DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 5, 6, 7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable by Kinast(US 9408542 B1) in view of Kayser(US 20210077035 A1) (both cited previously).
Regarding claim 1, Kinast discloses an apparatus, comprising: a monitor configured to estimate a blood pressure of a patient(In certain embodiments, a method of monitoring blood pressure of a patient includes receiving a physiological electrical signal from an electrical sensor coupled with a patient(col. 1, lines 42-43). Using the estimated changes in blood pressure, the parameter calculator 110 can trigger a blood pressure cuff 108 to obtain an occlusive blood pressure measurement(col. 5, lines 28-31)); a blood pressure measuring device configured to measure a blood pressure of the patient; and a controller operatively coupled to the monitor and to the blood pressure measuring device, the controller configured to cause the blood pressure measuring device to take a first blood pressure measurement of the patient in response to a first estimated blood pressure deviating from a first baseline, such that the first estimated blood pressure is outside of a first threshold, the controller being configured to cause the blood pressure measuring device to take a second blood pressure measurement of the patient in response to a second estimated blood pressure deviating from a second baseline such that the second estimated blood pressure is outside of a second threshold(The processor 530 can include, for example, one or more microprocessors, microcontrollers, cores, digital signal processors (DSPs), or the like. The processor 530 can store instructions in a computer-readable medium. The processor 530 can also perform other operations for the blood pressure monitoring system 500A that are not explicitly described herein(col. 13, lines 18-21).At block 1006, a difference between the two arterial PWTT measurements is determined. It is then determined at decision block 1008 whether a new blood pressure measurement is required. In certain embodiments, this decision can be made by determining whether the difference between the two measurements is greater than a threshold. A difference greater than a threshold can be indicative of a change in a patient's blood pressure. Therefore, if the difference is greater than the threshold, an occlusive cuff is triggered to take a new blood pressure measurement at block 1010. If the difference is not greater than the threshold, then the process 1000 loops back to block 1002. Effectively, the process 1000 therefore can trigger occlusive cuff measurements when the threshold is exceeded and can continue monitoring arterial PWTT measurements otherwise(col. 23, lines 56-68). Fig 9E and Fig. 9F show initial and second measurements going to a comparison module to determine the different between values. In some implementations, the initial arterial PWTT values (a-PWTT A and a-PWTT B) can be provided to a comparison module 936. The comparison module 906 can analyze the two initial arterial PWTT values to generate a final arterial PWTT output value. In some implementations, the comparison module 936 can compare the two initial arterial PWTT values to determine a difference between the two values(col. 22, lines 19-25)). Kinast fails to disclose wherein the first blood pressure measurement us used to set the second baseline and the second threshold, and wherein the second baseline is different than the first baseline and the second threshold is different that the first threshold.
However, Kayser teaches “a first signal indicating first measurements of a vital sign of an individual taken during a first time period; determining a baseline of the vital sign based on the first measurements; identifying a threshold of the vital sign based on the baseline; receiving, from the sensor, a second signal indicating second measurements of the vital sign of the individual taken during a second time period; determining that at least one of the second measurements is outside of a range bounded by the threshold[claim 9]” and “determining a baseline of the vital sign based on the first measurements by calculating an arithmetic mean of the first measurements; identifying a second threshold of the vital sign based on the baseline, the second threshold being a predetermined percentage of the baseline[0129]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the non-invasive blood pressure measurement system with the vital signs monitoring system of Kayser. Doing so would specify that each measurement taken would be compared to a different threshold or baseline based on the previous measurements so the system is updating for the patient.
Regarding claim 5, Kinast in view of Kayser teaches the apparatus of claim 1, wherein the monitor is a pulse oximeter(The optical sensor 102 can be a pulse oximetry sensor, a co-oximetry sensor, or the like(col. 4, lines 42-44)).
Regarding claim 6, Kinast in view of Kayser teaches the apparatus of claim 1, wherein the blood pressure measuring device is a non-invasive blood pressure measuring device(A system for non-invasively determining an indication of an individual's blood pressure is described[abstract]).
