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 Amendment
Claims 1, 3-7, 9, 11-12, 16-18, and 20 have been amended.
Claims 8 and 19 has been canceled.
Claims 21-22 has been newly added.
Claims 1-7, 9-18, and 20-22 are still pending for consideration.
Objection to the Drawings has been withdraw through Applicant’s amendment to the drawings.
Response to Arguments
The newly applied Gu et al. reference is necessitated by Applicant’s amendment to claim 1, which now requires the first imaging data and the reference data, the supply data to correspond to different temporal points, with the third point in time occurring after the first point in time and the second point in time. The prior rejection did not need to address this temporal relationship because it was not recited in ordinal independent claim 1. Therefore, the new ground of rejection based on Gu et al. is made necessary by the amendment, and final rejection is proper.
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.
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 1-4, 6-7, 9-16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Deuerling-Zheng et al. (US 20100246916 A1) herein after Zheng in view of Gu et al. (US 20190365344 A1)
Regarding claim 1, Zheng teaches a method for providing supply data relating to a supply to a parenchyma (see para [0004]; “The flow of blood through tissue, in other words the perfusion of an organ for example, is a further important functional parameter”, see also para [0018]; “The perfused region of the human or animal body is a region in which tissue, which is supplied with blood and is therefore capillarized, is present. The region preferably contains an organ such as the brain or liver, kidney, lung, prostate, pancreas or heart. It can also be a muscle or another human or animal organ”), the method comprising: receiving first imaging data, the first imaging data corresponding to at least one of the parenchyma or a vascular structure at a first point in time, and the vascular structure that serves corresponding to supply the parenchyma (see para [0013]; “a first method for generating at least one functional data set of a perfused region of the human or animal body is claimed, having the following steps… Supplying a first image data set, comprising at least two images of the perfused region, which were recorded at different times before and after an injection of contrast agent into a first artery supplying the region”, see also para [0018]; “The perfused region … is a region in which tissue, which is supplied with blood and is therefore capillarized, is present” Note perfusion region containing tissue implies parenchyma); receiving reference data corresponding to the supply to the parenchyma at a second point in time (see para [0036]; “normalize the image data set or functional data to the contrast agent concentration. This is preferably done against what is known as the arterial input function (AIF)…. a pixel in the contrasted image, which is on the supplying artery, is selected and used for normalization”, see also para [0042]; “The time intensity curve in this ROI is taken as the AIF”, Note: obtaining AIF from the supplying artery as reference data for perfusion/supply analysis); and providing the supply data (see para [0053]; “Once the functional data sets or an overall functional data set have/has been generated, they are preferably displayed with color coding”, see also para [0059]; “a screen to display the functional data sets”). However, Zhang does not teach calculating supply data based on the first imaging data and the reference data, the supply data corresponding to the supply to the parenchyma at a third point in time, and the third point in time being after the first point in time and the second point in time.
In the same field of endeavor, Gu et al. teaches calculating supply data based on the first imaging data and the reference data, the supply data corresponding to the supply to the parenchyma at a third point in time (see para [0015]; “producing time-intensity curve data representative of arterial flow in the ROI by scaling the time-intensity curve of contrast agent flow in the hepatic artery location to match the time-intensity curve of contrast agent flow in the ROI, and producing time-intensity curve data representative of venous flow in the ROI”, see para [0045]; “the flow into the parenchyma from the two sources of blood, the hepatic artery and the portal vein is then estimated”, Note: To estimate the supply data, the software plots how contrast moves over time (time-intensity curves). It evaluates the pure arterial signal (from the hepatic artery) and the pure venous signal (from the portal vein or surrounding tissue) and scales them against the specific Region of Interest (ROI) in the parenchyma. Once these curves are aligned and analyzed, it yields the exact blood supply estimations), and the third point in time being after the first point in time and the second point in time (see para [0004]; “The inflow of blood from the portal vein occurs later in the heart cycle”, see also para [0007]; “The arrival time of contrast from the portal vein in the ROI can be presumably estimated as being later than the arrival of the contrast in the ROI by a predetermined time interval”, and [0008]; “the time-intensity curve of contrast agent flow in the hepatic artery can be further scaled in time. For example, the scaling in time can be implemented as a time shift”).
Regarding claim 2, the rejection of claim 1 is incorporated herein.
Zheng in the combination further teach wherein the vascular structure is ring-shaped (see para [0024]; “a flow of blood through the opposite hemisphere by way of the Circulus Willisi (cerebral arterial circle)”, Note: (cerebral arterial circle implies ring-shaped).
Regarding claim 3, the rejection of claim 1 is incorporated herein.
