardiogram and measuring the peaks of the R-waves ([0031], [0034]), from which it is well-known to derive a patient’s heart rate, for example by counting the number of peaks in a given time period. Based on this, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to determine a patient’s current heart rate when using the described method, as doing so advantageously allows the blood pressure measurement to be corrected based on the heart rate, thereby minimizing false alarms and/or unnecessary additional blood pressure measurements, as is a goal of Muhlsteff’s method (Abstract). The Examiner also notes that it is well-known in the art that a patient’s heart rate affects the arterial blood pressure, motivating the skilled artisan to account for the heart rate when using the blood pressure for diagnostic or therapeutic purposes.
Therefore, regarding claim 6, Muhlsteff suggests wherein
the determining at least one of the current posture, or the current activity level, or the current HR of the patient comprises determining the current HR of the patient ([0031], via the ECG sensors)
the identifying one or more of the stored calibration factors comprises identifying one or more stored calibration factors that correspond to the current HR of the patient ([0011])
the determining the one or more values indicative of the patient’s arterial blood pressure comprises determining the one or more values indicative of the patient’s arterial blood pressure based on the PAT value and at least one of the one or more stored calibration factors that correspond to the current HR of the patient ([0016], wherein the calibration factors may be based on the heart rate as described in [0011])
Regarding claim 7, Muhlsteff describes determining the current posture ([0033]) and suggests determining the current heart rate ([0031], please see discussion of claim 6 above). Therefore, Muhlsteff suggests wherein
the determining at least one of the current posture, the current activity level or the current HR of the patient comprises determining both the current posture and the current HR of the patient ([0033], [0031])
the identifying one or more of the stored calibration factors comprises identifying one or more stored calibration factors that correspond to a combination of the current posture and the current HR of the patient ([0025], [0039], [0011])
the determining the one or more values indicative of the patient’s arterial blood pressure comprises determining the one or more values indicative of the patient’s arterial blood pressure based on the PAT value and at least one of the one or more stored calibration factors that correspond to the combination of the current posture and the current HR of the patient ([0016])
Regarding claim 8, Muhlsteff suggests determining a current activity level ([0015] - [0016], please see discussion of claim 5 above) and determining a current heart rate ([0031], please see discussion of claim 6 above). Therefore, Muhlsteff suggests wherein
the determining at least one of the current posture, the current activity level or the current HR of the patient comprises determining both the current activity level and the current HR of the patient ([0015], [0016], [0031])
the identifying one or more of the stored calibration factors comprises identifying one or more stored calibration factors that correspond to a combination of the current activity level and the current HR of the patient [0025], [0039], wherein the look-up table may be populated based on activity signals as measured via the accelerometer as described in [0015] - [0016] or heart rate as described in [0011])
the determining the one or more values indicative of the patient’s arterial blood pressure comprises determining the one or more values indicative of the patient’s arterial blood pressure based on the PAT value and at least one of the one or more stored calibration factors that correspond to the combination of the current activity level and the current HR of the patient ([0016], wherein the calibration factors may be based on the accelerometer signals as described in [0015] - [0016] or the heart rate as described in [0011])
Regarding claim 9, Muhlsteff describes determining the current posture ([0033]) and suggests determining the current activity level ([0015] - [0016], please see discussion of claim 5 above). Therefore, Muhlsteff suggests wherein
the determining at least one of the current posture, the current activity level or the current HR of the patient comprises determining both the current posture and the current activity level of the patient ([0033], [0015] - [0016])
the identifying one or more of the stored calibration factors comprises identifying one or more stored calibration factors that correspond to a combination of the current posture and the current activity level of the patient ([0025], [0039], [0015] - [0016])
the determining the one or more values indicative of the patient’s arterial blood pressure comprises determining the one or more values indicative of the patient’s arterial blood pressure based on the PAT value and at least one of the one or more stored calibration factors that correspond to the combination of the current posture and the current activity level of the patient ([0016], wherein the calibration factors may be based on the accelerometer signals as described in [0015] - [0016])
Claims 13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Muhlsteff in view of Areny et al. (US 2014/0194721 A1).
