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 § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 12-17 and 24-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Heesch et al (2021/0085280).
Regarding claim 1, Van Heesch et al disclose a method for monitoring a patient during surgery, a medical procedure, or a medical observation with a blood flow monitor in communication with an ultrasound transducer probe, the method comprising:
obtaining a Doppler flow signal of a targeted organ blood flow of the patient with the ultrasound transducer probe attached to a stationary position to an abdomen of the patient (at least one Doppler ultrasound probe – [0023]; the wearable ultrasound sensor probe may come in any suitable form, such as an adhesive patch – [0057]; kidney – [0090]);
determining by a processor of the blood flow monitor at least one characteristic associated with the targeted organ blood flow of the patient from the Doppler flow signal (blood flow is measured at the heart, and the kidney (renal artery) – [0090]; fig.8);
determining, by the processor, a baseline value of the at least one characteristic (predetermined function of the arterial blood flows is preferable their numerical function – [0018]; compare the predetermined function…the numerical ration can be compared – [0019]); and
continuously monitoring over time by the processor of the blood flow monitor the Doppler flow signal and the at least one characteristic during the surgery, medical procedure, or medical observation of the patient (determine trends in the haemodynamic data over time – [0051]; measure flow continuously – [0087]).
Regarding claim 2, Van Heesch et al disclose positioning the ultrasound transducer probe on the abdomen of the patient and attaching the ultrasound transducer probe to the abdomen of the patient with an adhesive patch to maintain contact between the ultrasound transducer probe and the patient without an ultrasound operator (at least one Doppler ultrasound probe – [0023]; the wearable ultrasound sensor probe may come in any suitable form, such as an adhesive patch – [0057]; kidney – [0090]); and scanning the abdomen of the patient with the ultrasound transducer probe to find the Doppler flow signal of the targeted organ blood flow of the patient (blood flow is measured at the heart, and the kidney (renal artery) – [0090]; fig.8).
Regarding claim 3, Van Heesch et al disclose outputting in real time to a display in communication with the processor a representation of the Doppler flow signal over time and a representation of the at least one characteristic over time (provide a display of a number of haemodynamic indications and/or of vital signs such as blood pressure and pulse – [0021] including output indicative of the monitored changes – [0024]; fig.8).
Regarding claim 4, Van Heesch et al disclose wherein continuously monitoring over time the Doppler flow signal and the at least one characteristic during the surgery, medical procedure, or medical observation of the patient comprises: collecting, by the blood flow monitor, a running sum of time that the at least one characteristic is below the baseline value of the at least one characteristic during the surgery, medical procedure, or medical observation of the patient (time-integrated values – [0018]; traces that progress in time…evaluate haemodynamic stability – [0047]).
Regarding claim 5, Van Heesch et al disclose wherein continuously monitoring over time the Doppler flow signal and the at least one characteristic during the surgery, medical procedure, or medical observation of the patient comprises: collecting, by the processor of the blood flow monitor, a running average, or a running mean, of abnormal values of the at least one characteristic during surgery, medical procedure, or medical observation of the patient (changes in ratio of, e.g., (highest, lowest, or mean) – [0078]; fig.5).
Regarding claim 6, Van Heesch et al disclose wherein the at least one characteristic associated with the targeted organ blood flow of the patient from the Doppler flow signal comprises: a flow rate of the targeted organ blood flow of the patient (volumetric flow rate at each location - abstract).
Regarding claim 12, Van Heesch et al disclose executing beamformer software code by the processor to track-scan the Doppler flow signal of the targeted organ blood flow of the patient with a two-dimensional phased array of transducer elements of the ultrasound transducer probe to continuously sense the Doppler flow signal of the targeted organ blood flow of the patient during the surgery, medical procedure, or medical observation without an ultrasound operator (transducer array 106 is coupled to a micro-beamformer 112 which controls transmission and reception of signals by the CMUT array cells - [0063]).
Regarding claim 13, Van Heesch et al disclose executing the beamformer software code by the processor to emit a set of sequential beams from the array of transducer elements into the abdomen of the patient to track a center of the targeted organ blood flow relative to the array of transducer elements; focusing, by the processor and the beamformer software code, each beam from the set of sequential beams in different locations; and adjusting, by the processor and the beamformer software code, the position of the set of sequential beams onto the center of the targeted organ blood flow to maintain the Doppler flow signal of the targeted organ blood flow of the patient ([0063];[0064];[0066]).