Zheng in the combination further teach wherein the reference data includes second imaging data corresponding to at least one of the vascular structure or the parenchyma at the second point in time (see para [0014]; “Supplying a first image data set, comprising at least two images of the perfused region, which were recorded at different times before and after an injection of contrast agent into a first artery supplying the region; [0015] Supplying a second image data set, comprising at least two images of the perfused region, which were recorded at different times before and after an injection of contrast agent into a second artery supplying the region”, see also para [0038]; “the first and second image data sets each comprise a series from consecutively recorded 2D images”).
Regarding claim 4, the rejection of claim 3 is incorporated herein.
Zheng in the combination further teach wherein at least one of flow dynamics of the vascular structure at the first point in time differ from the flow dynamics of the vascular structure at the second point in time, or perfusion dynamics of the parenchyma at the first point in time differ from the perfusion dynamics of the parenchyma at the second point in time (see para [0004]; “The flow of blood through tissue, in other words the perfusion of an organ”, see also para [0039]; “The recording of a series has the advantage that further perfusion parameters can be calculated from the dynamic of the arrival and departure of the contrast agent, e.g. the blood flow and also the time up to the arrival of the contrast agent and the time up to maximum fill”, Note: different arrival and departure of the contrast agent implies flow/perfusion dynamics differ between time points).
Regarding claim 6, the rejection of claim 5 is incorporated herein.
Zheng in the combination further teach further comprising: receiving first blood pressure data and second blood pressure data, the first blood pressure data relating to the blood pressure at the first point in time, and the second blood pressure data relating to the blood pressure at the second point in time, and comparing the first blood pressure data with the second blood pressure data (see para [0027]; “A functional data set therefore refers to a 2D or 3D data set, which contains spatially resolved data, which corresponds to at least one perfusion parameter, for example the blood volume (BV), blood flow (BF), time to arrival of the contrast agent (arrival time), time to maximum contrast/fill (time to peak), mean-transit time (MTT) of the contrast agent over time or a parameter proportional to one of these values or composed from these values. The functional data set can also contain data relating to a number of these perfusion parameters, e.g. one value proportional to the blood volume (BV) and one value proportional to the blood flow (BF) for each pixel/voxel”, see also para [0036]; “In order to be able to compare the first and second image data sets or the first and second functional data sets obtained therefrom”).
Regarding claim 7, the rejection of claim 5 is incorporated herein.
Zheng in the combination further teach further comprising: calculating a first vessel diameter of the vascular structure at the first point in time, based on the first imaging data, calculating a second vessel diameter of the vascular structure at the second point in time, based on the second imaging data, and comparing the first vessel diameter with the second vessel diameter (see para [0016]; “Generating a first functional data set by pixel-based calculation of at least one perfusion parameter from the first image data set”, see also para [0042]; “A region of interest (ROI) for example is selected by the user, which is preferably in the region of the supplying artery, into which the contrast agent is also injected”, and para [0054]; “In order to be able to compare the first and second image data sets or the first and second functional data sets obtained therefrom… In order to determine the AIF as locally as possible, in other words in the vessels supplying the perfused region, a pixel in the contrasted image, which is on the supplying artery, is selected and used for normalization”).
Regarding claim 9, the rejection of claim 3 is incorporated herein.
Zheng in the combination further teach wherein at least one of the first imaging data is based on a first contrast medium imaging of the vascular structure and on a first contrast medium imaging of the parenchyma, or the second imaging data is based on a second contrast medium imaging of the vascular structure and on a second contrast medium imaging of the parenchyma (see para [0014]; “Supplying a first image data set, comprising at least two images of the perfused region, which were recorded at different times before and after an injection of contrast agent into a first artery supplying the region; [0015] Supplying a second image data set, comprising at least two images of the perfused region, which were recorded at different times before and after an injection of contrast agent into a second artery supplying the region”, see also para [009]; “The invention is based on the knowledge that perfusion measurement after a selective contrast agent injection into two different arteries”).
Regarding claim 10, the rejection of claim 1 is incorporated herein.
Zheng in the combination further teach wherein the supply to the parenchyma includes at least one of a blood supply to the parenchyma or an oxygen supply to the parenchyma (see para [0027]; “perfusion parameter, for example the blood volume (BV), blood flow (BF)”, see also para [0004]; “The flow of blood through tissue, in other words the perfusion of an organ”).
Regarding claim 11, the rejection of claim 1 is incorporated herein.