Regarding claim 7, Kinast in view of Kayser teaches the apparatus of claim 1, wherein the blood pressure measuring device includes an inflatable cuff(The control unit 520 can control the inflation of the cuff 522 and receive signals from the cuff 522 regarding systolic and diastolic blood pressure(col. 12, lines 18-21)(Fig. 5B)).
Regarding claim 10, Kinast in view if Kayser teaches the apparatus of claim 1, wherein the controller is configured to cause the blood pressure measuring device to take the first blood pressure measurement of the patient in response to the first estimated blood pressure that deviates from the first baseline by an amount greater than a threshold amount(The processor 530 can include, for example, one or more microprocessors, microcontrollers, cores, digital signal processors (DSPs), or the like. The processor 530 can store instructions in a computer-readable medium. The processor 530 can also perform other operations for the blood pressure monitoring system 500A that are not explicitly described herein(col. 13, lines 18-21).At block 1006, a difference between the two arterial PWTT measurements is determined. It is then determined at decision block 1008 whether a new blood pressure measurement is required. In certain embodiments, this decision can be made by determining whether the difference between the two measurements is greater than a threshold. A difference greater than a threshold can be indicative of a change in a patient's blood pressure. Therefore, if the difference is greater than the threshold, an occlusive cuff is triggered to take a new blood pressure measurement at block 1010. If the difference is not greater than the threshold, then the process 1000 loops back to block 1002. Effectively, the process 1000 therefore can trigger occlusive cuff measurements when the threshold is exceeded and can continue monitoring arterial PWTT measurements otherwise(col. 23, lines 56-68). For example, if an estimated blood pressure change exceeds a threshold change, a blood pressure cuff measurement can be triggered to determine and/or confirm the accuracy of the estimated blood pressure change. In some embodiments, the new blood pressure measurement can be added to a running tally to refine the individualized patient calibration factor(col. 29, lines 25-31)).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kinast in view of Kayser and further in view of Kelly(WO 2022038364 A1) (cited previously).
Regarding claim 2, Kinast in view of Kayser teaches the apparatus of claim 1, but fails to specify wherein the controller is configured to prevent the blood pressure measuring device from taking the second blood pressure measurement until a time period has expired since the first blood pressure measurement of the patient.
However, Kelly teaches The processor 102 can be programmed to instruct the sensor to monitor in real-time a blood flow of the person when the sensor is worn on the person while the blood flow is associated with a first blood pressure (or heart rate) measurement (e.g., via the sphygmomanometer 108 or another device). The sensor generates a waveform associated with the blood flow and sends the waveform to the processor 102. The processor 102 can be programmed to determine whether there is a shape change in the waveform indicative of a value change in the first blood pressure (or heart rate) measurement and obtain a second blood pressure (or heart rate) measurement of the person based on at least one of the shape change satisfying a predetermined threshold for the patient or a preset time period having expired from when the first blood (or heart rate) measurement was received, where the second blood pressure measurement is after the first blood pressure measurement[71].
It would be obvious to one of ordinary skill in the art before the effective filing to configure the non-invasive blood pressure measurement system of Kinast with the non-invasive blood pressure monitoring of Kelly. Doing so would allow the blood pressure monitor to take a second measurement after a specific time period has passed to ensure it’s safe for the patient.
Claim(s) 3, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kinast in view of Kayser and further in view of Grudic(WO 2015069940 A1) (cited previously).
Regarding claim 3, Kinast in view of Kayser teaches the apparatus of claim 1, but fails to specify wherein the first baseline is set based on a measured blood pressure of the patient. However, Grudic teaches displaying an estimate and/or prediction of a patients current and/or future blood pressure status[0041]. In various embodiments, CRI estimates can be (i) based on a fixed time history of patient monitoring (for example a 30 second or 30 heart beat window); (ii) based on a dynamic time history of patient monitoring (for example monitoring for 200 minutes may use all sensor information gathered during that time to refine and improve CRI estimates); (iii) based on either establishing a baseline estimate of CRI when the patient is normovolemic (no volume loss has occurred)[0042].