Regarding claim 14, Van Heesch et al disclose a system comprising:
an ultrasound transducer probe comprising a two-dimensional array of transducer elements configured to measure a Doppler flow signal of a targeted organ blood flow of a patient (transducer array 106 is coupled to a micro-beamformer 112 which controls transmission and reception of signals by the CMUT array cells - [0063]);
an adhesive patch connected to the ultrasound transducer probe and configured to attach the ultrasound transducer probe to the patient and maintain contact between the patient and the ultrasound transducer probe without an operator (the wearable ultrasound sensor probe may come in any suitable form, such as an adhesive patch – [0057]; kidney – [0090]);
a blood flow monitor in communication with the ultrasound transducer probe, wherein the blood flow monitor comprises:
a system memory that stores monitoring software code ([0061]); and
a processor configured to execute the monitoring software code (a processor is one example of a controller which employs one or more microprocessors that may be programmed using software – [0093]) to:
determine at least one characteristic associated with the target organ blood flow of the patient (blood flow is measured at the heart, and the kidney (renal artery) – [0090]; fig.8); and
monitor over time the at least one characteristic associated with the targeted organ blood flow of the patient during a surgery, medical procedure, or medical observation of the patient (determine trends in the haemodynamic data over time – [0051]; measure flow continuously – [0087]).
Regarding claim 15, Van Heesch et al disclose a display in communication with the processor to receive and show a continuous reading of the Doppler flow signal from the ultraosund transducer probe and a representation of the at least one characteristic over time (provide a display of a number of haemodynamic indications and/or of vital signs such as blood pressure and pulse – [0021] including output indicative of the monitored changes – [0024]; fig.8).
Regarding claim 16, Van Heesch et al disclose wherein the processor is configured to execute the monitoring software code to: determine a baseline value of the at least one characteristic associated with the targeted organ blood flow of the patient (predetermined function of the arterial blood flows is preferable their numerical function – [0018]; compare the predetermined function…the numerical ration can be compared – [0019]).
Regarding claim 17, Van Heesch et al disclose wherein the at least one characteristic associated with the targeted organ blood flow of the patient from the Doppler flow signal comprises: a flow rate of the targeted organ blood flow of the patient (volumetric flow rate at each location - abstract).
Regarding claim 24, Van Heesch et al disclose wherein the two-dimensional array of transducer elements of the ultrasound transducer probe comprises a phased array of transducer elements (transducer array 106 is coupled to a micro-beamformer 112 which controls transmission and reception of signals by the CMUT array cells…as described in U.S. Pat. No. 5,997,479 (Savord et al.), U.S. Pat. No. 6,013,032 (Savord), and U.S. Pat. No. 6,623,432 (Powers et al.) - [0063]).
Regarding claim 25, Van Heesch et al disclose wherein the system memory stores probe control software code with beamformer software code, and wherein the processor is configured to execute the beamformer software code to: to track-scan the Doppler flow signal of the targeted organ blood flow of the patient by emitting multiple ultrasound beams from the phased array of transducer elements to track the Doppler flow signal of the targeted organ blood flow of the patient relative to the phased array of transducer elements ([0064];[0066]).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Heesch et al (2021/0085280) in view of Xu et al (2020/0261059).
Regarding claim 7, Van Heesch et al disclose the targeted organ blood flow is a renal blood flow of the patient (blood flow is measured at the heart and at the kidney (renal artery) – [0090];fig.8), but fail to explicitly disclose wherein the at least one characteristic associated with the targeted organ blood flow of the patient from the Doppler flow signal comprises a blood flow index of the targeted organ blood flow of the patient, and the blood flow index comprises a Venous Impedance Index (VII) and/or a Renal Resistive Index (RRI).
However, Xu et al teach in the same medical field of endeavor, wherein an at least one characteristic associated with a targeted organ blood flow of a patient from a Doppler flow signal comprises a blood flow index of the targeted organ blood flow of the patient and the blood flow index comprises a Renal Resistive Index (RRI) (quantitative Doppler parameters such as Resistance Index (RI) – [0035]; monitoring blood flow in the renal artery – [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the Doppler flow signal comprising the targeted organ blood flow is a renal blood flow of the patient of Van Heesch et al with a blood flow index comprising a Renal Resistive Index (RRI) of Xu et al as it would provide quantitative Doppler parameters to monitor kidney function.
Regarding claim 18, Van Heesch et al disclose the targeted organ blood flow is a renal blood flow of the patient (blood flow is measured at the heart and at the kidney (renal artery) – [0090];fig.8), but fail to explicitly disclose wherein the at least one characteristic associated with the targeted organ blood flow of the patient from the Doppler flow signal comprises a blood flow index of the targeted organ blood flow of the patient, and the blood flow index comprises a Venous Impedance Index (VII) and/or a Renal Resistive Index (RRI).
However, Xu et al teach in the same medical field of endeavor, wherein an at least one characteristic associated with a targeted organ blood flow of a patient from a Doppler flow signal comprises a blood flow index of the targeted organ blood flow of the patient and the blood flow index comprises a Renal Resistive Index (RRI) (quantitative Doppler parameters such as Resistance Index (RI) – [0035]; monitoring blood flow in the renal artery – [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the Doppler flow signal comprising the targeted organ blood flow is a renal blood flow of the patient of Van Heesch et al with a blood flow index comprising a Renal Resistive Index (RRI) of Xu et al as it would provide quantitative Doppler parameters to monitor kidney function.
