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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-11, & 14-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1-8, 11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wachter (I. Wächter, dissertation, University College London (University of London), Great Britain, 2009) in view of Wilson et al (US20190357778A1; hereinafter referred to as Wilson) and further in view of Huo et al (WO2020098704A1; US20210236000A1 used for the purpose of citation; hereinafter referred to as Huo)
Regarding Claim 1, Wachter discloses a device for obtaining an angiogram of a vessel of the subject (“For the acquisition of rotational angiography, a long contrast agent injection is given. When the whole vessel tree is filled with contrast agent, the acquisition of x-ray images starts and simultaneously the c-arm rotates around the patient. This gives the rotational angiographic sequence. Under certain circumstances this sequence can be used to reconstruct a CT-like volume dataset, the 3DRA dataset” [Pg. 32]), the device comprising:
a processor (“For such a case, the flow map fitting took between 4 and 8 minutes on a PC with an Intel Xeon, 3 GHz processor.“ [0159]) configured to:
obtain the angiogram comprising a plurality of angiogram image frames (“As all information about the vessel is contained in the projection images, for every voxel v, the neighbourhood of the projection points Π(v, G(t)) in the rotational angiography images is analysed for every i-th frame during the interval when the segment is enhanced. For every selected frame, the edge elements near to the projection point are determined and two parallel lines are fitted to the edge elements to get the 2D borders of the vessel.” [Pg. 121]),
wherein the angiogram is representative of the vessel including a contrast agent (“For the acquisition of rotational angiography, a long contrast agent injection is given. When the whole vessel tree is filled with contrast agent, the acquisition of x-ray images starts and simultaneously the c-arm rotates around the patient. This gives the rotational angiographic sequence. Under certain circumstances this sequence can be used to reconstruct a CT-like volume dataset, the 3DRA dataset” [Pg. 32]), thereby providing contrast data within the angiogram:
for each angiogram image frame of the angiogram that includes contrast data (“The proposed model can predict the concentration of iodine after an injection of contrast agent into a pulsatile flow field through a tube or a vessel. This model involves the following components: • model of the shape of the waveform, • model of the contrast agent injection, • model of the mixing of blood and contrast agent at the injection site, • model of the geometry of the vessel tree, • model of the contrast agent propagation through the vessel tree.” [Pg. 71]):
estimate an instantaneous blood flow velocity based on the contrast data (“The waveform model is used to describe the changes in the volumetric blood flow rate during the cardiac cycle. When modelling the waveform, it is assumed that the waveform can be described by a periodic function. This is reasonable for patients without cardiac arrhythmia over the time scale of a typical rotational angiography acquisition. The instantaneous volumetric blood flow rate QB(t) is given by QB(t) = QB · w(t),” [Pg. 72]);
calculate a confidence value of the angiogram image frame based on the contrast data (“The last prerequisite step of the flow quantification is the determination of a reliability map. The reliability map gives the reliability of each entry of the flow map. Due to the rotation of the c-arm, two artefacts can occur in the flow map: artefacts due to foreshortening and artefacts due to overlapping vessels (Chen et al., 2002). In addition to that, subtraction artefacts due to motion between the CA scan and the mask scan can occur. The first two can be detected automatically.. The reliability map R serves the purpose of excluding potentially corrupted values from the error computation.” [Pg. 133]);
and estimate a point within a cardiac cycle (“The following parameters were assumed to be known: the start time of the cardiac cycle, the duration TH of the cardiac cycle, the maximum flow of injection QeI , the diffusion constant D, the resistance factor m, the density of iodine in contrast agent ρI , the duration of acquisition TA, the total number of images M and the distance between the injection site and the first observation point.” [Pg. 135];
estimate a period of the cardiac cycle (“The waveform model is used to describe the changes in the volumetric blood flow rate during the cardiac cycle.” [Pg. 72]);
and generate a velocity curve representing the blood flow velocity within the vessel over the cardiac cycle based on the period of the cardiac cycle, the estimated instantaneous blood flow velocity of each angiogram image frame, the confidence value of each angiogram image frame and the point within the cardiac cycle represented by each angiogram image frame (“Then, for each segment, the so-called reliability map and flow map are extracted. The flow map and its characteristics were described in Section 2.6. Since the observed flow maps were extracted from an image sequence, they will be referred to as extracted flow maps. For flow quantification, a simulated flow map is fitted to the extracted flow map. Therefore, this process is referred to as flow map fitting. The simulated flow map is generated using a model based on the physics of blood flow and contrast agent transport. During the fitting process, the optimal parameters of the model, including the blood flow waveform, and for the contrast agent injection are determined.” [Pg. 129], also section 7.2.3 provides more information of the flow map [Pg. 133]).