Zheng in the combination further teach further comprising: calculating, a simulation based on the first imaging data and the reference data, the simulation being of at least one of flow dynamics of the vascular structure or perfusion dynamics of the parenchyma, wherein the calculating the supply data calculates the supply data based on the simulation (see para [0016]; “Generating a first functional data set by pixel-based calculation of at least one perfusion parameter from the first image data set”, see also para [0039]; “perfusion parameters can be calculated from the dynamic of the arrival and departure of the contrast agent, e.g. the blood flow and also the time up to the arrival of the contrast agent and the time up to maximum fill. These parameters provide important information about the state of the supplying arteries”, and para [0094]; “Analysis of the overall data set (calculation of the blood volume, blood flow, MTT, time of arrival, time to peak or other functional parameters)”, Note: pixel based, time-dependent perfusion calculations constitute computational simulation of flow/perfusion dynamics, and supply data is calculated based on that simulation).
Regarding claim 12, the rejection of claim 1 is incorporated herein.
Zheng in the combination further teach a data processing system for providing supply data corresponding to a supply to a parenchyma (see para [0004]; “The flow of blood through tissue, in other words the perfusion of an organ for example, is a further important functional parameter”, see also para [0018]; “The perfused region of the human or animal body is a region in which tissue, which is supplied with blood and is therefore capillarized, is present. The region preferably contains an organ such as the brain or liver, kidney, lung, prostate, pancreas or heart. It can also be a muscle or another human or animal organ”), the data processing system comprising: a data interface and a processor, the data processing system being configured to perform the method (see para [0075]; “image processing computer 20 are a screen 26 for displaying the projection images and functional data sets and a mouse 28 for selecting points, lines, regions, etc. on the projection images. Alternatively the means 28 can also be another cursor moving means such as a trackball or touchscreen”).
Regarding claim 13, the rejection of claim 12 is incorporated herein.
Zheng in the combination further teach medical imaging system comprising: the data processing system; and a medical imaging device configured to record the first imaging data (see para [0020]; “The method is preferably carried out using images from the first and second image data sets, which were generated using an angiography device, in particular a C-arm x-ray device”, see also para [0022]; “Such angiography devices have the advantage that the first and second image data sets can be recorded during the same session or intervention”).
Regarding claim 14, the rejection of claim 1 is incorporated herein.
Zheng in the combination further teach a non-transitory computer program product including instructions which, when executed by a computer, cause the computer to carry out the method (see para [0002]; “The invention also relates to a computer program product, which implements the inventive method”).
Regarding claim 15, the rejection of claim 1 is incorporated herein.
Zheng in the combination further teach a non-transitory computer-readable storage medium storing instructions which, when executed by a computer, cause the computer to carry out the method (see para [0074]; “These projection images are transferred to the data storage unit 22 of a control and image processing computer 20. The computer 20 also contains a computation module 24”).
Regarding claim 16, the rejection of claim 2 is incorporated herein.
Zheng in the combination further teach wherein the reference data includes second imaging data corresponding to at least one of the vascular structure or the parenchyma at the second point in time (see para [0015] Supplying a second image data set, comprising at least two images of the perfused region, which were recorded at different times before and after an injection of contrast agent into a second artery supplying the region”, see also para [0038]; “the first and second image data sets each comprise a series from consecutively recorded 2D images”).
Regarding claim 18, the rejection of claim 6 is incorporated herein.
Zheng further teach further comprising; calculating a first vessel diameter of the vascular structure at the first point in time, based on the first imaging data, calculating a second vessel diameter of the vascular structure at the second point in time, based on the second imaging data, and comparing the first vessel diameter with the second vessel diameter (see para [0016]; “Generating a first functional data set by pixel-based calculation of at least one perfusion parameter from the first image data set”, see also para [0042]; “A region of interest (ROI) for example is selected by the user, which is preferably in the region of the supplying artery, into which the contrast agent is also injected”, and para [0054]; “In order to be able to compare the first and second image data sets or the first and second functional data sets obtained therefrom… In order to determine the AIF as locally as possible, in other words in the vessels supplying the perfused region, a pixel in the contrasted image, which is on the supplying artery, is selected and used for normalization”).
Regarding claim 20, the rejection of claim 4 is incorporated herein.
Zheng in the combination further teach wherein at least one of the first imaging data is based on a first contrast medium imaging of the vascular structure and on a first contrast medium imaging of the parenchyma, or the second imaging data is based on a second contrast medium imaging of the vascular structure and on a second contrast medium imaging of the parenchyma (see para [0014]; “Supplying a first image data set, comprising at least two images of the perfused region, which were recorded at different times before and after an injection of contrast agent into a first artery supplying the region; [0015] Supplying a second image data set, comprising at least two images of the perfused region, which were recorded at different times before and after an injection of contrast agent into a second artery supplying the region”, see also para [009]; “The invention is based on the knowledge that perfusion measurement after a selective contrast agent injection into two different arteries”).