Regarding claims 13 and 21, Muhlsteff describes the method of claim 1 and the system of claim 16, including sensing a photoplethysmography or an impedance plethysmography signal ([0017]), but Muhlsteff does not explicitly disclose wherein
the obtaining the signal indicative of changes in arterial blood volume of the patient comprises sensing both a photoplethysmography signal and an impedance plethysmography signal
the determining the PAT value comprises determining a first PAT value using the PPG signal and determining a second PAT value using the IPG signal
the determining the one or more values indicative of the patient’s arterial blood pressure comprises determining a first value indicative of the patient’s arterial blood pressure based on the first PAT value and determining a second value indicative of the patient’s arterial blood pressure based on the second PAT value
However, Areny also describes a method for determining pulse arrival times and arterial blood pressures, including wherein
obtaining the signal indicative of changes in arterial blood volume of the patient comprises sensing both a photoplethysmography signal and an impedance plethysmography signal ([0013], [0022])
determining the PAT value comprises determining a first PAT value using the PPG signal and determining a second PAT value using the IPG signal ([0027])
determining the one or more values indicative of the patient’s arterial blood pressure comprises determining a first value indicative of the patient’s arterial blood pressure based on the first PAT value and determining a second value indicative of the patient’s arterial blood pressure based on the second PAT value ([0005], [0027])
The Examiner also notes that Areny explicitly states that “since both the PPG and the IPG measure changes of volume, the wave forms of both signals are analogous, and therefore the IPG has been used as an alternative signal to the PPG to measure time intervals related with the propagation of the pulse wave in the arteries” ([0005]), thereby suggesting to the skilled artisan that both the IPG and PPG may be used to determine a patient’s pulse arrival time and arterial blood pressure. As Areny is also directed towards a method for determining pulse arrival times and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use both IPG and PPG measurements, in a manner similar to that described by Areny, when using the method described by Muhlsteff, as doing so advantageously allows the resulting method to use a wider array of sensors for determining patient parameters.
Allowable Subject Matter
Claims 12, 14, 15, 20, 22, and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claims 12 and 20, Muhlsteff describes the method of claim 1 and the system of claim 16, including sensing a photoplethysmography or an impedance plethysmography signal ([0017]), and Areny describes sensing both a photoplethysmography and an impedance plethysmography signal ([0013], [0022]). However, Muhlsteff, Areny, and the other prior art of record do not disclose or suggest the step of “selecting, based on at least one of the current posture, the current activity level, or the current HR of the patient, which one of the PPG and the IPG signals is to be used for the determining the PAT value, which is used for the determining the one or more values indicative of the patient’s arterial blood pressure.” Although Muhlsteff describes measuring the current posture of the patient ([0025], [0039]), there is no indication that this measured current posture is used to select which plethysmographic signal is to be used for determining the pulse arrival time and arterial blood pressure.
Regarding claims 14 and 22, Muhlsteff, Areny, and the other prior art of record do not disclose or suggest the step of “selecting, based on at least one of the current posture, the current activity level or the current HR of the patient, which one of the first and the second values indicative of the patient’s arterial blood pressure is to be at least one of stored or used by the IMD.” Similar to the reasoning above regarding claim 12, there is no indication that the current posture measured by Muhlsteff can, or should, be used to select which arterial blood pressure value to store or use for further analysis.
Regarding claims 15 and 23, Muhlsteff, Areny, and the other prior art of record do not disclose or suggest the steps of “selecting, based on at least one of the current posture, the current activity level or the current HR of the patient, one of a plurality of different ways to determine a weighted average of the first and the second values indicative of the patient’s arterial blood pressure; and at least one of storing or using the weighted average of the first and the second values indicative of the patient’s arterial blood pressure.” Although Muhlsteff determines a corrected pulse arrival time and arterial blood pressure based on the current posture of the patient ([0009], [0016]), Muhlsteff does not disclose or suggest determining the weighted average of two different values of the patient’s arterial blood pressure, and Muhlsteff does not disclose or suggest a plurality of different ways to determine this weighted average.
Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
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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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Carl Layno, can be reached by telephone at 571-272-4949. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792
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