Wachter does not specifically teach that the contrast agent has been provided to the vessel in bursts, thereby providing contrast data within the angiogram; and estimate a period of the cycle based on the angiogram.
However, in a similar field of endeavor, teaches Wilson assessing flow at an anatomical region of interest by using pulsed contrast media injections [Abstract].
Wilson also teaches that the contrast agent has been provided to the vessel in bursts, thereby providing contrast data within the angiogram (“the frequency at which the contrast boluses 305, 310, 315 are injected into the vessel 300 can be set at the powered fluid injector such that contrast media is injected for a predetermined duration every predetermined interval of time.” [0041])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter as outlined above with the contrast agent has been provided to the vessel in bursts taught by Wilson, because it can improve the consistency and accuracy of frame counting techniques for estimating flow velocity [0007].
Wilson does not specifically teach estimate a period of the cycle based on the angiogram.
However, in a similar field of endeavor, Huo teaches a method, device and system for acquiring blood vessel evaluation parameters based on an angiographic image [Abstract].
Huo also teaches to estimate a period of the cycle based on the angiogram (“acquiring a start point of the cardiac cycle from an image corresponding to a two-dimensional starting frame and an end point of the cardiac cycle from an image corresponding to a two-dimensional end frame, respectively: and taking a length L of the blood vessel within one cardiac cycle from three-dimensional grid model for the blood vessel by using the start point and the end point:” [0035], “wherein, ΔL represents the length difference for the flow of the contrast agent in the blood vessel between two adjacent frames of images H represents the patient's heart rate with a unit of beats/min, and x represents the number of the frames of the coronary artery angiographic images during the cardiac cycle;” [0037]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter in view of Wilson as outlined above with the contrast agent has been provided to the vessel in bursts taught by Wilson, because it can improve for the diagnosis of the cardioblood vessel diseases [0003].
Regarding Claim 2, Wachter teaches all limitations noted above except a frequency of bursts of the contrast agent that has been provided to the vessel is desynchronized with the respect to the frequency of the cardiac cycle.
However, in a similar field of endeavor, Wilson teaches a frequency of bursts of the contrast agent that has been provided to the vessel is desynchronized with the respect to the frequency of the cardiac cycle (“This method embodiment includes a step of injecting pulsed contrast boluses into the vessel at a known frequency by injecting a first bolus of contrast media into the vessel over a first time, terminating injection of contrast media over a second time that is after the first time, and injecting a second bolus of contrast media into the vessel over a third time that is after the second time.“ [0008]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter as outlined above with a frequency of bursts of the contrast agent that has been provided to the vessel is desynchronized with the respect to the frequency of the cardiac cycle as taught by Wilson, because it can improve the consistency and accuracy of frame counting techniques for estimating flow velocity [0007].
Regarding Claim 3, Wachter teaches all limitations noted above except the bursts are separated by regular intervals.
However, in a similar field of endeavor, Wilson teaches the bursts are separated by regular intervals (“This method embodiment includes a step of injecting pulsed contrast boluses into the vessel at a known frequency by injecting a first bolus of contrast media into the vessel over a first time, terminating injection of contrast media over a second time that is after the first time, and injecting a second bolus of contrast media into the vessel over a third time that is after the second time.“ [0008]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter as outlined above with the bursts are separated by regular intervals as taught by Wilson, because it can improve the consistency and accuracy of frame counting techniques for estimating flow velocity.