Claim(s) 8, 9 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Heesch et al (2021/0085280) in view of Benni et al (2024/0156358).
Regarding claim 8, Van Heesch et al disclose wherein the at least one characteristic associated with the targeted organ blood flow of the patient from the Doppler flow signal comprises renal blood flow of the patient is the targeted organ blood flow (monitoring blood flow in the renal artery – [0038]), and the method further comprises: estimating by the processor of the blood flow monitor a flow rate of the renal blood flow of the patient from the Doppler flow signal of the renal blood flow; and monitoring by the processor changes in the flow rate of the renal blood flow over time (volumetric flow rate at each location, to monitor changes in a predetermined function of the blood flows – abstract; monitoring blood flow in the renal artery – [0038]), but fail to explicitly disclose an autoregulation profile of the targeted organ blood flow of the patient, obtaining an arterial pressure of the patient with a pressure sensor attached to the patient; monitoring by the processor changes in the arterial pressure over time, evaluating a correlation or non-correlation by the processor between the changes in the arterial pressure and the changes in the flow rate of the renal blood flow; and determining by the processor the autoregulation profile of the renal blood flow of the patient based on the correlation or non-correlation between the changes in the arterial pressure and the changes in the flow rate of the renal blood flow.
However, Benni et al teach in the same medical field of endeavor, an autoregulation profile of a targeted organ blood flow of a patient (producing a recent profile of autoregulation data using the first and second signals from a recent portion of the period of time - abstract), obtaining an arterial pressure of the patient with a pressure sensor attached to the patient (the blood pressure sensing device may be any sensor or device configured to continuously determine a subject’s blood pressure (e.g., arterial blood pressure) – [0061]); monitoring by a processor changes in the arterial pressure over time ([0061]), evaluating a correlation or non-correlation by the processor between the changes in the arterial pressure and changes in the flow rate of the renal blood flow; and determining by the processor the autoregulation profile of the renal blood flow of the patient based on the correlation or non-correlation between the changes in the arterial pressure and the changes in the flow rate of the renal blood flow (autoregulation function data indicative of a correlation (e.g., based on time domain) between at least one NIRS index and blood pressure data to determine autoregulation data for a subject – [0073]; the organization of data into a historical autoregulation profile, a recent autoregulation profile, and a final autoregulation profile…processed using a correlation technique – [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the at least one characteristic associated with the targeted organ blood flow of the patient from the Doppler flow signal comprises renal blood flow of the patient is the targeted organ blood flow of Van Heesch et al with an autoregulation profile based on the correlation of changes in the arterial pressure and the changes in the flow rate and obtaining an arterial pressure of Benni et al as it would provide the user with data indicating maintenance of adequate and stable blood flow to organs.
Regarding claim 9, Van Heesch et al as modified by Benni et al disclose the invention as claimed and discussed above. Benni et al further teaches wherein the pressure sensor is attached to the patient by a radial arterial catheter, femoral arterial catheter, or non-invasively to an extremity of the patient (the BP sensing device may be a device that is configured to provide continuous blood pressure measurement, such as an arterial catheter line, or a continuous non-invasive pressure device – [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Van Heesch et al with a pressure sensor attached to the patient by an arterial catheter or non-invasively as it would provide continuous blood pressure measurements for the user to monitor.
Regarding claim 19, Van Heesch et al disclose the invention substantially as claimed, but fail to explicitly disclose wherein the at least one characteristic associated with the targeted organ blood flow of the patient from the Doppler flow signal comprises an autoregulation profile of the targeted organ blood flow of the patient, and the processor is configured to execute the monitoring software code to: collect a running sum of a duration of inactive autoregulation of the targeted organ blood flow of the patient during the surgery, the medical procedure, or the medical observation.
However, Benni et al teach in the same medical field of endeavor, wherein at least one characteristic associated with a targeted organ blood flow of a patient from a Doppler flow signal comprises an autoregulation profile of the targeted organ blood flow of the patient, and a processor is configured to execute monitoring software code to: collect a running sum of a duration of inactive autoregulation of the targeted organ blood flow of the patient during the surgery, the medical procedure, or the medical observation (producing a recent profile of autoregulation data using the first and second signals from a recent portion of the period of time - abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the at least one characteristic associated with a target organ blood flow of a patient from a Doppler flow signal of Van Heesch et al with an autoregulation profile and a running sum of a duration of inactive autoregulation as it would provide the user with data indicating maintenance of adequate and stable blood flow.