Claims 5, 7, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Deuerling- Zheng in view of Gu et al. as applied in claims 1, 3 and 4 above and further in view of Taylor (US 20180368916 A1)
Regarding claim 5, the rejection of claim 3 is incorporated herein. The combination of Zheng and Gu et al as a whole does not teach wherein at least one of: a blood pressure of the vascular structure at the first point in time differs from a blood pressure of the vascular structure at the second point in time with respect to at least one of a blood pressure or a vessel diameter of the vascular structure at the first point in time differs from a vessel diameter of the vascular structure at the second point in time.
In the same field of endeavor, Taylor teach wherein at least one of: a blood pressure of the vascular structure at the first point in time differs from a blood pressure of the vascular structure at the second point in time with respect to at least one of a blood pressure or a vessel diameter of the vascular structure at the first point in time differs from a vessel diameter of the vascular structure at the second point in time (see para [0025]; “determine information regarding a change in a blood flow characteristic over time within the anatomical structure of the patient based on the three-dimensional model and a physics-based model relating to the anatomical structure of the patient”, see also para [0209]; “FIG. 21 is a graph of the pressure (e.g., in millimeters of mercury or mmHg) over time in the aorta and at points LAD1, LAD2, and LAD3…. The top plot on the graph indicates the pressure in the aorta, the second plot from the top indicates the pressure at point LAD1, the third plot from the top indicates the pressure at point LAD2, and the bottom plot indicates the pressure at point LAD3”, and para [0395]; “the effect of changes in blood flow, heart rate, blood pressure, … modeled through changes in the boundary conditions and used to calculate the cumulative effects of these variables over time”).
Regarding claim 17, the rejection of claim 4 is incorporated herein.
Taylor in the combination further teach wherein at least one of: a blood pressure of the vascular structure at the first point in time differs from a blood pressure of the vascular structure at the second point in time or a vessel diameter of the vascular structure at the first point in time differs from a vessel diameter of the vascular structure at the second point in time (see para [0025]; “determine information regarding a change in a blood flow characteristic over time within the anatomical structure of the patient based on the three-dimensional model and a physics-based model relating to the anatomical structure of the patient”, see also para [0209]; “FIG. 21 is a graph of the pressure (e.g., in millimeters of mercury or mmHg) over time in the aorta and at points LAD1, LAD2, and LAD3…. The top plot on the graph indicates the pressure in the aorta, the second plot from the top indicates the pressure at point LAD1, the third plot from the top indicates the pressure at point LAD2, and the bottom plot indicates the pressure at point LAD3”, and para [0395]; “the effect of changes in blood flow, heart rate, blood pressure, … modeled through changes in the boundary conditions and used to calculate the cumulative effects of these variables over time”).
Regarding claim 21, the rejection of claim 4 is incorporated herein.
Taylor in the combination further teach wherein at least one of: a difference between the flow dynamics of the vascular structure at the first point in time and the flow dynamics of the vascular structure at the second point in time is based on a medication; or a difference between the perfusion dynamics of the parenchyma at the first point in time and the perfusion dynamics of the parenchyma at the second point in time is based on the medication (see para [0017]; “determine first information regarding a blood flow characteristic …. based on a physiological condition of the patient, modify the physiological condition of the patient, and determine second information regarding the blood flow characteristic …. based on the modified physiological condition”, see also para [0241]; “physiologic parameters that may alter the boundary conditions determined above, e.g., a change in a cardiac output, a heart rate, a stroke volume, a blood pressure, an exercise or exertion level, a hyperemia level, medications, etc”, and para [0227]; “physiologic (physics-based) model may be used to determine the effect of different medications that alters heart rate, stroke volume, blood pressure, or coronary microcirculatory function on coronary artery blood flow”).
Regarding claim 22, the rejection of claim 5 is incorporated herein.
Taylor in the combination further teach wherein at least one of: a difference between the blood pressure of the vascular structure at the first point in time and the blood pressure of the vascular structure at the second point in time is based on a medication; or a difference between the vessel diameter of the vascular structure at the first point in time and the vessel diameter of the vascular structure at the second point in time is based on the medication (see para [0017]; “determine first information regarding a blood flow characteristic …. based on a physiological condition of the patient, modify the physiological condition of the patient, and determine second information regarding the blood flow characteristic …. based on the modified physiological condition”, see also para [0241]; “physiologic parameters that may alter the boundary conditions determined above, e.g., a change in a cardiac output, a heart rate, a stroke volume, a blood pressure, an exercise or exertion level, a hyperemia level, medications, etc”, and para [0227]; “physiologic (physics-based) model may be used to determine the effect of different medications that alters heart rate, stroke volume, blood pressure, or coronary microcirculatory function on coronary artery blood flow”).
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.
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/WINTA GEBRESLASSIE/ Examiner, Art Unit 2677
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