Regarding Claim 4, Wachter teaches all limitations noted above except the bursts are separated by irregular intervals.
However, in a similar field of endeavor, Wilson teaches the bursts are separated by irregular intervals (“The duty cycle can be the percentage of the first time compared to the total of the first time and the second time. In some examples, the duty cycle may be between 5% (from the start of one injection to the start of the next injection, contrast media is injected for 5% of the time) and 75%. “ [0042]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter as outlined above with the bursts are separated by irregular intervals as taught by Wilson, because it can improve the consistency and accuracy of frame counting techniques for estimating flow velocity.
Regarding Claim 5, Wachter teaches all limitations noted above except a predetermined average frequency of bursts is less than or equal to 15Hz.
However, in a similar field of endeavor, Wilson teaches the bursts are separated by irregular intervals (“ In some examples, the frequency may be between 5 Hz and 20 Hz.“ [0042]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter as outlined above with a predetermined average frequency of bursts is less than or equal to 15Hz as taught by Wilson, because it can improve the consistency and accuracy of frame counting techniques for estimating flow velocity.
Regarding Claim 6, Wachter teaches all limitations noted above except calculating the confidence value is further based on a noise level of the angiogram image frame or on the estimated instantaneous blood flow velocity (“The last prerequisite step of the flow quantification is the determination of a reliability map. The reliability map gives the reliability of each entry of the flow map. Due to the rotation of the c-arm, two artefacts can occur in the flow map: artefacts due to foreshortening and artefacts due to overlapping vessels (Chen et al., 2002). In addition to that, subtraction artefacts due to motion between the CA scan and the mask scan can occur. The first two can be detected automatically.. The reliability map R serves the purpose of excluding potentially corrupted values from the error computation.” [Pg. 133]).
Regarding Claim 7, Wachter teaches estimating the period of the cardiac cycle is further based on one or more of ECG data and blood pressure measurement (“Then, for each patient, between one and three planar acquisitions were made (flow sequence). This time, amperage and voltage were kept constant. The ECG signal was recorded for each frame of the flow sequence.” [Pg 168]).
Regarding Claim 8, Wachter teaches that the processor is further configured to identify, based on the velocity curve, one or more of: an optimal injection pattern for the contrast agent to be provided to the vessel; and an optimal injection duration for the contrast agent to be provided to the vessel (“During the fitting process, the optimal parameters of the model, including the blood flow waveform, and for the contrast agent injection are determined” [Pg. 129]).
Regarding Claim 11, Wachter teaches that the processor is further configured to: determine a vessel diameter for on each angiogram image frame and determine a blood flow volume based on the vessel diameters and the velocity curve (“To determine volume blood flow from the blood velocity, the knowledge of CSA or the radius is required and to establish an analytic representation of the vessel tree, the knowledge of the centreline is helpful. Thus, for the purpose of flow extraction, this review is focused on the centreline-radius representation.” [Pg. 48]).