It would be obvious to one of ordinary skill in the art before the effective filing to configure the non-invasive blood pressure measurement system of Kinast with the non-invasive predictive/estimative blood pressure monitoring of Grudic. Doing so would clarify a baseline blood pressure measurement for the patient in order for the system to have a metric to compare future measurements to and from estimations off of.
Regarding claim 8, Kinast in view of Kayser teaches the apparatus of claim 1, but fails to specify further comprising: a patient status detector operatively coupled to the controller. However, Grudic teaches displaying an estimate and/or prediction of a patient’s current and/or future blood pressure status[0041].
It would be obvious to one of ordinary skill in the art before the effective filing to configure the non-invasive blood pressure measurement system of Kinast with the non-invasive predictive/estimative blood pressure monitoring of Grudic. Doing so would clarify a display of patient status throughout blood pressure measurement to make the patient and/or physician aware of measurements.
Regarding claim 9, Kinast in view of Kayser and Grudic teaches the apparatus of claim 8, wherein the patient status detector comprises an accelerometer configured to determine whether the patient is lying down and whether the patient is not moving(Kinast - For example, a first blood pressure measurement can be taken when the patient is lying down on a bed or table with the arm at the patient's side and a second blood pressure measurement can be taken with the arm raised up at least approximately perpendicularly to the patient's body. The blood pressure measurements can be normalized to account for changes in pressure due to the change in elevation(col. 28, lines 19-26)). Kinast fails to disclose the accelerometer. However, Grudic teaches such sensors can include, but are not limited to, a blood pressure sensor, an intracranial pressure monitor, a central venous pressure monitoring catheter, an arterial catheter, an electroencephalograph, a cardiac monitor, a transcranial Doppler sensor, a transthoracic impedance plethysmograph, a pulse oximeter, a near infrared spectrometer, a ventilator, an accelerometer, an electrooculogram, a transcutaneous glucometer, an electrolyte sensor, and/or an electronic stethoscope[0010].
It would be obvious to one of ordinary skill in the art before the effective filing to configure the non-invasive blood pressure measurement system of Kinast with the non-invasive predictive/estimative blood pressure monitoring of Grudic. Doing so would incorporate an accelerometer as one of the sensors in the system in order to help gage patient positioning during blood pressure monitoring.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kinast in view of Kayser and further in view of Reich(US 20190357854 A1) (cited previously).
Regarding claim 4, Kinast in view of Chen teaches the apparatus of claim 1, but fails to disclose wherein the monitor is configured to estimate an aortic blood pressure of the patient. However, Reich teaches the output of the probabilistic digital signal processor when provided with the pulse oximeter data is one or more of: [0078] a heart stroke volume; [0079] a cardiac output flow rate; [0080] an aortic blood pressure; and/or [0081] a radial blood pressure.
It would be obvious to one of ordinary skill in the art before the effective filing to configure the non-invasive blood pressure measurement system of Kinast with the estimation apparatus of the cardiovascular system of Reich. Doing so would clarify the blood pressure measurements are taken of the aortic valve.
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive. Applicant argues a lack of prima facie obvious between primary reference Kinast and secondary reference Kayser. However, it is obvious to combine the two references because both applications contain sensors in a wearable monitor system to take multiple measurements of a patients vital signs(i.e. blood pressure). A baseline measurement can be calculated from the obtained measurements to as well as determining whether or not the signal meets a set threshold. The references are combined because Kinast fails to teach wherein the first blood pressure measurement is used to set the second baseline and the second threshold , and wherein the second baseline is different than the first baseline and the second threshold is different that the first threshold. Kayser teaches “First measurements of a vital sign of an individual determined automatically during a first time period and determining a baseline of the vital sign based on the first measurements by averaging the first measurements[abstract]. Determining a baseline of the vital sign based on the first measurements by calculating an arithmetic mean of the first measurements; identifying a second threshold of the vital sign based on the baseline[0129], In some example implementations, the processor(s) may calculate a potential threshold based on the baseline[0092]”. The first measurements taken in Kayser are used to calculate a baseline and threshold that are used for the second measurements. Kinast contains a processor in the comparison module with the ability to calculate thresholds to measure values against so it has the ability to be combined with Kayser and disclose the claimed material.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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 on (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 (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.
/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796