Regarding claim 20, Van Heesch et al disclose the invention substantially as claimed, but fail to explicitly disclose a hemodynamic pressure sensor configured to measure an arterial pressure of the patient; wherein the processor is configured to monitor the arterial pressure of the patient measured by the hemodynamic pressure sensor; and wherein the processor is configured to determine the autoregulation profile of the targeted organ blood flow of the patient based on changes in the targeted organ blood flow determined from the Doppler flow signal over time and based on changes in the arterial pressure of the patient over time measured by the hemodynamic pressure sensor.
However, Benni et al teach in the same medical field of endeavor, a hemodynamic pressure sensor configured to measure an arterial pressure of a patient; wherein a processor is configured to monitor the arterial pressure of the patient measured by the hemodynamic pressure sensor (the blood pressure sensing device may be any sensor or device configured to continuously determine a subject’s blood pressure (e.g., arterial blood pressure) – [0061); and wherein the processor is configured to determine the autoregulation profile of the targeted organ blood flow of the patient based on changes in the targeted organ blood flow determined from the Doppler flow signal over time and based on changes in the arterial pressure of the patient over time measured by the hemodynamic pressure sensor (autoregulation function data indicative of a correlation (e.g., based on time domain) between at least one NIRS index and blood pressure data to determine autoregulation data for a subject – [0073]; the organization of data into a historical autoregulation profile, a recent autoregulation profile, and a final autoregulation profile…processed using a correlation technique – [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the at least one characteristic associated with the targeted organ blood flow of the patient from the Doppler flow signal of Van Heesch et al with an autoregulation profile based on the correlation of changes in the arterial pressure and the changes in the flow rate and obtaining an arterial pressure of Benni et al as it would provide the user with data indicating maintenance of adequate and stable blood flow to organs.
Regarding claim 21, Van Heesch et al as modified by Benni et al disclose the invention as claimed and discussed above. Benni et al further teaches wherein the hemodynamic pressure sensor is: connected to a radial arterial catheter, femoral arterial catheter, or a non-invasive hemodynamic pressure sensor configured for attachment to an extremity of the patient (the BP sensing device may be a device that is configured to provide continuous blood pressure measurement, such as an arterial catheter line, or a continuous non-invasive pressure device – [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Van Heesch et al with a pressure sensor attached to the patient by an arterial catheter or non-invasively as it would provide continuous blood pressure measurements for the user to monitor.
Claim(s) 10-11 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Heesch et al (2021/0085280) in view of Taylor (2019/0008462).
Regarding claims 10 and 11, Van Heesch et al disclose the invention as claimed and discussed above, but fail to explicitly disclose estimating, by the processor of the blood flow monitor, a real-time organ injury risk score of the patient from the at least one characteristic and the baseline value of the at least one characteristic; and outputting in real time to the display a representation of the real-time organ injury risk score of the patient over time, and tracking over time, by the processor, the real-time organ injury risk score of the patient to determine a final organ injury risk score of the patient.
However, Taylor teaches in the same medical field of endeavor, estimating, by a processor of a blood flow monitor, a real-time organ injury risk score of a patient from at least one characteristic and a baseline value of the at least one characteristic; and outputting in real time to a display a representation of the real-time organ injury risk score of the patient over time, and tracking over time, by the processor, the real-time organ injury risk score of the patient to determine a final organ injury risk score of the patient (determining a score quantifying a risk of injury to the patient at the second physiological state, based on the computed blood flow characteristic – claim 31).
It would have been obvious to one of ordinary skill in the are before the effective filing date of the invention to modify the blood flow monitoring of Van Heesch et al with a real-time organ injury risk score of the patient over time as it would provide acceptable risk levels for the patient.
Regarding claims 22 and 23, Van Heesch et al disclose the invention as claimed and discussed above, but fail to explicitly disclose wherein the monitoring software code comprises organ injury monitoring software code, and wherein the processor is configured to execute the organ injury monitoring software code to: estimate a real-time organ injury risk score of the patient from the at least one characteristic; and output in real time to the display a representation of the real-time organ injury risk score of the patient over time, and track over time the real-time organ injury risk score of the patient to determine a final organ injury risk score of the patient.
However, Taylor teaches in the same medical field of endeavor, wherein monitoring software code comprises organ injury monitoring software code, and wherein a processor is configured to execute the organ injury monitoring software code to: estimate a real-time organ injury risk score of the patient from the at least one characteristic; and output in real time to the display a representation of the real-time organ injury risk score of the patient over time, and track over time the real-time organ injury risk score of the patient to determine a final organ injury risk score of the patient.
(determining a score quantifying a risk of injury to the patient at the second physiological state, based on the computed blood flow characteristic – claim 31).
It would have been obvious to one of ordinary skill in the are before the effective filing date of the invention to modify the blood flow monitoring of Van Heesch et al with a real-time organ injury risk score of the patient over time as it would provide acceptable risk levels for the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30.
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797
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