Regarding Claim 1, Wachter discloses A method of ascertaining blood flow velocity based on an angiogram obtained from a subject (“For the acquisition of rotational angiography, a long contrast agent injection is given. When the whole vessel tree is filled with contrast agent, the acquisition of x-ray images starts and simultaneously the c-arm rotates around the patient. This gives the rotational angiographic sequence. Under certain circumstances this sequence can be used to reconstruct a CT-like volume dataset, the 3DRA dataset” [Pg. 32]), the method comprising:
obtaining the angiogram comprising a plurality of angiogram image frames (“As all information about the vessel is contained in the projection images, for every voxel v, the neighbourhood of the projection points Π(v, G(t)) in the rotational angiography images is analysed for every i-th frame during the interval when the segment is enhanced. For every selected frame, the edge elements near to the projection point are determined and two parallel lines are fitted to the edge elements to get the 2D borders of the vessel.” [Pg. 121]),
wherein the angiogram is representative of the vessel including a contrast agent (“For the acquisition of rotational angiography, a long contrast agent injection is given. When the whole vessel tree is filled with contrast agent, the acquisition of x-ray images starts and simultaneously the c-arm rotates around the patient. This gives the rotational angiographic sequence. Under certain circumstances this sequence can be used to reconstruct a CT-like volume dataset, the 3DRA dataset” [Pg. 32]), thereby providing contrast data within the angiogram:
for each angiogram image frame of the angiogram that includes contrast data (“The proposed model can predict the concentration of iodine after an injection of contrast agent into a pulsatile flow field through a tube or a vessel. This model involves the following components: • model of the shape of the waveform, • model of the contrast agent injection, • model of the mixing of blood and contrast agent at the injection site, • model of the geometry of the vessel tree, • model of the contrast agent propagation through the vessel tree.” [Pg. 71]):
estimating an instantaneous blood flow velocity based on the contrast data (“The waveform model is used to describe the changes in the volumetric blood flow rate during the cardiac cycle. When modelling the waveform, it is assumed that the waveform can be described by a periodic function. This is reasonable for patients without cardiac arrhythmia over the time scale of a typical rotational angiography acquisition. The instantaneous volumetric blood flow rate QB(t) is given by QB(t) = QB · w(t),” [Pg. 72]);
calculating a confidence value of the angiogram image frame based on the contrast data (“The last prerequisite step of the flow quantification is the determination of a reliability map. The reliability map gives the reliability of each entry of the flow map. Due to the rotation of the c-arm, two artefacts can occur in the flow map: artefacts due to foreshortening and artefacts due to overlapping vessels (Chen et al., 2002). In addition to that, subtraction artefacts due to motion between the CA scan and the mask scan can occur. The first two can be detected automatically.. The reliability map R serves the purpose of excluding potentially corrupted values from the error computation.” [Pg. 133]);
and estimating a point within a cardiac cycle (“The following parameters were assumed to be known: the start time of the cardiac cycle, the duration TH of the cardiac cycle, the maximum flow of injection QeI , the diffusion constant D, the resistance factor m, the density of iodine in contrast agent ρI , the duration of acquisition TA, the total number of images M and the distance between the injection site and the first observation point.” [Pg. 135];
estimating a period of the cardiac cycle (“The waveform model is used to describe the changes in the volumetric blood flow rate during the cardiac cycle.” [Pg. 72]);
and generating a velocity curve representing the blood flow velocity within the vessel over the cardiac cycle based on the period of the cardiac cycle, the estimated instantaneous blood flow velocity of each angiogram image frame, the confidence value of each angiogram image frame and the point within the cardiac cycle represented by each angiogram image frame (“Then, for each segment, the so-called reliability map and flow map are extracted. The flow map and its characteristics were described in Section 2.6. Since the observed flow maps were extracted from an image sequence, they will be referred to as extracted flow maps. For flow quantification, a simulated flow map is fitted to the extracted flow map. Therefore, this process is referred to as flow map fitting. The simulated flow map is generated using a model based on the physics of blood flow and contrast agent transport. During the fitting process, the optimal parameters of the model, including the blood flow waveform, and for the contrast agent injection are determined.” [Pg. 129], also section 7.2.3 provides more information of the flow map [Pg. 133]).
Wachter does not specifically teach that the contrast agent has been provided to the vessel in bursts, thereby providing contrast data within the angiogram; and estimate a period of the cycle based on the angiogram.
However, in a similar field of endeavor, teaches Wilson assessing flow at an anatomical region of interest by using pulsed contrast media injections [Abstract].
Wilson also teaches that the contrast agent has been provided to the vessel in bursts, thereby providing contrast data within the angiogram (“the frequency at which the contrast boluses 305, 310, 315 are injected into the vessel 300 can be set at the powered fluid injector such that contrast media is injected for a predetermined duration every predetermined interval of time.” [0041])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter as outlined above with the contrast agent has been provided to the vessel in bursts taught by Wilson, because it can improve the consistency and accuracy of frame counting techniques for estimating flow velocity [0007].
Wilson does not specifically teach estimate a period of the cycle based on the angiogram.
However, in a similar field of endeavor, Huo teaches a method, device and system for acquiring blood vessel evaluation parameters based on an angiographic image [Abstract].
Huo also teaches to estimate a period of the cycle based on the angiogram (“acquiring a start point of the cardiac cycle from an image corresponding to a two-dimensional starting frame and an end point of the cardiac cycle from an image corresponding to a two-dimensional end frame, respectively: and taking a length L of the blood vessel within one cardiac cycle from three-dimensional grid model for the blood vessel by using the start point and the end point:” [0035], “wherein, ΔL represents the length difference for the flow of the contrast agent in the blood vessel between two adjacent frames of images H represents the patient's heart rate with a unit of beats/min, and x represents the number of the frames of the coronary artery angiographic images during the cardiac cycle;” [0037]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter in view of Wilson as outlined above with the contrast agent has been provided to the vessel in bursts taught by Wilson, because it can improve for the diagnosis of the cardioblood vessel diseases [0003].
Regarding Claim 15, Wachter discloses A non-transitory computer-readable storage medium having stored a computer program comprising instructions which, when executed by a processor (“For the acquisition of rotational angiography, a long contrast agent injection is given. When the whole vessel tree is filled with contrast agent, the acquisition of x-ray images starts and simultaneously the c-arm rotates around the patient. This gives the rotational angiographic sequence. Under certain circumstances this sequence can be used to reconstruct a CT-like volume dataset, the 3DRA dataset” [Pg. 32], “For such a case, the flow map fitting took between 4 and 8 minutes on a PC with an Intel Xeon, 3 GHz processor.“ [0159]) cause the processor to:
obtain the angiogram comprising a plurality of angiogram image frames (“As all information about the vessel is contained in the projection images, for every voxel v, the neighbourhood of the projection points Π(v, G(t)) in the rotational angiography images is analysed for every i-th frame during the interval when the segment is enhanced. For every selected frame, the edge elements near to the projection point are determined and two parallel lines are fitted to the edge elements to get the 2D borders of the vessel.” [Pg. 121]),
wherein the angiogram is representative of the vessel including a contrast agent (“For the acquisition of rotational angiography, a long contrast agent injection is given. When the whole vessel tree is filled with contrast agent, the acquisition of x-ray images starts and simultaneously the c-arm rotates around the patient. This gives the rotational angiographic sequence. Under certain circumstances this sequence can be used to reconstruct a CT-like volume dataset, the 3DRA dataset” [Pg. 32]), thereby providing contrast data within the angiogram:
for each angiogram image frame of the angiogram that includes contrast data (“The proposed model can predict the concentration of iodine after an injection of contrast agent into a pulsatile flow field through a tube or a vessel. This model involves the following components: • model of the shape of the waveform, • model of the contrast agent injection, • model of the mixing of blood and contrast agent at the injection site, • model of the geometry of the vessel tree, • model of the contrast agent propagation through the vessel tree.” [Pg. 71]):
estimate an instantaneous blood flow velocity based on the contrast data (“The waveform model is used to describe the changes in the volumetric blood flow rate during the cardiac cycle. When modelling the waveform, it is assumed that the waveform can be described by a periodic function. This is reasonable for patients without cardiac arrhythmia over the time scale of a typical rotational angiography acquisition. The instantaneous volumetric blood flow rate QB(t) is given by QB(t) = QB · w(t),” [Pg. 72]);
calculate a confidence value of the angiogram image frame based on the contrast data (“The last prerequisite step of the flow quantification is the determination of a reliability map. The reliability map gives the reliability of each entry of the flow map. Due to the rotation of the c-arm, two artefacts can occur in the flow map: artefacts due to foreshortening and artefacts due to overlapping vessels (Chen et al., 2002). In addition to that, subtraction artefacts due to motion between the CA scan and the mask scan can occur. The first two can be detected automatically.. The reliability map R serves the purpose of excluding potentially corrupted values from the error computation.” [Pg. 133]);
and estimate a point within a cardiac cycle (“The following parameters were assumed to be known: the start time of the cardiac cycle, the duration TH of the cardiac cycle, the maximum flow of injection QeI , the diffusion constant D, the resistance factor m, the density of iodine in contrast agent ρI , the duration of acquisition TA, the total number of images M and the distance between the injection site and the first observation point.” [Pg. 135];
estimate a period of the cardiac cycle (“The waveform model is used to describe the changes in the volumetric blood flow rate during the cardiac cycle.” [Pg. 72]);
and generate a velocity curve representing the blood flow velocity within the vessel over the cardiac cycle based on the period of the cardiac cycle, the estimated instantaneous blood flow velocity of each angiogram image frame, the confidence value of each angiogram image frame and the point within the cardiac cycle represented by each angiogram image frame (“Then, for each segment, the so-called reliability map and flow map are extracted. The flow map and its characteristics were described in Section 2.6. Since the observed flow maps were extracted from an image sequence, they will be referred to as extracted flow maps. For flow quantification, a simulated flow map is fitted to the extracted flow map. Therefore, this process is referred to as flow map fitting. The simulated flow map is generated using a model based on the physics of blood flow and contrast agent transport. During the fitting process, the optimal parameters of the model, including the blood flow waveform, and for the contrast agent injection are determined.” [Pg. 129], also section 7.2.3 provides more information of the flow map [Pg. 133]).
Wachter does not specifically teach that the contrast agent has been provided to the vessel in bursts, thereby providing contrast data within the angiogram; and estimate a period of the cycle based on the angiogram.
However, in a similar field of endeavor, teaches Wilson assessing flow at an anatomical region of interest by using pulsed contrast media injections [Abstract].
Wilson also teaches that the contrast agent has been provided to the vessel in bursts, thereby providing contrast data within the angiogram (“the frequency at which the contrast boluses 305, 310, 315 are injected into the vessel 300 can be set at the powered fluid injector such that contrast media is injected for a predetermined duration every predetermined interval of time.” [0041])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter as outlined above with the contrast agent has been provided to the vessel in bursts taught by Wilson, because it can improve the consistency and accuracy of frame counting techniques for estimating flow velocity [0007].
Wilson does not specifically teach estimate a period of the cycle based on the angiogram.
However, in a similar field of endeavor, Huo teaches a method, device and system for acquiring blood vessel evaluation parameters based on an angiographic image [Abstract].
Huo also teaches to estimate a period of the cycle based on the angiogram (“acquiring a start point of the cardiac cycle from an image corresponding to a two-dimensional starting frame and an end point of the cardiac cycle from an image corresponding to a two-dimensional end frame, respectively: and taking a length L of the blood vessel within one cardiac cycle from three-dimensional grid model for the blood vessel by using the start point and the end point:” [0035], “wherein, ΔL represents the length difference for the flow of the contrast agent in the blood vessel between two adjacent frames of images H represents the patient's heart rate with a unit of beats/min, and x represents the number of the frames of the coronary artery angiographic images during the cardiac cycle;” [0037]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter in view of Wilson as outlined above with the contrast agent has been provided to the vessel in bursts taught by Wilson, because it can improve for the diagnosis of the cardioblood vessel diseases [0003].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wachter in view of Wilson and further in view of Huo as applied to Claim 1, and further in view of Denney et al (;hereinafter referred to as Denney).
Regarding Claim 9, Wachter in view of Wilson and further in view of Huo teaches all limitations noted above except that the processor is further configured to: obtain blood pressure measurement data from the vessel; and calculate a vascular impedance based on the pressure measurement data and the velocity curve.
However, in a similar field of endeavor, Denney teaches a method and system for evaluating physiological properties of a segment of blood vessel [Abstract].
Denney also teaches the processor is further configured to: obtain blood pressure measurement data from the vessel; and calculate a vascular impedance based on the pressure measurement data and the velocity curve (“each of the first measurement and the second measurement can be one of blood velocity waveform, blood flow waveform, or blood pressure waveform.” [0019], “Impedance is a specific case of a transfer function when the two functions are voltage and current or pressure and flow measured at the same point in the artery: Impedance(f)=Pressure(f)/Flow(f).” [0141]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter in view of Wilson and further in view of Huo as outlined above with the processor is further configured to: obtain blood pressure measurement data from the vessel; and calculate a vascular impedance based on the pressure measurement data and the velocity curve as taught by Denney, because it can provide physicians with important information for making clinical decisions and managing patients with arterial diseases [0004].
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wachter in view of Wilson and further in view of Huo as applied to Claim 1, and further in view of Schormans et al (US20180330507A1; hereinafter referred to as Schormans).
Regarding Claim 10, Wachter teaches that the processor is further configured to: obtain a second angiogram of a vessel of the subject the second angiogram comprising a plurality of second angiogram image frames, (“As all information about the vessel is contained in the projection images, for every voxel v, the neighbourhood of the projection points Π(v, G(t)) in the rotational angiography images is analysed for every i-th frame during the interval when the segment is enhanced. For every selected frame, the edge elements near to the projection point are determined and two parallel lines are fitted to the edge elements to get the 2D borders of the vessel.” [Pg. 121]),
wherein the second angiogram is representative of the vessel including a contrast agent therein (“For the acquisition of rotational angiography, a long contrast agent injection is given. When the whole vessel tree is filled with contrast agent, the acquisition of x-ray images starts and simultaneously the c-arm rotates around the patient. This gives the rotational angiographic sequence. Under certain circumstances this sequence can be used to reconstruct a CT-like volume dataset, the 3DRA dataset” [Pg. 32]), thereby providing contrast data within the angiogram:
for each second angiogram image frame of the angiogram that includes contrast data (“The proposed model can predict the concentration of iodine after an injection of contrast agent into a pulsatile flow field through a tube or a vessel. This model involves the following components: • model of the shape of the waveform, • model of the contrast agent injection, • model of the mixing of blood and contrast agent at the injection site, • model of the geometry of the vessel tree, • model of the contrast agent propagation through the vessel tree.” [Pg. 71]):
estimate a stimulated instantaneous blood flow velocity based on the second angiogram image frame (“The waveform model is used to describe the changes in the volumetric blood flow rate during the cardiac cycle. When modelling the waveform, it is assumed that the waveform can be described by a periodic function. This is reasonable for patients without cardiac arrhythmia over the time scale of a typical rotational angiography acquisition. The instantaneous volumetric blood flow rate QB(t) is given by QB(t) = QB · w(t),” [Pg. 72]);
calculate a stimulated confidence value of the second angiogram image frame based on the contrast data (“The last prerequisite step of the flow quantification is the determination of a reliability map. The reliability map gives the reliability of each entry of the flow map. Due to the rotation of the c-arm, two artefacts can occur in the flow map: artefacts due to foreshortening and artefacts due to overlapping vessels (Chen et al., 2002). In addition to that, subtraction artefacts due to motion between the CA scan and the mask scan can occur. The first two can be detected automatically.. The reliability map R serves the purpose of excluding potentially corrupted values from the error computation.” [Pg. 133]);
estimate a point within a cardiac cycle (“The following parameters were assumed to be known: the start time of the cardiac cycle, the duration TH of the cardiac cycle, the maximum flow of injection QeI , the diffusion constant D, the resistance factor m, the density of iodine in contrast agent ρI , the duration of acquisition TA, the total number of images M and the distance between the injection site and the first observation point.” [Pg. 135];
estimate a period of the cardiac cycle (“The waveform model is used to describe the changes in the volumetric blood flow rate during the cardiac cycle.” [Pg. 72]);
generate a stimulated velocity curve for the cardiac cycle based on the period of the cardiac cycle, the estimated stimulated instantaneous blood flow velocity of each second angiogram image frame, the stimulated confidence value of each second angiogram image frame and the point within the cardiac cycle represented by each second angiogram image frame (“Then, for each segment, the so-called reliability map and flow map are extracted. The flow map and its characteristics were described in Section 2.6. Since the observed flow maps were extracted from an image sequence, they will be referred to as extracted flow maps. For flow quantification, a simulated flow map is fitted to the extracted flow map. Therefore, this process is referred to as flow map fitting. The simulated flow map is generated using a model based on the physics of blood flow and contrast agent transport. During the fitting process, the optimal parameters of the model, including the blood flow waveform, and for the contrast agent injection are determined.” [Pg. 129], also section 7.2.3 provides more information of the flow map [Pg. 133]).
Wachter does not specifically disclose that the second angiogram having been acquired after a stimulus was provided to the subject, the contrast agent has been provided to the vessel in bursts, compare the velocity curve and the stimulated velocity curve; and calculate a relative index based on the comparison.
However, in a similar field of endeavor, Wilson teaches the second angiogram having been acquired after a stimulus was provided to the subject (“pulsed contrast boluses can be created by alternating injection of contrast media with injection of saline such that alternating packets of contrast and saline are introduced into the vessel 300. For instance, in the injection sequence example described above, saline fluid can be injected into the vessel 300 over the second time when the contrast injection is terminated such that saline fluid is present in the vessel 300 between the first bolus of contrast media 305 and the second bolus of contrast media 310.” [0043]),
the contrast agent has been provided to the vessel in bursts (“the frequency at which the contrast boluses 305, 310, 315 are injected into the vessel 300 can be set at the powered fluid injector such that contrast media is injected for a predetermined duration every predetermined interval of time.” [0041])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter as outlined above with the second angiogram having been acquired after a stimulus was provided to the subject, and the contrast agent has been provided to the vessel in bursts as taught by Wilson, because it can improve the consistency and accuracy of frame counting techniques for estimating flow velocity [0007].
Wilson in view of Huo does not specifically teach to compare the velocity curve and the stimulated velocity curve; and calculate a relative index based on the comparison.
However, in a similar field of endeavor, Schormans teaches methods are provided for quantitative flow analysis of a fluid flowing in a conduit from a sequence of consecutive image frames of such a conduit [0022].
Schormans also teaches to compare the velocity curve and the stimulated velocity curve; and calculate a relative index based on the comparison (“ The method requires a velocity matrix and derived from this a velocity graph to be created (FIG. 7 and FIG. 8). A velocity graph v(x) with an interval time of a single frame per measured point gives a profile not unlike the generic profile vgen(x) as seen in FIG. 10. By fitting v(x) to vgen(x), it is possible to determine which part of the heart cycle corresponds to v(x). Once this is known, it is possible to use (eq. 2) and (eq. 3) to establish the true velocity vmean, and after this the volumetric flow Q using (eq. 4).” [0144], “The average velocity vmean as computed above over a heart cycle can be the starting point of further calculations and estimations, such as for instance coronary flow reserve (CFR) or computational fluid dynamics (CFD) calculations for instance to assess wall shear stress or pressure drop within the conduit.” [0145], As mentioned in Applicants Specification [0107] CFR is considered a relative index).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Wachter in view of Wilson and further in view of Huo as outlined above with compare the velocity curve and the stimulated velocity curve; and calculate a relative index based on the comparison as taught by Schormans, because it allows for a clinician to have a full understanding of Coronary Artery Disease [0005].
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 STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th 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
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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